User login
Formula Type May Fuel NEC in Premature Infants
DENVER – , according to new data presented at the American Academy of Pediatrics (AAP) 2025 National Conference & Exhibition.
Necrotizing enterocolitis (NEC) can affect the intestinal wall of neonates, with potentially life-threatening results. The inflammatory condition is characterized by feeding intolerance, rectal bleeding, and bowel perforations, said presenting author Puja Kulkarni, medical student at California Northstate University College of Medicine, Elk Grove, California, and colleagues.
The etiology of NEC remains unclear, but previous research suggests that formula feeding may play a role, the researchers said. “NEC remains a leading cause of morbidity and mortality in premature infants, yet there is still no clear consensus on the optimal feeding strategy to reduce risk,” Kulkarni said in an interview with GI & Hepatology News.
Most hospital guidelines call for solely using SPFs in NICUs, especially in cases where maternal breast milk is not available, said Kulkarni. Therefore, “it was critical to investigate whether different types of formula, such as extensively hydrolyzed formula, could influence the incidence of NEC,” she said.
Kulkarni and colleagues conducted a literature search and identified three randomized, controlled trials that compared eHFs to SPFs in a study population of 1180 premature infants.
Overall, infants who received SPFs had a significantly greater risk for both NEC and feeding intolerance than those who received eHFs, with odds ratios of 2.54 and 2.87, respectively, and these associations remained after a sensitivity analysis.
Other research, such as the German Infant Nutritional Intervention (GINI) study, has shown similar results regarding the effect of formula type on childhood pathologies, Kulkarni noted. The GINI study showed that HFs can help prevent the development of allergic diseases in children with a family history of allergies, she said.
The results of the current analysis suggest a significantly increased risk for NEC, as well as feeding intolerance, which can be a precursor to NEC, in premature infants fed SPFs compared to those fed eHFs, said Kulkarni. “If validated by further research, this could lead to changes in NICU feeding protocols, especially in situations where donor breast milk is not available. Clinicians may want to consider the type of protein in formula as an important factor in NEC prevention,” she said. The current findings support the need for more research into the effects of formula throughout the infant and childhood years.
Additional studies are needed to validate the findings in larger, multicenter cohorts to ensure generalizability, especially in the US, where current guidelines favor SPFs based on limited data, said Kulkarni. Much of the research in the US has been conducted by the formula companies themselves, and she and her colleagues took this risk for bias into account in their meta-analysis.
Younger Babies at Greater Risk
Documented rates of NEC have remained stable or decreased slightly over the past 20 years, which supports the need for research on prevention and early identification, as well as effective medical treatment, said Catherine Haut, DNP, CPNP-AC/PC, in an interview.
“With improved neonatal intensive care, younger neonates are surviving, but these babies also have a higher risk of development of NEC,” said Haut, director of nursing research and evidence-based practice at Nemours Children’s Health, Delaware, New Jersey, who was not involved in the study.
“Historically, NEC has been related to feeding, among other variables, but the use of more specific or standardized feeding methods including increased use of human milk in very low-birth weight infants has resulted in better outcomes,” she said.
The finding from the current meta-analysis that the use of SPFs poses a higher risk for NEC than the use of eHFs was not unexpected, Haut told GI & Hepatology News. Some infants are allergic to cow’s milk, and replacing this type of formula with eHF is the recommended treatment as these formulas incorporate proteins which are more easily digested, she said.
Systematic reviews and meta-analyses are considered high levels of evidence, and the current study’s documentation of the benefits of eHF could help decrease the rate of NEC in premature infants, Haut said. “Despite a higher cost associated with eHF, in formula-fed preterm neonates, there would be benefit to using eHF vs risk of standard protein formulas,” she said.
However, the current study represents a very small population compared to the total number of infants born at less than 37 weeks’ gestation, which is reported to be 10% of all newborns in the US each year, Haut noted.
Additional large studies, including randomized control trials, are needed to further document the effects of using eHF in very young premature infants and potentially help reduce the incidence of NEC in this population, she said.
The study received no outside funding. The researchers and Haut had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
DENVER – , according to new data presented at the American Academy of Pediatrics (AAP) 2025 National Conference & Exhibition.
Necrotizing enterocolitis (NEC) can affect the intestinal wall of neonates, with potentially life-threatening results. The inflammatory condition is characterized by feeding intolerance, rectal bleeding, and bowel perforations, said presenting author Puja Kulkarni, medical student at California Northstate University College of Medicine, Elk Grove, California, and colleagues.
The etiology of NEC remains unclear, but previous research suggests that formula feeding may play a role, the researchers said. “NEC remains a leading cause of morbidity and mortality in premature infants, yet there is still no clear consensus on the optimal feeding strategy to reduce risk,” Kulkarni said in an interview with GI & Hepatology News.
Most hospital guidelines call for solely using SPFs in NICUs, especially in cases where maternal breast milk is not available, said Kulkarni. Therefore, “it was critical to investigate whether different types of formula, such as extensively hydrolyzed formula, could influence the incidence of NEC,” she said.
Kulkarni and colleagues conducted a literature search and identified three randomized, controlled trials that compared eHFs to SPFs in a study population of 1180 premature infants.
Overall, infants who received SPFs had a significantly greater risk for both NEC and feeding intolerance than those who received eHFs, with odds ratios of 2.54 and 2.87, respectively, and these associations remained after a sensitivity analysis.
Other research, such as the German Infant Nutritional Intervention (GINI) study, has shown similar results regarding the effect of formula type on childhood pathologies, Kulkarni noted. The GINI study showed that HFs can help prevent the development of allergic diseases in children with a family history of allergies, she said.
The results of the current analysis suggest a significantly increased risk for NEC, as well as feeding intolerance, which can be a precursor to NEC, in premature infants fed SPFs compared to those fed eHFs, said Kulkarni. “If validated by further research, this could lead to changes in NICU feeding protocols, especially in situations where donor breast milk is not available. Clinicians may want to consider the type of protein in formula as an important factor in NEC prevention,” she said. The current findings support the need for more research into the effects of formula throughout the infant and childhood years.
Additional studies are needed to validate the findings in larger, multicenter cohorts to ensure generalizability, especially in the US, where current guidelines favor SPFs based on limited data, said Kulkarni. Much of the research in the US has been conducted by the formula companies themselves, and she and her colleagues took this risk for bias into account in their meta-analysis.
Younger Babies at Greater Risk
Documented rates of NEC have remained stable or decreased slightly over the past 20 years, which supports the need for research on prevention and early identification, as well as effective medical treatment, said Catherine Haut, DNP, CPNP-AC/PC, in an interview.
“With improved neonatal intensive care, younger neonates are surviving, but these babies also have a higher risk of development of NEC,” said Haut, director of nursing research and evidence-based practice at Nemours Children’s Health, Delaware, New Jersey, who was not involved in the study.
“Historically, NEC has been related to feeding, among other variables, but the use of more specific or standardized feeding methods including increased use of human milk in very low-birth weight infants has resulted in better outcomes,” she said.
The finding from the current meta-analysis that the use of SPFs poses a higher risk for NEC than the use of eHFs was not unexpected, Haut told GI & Hepatology News. Some infants are allergic to cow’s milk, and replacing this type of formula with eHF is the recommended treatment as these formulas incorporate proteins which are more easily digested, she said.
Systematic reviews and meta-analyses are considered high levels of evidence, and the current study’s documentation of the benefits of eHF could help decrease the rate of NEC in premature infants, Haut said. “Despite a higher cost associated with eHF, in formula-fed preterm neonates, there would be benefit to using eHF vs risk of standard protein formulas,” she said.
However, the current study represents a very small population compared to the total number of infants born at less than 37 weeks’ gestation, which is reported to be 10% of all newborns in the US each year, Haut noted.
Additional large studies, including randomized control trials, are needed to further document the effects of using eHF in very young premature infants and potentially help reduce the incidence of NEC in this population, she said.
The study received no outside funding. The researchers and Haut had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
DENVER – , according to new data presented at the American Academy of Pediatrics (AAP) 2025 National Conference & Exhibition.
Necrotizing enterocolitis (NEC) can affect the intestinal wall of neonates, with potentially life-threatening results. The inflammatory condition is characterized by feeding intolerance, rectal bleeding, and bowel perforations, said presenting author Puja Kulkarni, medical student at California Northstate University College of Medicine, Elk Grove, California, and colleagues.
The etiology of NEC remains unclear, but previous research suggests that formula feeding may play a role, the researchers said. “NEC remains a leading cause of morbidity and mortality in premature infants, yet there is still no clear consensus on the optimal feeding strategy to reduce risk,” Kulkarni said in an interview with GI & Hepatology News.
Most hospital guidelines call for solely using SPFs in NICUs, especially in cases where maternal breast milk is not available, said Kulkarni. Therefore, “it was critical to investigate whether different types of formula, such as extensively hydrolyzed formula, could influence the incidence of NEC,” she said.
Kulkarni and colleagues conducted a literature search and identified three randomized, controlled trials that compared eHFs to SPFs in a study population of 1180 premature infants.
Overall, infants who received SPFs had a significantly greater risk for both NEC and feeding intolerance than those who received eHFs, with odds ratios of 2.54 and 2.87, respectively, and these associations remained after a sensitivity analysis.
Other research, such as the German Infant Nutritional Intervention (GINI) study, has shown similar results regarding the effect of formula type on childhood pathologies, Kulkarni noted. The GINI study showed that HFs can help prevent the development of allergic diseases in children with a family history of allergies, she said.
The results of the current analysis suggest a significantly increased risk for NEC, as well as feeding intolerance, which can be a precursor to NEC, in premature infants fed SPFs compared to those fed eHFs, said Kulkarni. “If validated by further research, this could lead to changes in NICU feeding protocols, especially in situations where donor breast milk is not available. Clinicians may want to consider the type of protein in formula as an important factor in NEC prevention,” she said. The current findings support the need for more research into the effects of formula throughout the infant and childhood years.
Additional studies are needed to validate the findings in larger, multicenter cohorts to ensure generalizability, especially in the US, where current guidelines favor SPFs based on limited data, said Kulkarni. Much of the research in the US has been conducted by the formula companies themselves, and she and her colleagues took this risk for bias into account in their meta-analysis.
Younger Babies at Greater Risk
Documented rates of NEC have remained stable or decreased slightly over the past 20 years, which supports the need for research on prevention and early identification, as well as effective medical treatment, said Catherine Haut, DNP, CPNP-AC/PC, in an interview.
“With improved neonatal intensive care, younger neonates are surviving, but these babies also have a higher risk of development of NEC,” said Haut, director of nursing research and evidence-based practice at Nemours Children’s Health, Delaware, New Jersey, who was not involved in the study.
“Historically, NEC has been related to feeding, among other variables, but the use of more specific or standardized feeding methods including increased use of human milk in very low-birth weight infants has resulted in better outcomes,” she said.
The finding from the current meta-analysis that the use of SPFs poses a higher risk for NEC than the use of eHFs was not unexpected, Haut told GI & Hepatology News. Some infants are allergic to cow’s milk, and replacing this type of formula with eHF is the recommended treatment as these formulas incorporate proteins which are more easily digested, she said.
Systematic reviews and meta-analyses are considered high levels of evidence, and the current study’s documentation of the benefits of eHF could help decrease the rate of NEC in premature infants, Haut said. “Despite a higher cost associated with eHF, in formula-fed preterm neonates, there would be benefit to using eHF vs risk of standard protein formulas,” she said.
However, the current study represents a very small population compared to the total number of infants born at less than 37 weeks’ gestation, which is reported to be 10% of all newborns in the US each year, Haut noted.
Additional large studies, including randomized control trials, are needed to further document the effects of using eHF in very young premature infants and potentially help reduce the incidence of NEC in this population, she said.
The study received no outside funding. The researchers and Haut had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
Prevention and Risk-Based Surveillance Key to Curbing HCC
BERLIN — according to a joint statement from United European Gastroenterology (UEG) and the German Society for Gastroenterology, Digestive and Metabolic Diseases (DGVS).
The statement calls on EU and national policymakers to embed a twofold approach into healthcare systems that combines surveillance and prevention, rather than relying on voluntary participation. It also encourages stronger prevention measures, such as improved food labeling and restrictions on marketing unhealthy foods to children. The statement — which was also endorsed by the European Association for the Study of the Liver (EASL) — was presented at UEG Week 2025 .
“Curing HCC in early stages rather than treating the disease in a palliative setting should be the goal for all liver doctors and carers, and this is certainly the goal for patients,” said Thomas Seufferlein, MD, professor of gastroenterology at Ulm University, Germany, and one of the members of the DGVS who initiated the statement.
“We have to take HCC screening seriously which means setting up a structured, nationwide, well-documented, and evaluated program for HCC screening in Germany,” he said in an interview.
HCC is mainly curable in the early stages by local ablation, resection, or liver transplantation, “so early diagnosis is of the utmost importance for improving survival,” added Patrick Michl, MD, gastroenterologist, University of Heidelberg, Germany, DGVS member and co-initiator of the statement.
Risk-Stratified HCC Surveillance
In the face of rising rates worldwide, the UEG/DGVS call on policymakers to recognize liver cancer as a preventable and growing public health priority and to implement structured surveillance programs guided by risk thresholds. In particular, they support the recent policy statement from EASL recommending risk-based screening.
EASL’s key recommendations include:
- Targeted surveillance for individuals with an annual HCC risk exceeding 1.5%, where it is both clinically beneficial and cost-effective
- Risk scoring tools such as the age-male-albumin-bilirubin-platelets score that incorporates age, sex, platelet count, albumin, and bilirubin, to stratify patients by HCC risk, including those without established cirrhosis
- Enhanced surveillance for very high-risk groups, where MRI-based surveillance may be warranted despite higher costs, given its superior sensitivity for early-stage disease
- A de-escalation in low-risk individuals
- Patients with an annual HCC risk < 0.5% may be safely spared surveillance, avoiding unnecessary interventions
Evidence from France, Italy, and the UK showed that structured surveillance in high-risk groups is both clinically beneficial and cost-effective. National models in France have demonstrated higher curative treatment rates and fewer costly late-stage cases with structured surveillance. In the UK, health technology assessments indicate targeted surveillance is an efficient use of National Health Services resources, particularly when uptake is optimized. Italian models show that earlier diagnosis in well-defined high-risk groups can offset downstream treatment costs.
Seufferlein noted that Germany needs a “structured program to be implemented and there is currently little public awareness regarding this surveillance strategy.” However, he added there is a structured hepatitis B vaccination program in Germany, which has been successful. “Studies show that the inclusion of hep B vaccination in infancy and childhood has led to good uptake among young age groups.”
Germany, however, has yet to conduct national studies. “Prospective data on HCC surveillance benefits in Germany are lacking,” said Michl, “but multi-country models incorporating Germany’s cost structures suggest similar benefits would accrue if there were greater adherence to guideline-based recommendations and if publicly funded screening programs were implemented.”
Current recommendations in Germany for surveillance are based on evidence-based guidelines of the DGVS with stronger (‘should’) or weaker (‘may’) evidence-based recommendations. For example, patients with chronic hepatitis B virus infection should be offered regular surveillance once their platelet age gender–hepatitis B risk score is ≥ 10. In patients with advanced fibrosis because of chronic hepatitis C virus infection, regular surveillance should also be offered.
Barriers to Screening Uptake
HCC remains one of the most lethal cancers in Europe, largely because it is often diagnosed too late. Underdiagnosis of chronic liver disease, limited access to imaging, and reimbursement gaps prevent timely intervention.
Maria Buti, MD, consultant hepatologist, Hospital Vall d’Hebron, Barcelona, Spain, who was not involved in drafting the statement, remarked that “Patients with liver cirrhosis, or with advanced fibrosis, and also some high-risk noncirrhotic patients such as those with hepatitis B, clearly benefit from surveillance. Surveillance can change life expectancy and also reduce morbidity.”
However, structural barriers continue to impede uptake. “It is not always easy to identify patients with liver cirrhosis because the majority are completely asymptomatic in the early stages,” she said.
Even when risk factors are identified, adherence to 6-monthly surveillance remains patchy. “Sometimes physicians forget to request ultrasounds, or patients don’t understand the importance of it because they feel well,” Buti told GI & Hepatology News.
Expanded Training and Public Health Measures
The joint statement also advocates for expanded physician training in nutrition and hepatology, equitable access to diagnostic tools including MRI, and EU-wide nutrition labeling systems such as Nutri-Score.
The authors also called for strengthened public health measures to tackle obesity, alcohol misuse, and hepatitis transmission, and fiscal and regulatory measures such as taxation of obesogenic foods, and reducing the cost burden of healthier foods.
“If we decrease the percentage of people with liver cirrhosis through prevention, fewer people will need surveillance,” Buti stated.
Seufferlein, Michl, and Buti all declared no relevant disclosures. All three experts are members of the UEG Public Affairs Group.
A version of this article appeared on Medscape.com.
BERLIN — according to a joint statement from United European Gastroenterology (UEG) and the German Society for Gastroenterology, Digestive and Metabolic Diseases (DGVS).
The statement calls on EU and national policymakers to embed a twofold approach into healthcare systems that combines surveillance and prevention, rather than relying on voluntary participation. It also encourages stronger prevention measures, such as improved food labeling and restrictions on marketing unhealthy foods to children. The statement — which was also endorsed by the European Association for the Study of the Liver (EASL) — was presented at UEG Week 2025 .
“Curing HCC in early stages rather than treating the disease in a palliative setting should be the goal for all liver doctors and carers, and this is certainly the goal for patients,” said Thomas Seufferlein, MD, professor of gastroenterology at Ulm University, Germany, and one of the members of the DGVS who initiated the statement.
“We have to take HCC screening seriously which means setting up a structured, nationwide, well-documented, and evaluated program for HCC screening in Germany,” he said in an interview.
HCC is mainly curable in the early stages by local ablation, resection, or liver transplantation, “so early diagnosis is of the utmost importance for improving survival,” added Patrick Michl, MD, gastroenterologist, University of Heidelberg, Germany, DGVS member and co-initiator of the statement.
Risk-Stratified HCC Surveillance
In the face of rising rates worldwide, the UEG/DGVS call on policymakers to recognize liver cancer as a preventable and growing public health priority and to implement structured surveillance programs guided by risk thresholds. In particular, they support the recent policy statement from EASL recommending risk-based screening.
EASL’s key recommendations include:
- Targeted surveillance for individuals with an annual HCC risk exceeding 1.5%, where it is both clinically beneficial and cost-effective
- Risk scoring tools such as the age-male-albumin-bilirubin-platelets score that incorporates age, sex, platelet count, albumin, and bilirubin, to stratify patients by HCC risk, including those without established cirrhosis
- Enhanced surveillance for very high-risk groups, where MRI-based surveillance may be warranted despite higher costs, given its superior sensitivity for early-stage disease
- A de-escalation in low-risk individuals
- Patients with an annual HCC risk < 0.5% may be safely spared surveillance, avoiding unnecessary interventions
Evidence from France, Italy, and the UK showed that structured surveillance in high-risk groups is both clinically beneficial and cost-effective. National models in France have demonstrated higher curative treatment rates and fewer costly late-stage cases with structured surveillance. In the UK, health technology assessments indicate targeted surveillance is an efficient use of National Health Services resources, particularly when uptake is optimized. Italian models show that earlier diagnosis in well-defined high-risk groups can offset downstream treatment costs.
Seufferlein noted that Germany needs a “structured program to be implemented and there is currently little public awareness regarding this surveillance strategy.” However, he added there is a structured hepatitis B vaccination program in Germany, which has been successful. “Studies show that the inclusion of hep B vaccination in infancy and childhood has led to good uptake among young age groups.”
Germany, however, has yet to conduct national studies. “Prospective data on HCC surveillance benefits in Germany are lacking,” said Michl, “but multi-country models incorporating Germany’s cost structures suggest similar benefits would accrue if there were greater adherence to guideline-based recommendations and if publicly funded screening programs were implemented.”
Current recommendations in Germany for surveillance are based on evidence-based guidelines of the DGVS with stronger (‘should’) or weaker (‘may’) evidence-based recommendations. For example, patients with chronic hepatitis B virus infection should be offered regular surveillance once their platelet age gender–hepatitis B risk score is ≥ 10. In patients with advanced fibrosis because of chronic hepatitis C virus infection, regular surveillance should also be offered.
Barriers to Screening Uptake
HCC remains one of the most lethal cancers in Europe, largely because it is often diagnosed too late. Underdiagnosis of chronic liver disease, limited access to imaging, and reimbursement gaps prevent timely intervention.
Maria Buti, MD, consultant hepatologist, Hospital Vall d’Hebron, Barcelona, Spain, who was not involved in drafting the statement, remarked that “Patients with liver cirrhosis, or with advanced fibrosis, and also some high-risk noncirrhotic patients such as those with hepatitis B, clearly benefit from surveillance. Surveillance can change life expectancy and also reduce morbidity.”
However, structural barriers continue to impede uptake. “It is not always easy to identify patients with liver cirrhosis because the majority are completely asymptomatic in the early stages,” she said.
Even when risk factors are identified, adherence to 6-monthly surveillance remains patchy. “Sometimes physicians forget to request ultrasounds, or patients don’t understand the importance of it because they feel well,” Buti told GI & Hepatology News.
Expanded Training and Public Health Measures
The joint statement also advocates for expanded physician training in nutrition and hepatology, equitable access to diagnostic tools including MRI, and EU-wide nutrition labeling systems such as Nutri-Score.
The authors also called for strengthened public health measures to tackle obesity, alcohol misuse, and hepatitis transmission, and fiscal and regulatory measures such as taxation of obesogenic foods, and reducing the cost burden of healthier foods.
“If we decrease the percentage of people with liver cirrhosis through prevention, fewer people will need surveillance,” Buti stated.
Seufferlein, Michl, and Buti all declared no relevant disclosures. All three experts are members of the UEG Public Affairs Group.
A version of this article appeared on Medscape.com.
BERLIN — according to a joint statement from United European Gastroenterology (UEG) and the German Society for Gastroenterology, Digestive and Metabolic Diseases (DGVS).
The statement calls on EU and national policymakers to embed a twofold approach into healthcare systems that combines surveillance and prevention, rather than relying on voluntary participation. It also encourages stronger prevention measures, such as improved food labeling and restrictions on marketing unhealthy foods to children. The statement — which was also endorsed by the European Association for the Study of the Liver (EASL) — was presented at UEG Week 2025 .
“Curing HCC in early stages rather than treating the disease in a palliative setting should be the goal for all liver doctors and carers, and this is certainly the goal for patients,” said Thomas Seufferlein, MD, professor of gastroenterology at Ulm University, Germany, and one of the members of the DGVS who initiated the statement.
“We have to take HCC screening seriously which means setting up a structured, nationwide, well-documented, and evaluated program for HCC screening in Germany,” he said in an interview.
HCC is mainly curable in the early stages by local ablation, resection, or liver transplantation, “so early diagnosis is of the utmost importance for improving survival,” added Patrick Michl, MD, gastroenterologist, University of Heidelberg, Germany, DGVS member and co-initiator of the statement.
Risk-Stratified HCC Surveillance
In the face of rising rates worldwide, the UEG/DGVS call on policymakers to recognize liver cancer as a preventable and growing public health priority and to implement structured surveillance programs guided by risk thresholds. In particular, they support the recent policy statement from EASL recommending risk-based screening.
EASL’s key recommendations include:
- Targeted surveillance for individuals with an annual HCC risk exceeding 1.5%, where it is both clinically beneficial and cost-effective
- Risk scoring tools such as the age-male-albumin-bilirubin-platelets score that incorporates age, sex, platelet count, albumin, and bilirubin, to stratify patients by HCC risk, including those without established cirrhosis
- Enhanced surveillance for very high-risk groups, where MRI-based surveillance may be warranted despite higher costs, given its superior sensitivity for early-stage disease
- A de-escalation in low-risk individuals
- Patients with an annual HCC risk < 0.5% may be safely spared surveillance, avoiding unnecessary interventions
Evidence from France, Italy, and the UK showed that structured surveillance in high-risk groups is both clinically beneficial and cost-effective. National models in France have demonstrated higher curative treatment rates and fewer costly late-stage cases with structured surveillance. In the UK, health technology assessments indicate targeted surveillance is an efficient use of National Health Services resources, particularly when uptake is optimized. Italian models show that earlier diagnosis in well-defined high-risk groups can offset downstream treatment costs.
Seufferlein noted that Germany needs a “structured program to be implemented and there is currently little public awareness regarding this surveillance strategy.” However, he added there is a structured hepatitis B vaccination program in Germany, which has been successful. “Studies show that the inclusion of hep B vaccination in infancy and childhood has led to good uptake among young age groups.”
Germany, however, has yet to conduct national studies. “Prospective data on HCC surveillance benefits in Germany are lacking,” said Michl, “but multi-country models incorporating Germany’s cost structures suggest similar benefits would accrue if there were greater adherence to guideline-based recommendations and if publicly funded screening programs were implemented.”
Current recommendations in Germany for surveillance are based on evidence-based guidelines of the DGVS with stronger (‘should’) or weaker (‘may’) evidence-based recommendations. For example, patients with chronic hepatitis B virus infection should be offered regular surveillance once their platelet age gender–hepatitis B risk score is ≥ 10. In patients with advanced fibrosis because of chronic hepatitis C virus infection, regular surveillance should also be offered.
Barriers to Screening Uptake
HCC remains one of the most lethal cancers in Europe, largely because it is often diagnosed too late. Underdiagnosis of chronic liver disease, limited access to imaging, and reimbursement gaps prevent timely intervention.
Maria Buti, MD, consultant hepatologist, Hospital Vall d’Hebron, Barcelona, Spain, who was not involved in drafting the statement, remarked that “Patients with liver cirrhosis, or with advanced fibrosis, and also some high-risk noncirrhotic patients such as those with hepatitis B, clearly benefit from surveillance. Surveillance can change life expectancy and also reduce morbidity.”
However, structural barriers continue to impede uptake. “It is not always easy to identify patients with liver cirrhosis because the majority are completely asymptomatic in the early stages,” she said.
Even when risk factors are identified, adherence to 6-monthly surveillance remains patchy. “Sometimes physicians forget to request ultrasounds, or patients don’t understand the importance of it because they feel well,” Buti told GI & Hepatology News.
Expanded Training and Public Health Measures
The joint statement also advocates for expanded physician training in nutrition and hepatology, equitable access to diagnostic tools including MRI, and EU-wide nutrition labeling systems such as Nutri-Score.
The authors also called for strengthened public health measures to tackle obesity, alcohol misuse, and hepatitis transmission, and fiscal and regulatory measures such as taxation of obesogenic foods, and reducing the cost burden of healthier foods.
“If we decrease the percentage of people with liver cirrhosis through prevention, fewer people will need surveillance,” Buti stated.
Seufferlein, Michl, and Buti all declared no relevant disclosures. All three experts are members of the UEG Public Affairs Group.
A version of this article appeared on Medscape.com.
FROM UEG WEEK 2025
‘At-Need’ Endoscopy Equal to Standard Surveillance in Barrett’s Patients?
based on results of a randomized controlled trial.
The Barrett’s Oesophagus Surveillance Versus Endoscopy at Need Study (BOSS) showed that surveillance endoscopy did not significantly improve overall survival (OS) or cancer-specific survival, compared with “at-need” endoscopy requested by patients with symptoms, reported Oliver Old, MD, of Gloucestershire Hospitals NHS Foundation Trust, Gloucester, England, and colleagues.
“Surveillance endoscopy at regular intervals is advocated by major gastroenterology societies and practiced in numerous countries worldwide to detect esophageal adenocarcinoma (EAC) early in these high-risk patients,” investigators wrote in Gastroenterology. However, “there are conflicting observational studies on the benefits of Barrett’s esophagus surveillance.”
To address this knowledge gap, Old and colleagues conducted the first randomized study of its kind. The BOSS trial was a multicenter trial conducted at 109 hospitals across the United Kingdom. Adults with an endoscopic and histologic diagnosis of BE were eligible if they were fit for endoscopy and had no history of high-grade dysplasia, esophageal adenocarcinoma, or prior upper gastrointestinal cancer. Patients with low-grade dysplasia were permitted to enroll, consistent with practice guidelines at the time.
A total of 3,453 participants were randomized between 2009 and 2011 to undergo surveillance endoscopy every 2 years or to receive at-need endoscopy triggered only by symptoms. Patients and clinicians were aware of treatment assignment. In the surveillance group, quadrantic biopsies were taken at 2-cm intervals throughout the Barrett’s segment.
The primary endpoint was OS. Secondary outcomes included cancer-specific survival (deaths from any cancer), time to diagnosis of EAC, stage at diagnosis, number of endoscopies performed, and procedure-related adverse events.
Of the 3,453 patients randomized, 1,733 were assigned to surveillance and 1,719 to symptom-driven, at-need endoscopy. Baseline characteristics were similar between groups; the mean age was 63 years, and about 70% were men.
Over the course of the trial, 25% of patients in the surveillance arm, and 9% in the at-need arm, withdrew from the trial back into clinical care, but allowed data collection of their outcomes. After a median of 12.8 years of follow-up, there was no significant difference in overall survival: 333 deaths occurred in the surveillance group (19.2%) and 356 in the at-need group (20.7%; hazard ratio [HR], 0.95; 95% CI, 0.82-1.10). Cancer-specific survival was also similar across groups, with 108 cancer-related deaths in the surveillance arm and 106 in the at-need arm (HR, 1.01; 95% CI, 0.77-1.33).
EAC was diagnosed in 40 patients in the surveillance arm (2.3%) and 31 in the at-need arm (1.8%), a nonsignificant difference (HR, 1.32; 95% CI, 0.82-2.11). Stage at diagnosis did not differ between the two groups.
Endoscopy use was higher in the surveillance arm, with 6,124 procedures compared with 2,424 in the at-need arm. Serious adverse events were rare, reported in 0.5% of surveillance patients and 0.4% of at-need patients, with most related to complications of endoscopy such as bleeding or perforation.
End-of-trial exit endoscopy, offered only to patients in the at-need group (based on data and safety monitoring committee recommendation), detected an additional eight cases of EAC and eight cases of high-grade dysplasia, but these findings were not included in the primary trial analysis.
“These data challenge current clinical practice where surveillance is advocated for all patients with BE,” the investigators wrote. “These results are likely to influence societal guidelines regarding surveillance for nondysplastic BE and inform decision making for individual patients and clinicians.”
The study was supported by the Health Technology Assessment Programme, United Kingdom. The investigators disclosed no conflicts of interest.
Old et al report the results of a herculean effort to randomize patients with Barrett’s esophagus (BE) to either scheduled endoscopy at 2-year intervals or endoscopy “at need.” While the intent was to understand the protective effect of endoscopic surveillance, this goal was frustrated by the extensive use of endoscopy in the at-need arm. All told, 59% of at-need patients underwent endoscopy at a median of 25.7 month intervals (compared to the 24.8-month median interval in the surveillance group).
This degree of endoscopy use in at-need patients complicates interpretation, since, as the authors note, such contamination would likely bias the results to the null. Also, only 26% of randomized at-need patients took advantage of the study-end endoscopy. In this group, an additional eight cancers and nine high-grade dysplasia were noted, raising the specter that undiagnosed important disease was present in the at-need group.
Given these concerns, the BOSS results do not provide compelling evidence to change clinical practice. I continue to recommend endoscopic surveillance to my BE patients. However, the trial provides valuable insight. First, it prospectively confirms the low incidence of esophageal adenocarcinoma in low-risk BE, a rate of 0.23%/patient-year. Second, a lot of endoscopy is probably not better than some endoscopy in BE surveillance, and current trends seen in guidelines toward lengthening intervals in low-risk patients are likely merited. Finally, clinicians and patients may overestimate the utility of surveillance, and a patient-centered approach, acknowledging the uncertainties of the utility of endoscopy and the low risk of progression to cancer, is appropriate.
Nicholas J. Shaheen, MD, MPH, AGAF, is the Bozymski-Heizer Distinguished Professor of Medicine and senior associate dean for Clinical Research at the University of North Carolina School of Medicine, Chapel Hill, N.C. He has no conflicts to report.
Old et al report the results of a herculean effort to randomize patients with Barrett’s esophagus (BE) to either scheduled endoscopy at 2-year intervals or endoscopy “at need.” While the intent was to understand the protective effect of endoscopic surveillance, this goal was frustrated by the extensive use of endoscopy in the at-need arm. All told, 59% of at-need patients underwent endoscopy at a median of 25.7 month intervals (compared to the 24.8-month median interval in the surveillance group).
This degree of endoscopy use in at-need patients complicates interpretation, since, as the authors note, such contamination would likely bias the results to the null. Also, only 26% of randomized at-need patients took advantage of the study-end endoscopy. In this group, an additional eight cancers and nine high-grade dysplasia were noted, raising the specter that undiagnosed important disease was present in the at-need group.
Given these concerns, the BOSS results do not provide compelling evidence to change clinical practice. I continue to recommend endoscopic surveillance to my BE patients. However, the trial provides valuable insight. First, it prospectively confirms the low incidence of esophageal adenocarcinoma in low-risk BE, a rate of 0.23%/patient-year. Second, a lot of endoscopy is probably not better than some endoscopy in BE surveillance, and current trends seen in guidelines toward lengthening intervals in low-risk patients are likely merited. Finally, clinicians and patients may overestimate the utility of surveillance, and a patient-centered approach, acknowledging the uncertainties of the utility of endoscopy and the low risk of progression to cancer, is appropriate.
Nicholas J. Shaheen, MD, MPH, AGAF, is the Bozymski-Heizer Distinguished Professor of Medicine and senior associate dean for Clinical Research at the University of North Carolina School of Medicine, Chapel Hill, N.C. He has no conflicts to report.
Old et al report the results of a herculean effort to randomize patients with Barrett’s esophagus (BE) to either scheduled endoscopy at 2-year intervals or endoscopy “at need.” While the intent was to understand the protective effect of endoscopic surveillance, this goal was frustrated by the extensive use of endoscopy in the at-need arm. All told, 59% of at-need patients underwent endoscopy at a median of 25.7 month intervals (compared to the 24.8-month median interval in the surveillance group).
This degree of endoscopy use in at-need patients complicates interpretation, since, as the authors note, such contamination would likely bias the results to the null. Also, only 26% of randomized at-need patients took advantage of the study-end endoscopy. In this group, an additional eight cancers and nine high-grade dysplasia were noted, raising the specter that undiagnosed important disease was present in the at-need group.
Given these concerns, the BOSS results do not provide compelling evidence to change clinical practice. I continue to recommend endoscopic surveillance to my BE patients. However, the trial provides valuable insight. First, it prospectively confirms the low incidence of esophageal adenocarcinoma in low-risk BE, a rate of 0.23%/patient-year. Second, a lot of endoscopy is probably not better than some endoscopy in BE surveillance, and current trends seen in guidelines toward lengthening intervals in low-risk patients are likely merited. Finally, clinicians and patients may overestimate the utility of surveillance, and a patient-centered approach, acknowledging the uncertainties of the utility of endoscopy and the low risk of progression to cancer, is appropriate.
Nicholas J. Shaheen, MD, MPH, AGAF, is the Bozymski-Heizer Distinguished Professor of Medicine and senior associate dean for Clinical Research at the University of North Carolina School of Medicine, Chapel Hill, N.C. He has no conflicts to report.
based on results of a randomized controlled trial.
The Barrett’s Oesophagus Surveillance Versus Endoscopy at Need Study (BOSS) showed that surveillance endoscopy did not significantly improve overall survival (OS) or cancer-specific survival, compared with “at-need” endoscopy requested by patients with symptoms, reported Oliver Old, MD, of Gloucestershire Hospitals NHS Foundation Trust, Gloucester, England, and colleagues.
“Surveillance endoscopy at regular intervals is advocated by major gastroenterology societies and practiced in numerous countries worldwide to detect esophageal adenocarcinoma (EAC) early in these high-risk patients,” investigators wrote in Gastroenterology. However, “there are conflicting observational studies on the benefits of Barrett’s esophagus surveillance.”
To address this knowledge gap, Old and colleagues conducted the first randomized study of its kind. The BOSS trial was a multicenter trial conducted at 109 hospitals across the United Kingdom. Adults with an endoscopic and histologic diagnosis of BE were eligible if they were fit for endoscopy and had no history of high-grade dysplasia, esophageal adenocarcinoma, or prior upper gastrointestinal cancer. Patients with low-grade dysplasia were permitted to enroll, consistent with practice guidelines at the time.
A total of 3,453 participants were randomized between 2009 and 2011 to undergo surveillance endoscopy every 2 years or to receive at-need endoscopy triggered only by symptoms. Patients and clinicians were aware of treatment assignment. In the surveillance group, quadrantic biopsies were taken at 2-cm intervals throughout the Barrett’s segment.
The primary endpoint was OS. Secondary outcomes included cancer-specific survival (deaths from any cancer), time to diagnosis of EAC, stage at diagnosis, number of endoscopies performed, and procedure-related adverse events.
Of the 3,453 patients randomized, 1,733 were assigned to surveillance and 1,719 to symptom-driven, at-need endoscopy. Baseline characteristics were similar between groups; the mean age was 63 years, and about 70% were men.
Over the course of the trial, 25% of patients in the surveillance arm, and 9% in the at-need arm, withdrew from the trial back into clinical care, but allowed data collection of their outcomes. After a median of 12.8 years of follow-up, there was no significant difference in overall survival: 333 deaths occurred in the surveillance group (19.2%) and 356 in the at-need group (20.7%; hazard ratio [HR], 0.95; 95% CI, 0.82-1.10). Cancer-specific survival was also similar across groups, with 108 cancer-related deaths in the surveillance arm and 106 in the at-need arm (HR, 1.01; 95% CI, 0.77-1.33).
EAC was diagnosed in 40 patients in the surveillance arm (2.3%) and 31 in the at-need arm (1.8%), a nonsignificant difference (HR, 1.32; 95% CI, 0.82-2.11). Stage at diagnosis did not differ between the two groups.
Endoscopy use was higher in the surveillance arm, with 6,124 procedures compared with 2,424 in the at-need arm. Serious adverse events were rare, reported in 0.5% of surveillance patients and 0.4% of at-need patients, with most related to complications of endoscopy such as bleeding or perforation.
End-of-trial exit endoscopy, offered only to patients in the at-need group (based on data and safety monitoring committee recommendation), detected an additional eight cases of EAC and eight cases of high-grade dysplasia, but these findings were not included in the primary trial analysis.
“These data challenge current clinical practice where surveillance is advocated for all patients with BE,” the investigators wrote. “These results are likely to influence societal guidelines regarding surveillance for nondysplastic BE and inform decision making for individual patients and clinicians.”
The study was supported by the Health Technology Assessment Programme, United Kingdom. The investigators disclosed no conflicts of interest.
based on results of a randomized controlled trial.
The Barrett’s Oesophagus Surveillance Versus Endoscopy at Need Study (BOSS) showed that surveillance endoscopy did not significantly improve overall survival (OS) or cancer-specific survival, compared with “at-need” endoscopy requested by patients with symptoms, reported Oliver Old, MD, of Gloucestershire Hospitals NHS Foundation Trust, Gloucester, England, and colleagues.
“Surveillance endoscopy at regular intervals is advocated by major gastroenterology societies and practiced in numerous countries worldwide to detect esophageal adenocarcinoma (EAC) early in these high-risk patients,” investigators wrote in Gastroenterology. However, “there are conflicting observational studies on the benefits of Barrett’s esophagus surveillance.”
To address this knowledge gap, Old and colleagues conducted the first randomized study of its kind. The BOSS trial was a multicenter trial conducted at 109 hospitals across the United Kingdom. Adults with an endoscopic and histologic diagnosis of BE were eligible if they were fit for endoscopy and had no history of high-grade dysplasia, esophageal adenocarcinoma, or prior upper gastrointestinal cancer. Patients with low-grade dysplasia were permitted to enroll, consistent with practice guidelines at the time.
A total of 3,453 participants were randomized between 2009 and 2011 to undergo surveillance endoscopy every 2 years or to receive at-need endoscopy triggered only by symptoms. Patients and clinicians were aware of treatment assignment. In the surveillance group, quadrantic biopsies were taken at 2-cm intervals throughout the Barrett’s segment.
The primary endpoint was OS. Secondary outcomes included cancer-specific survival (deaths from any cancer), time to diagnosis of EAC, stage at diagnosis, number of endoscopies performed, and procedure-related adverse events.
Of the 3,453 patients randomized, 1,733 were assigned to surveillance and 1,719 to symptom-driven, at-need endoscopy. Baseline characteristics were similar between groups; the mean age was 63 years, and about 70% were men.
Over the course of the trial, 25% of patients in the surveillance arm, and 9% in the at-need arm, withdrew from the trial back into clinical care, but allowed data collection of their outcomes. After a median of 12.8 years of follow-up, there was no significant difference in overall survival: 333 deaths occurred in the surveillance group (19.2%) and 356 in the at-need group (20.7%; hazard ratio [HR], 0.95; 95% CI, 0.82-1.10). Cancer-specific survival was also similar across groups, with 108 cancer-related deaths in the surveillance arm and 106 in the at-need arm (HR, 1.01; 95% CI, 0.77-1.33).
EAC was diagnosed in 40 patients in the surveillance arm (2.3%) and 31 in the at-need arm (1.8%), a nonsignificant difference (HR, 1.32; 95% CI, 0.82-2.11). Stage at diagnosis did not differ between the two groups.
Endoscopy use was higher in the surveillance arm, with 6,124 procedures compared with 2,424 in the at-need arm. Serious adverse events were rare, reported in 0.5% of surveillance patients and 0.4% of at-need patients, with most related to complications of endoscopy such as bleeding or perforation.
End-of-trial exit endoscopy, offered only to patients in the at-need group (based on data and safety monitoring committee recommendation), detected an additional eight cases of EAC and eight cases of high-grade dysplasia, but these findings were not included in the primary trial analysis.
“These data challenge current clinical practice where surveillance is advocated for all patients with BE,” the investigators wrote. “These results are likely to influence societal guidelines regarding surveillance for nondysplastic BE and inform decision making for individual patients and clinicians.”
The study was supported by the Health Technology Assessment Programme, United Kingdom. The investigators disclosed no conflicts of interest.
FROM GASTROENTEROLOGY
Linerixibat Reduces Itching in PBC
BERLIN — , according to phase 3 results from the GLISTEN trial.
The therapy also improved sleep interference associated with itching and was generally well-tolerated, offering hope for patients who do not respond to existing treatments.
“Linerixibat has the potential to be the first global therapy indicated for pruritus,” asserted Andreas E. Kremer, MD, Department of Gastroenterology and Hepatology, University Hospital Zürich, Switzerland, who presented the findings at United European Gastroenterology (UEG) Week 2025.
Cholestatic pruritus is one of the most distressing and disabling symptoms of PBC, often unrelieved by existing first-line therapies such as ursodeoxycholic acid.
Up to 70% of patients with PBC experience cholestatic pruritus which can seriously impair quality of life, comparable to that seen in severe Parkinson’s disease or heart failure, said Kremer. With the limitations of existing treatments, symptom control remains a major unmet clinical need.
The GLISTEN Trial
Linerixibat is a minimally absorbed oral IBAT inhibitor that inhibits bile acid reuptake and reduces key mediators of pruritus.
Participants in the double-blind, placebo-controlled trial were randomized to oral linerixibat 40 mg twice daily (n = 119) or to placebo (n = 119) for 24 weeks. Patients had PBC and moderate-to-severe pruritus (Worst Itch Numerical Rating Scale [WI-NRS] ≥ 4).
The primary endpoint was change from baseline in monthly worst-itch score over 24 weeks. Key secondary endpoints included change in itch at week 2, change in sleep interference over 24 weeks, responder rates (≥ 2-, ≥ 3-, and ≥ 4-point reduction), and patient-reported global impression of severity and change.
The majority of participants (95%) were women and had a mean WI-NRS of 7.3 at baseline. After 24 weeks of twice daily dosing of linerixibat or placebo, participants entered a blinded crossover period for 8 weeks.
24-Week Data
Linerixibat produced a significant improvement in pruritus vs placebo, with a least-squares mean change in WI-NRS of -2.86 compared with -2.15, respectively, resulting in an adjusted mean difference of -0.72 (P = .001). The benefit appeared rapid, with superiority already evident at 2 weeks (P < .001), noted Kremer, adding this is important for patients.
Pruritus-related sleep interference NRS also improved significantly (-2.77 vs -2.24; difference, -0.53; P = .024). By week 24, 56% of patients with linerixibat achieved a ≥ 3-point reduction compared with 43% of those treated with placebo (nominal P = .043).
“A three-point reduction for a patient with pruritus is a clearly meaningful benefit,” said Kremer.
In addition, a greater proportion of patients with linerixibat rated their itch as “absent” (21% vs 9%) on the patient global impression of severity scales. The ideal goal for these patients is complete relief, “and here we saw that every fifth patient on linerixibat achieved such relief,” he pointed out.
Linerixibat was generally well-tolerated, and the most frequent on-treatment adverse event was diarrhea, which occurred in 61% of patients compared with 18% of those on placebo. There were five (4%) discontinuations on linerixibat vs one (< 1%) on placebo. Abdominal pain was experienced by 18% on linerixibat and 3% on placebo. There was also a slight elevation of alanine aminotransferase in 11 (9%) vs three patients (3%).
“In summary, it is a safe drug from our perspective,” said Kremer.
Focusing on Symptoms, Not Biochemical Response
Commenting for GI & Hepatology News, Frank Tacke, MD, head of the Department of Hepatology and Gastroenterology at Charité Medical University Berlin, Germany, explained that so far drugs for the treatment of PBC focused on the biochemical response. These treatments have shown a reduction in liver enzymes and in disease activity, but less of a reduction in symptoms, he explained. “This is the first drug at phase 3 that focuses on itching, which is one of the major symptoms in people with PBC. As such, this is a major breakthrough.”
Sabine Weber, MD, gastroenterologist at the University Hospital of Munich, Germany, said that the data suggested particular potential for patients whose pruritus doesn’t respond to first-line treatment, even if the treatment is otherwise effective.
“This is so important for patients who — due to their extreme itching — experience serious lifestyle effects such as isolation because they can’t go out socially,” she said. “We desperately need drugs to help these patients, and here we have one drug that seems to do this.”
Weber noted that linerixibat works differently from other PBC treatments. It is licensed in pediatric medicine for a number of diseases, but “this is the first time we’ve seen it for use in adults,” she added.
Kremer disclosed receiving research support from Gilead, Intercept Pharmaceuticals, and Roche; consulting for AbbVie, Advanz, Alentis, Alphasigma, AstraZeneca, Avior, Bayer, CymaBay Therapeutics, Eisai, Escient, Falk, Gilead, GSK, Intercept Pharmaceuticals, Ipsen, Mirum, MSD, Roche, Takeda, and Vifor; and receiving payment or honoraria from AbbVie, Advanz, Alphasigma, Falk, Gilead, GSK, Intercept Pharmaceuticals, Ipsen, Mirum, MSD, Roche, Takeda, and Vifor. Tache declared that he previously gave lectures for GSK. Weber declared no relevant conflicts of interest.
The GLISTEN study was funded by GSK.
A version of this article appeared on Medscape.com.
BERLIN — , according to phase 3 results from the GLISTEN trial.
The therapy also improved sleep interference associated with itching and was generally well-tolerated, offering hope for patients who do not respond to existing treatments.
“Linerixibat has the potential to be the first global therapy indicated for pruritus,” asserted Andreas E. Kremer, MD, Department of Gastroenterology and Hepatology, University Hospital Zürich, Switzerland, who presented the findings at United European Gastroenterology (UEG) Week 2025.
Cholestatic pruritus is one of the most distressing and disabling symptoms of PBC, often unrelieved by existing first-line therapies such as ursodeoxycholic acid.
Up to 70% of patients with PBC experience cholestatic pruritus which can seriously impair quality of life, comparable to that seen in severe Parkinson’s disease or heart failure, said Kremer. With the limitations of existing treatments, symptom control remains a major unmet clinical need.
The GLISTEN Trial
Linerixibat is a minimally absorbed oral IBAT inhibitor that inhibits bile acid reuptake and reduces key mediators of pruritus.
Participants in the double-blind, placebo-controlled trial were randomized to oral linerixibat 40 mg twice daily (n = 119) or to placebo (n = 119) for 24 weeks. Patients had PBC and moderate-to-severe pruritus (Worst Itch Numerical Rating Scale [WI-NRS] ≥ 4).
The primary endpoint was change from baseline in monthly worst-itch score over 24 weeks. Key secondary endpoints included change in itch at week 2, change in sleep interference over 24 weeks, responder rates (≥ 2-, ≥ 3-, and ≥ 4-point reduction), and patient-reported global impression of severity and change.
The majority of participants (95%) were women and had a mean WI-NRS of 7.3 at baseline. After 24 weeks of twice daily dosing of linerixibat or placebo, participants entered a blinded crossover period for 8 weeks.
24-Week Data
Linerixibat produced a significant improvement in pruritus vs placebo, with a least-squares mean change in WI-NRS of -2.86 compared with -2.15, respectively, resulting in an adjusted mean difference of -0.72 (P = .001). The benefit appeared rapid, with superiority already evident at 2 weeks (P < .001), noted Kremer, adding this is important for patients.
Pruritus-related sleep interference NRS also improved significantly (-2.77 vs -2.24; difference, -0.53; P = .024). By week 24, 56% of patients with linerixibat achieved a ≥ 3-point reduction compared with 43% of those treated with placebo (nominal P = .043).
“A three-point reduction for a patient with pruritus is a clearly meaningful benefit,” said Kremer.
In addition, a greater proportion of patients with linerixibat rated their itch as “absent” (21% vs 9%) on the patient global impression of severity scales. The ideal goal for these patients is complete relief, “and here we saw that every fifth patient on linerixibat achieved such relief,” he pointed out.
Linerixibat was generally well-tolerated, and the most frequent on-treatment adverse event was diarrhea, which occurred in 61% of patients compared with 18% of those on placebo. There were five (4%) discontinuations on linerixibat vs one (< 1%) on placebo. Abdominal pain was experienced by 18% on linerixibat and 3% on placebo. There was also a slight elevation of alanine aminotransferase in 11 (9%) vs three patients (3%).
“In summary, it is a safe drug from our perspective,” said Kremer.
Focusing on Symptoms, Not Biochemical Response
Commenting for GI & Hepatology News, Frank Tacke, MD, head of the Department of Hepatology and Gastroenterology at Charité Medical University Berlin, Germany, explained that so far drugs for the treatment of PBC focused on the biochemical response. These treatments have shown a reduction in liver enzymes and in disease activity, but less of a reduction in symptoms, he explained. “This is the first drug at phase 3 that focuses on itching, which is one of the major symptoms in people with PBC. As such, this is a major breakthrough.”
Sabine Weber, MD, gastroenterologist at the University Hospital of Munich, Germany, said that the data suggested particular potential for patients whose pruritus doesn’t respond to first-line treatment, even if the treatment is otherwise effective.
“This is so important for patients who — due to their extreme itching — experience serious lifestyle effects such as isolation because they can’t go out socially,” she said. “We desperately need drugs to help these patients, and here we have one drug that seems to do this.”
Weber noted that linerixibat works differently from other PBC treatments. It is licensed in pediatric medicine for a number of diseases, but “this is the first time we’ve seen it for use in adults,” she added.
Kremer disclosed receiving research support from Gilead, Intercept Pharmaceuticals, and Roche; consulting for AbbVie, Advanz, Alentis, Alphasigma, AstraZeneca, Avior, Bayer, CymaBay Therapeutics, Eisai, Escient, Falk, Gilead, GSK, Intercept Pharmaceuticals, Ipsen, Mirum, MSD, Roche, Takeda, and Vifor; and receiving payment or honoraria from AbbVie, Advanz, Alphasigma, Falk, Gilead, GSK, Intercept Pharmaceuticals, Ipsen, Mirum, MSD, Roche, Takeda, and Vifor. Tache declared that he previously gave lectures for GSK. Weber declared no relevant conflicts of interest.
The GLISTEN study was funded by GSK.
A version of this article appeared on Medscape.com.
BERLIN — , according to phase 3 results from the GLISTEN trial.
The therapy also improved sleep interference associated with itching and was generally well-tolerated, offering hope for patients who do not respond to existing treatments.
“Linerixibat has the potential to be the first global therapy indicated for pruritus,” asserted Andreas E. Kremer, MD, Department of Gastroenterology and Hepatology, University Hospital Zürich, Switzerland, who presented the findings at United European Gastroenterology (UEG) Week 2025.
Cholestatic pruritus is one of the most distressing and disabling symptoms of PBC, often unrelieved by existing first-line therapies such as ursodeoxycholic acid.
Up to 70% of patients with PBC experience cholestatic pruritus which can seriously impair quality of life, comparable to that seen in severe Parkinson’s disease or heart failure, said Kremer. With the limitations of existing treatments, symptom control remains a major unmet clinical need.
The GLISTEN Trial
Linerixibat is a minimally absorbed oral IBAT inhibitor that inhibits bile acid reuptake and reduces key mediators of pruritus.
Participants in the double-blind, placebo-controlled trial were randomized to oral linerixibat 40 mg twice daily (n = 119) or to placebo (n = 119) for 24 weeks. Patients had PBC and moderate-to-severe pruritus (Worst Itch Numerical Rating Scale [WI-NRS] ≥ 4).
The primary endpoint was change from baseline in monthly worst-itch score over 24 weeks. Key secondary endpoints included change in itch at week 2, change in sleep interference over 24 weeks, responder rates (≥ 2-, ≥ 3-, and ≥ 4-point reduction), and patient-reported global impression of severity and change.
The majority of participants (95%) were women and had a mean WI-NRS of 7.3 at baseline. After 24 weeks of twice daily dosing of linerixibat or placebo, participants entered a blinded crossover period for 8 weeks.
24-Week Data
Linerixibat produced a significant improvement in pruritus vs placebo, with a least-squares mean change in WI-NRS of -2.86 compared with -2.15, respectively, resulting in an adjusted mean difference of -0.72 (P = .001). The benefit appeared rapid, with superiority already evident at 2 weeks (P < .001), noted Kremer, adding this is important for patients.
Pruritus-related sleep interference NRS also improved significantly (-2.77 vs -2.24; difference, -0.53; P = .024). By week 24, 56% of patients with linerixibat achieved a ≥ 3-point reduction compared with 43% of those treated with placebo (nominal P = .043).
“A three-point reduction for a patient with pruritus is a clearly meaningful benefit,” said Kremer.
In addition, a greater proportion of patients with linerixibat rated their itch as “absent” (21% vs 9%) on the patient global impression of severity scales. The ideal goal for these patients is complete relief, “and here we saw that every fifth patient on linerixibat achieved such relief,” he pointed out.
Linerixibat was generally well-tolerated, and the most frequent on-treatment adverse event was diarrhea, which occurred in 61% of patients compared with 18% of those on placebo. There were five (4%) discontinuations on linerixibat vs one (< 1%) on placebo. Abdominal pain was experienced by 18% on linerixibat and 3% on placebo. There was also a slight elevation of alanine aminotransferase in 11 (9%) vs three patients (3%).
“In summary, it is a safe drug from our perspective,” said Kremer.
Focusing on Symptoms, Not Biochemical Response
Commenting for GI & Hepatology News, Frank Tacke, MD, head of the Department of Hepatology and Gastroenterology at Charité Medical University Berlin, Germany, explained that so far drugs for the treatment of PBC focused on the biochemical response. These treatments have shown a reduction in liver enzymes and in disease activity, but less of a reduction in symptoms, he explained. “This is the first drug at phase 3 that focuses on itching, which is one of the major symptoms in people with PBC. As such, this is a major breakthrough.”
Sabine Weber, MD, gastroenterologist at the University Hospital of Munich, Germany, said that the data suggested particular potential for patients whose pruritus doesn’t respond to first-line treatment, even if the treatment is otherwise effective.
“This is so important for patients who — due to their extreme itching — experience serious lifestyle effects such as isolation because they can’t go out socially,” she said. “We desperately need drugs to help these patients, and here we have one drug that seems to do this.”
Weber noted that linerixibat works differently from other PBC treatments. It is licensed in pediatric medicine for a number of diseases, but “this is the first time we’ve seen it for use in adults,” she added.
Kremer disclosed receiving research support from Gilead, Intercept Pharmaceuticals, and Roche; consulting for AbbVie, Advanz, Alentis, Alphasigma, AstraZeneca, Avior, Bayer, CymaBay Therapeutics, Eisai, Escient, Falk, Gilead, GSK, Intercept Pharmaceuticals, Ipsen, Mirum, MSD, Roche, Takeda, and Vifor; and receiving payment or honoraria from AbbVie, Advanz, Alphasigma, Falk, Gilead, GSK, Intercept Pharmaceuticals, Ipsen, Mirum, MSD, Roche, Takeda, and Vifor. Tache declared that he previously gave lectures for GSK. Weber declared no relevant conflicts of interest.
The GLISTEN study was funded by GSK.
A version of this article appeared on Medscape.com.
mRNA Cancer Vaccines: Pipeline Insights for Clinicians
Since 1965, messenger RNA (mRNA) vaccines have been studied for cancer treatment, but it was the technological advances in vaccines during the COVID pandemic that helped accelerate research. Currently, no vaccine has been approved for tumor treatment, although many clinical studies are ongoing worldwide. According to experts consulted by Medscape’s Portuguese edition, the outlook is very promising, and these studies are expected to open doors for personalized therapies.
In cancer treatment, the vaccine would function as an immunotherapy, in which the immune system can be “trained” to act against an invader. Just as with pathogens, the platform would use parts of the tumor — which have altered proteins or are expressed at abnormal levels — to teach the body to defend itself against cancer.
Vladmir Lima, MD, PhD, clinical oncologist at A.C. Camargo Cancer Center, São Paulo, Brazil, explained that with this technology it will be possible to produce personalized vaccines, which prevents, for example, large-scale manufacturing. “In theory, these vaccines can be developed for any tumor type, but this does not mean that efficacy will be the same for all,” he said. Because cancer has specific characteristics in each individual, it is difficult to envision a single vaccine that works for all cancers.
Current evidence suggests the vaccine could be administered after chemotherapy or radiotherapy, with the goal of reducing tumor mass and increasing the effectiveness of mRNA-based treatment, according to Ana Paula Lepique, professor and researcher in tumor immunology at the Institute of Biomedical Sciences, University of São Paulo, São Paulo.
“There is also a study with pancreatic cancer patients, in which the vaccine was administered after surgery,” she explained. “It would not work, for example, to give chemotherapy or radiotherapy while the immune response is being triggered by the vaccine. This would make the vaccine ineffective, since chemotherapy and radiotherapy are toxic to lymphocytes.”
Lepique also clarified that it is possible to combine the vaccine with immunotherapy targeting immune regulatory molecules. “In this case, in addition to administering the mRNA with the antigen, a strategy is used to improve the patient’s immune response.”
Challenges With mRNA Vaccines
Despite being a promising technology, there are challenges, warned Lepique. mRNA molecules degrade quickly when injected into the body, which can compromise vaccine efficacy. To overcome this, researchers have developed nanoencapsulation technologies that protect the molecules and allow safe use in vaccines. “Another alternative is transferring the mRNA into dendritic cells, known as antigen-presenting cells, and then administering these cells to the patient,” she explained.
Global Research Status
According to a study published this year in Med, over 120 clinical trials are exploring mRNA vaccines to treat lung, breast, prostate, and pancreatic tumors, as well as melanoma.
Lepique noted that the countries leading this research are the US, UK, Germany, China, and Japan. “Unfortunately, the US government recently cut funding for mRNA vaccine development and testing, which will likely have significant consequences,” she said.
Lepique reported that Brazilian researchers are collaborating with international institutions to develop these vaccines. “The Brazilian government, through the Ministry of Health and the Ministry of Science, Technology, and Innovation, recently announced investments in mRNA technologies for vaccines. While not specifically targeting cancer, these investments could also benefit this field,” she clarified.
Leading Studies
Lepique highlighted the most advanced studies to date:
- Pancreatic cancer: A study published in Nature in February demonstrated that a personalized mRNA vaccine reduced the risk for recurrence after surgery in 16 patients, with 3 years of follow-up.
- Melanoma: A study published in The Lancet reported improved survival in melanoma patients after mRNA vaccine administration combined with the checkpoint inhibitor pembrolizumab applied after surgical tumor resection.
- Universal vaccine: A study in Nature Biomedical Engineering described the creation of a “generic” vaccine capable of activating the patient’s immune system and inducing tumor regression. Lepique explained that this vaccine acts more as an immune response modulator than a classical neoantigen-specific vaccine. “Because it is not limited to a single neoantigen, it could potentially be universal, though further testing is needed to determine efficacy across all cancer types,” she added.
Lima highlighted a 2024 study being conducted by MSD and Moderna against lung cancer, with results yet to be published. “Patients first receive immunotherapy after surgery. Once the vaccine is ready, it is added to the ongoing immunotherapy,” he explained. The global phase 3 study involves 868 patients with resected lung cancer who previously underwent chemotherapy. Participants receive the vaccine (1 mg every 3 weeks, up to nine doses) alongside pembrolizumab (400 mg every 6 weeks, up to nine cycles) over approximately 1 year.
Other mRNA vaccines remain in early-stage development. For example, in May 2024, the UK National Health Service recruited participants for a personalized colorectal cancer mRNA vaccine trial.
Advantages of mRNA Technology
Experts noted that mRNA-based cancer vaccines are considered safer for patients because the tumor mRNA is synthesized in the laboratory. According to Lepique, these vaccines are more specific than many other cancer therapies, and therefore carry a lower risk for serious side effects.
“Clinical studies have shown that these vaccines can generate immunological memory, meaning lymphocytes that recognize tumor antigens remain in the body and can respond to recurrence,” she explained.
It is also possible to combine multiple mRNA molecules in a single vaccine, creating a platform that targets several tumor antigens simultaneously. “Formulations can additionally include adjuvants to further enhance immune responses against tumors,” she said. However, as a personalized therapy, costs are high, and vaccine formulation requires considerable time.
Lima emphasized the customization advantage: “We can take a portion of the patient’s tumor, sequence it to identify alterations, and develop a vaccine specifically for that tumor.” He also highlighted safety data, noting that the platform has been widely used in SARS-CoV-2 vaccine development, providing confidence in large-scale application. “The potential exists to achieve more personalized, tumor-directed immunotherapy with greater scalability,” he explained.
Outlook and Limitations
Lima noted that although the projected efficacy is promising, definitive results are still pending.
“We have very positive expectations, but we must wait for study outcomes. Efficacy may vary across scenarios and among patients. The immune system may also respond against the vaccine itself, potentially reducing effectiveness at times,” he explained.
According to Lima, mRNA vaccines are expected to complement current treatments, enhancing outcomes without replacing conventional approaches entirely.
“It will not be a panacea. These vaccines are likely to add to and improve strategies we already use, but they will not work for all patients in every scenario,” he concluded.
Lepique highlighted the promise of combination strategies. “The outlook is positive, particularly because multiple mRNA types can be combined in a single formulation and used alongside drugs that enhance immune responses,” she explained.
Although mRNA vaccine research has been ongoing for many years, prior results have brought both progress and setbacks. “This new protocol appears more effective [and] capable of generating immunological memory and is also safe,” she noted. Still, she cautioned that cancer presents unique challenges: “The disease has multiple mechanisms to evade immune responses. Additionally, some tumors are naturally unrecognized by the immune system, the so-called ‘cold tumors.’”
This story was translated from Medscape’s Portuguese edition. A version of this article appeared on Medscape.com.
Since 1965, messenger RNA (mRNA) vaccines have been studied for cancer treatment, but it was the technological advances in vaccines during the COVID pandemic that helped accelerate research. Currently, no vaccine has been approved for tumor treatment, although many clinical studies are ongoing worldwide. According to experts consulted by Medscape’s Portuguese edition, the outlook is very promising, and these studies are expected to open doors for personalized therapies.
In cancer treatment, the vaccine would function as an immunotherapy, in which the immune system can be “trained” to act against an invader. Just as with pathogens, the platform would use parts of the tumor — which have altered proteins or are expressed at abnormal levels — to teach the body to defend itself against cancer.
Vladmir Lima, MD, PhD, clinical oncologist at A.C. Camargo Cancer Center, São Paulo, Brazil, explained that with this technology it will be possible to produce personalized vaccines, which prevents, for example, large-scale manufacturing. “In theory, these vaccines can be developed for any tumor type, but this does not mean that efficacy will be the same for all,” he said. Because cancer has specific characteristics in each individual, it is difficult to envision a single vaccine that works for all cancers.
Current evidence suggests the vaccine could be administered after chemotherapy or radiotherapy, with the goal of reducing tumor mass and increasing the effectiveness of mRNA-based treatment, according to Ana Paula Lepique, professor and researcher in tumor immunology at the Institute of Biomedical Sciences, University of São Paulo, São Paulo.
“There is also a study with pancreatic cancer patients, in which the vaccine was administered after surgery,” she explained. “It would not work, for example, to give chemotherapy or radiotherapy while the immune response is being triggered by the vaccine. This would make the vaccine ineffective, since chemotherapy and radiotherapy are toxic to lymphocytes.”
Lepique also clarified that it is possible to combine the vaccine with immunotherapy targeting immune regulatory molecules. “In this case, in addition to administering the mRNA with the antigen, a strategy is used to improve the patient’s immune response.”
Challenges With mRNA Vaccines
Despite being a promising technology, there are challenges, warned Lepique. mRNA molecules degrade quickly when injected into the body, which can compromise vaccine efficacy. To overcome this, researchers have developed nanoencapsulation technologies that protect the molecules and allow safe use in vaccines. “Another alternative is transferring the mRNA into dendritic cells, known as antigen-presenting cells, and then administering these cells to the patient,” she explained.
Global Research Status
According to a study published this year in Med, over 120 clinical trials are exploring mRNA vaccines to treat lung, breast, prostate, and pancreatic tumors, as well as melanoma.
Lepique noted that the countries leading this research are the US, UK, Germany, China, and Japan. “Unfortunately, the US government recently cut funding for mRNA vaccine development and testing, which will likely have significant consequences,” she said.
Lepique reported that Brazilian researchers are collaborating with international institutions to develop these vaccines. “The Brazilian government, through the Ministry of Health and the Ministry of Science, Technology, and Innovation, recently announced investments in mRNA technologies for vaccines. While not specifically targeting cancer, these investments could also benefit this field,” she clarified.
Leading Studies
Lepique highlighted the most advanced studies to date:
- Pancreatic cancer: A study published in Nature in February demonstrated that a personalized mRNA vaccine reduced the risk for recurrence after surgery in 16 patients, with 3 years of follow-up.
- Melanoma: A study published in The Lancet reported improved survival in melanoma patients after mRNA vaccine administration combined with the checkpoint inhibitor pembrolizumab applied after surgical tumor resection.
- Universal vaccine: A study in Nature Biomedical Engineering described the creation of a “generic” vaccine capable of activating the patient’s immune system and inducing tumor regression. Lepique explained that this vaccine acts more as an immune response modulator than a classical neoantigen-specific vaccine. “Because it is not limited to a single neoantigen, it could potentially be universal, though further testing is needed to determine efficacy across all cancer types,” she added.
Lima highlighted a 2024 study being conducted by MSD and Moderna against lung cancer, with results yet to be published. “Patients first receive immunotherapy after surgery. Once the vaccine is ready, it is added to the ongoing immunotherapy,” he explained. The global phase 3 study involves 868 patients with resected lung cancer who previously underwent chemotherapy. Participants receive the vaccine (1 mg every 3 weeks, up to nine doses) alongside pembrolizumab (400 mg every 6 weeks, up to nine cycles) over approximately 1 year.
Other mRNA vaccines remain in early-stage development. For example, in May 2024, the UK National Health Service recruited participants for a personalized colorectal cancer mRNA vaccine trial.
Advantages of mRNA Technology
Experts noted that mRNA-based cancer vaccines are considered safer for patients because the tumor mRNA is synthesized in the laboratory. According to Lepique, these vaccines are more specific than many other cancer therapies, and therefore carry a lower risk for serious side effects.
“Clinical studies have shown that these vaccines can generate immunological memory, meaning lymphocytes that recognize tumor antigens remain in the body and can respond to recurrence,” she explained.
It is also possible to combine multiple mRNA molecules in a single vaccine, creating a platform that targets several tumor antigens simultaneously. “Formulations can additionally include adjuvants to further enhance immune responses against tumors,” she said. However, as a personalized therapy, costs are high, and vaccine formulation requires considerable time.
Lima emphasized the customization advantage: “We can take a portion of the patient’s tumor, sequence it to identify alterations, and develop a vaccine specifically for that tumor.” He also highlighted safety data, noting that the platform has been widely used in SARS-CoV-2 vaccine development, providing confidence in large-scale application. “The potential exists to achieve more personalized, tumor-directed immunotherapy with greater scalability,” he explained.
Outlook and Limitations
Lima noted that although the projected efficacy is promising, definitive results are still pending.
“We have very positive expectations, but we must wait for study outcomes. Efficacy may vary across scenarios and among patients. The immune system may also respond against the vaccine itself, potentially reducing effectiveness at times,” he explained.
According to Lima, mRNA vaccines are expected to complement current treatments, enhancing outcomes without replacing conventional approaches entirely.
“It will not be a panacea. These vaccines are likely to add to and improve strategies we already use, but they will not work for all patients in every scenario,” he concluded.
Lepique highlighted the promise of combination strategies. “The outlook is positive, particularly because multiple mRNA types can be combined in a single formulation and used alongside drugs that enhance immune responses,” she explained.
Although mRNA vaccine research has been ongoing for many years, prior results have brought both progress and setbacks. “This new protocol appears more effective [and] capable of generating immunological memory and is also safe,” she noted. Still, she cautioned that cancer presents unique challenges: “The disease has multiple mechanisms to evade immune responses. Additionally, some tumors are naturally unrecognized by the immune system, the so-called ‘cold tumors.’”
This story was translated from Medscape’s Portuguese edition. A version of this article appeared on Medscape.com.
Since 1965, messenger RNA (mRNA) vaccines have been studied for cancer treatment, but it was the technological advances in vaccines during the COVID pandemic that helped accelerate research. Currently, no vaccine has been approved for tumor treatment, although many clinical studies are ongoing worldwide. According to experts consulted by Medscape’s Portuguese edition, the outlook is very promising, and these studies are expected to open doors for personalized therapies.
In cancer treatment, the vaccine would function as an immunotherapy, in which the immune system can be “trained” to act against an invader. Just as with pathogens, the platform would use parts of the tumor — which have altered proteins or are expressed at abnormal levels — to teach the body to defend itself against cancer.
Vladmir Lima, MD, PhD, clinical oncologist at A.C. Camargo Cancer Center, São Paulo, Brazil, explained that with this technology it will be possible to produce personalized vaccines, which prevents, for example, large-scale manufacturing. “In theory, these vaccines can be developed for any tumor type, but this does not mean that efficacy will be the same for all,” he said. Because cancer has specific characteristics in each individual, it is difficult to envision a single vaccine that works for all cancers.
Current evidence suggests the vaccine could be administered after chemotherapy or radiotherapy, with the goal of reducing tumor mass and increasing the effectiveness of mRNA-based treatment, according to Ana Paula Lepique, professor and researcher in tumor immunology at the Institute of Biomedical Sciences, University of São Paulo, São Paulo.
“There is also a study with pancreatic cancer patients, in which the vaccine was administered after surgery,” she explained. “It would not work, for example, to give chemotherapy or radiotherapy while the immune response is being triggered by the vaccine. This would make the vaccine ineffective, since chemotherapy and radiotherapy are toxic to lymphocytes.”
Lepique also clarified that it is possible to combine the vaccine with immunotherapy targeting immune regulatory molecules. “In this case, in addition to administering the mRNA with the antigen, a strategy is used to improve the patient’s immune response.”
Challenges With mRNA Vaccines
Despite being a promising technology, there are challenges, warned Lepique. mRNA molecules degrade quickly when injected into the body, which can compromise vaccine efficacy. To overcome this, researchers have developed nanoencapsulation technologies that protect the molecules and allow safe use in vaccines. “Another alternative is transferring the mRNA into dendritic cells, known as antigen-presenting cells, and then administering these cells to the patient,” she explained.
Global Research Status
According to a study published this year in Med, over 120 clinical trials are exploring mRNA vaccines to treat lung, breast, prostate, and pancreatic tumors, as well as melanoma.
Lepique noted that the countries leading this research are the US, UK, Germany, China, and Japan. “Unfortunately, the US government recently cut funding for mRNA vaccine development and testing, which will likely have significant consequences,” she said.
Lepique reported that Brazilian researchers are collaborating with international institutions to develop these vaccines. “The Brazilian government, through the Ministry of Health and the Ministry of Science, Technology, and Innovation, recently announced investments in mRNA technologies for vaccines. While not specifically targeting cancer, these investments could also benefit this field,” she clarified.
Leading Studies
Lepique highlighted the most advanced studies to date:
- Pancreatic cancer: A study published in Nature in February demonstrated that a personalized mRNA vaccine reduced the risk for recurrence after surgery in 16 patients, with 3 years of follow-up.
- Melanoma: A study published in The Lancet reported improved survival in melanoma patients after mRNA vaccine administration combined with the checkpoint inhibitor pembrolizumab applied after surgical tumor resection.
- Universal vaccine: A study in Nature Biomedical Engineering described the creation of a “generic” vaccine capable of activating the patient’s immune system and inducing tumor regression. Lepique explained that this vaccine acts more as an immune response modulator than a classical neoantigen-specific vaccine. “Because it is not limited to a single neoantigen, it could potentially be universal, though further testing is needed to determine efficacy across all cancer types,” she added.
Lima highlighted a 2024 study being conducted by MSD and Moderna against lung cancer, with results yet to be published. “Patients first receive immunotherapy after surgery. Once the vaccine is ready, it is added to the ongoing immunotherapy,” he explained. The global phase 3 study involves 868 patients with resected lung cancer who previously underwent chemotherapy. Participants receive the vaccine (1 mg every 3 weeks, up to nine doses) alongside pembrolizumab (400 mg every 6 weeks, up to nine cycles) over approximately 1 year.
Other mRNA vaccines remain in early-stage development. For example, in May 2024, the UK National Health Service recruited participants for a personalized colorectal cancer mRNA vaccine trial.
Advantages of mRNA Technology
Experts noted that mRNA-based cancer vaccines are considered safer for patients because the tumor mRNA is synthesized in the laboratory. According to Lepique, these vaccines are more specific than many other cancer therapies, and therefore carry a lower risk for serious side effects.
“Clinical studies have shown that these vaccines can generate immunological memory, meaning lymphocytes that recognize tumor antigens remain in the body and can respond to recurrence,” she explained.
It is also possible to combine multiple mRNA molecules in a single vaccine, creating a platform that targets several tumor antigens simultaneously. “Formulations can additionally include adjuvants to further enhance immune responses against tumors,” she said. However, as a personalized therapy, costs are high, and vaccine formulation requires considerable time.
Lima emphasized the customization advantage: “We can take a portion of the patient’s tumor, sequence it to identify alterations, and develop a vaccine specifically for that tumor.” He also highlighted safety data, noting that the platform has been widely used in SARS-CoV-2 vaccine development, providing confidence in large-scale application. “The potential exists to achieve more personalized, tumor-directed immunotherapy with greater scalability,” he explained.
Outlook and Limitations
Lima noted that although the projected efficacy is promising, definitive results are still pending.
“We have very positive expectations, but we must wait for study outcomes. Efficacy may vary across scenarios and among patients. The immune system may also respond against the vaccine itself, potentially reducing effectiveness at times,” he explained.
According to Lima, mRNA vaccines are expected to complement current treatments, enhancing outcomes without replacing conventional approaches entirely.
“It will not be a panacea. These vaccines are likely to add to and improve strategies we already use, but they will not work for all patients in every scenario,” he concluded.
Lepique highlighted the promise of combination strategies. “The outlook is positive, particularly because multiple mRNA types can be combined in a single formulation and used alongside drugs that enhance immune responses,” she explained.
Although mRNA vaccine research has been ongoing for many years, prior results have brought both progress and setbacks. “This new protocol appears more effective [and] capable of generating immunological memory and is also safe,” she noted. Still, she cautioned that cancer presents unique challenges: “The disease has multiple mechanisms to evade immune responses. Additionally, some tumors are naturally unrecognized by the immune system, the so-called ‘cold tumors.’”
This story was translated from Medscape’s Portuguese edition. A version of this article appeared on Medscape.com.
US Health Official Calls for Separating Measles Combination Shots, Pulls Broad COVID Vaccine Support
(Reuters) -A top U.S. health official on Monday called for the combined measles-mumps-rubella shot to be broken up, drawing a quick rebuke from vaccine maker Merck, which said there is no scientific evidence that shows any benefit to doing so.
The U.S. CDC earlier on Monday pulled broad support for COVID-19 shots, saying they should be administered through shared decision-making with a health care provider in accordance with recommendations from Health Secretary Robert F. Kennedy Jr.’s hand-picked vaccine advisory panel.
The acting director of the Centers for Disease Control and Prevention, Jim O’Neill, in an X post on Monday called on vaccine manufacturers to develop three separate vaccines to replace the combined MMR inoculation.
In a September 23 news conference at the White House, President Donald Trump delivered medical advice to pregnant women and parents of young children, repeatedly telling them common vaccines should not be taken together or so early in a child’s life, and urging them not to use or administer Tylenol, against the advice of medical societies.
Kennedy, a long-time anti-vaccine crusader before taking on the nation’s top health post, has linked vaccines to autism and sought to rewrite the country’s immunization policies. He fired all members of the national vaccine advisory board of outside experts and replaced them with new members, many of whom shared his views. The committee is reviewing the childhood vaccine schedule.
The causes of autism are unclear. But no rigorous studies have found links between autism and vaccines or medications, or their components such as thimerosal or formaldehyde. Vaccination rates have declined as autism rates have climbed.
MERCK, EXPERTS DEFEND MMR SHOT
Merck said there is no published scientific evidence that shows any benefit in separating the MMR shot.
According to the U.S. Food and Drug Administration’s website, there are currently no separate single virus shots for measles, mumps or rubella licensed for use in the United States. That means manufacturers could need to go through the FDA approval process before any become available.
“Use of the individual components of combination vaccines increases the number of injections for the individual and may result in delayed or missed immunizations,” Merck said in a statement.
Dr. Rana Alissa, president of the Florida chapter of the American Academy of Pediatrics, said the purpose of combining the three shots in the MMR vaccine is not only to save parents extra visits to the doctor’s office.
“Studies have shown that when you give them together, the immune response is much better,” she said. “This is how you get lifelong immunity.”
GSK, which also makes an MMR shot, declined to comment. A spokesman for the U.S. Department of Health and Human Services, where O’Neill is deputy secretary, was not immediately available for comment.
The break-up of the MMR shot would “falsely imply that there is something unsafe about giving the measles, mumps, and rubella vaccines at the same time,” said Dr. Amesh Adalja, an infectious disease expert at the Johns Hopkins Center for Health Security.
“It would be another example of the federal government pandering to the anti-vaccine movement,” Adalja added.
Earlier in the day, the CDC signed off on the advisers’ recommendations against use of the combined measles-mumps-rubella-varicella vaccine before the age of 4 years because of a slight risk of seizures related to high fevers. Instead, varicella, commonly known as chickenpox, is recommended as a standalone shot.
Merck also makes the measles-mumps-rubella-varicella shot.
CDC CHANGES COVID VIEWS
The new CDC recommendation on the COVID vaccine calls for physician involvement but maintains access for the shot through health insurance.
The immunization schedules will be updated on the CDC website by Tuesday, the agency said.
The recommendations come after upheaval at the CDC, including the ouster of its former Director Susan Monarez, who had resisted changes to vaccine policy advanced by Kennedy. Monarez said she was told to rubber-stamp the committee’s recommendations without reviewing the scientific evidence.
The new advisory panel made its recommendations at a two-day meeting in September that highlighted deep divisions over the future of the U.S. immunization schedules under Kennedy.
The American Academy of Pediatrics, an influential U.S. medical group, has already broken from federal policy and pushed its own vaccine recommendations, suggesting all young children get vaccinated against COVID-19.
The U.S. Food and Drug Administration in August cleared updated COVID-19 vaccines for everyone over age 65, but limited its approval for younger people to those with health risks.
The 3 approved COVID shots are made by Pfizer with German partner BioNTech, Moderna, and Novavax with Sanofi.
(Reporting by Mariam Sunny in Bengaluru, Michael Erman in New York and Julie Steenhuysen in Chicago; Editing by Caroline Humer and Bill Berkrot)■
A version of this article appeared on Medscape.com.
(Reuters) -A top U.S. health official on Monday called for the combined measles-mumps-rubella shot to be broken up, drawing a quick rebuke from vaccine maker Merck, which said there is no scientific evidence that shows any benefit to doing so.
The U.S. CDC earlier on Monday pulled broad support for COVID-19 shots, saying they should be administered through shared decision-making with a health care provider in accordance with recommendations from Health Secretary Robert F. Kennedy Jr.’s hand-picked vaccine advisory panel.
The acting director of the Centers for Disease Control and Prevention, Jim O’Neill, in an X post on Monday called on vaccine manufacturers to develop three separate vaccines to replace the combined MMR inoculation.
In a September 23 news conference at the White House, President Donald Trump delivered medical advice to pregnant women and parents of young children, repeatedly telling them common vaccines should not be taken together or so early in a child’s life, and urging them not to use or administer Tylenol, against the advice of medical societies.
Kennedy, a long-time anti-vaccine crusader before taking on the nation’s top health post, has linked vaccines to autism and sought to rewrite the country’s immunization policies. He fired all members of the national vaccine advisory board of outside experts and replaced them with new members, many of whom shared his views. The committee is reviewing the childhood vaccine schedule.
The causes of autism are unclear. But no rigorous studies have found links between autism and vaccines or medications, or their components such as thimerosal or formaldehyde. Vaccination rates have declined as autism rates have climbed.
MERCK, EXPERTS DEFEND MMR SHOT
Merck said there is no published scientific evidence that shows any benefit in separating the MMR shot.
According to the U.S. Food and Drug Administration’s website, there are currently no separate single virus shots for measles, mumps or rubella licensed for use in the United States. That means manufacturers could need to go through the FDA approval process before any become available.
“Use of the individual components of combination vaccines increases the number of injections for the individual and may result in delayed or missed immunizations,” Merck said in a statement.
Dr. Rana Alissa, president of the Florida chapter of the American Academy of Pediatrics, said the purpose of combining the three shots in the MMR vaccine is not only to save parents extra visits to the doctor’s office.
“Studies have shown that when you give them together, the immune response is much better,” she said. “This is how you get lifelong immunity.”
GSK, which also makes an MMR shot, declined to comment. A spokesman for the U.S. Department of Health and Human Services, where O’Neill is deputy secretary, was not immediately available for comment.
The break-up of the MMR shot would “falsely imply that there is something unsafe about giving the measles, mumps, and rubella vaccines at the same time,” said Dr. Amesh Adalja, an infectious disease expert at the Johns Hopkins Center for Health Security.
“It would be another example of the federal government pandering to the anti-vaccine movement,” Adalja added.
Earlier in the day, the CDC signed off on the advisers’ recommendations against use of the combined measles-mumps-rubella-varicella vaccine before the age of 4 years because of a slight risk of seizures related to high fevers. Instead, varicella, commonly known as chickenpox, is recommended as a standalone shot.
Merck also makes the measles-mumps-rubella-varicella shot.
CDC CHANGES COVID VIEWS
The new CDC recommendation on the COVID vaccine calls for physician involvement but maintains access for the shot through health insurance.
The immunization schedules will be updated on the CDC website by Tuesday, the agency said.
The recommendations come after upheaval at the CDC, including the ouster of its former Director Susan Monarez, who had resisted changes to vaccine policy advanced by Kennedy. Monarez said she was told to rubber-stamp the committee’s recommendations without reviewing the scientific evidence.
The new advisory panel made its recommendations at a two-day meeting in September that highlighted deep divisions over the future of the U.S. immunization schedules under Kennedy.
The American Academy of Pediatrics, an influential U.S. medical group, has already broken from federal policy and pushed its own vaccine recommendations, suggesting all young children get vaccinated against COVID-19.
The U.S. Food and Drug Administration in August cleared updated COVID-19 vaccines for everyone over age 65, but limited its approval for younger people to those with health risks.
The 3 approved COVID shots are made by Pfizer with German partner BioNTech, Moderna, and Novavax with Sanofi.
(Reporting by Mariam Sunny in Bengaluru, Michael Erman in New York and Julie Steenhuysen in Chicago; Editing by Caroline Humer and Bill Berkrot)■
A version of this article appeared on Medscape.com.
(Reuters) -A top U.S. health official on Monday called for the combined measles-mumps-rubella shot to be broken up, drawing a quick rebuke from vaccine maker Merck, which said there is no scientific evidence that shows any benefit to doing so.
The U.S. CDC earlier on Monday pulled broad support for COVID-19 shots, saying they should be administered through shared decision-making with a health care provider in accordance with recommendations from Health Secretary Robert F. Kennedy Jr.’s hand-picked vaccine advisory panel.
The acting director of the Centers for Disease Control and Prevention, Jim O’Neill, in an X post on Monday called on vaccine manufacturers to develop three separate vaccines to replace the combined MMR inoculation.
In a September 23 news conference at the White House, President Donald Trump delivered medical advice to pregnant women and parents of young children, repeatedly telling them common vaccines should not be taken together or so early in a child’s life, and urging them not to use or administer Tylenol, against the advice of medical societies.
Kennedy, a long-time anti-vaccine crusader before taking on the nation’s top health post, has linked vaccines to autism and sought to rewrite the country’s immunization policies. He fired all members of the national vaccine advisory board of outside experts and replaced them with new members, many of whom shared his views. The committee is reviewing the childhood vaccine schedule.
The causes of autism are unclear. But no rigorous studies have found links between autism and vaccines or medications, or their components such as thimerosal or formaldehyde. Vaccination rates have declined as autism rates have climbed.
MERCK, EXPERTS DEFEND MMR SHOT
Merck said there is no published scientific evidence that shows any benefit in separating the MMR shot.
According to the U.S. Food and Drug Administration’s website, there are currently no separate single virus shots for measles, mumps or rubella licensed for use in the United States. That means manufacturers could need to go through the FDA approval process before any become available.
“Use of the individual components of combination vaccines increases the number of injections for the individual and may result in delayed or missed immunizations,” Merck said in a statement.
Dr. Rana Alissa, president of the Florida chapter of the American Academy of Pediatrics, said the purpose of combining the three shots in the MMR vaccine is not only to save parents extra visits to the doctor’s office.
“Studies have shown that when you give them together, the immune response is much better,” she said. “This is how you get lifelong immunity.”
GSK, which also makes an MMR shot, declined to comment. A spokesman for the U.S. Department of Health and Human Services, where O’Neill is deputy secretary, was not immediately available for comment.
The break-up of the MMR shot would “falsely imply that there is something unsafe about giving the measles, mumps, and rubella vaccines at the same time,” said Dr. Amesh Adalja, an infectious disease expert at the Johns Hopkins Center for Health Security.
“It would be another example of the federal government pandering to the anti-vaccine movement,” Adalja added.
Earlier in the day, the CDC signed off on the advisers’ recommendations against use of the combined measles-mumps-rubella-varicella vaccine before the age of 4 years because of a slight risk of seizures related to high fevers. Instead, varicella, commonly known as chickenpox, is recommended as a standalone shot.
Merck also makes the measles-mumps-rubella-varicella shot.
CDC CHANGES COVID VIEWS
The new CDC recommendation on the COVID vaccine calls for physician involvement but maintains access for the shot through health insurance.
The immunization schedules will be updated on the CDC website by Tuesday, the agency said.
The recommendations come after upheaval at the CDC, including the ouster of its former Director Susan Monarez, who had resisted changes to vaccine policy advanced by Kennedy. Monarez said she was told to rubber-stamp the committee’s recommendations without reviewing the scientific evidence.
The new advisory panel made its recommendations at a two-day meeting in September that highlighted deep divisions over the future of the U.S. immunization schedules under Kennedy.
The American Academy of Pediatrics, an influential U.S. medical group, has already broken from federal policy and pushed its own vaccine recommendations, suggesting all young children get vaccinated against COVID-19.
The U.S. Food and Drug Administration in August cleared updated COVID-19 vaccines for everyone over age 65, but limited its approval for younger people to those with health risks.
The 3 approved COVID shots are made by Pfizer with German partner BioNTech, Moderna, and Novavax with Sanofi.
(Reporting by Mariam Sunny in Bengaluru, Michael Erman in New York and Julie Steenhuysen in Chicago; Editing by Caroline Humer and Bill Berkrot)■
A version of this article appeared on Medscape.com.
Hepatitis D Virus Classified as Carcinogenic: Implications
The International Agency for Research on Cancer (IARC) of the World Health Organization has classified hepatitis D virus (HDV) as carcinogenic, citing sufficient evidence and placing it alongside hepatitis B virus (HBV) and hepatitis C virus (HCV) as a cause of hepatocellular carcinoma (HCC).
Individuals with HBV-HDV coinfection face an elevated risk for liver cancer, highlighting the need for HBV vaccination, systematic screening, and early antiviral treatment to reduce the progression to cirrhosis and HCC.
About 12 million people globally have HBV-HDV coinfection, representing 5% of all chronic HBV cases. The prevalence of this condition varies regionally, with a likely underdiagnosis. True coinfection rates may reach 13%-14%, the highest in Europe’s Mediterranean region.
Virus Biology
HDV is an incomplete virus that infects hepatocytes and requires the envelope protein of hepatitis B surface antigen (HBsAg) for cell exit. Infection occurs only with chronic HBV infection, either as a superinfection or simultaneous acquisition. Humans are the only known natural host.
HDV coinfection worsens HBV-induced hepatic inflammation and prognosis, and up to 80% of patients develop cirrhosis. Triple infection with the HBV virus, HDV, and HIV further increases this risk, and the global prevalence is likely underestimated.
Cancer Risk
HDV infection significantly increases the risk for HCC compared with HBV infection alone. Many patients die from decompensated cirrhosis or HCC, reflecting the aggressive nature of coinfection.
The molecular mechanisms underlying HDV oncogenesis remain unclear. Research conducted over the past 15 years has provided insights that could inform the development of more effective treatments.
Early vaccination prophylaxis is critical for reducing the risk for HCC, despite limited options.
Treatment Options
Randomized controlled trials have demonstrated antiviral efficacy for:
- Pegylated interferon alpha (Peg-IFN) is approved for HBV and is active against HDV.
- Bulevirtide, a synthetic myristoylated lipopeptide entry inhibitor, is used alone or in combination with Peg-IFN.
Suppression of HBV remains central. Nucleoside and nucleotide analogs, such as entecavir, tenofovir alafenamide fumarate, and tenofovir disoproxil fumarate, significantly reduce HCC progression in treated patients compared with untreated patients at risk.
Promising therapeutics include lonafarnib, a farnesyltransferase inhibitor that blocks HDV particle formation, and nucleic acid polymers targeting the host chaperone DNAJB12 to inhibit HBV and HDV replication.
Guideline Updates
The 2023 addendum to the S3 guidelines covers the prophylaxis, diagnosis, and treatment of HBV, including HDV management.
IARC experts also re-evaluated the human cytomegalovirus and Merkel cell polyomavirus. Complete assessments are expected in the next edition of IARC Monographs.
HBV Vaccination
HBV vaccination is the only effective prophylaxis against HBV and HDV. Introduced in 1982 for high-risk groups, it reduced chronic infections, with the WHO expanding its recommendations from 1992 onward.
Infants and young children are at the highest risk of developing this disease. Acute HBV infection often resolves in adults, but infants face up to a 90% risk of developing chronic infection. Newborns of mothers with chronic or undiagnosed HBV infections are particularly vulnerable.
Routine infant immunization includes three doses, with the first dose administered within 12 hours of birth. In Germany, the Standing Committee on Vaccination (STIKO) recommends the administration of combination vaccines, with the hexavalent vaccine administered at 2, 4, and 11 months in a 2 + 1 schedule.
Timely vaccination is crucial because undetected chronic infections often lead to late-stage HCC diagnosis. Adults in high-risk groups should receive HBV vaccination counseling.
STIKO recommends vaccination for close contacts of individuals who are HBsAg-positive, individuals with high-risk sexual contacts, immunocompromised persons, and those with preexisting conditions that increase the risk for severe HBV infection.
Since 2021, insured adults aged 35 years or older in Germany have undergone one-time HBV and HCV screening. HDV testing is recommended for all HBsAg-positive patients. Current frameworks may miss cases, and additional or personalized screening could improve the detection of previously unrecognized infections.
This story was translated from Univadis Germany.
A version of this article appeared on Medscape.com.
The International Agency for Research on Cancer (IARC) of the World Health Organization has classified hepatitis D virus (HDV) as carcinogenic, citing sufficient evidence and placing it alongside hepatitis B virus (HBV) and hepatitis C virus (HCV) as a cause of hepatocellular carcinoma (HCC).
Individuals with HBV-HDV coinfection face an elevated risk for liver cancer, highlighting the need for HBV vaccination, systematic screening, and early antiviral treatment to reduce the progression to cirrhosis and HCC.
About 12 million people globally have HBV-HDV coinfection, representing 5% of all chronic HBV cases. The prevalence of this condition varies regionally, with a likely underdiagnosis. True coinfection rates may reach 13%-14%, the highest in Europe’s Mediterranean region.
Virus Biology
HDV is an incomplete virus that infects hepatocytes and requires the envelope protein of hepatitis B surface antigen (HBsAg) for cell exit. Infection occurs only with chronic HBV infection, either as a superinfection or simultaneous acquisition. Humans are the only known natural host.
HDV coinfection worsens HBV-induced hepatic inflammation and prognosis, and up to 80% of patients develop cirrhosis. Triple infection with the HBV virus, HDV, and HIV further increases this risk, and the global prevalence is likely underestimated.
Cancer Risk
HDV infection significantly increases the risk for HCC compared with HBV infection alone. Many patients die from decompensated cirrhosis or HCC, reflecting the aggressive nature of coinfection.
The molecular mechanisms underlying HDV oncogenesis remain unclear. Research conducted over the past 15 years has provided insights that could inform the development of more effective treatments.
Early vaccination prophylaxis is critical for reducing the risk for HCC, despite limited options.
Treatment Options
Randomized controlled trials have demonstrated antiviral efficacy for:
- Pegylated interferon alpha (Peg-IFN) is approved for HBV and is active against HDV.
- Bulevirtide, a synthetic myristoylated lipopeptide entry inhibitor, is used alone or in combination with Peg-IFN.
Suppression of HBV remains central. Nucleoside and nucleotide analogs, such as entecavir, tenofovir alafenamide fumarate, and tenofovir disoproxil fumarate, significantly reduce HCC progression in treated patients compared with untreated patients at risk.
Promising therapeutics include lonafarnib, a farnesyltransferase inhibitor that blocks HDV particle formation, and nucleic acid polymers targeting the host chaperone DNAJB12 to inhibit HBV and HDV replication.
Guideline Updates
The 2023 addendum to the S3 guidelines covers the prophylaxis, diagnosis, and treatment of HBV, including HDV management.
IARC experts also re-evaluated the human cytomegalovirus and Merkel cell polyomavirus. Complete assessments are expected in the next edition of IARC Monographs.
HBV Vaccination
HBV vaccination is the only effective prophylaxis against HBV and HDV. Introduced in 1982 for high-risk groups, it reduced chronic infections, with the WHO expanding its recommendations from 1992 onward.
Infants and young children are at the highest risk of developing this disease. Acute HBV infection often resolves in adults, but infants face up to a 90% risk of developing chronic infection. Newborns of mothers with chronic or undiagnosed HBV infections are particularly vulnerable.
Routine infant immunization includes three doses, with the first dose administered within 12 hours of birth. In Germany, the Standing Committee on Vaccination (STIKO) recommends the administration of combination vaccines, with the hexavalent vaccine administered at 2, 4, and 11 months in a 2 + 1 schedule.
Timely vaccination is crucial because undetected chronic infections often lead to late-stage HCC diagnosis. Adults in high-risk groups should receive HBV vaccination counseling.
STIKO recommends vaccination for close contacts of individuals who are HBsAg-positive, individuals with high-risk sexual contacts, immunocompromised persons, and those with preexisting conditions that increase the risk for severe HBV infection.
Since 2021, insured adults aged 35 years or older in Germany have undergone one-time HBV and HCV screening. HDV testing is recommended for all HBsAg-positive patients. Current frameworks may miss cases, and additional or personalized screening could improve the detection of previously unrecognized infections.
This story was translated from Univadis Germany.
A version of this article appeared on Medscape.com.
The International Agency for Research on Cancer (IARC) of the World Health Organization has classified hepatitis D virus (HDV) as carcinogenic, citing sufficient evidence and placing it alongside hepatitis B virus (HBV) and hepatitis C virus (HCV) as a cause of hepatocellular carcinoma (HCC).
Individuals with HBV-HDV coinfection face an elevated risk for liver cancer, highlighting the need for HBV vaccination, systematic screening, and early antiviral treatment to reduce the progression to cirrhosis and HCC.
About 12 million people globally have HBV-HDV coinfection, representing 5% of all chronic HBV cases. The prevalence of this condition varies regionally, with a likely underdiagnosis. True coinfection rates may reach 13%-14%, the highest in Europe’s Mediterranean region.
Virus Biology
HDV is an incomplete virus that infects hepatocytes and requires the envelope protein of hepatitis B surface antigen (HBsAg) for cell exit. Infection occurs only with chronic HBV infection, either as a superinfection or simultaneous acquisition. Humans are the only known natural host.
HDV coinfection worsens HBV-induced hepatic inflammation and prognosis, and up to 80% of patients develop cirrhosis. Triple infection with the HBV virus, HDV, and HIV further increases this risk, and the global prevalence is likely underestimated.
Cancer Risk
HDV infection significantly increases the risk for HCC compared with HBV infection alone. Many patients die from decompensated cirrhosis or HCC, reflecting the aggressive nature of coinfection.
The molecular mechanisms underlying HDV oncogenesis remain unclear. Research conducted over the past 15 years has provided insights that could inform the development of more effective treatments.
Early vaccination prophylaxis is critical for reducing the risk for HCC, despite limited options.
Treatment Options
Randomized controlled trials have demonstrated antiviral efficacy for:
- Pegylated interferon alpha (Peg-IFN) is approved for HBV and is active against HDV.
- Bulevirtide, a synthetic myristoylated lipopeptide entry inhibitor, is used alone or in combination with Peg-IFN.
Suppression of HBV remains central. Nucleoside and nucleotide analogs, such as entecavir, tenofovir alafenamide fumarate, and tenofovir disoproxil fumarate, significantly reduce HCC progression in treated patients compared with untreated patients at risk.
Promising therapeutics include lonafarnib, a farnesyltransferase inhibitor that blocks HDV particle formation, and nucleic acid polymers targeting the host chaperone DNAJB12 to inhibit HBV and HDV replication.
Guideline Updates
The 2023 addendum to the S3 guidelines covers the prophylaxis, diagnosis, and treatment of HBV, including HDV management.
IARC experts also re-evaluated the human cytomegalovirus and Merkel cell polyomavirus. Complete assessments are expected in the next edition of IARC Monographs.
HBV Vaccination
HBV vaccination is the only effective prophylaxis against HBV and HDV. Introduced in 1982 for high-risk groups, it reduced chronic infections, with the WHO expanding its recommendations from 1992 onward.
Infants and young children are at the highest risk of developing this disease. Acute HBV infection often resolves in adults, but infants face up to a 90% risk of developing chronic infection. Newborns of mothers with chronic or undiagnosed HBV infections are particularly vulnerable.
Routine infant immunization includes three doses, with the first dose administered within 12 hours of birth. In Germany, the Standing Committee on Vaccination (STIKO) recommends the administration of combination vaccines, with the hexavalent vaccine administered at 2, 4, and 11 months in a 2 + 1 schedule.
Timely vaccination is crucial because undetected chronic infections often lead to late-stage HCC diagnosis. Adults in high-risk groups should receive HBV vaccination counseling.
STIKO recommends vaccination for close contacts of individuals who are HBsAg-positive, individuals with high-risk sexual contacts, immunocompromised persons, and those with preexisting conditions that increase the risk for severe HBV infection.
Since 2021, insured adults aged 35 years or older in Germany have undergone one-time HBV and HCV screening. HDV testing is recommended for all HBsAg-positive patients. Current frameworks may miss cases, and additional or personalized screening could improve the detection of previously unrecognized infections.
This story was translated from Univadis Germany.
A version of this article appeared on Medscape.com.
Physician Compensation: Gains Small, Gaps Large
Few would deny that physicians today face many challenges: a growing and aging patient population, personnel shortages, mounting paperwork, regulatory and reimbursement pressures, and personal burnout. Collectively these could work to worsen patient access to care. Yet despite these headwinds, Doximity’s survey-based Physician Compensation Report 2025 found that more than three-quarters of physicians polled would still choose to enter their profession.
“Physician burnout isn’t new. It’s been a persistent problem over the past decade,” said Amit Phull, MD, chief clinical experience officer at Doximity. “In a Doximity poll of nearly 2,000 physicians conducted in May 2025, 85% reported they feel overworked, up from 73% just four years ago. As a result, about 68% of physicians said they are looking for an employment change or considering early retirement.”
Greater awareness of contemporary trends may help physicians make more-informed career decisions and more effectively advocate for both themselves and the patients who need them, the report’s authors stated.
Compensation Lag May Impact Care
A small overall average compensation increase of 3.7% from 2023 to 2024 – a slightly lower increase than the 5.9% in the prior year – has done little to close existing pay gaps across the profession.
In 2024, average compensation for men rose 5.7% over 2023, compared with just 1.7% for women – widening the gender pay gap to 26% vs 23% in 2023 and matching the gender gap seen in 2022. And significant disparities persist between physicians caring for adults vs children. In some specialties, the pay gap between pediatric and adult specialists exceeded 80% despite practitioners’ similar levels of training and clinical complexity.
Nearly 60% of respondents said reimbursement pressures could affect their ability to serve Medicare or Medicaid patients in the next year. Additionally, 81% reported that reimbursement policies have significantly contributed to the decline of private practices, and more than a third said they could stifle practice growth with compensation concerns forcing them to delay or cancel hiring or expansion plans. Almost 90% reported an adverse impact from physician shortages, with more citing an inability or limited ability to accept new patients.
Narrowing the Gap for Primary Care?
Over the past three years, the percent pay gap between primary care and specialist medicine declined modestly, the report noted. In 2024, surgical specialists earned 87% more than primary care physicians, down from 100% in 2022. Non-surgical specialists, emergency medicine physicians, and Ob/Gyns also continued to earn significantly more than primary care physicians, though the gaps have narrowed slightly.
“These trends come at a time when primary care remains critical to meeting high patient demand, especially amid ongoing physician shortages,” the report stated. “Primary care physicians continue to earn considerably less than many of their medical colleagues despite their essential role in the healthcare system.”
Significantly, many physicians believe that current reimbursement policies have contributed to the steady decline of independent practices in their fields. According to the American Medical Association, the share of physicians working in private practices dropped by 18 percentage points from 60.1% to 42.2% from 2012 to 2024.
The Specialties
This year’s review found that among 20 specialties, the highest average compensation occurred in surgical and procedural specialties, while the lowest paid were, as mentioned, pediatric medicine and primary care. Pediatric nephrology saw the largest average compensation growth in 2024 at 15.6%, yet compensation still lagged behind adult nephrology with a 40% pay gap.
By medical discipline, gastroenterologists ranked 13th overall in average annual compensation. Gastroenterology remained in the top 20 compensated specialties, with average annual compensation of $537,870 – an increase from $514,208 in 2024, representing a 4.5% growth rate over 2023. Neurosurgeons topped the list at $749,140, followed by thoracic surgeons at $689,969 and orthopedic surgeons at $679,517.
The three lowest-paid branches were all pediatric: endocrinology at $230,426, rheumatology at $231,574, and infectious diseases at $248,322. Pediatric gastroenterology paid somewhat higher at $298,457.
The largest disparities were seen in hematology and oncology, where adult specialists earned 93% more than their pediatric peers. Pediatric gastroenterology showed an 80% pay gap. There were also substantial pay differences across cardiology, pulmonology, and rheumatology. “These gaps appear to reflect a systemic lag in pay for pediatric specialty care, even as demand for pediatric subspecialists continues to rise,” the report stated.
Practice Setting and Location
Where a doctor practices impacts the bottom line, too: in 2024 the highest compensation reported for a metro area was in Rochester, Minnesota (the Mayo Clinic effect?), at $495,532, while the lowest reported was in Durham-Chapel Hill, North Carolina, at $368,782. St. Louis, Missouri ($484,883) and Los Angeles, California ($470,198) were 2nd and 3rd at the top of the list. Rochester, Minnesota, also emerged as best for annual compensation after cost-of-living adjustment, while Boston, Massachusetts, occupied the bottom rung.
The Gender Effect
With a women’s pay increase in 2024 of just 1.7%, the gender gap returned to its 2022-level disparity of 26%, with women physicians earning an average of $120,917 less than men after adjusting for specialty, location, and years of experience.
Doximity’s analysis of data from 2014 to 2019 estimated that on average men make at least $2 million more than women over the course of a 40-year career. This gap is often attributed to the fewer hours worked by female physician with their generally heavier familial responsibilities, “but Doximity’s gender wage gap analysis controls for the number of hours worked and career stage, along with specialty, work type, employment status, region, and credentials,” Phull said.
Women physicians had lower average earnings than men physicians across all specialties, a trend consistent with prior years. As a percentage of pay, the largest gender disparity was seen in pediatric nephrology (16.5%), a specialty that in fact saw the largest annual growth in physician pay. Neurosurgery had the smallest gender gap at 11.3%, while infectious diseases came in at 11.5% and oncology at 12%.
According to Maria T. Abreu, MD, AGAF, executive director of the F. Widjaja Inflammatory Bowel Disease Institute at Cedars-Sinai Medical Center in Los Angeles and past president of AGA, the remuneration gender gap in gastroenterology is being taken seriously by AGA and several other GI societies. “The discrepancies in pay start from the beginning and therefore are magnified over time. We are helping to empower women to negotiate better as well as to gather data on the roots of inequity, she told GI & Hepatology News.
The AGA Women’s Committee has developed a project to support the advancement of women in gastroenterology, Abreu said. The initiative, which includes the AGA Gender Equity Framework and Gender Equity Road Map. focuses attention on disparities in the workplace and promotes opportunities for women’s leadership, career advancement, mentorship and physician health and wellness, she added.
Are these disparities due mainly to the “motherhood penalty,” with career interruption and time lost to maternity leave and fewer hours worked owing to the greater parenting burden of physician mothers? Or are they due to the systemic effects of gender expectations around compensation?
Hours worked appear to be a factor. A 2017 study of dual physician couples found that among childless respondents men worked an average of 57 hours and women 52 hours weekly. Compared with childless men, men with children worked similar numbers of hours weekly. However, compared with childless physicians, mothers worked significantly fewer hours – roughly 40 to 43 hours weekly – depending on the age of their youngest child.
Abreu pushed back on this stereotype. “Most women physicians, including gastroenterologists, do not take the maternity leave they are allowed because they are concerned about burdening their colleagues,” she said. “Thus, it is unlikely to explain the disparities. Many systemic issues remain challenging, but we want women to be empowered to advocate for themselves at the time of hiring and along the arc of their career paths.”
In Abreu’s view, having women assume more leadership roles in the field of gastroenterology provides an opportunity to focus on reducing the disparities in compensation.
Regardless of gender, among all physicians surveyed, autonomy and work-life balance appeared to be a high priority: 77% of doctors said they would be willing to accept or have already accepted lower pay for more autonomy or work-life balance. “Overwork appears to be especially prevalent among women physicians,” said Phull, noting that 91% of women respondents reported being overworked compared with 80% of men. “This overwork has compelled 74% of women to consider making a career change, compared with 62% of men.” Differences emerged among specialties as well: 90% of primary care physicians said they are overworked compared with 84% of surgeons and 83% of non-surgical specialists.
Looking ahead, the report raised an important question. Are we relying too heavily on physicians rather than addressing the underlying need for policies that support a healthier, more sustainable future for all? “Building that future will take more than physician dedication alone,” Phull said. “It will require meaningful collaboration across the entire health care ecosystem – including health systems, hospitals, payors, and policymakers. And physicians must not only have a voice in shaping the path forward; they must have a seat at the table.”
Abreu reported no conflicts of interest in regard to her comments.
Few would deny that physicians today face many challenges: a growing and aging patient population, personnel shortages, mounting paperwork, regulatory and reimbursement pressures, and personal burnout. Collectively these could work to worsen patient access to care. Yet despite these headwinds, Doximity’s survey-based Physician Compensation Report 2025 found that more than three-quarters of physicians polled would still choose to enter their profession.
“Physician burnout isn’t new. It’s been a persistent problem over the past decade,” said Amit Phull, MD, chief clinical experience officer at Doximity. “In a Doximity poll of nearly 2,000 physicians conducted in May 2025, 85% reported they feel overworked, up from 73% just four years ago. As a result, about 68% of physicians said they are looking for an employment change or considering early retirement.”
Greater awareness of contemporary trends may help physicians make more-informed career decisions and more effectively advocate for both themselves and the patients who need them, the report’s authors stated.
Compensation Lag May Impact Care
A small overall average compensation increase of 3.7% from 2023 to 2024 – a slightly lower increase than the 5.9% in the prior year – has done little to close existing pay gaps across the profession.
In 2024, average compensation for men rose 5.7% over 2023, compared with just 1.7% for women – widening the gender pay gap to 26% vs 23% in 2023 and matching the gender gap seen in 2022. And significant disparities persist between physicians caring for adults vs children. In some specialties, the pay gap between pediatric and adult specialists exceeded 80% despite practitioners’ similar levels of training and clinical complexity.
Nearly 60% of respondents said reimbursement pressures could affect their ability to serve Medicare or Medicaid patients in the next year. Additionally, 81% reported that reimbursement policies have significantly contributed to the decline of private practices, and more than a third said they could stifle practice growth with compensation concerns forcing them to delay or cancel hiring or expansion plans. Almost 90% reported an adverse impact from physician shortages, with more citing an inability or limited ability to accept new patients.
Narrowing the Gap for Primary Care?
Over the past three years, the percent pay gap between primary care and specialist medicine declined modestly, the report noted. In 2024, surgical specialists earned 87% more than primary care physicians, down from 100% in 2022. Non-surgical specialists, emergency medicine physicians, and Ob/Gyns also continued to earn significantly more than primary care physicians, though the gaps have narrowed slightly.
“These trends come at a time when primary care remains critical to meeting high patient demand, especially amid ongoing physician shortages,” the report stated. “Primary care physicians continue to earn considerably less than many of their medical colleagues despite their essential role in the healthcare system.”
Significantly, many physicians believe that current reimbursement policies have contributed to the steady decline of independent practices in their fields. According to the American Medical Association, the share of physicians working in private practices dropped by 18 percentage points from 60.1% to 42.2% from 2012 to 2024.
The Specialties
This year’s review found that among 20 specialties, the highest average compensation occurred in surgical and procedural specialties, while the lowest paid were, as mentioned, pediatric medicine and primary care. Pediatric nephrology saw the largest average compensation growth in 2024 at 15.6%, yet compensation still lagged behind adult nephrology with a 40% pay gap.
By medical discipline, gastroenterologists ranked 13th overall in average annual compensation. Gastroenterology remained in the top 20 compensated specialties, with average annual compensation of $537,870 – an increase from $514,208 in 2024, representing a 4.5% growth rate over 2023. Neurosurgeons topped the list at $749,140, followed by thoracic surgeons at $689,969 and orthopedic surgeons at $679,517.
The three lowest-paid branches were all pediatric: endocrinology at $230,426, rheumatology at $231,574, and infectious diseases at $248,322. Pediatric gastroenterology paid somewhat higher at $298,457.
The largest disparities were seen in hematology and oncology, where adult specialists earned 93% more than their pediatric peers. Pediatric gastroenterology showed an 80% pay gap. There were also substantial pay differences across cardiology, pulmonology, and rheumatology. “These gaps appear to reflect a systemic lag in pay for pediatric specialty care, even as demand for pediatric subspecialists continues to rise,” the report stated.
Practice Setting and Location
Where a doctor practices impacts the bottom line, too: in 2024 the highest compensation reported for a metro area was in Rochester, Minnesota (the Mayo Clinic effect?), at $495,532, while the lowest reported was in Durham-Chapel Hill, North Carolina, at $368,782. St. Louis, Missouri ($484,883) and Los Angeles, California ($470,198) were 2nd and 3rd at the top of the list. Rochester, Minnesota, also emerged as best for annual compensation after cost-of-living adjustment, while Boston, Massachusetts, occupied the bottom rung.
The Gender Effect
With a women’s pay increase in 2024 of just 1.7%, the gender gap returned to its 2022-level disparity of 26%, with women physicians earning an average of $120,917 less than men after adjusting for specialty, location, and years of experience.
Doximity’s analysis of data from 2014 to 2019 estimated that on average men make at least $2 million more than women over the course of a 40-year career. This gap is often attributed to the fewer hours worked by female physician with their generally heavier familial responsibilities, “but Doximity’s gender wage gap analysis controls for the number of hours worked and career stage, along with specialty, work type, employment status, region, and credentials,” Phull said.
Women physicians had lower average earnings than men physicians across all specialties, a trend consistent with prior years. As a percentage of pay, the largest gender disparity was seen in pediatric nephrology (16.5%), a specialty that in fact saw the largest annual growth in physician pay. Neurosurgery had the smallest gender gap at 11.3%, while infectious diseases came in at 11.5% and oncology at 12%.
According to Maria T. Abreu, MD, AGAF, executive director of the F. Widjaja Inflammatory Bowel Disease Institute at Cedars-Sinai Medical Center in Los Angeles and past president of AGA, the remuneration gender gap in gastroenterology is being taken seriously by AGA and several other GI societies. “The discrepancies in pay start from the beginning and therefore are magnified over time. We are helping to empower women to negotiate better as well as to gather data on the roots of inequity, she told GI & Hepatology News.
The AGA Women’s Committee has developed a project to support the advancement of women in gastroenterology, Abreu said. The initiative, which includes the AGA Gender Equity Framework and Gender Equity Road Map. focuses attention on disparities in the workplace and promotes opportunities for women’s leadership, career advancement, mentorship and physician health and wellness, she added.
Are these disparities due mainly to the “motherhood penalty,” with career interruption and time lost to maternity leave and fewer hours worked owing to the greater parenting burden of physician mothers? Or are they due to the systemic effects of gender expectations around compensation?
Hours worked appear to be a factor. A 2017 study of dual physician couples found that among childless respondents men worked an average of 57 hours and women 52 hours weekly. Compared with childless men, men with children worked similar numbers of hours weekly. However, compared with childless physicians, mothers worked significantly fewer hours – roughly 40 to 43 hours weekly – depending on the age of their youngest child.
Abreu pushed back on this stereotype. “Most women physicians, including gastroenterologists, do not take the maternity leave they are allowed because they are concerned about burdening their colleagues,” she said. “Thus, it is unlikely to explain the disparities. Many systemic issues remain challenging, but we want women to be empowered to advocate for themselves at the time of hiring and along the arc of their career paths.”
In Abreu’s view, having women assume more leadership roles in the field of gastroenterology provides an opportunity to focus on reducing the disparities in compensation.
Regardless of gender, among all physicians surveyed, autonomy and work-life balance appeared to be a high priority: 77% of doctors said they would be willing to accept or have already accepted lower pay for more autonomy or work-life balance. “Overwork appears to be especially prevalent among women physicians,” said Phull, noting that 91% of women respondents reported being overworked compared with 80% of men. “This overwork has compelled 74% of women to consider making a career change, compared with 62% of men.” Differences emerged among specialties as well: 90% of primary care physicians said they are overworked compared with 84% of surgeons and 83% of non-surgical specialists.
Looking ahead, the report raised an important question. Are we relying too heavily on physicians rather than addressing the underlying need for policies that support a healthier, more sustainable future for all? “Building that future will take more than physician dedication alone,” Phull said. “It will require meaningful collaboration across the entire health care ecosystem – including health systems, hospitals, payors, and policymakers. And physicians must not only have a voice in shaping the path forward; they must have a seat at the table.”
Abreu reported no conflicts of interest in regard to her comments.
Few would deny that physicians today face many challenges: a growing and aging patient population, personnel shortages, mounting paperwork, regulatory and reimbursement pressures, and personal burnout. Collectively these could work to worsen patient access to care. Yet despite these headwinds, Doximity’s survey-based Physician Compensation Report 2025 found that more than three-quarters of physicians polled would still choose to enter their profession.
“Physician burnout isn’t new. It’s been a persistent problem over the past decade,” said Amit Phull, MD, chief clinical experience officer at Doximity. “In a Doximity poll of nearly 2,000 physicians conducted in May 2025, 85% reported they feel overworked, up from 73% just four years ago. As a result, about 68% of physicians said they are looking for an employment change or considering early retirement.”
Greater awareness of contemporary trends may help physicians make more-informed career decisions and more effectively advocate for both themselves and the patients who need them, the report’s authors stated.
Compensation Lag May Impact Care
A small overall average compensation increase of 3.7% from 2023 to 2024 – a slightly lower increase than the 5.9% in the prior year – has done little to close existing pay gaps across the profession.
In 2024, average compensation for men rose 5.7% over 2023, compared with just 1.7% for women – widening the gender pay gap to 26% vs 23% in 2023 and matching the gender gap seen in 2022. And significant disparities persist between physicians caring for adults vs children. In some specialties, the pay gap between pediatric and adult specialists exceeded 80% despite practitioners’ similar levels of training and clinical complexity.
Nearly 60% of respondents said reimbursement pressures could affect their ability to serve Medicare or Medicaid patients in the next year. Additionally, 81% reported that reimbursement policies have significantly contributed to the decline of private practices, and more than a third said they could stifle practice growth with compensation concerns forcing them to delay or cancel hiring or expansion plans. Almost 90% reported an adverse impact from physician shortages, with more citing an inability or limited ability to accept new patients.
Narrowing the Gap for Primary Care?
Over the past three years, the percent pay gap between primary care and specialist medicine declined modestly, the report noted. In 2024, surgical specialists earned 87% more than primary care physicians, down from 100% in 2022. Non-surgical specialists, emergency medicine physicians, and Ob/Gyns also continued to earn significantly more than primary care physicians, though the gaps have narrowed slightly.
“These trends come at a time when primary care remains critical to meeting high patient demand, especially amid ongoing physician shortages,” the report stated. “Primary care physicians continue to earn considerably less than many of their medical colleagues despite their essential role in the healthcare system.”
Significantly, many physicians believe that current reimbursement policies have contributed to the steady decline of independent practices in their fields. According to the American Medical Association, the share of physicians working in private practices dropped by 18 percentage points from 60.1% to 42.2% from 2012 to 2024.
The Specialties
This year’s review found that among 20 specialties, the highest average compensation occurred in surgical and procedural specialties, while the lowest paid were, as mentioned, pediatric medicine and primary care. Pediatric nephrology saw the largest average compensation growth in 2024 at 15.6%, yet compensation still lagged behind adult nephrology with a 40% pay gap.
By medical discipline, gastroenterologists ranked 13th overall in average annual compensation. Gastroenterology remained in the top 20 compensated specialties, with average annual compensation of $537,870 – an increase from $514,208 in 2024, representing a 4.5% growth rate over 2023. Neurosurgeons topped the list at $749,140, followed by thoracic surgeons at $689,969 and orthopedic surgeons at $679,517.
The three lowest-paid branches were all pediatric: endocrinology at $230,426, rheumatology at $231,574, and infectious diseases at $248,322. Pediatric gastroenterology paid somewhat higher at $298,457.
The largest disparities were seen in hematology and oncology, where adult specialists earned 93% more than their pediatric peers. Pediatric gastroenterology showed an 80% pay gap. There were also substantial pay differences across cardiology, pulmonology, and rheumatology. “These gaps appear to reflect a systemic lag in pay for pediatric specialty care, even as demand for pediatric subspecialists continues to rise,” the report stated.
Practice Setting and Location
Where a doctor practices impacts the bottom line, too: in 2024 the highest compensation reported for a metro area was in Rochester, Minnesota (the Mayo Clinic effect?), at $495,532, while the lowest reported was in Durham-Chapel Hill, North Carolina, at $368,782. St. Louis, Missouri ($484,883) and Los Angeles, California ($470,198) were 2nd and 3rd at the top of the list. Rochester, Minnesota, also emerged as best for annual compensation after cost-of-living adjustment, while Boston, Massachusetts, occupied the bottom rung.
The Gender Effect
With a women’s pay increase in 2024 of just 1.7%, the gender gap returned to its 2022-level disparity of 26%, with women physicians earning an average of $120,917 less than men after adjusting for specialty, location, and years of experience.
Doximity’s analysis of data from 2014 to 2019 estimated that on average men make at least $2 million more than women over the course of a 40-year career. This gap is often attributed to the fewer hours worked by female physician with their generally heavier familial responsibilities, “but Doximity’s gender wage gap analysis controls for the number of hours worked and career stage, along with specialty, work type, employment status, region, and credentials,” Phull said.
Women physicians had lower average earnings than men physicians across all specialties, a trend consistent with prior years. As a percentage of pay, the largest gender disparity was seen in pediatric nephrology (16.5%), a specialty that in fact saw the largest annual growth in physician pay. Neurosurgery had the smallest gender gap at 11.3%, while infectious diseases came in at 11.5% and oncology at 12%.
According to Maria T. Abreu, MD, AGAF, executive director of the F. Widjaja Inflammatory Bowel Disease Institute at Cedars-Sinai Medical Center in Los Angeles and past president of AGA, the remuneration gender gap in gastroenterology is being taken seriously by AGA and several other GI societies. “The discrepancies in pay start from the beginning and therefore are magnified over time. We are helping to empower women to negotiate better as well as to gather data on the roots of inequity, she told GI & Hepatology News.
The AGA Women’s Committee has developed a project to support the advancement of women in gastroenterology, Abreu said. The initiative, which includes the AGA Gender Equity Framework and Gender Equity Road Map. focuses attention on disparities in the workplace and promotes opportunities for women’s leadership, career advancement, mentorship and physician health and wellness, she added.
Are these disparities due mainly to the “motherhood penalty,” with career interruption and time lost to maternity leave and fewer hours worked owing to the greater parenting burden of physician mothers? Or are they due to the systemic effects of gender expectations around compensation?
Hours worked appear to be a factor. A 2017 study of dual physician couples found that among childless respondents men worked an average of 57 hours and women 52 hours weekly. Compared with childless men, men with children worked similar numbers of hours weekly. However, compared with childless physicians, mothers worked significantly fewer hours – roughly 40 to 43 hours weekly – depending on the age of their youngest child.
Abreu pushed back on this stereotype. “Most women physicians, including gastroenterologists, do not take the maternity leave they are allowed because they are concerned about burdening their colleagues,” she said. “Thus, it is unlikely to explain the disparities. Many systemic issues remain challenging, but we want women to be empowered to advocate for themselves at the time of hiring and along the arc of their career paths.”
In Abreu’s view, having women assume more leadership roles in the field of gastroenterology provides an opportunity to focus on reducing the disparities in compensation.
Regardless of gender, among all physicians surveyed, autonomy and work-life balance appeared to be a high priority: 77% of doctors said they would be willing to accept or have already accepted lower pay for more autonomy or work-life balance. “Overwork appears to be especially prevalent among women physicians,” said Phull, noting that 91% of women respondents reported being overworked compared with 80% of men. “This overwork has compelled 74% of women to consider making a career change, compared with 62% of men.” Differences emerged among specialties as well: 90% of primary care physicians said they are overworked compared with 84% of surgeons and 83% of non-surgical specialists.
Looking ahead, the report raised an important question. Are we relying too heavily on physicians rather than addressing the underlying need for policies that support a healthier, more sustainable future for all? “Building that future will take more than physician dedication alone,” Phull said. “It will require meaningful collaboration across the entire health care ecosystem – including health systems, hospitals, payors, and policymakers. And physicians must not only have a voice in shaping the path forward; they must have a seat at the table.”
Abreu reported no conflicts of interest in regard to her comments.
Supporting Exceptional Researchers
Did you know that the AGA Research Foundation helped support 74 researchers this past May?
But we can’t do it without you. We depend on the generosity of our supporters to make our vision for the future a reality.
When you donate to AGA Research Foundation, you don’t just give funds – you personally give our beneficiaries grant funding that will lead to new discoveries in GI. Your support goes directly towards funding GI research, helping us address immediate needs while building the foundation for long-term solutions. Plus, you’ll become part of a community full of passionate members like you.
It’s easy to make your mark on our efforts to support investigators. Simply visit our website or learn more ways to give here: [email protected] or contact us at [email protected].
Did you know that the AGA Research Foundation helped support 74 researchers this past May?
But we can’t do it without you. We depend on the generosity of our supporters to make our vision for the future a reality.
When you donate to AGA Research Foundation, you don’t just give funds – you personally give our beneficiaries grant funding that will lead to new discoveries in GI. Your support goes directly towards funding GI research, helping us address immediate needs while building the foundation for long-term solutions. Plus, you’ll become part of a community full of passionate members like you.
It’s easy to make your mark on our efforts to support investigators. Simply visit our website or learn more ways to give here: [email protected] or contact us at [email protected].
Did you know that the AGA Research Foundation helped support 74 researchers this past May?
But we can’t do it without you. We depend on the generosity of our supporters to make our vision for the future a reality.
When you donate to AGA Research Foundation, you don’t just give funds – you personally give our beneficiaries grant funding that will lead to new discoveries in GI. Your support goes directly towards funding GI research, helping us address immediate needs while building the foundation for long-term solutions. Plus, you’ll become part of a community full of passionate members like you.
It’s easy to make your mark on our efforts to support investigators. Simply visit our website or learn more ways to give here: [email protected] or contact us at [email protected].
Racial, Ethnic Discrimination Tied to Psychosis Risk
TOPLINE:
Racial and ethnic discrimination was consistently associated with increased risk for psychosis in studies included in a new umbrella review, with odds nearly doubled for both psychotic symptoms and experiences.
METHODOLOGY:
- Researchers searched 5 databases and then conducted an umbrella review of 7 systematic reviews, 4 of which included meta-analyses, published between 2003 and 2023.
- The systematic reviews included 23 primary studies representing more than 40,000 participants from Europe and the US.
- Investigators assessed the potential association between perceived racial or ethnic discrimination (mostly measured using self-reported questionnaires) and risk for psychosis (measured using established questionnaires).
- They assessed the risk for bias using the 16-item A MeaSurement Tool to Assess systematic Reviews, version 2 (AMSTAR-2) checklist.
TAKEAWAY:
- All reviews that included meta-analyses showed significant associations between perceived ethnic discrimination and psychotic symptoms (adjusted odds ratio [aOR], 1.78; 95% CI, 1.3-2.5) and psychotic experiences (pooled OR, 1.9; 95% CI, 1.4-2.7).
- Perceived racial or ethnic discrimination was also strongly linked to delusional symptoms (OR, 2.5; 95% CI, 1.6-4.0) and hallucinatory symptoms (OR, 1.65; 95% CI, 1.3-2.1).
- The largest of the included studies showed a dose-response relationship between higher levels of lifetime perceived racial or ethnic discrimination and greater likelihood of psychotic experiences.
- More robust associations were found in nonclinical populations compared to clinical ones, but there were significant associations in both.
IN PRACTICE:
“Our review was only looking at the impact of a person directly perceiving racism or interpersonal racial or ethnic discrimination; it may be that systemic racism, which can go unseen but still have profound impacts, could further contribute to mental health disparities,” lead investigator India Francis-Crossley, University College London, London, UK, said in a press release.
SOURCE:
The study was published online in PLOS Mental Health.
LIMITATIONS:
The evidence was primarily based on cross-sectional studies and was limited by high heterogeneity. The reviews included showed low or critically low AMSTAR-2 quality scores, which may have affected the robustness of the findings. More robust evidence was observed for psychotic outcomes in nonclinical populations compared to clinical samples. Additionally, the study potentially exacerbated errors or misreporting in the original reviews and did not include relevant structural factors such as income, education, housing, and poverty.
DISCLOSURES:
The study was funded by the University College London-Windsor Fellowship Research Opportunities scholarship, Wellcome Trust PhD Fellowship in Mental Health Science, Mental Health Mission Early Psychosis Workstream, and UK Research and Innovation funding for the Population Mental Health Consortium. The investigators reported having no relevant conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
TOPLINE:
Racial and ethnic discrimination was consistently associated with increased risk for psychosis in studies included in a new umbrella review, with odds nearly doubled for both psychotic symptoms and experiences.
METHODOLOGY:
- Researchers searched 5 databases and then conducted an umbrella review of 7 systematic reviews, 4 of which included meta-analyses, published between 2003 and 2023.
- The systematic reviews included 23 primary studies representing more than 40,000 participants from Europe and the US.
- Investigators assessed the potential association between perceived racial or ethnic discrimination (mostly measured using self-reported questionnaires) and risk for psychosis (measured using established questionnaires).
- They assessed the risk for bias using the 16-item A MeaSurement Tool to Assess systematic Reviews, version 2 (AMSTAR-2) checklist.
TAKEAWAY:
- All reviews that included meta-analyses showed significant associations between perceived ethnic discrimination and psychotic symptoms (adjusted odds ratio [aOR], 1.78; 95% CI, 1.3-2.5) and psychotic experiences (pooled OR, 1.9; 95% CI, 1.4-2.7).
- Perceived racial or ethnic discrimination was also strongly linked to delusional symptoms (OR, 2.5; 95% CI, 1.6-4.0) and hallucinatory symptoms (OR, 1.65; 95% CI, 1.3-2.1).
- The largest of the included studies showed a dose-response relationship between higher levels of lifetime perceived racial or ethnic discrimination and greater likelihood of psychotic experiences.
- More robust associations were found in nonclinical populations compared to clinical ones, but there were significant associations in both.
IN PRACTICE:
“Our review was only looking at the impact of a person directly perceiving racism or interpersonal racial or ethnic discrimination; it may be that systemic racism, which can go unseen but still have profound impacts, could further contribute to mental health disparities,” lead investigator India Francis-Crossley, University College London, London, UK, said in a press release.
SOURCE:
The study was published online in PLOS Mental Health.
LIMITATIONS:
The evidence was primarily based on cross-sectional studies and was limited by high heterogeneity. The reviews included showed low or critically low AMSTAR-2 quality scores, which may have affected the robustness of the findings. More robust evidence was observed for psychotic outcomes in nonclinical populations compared to clinical samples. Additionally, the study potentially exacerbated errors or misreporting in the original reviews and did not include relevant structural factors such as income, education, housing, and poverty.
DISCLOSURES:
The study was funded by the University College London-Windsor Fellowship Research Opportunities scholarship, Wellcome Trust PhD Fellowship in Mental Health Science, Mental Health Mission Early Psychosis Workstream, and UK Research and Innovation funding for the Population Mental Health Consortium. The investigators reported having no relevant conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
TOPLINE:
Racial and ethnic discrimination was consistently associated with increased risk for psychosis in studies included in a new umbrella review, with odds nearly doubled for both psychotic symptoms and experiences.
METHODOLOGY:
- Researchers searched 5 databases and then conducted an umbrella review of 7 systematic reviews, 4 of which included meta-analyses, published between 2003 and 2023.
- The systematic reviews included 23 primary studies representing more than 40,000 participants from Europe and the US.
- Investigators assessed the potential association between perceived racial or ethnic discrimination (mostly measured using self-reported questionnaires) and risk for psychosis (measured using established questionnaires).
- They assessed the risk for bias using the 16-item A MeaSurement Tool to Assess systematic Reviews, version 2 (AMSTAR-2) checklist.
TAKEAWAY:
- All reviews that included meta-analyses showed significant associations between perceived ethnic discrimination and psychotic symptoms (adjusted odds ratio [aOR], 1.78; 95% CI, 1.3-2.5) and psychotic experiences (pooled OR, 1.9; 95% CI, 1.4-2.7).
- Perceived racial or ethnic discrimination was also strongly linked to delusional symptoms (OR, 2.5; 95% CI, 1.6-4.0) and hallucinatory symptoms (OR, 1.65; 95% CI, 1.3-2.1).
- The largest of the included studies showed a dose-response relationship between higher levels of lifetime perceived racial or ethnic discrimination and greater likelihood of psychotic experiences.
- More robust associations were found in nonclinical populations compared to clinical ones, but there were significant associations in both.
IN PRACTICE:
“Our review was only looking at the impact of a person directly perceiving racism or interpersonal racial or ethnic discrimination; it may be that systemic racism, which can go unseen but still have profound impacts, could further contribute to mental health disparities,” lead investigator India Francis-Crossley, University College London, London, UK, said in a press release.
SOURCE:
The study was published online in PLOS Mental Health.
LIMITATIONS:
The evidence was primarily based on cross-sectional studies and was limited by high heterogeneity. The reviews included showed low or critically low AMSTAR-2 quality scores, which may have affected the robustness of the findings. More robust evidence was observed for psychotic outcomes in nonclinical populations compared to clinical samples. Additionally, the study potentially exacerbated errors or misreporting in the original reviews and did not include relevant structural factors such as income, education, housing, and poverty.
DISCLOSURES:
The study was funded by the University College London-Windsor Fellowship Research Opportunities scholarship, Wellcome Trust PhD Fellowship in Mental Health Science, Mental Health Mission Early Psychosis Workstream, and UK Research and Innovation funding for the Population Mental Health Consortium. The investigators reported having no relevant conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.