Key clinical point: Prophylactic hyperthermic intraperitoneal chemotherapy (HIPEC) significantly decreased postoperative peritoneal recurrence and prolonged survival in patients with clinical T4 gastric cancer who underwent gastrectomy with lymphadenectomy.

Major finding: Prophylactic HIPEC vs no HIPEC significantly lowered the overall recurrence rate (34.3% vs 62.9%; P = .04) and postoperative peritoneal carcinomatosis (21.7% vs 57.1%; P = .03). HIPEC significantly improved the overall survival (OS) rate (71.4% vs 40.0%; P = .01). Patients in the HIPEC group had a significantly longer OS (adjusted hazard ratio [aHR] 0.37; P = .035) and disease-free survival (aHR 0.33; P = .017).

Study details: This was a retrospective study of 132 patients with clinical stage T4 gastric cancer who underwent gastrectomy plus D2 lymphadenectomy between 2014 and 2020. Thirty-five of the 132 patients received prophylactic HIPEC perioperatively.

Disclosures: No funding source was identified for this work. The authors declared no competing interests.

Source: Lee TY et al. Prophylactic hyperthermic intraperitoneal chemotherapy for patients with clinical T4 gastric cancer. Eur J Surg Oncol. 2022 (Apr 27). Doi: 10.1016/j.ejso.2022.04.018

Key clinical point: Prophylactic hyperthermic intraperitoneal chemotherapy (HIPEC) significantly decreased postoperative peritoneal recurrence and prolonged survival in patients with clinical T4 gastric cancer who underwent gastrectomy with lymphadenectomy.

Major finding: Prophylactic HIPEC vs no HIPEC significantly lowered the overall recurrence rate (34.3% vs 62.9%; P = .04) and postoperative peritoneal carcinomatosis (21.7% vs 57.1%; P = .03). HIPEC significantly improved the overall survival (OS) rate (71.4% vs 40.0%; P = .01). Patients in the HIPEC group had a significantly longer OS (adjusted hazard ratio [aHR] 0.37; P = .035) and disease-free survival (aHR 0.33; P = .017).

Study details: This was a retrospective study of 132 patients with clinical stage T4 gastric cancer who underwent gastrectomy plus D2 lymphadenectomy between 2014 and 2020. Thirty-five of the 132 patients received prophylactic HIPEC perioperatively.

Disclosures: No funding source was identified for this work. The authors declared no competing interests.

Source: Lee TY et al. Prophylactic hyperthermic intraperitoneal chemotherapy for patients with clinical T4 gastric cancer. Eur J Surg Oncol. 2022 (Apr 27). Doi: 10.1016/j.ejso.2022.04.018

Key clinical point: Prophylactic hyperthermic intraperitoneal chemotherapy (HIPEC) significantly decreased postoperative peritoneal recurrence and prolonged survival in patients with clinical T4 gastric cancer who underwent gastrectomy with lymphadenectomy.

Major finding: Prophylactic HIPEC vs no HIPEC significantly lowered the overall recurrence rate (34.3% vs 62.9%; P = .04) and postoperative peritoneal carcinomatosis (21.7% vs 57.1%; P = .03). HIPEC significantly improved the overall survival (OS) rate (71.4% vs 40.0%; P = .01). Patients in the HIPEC group had a significantly longer OS (adjusted hazard ratio [aHR] 0.37; P = .035) and disease-free survival (aHR 0.33; P = .017).

Study details: This was a retrospective study of 132 patients with clinical stage T4 gastric cancer who underwent gastrectomy plus D2 lymphadenectomy between 2014 and 2020. Thirty-five of the 132 patients received prophylactic HIPEC perioperatively.

Disclosures: No funding source was identified for this work. The authors declared no competing interests.

Source: Lee TY et al. Prophylactic hyperthermic intraperitoneal chemotherapy for patients with clinical T4 gastric cancer. Eur J Surg Oncol. 2022 (Apr 27). Doi: 10.1016/j.ejso.2022.04.018

Key clinical point: The body composition variables were associated with major postoperative complications in patients with gastric cancer who received preoperative chemotherapy followed by gastrectomy.

Major finding: A high skeletal muscle (SM)-mass Z-score (difference in each patient’s standard deviation from the mean value) was associated with a lower risk for major postoperative complications (relative risk [RR] 0.47, P = .004). High visceral adipose tissue-radiation attenuation (VAT-RA; RR 2.82; P = .001) and subcutaneous adipose tissue-RA (SAT-RA; RR 1.95; P = .015) Z-scores were associated with an increased risk for major postoperative complications.

Study details: This was a side study of 112 patients with gastric cancer who received preoperative chemotherapy followed by gastrectomy in the LOGICA trial. The preoperative computed tomography scan was used to calculate the mass and RA for SM, VAT, and SAT.

Disclosures: This study was sponsored by the Netherlands Organization for Health Research and Development. The authors received consulting or advisory fees, travel or accommodations expenses, or grants outside this work.

Source: Tweed TTT et al. Body composition is a predictor for postoperative complications after gastrectomy for gastric cancer: A prospective side study of the LOGICA trial. J Gastrointest Surg. 2022 (Apr 29). Doi: 10.1007/s11605-022-05321-0

Key clinical point: The body composition variables were associated with major postoperative complications in patients with gastric cancer who received preoperative chemotherapy followed by gastrectomy.

Major finding: A high skeletal muscle (SM)-mass Z-score (difference in each patient’s standard deviation from the mean value) was associated with a lower risk for major postoperative complications (relative risk [RR] 0.47, P = .004). High visceral adipose tissue-radiation attenuation (VAT-RA; RR 2.82; P = .001) and subcutaneous adipose tissue-RA (SAT-RA; RR 1.95; P = .015) Z-scores were associated with an increased risk for major postoperative complications.

Study details: This was a side study of 112 patients with gastric cancer who received preoperative chemotherapy followed by gastrectomy in the LOGICA trial. The preoperative computed tomography scan was used to calculate the mass and RA for SM, VAT, and SAT.

Disclosures: This study was sponsored by the Netherlands Organization for Health Research and Development. The authors received consulting or advisory fees, travel or accommodations expenses, or grants outside this work.

Source: Tweed TTT et al. Body composition is a predictor for postoperative complications after gastrectomy for gastric cancer: A prospective side study of the LOGICA trial. J Gastrointest Surg. 2022 (Apr 29). Doi: 10.1007/s11605-022-05321-0

Key clinical point: The body composition variables were associated with major postoperative complications in patients with gastric cancer who received preoperative chemotherapy followed by gastrectomy.

Major finding: A high skeletal muscle (SM)-mass Z-score (difference in each patient’s standard deviation from the mean value) was associated with a lower risk for major postoperative complications (relative risk [RR] 0.47, P = .004). High visceral adipose tissue-radiation attenuation (VAT-RA; RR 2.82; P = .001) and subcutaneous adipose tissue-RA (SAT-RA; RR 1.95; P = .015) Z-scores were associated with an increased risk for major postoperative complications.

Study details: This was a side study of 112 patients with gastric cancer who received preoperative chemotherapy followed by gastrectomy in the LOGICA trial. The preoperative computed tomography scan was used to calculate the mass and RA for SM, VAT, and SAT.

Disclosures: This study was sponsored by the Netherlands Organization for Health Research and Development. The authors received consulting or advisory fees, travel or accommodations expenses, or grants outside this work.

Source: Tweed TTT et al. Body composition is a predictor for postoperative complications after gastrectomy for gastric cancer: A prospective side study of the LOGICA trial. J Gastrointest Surg. 2022 (Apr 29). Doi: 10.1007/s11605-022-05321-0

Key clinical point: First-degree relatives of patients with gastric cancer show a high prevalence of preneoplastic lesions (PNL).

Major finding: The prevalence of PNL, atrophic gastritis, and intestinal metaplasia in first-degree relatives of gastric cancer patients were 86.4%, 82.7%, and 54.5%, respectively. The incidence of PNL was not significantly associated with sex (odds ratio [OR] 3.10; 95% confidence interval [CI] 1.00-9.64), age (OR 0.74; 95% CI, 0.26-2.14), and Helicobacter pylorii infection (OR 0.58; 95% CI 0.12-2.77). The advanced stages of Operative Link on Gastritis Assessment and Operative Link on Gastritis/Intestinal-Metaplasia Assessment were verified in 18.0% and 16.3% of the first-degree relatives, respectively.

Study details: This was a cross-sectional study including 110 first-degree relatives of patients with gastric cancer.

Disclosures: This study was partially supported by CONICYT, Chile. The authors declared no conflicts of interest.

Source: Sotelo S et al. Prevalence of gastric preneoplastic lesions in first-degree relatives of patients with gastric cancer: A cross-sectional study. J Gastrointest Cancer. 2022 (Apr 30). Doi: 10.1007/s12029-022-00827-x

Key clinical point: First-degree relatives of patients with gastric cancer show a high prevalence of preneoplastic lesions (PNL).

Major finding: The prevalence of PNL, atrophic gastritis, and intestinal metaplasia in first-degree relatives of gastric cancer patients were 86.4%, 82.7%, and 54.5%, respectively. The incidence of PNL was not significantly associated with sex (odds ratio [OR] 3.10; 95% confidence interval [CI] 1.00-9.64), age (OR 0.74; 95% CI, 0.26-2.14), and Helicobacter pylorii infection (OR 0.58; 95% CI 0.12-2.77). The advanced stages of Operative Link on Gastritis Assessment and Operative Link on Gastritis/Intestinal-Metaplasia Assessment were verified in 18.0% and 16.3% of the first-degree relatives, respectively.

Study details: This was a cross-sectional study including 110 first-degree relatives of patients with gastric cancer.

Disclosures: This study was partially supported by CONICYT, Chile. The authors declared no conflicts of interest.

Source: Sotelo S et al. Prevalence of gastric preneoplastic lesions in first-degree relatives of patients with gastric cancer: A cross-sectional study. J Gastrointest Cancer. 2022 (Apr 30). Doi: 10.1007/s12029-022-00827-x

Key clinical point: First-degree relatives of patients with gastric cancer show a high prevalence of preneoplastic lesions (PNL).

Major finding: The prevalence of PNL, atrophic gastritis, and intestinal metaplasia in first-degree relatives of gastric cancer patients were 86.4%, 82.7%, and 54.5%, respectively. The incidence of PNL was not significantly associated with sex (odds ratio [OR] 3.10; 95% confidence interval [CI] 1.00-9.64), age (OR 0.74; 95% CI, 0.26-2.14), and Helicobacter pylorii infection (OR 0.58; 95% CI 0.12-2.77). The advanced stages of Operative Link on Gastritis Assessment and Operative Link on Gastritis/Intestinal-Metaplasia Assessment were verified in 18.0% and 16.3% of the first-degree relatives, respectively.

Study details: This was a cross-sectional study including 110 first-degree relatives of patients with gastric cancer.

Disclosures: This study was partially supported by CONICYT, Chile. The authors declared no conflicts of interest.

Source: Sotelo S et al. Prevalence of gastric preneoplastic lesions in first-degree relatives of patients with gastric cancer: A cross-sectional study. J Gastrointest Cancer. 2022 (Apr 30). Doi: 10.1007/s12029-022-00827-x

Key clinical point: The oxaliplatin- vs cisplatin-based regimen does not show significant difference in survival benefits in elderly patients with advanced gastric cancer.

Major finding: The overall survival was not significantly different between the oxaliplatin and cisplatin groups (hazard ratio 1.13; P = .70). A significantly lower number of patients received granulocyte colony-stimulating factor in the oxaliplatin vs cisplatin group (2.3% vs 22.7%; P = .01).

Study details: This was a propensity score-matched analysis of 242 patients aged ≥70 years with advanced gastric cancer who received oxaliplatin- or cisplatin-based treatment regimen.

Disclosures: This study was supported by the Ministry of Education, Culture, Sports, Science, and Technology, Japan. The authors declared no competing interests.

Source: Chinen T et al. Oxaliplatin- versus cisplatin-based regimens for elderly individuals with advanced gastric cancer: a retrospective cohort study. BMC Cancer. 2022;22:460 (Apr 26). Doi: 10.1186/s12885-022-09581-6

Key clinical point: The oxaliplatin- vs cisplatin-based regimen does not show significant difference in survival benefits in elderly patients with advanced gastric cancer.

Major finding: The overall survival was not significantly different between the oxaliplatin and cisplatin groups (hazard ratio 1.13; P = .70). A significantly lower number of patients received granulocyte colony-stimulating factor in the oxaliplatin vs cisplatin group (2.3% vs 22.7%; P = .01).

Study details: This was a propensity score-matched analysis of 242 patients aged ≥70 years with advanced gastric cancer who received oxaliplatin- or cisplatin-based treatment regimen.

Disclosures: This study was supported by the Ministry of Education, Culture, Sports, Science, and Technology, Japan. The authors declared no competing interests.

Source: Chinen T et al. Oxaliplatin- versus cisplatin-based regimens for elderly individuals with advanced gastric cancer: a retrospective cohort study. BMC Cancer. 2022;22:460 (Apr 26). Doi: 10.1186/s12885-022-09581-6

Key clinical point: The oxaliplatin- vs cisplatin-based regimen does not show significant difference in survival benefits in elderly patients with advanced gastric cancer.

Major finding: The overall survival was not significantly different between the oxaliplatin and cisplatin groups (hazard ratio 1.13; P = .70). A significantly lower number of patients received granulocyte colony-stimulating factor in the oxaliplatin vs cisplatin group (2.3% vs 22.7%; P = .01).

Study details: This was a propensity score-matched analysis of 242 patients aged ≥70 years with advanced gastric cancer who received oxaliplatin- or cisplatin-based treatment regimen.

Disclosures: This study was supported by the Ministry of Education, Culture, Sports, Science, and Technology, Japan. The authors declared no competing interests.

Source: Chinen T et al. Oxaliplatin- versus cisplatin-based regimens for elderly individuals with advanced gastric cancer: a retrospective cohort study. BMC Cancer. 2022;22:460 (Apr 26). Doi: 10.1186/s12885-022-09581-6

Key clinical point: Baseline serum pepsinogen levels are associated with a significant risk for gastric cancer, particularly the noncardia type.

Major finding: A higher proportion of patients with gastric cancer vs matched controls had a positive baseline serum pepsinogen status (31.4% vs 5.5%; P < .001). A positive serum pepsinogen status was associated with an increased risk for gastric cancer (adjusted odds ratio [aOR] 10.6; 95% CI 4.3-26.2). In subgroup analysis, a positive pepsinogen status was associated with a higher risk for noncardia gastric cancer (aOR 14.3; 95% CI 4.8-42.0).

Study details: This was a nested case-control study using the Prostate, Lung, Colorectal, and Ovarian Cancer Screening trial data of 105 participants who developed gastric cancer and 209 matched control individuals.

Disclosures: This study was sponsored by the Society for Surgery of the Alimentary Tract Health Care Disparities Research Award and National Institutes of Health-National Center for Advancing Translational Sciences grant. The authors declared no competing interests.

Source: In H et al. Serum pepsinogen as a biomarker for gastric cancer in the United States: A nested case-control study using the PLCO Cancer Screening Trial Data. Cancer Epidemiol Biomarkers Prev. 2022 (May 9). Doi: 10.1158/1055-9965.EPI-21-1328

Key clinical point: Baseline serum pepsinogen levels are associated with a significant risk for gastric cancer, particularly the noncardia type.

Major finding: A higher proportion of patients with gastric cancer vs matched controls had a positive baseline serum pepsinogen status (31.4% vs 5.5%; P < .001). A positive serum pepsinogen status was associated with an increased risk for gastric cancer (adjusted odds ratio [aOR] 10.6; 95% CI 4.3-26.2). In subgroup analysis, a positive pepsinogen status was associated with a higher risk for noncardia gastric cancer (aOR 14.3; 95% CI 4.8-42.0).

Study details: This was a nested case-control study using the Prostate, Lung, Colorectal, and Ovarian Cancer Screening trial data of 105 participants who developed gastric cancer and 209 matched control individuals.

Disclosures: This study was sponsored by the Society for Surgery of the Alimentary Tract Health Care Disparities Research Award and National Institutes of Health-National Center for Advancing Translational Sciences grant. The authors declared no competing interests.

Source: In H et al. Serum pepsinogen as a biomarker for gastric cancer in the United States: A nested case-control study using the PLCO Cancer Screening Trial Data. Cancer Epidemiol Biomarkers Prev. 2022 (May 9). Doi: 10.1158/1055-9965.EPI-21-1328

Key clinical point: Baseline serum pepsinogen levels are associated with a significant risk for gastric cancer, particularly the noncardia type.

Major finding: A higher proportion of patients with gastric cancer vs matched controls had a positive baseline serum pepsinogen status (31.4% vs 5.5%; P < .001). A positive serum pepsinogen status was associated with an increased risk for gastric cancer (adjusted odds ratio [aOR] 10.6; 95% CI 4.3-26.2). In subgroup analysis, a positive pepsinogen status was associated with a higher risk for noncardia gastric cancer (aOR 14.3; 95% CI 4.8-42.0).

Study details: This was a nested case-control study using the Prostate, Lung, Colorectal, and Ovarian Cancer Screening trial data of 105 participants who developed gastric cancer and 209 matched control individuals.

Disclosures: This study was sponsored by the Society for Surgery of the Alimentary Tract Health Care Disparities Research Award and National Institutes of Health-National Center for Advancing Translational Sciences grant. The authors declared no competing interests.

Source: In H et al. Serum pepsinogen as a biomarker for gastric cancer in the United States: A nested case-control study using the PLCO Cancer Screening Trial Data. Cancer Epidemiol Biomarkers Prev. 2022 (May 9). Doi: 10.1158/1055-9965.EPI-21-1328

Key clinical point: Taxanes plus basic chemotherapy vs basic chemotherapy alone improves oncologic outcomes in treatment-naive patients with advanced gastric cancer.

Major finding: Basic chemotherapy with vs without taxanes significantly improved progression-free survival (hazard ratio [HR] 0.73; P = .001), overall survival (HR 0.80; P = .003), objective response rate (risk ratio [RR] 1.34; P = .0001), and disease control rate (RR 1.20; P = .001). Patients who received taxanes had a significantly higher risk for neutropenia (RR 3.54; P = .0003), leucopenia (RR 24.99; P = .03), and diarrhea (RR 4.41; P < .00001).

Study details: A meta-analysis of six randomized controlled trials including 2263 patients with advanced gastric cancer who received first-line chemotherapy.

Disclosures: This study was supported by Beijing Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Ma X et al. Efficacy and safety of combination chemotherapy regimens containing taxanes for first-line treatment in advanced gastric cancer. Clin Exp Med. 2022 (Apr 16). Doi: 10.1007/s10238-022-00824-1

Key clinical point: Taxanes plus basic chemotherapy vs basic chemotherapy alone improves oncologic outcomes in treatment-naive patients with advanced gastric cancer.

Major finding: Basic chemotherapy with vs without taxanes significantly improved progression-free survival (hazard ratio [HR] 0.73; P = .001), overall survival (HR 0.80; P = .003), objective response rate (risk ratio [RR] 1.34; P = .0001), and disease control rate (RR 1.20; P = .001). Patients who received taxanes had a significantly higher risk for neutropenia (RR 3.54; P = .0003), leucopenia (RR 24.99; P = .03), and diarrhea (RR 4.41; P < .00001).

Study details: A meta-analysis of six randomized controlled trials including 2263 patients with advanced gastric cancer who received first-line chemotherapy.

Disclosures: This study was supported by Beijing Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Ma X et al. Efficacy and safety of combination chemotherapy regimens containing taxanes for first-line treatment in advanced gastric cancer. Clin Exp Med. 2022 (Apr 16). Doi: 10.1007/s10238-022-00824-1

Key clinical point: Taxanes plus basic chemotherapy vs basic chemotherapy alone improves oncologic outcomes in treatment-naive patients with advanced gastric cancer.

Major finding: Basic chemotherapy with vs without taxanes significantly improved progression-free survival (hazard ratio [HR] 0.73; P = .001), overall survival (HR 0.80; P = .003), objective response rate (risk ratio [RR] 1.34; P = .0001), and disease control rate (RR 1.20; P = .001). Patients who received taxanes had a significantly higher risk for neutropenia (RR 3.54; P = .0003), leucopenia (RR 24.99; P = .03), and diarrhea (RR 4.41; P < .00001).

Study details: A meta-analysis of six randomized controlled trials including 2263 patients with advanced gastric cancer who received first-line chemotherapy.

Disclosures: This study was supported by Beijing Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Ma X et al. Efficacy and safety of combination chemotherapy regimens containing taxanes for first-line treatment in advanced gastric cancer. Clin Exp Med. 2022 (Apr 16). Doi: 10.1007/s10238-022-00824-1

SAN DIEGO – An analysis of a large, international cohort suggests that treatment with protease-inhibitor (PI)–based direct-acting antivirals (DAAs) may be safe for patients with hepatitis C virus (HCV) with cirrhosis and early-stage liver decompensation.

The study relied on data from the REAL-C registry, including 935 patients treated with oral DAAs at 27 centers in the U.S., Europe, and Asia Pacific countries. The researchers compared efficacy and tolerability outcomes from PI-based and non PI-based DAA regimens in patients deemed to have decompensated HCV cirrhosis.

The findings were encouraging. “It is something important because currently we are short of treatments for decompensated HCV patients. If the tolerability is similar, we perhaps should not withhold [PI] treatment for these patients that sometimes need them the most,” said Yu Jun Wong, MD, who presented the study at the annual Digestive Disease Week^® (DDW). Dr. Wong is a second-year consultant at Changchi General Hospital in Singapore.

“I think it was a very interesting study and something that needed to be done. It was encouraging that patients who did have some level of decompensated cirrhosis did not worsen compared to those who were on a non PI-based therapy,” said Meena Bansal, MD, who comoderated the session where the research was presented.

However, the study was limited by some uncertainty around the definition of decompensation among the study participants. During the Q&A session, audience members questioned whether patients categorized as decompensated were truly decompensated at the time of treatment initiation. Dr. Bansal noted, for example, that a patient might experience a variceal bleed in the context of heavy alcohol consumption, and therefore be considered decompensated, but might stop drinking afterward with a reduction in portal hypertension and recovery of liver function. “So it would be important to know if they were still decompensated at the time they initiated therapy. If that was the case, then these results are more promising,” said Dr. Bansal.

Despite these limitations, the study is good news. “If you do not have access to non-PI based therapy, you might feel a little bit more secure starting a PI-based therapy, particularly the second generation PI-based therapies, if they’re at least on the earlier side of that decompensation scale. But it’s still unclear in true decompensated Child’s B or C whether or not PI-based therapy would have the same results,” said Dr. Bansal.

Dr. Wong acknowledged the limitation that the study doesn’t apply to more severely decompensated patients. “Whether it remains safe in patients with higher Child-Pugh scores is hard to extrapolate at this point of time. We still need to look further into the data,” said Dr. Wong.

Still, the results offer hope to physicians and patients who might find themselves in difficult circumstances. “If you’re resource limited, and you don’t even have access to transplant, these findings suggest that early decompensated patients may benefit from PI-based therapy. If I say to the patient, there’s a chance this could make you worse, but there’s a chance this could make you better, [this is an option] as long as the patient is aware of the possible outcomes,” said Dr. Bansal.

The study included patients with a history of ascites, variceal bleeding, jaundice, or hepatic encephalopathy 6 months before treatment with DAA, or baseline measures of Child-Turcotte-Pugh (CTP) score ≥7 or Model of End-Stage Liver Disease (MELD) score >10. The analysis included data between 2014 and 2021.

The mean age was 64, and 59.6% of participants were male. Overall, 70.8% had genotype 1, and 32% were treatment experienced. In total, 45.2% were treated with PI-based DAAs.

The PI cohort was older (64.6 versus 62.7; P = .01), and more likely to have genotype 1 (87.2% versus 56.3%; P < .001) and chronic renal disease (64.0% vs. 53.9%; P = .001).

The two groups had similar rates of sustained virologic response at 12 and 24 weeks, as well as similar rates of significant improvement or significant worsening, suggesting similar tolerability. There was a lower frequency of liver decompensation in the PI group at 12 weeks (4.4% vs. 7.9%; P = .04) and a trend at 24 weeks (8.8% versus 12.6%; P = .08).

Another limitation of the study is the potential for bias due to its retrospective nature.

Dr. Wong has been an invited speaker for AbbVie and Gilead. Dr. Bansal has no relevant financial disclosures.

SAN DIEGO – An analysis of a large, international cohort suggests that treatment with protease-inhibitor (PI)–based direct-acting antivirals (DAAs) may be safe for patients with hepatitis C virus (HCV) with cirrhosis and early-stage liver decompensation.

The study relied on data from the REAL-C registry, including 935 patients treated with oral DAAs at 27 centers in the U.S., Europe, and Asia Pacific countries. The researchers compared efficacy and tolerability outcomes from PI-based and non PI-based DAA regimens in patients deemed to have decompensated HCV cirrhosis.

The findings were encouraging. “It is something important because currently we are short of treatments for decompensated HCV patients. If the tolerability is similar, we perhaps should not withhold [PI] treatment for these patients that sometimes need them the most,” said Yu Jun Wong, MD, who presented the study at the annual Digestive Disease Week^® (DDW). Dr. Wong is a second-year consultant at Changchi General Hospital in Singapore.

“I think it was a very interesting study and something that needed to be done. It was encouraging that patients who did have some level of decompensated cirrhosis did not worsen compared to those who were on a non PI-based therapy,” said Meena Bansal, MD, who comoderated the session where the research was presented.

However, the study was limited by some uncertainty around the definition of decompensation among the study participants. During the Q&A session, audience members questioned whether patients categorized as decompensated were truly decompensated at the time of treatment initiation. Dr. Bansal noted, for example, that a patient might experience a variceal bleed in the context of heavy alcohol consumption, and therefore be considered decompensated, but might stop drinking afterward with a reduction in portal hypertension and recovery of liver function. “So it would be important to know if they were still decompensated at the time they initiated therapy. If that was the case, then these results are more promising,” said Dr. Bansal.

Despite these limitations, the study is good news. “If you do not have access to non-PI based therapy, you might feel a little bit more secure starting a PI-based therapy, particularly the second generation PI-based therapies, if they’re at least on the earlier side of that decompensation scale. But it’s still unclear in true decompensated Child’s B or C whether or not PI-based therapy would have the same results,” said Dr. Bansal.

Dr. Wong acknowledged the limitation that the study doesn’t apply to more severely decompensated patients. “Whether it remains safe in patients with higher Child-Pugh scores is hard to extrapolate at this point of time. We still need to look further into the data,” said Dr. Wong.

Still, the results offer hope to physicians and patients who might find themselves in difficult circumstances. “If you’re resource limited, and you don’t even have access to transplant, these findings suggest that early decompensated patients may benefit from PI-based therapy. If I say to the patient, there’s a chance this could make you worse, but there’s a chance this could make you better, [this is an option] as long as the patient is aware of the possible outcomes,” said Dr. Bansal.

The study included patients with a history of ascites, variceal bleeding, jaundice, or hepatic encephalopathy 6 months before treatment with DAA, or baseline measures of Child-Turcotte-Pugh (CTP) score ≥7 or Model of End-Stage Liver Disease (MELD) score >10. The analysis included data between 2014 and 2021.

The mean age was 64, and 59.6% of participants were male. Overall, 70.8% had genotype 1, and 32% were treatment experienced. In total, 45.2% were treated with PI-based DAAs.

The PI cohort was older (64.6 versus 62.7; P = .01), and more likely to have genotype 1 (87.2% versus 56.3%; P < .001) and chronic renal disease (64.0% vs. 53.9%; P = .001).

The two groups had similar rates of sustained virologic response at 12 and 24 weeks, as well as similar rates of significant improvement or significant worsening, suggesting similar tolerability. There was a lower frequency of liver decompensation in the PI group at 12 weeks (4.4% vs. 7.9%; P = .04) and a trend at 24 weeks (8.8% versus 12.6%; P = .08).

Another limitation of the study is the potential for bias due to its retrospective nature.

Dr. Wong has been an invited speaker for AbbVie and Gilead. Dr. Bansal has no relevant financial disclosures.

SAN DIEGO – An analysis of a large, international cohort suggests that treatment with protease-inhibitor (PI)–based direct-acting antivirals (DAAs) may be safe for patients with hepatitis C virus (HCV) with cirrhosis and early-stage liver decompensation.

The study relied on data from the REAL-C registry, including 935 patients treated with oral DAAs at 27 centers in the U.S., Europe, and Asia Pacific countries. The researchers compared efficacy and tolerability outcomes from PI-based and non PI-based DAA regimens in patients deemed to have decompensated HCV cirrhosis.

The findings were encouraging. “It is something important because currently we are short of treatments for decompensated HCV patients. If the tolerability is similar, we perhaps should not withhold [PI] treatment for these patients that sometimes need them the most,” said Yu Jun Wong, MD, who presented the study at the annual Digestive Disease Week^® (DDW). Dr. Wong is a second-year consultant at Changchi General Hospital in Singapore.

“I think it was a very interesting study and something that needed to be done. It was encouraging that patients who did have some level of decompensated cirrhosis did not worsen compared to those who were on a non PI-based therapy,” said Meena Bansal, MD, who comoderated the session where the research was presented.

However, the study was limited by some uncertainty around the definition of decompensation among the study participants. During the Q&A session, audience members questioned whether patients categorized as decompensated were truly decompensated at the time of treatment initiation. Dr. Bansal noted, for example, that a patient might experience a variceal bleed in the context of heavy alcohol consumption, and therefore be considered decompensated, but might stop drinking afterward with a reduction in portal hypertension and recovery of liver function. “So it would be important to know if they were still decompensated at the time they initiated therapy. If that was the case, then these results are more promising,” said Dr. Bansal.

Despite these limitations, the study is good news. “If you do not have access to non-PI based therapy, you might feel a little bit more secure starting a PI-based therapy, particularly the second generation PI-based therapies, if they’re at least on the earlier side of that decompensation scale. But it’s still unclear in true decompensated Child’s B or C whether or not PI-based therapy would have the same results,” said Dr. Bansal.

Dr. Wong acknowledged the limitation that the study doesn’t apply to more severely decompensated patients. “Whether it remains safe in patients with higher Child-Pugh scores is hard to extrapolate at this point of time. We still need to look further into the data,” said Dr. Wong.

Still, the results offer hope to physicians and patients who might find themselves in difficult circumstances. “If you’re resource limited, and you don’t even have access to transplant, these findings suggest that early decompensated patients may benefit from PI-based therapy. If I say to the patient, there’s a chance this could make you worse, but there’s a chance this could make you better, [this is an option] as long as the patient is aware of the possible outcomes,” said Dr. Bansal.

The study included patients with a history of ascites, variceal bleeding, jaundice, or hepatic encephalopathy 6 months before treatment with DAA, or baseline measures of Child-Turcotte-Pugh (CTP) score ≥7 or Model of End-Stage Liver Disease (MELD) score >10. The analysis included data between 2014 and 2021.

The mean age was 64, and 59.6% of participants were male. Overall, 70.8% had genotype 1, and 32% were treatment experienced. In total, 45.2% were treated with PI-based DAAs.

The PI cohort was older (64.6 versus 62.7; P = .01), and more likely to have genotype 1 (87.2% versus 56.3%; P < .001) and chronic renal disease (64.0% vs. 53.9%; P = .001).

The two groups had similar rates of sustained virologic response at 12 and 24 weeks, as well as similar rates of significant improvement or significant worsening, suggesting similar tolerability. There was a lower frequency of liver decompensation in the PI group at 12 weeks (4.4% vs. 7.9%; P = .04) and a trend at 24 weeks (8.8% versus 12.6%; P = .08).

Another limitation of the study is the potential for bias due to its retrospective nature.

Dr. Wong has been an invited speaker for AbbVie and Gilead. Dr. Bansal has no relevant financial disclosures.

SAN DIEGO – A novel combination of eight human commensal bacteria has shown efficacy in preventing recurrent Clostridioides difficile infections in high-risk populations. The cocktail of bacterial strains (VE303), produced under tightly-controlled conditions, is delivered in powdered form over a period of 14 days.

The approach, sponsored by Vedanta Biosciences, is one of several efforts to use carefully defined microbial populations instead of fecal microbiota transplantation (FMT) to treat or prevent C. diff infections.

The key issue is that not all of the bacteria found in FMTs are needed to provide a therapeutic effect, according to Thomas Louie, MD, professor of medicine at the University of Calgary (Alta.). “You don’t need all the bugs. You don’t need raw [stool]. You can take only the good parts,” said Dr. Louie, who presented the results of the phase 2 study at the annual Digestive Disease Week^® (DDW). In fact, FMT carries the risk of infection of pathogenic bacteria.

The strains found in VE303 were consistently identified in patients’ microbiota following successful FMTs, though they were absent before the transplant. Animal and human studies then showed that the microbes could repopulate microbiota.

Among 78 patients included in the efficacy analysis of the study, after 8 weeks, 13.8% of the VE303 group experienced a recurrent C. diff infection, versus 45.5% of the placebo group, amounting to more than an 80% reduction in risk (odds ratio, 0.192; P = .0077). Adverse events were mild and similar across both groups, with no treatment-related serious adverse events reported.

The same session included a post hoc analysis of a phase 3 study sponsored by Seres Therapeutics, which showed that the company’s oral product SER-109, composed of purified Firmicutes spores, reduced the risk of recurrent C. diff infection after 8 weeks compared to placebo (12.4% versus 39.8%; P < .001).

The new analysis examined short-, medium-, and branch-chained fatty acids in patient stools. After just 1 week of treatment, there was an increase in the short-chain fatty acid butyrate and medium-chain fatty acids valerate and hexanoate. They continued to be higher in weeks 2 and 8 in the treatment arm. The results suggest that increased fatty acid production might boost clinical outcomes, according to Kevin Litcofsky of Seres, who presented the results.

Both approaches have potential, according to Melinda Engevik, PhD, who comoderated the session where the study was presented. “I think that they’re both interesting ideas. The spores [from Seres], I think, are going to be better at passing through the stomach and a little bit more resistant, but then they have to germinate and engraft, whereas if you give the lyophilized bacteria [from Vedanta], you might lose some more, but they’re already primed and ready to go. So I think they’re both very different approaches, but the data from both seem to support that they worked and probably in different ways,” said Dr. Engevik, assistant professor at the Medical University of South Carolina, Charleston.

“Patients that have recurrent [C. diff], they are desperate to be able to break the cycle of recurrence. I think that they’ve shown a lot of safety with this, which is an issue for FMT. Both of the talks seemed like there is a path moving forward to help those patients. I was encouraged,” said Dr. Engevik.

Comoderator Anoop Kumar, PhD, assistant professor of gastroenterology and hepatology at University of Illinois, Chicago, agreed and noted the advantage of such treatments over FMT during the COVID-19 pandemic, which has disrupted FMT delivery.

Previous studies have looked at probiotics, but results so far have been mixed, said Dr. Engevik. She suspects these two approaches, containing more bacterial strains, are likely to have better success. “I think you really have to have a complex gut microbiota community, at least minimally complex, to be able to get the effects. I think it’s the wave of the future,” she said.

Dr. Engevik also suggested that the benefits might not stop at C. diff. She highlighted research in other gastrointestinal diseases such as inflammatory bowel disease, and even efforts underway to enhance responses to checkpoint inhibitors in the treatment of cancer. “Gut microbes are master regulators, so they have these wide-reaching effects. I think that a lot of human health will be started to be targeted by looking at the gut microbiota,” she said.

Dr. Louie also highlighted the potential for more applications. “C. diff is low-hanging fruit. I think these bugs will have some usefulness for [irritable bowel syndrome]. I’ve transplanted some patients with IBS and it seemed to work. I haven’t had time to design and do an IBS trial, but the future is these bugs.”

Dr. Louie also participated in the Seres study. He has been on the advisory board for Vedanta, Seres, Finch Therapeutics, and Artugen Therapeutics. Dr. Engevik and Dr. Kumar have no relevant financial disclosures.

SAN DIEGO – A novel combination of eight human commensal bacteria has shown efficacy in preventing recurrent Clostridioides difficile infections in high-risk populations. The cocktail of bacterial strains (VE303), produced under tightly-controlled conditions, is delivered in powdered form over a period of 14 days.

The approach, sponsored by Vedanta Biosciences, is one of several efforts to use carefully defined microbial populations instead of fecal microbiota transplantation (FMT) to treat or prevent C. diff infections.

The key issue is that not all of the bacteria found in FMTs are needed to provide a therapeutic effect, according to Thomas Louie, MD, professor of medicine at the University of Calgary (Alta.). “You don’t need all the bugs. You don’t need raw [stool]. You can take only the good parts,” said Dr. Louie, who presented the results of the phase 2 study at the annual Digestive Disease Week^® (DDW). In fact, FMT carries the risk of infection of pathogenic bacteria.

The strains found in VE303 were consistently identified in patients’ microbiota following successful FMTs, though they were absent before the transplant. Animal and human studies then showed that the microbes could repopulate microbiota.

Among 78 patients included in the efficacy analysis of the study, after 8 weeks, 13.8% of the VE303 group experienced a recurrent C. diff infection, versus 45.5% of the placebo group, amounting to more than an 80% reduction in risk (odds ratio, 0.192; P = .0077). Adverse events were mild and similar across both groups, with no treatment-related serious adverse events reported.

The same session included a post hoc analysis of a phase 3 study sponsored by Seres Therapeutics, which showed that the company’s oral product SER-109, composed of purified Firmicutes spores, reduced the risk of recurrent C. diff infection after 8 weeks compared to placebo (12.4% versus 39.8%; P < .001).

The new analysis examined short-, medium-, and branch-chained fatty acids in patient stools. After just 1 week of treatment, there was an increase in the short-chain fatty acid butyrate and medium-chain fatty acids valerate and hexanoate. They continued to be higher in weeks 2 and 8 in the treatment arm. The results suggest that increased fatty acid production might boost clinical outcomes, according to Kevin Litcofsky of Seres, who presented the results.

Both approaches have potential, according to Melinda Engevik, PhD, who comoderated the session where the study was presented. “I think that they’re both interesting ideas. The spores [from Seres], I think, are going to be better at passing through the stomach and a little bit more resistant, but then they have to germinate and engraft, whereas if you give the lyophilized bacteria [from Vedanta], you might lose some more, but they’re already primed and ready to go. So I think they’re both very different approaches, but the data from both seem to support that they worked and probably in different ways,” said Dr. Engevik, assistant professor at the Medical University of South Carolina, Charleston.

“Patients that have recurrent [C. diff], they are desperate to be able to break the cycle of recurrence. I think that they’ve shown a lot of safety with this, which is an issue for FMT. Both of the talks seemed like there is a path moving forward to help those patients. I was encouraged,” said Dr. Engevik.

Comoderator Anoop Kumar, PhD, assistant professor of gastroenterology and hepatology at University of Illinois, Chicago, agreed and noted the advantage of such treatments over FMT during the COVID-19 pandemic, which has disrupted FMT delivery.

Previous studies have looked at probiotics, but results so far have been mixed, said Dr. Engevik. She suspects these two approaches, containing more bacterial strains, are likely to have better success. “I think you really have to have a complex gut microbiota community, at least minimally complex, to be able to get the effects. I think it’s the wave of the future,” she said.

Dr. Engevik also suggested that the benefits might not stop at C. diff. She highlighted research in other gastrointestinal diseases such as inflammatory bowel disease, and even efforts underway to enhance responses to checkpoint inhibitors in the treatment of cancer. “Gut microbes are master regulators, so they have these wide-reaching effects. I think that a lot of human health will be started to be targeted by looking at the gut microbiota,” she said.

Dr. Louie also highlighted the potential for more applications. “C. diff is low-hanging fruit. I think these bugs will have some usefulness for [irritable bowel syndrome]. I’ve transplanted some patients with IBS and it seemed to work. I haven’t had time to design and do an IBS trial, but the future is these bugs.”

Dr. Louie also participated in the Seres study. He has been on the advisory board for Vedanta, Seres, Finch Therapeutics, and Artugen Therapeutics. Dr. Engevik and Dr. Kumar have no relevant financial disclosures.

SAN DIEGO – A novel combination of eight human commensal bacteria has shown efficacy in preventing recurrent Clostridioides difficile infections in high-risk populations. The cocktail of bacterial strains (VE303), produced under tightly-controlled conditions, is delivered in powdered form over a period of 14 days.

The approach, sponsored by Vedanta Biosciences, is one of several efforts to use carefully defined microbial populations instead of fecal microbiota transplantation (FMT) to treat or prevent C. diff infections.

The key issue is that not all of the bacteria found in FMTs are needed to provide a therapeutic effect, according to Thomas Louie, MD, professor of medicine at the University of Calgary (Alta.). “You don’t need all the bugs. You don’t need raw [stool]. You can take only the good parts,” said Dr. Louie, who presented the results of the phase 2 study at the annual Digestive Disease Week^® (DDW). In fact, FMT carries the risk of infection of pathogenic bacteria.

The strains found in VE303 were consistently identified in patients’ microbiota following successful FMTs, though they were absent before the transplant. Animal and human studies then showed that the microbes could repopulate microbiota.

Among 78 patients included in the efficacy analysis of the study, after 8 weeks, 13.8% of the VE303 group experienced a recurrent C. diff infection, versus 45.5% of the placebo group, amounting to more than an 80% reduction in risk (odds ratio, 0.192; P = .0077). Adverse events were mild and similar across both groups, with no treatment-related serious adverse events reported.

The same session included a post hoc analysis of a phase 3 study sponsored by Seres Therapeutics, which showed that the company’s oral product SER-109, composed of purified Firmicutes spores, reduced the risk of recurrent C. diff infection after 8 weeks compared to placebo (12.4% versus 39.8%; P < .001).

The new analysis examined short-, medium-, and branch-chained fatty acids in patient stools. After just 1 week of treatment, there was an increase in the short-chain fatty acid butyrate and medium-chain fatty acids valerate and hexanoate. They continued to be higher in weeks 2 and 8 in the treatment arm. The results suggest that increased fatty acid production might boost clinical outcomes, according to Kevin Litcofsky of Seres, who presented the results.

Both approaches have potential, according to Melinda Engevik, PhD, who comoderated the session where the study was presented. “I think that they’re both interesting ideas. The spores [from Seres], I think, are going to be better at passing through the stomach and a little bit more resistant, but then they have to germinate and engraft, whereas if you give the lyophilized bacteria [from Vedanta], you might lose some more, but they’re already primed and ready to go. So I think they’re both very different approaches, but the data from both seem to support that they worked and probably in different ways,” said Dr. Engevik, assistant professor at the Medical University of South Carolina, Charleston.

“Patients that have recurrent [C. diff], they are desperate to be able to break the cycle of recurrence. I think that they’ve shown a lot of safety with this, which is an issue for FMT. Both of the talks seemed like there is a path moving forward to help those patients. I was encouraged,” said Dr. Engevik.

Comoderator Anoop Kumar, PhD, assistant professor of gastroenterology and hepatology at University of Illinois, Chicago, agreed and noted the advantage of such treatments over FMT during the COVID-19 pandemic, which has disrupted FMT delivery.

Previous studies have looked at probiotics, but results so far have been mixed, said Dr. Engevik. She suspects these two approaches, containing more bacterial strains, are likely to have better success. “I think you really have to have a complex gut microbiota community, at least minimally complex, to be able to get the effects. I think it’s the wave of the future,” she said.

Dr. Engevik also suggested that the benefits might not stop at C. diff. She highlighted research in other gastrointestinal diseases such as inflammatory bowel disease, and even efforts underway to enhance responses to checkpoint inhibitors in the treatment of cancer. “Gut microbes are master regulators, so they have these wide-reaching effects. I think that a lot of human health will be started to be targeted by looking at the gut microbiota,” she said.

Dr. Louie also highlighted the potential for more applications. “C. diff is low-hanging fruit. I think these bugs will have some usefulness for [irritable bowel syndrome]. I’ve transplanted some patients with IBS and it seemed to work. I haven’t had time to design and do an IBS trial, but the future is these bugs.”

Dr. Louie also participated in the Seres study. He has been on the advisory board for Vedanta, Seres, Finch Therapeutics, and Artugen Therapeutics. Dr. Engevik and Dr. Kumar have no relevant financial disclosures.

SAN DIEGO – Treating people with alcoholic hepatitis for alcohol abuse may reduce their risk of hospital readmission, researchers reported.

In a retrospective analysis of nationwide data, 7.83% of those patients who received psychotherapy, counseling, or drug treatment for alcohol abuse were readmitted within 30 days, versus 11.67% of those who did not receive these kinds of treatment.

The finding lends support to the argument that hospitals should invest more in the treatments, despite the complexities involved.

“It takes a multidisciplinary approach, starting from the physician or the health care provider along with the pharmacists, the behavioral health specialists, or a psychiatrist or psychologist, along with case management as well,” said Harleen Chela, MD, a third-year resident at the University of Missouri in Columbia. She presented the findings at the annual Digestive Disease Week^® (DDW).

The researchers started with the premise that patients with alcoholic hepatitis can prevent the condition from worsening by abstaining from alcohol. To see whether interventions aimed at encouraging that abstention could prevent readmissions, Dr. Chela and colleagues analyzed data on readmissions for the first 11 months of the year 2018.

They included patients who were at least 18 years of age and who had a nonelective admission with a principal diagnosis of alcohol abuse.

Using procedure codes, they compared those patients given psychotherapy (including cognitive behavioral therapy), formal inpatient counseling, and drug treatment for alcohol abuse to those who didn’t. Then they counted how many patients were readmitted within 30 days.

They found records of 45,617 patients admitted for alcoholic hepatitis of whom 1,552 received treatment for alcohol abuse and 44,065 did not.

They did not find any significant difference between the two groups in demographics, income, or insurance status.

Adjusting for such factors, the researchers found that people who received alcohol abuse treatment were 64% as likely to be readmitted as were those who did not (hazard ratio, 0.64; 95% confidence interval, 0.46-0.91; P = 0.01).

If alcohol abuse treatment is so effective, why isn’t it routine? “It’s not always feasible to implement this, on the inpatient side, because it takes more than a day or two just to get some of these things put in place,” Dr. Chela told this news organization.

They did find that people were more likely to get treatment for alcohol abuse if they were admitted to a hospital in a big city rather than a small town and if their hospital was owned by private investors rather than by a not-for-profit organization or the government.

“Larger hospitals and private sector institutions have more access to resources and money to have those kinds of systems in place for the patients,” said Dr. Chela.

She became interested in the issue at her hospital when she noticed that patients with alcoholic hepatitis were not getting behavioral counseling. “The inpatient load in the behavioral health side is so much that they don’t have time for these kinds of consults,” she said. “That’s one of the challenges: A shortage of behavioral specialists like psychiatrists.”

And hospitals tend to focus on treating conditions that threaten their patients’ lives in the short term. “Someone who has a heart attack or a gastrointestinal bleed – there’s more focus on resources for those kinds of patients,” she said.

Virginia Commonwealth University in Richmond provides alcohol abuse treatment to patients with alcoholic hepatitis partly using telehealth, said Richard Sterling, MD, MSc, chief of hepatology, who was not involved in the study. “For people who live too far away, don’t have transportation, or have other health disparities, we now have technology and mechanisms to keep them engaged in care,” he told this news organization. “We’re doing a lot of Zoom visits.”

Dr. Chela and colleagues also found that those who got alcohol abuse treatment were less likely to be discharged to a skilled nursing facility or to home health. The data couldn’t give the researchers a definitive reason for this, but Dr. Chela speculated that the patients who received treatment for alcohol abuse stayed longer in the hospital and may have been in better shape when they were discharged.

The U.S. health care system doesn’t necessarily provide incentives to keep patients healthy, Dr. Sterling said. “Hospital systems make money off of filling beds, and providing a lot of inpatient care and hospital days,” he said. “That may be not necessarily congruent with a health system that is supposed to provide health for these covered lives.”

Neither Dr. Chela nor Dr. Sterling reported any relevant financial relationships.

SAN DIEGO – Treating people with alcoholic hepatitis for alcohol abuse may reduce their risk of hospital readmission, researchers reported.

In a retrospective analysis of nationwide data, 7.83% of those patients who received psychotherapy, counseling, or drug treatment for alcohol abuse were readmitted within 30 days, versus 11.67% of those who did not receive these kinds of treatment.

The finding lends support to the argument that hospitals should invest more in the treatments, despite the complexities involved.

“It takes a multidisciplinary approach, starting from the physician or the health care provider along with the pharmacists, the behavioral health specialists, or a psychiatrist or psychologist, along with case management as well,” said Harleen Chela, MD, a third-year resident at the University of Missouri in Columbia. She presented the findings at the annual Digestive Disease Week^® (DDW).

The researchers started with the premise that patients with alcoholic hepatitis can prevent the condition from worsening by abstaining from alcohol. To see whether interventions aimed at encouraging that abstention could prevent readmissions, Dr. Chela and colleagues analyzed data on readmissions for the first 11 months of the year 2018.

They included patients who were at least 18 years of age and who had a nonelective admission with a principal diagnosis of alcohol abuse.

Using procedure codes, they compared those patients given psychotherapy (including cognitive behavioral therapy), formal inpatient counseling, and drug treatment for alcohol abuse to those who didn’t. Then they counted how many patients were readmitted within 30 days.

They found records of 45,617 patients admitted for alcoholic hepatitis of whom 1,552 received treatment for alcohol abuse and 44,065 did not.

They did not find any significant difference between the two groups in demographics, income, or insurance status.

Adjusting for such factors, the researchers found that people who received alcohol abuse treatment were 64% as likely to be readmitted as were those who did not (hazard ratio, 0.64; 95% confidence interval, 0.46-0.91; P = 0.01).

If alcohol abuse treatment is so effective, why isn’t it routine? “It’s not always feasible to implement this, on the inpatient side, because it takes more than a day or two just to get some of these things put in place,” Dr. Chela told this news organization.

They did find that people were more likely to get treatment for alcohol abuse if they were admitted to a hospital in a big city rather than a small town and if their hospital was owned by private investors rather than by a not-for-profit organization or the government.

“Larger hospitals and private sector institutions have more access to resources and money to have those kinds of systems in place for the patients,” said Dr. Chela.

She became interested in the issue at her hospital when she noticed that patients with alcoholic hepatitis were not getting behavioral counseling. “The inpatient load in the behavioral health side is so much that they don’t have time for these kinds of consults,” she said. “That’s one of the challenges: A shortage of behavioral specialists like psychiatrists.”

And hospitals tend to focus on treating conditions that threaten their patients’ lives in the short term. “Someone who has a heart attack or a gastrointestinal bleed – there’s more focus on resources for those kinds of patients,” she said.

Virginia Commonwealth University in Richmond provides alcohol abuse treatment to patients with alcoholic hepatitis partly using telehealth, said Richard Sterling, MD, MSc, chief of hepatology, who was not involved in the study. “For people who live too far away, don’t have transportation, or have other health disparities, we now have technology and mechanisms to keep them engaged in care,” he told this news organization. “We’re doing a lot of Zoom visits.”

Dr. Chela and colleagues also found that those who got alcohol abuse treatment were less likely to be discharged to a skilled nursing facility or to home health. The data couldn’t give the researchers a definitive reason for this, but Dr. Chela speculated that the patients who received treatment for alcohol abuse stayed longer in the hospital and may have been in better shape when they were discharged.

The U.S. health care system doesn’t necessarily provide incentives to keep patients healthy, Dr. Sterling said. “Hospital systems make money off of filling beds, and providing a lot of inpatient care and hospital days,” he said. “That may be not necessarily congruent with a health system that is supposed to provide health for these covered lives.”

Neither Dr. Chela nor Dr. Sterling reported any relevant financial relationships.

SAN DIEGO – Treating people with alcoholic hepatitis for alcohol abuse may reduce their risk of hospital readmission, researchers reported.

In a retrospective analysis of nationwide data, 7.83% of those patients who received psychotherapy, counseling, or drug treatment for alcohol abuse were readmitted within 30 days, versus 11.67% of those who did not receive these kinds of treatment.

The finding lends support to the argument that hospitals should invest more in the treatments, despite the complexities involved.

“It takes a multidisciplinary approach, starting from the physician or the health care provider along with the pharmacists, the behavioral health specialists, or a psychiatrist or psychologist, along with case management as well,” said Harleen Chela, MD, a third-year resident at the University of Missouri in Columbia. She presented the findings at the annual Digestive Disease Week^® (DDW).

The researchers started with the premise that patients with alcoholic hepatitis can prevent the condition from worsening by abstaining from alcohol. To see whether interventions aimed at encouraging that abstention could prevent readmissions, Dr. Chela and colleagues analyzed data on readmissions for the first 11 months of the year 2018.

They included patients who were at least 18 years of age and who had a nonelective admission with a principal diagnosis of alcohol abuse.

Using procedure codes, they compared those patients given psychotherapy (including cognitive behavioral therapy), formal inpatient counseling, and drug treatment for alcohol abuse to those who didn’t. Then they counted how many patients were readmitted within 30 days.

They found records of 45,617 patients admitted for alcoholic hepatitis of whom 1,552 received treatment for alcohol abuse and 44,065 did not.

They did not find any significant difference between the two groups in demographics, income, or insurance status.

Adjusting for such factors, the researchers found that people who received alcohol abuse treatment were 64% as likely to be readmitted as were those who did not (hazard ratio, 0.64; 95% confidence interval, 0.46-0.91; P = 0.01).

If alcohol abuse treatment is so effective, why isn’t it routine? “It’s not always feasible to implement this, on the inpatient side, because it takes more than a day or two just to get some of these things put in place,” Dr. Chela told this news organization.

They did find that people were more likely to get treatment for alcohol abuse if they were admitted to a hospital in a big city rather than a small town and if their hospital was owned by private investors rather than by a not-for-profit organization or the government.

“Larger hospitals and private sector institutions have more access to resources and money to have those kinds of systems in place for the patients,” said Dr. Chela.

She became interested in the issue at her hospital when she noticed that patients with alcoholic hepatitis were not getting behavioral counseling. “The inpatient load in the behavioral health side is so much that they don’t have time for these kinds of consults,” she said. “That’s one of the challenges: A shortage of behavioral specialists like psychiatrists.”

And hospitals tend to focus on treating conditions that threaten their patients’ lives in the short term. “Someone who has a heart attack or a gastrointestinal bleed – there’s more focus on resources for those kinds of patients,” she said.

Virginia Commonwealth University in Richmond provides alcohol abuse treatment to patients with alcoholic hepatitis partly using telehealth, said Richard Sterling, MD, MSc, chief of hepatology, who was not involved in the study. “For people who live too far away, don’t have transportation, or have other health disparities, we now have technology and mechanisms to keep them engaged in care,” he told this news organization. “We’re doing a lot of Zoom visits.”

Dr. Chela and colleagues also found that those who got alcohol abuse treatment were less likely to be discharged to a skilled nursing facility or to home health. The data couldn’t give the researchers a definitive reason for this, but Dr. Chela speculated that the patients who received treatment for alcohol abuse stayed longer in the hospital and may have been in better shape when they were discharged.

The U.S. health care system doesn’t necessarily provide incentives to keep patients healthy, Dr. Sterling said. “Hospital systems make money off of filling beds, and providing a lot of inpatient care and hospital days,” he said. “That may be not necessarily congruent with a health system that is supposed to provide health for these covered lives.”

Neither Dr. Chela nor Dr. Sterling reported any relevant financial relationships.

The U.S. Food and Drug Administration has approved dupilumab (Dupixent, Regeneron) to treat eosinophilic esophagitis (EoE) in adults and children aged 12 years and older weighing at least 40 kg.

EoE is a chronic inflammatory disorder driven by type 2 inflammation that damages the esophagus and causes difficulty swallowing and eating.

Dupilumab is a monoclonal antibody that acts to inhibit part of the inflammatory pathway. It’s the first drug to be approved by the FDA for EoE.

In a phase 3 trial, dupilumab 300 mg weekly significantly improved signs and symptoms of eosinophilic esophagitis, compared with placebo, underscoring the role of type 2 inflammation in this disease, Regeneron says in a news release.

According to the company, there are roughly 160,000 patients in the United States living with EoE who are currently using treatments not specifically approved for the disease. Of those patients, about 48,000 continue to experience symptoms despite multiple treatments.

“As researchers and clinicians have gained knowledge about eosinophilic esophagitis in recent years, more cases of the disorder have been recognized and diagnosed in the U.S.,” Jessica Lee, MD, director of the Division of Gastroenterology in the FDA’s Center for Drug Evaluation and Research, said in an FDA news release.

The approval of dupilumab will “fulfill an important unmet need for the increasing number of patients with eosinophilic esophagitis,” Dr. Lee said.

The efficacy and safety of dupilumab in EoE was demonstrated in a randomized, double-blind, parallel-group, multicenter, placebo-controlled trial that included two 24-week treatment periods (parts A and B) that were conducted independently in separate groups of patients.

In both part A and B, patients received dupilumab 300 mg or placebo every week.

In part A of the trial, 60% of the 42 patients who received dupilumab achieved the predetermined level of reduction of eosinophils in the esophagus, compared with 5% of the 39 patients who received placebo, the FDA said.

Patients who received dupilumab also experienced an average improvement of 22 points in the Dysphagia Symptom Questionnaire (DSQ) score, compared with 10 points for patients who received placebo.

In part B, 59% of the 80 patients who received dupilumab achieved the predetermined level of reduction of eosinophils in the esophagus, compared with 6% of the 79 patients who received placebo.

Patients who received dupilumab also experienced an average improvement of 24 points in their DSQ score, compared with 14 points for patients who received placebo.

“Assessments incorporating the perspectives from patients with EoE supported that the DSQ score improvement in patients who received Dupixent in the clinical trial was representative of clinically meaningful improvement in dysphagia,” the FDA noted.

“Treatment for patients with eosinophilic esophagitis can be challenging, particularly with no previously approved medications,” Evan Dellon, MD, principal investigator for the phase 3 trial, said in the company news release.

“Now, patients and their doctors have a treatment option available as part of their management plan that has the potential to control symptoms, improve inflammation, and heal the changes in the esophagus caused by this progressive and burdensome disease,” added Dr. Dellon, who is professor of medicine in the division of gastroenterology and hepatology at the University of North Carolina at Chapel Hill.

The FDA granted dupilumab priority review and breakthrough therapy designations for EoE.

Dupilumab is already approved in the United States for treatment of moderate to severe atopic dermatitis in adults and children aged 6 years and older whose disease is not adequately controlled by topical prescription therapies or for whom those therapies are not advisable.

The drug is also approved as an add-on maintenance treatment for adults and children aged 6 years and older with certain types of moderate to severe asthma and as an add-on maintenance treatment for adults with inadequately controlled chronic rhinosinusitis with nasal polyposis.

A version of this article first appeared on Medscape.com .

The U.S. Food and Drug Administration has approved dupilumab (Dupixent, Regeneron) to treat eosinophilic esophagitis (EoE) in adults and children aged 12 years and older weighing at least 40 kg.

EoE is a chronic inflammatory disorder driven by type 2 inflammation that damages the esophagus and causes difficulty swallowing and eating.

Dupilumab is a monoclonal antibody that acts to inhibit part of the inflammatory pathway. It’s the first drug to be approved by the FDA for EoE.

In a phase 3 trial, dupilumab 300 mg weekly significantly improved signs and symptoms of eosinophilic esophagitis, compared with placebo, underscoring the role of type 2 inflammation in this disease, Regeneron says in a news release.

According to the company, there are roughly 160,000 patients in the United States living with EoE who are currently using treatments not specifically approved for the disease. Of those patients, about 48,000 continue to experience symptoms despite multiple treatments.

“As researchers and clinicians have gained knowledge about eosinophilic esophagitis in recent years, more cases of the disorder have been recognized and diagnosed in the U.S.,” Jessica Lee, MD, director of the Division of Gastroenterology in the FDA’s Center for Drug Evaluation and Research, said in an FDA news release.

The approval of dupilumab will “fulfill an important unmet need for the increasing number of patients with eosinophilic esophagitis,” Dr. Lee said.

The efficacy and safety of dupilumab in EoE was demonstrated in a randomized, double-blind, parallel-group, multicenter, placebo-controlled trial that included two 24-week treatment periods (parts A and B) that were conducted independently in separate groups of patients.

In both part A and B, patients received dupilumab 300 mg or placebo every week.

In part A of the trial, 60% of the 42 patients who received dupilumab achieved the predetermined level of reduction of eosinophils in the esophagus, compared with 5% of the 39 patients who received placebo, the FDA said.

Patients who received dupilumab also experienced an average improvement of 22 points in the Dysphagia Symptom Questionnaire (DSQ) score, compared with 10 points for patients who received placebo.

In part B, 59% of the 80 patients who received dupilumab achieved the predetermined level of reduction of eosinophils in the esophagus, compared with 6% of the 79 patients who received placebo.

Patients who received dupilumab also experienced an average improvement of 24 points in their DSQ score, compared with 14 points for patients who received placebo.

“Assessments incorporating the perspectives from patients with EoE supported that the DSQ score improvement in patients who received Dupixent in the clinical trial was representative of clinically meaningful improvement in dysphagia,” the FDA noted.

“Treatment for patients with eosinophilic esophagitis can be challenging, particularly with no previously approved medications,” Evan Dellon, MD, principal investigator for the phase 3 trial, said in the company news release.

“Now, patients and their doctors have a treatment option available as part of their management plan that has the potential to control symptoms, improve inflammation, and heal the changes in the esophagus caused by this progressive and burdensome disease,” added Dr. Dellon, who is professor of medicine in the division of gastroenterology and hepatology at the University of North Carolina at Chapel Hill.

The FDA granted dupilumab priority review and breakthrough therapy designations for EoE.

Dupilumab is already approved in the United States for treatment of moderate to severe atopic dermatitis in adults and children aged 6 years and older whose disease is not adequately controlled by topical prescription therapies or for whom those therapies are not advisable.

The drug is also approved as an add-on maintenance treatment for adults and children aged 6 years and older with certain types of moderate to severe asthma and as an add-on maintenance treatment for adults with inadequately controlled chronic rhinosinusitis with nasal polyposis.

A version of this article first appeared on Medscape.com .

The U.S. Food and Drug Administration has approved dupilumab (Dupixent, Regeneron) to treat eosinophilic esophagitis (EoE) in adults and children aged 12 years and older weighing at least 40 kg.

EoE is a chronic inflammatory disorder driven by type 2 inflammation that damages the esophagus and causes difficulty swallowing and eating.

Dupilumab is a monoclonal antibody that acts to inhibit part of the inflammatory pathway. It’s the first drug to be approved by the FDA for EoE.

In a phase 3 trial, dupilumab 300 mg weekly significantly improved signs and symptoms of eosinophilic esophagitis, compared with placebo, underscoring the role of type 2 inflammation in this disease, Regeneron says in a news release.

According to the company, there are roughly 160,000 patients in the United States living with EoE who are currently using treatments not specifically approved for the disease. Of those patients, about 48,000 continue to experience symptoms despite multiple treatments.

“As researchers and clinicians have gained knowledge about eosinophilic esophagitis in recent years, more cases of the disorder have been recognized and diagnosed in the U.S.,” Jessica Lee, MD, director of the Division of Gastroenterology in the FDA’s Center for Drug Evaluation and Research, said in an FDA news release.

The approval of dupilumab will “fulfill an important unmet need for the increasing number of patients with eosinophilic esophagitis,” Dr. Lee said.

The efficacy and safety of dupilumab in EoE was demonstrated in a randomized, double-blind, parallel-group, multicenter, placebo-controlled trial that included two 24-week treatment periods (parts A and B) that were conducted independently in separate groups of patients.

In both part A and B, patients received dupilumab 300 mg or placebo every week.

In part A of the trial, 60% of the 42 patients who received dupilumab achieved the predetermined level of reduction of eosinophils in the esophagus, compared with 5% of the 39 patients who received placebo, the FDA said.

Patients who received dupilumab also experienced an average improvement of 22 points in the Dysphagia Symptom Questionnaire (DSQ) score, compared with 10 points for patients who received placebo.

In part B, 59% of the 80 patients who received dupilumab achieved the predetermined level of reduction of eosinophils in the esophagus, compared with 6% of the 79 patients who received placebo.

Patients who received dupilumab also experienced an average improvement of 24 points in their DSQ score, compared with 14 points for patients who received placebo.

“Assessments incorporating the perspectives from patients with EoE supported that the DSQ score improvement in patients who received Dupixent in the clinical trial was representative of clinically meaningful improvement in dysphagia,” the FDA noted.

“Treatment for patients with eosinophilic esophagitis can be challenging, particularly with no previously approved medications,” Evan Dellon, MD, principal investigator for the phase 3 trial, said in the company news release.

“Now, patients and their doctors have a treatment option available as part of their management plan that has the potential to control symptoms, improve inflammation, and heal the changes in the esophagus caused by this progressive and burdensome disease,” added Dr. Dellon, who is professor of medicine in the division of gastroenterology and hepatology at the University of North Carolina at Chapel Hill.

The FDA granted dupilumab priority review and breakthrough therapy designations for EoE.

Dupilumab is already approved in the United States for treatment of moderate to severe atopic dermatitis in adults and children aged 6 years and older whose disease is not adequately controlled by topical prescription therapies or for whom those therapies are not advisable.

The drug is also approved as an add-on maintenance treatment for adults and children aged 6 years and older with certain types of moderate to severe asthma and as an add-on maintenance treatment for adults with inadequately controlled chronic rhinosinusitis with nasal polyposis.

A version of this article first appeared on Medscape.com .