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Richard Pizzi is editor of The Hospitalist. He has been an editor at Frontline Medical Communications since 2015, and previously served as editor of MDedge publications Hospitalist News and ID Practitioner. He has also worked as an editor and in editorial management roles for HIMSS Media, MedTech Media, and the American Association for Clinical Chemistry. Follow him on Twitter @richpizzi
Ebola research update: March 2016
The struggle to defeat Ebola virus disease continues globally, although it may not always make the headlines. To catch up on what you may have missed, here are some notable news items and journal articles published over the past few weeks that are worth a second look.
The potential exists for the emergence of a new form of Ebola virus, according to research published in Scientific Reports. Only a few mutations in one Ebola virus protein, VP24, may be necessary to render the Reston virus, which currently circulates in pigs, into a virus that can cause human disease and to develop into a novel health threat.
According to a report in MMWR, a single, traditional funeral of a prominent pharmacist was associated with a sharp increase in the number of reported Ebola cases in a previously low-incidence district of Sierra Leone. This affirms that vigilant Ebola surveillance and rapid response are essential, and immediate, safe burials by trained teams are critical to interrupting transmission and controlling Ebola.
Rhesus monkeys were completely protected from Ebola virus when treated three days after infection with a compound that blocks the virus’s ability to replicate. Investigators say these encouraging preclinical results suggest the compound, known as GS-5734, should be further developed as a potential treatment.
Social media tools could be used effectively as surveillance response mechanisms for improving the detection of, preparedness, and response to Ebola virus outbreaks, as a complement to traditional, filed, work-based surveillance approach, according to a study. The research, published in Epidemiology & Infection, suggested that the public health response to an Ebola outbreak could be more proactive rather than reactive by the use of social media to fill in the “missing gaps” in news reports and outreach.
CDC investigators, in a perspectives article in Emerging Infectious Diseases, offered suggestions to improve governmental and health care organizational response to future Ebola virus outbreaks. Ideal responses should include accurately identifying the viral reservoir, improving in-country detection and response capacity, conducting survivor studies and supporting survivors, engaging in culturally appropriate public education and risk communication, building productive interagency relationships, and continuing support for basic research.
During the Ebola epidemic in Guinea, calls to prefecture health departments were more sensitive for Ebola virus disease case detection than those to a national call center, according to a study in MMWR. The authors said low sensitivity for Ebola case detection limits the utility of a national call center as a surveillance system.
A report in Science Translational Medicine suggests that the antibody cocktail used in Ebola virus–infected patients can be further simplified to only two antibodies and that these antibodies can be produced in engineered Chinese hamster ovary cells. Such a cocktail protected nonhuman primates against the virus responsible for the 2014-2015 outbreak up to 3 days after exposure, and combining these antibodies with those specific for other strains may lead to a broad Ebola virus therapy.
Rapid testing for the Zika virus is a critical need in the recent Ebola-affected countries of Liberia, Sierra Leone, and Guinea, said Dr. Daniel R. Lucey, adjunct professor of medicine at Georgetown University, Washington, because of the recent Zika outbreak on nearby Cape Verde and the similarity in symptoms between Zika and early Ebola.
A meta-analysis of the risk factors for transmission of Ebola or Marburg virus disease found that transmission of any African filovirus is unlikely except through close contact, especially during the most severe stages of acute illness. However, the investigators said more data are needed about the context, intimacy, and timing of contact required to raise the odds of disease transmission, as well as risk factors specific to urban settings.
There is no shortage of lessons learned from the recent Ebola epidemic, including the need for reforms in rapid response capability, research, leadership, and better governance, notes an essay in the International Journal of Epidemiology. But the importance of disease mapping appears to have been overlooked.
A meta-analysis of the Ebola household secondary attack rate (SAR) estimated that 27.1% of Ebola infections are asymptomatic. Transmission was driven by direct contact, with little transmission occurring in its absence (SAR, 0.8%). The greatest risk factor was the provision of nursing care. The findings suggest that surveillance and containment measures should be effective for controlling Ebola.
A study of Ebola virus disease survivors in Sierra Leone found patients experiencing a variety of long-term complications, including ocular problems like uveitis. In fact, EVD survivors were 10 times more likely to develop uveitis post EVD if they presented with red/injected eyes during the acute phase of their illness.
A review essay in Lancet Infectious Diseases assesses what is known regarding the sequelae of Ebola virus disease, including possible delayed virus clearance. The authors discuss some of the key challenges regarding the provision of care to survivors – calling it the “emergency within the emergency” – and implementation of necessary future research.
Researchers at Middle Tennessee State University investigated the potential of basic Susceptible-Exposed-Infectious-Recovered (SEIR) models to describe the 2014 Ebola outbreak in Meliandou, Guinea. They found that density-dependent transmission and mortality-induced behavioral changes shaped the course of the Ebola epidemic in Meliandou, while frequency-dependent transmission, disease-induced emigration, and infection-induced behavioral changes are not consistent with the data from that particular epidemic.
A study in Preventive Medicine proposes an alternative policy for Ebola entry screening at airports in the United States. This alternative policy considers a social contact tracing (SCT) risk level, in addition to the current health risk level used by the CDC.
A study evaluating the performance of the Cepheid GeneXpert Ebola assay on clinical venipuncture whole blood (WB) and buccal swab (BS) specimens found the assay had excellent performance compared to an established RT-PCR benchmark on WB and BS samples in a field laboratory setting. The authors said future studies should evaluate feasibility and performance outside of a biocontainment laboratory setting to facilitate expanded access to testing.
On Twitter @richpizzi
The struggle to defeat Ebola virus disease continues globally, although it may not always make the headlines. To catch up on what you may have missed, here are some notable news items and journal articles published over the past few weeks that are worth a second look.
The potential exists for the emergence of a new form of Ebola virus, according to research published in Scientific Reports. Only a few mutations in one Ebola virus protein, VP24, may be necessary to render the Reston virus, which currently circulates in pigs, into a virus that can cause human disease and to develop into a novel health threat.
According to a report in MMWR, a single, traditional funeral of a prominent pharmacist was associated with a sharp increase in the number of reported Ebola cases in a previously low-incidence district of Sierra Leone. This affirms that vigilant Ebola surveillance and rapid response are essential, and immediate, safe burials by trained teams are critical to interrupting transmission and controlling Ebola.
Rhesus monkeys were completely protected from Ebola virus when treated three days after infection with a compound that blocks the virus’s ability to replicate. Investigators say these encouraging preclinical results suggest the compound, known as GS-5734, should be further developed as a potential treatment.
Social media tools could be used effectively as surveillance response mechanisms for improving the detection of, preparedness, and response to Ebola virus outbreaks, as a complement to traditional, filed, work-based surveillance approach, according to a study. The research, published in Epidemiology & Infection, suggested that the public health response to an Ebola outbreak could be more proactive rather than reactive by the use of social media to fill in the “missing gaps” in news reports and outreach.
CDC investigators, in a perspectives article in Emerging Infectious Diseases, offered suggestions to improve governmental and health care organizational response to future Ebola virus outbreaks. Ideal responses should include accurately identifying the viral reservoir, improving in-country detection and response capacity, conducting survivor studies and supporting survivors, engaging in culturally appropriate public education and risk communication, building productive interagency relationships, and continuing support for basic research.
During the Ebola epidemic in Guinea, calls to prefecture health departments were more sensitive for Ebola virus disease case detection than those to a national call center, according to a study in MMWR. The authors said low sensitivity for Ebola case detection limits the utility of a national call center as a surveillance system.
A report in Science Translational Medicine suggests that the antibody cocktail used in Ebola virus–infected patients can be further simplified to only two antibodies and that these antibodies can be produced in engineered Chinese hamster ovary cells. Such a cocktail protected nonhuman primates against the virus responsible for the 2014-2015 outbreak up to 3 days after exposure, and combining these antibodies with those specific for other strains may lead to a broad Ebola virus therapy.
Rapid testing for the Zika virus is a critical need in the recent Ebola-affected countries of Liberia, Sierra Leone, and Guinea, said Dr. Daniel R. Lucey, adjunct professor of medicine at Georgetown University, Washington, because of the recent Zika outbreak on nearby Cape Verde and the similarity in symptoms between Zika and early Ebola.
A meta-analysis of the risk factors for transmission of Ebola or Marburg virus disease found that transmission of any African filovirus is unlikely except through close contact, especially during the most severe stages of acute illness. However, the investigators said more data are needed about the context, intimacy, and timing of contact required to raise the odds of disease transmission, as well as risk factors specific to urban settings.
There is no shortage of lessons learned from the recent Ebola epidemic, including the need for reforms in rapid response capability, research, leadership, and better governance, notes an essay in the International Journal of Epidemiology. But the importance of disease mapping appears to have been overlooked.
A meta-analysis of the Ebola household secondary attack rate (SAR) estimated that 27.1% of Ebola infections are asymptomatic. Transmission was driven by direct contact, with little transmission occurring in its absence (SAR, 0.8%). The greatest risk factor was the provision of nursing care. The findings suggest that surveillance and containment measures should be effective for controlling Ebola.
A study of Ebola virus disease survivors in Sierra Leone found patients experiencing a variety of long-term complications, including ocular problems like uveitis. In fact, EVD survivors were 10 times more likely to develop uveitis post EVD if they presented with red/injected eyes during the acute phase of their illness.
A review essay in Lancet Infectious Diseases assesses what is known regarding the sequelae of Ebola virus disease, including possible delayed virus clearance. The authors discuss some of the key challenges regarding the provision of care to survivors – calling it the “emergency within the emergency” – and implementation of necessary future research.
Researchers at Middle Tennessee State University investigated the potential of basic Susceptible-Exposed-Infectious-Recovered (SEIR) models to describe the 2014 Ebola outbreak in Meliandou, Guinea. They found that density-dependent transmission and mortality-induced behavioral changes shaped the course of the Ebola epidemic in Meliandou, while frequency-dependent transmission, disease-induced emigration, and infection-induced behavioral changes are not consistent with the data from that particular epidemic.
A study in Preventive Medicine proposes an alternative policy for Ebola entry screening at airports in the United States. This alternative policy considers a social contact tracing (SCT) risk level, in addition to the current health risk level used by the CDC.
A study evaluating the performance of the Cepheid GeneXpert Ebola assay on clinical venipuncture whole blood (WB) and buccal swab (BS) specimens found the assay had excellent performance compared to an established RT-PCR benchmark on WB and BS samples in a field laboratory setting. The authors said future studies should evaluate feasibility and performance outside of a biocontainment laboratory setting to facilitate expanded access to testing.
On Twitter @richpizzi
The struggle to defeat Ebola virus disease continues globally, although it may not always make the headlines. To catch up on what you may have missed, here are some notable news items and journal articles published over the past few weeks that are worth a second look.
The potential exists for the emergence of a new form of Ebola virus, according to research published in Scientific Reports. Only a few mutations in one Ebola virus protein, VP24, may be necessary to render the Reston virus, which currently circulates in pigs, into a virus that can cause human disease and to develop into a novel health threat.
According to a report in MMWR, a single, traditional funeral of a prominent pharmacist was associated with a sharp increase in the number of reported Ebola cases in a previously low-incidence district of Sierra Leone. This affirms that vigilant Ebola surveillance and rapid response are essential, and immediate, safe burials by trained teams are critical to interrupting transmission and controlling Ebola.
Rhesus monkeys were completely protected from Ebola virus when treated three days after infection with a compound that blocks the virus’s ability to replicate. Investigators say these encouraging preclinical results suggest the compound, known as GS-5734, should be further developed as a potential treatment.
Social media tools could be used effectively as surveillance response mechanisms for improving the detection of, preparedness, and response to Ebola virus outbreaks, as a complement to traditional, filed, work-based surveillance approach, according to a study. The research, published in Epidemiology & Infection, suggested that the public health response to an Ebola outbreak could be more proactive rather than reactive by the use of social media to fill in the “missing gaps” in news reports and outreach.
CDC investigators, in a perspectives article in Emerging Infectious Diseases, offered suggestions to improve governmental and health care organizational response to future Ebola virus outbreaks. Ideal responses should include accurately identifying the viral reservoir, improving in-country detection and response capacity, conducting survivor studies and supporting survivors, engaging in culturally appropriate public education and risk communication, building productive interagency relationships, and continuing support for basic research.
During the Ebola epidemic in Guinea, calls to prefecture health departments were more sensitive for Ebola virus disease case detection than those to a national call center, according to a study in MMWR. The authors said low sensitivity for Ebola case detection limits the utility of a national call center as a surveillance system.
A report in Science Translational Medicine suggests that the antibody cocktail used in Ebola virus–infected patients can be further simplified to only two antibodies and that these antibodies can be produced in engineered Chinese hamster ovary cells. Such a cocktail protected nonhuman primates against the virus responsible for the 2014-2015 outbreak up to 3 days after exposure, and combining these antibodies with those specific for other strains may lead to a broad Ebola virus therapy.
Rapid testing for the Zika virus is a critical need in the recent Ebola-affected countries of Liberia, Sierra Leone, and Guinea, said Dr. Daniel R. Lucey, adjunct professor of medicine at Georgetown University, Washington, because of the recent Zika outbreak on nearby Cape Verde and the similarity in symptoms between Zika and early Ebola.
A meta-analysis of the risk factors for transmission of Ebola or Marburg virus disease found that transmission of any African filovirus is unlikely except through close contact, especially during the most severe stages of acute illness. However, the investigators said more data are needed about the context, intimacy, and timing of contact required to raise the odds of disease transmission, as well as risk factors specific to urban settings.
There is no shortage of lessons learned from the recent Ebola epidemic, including the need for reforms in rapid response capability, research, leadership, and better governance, notes an essay in the International Journal of Epidemiology. But the importance of disease mapping appears to have been overlooked.
A meta-analysis of the Ebola household secondary attack rate (SAR) estimated that 27.1% of Ebola infections are asymptomatic. Transmission was driven by direct contact, with little transmission occurring in its absence (SAR, 0.8%). The greatest risk factor was the provision of nursing care. The findings suggest that surveillance and containment measures should be effective for controlling Ebola.
A study of Ebola virus disease survivors in Sierra Leone found patients experiencing a variety of long-term complications, including ocular problems like uveitis. In fact, EVD survivors were 10 times more likely to develop uveitis post EVD if they presented with red/injected eyes during the acute phase of their illness.
A review essay in Lancet Infectious Diseases assesses what is known regarding the sequelae of Ebola virus disease, including possible delayed virus clearance. The authors discuss some of the key challenges regarding the provision of care to survivors – calling it the “emergency within the emergency” – and implementation of necessary future research.
Researchers at Middle Tennessee State University investigated the potential of basic Susceptible-Exposed-Infectious-Recovered (SEIR) models to describe the 2014 Ebola outbreak in Meliandou, Guinea. They found that density-dependent transmission and mortality-induced behavioral changes shaped the course of the Ebola epidemic in Meliandou, while frequency-dependent transmission, disease-induced emigration, and infection-induced behavioral changes are not consistent with the data from that particular epidemic.
A study in Preventive Medicine proposes an alternative policy for Ebola entry screening at airports in the United States. This alternative policy considers a social contact tracing (SCT) risk level, in addition to the current health risk level used by the CDC.
A study evaluating the performance of the Cepheid GeneXpert Ebola assay on clinical venipuncture whole blood (WB) and buccal swab (BS) specimens found the assay had excellent performance compared to an established RT-PCR benchmark on WB and BS samples in a field laboratory setting. The authors said future studies should evaluate feasibility and performance outside of a biocontainment laboratory setting to facilitate expanded access to testing.
On Twitter @richpizzi
Climate change raises dengue risk in Europe
Higher global temperatures and greater temperature variation due to climate change could increase the epidemic potential of the dengue virus in Europe, a new study indicates.
The research, published online in EBioMedicine, “maps dengue epidemic potential in Europe and identifies seasonal time windows when major cities are most conducive for dengue transmission from 1901 to 2099.” The investigators examined the effects of temperature on the vectorial capacity of Aedes mosquitoes. They used historic and present climate data and vector surveillance data as well as various climate-change scenarios as the basis for their projections.
“Although Europe currently does not have a sufficiently high DEP [dengue epidemic potential] year round, increasing periods with higher temperatures and greater temperature variation in the future due to climate change could elevate DEP along a south to north gradient,” wrote Dr. Jing Liu-Helmersson of the department of public health and clinical medicine at Umeå University, Sweden, and her coauthors. Comparing climate data across two centuries, Dr. Liu-Helmersson and her colleagues found a slow increase in the intensity and duration of dengue transmission over the past century, and more rapidly changing trajectories projected in the 21st century with the rate of change depending on the level of greenhouse gas emissions.
Compared with tropical regions where dengue is endemic, the authors said Europe shows “pronounced seasonality and geographical heterogeneity.” Still, they wrote, the vectorial capacity (VC) of Aedes mosquitoes during summer, although low, “is currently sufficient for dengue outbreaks in Southern Europe to commence – if sufficient vector populations (either Aedes aegypti and Aedes albopictus) were active and virus were introduced.” More ominously, the researchers found that – by the end of this century – the DEP for A. aegypti could expand to Northern Europe and extend to up to 8 months in Southern Europe under the highest emission pathway. Under the lowest emission pathway, it could expand to Nice and Paris for A. aegypti from Southern European cities. For A. albopictus, the DEP could expand to significant parts of Central Europe.
“Dengue epidemic outbreak is a complex process involving many factors, with mean temperature and diurnal temperature range just being two of many,” Dr. Liu-Helmersson and her associates said. “Our findings illustrate that besides vector control, reducing greenhouse gas emissions is very important in reducing DEP for Europe especially toward the latter half of this century.”
Read the complete study in EBioMedicine (doi:10.1016/j.ebiom.2016.03.046).
On Twitter @richpizzi
Higher global temperatures and greater temperature variation due to climate change could increase the epidemic potential of the dengue virus in Europe, a new study indicates.
The research, published online in EBioMedicine, “maps dengue epidemic potential in Europe and identifies seasonal time windows when major cities are most conducive for dengue transmission from 1901 to 2099.” The investigators examined the effects of temperature on the vectorial capacity of Aedes mosquitoes. They used historic and present climate data and vector surveillance data as well as various climate-change scenarios as the basis for their projections.
“Although Europe currently does not have a sufficiently high DEP [dengue epidemic potential] year round, increasing periods with higher temperatures and greater temperature variation in the future due to climate change could elevate DEP along a south to north gradient,” wrote Dr. Jing Liu-Helmersson of the department of public health and clinical medicine at Umeå University, Sweden, and her coauthors. Comparing climate data across two centuries, Dr. Liu-Helmersson and her colleagues found a slow increase in the intensity and duration of dengue transmission over the past century, and more rapidly changing trajectories projected in the 21st century with the rate of change depending on the level of greenhouse gas emissions.
Compared with tropical regions where dengue is endemic, the authors said Europe shows “pronounced seasonality and geographical heterogeneity.” Still, they wrote, the vectorial capacity (VC) of Aedes mosquitoes during summer, although low, “is currently sufficient for dengue outbreaks in Southern Europe to commence – if sufficient vector populations (either Aedes aegypti and Aedes albopictus) were active and virus were introduced.” More ominously, the researchers found that – by the end of this century – the DEP for A. aegypti could expand to Northern Europe and extend to up to 8 months in Southern Europe under the highest emission pathway. Under the lowest emission pathway, it could expand to Nice and Paris for A. aegypti from Southern European cities. For A. albopictus, the DEP could expand to significant parts of Central Europe.
“Dengue epidemic outbreak is a complex process involving many factors, with mean temperature and diurnal temperature range just being two of many,” Dr. Liu-Helmersson and her associates said. “Our findings illustrate that besides vector control, reducing greenhouse gas emissions is very important in reducing DEP for Europe especially toward the latter half of this century.”
Read the complete study in EBioMedicine (doi:10.1016/j.ebiom.2016.03.046).
On Twitter @richpizzi
Higher global temperatures and greater temperature variation due to climate change could increase the epidemic potential of the dengue virus in Europe, a new study indicates.
The research, published online in EBioMedicine, “maps dengue epidemic potential in Europe and identifies seasonal time windows when major cities are most conducive for dengue transmission from 1901 to 2099.” The investigators examined the effects of temperature on the vectorial capacity of Aedes mosquitoes. They used historic and present climate data and vector surveillance data as well as various climate-change scenarios as the basis for their projections.
“Although Europe currently does not have a sufficiently high DEP [dengue epidemic potential] year round, increasing periods with higher temperatures and greater temperature variation in the future due to climate change could elevate DEP along a south to north gradient,” wrote Dr. Jing Liu-Helmersson of the department of public health and clinical medicine at Umeå University, Sweden, and her coauthors. Comparing climate data across two centuries, Dr. Liu-Helmersson and her colleagues found a slow increase in the intensity and duration of dengue transmission over the past century, and more rapidly changing trajectories projected in the 21st century with the rate of change depending on the level of greenhouse gas emissions.
Compared with tropical regions where dengue is endemic, the authors said Europe shows “pronounced seasonality and geographical heterogeneity.” Still, they wrote, the vectorial capacity (VC) of Aedes mosquitoes during summer, although low, “is currently sufficient for dengue outbreaks in Southern Europe to commence – if sufficient vector populations (either Aedes aegypti and Aedes albopictus) were active and virus were introduced.” More ominously, the researchers found that – by the end of this century – the DEP for A. aegypti could expand to Northern Europe and extend to up to 8 months in Southern Europe under the highest emission pathway. Under the lowest emission pathway, it could expand to Nice and Paris for A. aegypti from Southern European cities. For A. albopictus, the DEP could expand to significant parts of Central Europe.
“Dengue epidemic outbreak is a complex process involving many factors, with mean temperature and diurnal temperature range just being two of many,” Dr. Liu-Helmersson and her associates said. “Our findings illustrate that besides vector control, reducing greenhouse gas emissions is very important in reducing DEP for Europe especially toward the latter half of this century.”
Read the complete study in EBioMedicine (doi:10.1016/j.ebiom.2016.03.046).
On Twitter @richpizzi
FROM EBIOMEDICINE
Hepatitis Outlook: March 2016
If you work on the front lines of medical care treating patients with hepatitis, you may not have time to review all the hepatitis research that enters the medical literature every month. Here’s a quick look at some notable news items and journal articles published over the past month, covering a variety of the major hepatitis viruses.
In the United States, hepatitis C virus (HCV)-associated mortality is increasing. From 2003-2013, the number of deaths associated with HCV has now surpassed 60 other nationally notifiable infectious conditions combined.
Chronic hepatitis B infection increased mortality and complexity among a cohort of HIV-coinfected patients in South Africa, according to a study in HIV Medicine. Researchers found that mortality was increased for chronic hepatitis B patients with hepatitis B virus DNA levels greater than 10,000 copies/mL, compared with non-coinfected patients.
A study in the Journal of Infectious Diseases found that Interferon Lambda (IFNL) genotypes were individually linked to higher rates of fibrosis in HIV–hepatitis C co-infection. Investigators said IFNL genotypes may be useful to target hepatitis C virus treatments to those who are at higher risk of liver disease.
A phase I study of a new NS3/4A protease inhibitor for treatment of chronic hepatitis C virus genotype 1-4 infection yielded positive tolerability, efficacy, and pharmacokinetic results, indicating further evaluation is warranted. The drug, GS-9857, produced by Gilead Sciences, achieved mean and median maximum reductions in HCV RNA of greater than or equal to 3 log10 IU/mL following administration of a 100-mg dose in patients with HCV genotype 1a, 1b, 2, 3, or 4 infection.
High baseline bilirubin and low albumin predict liver decompensation and serious adverse events in hepatitis C-infected patients treated with sofosbuvir-containing regimens, according to a study in the Journal of Viral Hepatitis. Among 499 previously stable patients in the cohort, the incidence of decompensation/events was 4.5%, and the mortality rate was 0.6%.
A meta-analysis of national-level hepatitis C virus prevalence in the Arabian Gulf region found that it is comparable to global levels, although higher HCV prevalence is found in specific expatriate populations reflecting the prevalence in their countries of origin.
A resistance analysis of the drug GS-9190, a NS5B non-nucleoside analogue for the treatment of hepatitis C virus infection, found that the Y448H mutation was rapidly selected in the majority of patients receiving multiple doses of GS-9190 as monotherapy, despite undetectable levels in pretreatment samples. Researchers concluded that Y448H confers reduced susceptibility to GS-9190 and other non-nucleoside inhibitors and persisted in most patients for months post-treatment.
A study published in the International Journal of Infectious Diseases found that hepatitis delta virus (HDV) patients in the Amazon region can be treated with a combination of Pegylated Interferon Alpha and Entecavir for 48 weeks, with good chances of negative HDV RNA at week 24. The results suggest that HDV-3 in the native population may be an “easy to treat” variant compared to HDV-1.
Development of acute hepatitis B virus disease in successfully vaccinated individuals is a rare event, affirmed a study of the Italian Surveillance System for Acute Viral Hepatitis (SEIEVA) from 1993 to 2014. Only 3.2% of acute hepatitis B cases had been vaccinated. Investigators said further efforts are needed to enhance the vaccine coverage rate in people at increased risk of infection, as hepatitis B is a vaccine-preventable disease.
Lab-made hepatocyte transplantation has therapeutic potential as a bridge or even alternative to whole organ liver transplantation, but researchers say deficiencies and uncertainties must be addressed in future studies aimed at developing liver cell therapies with such hepatocytes.
A major concern in potential liver transplant candidates is of unintended harm by achieving sustained viral response rates to direct-acting antiviral treatment, but without improvement in hepatic function to an extent where the patients might function well. A review essay in the Journal of Viral Hepatitis says there is a growing sentiment in some transplant quarters that those with decompensated liver disease awaiting liver transplant be treated for HCV after liver transplant instead of pre-transplant. The authors say it is essential that to develop robust predictors of improvement in liver function so patients can be carefully selected for therapy in the context of liver transplantation.
Treating mild-stage hepatitis C infection in people who inject drugs had virtually no impact on HCV-related end-stage liver disease/hepatocellular carcinoma (ESLD/HCC) within 15 years, a recent study found, but the long timescale of liver disease means relatively few people who inject drugs reach cirrhosis before cessation of injecting. Investigators said strategies focusing on treating advanced disease have the potential for dramatic reductions in severe morbidity, but virtually no preventative impact.
AGA Resource
AGA offers a Hepatitis C Clinical Service Line to provide gastroenterologists with tools to support high-quality patient care.
On Twitter @richpizzi
If you work on the front lines of medical care treating patients with hepatitis, you may not have time to review all the hepatitis research that enters the medical literature every month. Here’s a quick look at some notable news items and journal articles published over the past month, covering a variety of the major hepatitis viruses.
In the United States, hepatitis C virus (HCV)-associated mortality is increasing. From 2003-2013, the number of deaths associated with HCV has now surpassed 60 other nationally notifiable infectious conditions combined.
Chronic hepatitis B infection increased mortality and complexity among a cohort of HIV-coinfected patients in South Africa, according to a study in HIV Medicine. Researchers found that mortality was increased for chronic hepatitis B patients with hepatitis B virus DNA levels greater than 10,000 copies/mL, compared with non-coinfected patients.
A study in the Journal of Infectious Diseases found that Interferon Lambda (IFNL) genotypes were individually linked to higher rates of fibrosis in HIV–hepatitis C co-infection. Investigators said IFNL genotypes may be useful to target hepatitis C virus treatments to those who are at higher risk of liver disease.
A phase I study of a new NS3/4A protease inhibitor for treatment of chronic hepatitis C virus genotype 1-4 infection yielded positive tolerability, efficacy, and pharmacokinetic results, indicating further evaluation is warranted. The drug, GS-9857, produced by Gilead Sciences, achieved mean and median maximum reductions in HCV RNA of greater than or equal to 3 log10 IU/mL following administration of a 100-mg dose in patients with HCV genotype 1a, 1b, 2, 3, or 4 infection.
High baseline bilirubin and low albumin predict liver decompensation and serious adverse events in hepatitis C-infected patients treated with sofosbuvir-containing regimens, according to a study in the Journal of Viral Hepatitis. Among 499 previously stable patients in the cohort, the incidence of decompensation/events was 4.5%, and the mortality rate was 0.6%.
A meta-analysis of national-level hepatitis C virus prevalence in the Arabian Gulf region found that it is comparable to global levels, although higher HCV prevalence is found in specific expatriate populations reflecting the prevalence in their countries of origin.
A resistance analysis of the drug GS-9190, a NS5B non-nucleoside analogue for the treatment of hepatitis C virus infection, found that the Y448H mutation was rapidly selected in the majority of patients receiving multiple doses of GS-9190 as monotherapy, despite undetectable levels in pretreatment samples. Researchers concluded that Y448H confers reduced susceptibility to GS-9190 and other non-nucleoside inhibitors and persisted in most patients for months post-treatment.
A study published in the International Journal of Infectious Diseases found that hepatitis delta virus (HDV) patients in the Amazon region can be treated with a combination of Pegylated Interferon Alpha and Entecavir for 48 weeks, with good chances of negative HDV RNA at week 24. The results suggest that HDV-3 in the native population may be an “easy to treat” variant compared to HDV-1.
Development of acute hepatitis B virus disease in successfully vaccinated individuals is a rare event, affirmed a study of the Italian Surveillance System for Acute Viral Hepatitis (SEIEVA) from 1993 to 2014. Only 3.2% of acute hepatitis B cases had been vaccinated. Investigators said further efforts are needed to enhance the vaccine coverage rate in people at increased risk of infection, as hepatitis B is a vaccine-preventable disease.
Lab-made hepatocyte transplantation has therapeutic potential as a bridge or even alternative to whole organ liver transplantation, but researchers say deficiencies and uncertainties must be addressed in future studies aimed at developing liver cell therapies with such hepatocytes.
A major concern in potential liver transplant candidates is of unintended harm by achieving sustained viral response rates to direct-acting antiviral treatment, but without improvement in hepatic function to an extent where the patients might function well. A review essay in the Journal of Viral Hepatitis says there is a growing sentiment in some transplant quarters that those with decompensated liver disease awaiting liver transplant be treated for HCV after liver transplant instead of pre-transplant. The authors say it is essential that to develop robust predictors of improvement in liver function so patients can be carefully selected for therapy in the context of liver transplantation.
Treating mild-stage hepatitis C infection in people who inject drugs had virtually no impact on HCV-related end-stage liver disease/hepatocellular carcinoma (ESLD/HCC) within 15 years, a recent study found, but the long timescale of liver disease means relatively few people who inject drugs reach cirrhosis before cessation of injecting. Investigators said strategies focusing on treating advanced disease have the potential for dramatic reductions in severe morbidity, but virtually no preventative impact.
AGA Resource
AGA offers a Hepatitis C Clinical Service Line to provide gastroenterologists with tools to support high-quality patient care.
On Twitter @richpizzi
If you work on the front lines of medical care treating patients with hepatitis, you may not have time to review all the hepatitis research that enters the medical literature every month. Here’s a quick look at some notable news items and journal articles published over the past month, covering a variety of the major hepatitis viruses.
In the United States, hepatitis C virus (HCV)-associated mortality is increasing. From 2003-2013, the number of deaths associated with HCV has now surpassed 60 other nationally notifiable infectious conditions combined.
Chronic hepatitis B infection increased mortality and complexity among a cohort of HIV-coinfected patients in South Africa, according to a study in HIV Medicine. Researchers found that mortality was increased for chronic hepatitis B patients with hepatitis B virus DNA levels greater than 10,000 copies/mL, compared with non-coinfected patients.
A study in the Journal of Infectious Diseases found that Interferon Lambda (IFNL) genotypes were individually linked to higher rates of fibrosis in HIV–hepatitis C co-infection. Investigators said IFNL genotypes may be useful to target hepatitis C virus treatments to those who are at higher risk of liver disease.
A phase I study of a new NS3/4A protease inhibitor for treatment of chronic hepatitis C virus genotype 1-4 infection yielded positive tolerability, efficacy, and pharmacokinetic results, indicating further evaluation is warranted. The drug, GS-9857, produced by Gilead Sciences, achieved mean and median maximum reductions in HCV RNA of greater than or equal to 3 log10 IU/mL following administration of a 100-mg dose in patients with HCV genotype 1a, 1b, 2, 3, or 4 infection.
High baseline bilirubin and low albumin predict liver decompensation and serious adverse events in hepatitis C-infected patients treated with sofosbuvir-containing regimens, according to a study in the Journal of Viral Hepatitis. Among 499 previously stable patients in the cohort, the incidence of decompensation/events was 4.5%, and the mortality rate was 0.6%.
A meta-analysis of national-level hepatitis C virus prevalence in the Arabian Gulf region found that it is comparable to global levels, although higher HCV prevalence is found in specific expatriate populations reflecting the prevalence in their countries of origin.
A resistance analysis of the drug GS-9190, a NS5B non-nucleoside analogue for the treatment of hepatitis C virus infection, found that the Y448H mutation was rapidly selected in the majority of patients receiving multiple doses of GS-9190 as monotherapy, despite undetectable levels in pretreatment samples. Researchers concluded that Y448H confers reduced susceptibility to GS-9190 and other non-nucleoside inhibitors and persisted in most patients for months post-treatment.
A study published in the International Journal of Infectious Diseases found that hepatitis delta virus (HDV) patients in the Amazon region can be treated with a combination of Pegylated Interferon Alpha and Entecavir for 48 weeks, with good chances of negative HDV RNA at week 24. The results suggest that HDV-3 in the native population may be an “easy to treat” variant compared to HDV-1.
Development of acute hepatitis B virus disease in successfully vaccinated individuals is a rare event, affirmed a study of the Italian Surveillance System for Acute Viral Hepatitis (SEIEVA) from 1993 to 2014. Only 3.2% of acute hepatitis B cases had been vaccinated. Investigators said further efforts are needed to enhance the vaccine coverage rate in people at increased risk of infection, as hepatitis B is a vaccine-preventable disease.
Lab-made hepatocyte transplantation has therapeutic potential as a bridge or even alternative to whole organ liver transplantation, but researchers say deficiencies and uncertainties must be addressed in future studies aimed at developing liver cell therapies with such hepatocytes.
A major concern in potential liver transplant candidates is of unintended harm by achieving sustained viral response rates to direct-acting antiviral treatment, but without improvement in hepatic function to an extent where the patients might function well. A review essay in the Journal of Viral Hepatitis says there is a growing sentiment in some transplant quarters that those with decompensated liver disease awaiting liver transplant be treated for HCV after liver transplant instead of pre-transplant. The authors say it is essential that to develop robust predictors of improvement in liver function so patients can be carefully selected for therapy in the context of liver transplantation.
Treating mild-stage hepatitis C infection in people who inject drugs had virtually no impact on HCV-related end-stage liver disease/hepatocellular carcinoma (ESLD/HCC) within 15 years, a recent study found, but the long timescale of liver disease means relatively few people who inject drugs reach cirrhosis before cessation of injecting. Investigators said strategies focusing on treating advanced disease have the potential for dramatic reductions in severe morbidity, but virtually no preventative impact.
AGA Resource
AGA offers a Hepatitis C Clinical Service Line to provide gastroenterologists with tools to support high-quality patient care.
On Twitter @richpizzi
SHM launches medication reconcilation project
The Society of Hospital Medicine (SHM) has announced it will launch a second iteration of the Multi-Center Medication Reconciliation Quality Improvement Study, a program focused on improving ways for medications to be prescribed, documented, and reconciled accurately and safely during transitions of care.
The initial Multi-Center Medication Reconciliation Quality Improvement Study (MARQUIS) was launched in 2010 by SHM with a grant from the Agency for Healthcare Research and Quality (AHRQ). The new version of the program, called MARQUIS2 and also supported by an AHRQ grant, will be managed through SHM’s Center for Hospital Innovation and Improvement in partnership with Brigham and Women’s Hospital in Boston.
MARQUIS and MARQUIS2 are mentored implementation studies developed to assist hospitals and hospital-based clinicians in reducing medication errors, adverse drug events, and patient harm during transitions of care. Beginning in April 2016, SHM will work with 18 hospitals to identify, implement, and sustain medication reconciliation interventions with guidance from expert physician mentors.
The medication reconciliation process is intended to help hospitalist physicians and other providers avoid medication errors such as omissions, duplications, dosing errors, and adverse drug interactions.
“SHM’s mentored implementation model and extensive experience in implementing key quality improvement programs across the country will prove to be an asset in assisting the 18 hospitals in reducing potentially harmful medication discrepancies,” Dr. Jeffrey L. Schnipper, director of clinical research, BWH Hospitalist Service, Brigham and Women’s Hospital, and principal investigator for MARQUIS2, said in a statement.
Key components in MARQUIS2 include educating providers on how to take a best possible medication history, improving access to preadmission medication sources, encouraging patient ownership of medication lists, and identifying patients at higher risk for adverse drug events in need of more intensive efforts.
“The implementation of MARQUIS2 will ultimately improve patient safety, teamwork, communication, and care transitions at these sites over the next year, providing resources and best practices that best suit each site’s individual environment,” Dr. Schnipper said.
On Twitter @richpizzi
The Society of Hospital Medicine (SHM) has announced it will launch a second iteration of the Multi-Center Medication Reconciliation Quality Improvement Study, a program focused on improving ways for medications to be prescribed, documented, and reconciled accurately and safely during transitions of care.
The initial Multi-Center Medication Reconciliation Quality Improvement Study (MARQUIS) was launched in 2010 by SHM with a grant from the Agency for Healthcare Research and Quality (AHRQ). The new version of the program, called MARQUIS2 and also supported by an AHRQ grant, will be managed through SHM’s Center for Hospital Innovation and Improvement in partnership with Brigham and Women’s Hospital in Boston.
MARQUIS and MARQUIS2 are mentored implementation studies developed to assist hospitals and hospital-based clinicians in reducing medication errors, adverse drug events, and patient harm during transitions of care. Beginning in April 2016, SHM will work with 18 hospitals to identify, implement, and sustain medication reconciliation interventions with guidance from expert physician mentors.
The medication reconciliation process is intended to help hospitalist physicians and other providers avoid medication errors such as omissions, duplications, dosing errors, and adverse drug interactions.
“SHM’s mentored implementation model and extensive experience in implementing key quality improvement programs across the country will prove to be an asset in assisting the 18 hospitals in reducing potentially harmful medication discrepancies,” Dr. Jeffrey L. Schnipper, director of clinical research, BWH Hospitalist Service, Brigham and Women’s Hospital, and principal investigator for MARQUIS2, said in a statement.
Key components in MARQUIS2 include educating providers on how to take a best possible medication history, improving access to preadmission medication sources, encouraging patient ownership of medication lists, and identifying patients at higher risk for adverse drug events in need of more intensive efforts.
“The implementation of MARQUIS2 will ultimately improve patient safety, teamwork, communication, and care transitions at these sites over the next year, providing resources and best practices that best suit each site’s individual environment,” Dr. Schnipper said.
On Twitter @richpizzi
The Society of Hospital Medicine (SHM) has announced it will launch a second iteration of the Multi-Center Medication Reconciliation Quality Improvement Study, a program focused on improving ways for medications to be prescribed, documented, and reconciled accurately and safely during transitions of care.
The initial Multi-Center Medication Reconciliation Quality Improvement Study (MARQUIS) was launched in 2010 by SHM with a grant from the Agency for Healthcare Research and Quality (AHRQ). The new version of the program, called MARQUIS2 and also supported by an AHRQ grant, will be managed through SHM’s Center for Hospital Innovation and Improvement in partnership with Brigham and Women’s Hospital in Boston.
MARQUIS and MARQUIS2 are mentored implementation studies developed to assist hospitals and hospital-based clinicians in reducing medication errors, adverse drug events, and patient harm during transitions of care. Beginning in April 2016, SHM will work with 18 hospitals to identify, implement, and sustain medication reconciliation interventions with guidance from expert physician mentors.
The medication reconciliation process is intended to help hospitalist physicians and other providers avoid medication errors such as omissions, duplications, dosing errors, and adverse drug interactions.
“SHM’s mentored implementation model and extensive experience in implementing key quality improvement programs across the country will prove to be an asset in assisting the 18 hospitals in reducing potentially harmful medication discrepancies,” Dr. Jeffrey L. Schnipper, director of clinical research, BWH Hospitalist Service, Brigham and Women’s Hospital, and principal investigator for MARQUIS2, said in a statement.
Key components in MARQUIS2 include educating providers on how to take a best possible medication history, improving access to preadmission medication sources, encouraging patient ownership of medication lists, and identifying patients at higher risk for adverse drug events in need of more intensive efforts.
“The implementation of MARQUIS2 will ultimately improve patient safety, teamwork, communication, and care transitions at these sites over the next year, providing resources and best practices that best suit each site’s individual environment,” Dr. Schnipper said.
On Twitter @richpizzi
HIV research update: Late March 2016
A great volume of HIV and AIDS research enters the medical literature every month. It’s difficult to monitor everything, so here’s a quick look at some notable news items and journal articles published over the past few weeks.
Investigators were able to maintain high rates of virologic suppression in HIV-infected patients when switching them from emtricitabine with tenofovir disoproxil fumarate to emtricitabine with tenofovir alafenamide. The researchers concluded that, with its safety advantages, fixed-dose emtricitabine with tenofovir alafenamide has the potential to become an important nucleoside reverse transcriptase inhibitor backbone.
Suppression of HIV-1 viremia is associated with changes in innate cellular function that may in part determine the restoration of protective immune responses, reported a study in JCI Insight. Researchers said plasma viral load had the strongest association with the change in innate functional capacity.
A study in PLOS Pathogens suggests that HIV infection dramatically increases the risk of Mycobacterium tuberculosis infection turning into active tuberculosis. Investigators discovered that HIV is associated with a failure to prevent harmful immune responses.
Because the efficacy of tenofovir-based pre-exposure prophylaxis (PrEP) for HIV-infected patients strongly depends on consistency of PrEP use, pill-taking patterns may have a substantial impact on the protection provided by PrEP, even when the same numbers of pills are taken, a recent study found.
Borderline personality disorder was strongly associated with STI/HIV risk in a cohort study of African American men being released from prison in North Carolina. The findings suggest borderline personality disorder, in addition to other mood disorders, may be an important risk factor for STI/HIV.
Poorly controlled HIV infection is an independent risk factor for liver fibrosis, according to a study in JAIDS. Investigators found that lower CD4 count and higher HIV viral load were significantly associated with progression to advanced hepatic fibrosis in a dose-dependent manner, independent of the risk associated with traditional factors: hepatitis C or hepatitis B virus coinfection, alcohol, and diabetes.
Food insecurity is associated with prevalent HIV, STIs, and illicit drug use among men in the U.S., according to a study published in JAIDS. The authors say further research is needed to establish whether and through what mechanisms improved food security may help prevent new HIV infections.
Using Medicaid claims data from 2006 to 2011, investigators found that the mean annual fee-for-service (FFS) payment for all HIV services was $47,434, while mean annual FFS payment for only medical services was $38,311. Estimated Medicaid payment amounts in this study are higher than some prior estimates, probably due to more complete capture of expensive inpatient hospitalizations in Medicaid data, the researchers said.
HIV-infected individuals may have poorer serologic responses to syphilis treatment and may be more likely to experience neurosyphilis, according to a study in the Journal of Infectious Diseases. Researchers found that serum T. pallidum–specific opsonic activity is significantly lower in HIV-infected individuals, and said impaired T. pallidum–specific immune responses could contribute to differences in the course of disease or treatment response.
The utilization of viral load monitoring may be necessary to truly assess the effectiveness of health facilities delivering antiretroviral therapy (ART) services to HIV-infected patients, reports a study in Tropical Medicine & International Health.
Among HIV-infected persons with median CD4+ count of approximately 500 cells/mm3, 3 months of weekly rifapentine plus isoniazid under direct observation was as effective and safe for treatment of latent M. tuberculosis infection as 9 months of daily isoniazid, and better tolerated, reported a recent study.
A study of the social consequences of early antiretroviral initiation in West Africa found that early ART does not carry detectable adverse social consequences that could impair its clinical and preventive benefits.
Research published in HIV & AIDS Review showed an association between national HIV prevalence values in Africa and the socioeconomic status of their albino populations. The investigators said poverty-stricken African albinos are apparently more likely to be HIV positive than their normal-pigmented counterparts.
A survey to assess Botswana’s progress toward achieving UNAIDS targets for 2020 found 83% of those infected with HIV knew their status; 95% of these people were receiving antiretroviral therapy; and 70% of HIV-infected people had virologic suppression. The authors conclude that UNAIDS 90-90-90 targets are achievable even in resource-constrained settings with high HIV burden.
A research review in Current Opinion in HIV & AIDS concluded that preantiretroviral levels of immune activation and inflammation have a consistently negative effect on bone mineral density, and suggest the immunocentric basis of bone loss in HIV. The findings support the benefits of earlier ART initiation.
On Twitter @richpizzi
A great volume of HIV and AIDS research enters the medical literature every month. It’s difficult to monitor everything, so here’s a quick look at some notable news items and journal articles published over the past few weeks.
Investigators were able to maintain high rates of virologic suppression in HIV-infected patients when switching them from emtricitabine with tenofovir disoproxil fumarate to emtricitabine with tenofovir alafenamide. The researchers concluded that, with its safety advantages, fixed-dose emtricitabine with tenofovir alafenamide has the potential to become an important nucleoside reverse transcriptase inhibitor backbone.
Suppression of HIV-1 viremia is associated with changes in innate cellular function that may in part determine the restoration of protective immune responses, reported a study in JCI Insight. Researchers said plasma viral load had the strongest association with the change in innate functional capacity.
A study in PLOS Pathogens suggests that HIV infection dramatically increases the risk of Mycobacterium tuberculosis infection turning into active tuberculosis. Investigators discovered that HIV is associated with a failure to prevent harmful immune responses.
Because the efficacy of tenofovir-based pre-exposure prophylaxis (PrEP) for HIV-infected patients strongly depends on consistency of PrEP use, pill-taking patterns may have a substantial impact on the protection provided by PrEP, even when the same numbers of pills are taken, a recent study found.
Borderline personality disorder was strongly associated with STI/HIV risk in a cohort study of African American men being released from prison in North Carolina. The findings suggest borderline personality disorder, in addition to other mood disorders, may be an important risk factor for STI/HIV.
Poorly controlled HIV infection is an independent risk factor for liver fibrosis, according to a study in JAIDS. Investigators found that lower CD4 count and higher HIV viral load were significantly associated with progression to advanced hepatic fibrosis in a dose-dependent manner, independent of the risk associated with traditional factors: hepatitis C or hepatitis B virus coinfection, alcohol, and diabetes.
Food insecurity is associated with prevalent HIV, STIs, and illicit drug use among men in the U.S., according to a study published in JAIDS. The authors say further research is needed to establish whether and through what mechanisms improved food security may help prevent new HIV infections.
Using Medicaid claims data from 2006 to 2011, investigators found that the mean annual fee-for-service (FFS) payment for all HIV services was $47,434, while mean annual FFS payment for only medical services was $38,311. Estimated Medicaid payment amounts in this study are higher than some prior estimates, probably due to more complete capture of expensive inpatient hospitalizations in Medicaid data, the researchers said.
HIV-infected individuals may have poorer serologic responses to syphilis treatment and may be more likely to experience neurosyphilis, according to a study in the Journal of Infectious Diseases. Researchers found that serum T. pallidum–specific opsonic activity is significantly lower in HIV-infected individuals, and said impaired T. pallidum–specific immune responses could contribute to differences in the course of disease or treatment response.
The utilization of viral load monitoring may be necessary to truly assess the effectiveness of health facilities delivering antiretroviral therapy (ART) services to HIV-infected patients, reports a study in Tropical Medicine & International Health.
Among HIV-infected persons with median CD4+ count of approximately 500 cells/mm3, 3 months of weekly rifapentine plus isoniazid under direct observation was as effective and safe for treatment of latent M. tuberculosis infection as 9 months of daily isoniazid, and better tolerated, reported a recent study.
A study of the social consequences of early antiretroviral initiation in West Africa found that early ART does not carry detectable adverse social consequences that could impair its clinical and preventive benefits.
Research published in HIV & AIDS Review showed an association between national HIV prevalence values in Africa and the socioeconomic status of their albino populations. The investigators said poverty-stricken African albinos are apparently more likely to be HIV positive than their normal-pigmented counterparts.
A survey to assess Botswana’s progress toward achieving UNAIDS targets for 2020 found 83% of those infected with HIV knew their status; 95% of these people were receiving antiretroviral therapy; and 70% of HIV-infected people had virologic suppression. The authors conclude that UNAIDS 90-90-90 targets are achievable even in resource-constrained settings with high HIV burden.
A research review in Current Opinion in HIV & AIDS concluded that preantiretroviral levels of immune activation and inflammation have a consistently negative effect on bone mineral density, and suggest the immunocentric basis of bone loss in HIV. The findings support the benefits of earlier ART initiation.
On Twitter @richpizzi
A great volume of HIV and AIDS research enters the medical literature every month. It’s difficult to monitor everything, so here’s a quick look at some notable news items and journal articles published over the past few weeks.
Investigators were able to maintain high rates of virologic suppression in HIV-infected patients when switching them from emtricitabine with tenofovir disoproxil fumarate to emtricitabine with tenofovir alafenamide. The researchers concluded that, with its safety advantages, fixed-dose emtricitabine with tenofovir alafenamide has the potential to become an important nucleoside reverse transcriptase inhibitor backbone.
Suppression of HIV-1 viremia is associated with changes in innate cellular function that may in part determine the restoration of protective immune responses, reported a study in JCI Insight. Researchers said plasma viral load had the strongest association with the change in innate functional capacity.
A study in PLOS Pathogens suggests that HIV infection dramatically increases the risk of Mycobacterium tuberculosis infection turning into active tuberculosis. Investigators discovered that HIV is associated with a failure to prevent harmful immune responses.
Because the efficacy of tenofovir-based pre-exposure prophylaxis (PrEP) for HIV-infected patients strongly depends on consistency of PrEP use, pill-taking patterns may have a substantial impact on the protection provided by PrEP, even when the same numbers of pills are taken, a recent study found.
Borderline personality disorder was strongly associated with STI/HIV risk in a cohort study of African American men being released from prison in North Carolina. The findings suggest borderline personality disorder, in addition to other mood disorders, may be an important risk factor for STI/HIV.
Poorly controlled HIV infection is an independent risk factor for liver fibrosis, according to a study in JAIDS. Investigators found that lower CD4 count and higher HIV viral load were significantly associated with progression to advanced hepatic fibrosis in a dose-dependent manner, independent of the risk associated with traditional factors: hepatitis C or hepatitis B virus coinfection, alcohol, and diabetes.
Food insecurity is associated with prevalent HIV, STIs, and illicit drug use among men in the U.S., according to a study published in JAIDS. The authors say further research is needed to establish whether and through what mechanisms improved food security may help prevent new HIV infections.
Using Medicaid claims data from 2006 to 2011, investigators found that the mean annual fee-for-service (FFS) payment for all HIV services was $47,434, while mean annual FFS payment for only medical services was $38,311. Estimated Medicaid payment amounts in this study are higher than some prior estimates, probably due to more complete capture of expensive inpatient hospitalizations in Medicaid data, the researchers said.
HIV-infected individuals may have poorer serologic responses to syphilis treatment and may be more likely to experience neurosyphilis, according to a study in the Journal of Infectious Diseases. Researchers found that serum T. pallidum–specific opsonic activity is significantly lower in HIV-infected individuals, and said impaired T. pallidum–specific immune responses could contribute to differences in the course of disease or treatment response.
The utilization of viral load monitoring may be necessary to truly assess the effectiveness of health facilities delivering antiretroviral therapy (ART) services to HIV-infected patients, reports a study in Tropical Medicine & International Health.
Among HIV-infected persons with median CD4+ count of approximately 500 cells/mm3, 3 months of weekly rifapentine plus isoniazid under direct observation was as effective and safe for treatment of latent M. tuberculosis infection as 9 months of daily isoniazid, and better tolerated, reported a recent study.
A study of the social consequences of early antiretroviral initiation in West Africa found that early ART does not carry detectable adverse social consequences that could impair its clinical and preventive benefits.
Research published in HIV & AIDS Review showed an association between national HIV prevalence values in Africa and the socioeconomic status of their albino populations. The investigators said poverty-stricken African albinos are apparently more likely to be HIV positive than their normal-pigmented counterparts.
A survey to assess Botswana’s progress toward achieving UNAIDS targets for 2020 found 83% of those infected with HIV knew their status; 95% of these people were receiving antiretroviral therapy; and 70% of HIV-infected people had virologic suppression. The authors conclude that UNAIDS 90-90-90 targets are achievable even in resource-constrained settings with high HIV burden.
A research review in Current Opinion in HIV & AIDS concluded that preantiretroviral levels of immune activation and inflammation have a consistently negative effect on bone mineral density, and suggest the immunocentric basis of bone loss in HIV. The findings support the benefits of earlier ART initiation.
On Twitter @richpizzi
Hepatitis Outlook: March 2016
If you work on the front lines of medical care treating patients with hepatitis, you may not have time to review all the hepatitis research that enters the medical literature every month. Here’s a quick look at some notable news items and journal articles published over the past month, covering a variety of the major hepatitis viruses.
In the United States, hepatitis C virus (HCV)-associated mortality is increasing. From 2003-2013, the number of deaths associated with HCV has now surpassed 60 other nationally notifiable infectious conditions combined.
Chronic hepatitis B infection increased mortality and complexity among a cohort of HIV-coinfected patients in South Africa, according to a study in HIV Medicine. Researchers found that mortality was increased for chronic hepatitis B patients with hepatitis B virus DNA levels greater than 10,000 copies/mL, compared with non-coinfected patients.
A study in the Journal of Infectious Diseases found that Interferon Lambda (IFNL) genotypes were individually linked to higher rates of fibrosis in HIV–hepatitis C co-infection. Investigators said IFNL genotypes may be useful to target hepatitis C virus treatments to those who are at higher risk of liver disease.
A phase I study of a new NS3/4A protease inhibitor for treatment of chronic hepatitis C virus genotype 1-4 infection yielded positive tolerability, efficacy, and pharmacokinetic results, indicating further evaluation is warranted. The drug, GS-9857, produced by Gilead Sciences, achieved mean and median maximum reductions in HCV RNA of greater than or equal to 3 log10 IU/mL following administration of a 100-mg dose in patients with HCV genotype 1a, 1b, 2, 3, or 4 infection.
High baseline bilirubin and low albumin predict liver decompensation and serious adverse events in hepatitis C-infected patients treated with sofosbuvir-containing regimens, according to a study in the Journal of Viral Hepatitis. Among 499 previously stable patients in the cohort, the incidence of decompensation/events was 4.5%, and the mortality rate was 0.6%.
A meta-analysis of national-level hepatitis C virus prevalence in the Arabian Gulf region found that it is comparable to global levels, although higher HCV prevalence is found in specific expatriate populations reflecting the prevalence in their countries of origin.
A resistance analysis of the drug GS-9190, a NS5B non-nucleoside analogue for the treatment of hepatitis C virus infection, found that the Y448H mutation was rapidly selected in the majority of patients receiving multiple doses of GS-9190 as monotherapy, despite undetectable levels in pretreatment samples. Researchers concluded that Y448H confers reduced susceptibility to GS-9190 and other non-nucleoside inhibitors and persisted in most patients for months post-treatment.
A study published in the International Journal of Infectious Diseases found that hepatitis delta virus (HDV) patients in the Amazon region can be treated with a combination of Pegylated Interferon Alpha and Entecavir for 48 weeks, with good chances of negative HDV RNA at week 24. The results suggest that HDV-3 in the native population may be an “easy to treat” variant compared to HDV-1.
Development of acute hepatitis B virus disease in successfully vaccinated individuals is a rare event, affirmed a study of the Italian Surveillance System for Acute Viral Hepatitis (SEIEVA) from 1993 to 2014. Only 3.2% of acute hepatitis B cases had been vaccinated. Investigators said further efforts are needed to enhance the vaccine coverage rate in people at increased risk of infection, as hepatitis B is a vaccine-preventable disease.
Lab-made hepatocyte transplantation has therapeutic potential as a bridge or even alternative to whole organ liver transplantation, but researchers say deficiencies and uncertainties must be addressed in future studies aimed at developing liver cell therapies with such hepatocytes.
A major concern in potential liver transplant candidates is of unintended harm by achieving sustained viral response rates to direct-acting antiviral treatment, but without improvement in hepatic function to an extent where the patients might function well. A review essay in the Journal of Viral Hepatitis says there is a growing sentiment in some transplant quarters that those with decompensated liver disease awaiting liver transplant be treated for HCV after liver transplant instead of pre-transplant. The authors say it is essential that to develop robust predictors of improvement in liver function so patients can be carefully selected for therapy in the context of liver transplantation.
Treating mild-stage hepatitis C infection in people who inject drugs had virtually no impact on HCV-related end-stage liver disease/hepatocellular carcinoma (ESLD/HCC) within 15 years, a recent study found, but the long timescale of liver disease means relatively few people who inject drugs reach cirrhosis before cessation of injecting. Investigators said strategies focusing on treating advanced disease have the potential for dramatic reductions in severe morbidity, but virtually no preventative impact.
On Twitter @richpizzi
If you work on the front lines of medical care treating patients with hepatitis, you may not have time to review all the hepatitis research that enters the medical literature every month. Here’s a quick look at some notable news items and journal articles published over the past month, covering a variety of the major hepatitis viruses.
In the United States, hepatitis C virus (HCV)-associated mortality is increasing. From 2003-2013, the number of deaths associated with HCV has now surpassed 60 other nationally notifiable infectious conditions combined.
Chronic hepatitis B infection increased mortality and complexity among a cohort of HIV-coinfected patients in South Africa, according to a study in HIV Medicine. Researchers found that mortality was increased for chronic hepatitis B patients with hepatitis B virus DNA levels greater than 10,000 copies/mL, compared with non-coinfected patients.
A study in the Journal of Infectious Diseases found that Interferon Lambda (IFNL) genotypes were individually linked to higher rates of fibrosis in HIV–hepatitis C co-infection. Investigators said IFNL genotypes may be useful to target hepatitis C virus treatments to those who are at higher risk of liver disease.
A phase I study of a new NS3/4A protease inhibitor for treatment of chronic hepatitis C virus genotype 1-4 infection yielded positive tolerability, efficacy, and pharmacokinetic results, indicating further evaluation is warranted. The drug, GS-9857, produced by Gilead Sciences, achieved mean and median maximum reductions in HCV RNA of greater than or equal to 3 log10 IU/mL following administration of a 100-mg dose in patients with HCV genotype 1a, 1b, 2, 3, or 4 infection.
High baseline bilirubin and low albumin predict liver decompensation and serious adverse events in hepatitis C-infected patients treated with sofosbuvir-containing regimens, according to a study in the Journal of Viral Hepatitis. Among 499 previously stable patients in the cohort, the incidence of decompensation/events was 4.5%, and the mortality rate was 0.6%.
A meta-analysis of national-level hepatitis C virus prevalence in the Arabian Gulf region found that it is comparable to global levels, although higher HCV prevalence is found in specific expatriate populations reflecting the prevalence in their countries of origin.
A resistance analysis of the drug GS-9190, a NS5B non-nucleoside analogue for the treatment of hepatitis C virus infection, found that the Y448H mutation was rapidly selected in the majority of patients receiving multiple doses of GS-9190 as monotherapy, despite undetectable levels in pretreatment samples. Researchers concluded that Y448H confers reduced susceptibility to GS-9190 and other non-nucleoside inhibitors and persisted in most patients for months post-treatment.
A study published in the International Journal of Infectious Diseases found that hepatitis delta virus (HDV) patients in the Amazon region can be treated with a combination of Pegylated Interferon Alpha and Entecavir for 48 weeks, with good chances of negative HDV RNA at week 24. The results suggest that HDV-3 in the native population may be an “easy to treat” variant compared to HDV-1.
Development of acute hepatitis B virus disease in successfully vaccinated individuals is a rare event, affirmed a study of the Italian Surveillance System for Acute Viral Hepatitis (SEIEVA) from 1993 to 2014. Only 3.2% of acute hepatitis B cases had been vaccinated. Investigators said further efforts are needed to enhance the vaccine coverage rate in people at increased risk of infection, as hepatitis B is a vaccine-preventable disease.
Lab-made hepatocyte transplantation has therapeutic potential as a bridge or even alternative to whole organ liver transplantation, but researchers say deficiencies and uncertainties must be addressed in future studies aimed at developing liver cell therapies with such hepatocytes.
A major concern in potential liver transplant candidates is of unintended harm by achieving sustained viral response rates to direct-acting antiviral treatment, but without improvement in hepatic function to an extent where the patients might function well. A review essay in the Journal of Viral Hepatitis says there is a growing sentiment in some transplant quarters that those with decompensated liver disease awaiting liver transplant be treated for HCV after liver transplant instead of pre-transplant. The authors say it is essential that to develop robust predictors of improvement in liver function so patients can be carefully selected for therapy in the context of liver transplantation.
Treating mild-stage hepatitis C infection in people who inject drugs had virtually no impact on HCV-related end-stage liver disease/hepatocellular carcinoma (ESLD/HCC) within 15 years, a recent study found, but the long timescale of liver disease means relatively few people who inject drugs reach cirrhosis before cessation of injecting. Investigators said strategies focusing on treating advanced disease have the potential for dramatic reductions in severe morbidity, but virtually no preventative impact.
On Twitter @richpizzi
If you work on the front lines of medical care treating patients with hepatitis, you may not have time to review all the hepatitis research that enters the medical literature every month. Here’s a quick look at some notable news items and journal articles published over the past month, covering a variety of the major hepatitis viruses.
In the United States, hepatitis C virus (HCV)-associated mortality is increasing. From 2003-2013, the number of deaths associated with HCV has now surpassed 60 other nationally notifiable infectious conditions combined.
Chronic hepatitis B infection increased mortality and complexity among a cohort of HIV-coinfected patients in South Africa, according to a study in HIV Medicine. Researchers found that mortality was increased for chronic hepatitis B patients with hepatitis B virus DNA levels greater than 10,000 copies/mL, compared with non-coinfected patients.
A study in the Journal of Infectious Diseases found that Interferon Lambda (IFNL) genotypes were individually linked to higher rates of fibrosis in HIV–hepatitis C co-infection. Investigators said IFNL genotypes may be useful to target hepatitis C virus treatments to those who are at higher risk of liver disease.
A phase I study of a new NS3/4A protease inhibitor for treatment of chronic hepatitis C virus genotype 1-4 infection yielded positive tolerability, efficacy, and pharmacokinetic results, indicating further evaluation is warranted. The drug, GS-9857, produced by Gilead Sciences, achieved mean and median maximum reductions in HCV RNA of greater than or equal to 3 log10 IU/mL following administration of a 100-mg dose in patients with HCV genotype 1a, 1b, 2, 3, or 4 infection.
High baseline bilirubin and low albumin predict liver decompensation and serious adverse events in hepatitis C-infected patients treated with sofosbuvir-containing regimens, according to a study in the Journal of Viral Hepatitis. Among 499 previously stable patients in the cohort, the incidence of decompensation/events was 4.5%, and the mortality rate was 0.6%.
A meta-analysis of national-level hepatitis C virus prevalence in the Arabian Gulf region found that it is comparable to global levels, although higher HCV prevalence is found in specific expatriate populations reflecting the prevalence in their countries of origin.
A resistance analysis of the drug GS-9190, a NS5B non-nucleoside analogue for the treatment of hepatitis C virus infection, found that the Y448H mutation was rapidly selected in the majority of patients receiving multiple doses of GS-9190 as monotherapy, despite undetectable levels in pretreatment samples. Researchers concluded that Y448H confers reduced susceptibility to GS-9190 and other non-nucleoside inhibitors and persisted in most patients for months post-treatment.
A study published in the International Journal of Infectious Diseases found that hepatitis delta virus (HDV) patients in the Amazon region can be treated with a combination of Pegylated Interferon Alpha and Entecavir for 48 weeks, with good chances of negative HDV RNA at week 24. The results suggest that HDV-3 in the native population may be an “easy to treat” variant compared to HDV-1.
Development of acute hepatitis B virus disease in successfully vaccinated individuals is a rare event, affirmed a study of the Italian Surveillance System for Acute Viral Hepatitis (SEIEVA) from 1993 to 2014. Only 3.2% of acute hepatitis B cases had been vaccinated. Investigators said further efforts are needed to enhance the vaccine coverage rate in people at increased risk of infection, as hepatitis B is a vaccine-preventable disease.
Lab-made hepatocyte transplantation has therapeutic potential as a bridge or even alternative to whole organ liver transplantation, but researchers say deficiencies and uncertainties must be addressed in future studies aimed at developing liver cell therapies with such hepatocytes.
A major concern in potential liver transplant candidates is of unintended harm by achieving sustained viral response rates to direct-acting antiviral treatment, but without improvement in hepatic function to an extent where the patients might function well. A review essay in the Journal of Viral Hepatitis says there is a growing sentiment in some transplant quarters that those with decompensated liver disease awaiting liver transplant be treated for HCV after liver transplant instead of pre-transplant. The authors say it is essential that to develop robust predictors of improvement in liver function so patients can be carefully selected for therapy in the context of liver transplantation.
Treating mild-stage hepatitis C infection in people who inject drugs had virtually no impact on HCV-related end-stage liver disease/hepatocellular carcinoma (ESLD/HCC) within 15 years, a recent study found, but the long timescale of liver disease means relatively few people who inject drugs reach cirrhosis before cessation of injecting. Investigators said strategies focusing on treating advanced disease have the potential for dramatic reductions in severe morbidity, but virtually no preventative impact.
On Twitter @richpizzi
CDC issues interim guidance for care of Ebola survivors
The Centers for Disease Control and Prevention has issued interim guidance for U.S. health care providers to safely care for survivors of Ebola virus disease (EVD).
The guidance includes information about sequelae of EVD as well as data on Ebola virus persistence in EVD survivors, and infection prevention and control recommendations for U.S. health care providers when evaluating a patient who is an EVD survivor. Of the eleven patients with Ebola virus disease who were managed in U.S. health care facilities during 2014-2015, nine survived. The CDC notes in the guidance that it is also possible that some EVD survivors from West Africa could seek medical care in the United States.
In most cases, the CDC notes, persons who have completely recovered from EVD do not experience a relapse of Ebola virus associated with systemic illness, although survivors can experience complications after surviving acute EVD. Reported complications among EVD survivors include nonspecific fatigue, joint pain, muscle aches, headaches, suppurative parotitis, pericarditis, orchitis, sexual dysfunction, hair loss, vision loss (including uveitis and permanent blindness), hearing loss, tinnitus, paresthesia or dysesthesia, memory loss, insomnia, depression, anxiety, and posttraumatic stress disorder.
The risk of infectivity from patients with persistent infection is unknown, the CDC guidance states, but “appears to be low and is likely to decrease over time.” The guidance includes infection control practices that should be used to “ensure that health care personnel do not contract infections from patients, whether or not they are known to be infectious,” and that personnel do not spread infectious material to other patients during routine medical care.
Medical professionals can view the complete care guidance on the CDC website. The CDC has also published additional resources to supplement the guidance. These include:
Messages for the Care of Survivors of Ebola Virus Disease. Topics in this resource include health problems EVD survivors may experience, guidance to use standard precautions for all patient care, and recommendations for when extra precautions may be needed.
FAQ on Screening for Ebola Virus Disease for Providers, Healthcare Facilities, and Health Departments. FAQs include information on adjusting screening practices for acutely ill patients while reiterating that a thorough travel history for all patients should be obtained to ensure proper infection control measures are in place. Additionally, information on hospital management recommendations for evaluating ill travelers from West Africa are included.
On Twitter @richpizzi
The Centers for Disease Control and Prevention has issued interim guidance for U.S. health care providers to safely care for survivors of Ebola virus disease (EVD).
The guidance includes information about sequelae of EVD as well as data on Ebola virus persistence in EVD survivors, and infection prevention and control recommendations for U.S. health care providers when evaluating a patient who is an EVD survivor. Of the eleven patients with Ebola virus disease who were managed in U.S. health care facilities during 2014-2015, nine survived. The CDC notes in the guidance that it is also possible that some EVD survivors from West Africa could seek medical care in the United States.
In most cases, the CDC notes, persons who have completely recovered from EVD do not experience a relapse of Ebola virus associated with systemic illness, although survivors can experience complications after surviving acute EVD. Reported complications among EVD survivors include nonspecific fatigue, joint pain, muscle aches, headaches, suppurative parotitis, pericarditis, orchitis, sexual dysfunction, hair loss, vision loss (including uveitis and permanent blindness), hearing loss, tinnitus, paresthesia or dysesthesia, memory loss, insomnia, depression, anxiety, and posttraumatic stress disorder.
The risk of infectivity from patients with persistent infection is unknown, the CDC guidance states, but “appears to be low and is likely to decrease over time.” The guidance includes infection control practices that should be used to “ensure that health care personnel do not contract infections from patients, whether or not they are known to be infectious,” and that personnel do not spread infectious material to other patients during routine medical care.
Medical professionals can view the complete care guidance on the CDC website. The CDC has also published additional resources to supplement the guidance. These include:
Messages for the Care of Survivors of Ebola Virus Disease. Topics in this resource include health problems EVD survivors may experience, guidance to use standard precautions for all patient care, and recommendations for when extra precautions may be needed.
FAQ on Screening for Ebola Virus Disease for Providers, Healthcare Facilities, and Health Departments. FAQs include information on adjusting screening practices for acutely ill patients while reiterating that a thorough travel history for all patients should be obtained to ensure proper infection control measures are in place. Additionally, information on hospital management recommendations for evaluating ill travelers from West Africa are included.
On Twitter @richpizzi
The Centers for Disease Control and Prevention has issued interim guidance for U.S. health care providers to safely care for survivors of Ebola virus disease (EVD).
The guidance includes information about sequelae of EVD as well as data on Ebola virus persistence in EVD survivors, and infection prevention and control recommendations for U.S. health care providers when evaluating a patient who is an EVD survivor. Of the eleven patients with Ebola virus disease who were managed in U.S. health care facilities during 2014-2015, nine survived. The CDC notes in the guidance that it is also possible that some EVD survivors from West Africa could seek medical care in the United States.
In most cases, the CDC notes, persons who have completely recovered from EVD do not experience a relapse of Ebola virus associated with systemic illness, although survivors can experience complications after surviving acute EVD. Reported complications among EVD survivors include nonspecific fatigue, joint pain, muscle aches, headaches, suppurative parotitis, pericarditis, orchitis, sexual dysfunction, hair loss, vision loss (including uveitis and permanent blindness), hearing loss, tinnitus, paresthesia or dysesthesia, memory loss, insomnia, depression, anxiety, and posttraumatic stress disorder.
The risk of infectivity from patients with persistent infection is unknown, the CDC guidance states, but “appears to be low and is likely to decrease over time.” The guidance includes infection control practices that should be used to “ensure that health care personnel do not contract infections from patients, whether or not they are known to be infectious,” and that personnel do not spread infectious material to other patients during routine medical care.
Medical professionals can view the complete care guidance on the CDC website. The CDC has also published additional resources to supplement the guidance. These include:
Messages for the Care of Survivors of Ebola Virus Disease. Topics in this resource include health problems EVD survivors may experience, guidance to use standard precautions for all patient care, and recommendations for when extra precautions may be needed.
FAQ on Screening for Ebola Virus Disease for Providers, Healthcare Facilities, and Health Departments. FAQs include information on adjusting screening practices for acutely ill patients while reiterating that a thorough travel history for all patients should be obtained to ensure proper infection control measures are in place. Additionally, information on hospital management recommendations for evaluating ill travelers from West Africa are included.
On Twitter @richpizzi
FDA approves new anthrax treatment
The Food and Drug Administration has approved Anthim (obiltoxaximab) injection to treat inhalational anthrax, in combination with appropriate antibacterial drugs.
Anthim is a monoclonal antibody that neutralizes toxins produced by the bacterium Bacillus anthracis. Anthim was approved under the FDA’s Animal Rule, which allows efficacy findings from adequate and well-controlled animal studies to support FDA approval when it is not feasible or ethical to conduct efficacy trials in humans. Anthim is also approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate.
The drug was developed by Elusys Therapeutics Inc. of Pine Brook, N.J., in conjunction with the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority.
Inhalational anthrax is a rare disease that can occur after exposure to infected animals or contaminated animal products, or as a result of an intentional release of anthrax spores. When inhaled, the anthrax bacteria replicate in the body and produce toxins that can cause massive and irreversible tissue injury and death.
Anthim’s effectiveness was demonstrated in studies conducted in animals based on survival at the end of the studies. More animals treated with Anthim lived, compared with animals treated with placebo. Anthim administered in combination with antibacterial drugs resulted in higher survival outcomes than antibacterial therapy alone.
The safety of Anthim was evaluated in 320 healthy human volunteers. The most frequently reported side effects were headache, itching (pruritus), upper respiratory tract infections, cough, nasal congestion, hives, and bruising, swelling and pain at the infusion site.
For more information, see the FDA’s approval announcement.
On Twitter @richpizzi
The Food and Drug Administration has approved Anthim (obiltoxaximab) injection to treat inhalational anthrax, in combination with appropriate antibacterial drugs.
Anthim is a monoclonal antibody that neutralizes toxins produced by the bacterium Bacillus anthracis. Anthim was approved under the FDA’s Animal Rule, which allows efficacy findings from adequate and well-controlled animal studies to support FDA approval when it is not feasible or ethical to conduct efficacy trials in humans. Anthim is also approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate.
The drug was developed by Elusys Therapeutics Inc. of Pine Brook, N.J., in conjunction with the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority.
Inhalational anthrax is a rare disease that can occur after exposure to infected animals or contaminated animal products, or as a result of an intentional release of anthrax spores. When inhaled, the anthrax bacteria replicate in the body and produce toxins that can cause massive and irreversible tissue injury and death.
Anthim’s effectiveness was demonstrated in studies conducted in animals based on survival at the end of the studies. More animals treated with Anthim lived, compared with animals treated with placebo. Anthim administered in combination with antibacterial drugs resulted in higher survival outcomes than antibacterial therapy alone.
The safety of Anthim was evaluated in 320 healthy human volunteers. The most frequently reported side effects were headache, itching (pruritus), upper respiratory tract infections, cough, nasal congestion, hives, and bruising, swelling and pain at the infusion site.
For more information, see the FDA’s approval announcement.
On Twitter @richpizzi
The Food and Drug Administration has approved Anthim (obiltoxaximab) injection to treat inhalational anthrax, in combination with appropriate antibacterial drugs.
Anthim is a monoclonal antibody that neutralizes toxins produced by the bacterium Bacillus anthracis. Anthim was approved under the FDA’s Animal Rule, which allows efficacy findings from adequate and well-controlled animal studies to support FDA approval when it is not feasible or ethical to conduct efficacy trials in humans. Anthim is also approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate.
The drug was developed by Elusys Therapeutics Inc. of Pine Brook, N.J., in conjunction with the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority.
Inhalational anthrax is a rare disease that can occur after exposure to infected animals or contaminated animal products, or as a result of an intentional release of anthrax spores. When inhaled, the anthrax bacteria replicate in the body and produce toxins that can cause massive and irreversible tissue injury and death.
Anthim’s effectiveness was demonstrated in studies conducted in animals based on survival at the end of the studies. More animals treated with Anthim lived, compared with animals treated with placebo. Anthim administered in combination with antibacterial drugs resulted in higher survival outcomes than antibacterial therapy alone.
The safety of Anthim was evaluated in 320 healthy human volunteers. The most frequently reported side effects were headache, itching (pruritus), upper respiratory tract infections, cough, nasal congestion, hives, and bruising, swelling and pain at the infusion site.
For more information, see the FDA’s approval announcement.
On Twitter @richpizzi
HIV Research Update: Early March 2016
A great volume of HIV and AIDS research enters the medical literature every month. It’s difficult to monitor everything, so here’s a quick look at some notable news items and journal articles published over the past few weeks.
Women needed daily doses of the antiviral combination tenofovir disoproxil fumarate plus emtricitabine to prevent HIV infection while men only needed two doses per week, according to a study in the Journal of Infectious Diseases.
A study published in the journal Science was the first to show the envelope glycoprotein trimer (Env) on the surface of HIV-1 in its native form. The research provides a highly detailed picture of the PGT151 site of vulnerability, the most complex and extensive broadly neutralizing epitope yet described.
The antiviral drug combination simeprevir/sofosbuvir/ribavirin (SMV/SOF with or without RBV) is an effective and safe option with minimal adverse effects for most HIV-positive patients with genotype 1 hepatitis C virus, according to a study in Clinical Infectious Diseases. However, the investigators said simeprevir should be avoided in patients with decompensated cirrhosis.
When compared with efavirenz (EFV)-based first-line antiretroviral therapy, atazanavir/ritonavir (ATV/r)-based antiretroviral therapy was associated with lower levels of oxidative stress biomarkers in HIV-infected patients, research published in HIV Medicine revealed. Investigators said the results were in part attributable to increased bilirubin levels.
The central nervous system HIV-1 viral reservoir is unique and presents a distinct set of challenges that need to be overcome to ensure successful viral elimination, said authors of a review in Current Opinion in HIV and AIDS.
Treatment interruptions of combination antiretroviral therapy (cART) of more than 30 days was the key factor associated with large increases in subsequent risk of treatment failure for HIV-infected patients, according to a study in Tropical Medicine & International Health. The authors say if treatment interruption is unavoidable, its duration should be minimized to reduce the risk of failure after treatment resumption.
According to a study in HIV Medicine, emerging clinical data suggest that elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide (E/C/F/TAF) as a single tablet regimen offers highly effective viral suppression in treatment-naïve and treatment-experienced patients with an improved renal and bone safety profile, compared with tenofovir disoproxil fumarate (TDF).
A cross-sectional, comparative study from India in Lancet HIV says that community viral load may serve as a useful impact evaluation measure for HIV transmission potential or level of HIV-associated health care in a given community or population.
An analysis of 80,843 HIV-infected patients in East Africa initiating non-nucleoside reverse-transcriptase inhibitor–based first-line antiretroviral therapy found that half had suboptimal immune recovery and failed to achieve a CD4 cell count of at least 350 cells/[mu]l after five years of first-line ART, and remain at increased risk of AIDS-related illnesses.
Patient self-testing for sexually-transmitted infections in HIV care settings significantly increases testing coverage and detection of gonorrhea and chlamydia, reported a study in JAIDS. The program is acceptable to patients, investigators said, but additional interventions to increase syphilis screening rates are needed.
Stronger efforts are required to increase HIV testing frequency among men who have sex with men in the U.K. in order to take full advantage of the opportunities provided by biomedical HIV prevention, a study in HIV Medicine concludes.
Being either overweight or underweight at initiation of antiretroviral therapy was associated with heightened systemic inflammation in HIV-infected patients, researchers reported. Weight gain among overweight and obese persons predicted increased inflammation, while weight gain among underweight persons predicted reduced inflammation.
A great volume of HIV and AIDS research enters the medical literature every month. It’s difficult to monitor everything, so here’s a quick look at some notable news items and journal articles published over the past few weeks.
Women needed daily doses of the antiviral combination tenofovir disoproxil fumarate plus emtricitabine to prevent HIV infection while men only needed two doses per week, according to a study in the Journal of Infectious Diseases.
A study published in the journal Science was the first to show the envelope glycoprotein trimer (Env) on the surface of HIV-1 in its native form. The research provides a highly detailed picture of the PGT151 site of vulnerability, the most complex and extensive broadly neutralizing epitope yet described.
The antiviral drug combination simeprevir/sofosbuvir/ribavirin (SMV/SOF with or without RBV) is an effective and safe option with minimal adverse effects for most HIV-positive patients with genotype 1 hepatitis C virus, according to a study in Clinical Infectious Diseases. However, the investigators said simeprevir should be avoided in patients with decompensated cirrhosis.
When compared with efavirenz (EFV)-based first-line antiretroviral therapy, atazanavir/ritonavir (ATV/r)-based antiretroviral therapy was associated with lower levels of oxidative stress biomarkers in HIV-infected patients, research published in HIV Medicine revealed. Investigators said the results were in part attributable to increased bilirubin levels.
The central nervous system HIV-1 viral reservoir is unique and presents a distinct set of challenges that need to be overcome to ensure successful viral elimination, said authors of a review in Current Opinion in HIV and AIDS.
Treatment interruptions of combination antiretroviral therapy (cART) of more than 30 days was the key factor associated with large increases in subsequent risk of treatment failure for HIV-infected patients, according to a study in Tropical Medicine & International Health. The authors say if treatment interruption is unavoidable, its duration should be minimized to reduce the risk of failure after treatment resumption.
According to a study in HIV Medicine, emerging clinical data suggest that elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide (E/C/F/TAF) as a single tablet regimen offers highly effective viral suppression in treatment-naïve and treatment-experienced patients with an improved renal and bone safety profile, compared with tenofovir disoproxil fumarate (TDF).
A cross-sectional, comparative study from India in Lancet HIV says that community viral load may serve as a useful impact evaluation measure for HIV transmission potential or level of HIV-associated health care in a given community or population.
An analysis of 80,843 HIV-infected patients in East Africa initiating non-nucleoside reverse-transcriptase inhibitor–based first-line antiretroviral therapy found that half had suboptimal immune recovery and failed to achieve a CD4 cell count of at least 350 cells/[mu]l after five years of first-line ART, and remain at increased risk of AIDS-related illnesses.
Patient self-testing for sexually-transmitted infections in HIV care settings significantly increases testing coverage and detection of gonorrhea and chlamydia, reported a study in JAIDS. The program is acceptable to patients, investigators said, but additional interventions to increase syphilis screening rates are needed.
Stronger efforts are required to increase HIV testing frequency among men who have sex with men in the U.K. in order to take full advantage of the opportunities provided by biomedical HIV prevention, a study in HIV Medicine concludes.
Being either overweight or underweight at initiation of antiretroviral therapy was associated with heightened systemic inflammation in HIV-infected patients, researchers reported. Weight gain among overweight and obese persons predicted increased inflammation, while weight gain among underweight persons predicted reduced inflammation.
A great volume of HIV and AIDS research enters the medical literature every month. It’s difficult to monitor everything, so here’s a quick look at some notable news items and journal articles published over the past few weeks.
Women needed daily doses of the antiviral combination tenofovir disoproxil fumarate plus emtricitabine to prevent HIV infection while men only needed two doses per week, according to a study in the Journal of Infectious Diseases.
A study published in the journal Science was the first to show the envelope glycoprotein trimer (Env) on the surface of HIV-1 in its native form. The research provides a highly detailed picture of the PGT151 site of vulnerability, the most complex and extensive broadly neutralizing epitope yet described.
The antiviral drug combination simeprevir/sofosbuvir/ribavirin (SMV/SOF with or without RBV) is an effective and safe option with minimal adverse effects for most HIV-positive patients with genotype 1 hepatitis C virus, according to a study in Clinical Infectious Diseases. However, the investigators said simeprevir should be avoided in patients with decompensated cirrhosis.
When compared with efavirenz (EFV)-based first-line antiretroviral therapy, atazanavir/ritonavir (ATV/r)-based antiretroviral therapy was associated with lower levels of oxidative stress biomarkers in HIV-infected patients, research published in HIV Medicine revealed. Investigators said the results were in part attributable to increased bilirubin levels.
The central nervous system HIV-1 viral reservoir is unique and presents a distinct set of challenges that need to be overcome to ensure successful viral elimination, said authors of a review in Current Opinion in HIV and AIDS.
Treatment interruptions of combination antiretroviral therapy (cART) of more than 30 days was the key factor associated with large increases in subsequent risk of treatment failure for HIV-infected patients, according to a study in Tropical Medicine & International Health. The authors say if treatment interruption is unavoidable, its duration should be minimized to reduce the risk of failure after treatment resumption.
According to a study in HIV Medicine, emerging clinical data suggest that elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide (E/C/F/TAF) as a single tablet regimen offers highly effective viral suppression in treatment-naïve and treatment-experienced patients with an improved renal and bone safety profile, compared with tenofovir disoproxil fumarate (TDF).
A cross-sectional, comparative study from India in Lancet HIV says that community viral load may serve as a useful impact evaluation measure for HIV transmission potential or level of HIV-associated health care in a given community or population.
An analysis of 80,843 HIV-infected patients in East Africa initiating non-nucleoside reverse-transcriptase inhibitor–based first-line antiretroviral therapy found that half had suboptimal immune recovery and failed to achieve a CD4 cell count of at least 350 cells/[mu]l after five years of first-line ART, and remain at increased risk of AIDS-related illnesses.
Patient self-testing for sexually-transmitted infections in HIV care settings significantly increases testing coverage and detection of gonorrhea and chlamydia, reported a study in JAIDS. The program is acceptable to patients, investigators said, but additional interventions to increase syphilis screening rates are needed.
Stronger efforts are required to increase HIV testing frequency among men who have sex with men in the U.K. in order to take full advantage of the opportunities provided by biomedical HIV prevention, a study in HIV Medicine concludes.
Being either overweight or underweight at initiation of antiretroviral therapy was associated with heightened systemic inflammation in HIV-infected patients, researchers reported. Weight gain among overweight and obese persons predicted increased inflammation, while weight gain among underweight persons predicted reduced inflammation.
HIV research update: Early March 2016
A great volume of HIV and AIDS research enters the medical literature every month. It’s difficult to monitor everything, so here’s a quick look at some notable news items and journal articles published over the past few weeks.
Women needed daily doses of the antiviral combination tenofovir disoproxil fumarate plus emtricitabine to prevent HIV infection while men only needed two doses per week, according to a study in the Journal of Infectious Diseases.
A study published in the journal Science was the first to show the envelope glycoprotein trimer (Env) on the surface of HIV-1 in its native form. The research provides a highly detailed picture of the PGT151 site of vulnerability, the most complex and extensive broadly neutralizing epitope yet described.
The antiviral drug combination simeprevir/sofosbuvir/ribavirin (SMV/SOF with or without RBV) is an effective and safe option with minimal adverse effects for most HIV-positive patients with genotype 1 hepatitis C virus, according to a study in Clinical Infectious Diseases. However, the investigators said simeprevir should be avoided in patients with decompensated cirrhosis.
When compared with efavirenz (EFV)-based first-line antiretroviral therapy, atazanavir/ritonavir (ATV/r)-based antiretroviral therapy was associated with lower levels of oxidative stress biomarkers in HIV-infected patients, research published in HIV Medicine revealed. Investigators said the results were in part attributable to increased bilirubin levels.
The central nervous system HIV-1 viral reservoir is unique and presents a distinct set of challenges that need to be overcome to ensure successful viral elimination, said authors of a review in Current Opinion in HIV and AIDS.
Treatment interruptions of combination antiretroviral therapy (cART) of more than 30 days was the key factor associated with large increases in subsequent risk of treatment failure for HIV-infected patients, according to a study in Tropical Medicine & International Health. The authors say if treatment interruption is unavoidable, its duration should be minimized to reduce the risk of failure after treatment resumption.
According to a study in HIV Medicine, emerging clinical data suggest that elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide (E/C/F/TAF) as a single tablet regimen offers highly effective viral suppression in treatment-naïve and treatment-experienced patients with an improved renal and bone safety profile, compared with tenofovir disoproxil fumarate (TDF).
A cross-sectional, comparative study from India in Lancet HIV says that community viral load may serve as a useful impact evaluation measure for HIV transmission potential or level of HIV-associated health care in a given community or population.
An analysis of 80,843 HIV-infected patients in East Africa initiating non-nucleoside reverse-transcriptase inhibitor–based first-line antiretroviral therapy found that half had suboptimal immune recovery and failed to achieve a CD4 cell count of at least 350 cells/[mu]l after five years of first-line ART, and remain at increased risk of AIDS-related illnesses.
Patient self-testing for sexually-transmitted infections in HIV care settings significantly increases testing coverage and detection of gonorrhea and chlamydia, reported a study in JAIDS. The program is acceptable to patients, investigators said, but additional interventions to increase syphilis screening rates are needed.
Stronger efforts are required to increase HIV testing frequency among men who have sex with men in the U.K. in order to take full advantage of the opportunities provided by biomedical HIV prevention, a study in HIV Medicine concludes.
Being either overweight or underweight at initiation of antiretroviral therapy was associated with heightened systemic inflammation in HIV-infected patients, researchers reported. Weight gain among overweight and obese persons predicted increased inflammation, while weight gain among underweight persons predicted reduced inflammation.
On Twitter @richpizzi
A great volume of HIV and AIDS research enters the medical literature every month. It’s difficult to monitor everything, so here’s a quick look at some notable news items and journal articles published over the past few weeks.
Women needed daily doses of the antiviral combination tenofovir disoproxil fumarate plus emtricitabine to prevent HIV infection while men only needed two doses per week, according to a study in the Journal of Infectious Diseases.
A study published in the journal Science was the first to show the envelope glycoprotein trimer (Env) on the surface of HIV-1 in its native form. The research provides a highly detailed picture of the PGT151 site of vulnerability, the most complex and extensive broadly neutralizing epitope yet described.
The antiviral drug combination simeprevir/sofosbuvir/ribavirin (SMV/SOF with or without RBV) is an effective and safe option with minimal adverse effects for most HIV-positive patients with genotype 1 hepatitis C virus, according to a study in Clinical Infectious Diseases. However, the investigators said simeprevir should be avoided in patients with decompensated cirrhosis.
When compared with efavirenz (EFV)-based first-line antiretroviral therapy, atazanavir/ritonavir (ATV/r)-based antiretroviral therapy was associated with lower levels of oxidative stress biomarkers in HIV-infected patients, research published in HIV Medicine revealed. Investigators said the results were in part attributable to increased bilirubin levels.
The central nervous system HIV-1 viral reservoir is unique and presents a distinct set of challenges that need to be overcome to ensure successful viral elimination, said authors of a review in Current Opinion in HIV and AIDS.
Treatment interruptions of combination antiretroviral therapy (cART) of more than 30 days was the key factor associated with large increases in subsequent risk of treatment failure for HIV-infected patients, according to a study in Tropical Medicine & International Health. The authors say if treatment interruption is unavoidable, its duration should be minimized to reduce the risk of failure after treatment resumption.
According to a study in HIV Medicine, emerging clinical data suggest that elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide (E/C/F/TAF) as a single tablet regimen offers highly effective viral suppression in treatment-naïve and treatment-experienced patients with an improved renal and bone safety profile, compared with tenofovir disoproxil fumarate (TDF).
A cross-sectional, comparative study from India in Lancet HIV says that community viral load may serve as a useful impact evaluation measure for HIV transmission potential or level of HIV-associated health care in a given community or population.
An analysis of 80,843 HIV-infected patients in East Africa initiating non-nucleoside reverse-transcriptase inhibitor–based first-line antiretroviral therapy found that half had suboptimal immune recovery and failed to achieve a CD4 cell count of at least 350 cells/[mu]l after five years of first-line ART, and remain at increased risk of AIDS-related illnesses.
Patient self-testing for sexually-transmitted infections in HIV care settings significantly increases testing coverage and detection of gonorrhea and chlamydia, reported a study in JAIDS. The program is acceptable to patients, investigators said, but additional interventions to increase syphilis screening rates are needed.
Stronger efforts are required to increase HIV testing frequency among men who have sex with men in the U.K. in order to take full advantage of the opportunities provided by biomedical HIV prevention, a study in HIV Medicine concludes.
Being either overweight or underweight at initiation of antiretroviral therapy was associated with heightened systemic inflammation in HIV-infected patients, researchers reported. Weight gain among overweight and obese persons predicted increased inflammation, while weight gain among underweight persons predicted reduced inflammation.
On Twitter @richpizzi
A great volume of HIV and AIDS research enters the medical literature every month. It’s difficult to monitor everything, so here’s a quick look at some notable news items and journal articles published over the past few weeks.
Women needed daily doses of the antiviral combination tenofovir disoproxil fumarate plus emtricitabine to prevent HIV infection while men only needed two doses per week, according to a study in the Journal of Infectious Diseases.
A study published in the journal Science was the first to show the envelope glycoprotein trimer (Env) on the surface of HIV-1 in its native form. The research provides a highly detailed picture of the PGT151 site of vulnerability, the most complex and extensive broadly neutralizing epitope yet described.
The antiviral drug combination simeprevir/sofosbuvir/ribavirin (SMV/SOF with or without RBV) is an effective and safe option with minimal adverse effects for most HIV-positive patients with genotype 1 hepatitis C virus, according to a study in Clinical Infectious Diseases. However, the investigators said simeprevir should be avoided in patients with decompensated cirrhosis.
When compared with efavirenz (EFV)-based first-line antiretroviral therapy, atazanavir/ritonavir (ATV/r)-based antiretroviral therapy was associated with lower levels of oxidative stress biomarkers in HIV-infected patients, research published in HIV Medicine revealed. Investigators said the results were in part attributable to increased bilirubin levels.
The central nervous system HIV-1 viral reservoir is unique and presents a distinct set of challenges that need to be overcome to ensure successful viral elimination, said authors of a review in Current Opinion in HIV and AIDS.
Treatment interruptions of combination antiretroviral therapy (cART) of more than 30 days was the key factor associated with large increases in subsequent risk of treatment failure for HIV-infected patients, according to a study in Tropical Medicine & International Health. The authors say if treatment interruption is unavoidable, its duration should be minimized to reduce the risk of failure after treatment resumption.
According to a study in HIV Medicine, emerging clinical data suggest that elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide (E/C/F/TAF) as a single tablet regimen offers highly effective viral suppression in treatment-naïve and treatment-experienced patients with an improved renal and bone safety profile, compared with tenofovir disoproxil fumarate (TDF).
A cross-sectional, comparative study from India in Lancet HIV says that community viral load may serve as a useful impact evaluation measure for HIV transmission potential or level of HIV-associated health care in a given community or population.
An analysis of 80,843 HIV-infected patients in East Africa initiating non-nucleoside reverse-transcriptase inhibitor–based first-line antiretroviral therapy found that half had suboptimal immune recovery and failed to achieve a CD4 cell count of at least 350 cells/[mu]l after five years of first-line ART, and remain at increased risk of AIDS-related illnesses.
Patient self-testing for sexually-transmitted infections in HIV care settings significantly increases testing coverage and detection of gonorrhea and chlamydia, reported a study in JAIDS. The program is acceptable to patients, investigators said, but additional interventions to increase syphilis screening rates are needed.
Stronger efforts are required to increase HIV testing frequency among men who have sex with men in the U.K. in order to take full advantage of the opportunities provided by biomedical HIV prevention, a study in HIV Medicine concludes.
Being either overweight or underweight at initiation of antiretroviral therapy was associated with heightened systemic inflammation in HIV-infected patients, researchers reported. Weight gain among overweight and obese persons predicted increased inflammation, while weight gain among underweight persons predicted reduced inflammation.
On Twitter @richpizzi
