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Several simple, inexpensive operational interventions substantially improve care for viral hepatitis, according to a report published in the Lancet.

Recent advances in treatment for chronic hepatitis B and chronic hepatitis C have the potential to halt or even reverse the progression of associated liver disease and to reduce related mortality, reported Kali Zhou, MD, of the division of gastroenterology, University of California, San Francisco, and her associates. But they can do so only if affected individuals are engaged and retained in the relatively long continuum of care, from diagnosis through viral suppression or cure.

To assess the usefulness of interventions that promote such patient engagement and retention, Dr. Zhou and her colleagues reviewed the scientific literature and performed a meta-analysis of 56 studies. They examined 15 studies on HBV care, 38 on HCV care, and 3 on both types of hepatitis (Lancet Infect Dis. 2016 Sep 5. doi: 10.1016/S1473-3099[16]30208-0).

Among their findings:

• Educating a single lay health worker to improve knowledge about the disease in his or her community and to promote diagnostic testing nearly tripled the testing rate (relative risk, 2.68), compared with no such intervention.

• Clinician reminders during regular office visits to consider hepatitis testing – such as prompts in the patients’ electronic medical records or stickers on their charts – nearly quadrupled the testing rate (RR, 3.70), compared with no clinician reminders.

• Providing guided referral to a hepatitis specialist for people at risk for the disorder markedly improved the rate of visits to such specialists (RR, 1.57), compared with no such referrals.

• Providing psychological counseling and motivational therapy for mental health and/or substance misuse problems along with medical care for hepatitis dramatically increased the number of patients treated (OR, 3.42) and raised the rate of treatment completion (RR, 1.14).

• Combining mental health, substance misuse, and hepatitis treatment services at one location increased the rate of treatment initiation (RR, 1.36), treatment adherence (RR, 1.22), and cure as measured by sustained virologic response rate (RR, 1.21), compared with usual care.

These interventions might be useful in augmenting hepatitis treatment programs worldwide, Dr. Zhou and her associates said.

The World Health Organization and the U.S. Fulbright Program supported the study. Dr. Zhou and her associates reported having no relevant financial disclosures.

Several simple, inexpensive operational interventions substantially improve care for viral hepatitis, according to a report published in the Lancet.

Recent advances in treatment for chronic hepatitis B and chronic hepatitis C have the potential to halt or even reverse the progression of associated liver disease and to reduce related mortality, reported Kali Zhou, MD, of the division of gastroenterology, University of California, San Francisco, and her associates. But they can do so only if affected individuals are engaged and retained in the relatively long continuum of care, from diagnosis through viral suppression or cure.

To assess the usefulness of interventions that promote such patient engagement and retention, Dr. Zhou and her colleagues reviewed the scientific literature and performed a meta-analysis of 56 studies. They examined 15 studies on HBV care, 38 on HCV care, and 3 on both types of hepatitis (Lancet Infect Dis. 2016 Sep 5. doi: 10.1016/S1473-3099[16]30208-0).

Among their findings:

• Educating a single lay health worker to improve knowledge about the disease in his or her community and to promote diagnostic testing nearly tripled the testing rate (relative risk, 2.68), compared with no such intervention.

• Clinician reminders during regular office visits to consider hepatitis testing – such as prompts in the patients’ electronic medical records or stickers on their charts – nearly quadrupled the testing rate (RR, 3.70), compared with no clinician reminders.

• Providing guided referral to a hepatitis specialist for people at risk for the disorder markedly improved the rate of visits to such specialists (RR, 1.57), compared with no such referrals.

• Providing psychological counseling and motivational therapy for mental health and/or substance misuse problems along with medical care for hepatitis dramatically increased the number of patients treated (OR, 3.42) and raised the rate of treatment completion (RR, 1.14).

• Combining mental health, substance misuse, and hepatitis treatment services at one location increased the rate of treatment initiation (RR, 1.36), treatment adherence (RR, 1.22), and cure as measured by sustained virologic response rate (RR, 1.21), compared with usual care.

These interventions might be useful in augmenting hepatitis treatment programs worldwide, Dr. Zhou and her associates said.

The World Health Organization and the U.S. Fulbright Program supported the study. Dr. Zhou and her associates reported having no relevant financial disclosures.

Several simple, inexpensive operational interventions substantially improve care for viral hepatitis, according to a report published in the Lancet.

Recent advances in treatment for chronic hepatitis B and chronic hepatitis C have the potential to halt or even reverse the progression of associated liver disease and to reduce related mortality, reported Kali Zhou, MD, of the division of gastroenterology, University of California, San Francisco, and her associates. But they can do so only if affected individuals are engaged and retained in the relatively long continuum of care, from diagnosis through viral suppression or cure.

To assess the usefulness of interventions that promote such patient engagement and retention, Dr. Zhou and her colleagues reviewed the scientific literature and performed a meta-analysis of 56 studies. They examined 15 studies on HBV care, 38 on HCV care, and 3 on both types of hepatitis (Lancet Infect Dis. 2016 Sep 5. doi: 10.1016/S1473-3099[16]30208-0).

Among their findings:

• Educating a single lay health worker to improve knowledge about the disease in his or her community and to promote diagnostic testing nearly tripled the testing rate (relative risk, 2.68), compared with no such intervention.

• Clinician reminders during regular office visits to consider hepatitis testing – such as prompts in the patients’ electronic medical records or stickers on their charts – nearly quadrupled the testing rate (RR, 3.70), compared with no clinician reminders.

• Providing guided referral to a hepatitis specialist for people at risk for the disorder markedly improved the rate of visits to such specialists (RR, 1.57), compared with no such referrals.

• Providing psychological counseling and motivational therapy for mental health and/or substance misuse problems along with medical care for hepatitis dramatically increased the number of patients treated (OR, 3.42) and raised the rate of treatment completion (RR, 1.14).

• Combining mental health, substance misuse, and hepatitis treatment services at one location increased the rate of treatment initiation (RR, 1.36), treatment adherence (RR, 1.22), and cure as measured by sustained virologic response rate (RR, 1.21), compared with usual care.

These interventions might be useful in augmenting hepatitis treatment programs worldwide, Dr. Zhou and her associates said.

The World Health Organization and the U.S. Fulbright Program supported the study. Dr. Zhou and her associates reported having no relevant financial disclosures.

A 12-week course of elbasvir plus grazoprevir proved effective against hepatitis C virus in 301 patients who were receiving opioid agonist therapy for injectable drug addiction, according to a report published online August 8 in Annals of Internal Medicine.

This patient population showed excellent treatment adherence and achieved sustained virologic response (SVR) rates of approximately 90%, even though most participants continued to use injectable drugs during the study. These findings demonstrate that current drug users can achieve HCV treatment outcomes that are comparable to those in the general HCV population, and “suggest that access to interferon-free direct-acting antiviral therapy should be expanded to patients receiving opioid agonist therapy, including the removal of drug use-based restrictions,” said Gregory J. Dore, MD, of the Kirby Institute, University of New South Wales, Sydney, and his associates.

Jarun011/Thinkstock

They assessed elbasvir-grazoprevir (Zepatier) treatment in patients with untreated chronic HCV who were aged 18 and older and had been receiving opioid agonist therapy with methadone, buprenorphine, or buprenorphine-naloxone for at least 3 months at facilities in 13 countries. The study participants were randomly assigned in double-blind fashion to receive either immediate active treatment for 12 weeks (201 patients) or matching placebo for 12 weeks followed by 4 weeks of follow-up followed by deferred open-label active treatment for 12 weeks (100 control subjects).

All patients were followed for 6 months after they completed active treatment. All underwent frequent urine testing for illegal drugs, and more than half of both study groups tested positive for at least one drug during active treatment and follow-up. Illegal drug use was stable throughout the study period and did not affect either treatment adherence or efficacy. Nearly every participant showed excellent adherence (over 95%) to elbasvir-grazoprevir.

The primary efficacy endpoint, the SVR rate immediately after active treatment, was 91.5% in the immediate-treatment group and 89.5% in the deferred-treatment group. Both rates are substantially higher than the historical reference SVR rate of 67%, Dr. Dore and his associates noted (Ann Intern Med. 2016 Aug 8. doi: 10.7326/M16-0816).

Elbasvir-grazoprevir was equally effective against the GT1a, GT1b, and GT4 strains of HCV, but was less effective against the GT6 strain, which occurs primarily in China and Southeast Asia. It also was effective across important subgroups of patients, including those who had cirrhosis and those who carried HCV variants associated with drug resistance.

Regarding treatment safety, the rate of serious adverse events was low in both study groups (3.5% and 4.0%, respectively), and only one event in each group was deemed to be related to elbasvir-grazoprevir.

The incidence of reinfection for the 24-week period after successful treatment was 4.6 per 100 person-years, and it often was attributed to continuing use of contaminated needles or sexual contact with an infected partner. The effect of reinfection is “of considerable clinical and public health interest,” and will be further examined during a 3-year extension of the follow-up of this study, the investigators said.

“Of interest, 3 of the 6 patients categorized as having HCV reinfection subsequently had undetectable HCV-RNA levels without additional HCV treatment, indicating that not all reinfection cases develop viral persistence,” they added.

This study was funded primarily by Merck, which markets Zepatier. Dr. Dore reported ties to AbbVie, Merck, Bristol-Myers Squibb, Janssen, Roche, Gilead, GlaxoSmithKline, and Abbott, and his associates reported ties to numerous industry sources.

A 12-week course of elbasvir plus grazoprevir proved effective against hepatitis C virus in 301 patients who were receiving opioid agonist therapy for injectable drug addiction, according to a report published online August 8 in Annals of Internal Medicine.

This patient population showed excellent treatment adherence and achieved sustained virologic response (SVR) rates of approximately 90%, even though most participants continued to use injectable drugs during the study. These findings demonstrate that current drug users can achieve HCV treatment outcomes that are comparable to those in the general HCV population, and “suggest that access to interferon-free direct-acting antiviral therapy should be expanded to patients receiving opioid agonist therapy, including the removal of drug use-based restrictions,” said Gregory J. Dore, MD, of the Kirby Institute, University of New South Wales, Sydney, and his associates.

Jarun011/Thinkstock

They assessed elbasvir-grazoprevir (Zepatier) treatment in patients with untreated chronic HCV who were aged 18 and older and had been receiving opioid agonist therapy with methadone, buprenorphine, or buprenorphine-naloxone for at least 3 months at facilities in 13 countries. The study participants were randomly assigned in double-blind fashion to receive either immediate active treatment for 12 weeks (201 patients) or matching placebo for 12 weeks followed by 4 weeks of follow-up followed by deferred open-label active treatment for 12 weeks (100 control subjects).

All patients were followed for 6 months after they completed active treatment. All underwent frequent urine testing for illegal drugs, and more than half of both study groups tested positive for at least one drug during active treatment and follow-up. Illegal drug use was stable throughout the study period and did not affect either treatment adherence or efficacy. Nearly every participant showed excellent adherence (over 95%) to elbasvir-grazoprevir.

The primary efficacy endpoint, the SVR rate immediately after active treatment, was 91.5% in the immediate-treatment group and 89.5% in the deferred-treatment group. Both rates are substantially higher than the historical reference SVR rate of 67%, Dr. Dore and his associates noted (Ann Intern Med. 2016 Aug 8. doi: 10.7326/M16-0816).

Elbasvir-grazoprevir was equally effective against the GT1a, GT1b, and GT4 strains of HCV, but was less effective against the GT6 strain, which occurs primarily in China and Southeast Asia. It also was effective across important subgroups of patients, including those who had cirrhosis and those who carried HCV variants associated with drug resistance.

Regarding treatment safety, the rate of serious adverse events was low in both study groups (3.5% and 4.0%, respectively), and only one event in each group was deemed to be related to elbasvir-grazoprevir.

The incidence of reinfection for the 24-week period after successful treatment was 4.6 per 100 person-years, and it often was attributed to continuing use of contaminated needles or sexual contact with an infected partner. The effect of reinfection is “of considerable clinical and public health interest,” and will be further examined during a 3-year extension of the follow-up of this study, the investigators said.

“Of interest, 3 of the 6 patients categorized as having HCV reinfection subsequently had undetectable HCV-RNA levels without additional HCV treatment, indicating that not all reinfection cases develop viral persistence,” they added.

This study was funded primarily by Merck, which markets Zepatier. Dr. Dore reported ties to AbbVie, Merck, Bristol-Myers Squibb, Janssen, Roche, Gilead, GlaxoSmithKline, and Abbott, and his associates reported ties to numerous industry sources.

A 12-week course of elbasvir plus grazoprevir proved effective against hepatitis C virus in 301 patients who were receiving opioid agonist therapy for injectable drug addiction, according to a report published online August 8 in Annals of Internal Medicine.

This patient population showed excellent treatment adherence and achieved sustained virologic response (SVR) rates of approximately 90%, even though most participants continued to use injectable drugs during the study. These findings demonstrate that current drug users can achieve HCV treatment outcomes that are comparable to those in the general HCV population, and “suggest that access to interferon-free direct-acting antiviral therapy should be expanded to patients receiving opioid agonist therapy, including the removal of drug use-based restrictions,” said Gregory J. Dore, MD, of the Kirby Institute, University of New South Wales, Sydney, and his associates.

Jarun011/Thinkstock

They assessed elbasvir-grazoprevir (Zepatier) treatment in patients with untreated chronic HCV who were aged 18 and older and had been receiving opioid agonist therapy with methadone, buprenorphine, or buprenorphine-naloxone for at least 3 months at facilities in 13 countries. The study participants were randomly assigned in double-blind fashion to receive either immediate active treatment for 12 weeks (201 patients) or matching placebo for 12 weeks followed by 4 weeks of follow-up followed by deferred open-label active treatment for 12 weeks (100 control subjects).

All patients were followed for 6 months after they completed active treatment. All underwent frequent urine testing for illegal drugs, and more than half of both study groups tested positive for at least one drug during active treatment and follow-up. Illegal drug use was stable throughout the study period and did not affect either treatment adherence or efficacy. Nearly every participant showed excellent adherence (over 95%) to elbasvir-grazoprevir.

The primary efficacy endpoint, the SVR rate immediately after active treatment, was 91.5% in the immediate-treatment group and 89.5% in the deferred-treatment group. Both rates are substantially higher than the historical reference SVR rate of 67%, Dr. Dore and his associates noted (Ann Intern Med. 2016 Aug 8. doi: 10.7326/M16-0816).

Elbasvir-grazoprevir was equally effective against the GT1a, GT1b, and GT4 strains of HCV, but was less effective against the GT6 strain, which occurs primarily in China and Southeast Asia. It also was effective across important subgroups of patients, including those who had cirrhosis and those who carried HCV variants associated with drug resistance.

Regarding treatment safety, the rate of serious adverse events was low in both study groups (3.5% and 4.0%, respectively), and only one event in each group was deemed to be related to elbasvir-grazoprevir.

The incidence of reinfection for the 24-week period after successful treatment was 4.6 per 100 person-years, and it often was attributed to continuing use of contaminated needles or sexual contact with an infected partner. The effect of reinfection is “of considerable clinical and public health interest,” and will be further examined during a 3-year extension of the follow-up of this study, the investigators said.

“Of interest, 3 of the 6 patients categorized as having HCV reinfection subsequently had undetectable HCV-RNA levels without additional HCV treatment, indicating that not all reinfection cases develop viral persistence,” they added.

This study was funded primarily by Merck, which markets Zepatier. Dr. Dore reported ties to AbbVie, Merck, Bristol-Myers Squibb, Janssen, Roche, Gilead, GlaxoSmithKline, and Abbott, and his associates reported ties to numerous industry sources.

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.

Although hepatitis E virus infections are increasingly recognized as a global public health problem, there are “few methods for prevention and treatment that are widely available,” according to a recent analysis.

©Zerbor/Thinkstock

A “suboptimal plasma level of the antiviral drug daclatasvir allows the selection of resistance-associated variants” and fails to contribute to antiviral activity in HIV-hepatitis C virus (HCV) coinfected patients, according to a recent study, although no definite reason for the low daclatasvir level was found.

The new preservative-free inactivated hepatitis A vaccine (Healive) in two doses showed better persistence of antibody concentrations for 5 years after full-course immunization among children, compared with Havrix. The endurance of protective immunogenicity was estimated for at least 20 years.

Because of transplacental transfer of antihepatitis B virus antibodies (anti-HBVs), high levels of maternal anti-HBVs may suppress infants’ immune response to standard HBV vaccination, according to an analysis in the Journal of Viral Hepatitis.

The gamma-glutamyl transpeptidase-to-platelet ratio (GPR) is “a new serum model for the diagnosis” of liver fibrosis and cirrhosis, according to a recent study. Researchers said it shows advantages in Chinese hepatitis Be antigen (HBeAg)-positive patients with hepatitis B virus DNA greater than or equal to 5 log₁₀ copies/mL and ALT less than or equal to two times ULN (upper limit of normal), compared with APRI (aspartate aminotransferase to platelet ratio index) and Fibrosis-4.

A baseline quantitative hepatitis B surface antigen (HBsAg) threshold of 3.141 log₁₀ IU/mL and a baseline quantitative hepatitis B core-related antigen 3.450 log₁₀ U/mL threshold, used separately or in combination, allow prediction of response to pegylated interferon-alpha-2a (PegIFN)-based “precision therapy” for hepatitis B virus infection, a new study found.

Male sex, age over 40 years, cirrhotic liver, and long length of stay are significant factors associated with death in hepatitis A virus-hospitalized cases, according to a study in the Journal of Viral Hepatitis.

Chronic kidney disease patients receiving three doses of hepatitis B adjuvanted vaccine were three times more likely to seroconvert than patients immunized with nonadjuvanted vaccines, according to results of a Spanish study. This meant fewer patients needed a second course of HBV vaccination and there were fewer outpatient visits.

Acute kidney injury is closely linked with increased short-term mortality in Chinese hepatitis B virus-related, acute-on-chronic liver failure patients, according to a study in the Journal of Viral Hepatitis.

Italian investigators attempted “to predict susceptibility of healthy patients to de novo HBV infection using a cultured IFN-gamma enzyme-linked immunospot (ELISPOT) assay.” Although the prognostic value of the assay was not demonstrated, data suggested that the subjects may be at risk for HBV infection.

Investigators demonstrated that treatment with sofosbuvir and simeprevir was effective in a real-life cohort of patients with hepatitis C virus genotype 4 infection and advanced liver fibrosis/cirrhosis. They said that adding ribavirin could be considered in treatment-experienced patients.

The presence of specific anti-envelope antibodies may be a factor that helps individuals at high risk of hepatitis C virus to resist infection, according to a study in the Journal of Viral Hepatitis.

A Chinese study determined that certain social network structural characteristics are related to hepatitis C virus infections in people who inject drugs, and used the data to identify the most susceptible individuals for HCV transmission in a network of people who inject drugs.

Drug resistance analyses of protease inhibitors that treat hepatitis C virus infection can be useful and essential in revealing the particular variants responsible for pretreatment natural resistance and also the particular mutations responsible for the viral breakthrough that may develop during the treatment, according to a study in the International Journal of Infectious Diseases.

Routine vaccination of toddlers against hepatitis A virus would be cost effective in Mexico using a single-dose vaccination strategy, according to a recent study, although the authors said the cost efficacy of a second dose depends on the assumptions of added safeguards by immune memory protection and the time horizon over which the analysis is enacted.

Hepatitis C virus-infected patients undergoing ribavirin-free sofosbuvir and velpatasvir regimens had significantly better patient-reported outcome scores during therapy, compared with those undergoing the ribavirin-containing regimen, a recent study found.

An analysis in Infectious Diseases in Clinical Practice reported the first case of visual hallucinations during chronic hepatitis C treatment with sofosbuvir and simeprevir. Investigators said hallucinations stopped upon starting antipsychotic medication, and the remainder of treatment was safe.

Sustained virologic response can be attained with pegylated interferon-alpha plus ribavirin combination therapy in hepatitis C virus–infected patients, but a relapse may occur in some patients, according to a recent study.

A quantitative HBsAg test can be used to ascertain high levels of hepatitis B viremia in women who might transmit the virus to their children, rather than a test for HBeAg or HBV DNA, according to a research letter in Hepatology.

A Chinese study found a robust relationship between Helicobacter pylori infection and chronic hepatitis B. This is especially true during hepatitis B virus progression.

The prevalence of antihepatitis E virus (HEV) antibodies was 49% (153/313) among blood donors in central Italy, according to a study published in Eurosurveillance. The authors said HEV infection is hyperendemic among blood donors (80% men, 18- to 64-years-old) from central Italy and associated with local dietary habits, such as eating raw dried pig liver sausage.

rpizzi@frontlinemedcom.com

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.

Although hepatitis E virus infections are increasingly recognized as a global public health problem, there are “few methods for prevention and treatment that are widely available,” according to a recent analysis.

©Zerbor/Thinkstock

A “suboptimal plasma level of the antiviral drug daclatasvir allows the selection of resistance-associated variants” and fails to contribute to antiviral activity in HIV-hepatitis C virus (HCV) coinfected patients, according to a recent study, although no definite reason for the low daclatasvir level was found.

The new preservative-free inactivated hepatitis A vaccine (Healive) in two doses showed better persistence of antibody concentrations for 5 years after full-course immunization among children, compared with Havrix. The endurance of protective immunogenicity was estimated for at least 20 years.

Because of transplacental transfer of antihepatitis B virus antibodies (anti-HBVs), high levels of maternal anti-HBVs may suppress infants’ immune response to standard HBV vaccination, according to an analysis in the Journal of Viral Hepatitis.

The gamma-glutamyl transpeptidase-to-platelet ratio (GPR) is “a new serum model for the diagnosis” of liver fibrosis and cirrhosis, according to a recent study. Researchers said it shows advantages in Chinese hepatitis Be antigen (HBeAg)-positive patients with hepatitis B virus DNA greater than or equal to 5 log₁₀ copies/mL and ALT less than or equal to two times ULN (upper limit of normal), compared with APRI (aspartate aminotransferase to platelet ratio index) and Fibrosis-4.

A baseline quantitative hepatitis B surface antigen (HBsAg) threshold of 3.141 log₁₀ IU/mL and a baseline quantitative hepatitis B core-related antigen 3.450 log₁₀ U/mL threshold, used separately or in combination, allow prediction of response to pegylated interferon-alpha-2a (PegIFN)-based “precision therapy” for hepatitis B virus infection, a new study found.

Male sex, age over 40 years, cirrhotic liver, and long length of stay are significant factors associated with death in hepatitis A virus-hospitalized cases, according to a study in the Journal of Viral Hepatitis.

Chronic kidney disease patients receiving three doses of hepatitis B adjuvanted vaccine were three times more likely to seroconvert than patients immunized with nonadjuvanted vaccines, according to results of a Spanish study. This meant fewer patients needed a second course of HBV vaccination and there were fewer outpatient visits.

Acute kidney injury is closely linked with increased short-term mortality in Chinese hepatitis B virus-related, acute-on-chronic liver failure patients, according to a study in the Journal of Viral Hepatitis.

Italian investigators attempted “to predict susceptibility of healthy patients to de novo HBV infection using a cultured IFN-gamma enzyme-linked immunospot (ELISPOT) assay.” Although the prognostic value of the assay was not demonstrated, data suggested that the subjects may be at risk for HBV infection.

Investigators demonstrated that treatment with sofosbuvir and simeprevir was effective in a real-life cohort of patients with hepatitis C virus genotype 4 infection and advanced liver fibrosis/cirrhosis. They said that adding ribavirin could be considered in treatment-experienced patients.

The presence of specific anti-envelope antibodies may be a factor that helps individuals at high risk of hepatitis C virus to resist infection, according to a study in the Journal of Viral Hepatitis.

A Chinese study determined that certain social network structural characteristics are related to hepatitis C virus infections in people who inject drugs, and used the data to identify the most susceptible individuals for HCV transmission in a network of people who inject drugs.

Drug resistance analyses of protease inhibitors that treat hepatitis C virus infection can be useful and essential in revealing the particular variants responsible for pretreatment natural resistance and also the particular mutations responsible for the viral breakthrough that may develop during the treatment, according to a study in the International Journal of Infectious Diseases.

Routine vaccination of toddlers against hepatitis A virus would be cost effective in Mexico using a single-dose vaccination strategy, according to a recent study, although the authors said the cost efficacy of a second dose depends on the assumptions of added safeguards by immune memory protection and the time horizon over which the analysis is enacted.

Hepatitis C virus-infected patients undergoing ribavirin-free sofosbuvir and velpatasvir regimens had significantly better patient-reported outcome scores during therapy, compared with those undergoing the ribavirin-containing regimen, a recent study found.

An analysis in Infectious Diseases in Clinical Practice reported the first case of visual hallucinations during chronic hepatitis C treatment with sofosbuvir and simeprevir. Investigators said hallucinations stopped upon starting antipsychotic medication, and the remainder of treatment was safe.

Sustained virologic response can be attained with pegylated interferon-alpha plus ribavirin combination therapy in hepatitis C virus–infected patients, but a relapse may occur in some patients, according to a recent study.

A quantitative HBsAg test can be used to ascertain high levels of hepatitis B viremia in women who might transmit the virus to their children, rather than a test for HBeAg or HBV DNA, according to a research letter in Hepatology.

A Chinese study found a robust relationship between Helicobacter pylori infection and chronic hepatitis B. This is especially true during hepatitis B virus progression.

The prevalence of antihepatitis E virus (HEV) antibodies was 49% (153/313) among blood donors in central Italy, according to a study published in Eurosurveillance. The authors said HEV infection is hyperendemic among blood donors (80% men, 18- to 64-years-old) from central Italy and associated with local dietary habits, such as eating raw dried pig liver sausage.

rpizzi@frontlinemedcom.com

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.

Although hepatitis E virus infections are increasingly recognized as a global public health problem, there are “few methods for prevention and treatment that are widely available,” according to a recent analysis.

©Zerbor/Thinkstock

A “suboptimal plasma level of the antiviral drug daclatasvir allows the selection of resistance-associated variants” and fails to contribute to antiviral activity in HIV-hepatitis C virus (HCV) coinfected patients, according to a recent study, although no definite reason for the low daclatasvir level was found.

The new preservative-free inactivated hepatitis A vaccine (Healive) in two doses showed better persistence of antibody concentrations for 5 years after full-course immunization among children, compared with Havrix. The endurance of protective immunogenicity was estimated for at least 20 years.

Because of transplacental transfer of antihepatitis B virus antibodies (anti-HBVs), high levels of maternal anti-HBVs may suppress infants’ immune response to standard HBV vaccination, according to an analysis in the Journal of Viral Hepatitis.

The gamma-glutamyl transpeptidase-to-platelet ratio (GPR) is “a new serum model for the diagnosis” of liver fibrosis and cirrhosis, according to a recent study. Researchers said it shows advantages in Chinese hepatitis Be antigen (HBeAg)-positive patients with hepatitis B virus DNA greater than or equal to 5 log₁₀ copies/mL and ALT less than or equal to two times ULN (upper limit of normal), compared with APRI (aspartate aminotransferase to platelet ratio index) and Fibrosis-4.

A baseline quantitative hepatitis B surface antigen (HBsAg) threshold of 3.141 log₁₀ IU/mL and a baseline quantitative hepatitis B core-related antigen 3.450 log₁₀ U/mL threshold, used separately or in combination, allow prediction of response to pegylated interferon-alpha-2a (PegIFN)-based “precision therapy” for hepatitis B virus infection, a new study found.

Male sex, age over 40 years, cirrhotic liver, and long length of stay are significant factors associated with death in hepatitis A virus-hospitalized cases, according to a study in the Journal of Viral Hepatitis.

Chronic kidney disease patients receiving three doses of hepatitis B adjuvanted vaccine were three times more likely to seroconvert than patients immunized with nonadjuvanted vaccines, according to results of a Spanish study. This meant fewer patients needed a second course of HBV vaccination and there were fewer outpatient visits.

Acute kidney injury is closely linked with increased short-term mortality in Chinese hepatitis B virus-related, acute-on-chronic liver failure patients, according to a study in the Journal of Viral Hepatitis.

Italian investigators attempted “to predict susceptibility of healthy patients to de novo HBV infection using a cultured IFN-gamma enzyme-linked immunospot (ELISPOT) assay.” Although the prognostic value of the assay was not demonstrated, data suggested that the subjects may be at risk for HBV infection.

Investigators demonstrated that treatment with sofosbuvir and simeprevir was effective in a real-life cohort of patients with hepatitis C virus genotype 4 infection and advanced liver fibrosis/cirrhosis. They said that adding ribavirin could be considered in treatment-experienced patients.

The presence of specific anti-envelope antibodies may be a factor that helps individuals at high risk of hepatitis C virus to resist infection, according to a study in the Journal of Viral Hepatitis.

A Chinese study determined that certain social network structural characteristics are related to hepatitis C virus infections in people who inject drugs, and used the data to identify the most susceptible individuals for HCV transmission in a network of people who inject drugs.

Drug resistance analyses of protease inhibitors that treat hepatitis C virus infection can be useful and essential in revealing the particular variants responsible for pretreatment natural resistance and also the particular mutations responsible for the viral breakthrough that may develop during the treatment, according to a study in the International Journal of Infectious Diseases.

Routine vaccination of toddlers against hepatitis A virus would be cost effective in Mexico using a single-dose vaccination strategy, according to a recent study, although the authors said the cost efficacy of a second dose depends on the assumptions of added safeguards by immune memory protection and the time horizon over which the analysis is enacted.

Hepatitis C virus-infected patients undergoing ribavirin-free sofosbuvir and velpatasvir regimens had significantly better patient-reported outcome scores during therapy, compared with those undergoing the ribavirin-containing regimen, a recent study found.

An analysis in Infectious Diseases in Clinical Practice reported the first case of visual hallucinations during chronic hepatitis C treatment with sofosbuvir and simeprevir. Investigators said hallucinations stopped upon starting antipsychotic medication, and the remainder of treatment was safe.

Sustained virologic response can be attained with pegylated interferon-alpha plus ribavirin combination therapy in hepatitis C virus–infected patients, but a relapse may occur in some patients, according to a recent study.

A quantitative HBsAg test can be used to ascertain high levels of hepatitis B viremia in women who might transmit the virus to their children, rather than a test for HBeAg or HBV DNA, according to a research letter in Hepatology.

A Chinese study found a robust relationship between Helicobacter pylori infection and chronic hepatitis B. This is especially true during hepatitis B virus progression.

The prevalence of antihepatitis E virus (HEV) antibodies was 49% (153/313) among blood donors in central Italy, according to a study published in Eurosurveillance. The authors said HEV infection is hyperendemic among blood donors (80% men, 18- to 64-years-old) from central Italy and associated with local dietary habits, such as eating raw dried pig liver sausage.

rpizzi@frontlinemedcom.com

On Twitter @richpizzi

At least two incretin-based drugs – glucagon-like peptide 1 agonists and dipeptidyl peptidase 4 inhibitors – do not appear to increase the risk of acute pancreatitis in individuals with diabetes but are associated with an increased risk of bile duct and gallbladder disease.

Two studies examining the impact on the pancreas of incretin-based drugs, including dipeptidyl peptidase 4 (DPP-4) inhibitors and glucagon-like peptide 1 (GLP-1) agonists, have been published online August 1 in JAMA Internal Medicine.

Incretin-based drugs have been associated with increased risk of elevated pancreatic enzyme levels, while GLP-1 has been shown to increase the proliferation and activity of cholangiocytes, which have raised concerns of an impact on the bile duct, gallbladder, and pancreas.

The first study was an international, population-based cohort study using the health records of more than 1.5 million individuals with type 2 diabetes, who began treatment with antidiabetic drugs between January 2007 and June 2013.

Analysis of these data showed there was no difference in the risk of hospitalization for acute pancreatitis between those taking incretin-based drugs and those on two or more other oral antidiabetic medications (JAMA Intern Med. 2016 Aug 1. doi: 10.1001/jamainternmed.2016.1522).

The study also found no significant increase in the risk of acute pancreatitis either with DPP-4 inhibitors or GLP-1 agonists, nor was there any increase with a longer duration of use or in patients with a history of acute or chronic pancreatitis.

Most previous observational studies of incretin-based drugs and pancreatitis had reported null findings, but four studies did find a positive association. Laurent Azoulay, PhD, from the Lady Davis Institute at Montreal’s Jewish General Hospital, and his coauthors suggested this heterogeneity was likely the result of methodologic shortcomings such as the use of inappropriate comparator groups and confoundings.

“Although it remains possible that these drugs may be associated with acute pancreatitis, the upper limit of our 95% [confidence interval] suggests that this risk is likely to be small,” the authors wrote. “Thus, the findings of this study should provide some reassurance to patients treated with incretin-based drugs.”

Meanwhile, a second population-based cohort study in 71,368 patients starting an antidiabetic drug found the use of GLP-1 analogues was associated with a significant 79% increase in the risk of bile duct and gallbladder disease, compared with the use of at least two other oral antidiabetic medications.

When stratified by duration of use, individuals taking GLP-1 analogues for less than 180 days showed a twofold increase in the risk of bile duct and gallbladder disease (adjusted hazard ratio, 2.01; 95% CI, 1.23-3.29) but those taking the drugs for longer than 180 days did not show an increased risk.

The use of GLP-1 analogues was also associated with a two-fold increase in the risk of undergoing a cholecystectomy.

However, the study found no increased risk of bile duct or gallbladder disease with DPP-4 inhibitors (JAMA Intern Med. 2016 Aug 1. doi: 10.1001/jamainternmed.2016.1531).

Jean-Luc Faillie, MD, PhD, of the University of Montpellier (France) and his associates suggested that rapid weight loss associated with GLP-1 analogues may explain the association with bile duct and gallbladder disease, which would also account for the observation that the association did not occur in patients taking the drugs for a longer period of time.

“Weight loss leads to supersaturation of cholesterol in the bile, a known risk factor for gallstones,” the authors wrote.

DPP-4 inhibitors have different effects on the GLP-1 pharmacologic factors and a weaker incretin action, which the authors suggested may explain the lack of association with bile duct and gallbladder disease, as well as their lower incidence of gastrointestinal adverse events.

“Although further studies are needed to confirm our findings and the mechanisms involved, physicians prescribing GLP-1 analogues should be aware of this association and carefully monitor patients for biliary tract complications.”

The first study was enabled by data-sharing agreements with the Canadian Network for Observational Drug Effect Studies, which is funded by the Canadian Institutes of Health Research. Two authors declared consulting fees, grant support, or financial compensation from the pharmaceutical industry, but there were no other conflicts of interest declared.

The second study was funded by the Canadian Institutes of Health Research. No conflicts of interest were declared.

At least two incretin-based drugs – glucagon-like peptide 1 agonists and dipeptidyl peptidase 4 inhibitors – do not appear to increase the risk of acute pancreatitis in individuals with diabetes but are associated with an increased risk of bile duct and gallbladder disease.

Two studies examining the impact on the pancreas of incretin-based drugs, including dipeptidyl peptidase 4 (DPP-4) inhibitors and glucagon-like peptide 1 (GLP-1) agonists, have been published online August 1 in JAMA Internal Medicine.

Incretin-based drugs have been associated with increased risk of elevated pancreatic enzyme levels, while GLP-1 has been shown to increase the proliferation and activity of cholangiocytes, which have raised concerns of an impact on the bile duct, gallbladder, and pancreas.

The first study was an international, population-based cohort study using the health records of more than 1.5 million individuals with type 2 diabetes, who began treatment with antidiabetic drugs between January 2007 and June 2013.

Analysis of these data showed there was no difference in the risk of hospitalization for acute pancreatitis between those taking incretin-based drugs and those on two or more other oral antidiabetic medications (JAMA Intern Med. 2016 Aug 1. doi: 10.1001/jamainternmed.2016.1522).

The study also found no significant increase in the risk of acute pancreatitis either with DPP-4 inhibitors or GLP-1 agonists, nor was there any increase with a longer duration of use or in patients with a history of acute or chronic pancreatitis.

Most previous observational studies of incretin-based drugs and pancreatitis had reported null findings, but four studies did find a positive association. Laurent Azoulay, PhD, from the Lady Davis Institute at Montreal’s Jewish General Hospital, and his coauthors suggested this heterogeneity was likely the result of methodologic shortcomings such as the use of inappropriate comparator groups and confoundings.

“Although it remains possible that these drugs may be associated with acute pancreatitis, the upper limit of our 95% [confidence interval] suggests that this risk is likely to be small,” the authors wrote. “Thus, the findings of this study should provide some reassurance to patients treated with incretin-based drugs.”

Meanwhile, a second population-based cohort study in 71,368 patients starting an antidiabetic drug found the use of GLP-1 analogues was associated with a significant 79% increase in the risk of bile duct and gallbladder disease, compared with the use of at least two other oral antidiabetic medications.

When stratified by duration of use, individuals taking GLP-1 analogues for less than 180 days showed a twofold increase in the risk of bile duct and gallbladder disease (adjusted hazard ratio, 2.01; 95% CI, 1.23-3.29) but those taking the drugs for longer than 180 days did not show an increased risk.

The use of GLP-1 analogues was also associated with a two-fold increase in the risk of undergoing a cholecystectomy.

However, the study found no increased risk of bile duct or gallbladder disease with DPP-4 inhibitors (JAMA Intern Med. 2016 Aug 1. doi: 10.1001/jamainternmed.2016.1531).

Jean-Luc Faillie, MD, PhD, of the University of Montpellier (France) and his associates suggested that rapid weight loss associated with GLP-1 analogues may explain the association with bile duct and gallbladder disease, which would also account for the observation that the association did not occur in patients taking the drugs for a longer period of time.

“Weight loss leads to supersaturation of cholesterol in the bile, a known risk factor for gallstones,” the authors wrote.

DPP-4 inhibitors have different effects on the GLP-1 pharmacologic factors and a weaker incretin action, which the authors suggested may explain the lack of association with bile duct and gallbladder disease, as well as their lower incidence of gastrointestinal adverse events.

“Although further studies are needed to confirm our findings and the mechanisms involved, physicians prescribing GLP-1 analogues should be aware of this association and carefully monitor patients for biliary tract complications.”

The first study was enabled by data-sharing agreements with the Canadian Network for Observational Drug Effect Studies, which is funded by the Canadian Institutes of Health Research. Two authors declared consulting fees, grant support, or financial compensation from the pharmaceutical industry, but there were no other conflicts of interest declared.

The second study was funded by the Canadian Institutes of Health Research. No conflicts of interest were declared.

At least two incretin-based drugs – glucagon-like peptide 1 agonists and dipeptidyl peptidase 4 inhibitors – do not appear to increase the risk of acute pancreatitis in individuals with diabetes but are associated with an increased risk of bile duct and gallbladder disease.

Two studies examining the impact on the pancreas of incretin-based drugs, including dipeptidyl peptidase 4 (DPP-4) inhibitors and glucagon-like peptide 1 (GLP-1) agonists, have been published online August 1 in JAMA Internal Medicine.

Incretin-based drugs have been associated with increased risk of elevated pancreatic enzyme levels, while GLP-1 has been shown to increase the proliferation and activity of cholangiocytes, which have raised concerns of an impact on the bile duct, gallbladder, and pancreas.

The first study was an international, population-based cohort study using the health records of more than 1.5 million individuals with type 2 diabetes, who began treatment with antidiabetic drugs between January 2007 and June 2013.

Analysis of these data showed there was no difference in the risk of hospitalization for acute pancreatitis between those taking incretin-based drugs and those on two or more other oral antidiabetic medications (JAMA Intern Med. 2016 Aug 1. doi: 10.1001/jamainternmed.2016.1522).

The study also found no significant increase in the risk of acute pancreatitis either with DPP-4 inhibitors or GLP-1 agonists, nor was there any increase with a longer duration of use or in patients with a history of acute or chronic pancreatitis.

Most previous observational studies of incretin-based drugs and pancreatitis had reported null findings, but four studies did find a positive association. Laurent Azoulay, PhD, from the Lady Davis Institute at Montreal’s Jewish General Hospital, and his coauthors suggested this heterogeneity was likely the result of methodologic shortcomings such as the use of inappropriate comparator groups and confoundings.

“Although it remains possible that these drugs may be associated with acute pancreatitis, the upper limit of our 95% [confidence interval] suggests that this risk is likely to be small,” the authors wrote. “Thus, the findings of this study should provide some reassurance to patients treated with incretin-based drugs.”

Meanwhile, a second population-based cohort study in 71,368 patients starting an antidiabetic drug found the use of GLP-1 analogues was associated with a significant 79% increase in the risk of bile duct and gallbladder disease, compared with the use of at least two other oral antidiabetic medications.

When stratified by duration of use, individuals taking GLP-1 analogues for less than 180 days showed a twofold increase in the risk of bile duct and gallbladder disease (adjusted hazard ratio, 2.01; 95% CI, 1.23-3.29) but those taking the drugs for longer than 180 days did not show an increased risk.

The use of GLP-1 analogues was also associated with a two-fold increase in the risk of undergoing a cholecystectomy.

However, the study found no increased risk of bile duct or gallbladder disease with DPP-4 inhibitors (JAMA Intern Med. 2016 Aug 1. doi: 10.1001/jamainternmed.2016.1531).

Jean-Luc Faillie, MD, PhD, of the University of Montpellier (France) and his associates suggested that rapid weight loss associated with GLP-1 analogues may explain the association with bile duct and gallbladder disease, which would also account for the observation that the association did not occur in patients taking the drugs for a longer period of time.

“Weight loss leads to supersaturation of cholesterol in the bile, a known risk factor for gallstones,” the authors wrote.

DPP-4 inhibitors have different effects on the GLP-1 pharmacologic factors and a weaker incretin action, which the authors suggested may explain the lack of association with bile duct and gallbladder disease, as well as their lower incidence of gastrointestinal adverse events.

“Although further studies are needed to confirm our findings and the mechanisms involved, physicians prescribing GLP-1 analogues should be aware of this association and carefully monitor patients for biliary tract complications.”

The first study was enabled by data-sharing agreements with the Canadian Network for Observational Drug Effect Studies, which is funded by the Canadian Institutes of Health Research. Two authors declared consulting fees, grant support, or financial compensation from the pharmaceutical industry, but there were no other conflicts of interest declared.

The second study was funded by the Canadian Institutes of Health Research. No conflicts of interest were declared.

Rates of hepatitis C virus detection increased in U.S. women aged 15-44 years and in children less than 2 years old from 2011 to 2014, according to investigators from the Centers for Disease Control and Prevention.

A report published July 21 in Morbidity and Mortality Weekly Report revealed hepatitis C virus (HCV) detection rates (detection via antibody or RNA positivity) that were determined using data collected from Quest Diagnostics for Kentucky and for the United States. In Kentucky, the rate of HCV detection in women aged 15-44 increased 213% over the study period, from 275 to 862 cases per 100,000 people, and for the entire U.S., the rate of detection increased by 22% from 139 to 169 cases per 100,000 people (65[28]:705-10).

The rate of HCV testing for children under 2 years old in Kentucky increased 151% over the study period, rising from 403 to 1,011 per 100,000 people, and the rate of children born to HCV-positive mothers increased from 0.71% to 1.59%. Nationwide, the HCV testing rate for children under 2 years old increased 14% from 310 to 353 per 100,000, and the rate of children born to HCV-positive mothers increased from 0.19% to 0.32%.

“These findings underscore the importance of providing primary prevention services and following current recommendations to identify persons at risk for HCV infection and test accordingly; doing so among pregnant women would improve early identification of HCV-infected infants and linkage of the mother and infant to care and treatment,” the CDC investigators said.

lfranki@frontlinemedcom.com

Rates of hepatitis C virus detection increased in U.S. women aged 15-44 years and in children less than 2 years old from 2011 to 2014, according to investigators from the Centers for Disease Control and Prevention.

A report published July 21 in Morbidity and Mortality Weekly Report revealed hepatitis C virus (HCV) detection rates (detection via antibody or RNA positivity) that were determined using data collected from Quest Diagnostics for Kentucky and for the United States. In Kentucky, the rate of HCV detection in women aged 15-44 increased 213% over the study period, from 275 to 862 cases per 100,000 people, and for the entire U.S., the rate of detection increased by 22% from 139 to 169 cases per 100,000 people (65[28]:705-10).

The rate of HCV testing for children under 2 years old in Kentucky increased 151% over the study period, rising from 403 to 1,011 per 100,000 people, and the rate of children born to HCV-positive mothers increased from 0.71% to 1.59%. Nationwide, the HCV testing rate for children under 2 years old increased 14% from 310 to 353 per 100,000, and the rate of children born to HCV-positive mothers increased from 0.19% to 0.32%.

“These findings underscore the importance of providing primary prevention services and following current recommendations to identify persons at risk for HCV infection and test accordingly; doing so among pregnant women would improve early identification of HCV-infected infants and linkage of the mother and infant to care and treatment,” the CDC investigators said.

lfranki@frontlinemedcom.com

Rates of hepatitis C virus detection increased in U.S. women aged 15-44 years and in children less than 2 years old from 2011 to 2014, according to investigators from the Centers for Disease Control and Prevention.

A report published July 21 in Morbidity and Mortality Weekly Report revealed hepatitis C virus (HCV) detection rates (detection via antibody or RNA positivity) that were determined using data collected from Quest Diagnostics for Kentucky and for the United States. In Kentucky, the rate of HCV detection in women aged 15-44 increased 213% over the study period, from 275 to 862 cases per 100,000 people, and for the entire U.S., the rate of detection increased by 22% from 139 to 169 cases per 100,000 people (65[28]:705-10).

The rate of HCV testing for children under 2 years old in Kentucky increased 151% over the study period, rising from 403 to 1,011 per 100,000 people, and the rate of children born to HCV-positive mothers increased from 0.71% to 1.59%. Nationwide, the HCV testing rate for children under 2 years old increased 14% from 310 to 353 per 100,000, and the rate of children born to HCV-positive mothers increased from 0.19% to 0.32%.

“These findings underscore the importance of providing primary prevention services and following current recommendations to identify persons at risk for HCV infection and test accordingly; doing so among pregnant women would improve early identification of HCV-infected infants and linkage of the mother and infant to care and treatment,” the CDC investigators said.

lfranki@frontlinemedcom.com

Although the disease burden of most other prevalent communicable diseases has gone down considerably over the last 25 years, viral hepatitis continues to be a challenge for health care professionals around the world, as incidences of the disease have climbed steadily between 1990 and 2013.

Advances in treating hepatitis A, B, C, and E viruses over the last 25 years have helped to “overcome many barriers to the control and treatment of viral hepatitis in low-income countries and are set to be important components of a new global health strategy,” wrote the study investigators, led by Jeffrey D. Stanaway, MD, of the University of Washington, Seattle. “However, a better understanding of the burden of disease is required to guide these efforts.”

©vchal/Thinkstock

Dr. Stanaway and his coauthors looked at the Global Burden of Disease (GBD) study for data on worldwide morbidity and mortality associated with hepatitis A, B, C, and E viruses, as well as cirrhosis and liver cancer secondary to hepatitis B or C virus. Data collected for the GBD was used to determine disability-adjusted life-years (DALYs), which is a metric calculated by adding up years of life lost (YLL) and years lived with disability (YLD), both of which were also measured by the GBD.

Data showed that worldwide deaths related to viral hepatitis numbered 0.89 million in 1990 (95% uncertainty interval [UI]: 0.86-0.94), but jumped up dramatically to 1.45 million in 2013 (95% UI: 1.38-1.54). Over the same time period, YLLs and YLDs also increased, going from 31.0 million (95% UI: 29.6-32.6) and 0.65 million (95% UI: 0.45-0.89), respectively, in 1990, to 41.6 million (95% UI: 39.1-44.7), and 0.87 million (95% UI: 0.61-1.18), respectively, in 2013. Consequently, DALYs increased from 31.7 million in 1990 (95% UI: 30.2-33.3) to 42.5 million (95% UI: 39.9-45.6).

These figures represent a 34% increase in viral hepatitis disease burden over that period of time. Furthermore, viral hepatitis went from being the 10th leading cause of death in the world in 1990 (95% UI: 10-12) to the seventh leading cause in 2013 (95% UI: 7-8). However, analysis without the data’s demographic trends showed that YLL and YLD rates declined by 20% and 13%, respectively (95% UI: 8-30 and 8-18), while DALY rates dropped by 20% (95% UI: 8-30) with no significant trend detected in age-specific mortality rates, indicating that demographic changes such as population growth may be the biggest factor contributing to viral hepatitis’ growing disease burden.

“HAV is the only hepatitis virus for which DALYs have declined significantly between 1990 and 2013. Some of this decline has been driven by changing population age structures, but most is due to declines in age-specific rates, most likely as a result of vaccination and improvements in water supply and sanitation,” the authors noted.

Dr. Stanaway and his coauthors also urged public health institutions around the world to devote more funding to targeting viral hepatitis, noting that the current state of funding is “disproportionate to [viral hepatitis’] importance as a major cause of death and disability.”

The Bill & Melinda Gates Foundation funded the study. Coauthor Graham S. Cooke, MD, reported being an investigator on trials of hepatitis C virus therapy sponsored by Boehringer Ingelheim, Gilead, Merck, and Bristol-Myers Squibb, and has acted in an advisory role to Merck, Boehringer Ingelheim, Gilead, Janssen, and WHO in relation to viral hepatitis and clinical trials unrelated to this work. Dr. Stanaway and other coauthors did not report any relevant financial disclosures.

dchitnis@frontlinemedcom.com

Although the disease burden of most other prevalent communicable diseases has gone down considerably over the last 25 years, viral hepatitis continues to be a challenge for health care professionals around the world, as incidences of the disease have climbed steadily between 1990 and 2013.

Advances in treating hepatitis A, B, C, and E viruses over the last 25 years have helped to “overcome many barriers to the control and treatment of viral hepatitis in low-income countries and are set to be important components of a new global health strategy,” wrote the study investigators, led by Jeffrey D. Stanaway, MD, of the University of Washington, Seattle. “However, a better understanding of the burden of disease is required to guide these efforts.”

©vchal/Thinkstock

Dr. Stanaway and his coauthors looked at the Global Burden of Disease (GBD) study for data on worldwide morbidity and mortality associated with hepatitis A, B, C, and E viruses, as well as cirrhosis and liver cancer secondary to hepatitis B or C virus. Data collected for the GBD was used to determine disability-adjusted life-years (DALYs), which is a metric calculated by adding up years of life lost (YLL) and years lived with disability (YLD), both of which were also measured by the GBD.

Data showed that worldwide deaths related to viral hepatitis numbered 0.89 million in 1990 (95% uncertainty interval [UI]: 0.86-0.94), but jumped up dramatically to 1.45 million in 2013 (95% UI: 1.38-1.54). Over the same time period, YLLs and YLDs also increased, going from 31.0 million (95% UI: 29.6-32.6) and 0.65 million (95% UI: 0.45-0.89), respectively, in 1990, to 41.6 million (95% UI: 39.1-44.7), and 0.87 million (95% UI: 0.61-1.18), respectively, in 2013. Consequently, DALYs increased from 31.7 million in 1990 (95% UI: 30.2-33.3) to 42.5 million (95% UI: 39.9-45.6).

These figures represent a 34% increase in viral hepatitis disease burden over that period of time. Furthermore, viral hepatitis went from being the 10th leading cause of death in the world in 1990 (95% UI: 10-12) to the seventh leading cause in 2013 (95% UI: 7-8). However, analysis without the data’s demographic trends showed that YLL and YLD rates declined by 20% and 13%, respectively (95% UI: 8-30 and 8-18), while DALY rates dropped by 20% (95% UI: 8-30) with no significant trend detected in age-specific mortality rates, indicating that demographic changes such as population growth may be the biggest factor contributing to viral hepatitis’ growing disease burden.

“HAV is the only hepatitis virus for which DALYs have declined significantly between 1990 and 2013. Some of this decline has been driven by changing population age structures, but most is due to declines in age-specific rates, most likely as a result of vaccination and improvements in water supply and sanitation,” the authors noted.

Dr. Stanaway and his coauthors also urged public health institutions around the world to devote more funding to targeting viral hepatitis, noting that the current state of funding is “disproportionate to [viral hepatitis’] importance as a major cause of death and disability.”

The Bill & Melinda Gates Foundation funded the study. Coauthor Graham S. Cooke, MD, reported being an investigator on trials of hepatitis C virus therapy sponsored by Boehringer Ingelheim, Gilead, Merck, and Bristol-Myers Squibb, and has acted in an advisory role to Merck, Boehringer Ingelheim, Gilead, Janssen, and WHO in relation to viral hepatitis and clinical trials unrelated to this work. Dr. Stanaway and other coauthors did not report any relevant financial disclosures.

dchitnis@frontlinemedcom.com

Although the disease burden of most other prevalent communicable diseases has gone down considerably over the last 25 years, viral hepatitis continues to be a challenge for health care professionals around the world, as incidences of the disease have climbed steadily between 1990 and 2013.

Advances in treating hepatitis A, B, C, and E viruses over the last 25 years have helped to “overcome many barriers to the control and treatment of viral hepatitis in low-income countries and are set to be important components of a new global health strategy,” wrote the study investigators, led by Jeffrey D. Stanaway, MD, of the University of Washington, Seattle. “However, a better understanding of the burden of disease is required to guide these efforts.”

©vchal/Thinkstock

Dr. Stanaway and his coauthors looked at the Global Burden of Disease (GBD) study for data on worldwide morbidity and mortality associated with hepatitis A, B, C, and E viruses, as well as cirrhosis and liver cancer secondary to hepatitis B or C virus. Data collected for the GBD was used to determine disability-adjusted life-years (DALYs), which is a metric calculated by adding up years of life lost (YLL) and years lived with disability (YLD), both of which were also measured by the GBD.

Data showed that worldwide deaths related to viral hepatitis numbered 0.89 million in 1990 (95% uncertainty interval [UI]: 0.86-0.94), but jumped up dramatically to 1.45 million in 2013 (95% UI: 1.38-1.54). Over the same time period, YLLs and YLDs also increased, going from 31.0 million (95% UI: 29.6-32.6) and 0.65 million (95% UI: 0.45-0.89), respectively, in 1990, to 41.6 million (95% UI: 39.1-44.7), and 0.87 million (95% UI: 0.61-1.18), respectively, in 2013. Consequently, DALYs increased from 31.7 million in 1990 (95% UI: 30.2-33.3) to 42.5 million (95% UI: 39.9-45.6).

These figures represent a 34% increase in viral hepatitis disease burden over that period of time. Furthermore, viral hepatitis went from being the 10th leading cause of death in the world in 1990 (95% UI: 10-12) to the seventh leading cause in 2013 (95% UI: 7-8). However, analysis without the data’s demographic trends showed that YLL and YLD rates declined by 20% and 13%, respectively (95% UI: 8-30 and 8-18), while DALY rates dropped by 20% (95% UI: 8-30) with no significant trend detected in age-specific mortality rates, indicating that demographic changes such as population growth may be the biggest factor contributing to viral hepatitis’ growing disease burden.

“HAV is the only hepatitis virus for which DALYs have declined significantly between 1990 and 2013. Some of this decline has been driven by changing population age structures, but most is due to declines in age-specific rates, most likely as a result of vaccination and improvements in water supply and sanitation,” the authors noted.

Dr. Stanaway and his coauthors also urged public health institutions around the world to devote more funding to targeting viral hepatitis, noting that the current state of funding is “disproportionate to [viral hepatitis’] importance as a major cause of death and disability.”

The Bill & Melinda Gates Foundation funded the study. Coauthor Graham S. Cooke, MD, reported being an investigator on trials of hepatitis C virus therapy sponsored by Boehringer Ingelheim, Gilead, Merck, and Bristol-Myers Squibb, and has acted in an advisory role to Merck, Boehringer Ingelheim, Gilead, Janssen, and WHO in relation to viral hepatitis and clinical trials unrelated to this work. Dr. Stanaway and other coauthors did not report any relevant financial disclosures.

dchitnis@frontlinemedcom.com

Patients with HIV infection should be screened routinely for chronic liver disease if their alanine aminotransferase (ALT) levels are elevated, according to a study published in AIDS Care.

“In HIV-positive individuals, liver disease (mostly due to hepatitis B and C virus [HBV and HCV]) is the third most common cause of mortality after AIDS-related illness and non-AIDS nonviral malignancy,” wrote Sumita Verma, MD, of Brighton and Sussex (U.K.) University Hospital, and her coauthors. “Our aim therefore was to assess prevalence, aetiology, and predictors of nonviral-related chronic liver disease (CLD) in a cohort with HIV monoinfection.”

Brighton and Sussex Medical School

Investigators recruited 3,872 HIV-positive subjects from a Southeast England teaching hospital between 2005 and 2012, of whom 1,654 (42.7%) were found to be at least two ALT levels above the upper limit of normal. Clinically significant CLD was classified as having at least F2 fibrosis (metavir scoring) on liver biopsy, having a liver stiffness measurement greater than F2 (metavir) on a transient elastography, moderate to severe hepatic steatosis on a liver biopsy, a portal hypertension that was either cirrhotic or noncirrhotic, hepatic decompensation, a liver-related mortality, or any combination of these factors. (AIDS Care. 2016 Ju 5. doi: 10.1080/09540121.2016.1191603)

Of the 1,654 subjects with HIV and elevated ALT levels, 1,047 (27.0%) had elevated ALT levels when tested again after 6 months, with 243 of those (23.2%) having a further radiologic or histologic examination done. The final cohort comprised 222 subjects, of which CLD was found in 147 (66.2%), while only 75 (33.8%) had no CLD despite having elevated ALT and HIV. CLD was determined to be “clinically significant” in one out of every four subjects who had it.

“Potential risk factors for CLD included alcohol use (44.2%), one or more feature of the [metabolic syndrome] (68%) and [antiretroviral] use (74.1%), with 68.7% having [more than one] risk factor [and] serum triglyceride (odds ratio, 1.482; 95% confidence interval. 1.053-2.086; P = .024) was the only independent predictor of CLD,” the investigators noted.

Furthermore, the study shows that “the most striking observation [is] that only 23% with persistently elevated ALT were investigated further, with only 58/1,047 (5.5%) undergoing objective assessment of hepatic fibrosis and 45/1,047 (4.3%) being referred to Hepatology.”

Dr. Verma and her coauthors did not report any relevant financial disclosures.

dchitnis@frontlinemedcom.com

Patients with HIV infection should be screened routinely for chronic liver disease if their alanine aminotransferase (ALT) levels are elevated, according to a study published in AIDS Care.

“In HIV-positive individuals, liver disease (mostly due to hepatitis B and C virus [HBV and HCV]) is the third most common cause of mortality after AIDS-related illness and non-AIDS nonviral malignancy,” wrote Sumita Verma, MD, of Brighton and Sussex (U.K.) University Hospital, and her coauthors. “Our aim therefore was to assess prevalence, aetiology, and predictors of nonviral-related chronic liver disease (CLD) in a cohort with HIV monoinfection.”

Brighton and Sussex Medical School

Investigators recruited 3,872 HIV-positive subjects from a Southeast England teaching hospital between 2005 and 2012, of whom 1,654 (42.7%) were found to be at least two ALT levels above the upper limit of normal. Clinically significant CLD was classified as having at least F2 fibrosis (metavir scoring) on liver biopsy, having a liver stiffness measurement greater than F2 (metavir) on a transient elastography, moderate to severe hepatic steatosis on a liver biopsy, a portal hypertension that was either cirrhotic or noncirrhotic, hepatic decompensation, a liver-related mortality, or any combination of these factors. (AIDS Care. 2016 Ju 5. doi: 10.1080/09540121.2016.1191603)

Of the 1,654 subjects with HIV and elevated ALT levels, 1,047 (27.0%) had elevated ALT levels when tested again after 6 months, with 243 of those (23.2%) having a further radiologic or histologic examination done. The final cohort comprised 222 subjects, of which CLD was found in 147 (66.2%), while only 75 (33.8%) had no CLD despite having elevated ALT and HIV. CLD was determined to be “clinically significant” in one out of every four subjects who had it.

“Potential risk factors for CLD included alcohol use (44.2%), one or more feature of the [metabolic syndrome] (68%) and [antiretroviral] use (74.1%), with 68.7% having [more than one] risk factor [and] serum triglyceride (odds ratio, 1.482; 95% confidence interval. 1.053-2.086; P = .024) was the only independent predictor of CLD,” the investigators noted.

Furthermore, the study shows that “the most striking observation [is] that only 23% with persistently elevated ALT were investigated further, with only 58/1,047 (5.5%) undergoing objective assessment of hepatic fibrosis and 45/1,047 (4.3%) being referred to Hepatology.”

Dr. Verma and her coauthors did not report any relevant financial disclosures.

dchitnis@frontlinemedcom.com

Patients with HIV infection should be screened routinely for chronic liver disease if their alanine aminotransferase (ALT) levels are elevated, according to a study published in AIDS Care.

“In HIV-positive individuals, liver disease (mostly due to hepatitis B and C virus [HBV and HCV]) is the third most common cause of mortality after AIDS-related illness and non-AIDS nonviral malignancy,” wrote Sumita Verma, MD, of Brighton and Sussex (U.K.) University Hospital, and her coauthors. “Our aim therefore was to assess prevalence, aetiology, and predictors of nonviral-related chronic liver disease (CLD) in a cohort with HIV monoinfection.”

Brighton and Sussex Medical School

Investigators recruited 3,872 HIV-positive subjects from a Southeast England teaching hospital between 2005 and 2012, of whom 1,654 (42.7%) were found to be at least two ALT levels above the upper limit of normal. Clinically significant CLD was classified as having at least F2 fibrosis (metavir scoring) on liver biopsy, having a liver stiffness measurement greater than F2 (metavir) on a transient elastography, moderate to severe hepatic steatosis on a liver biopsy, a portal hypertension that was either cirrhotic or noncirrhotic, hepatic decompensation, a liver-related mortality, or any combination of these factors. (AIDS Care. 2016 Ju 5. doi: 10.1080/09540121.2016.1191603)

Of the 1,654 subjects with HIV and elevated ALT levels, 1,047 (27.0%) had elevated ALT levels when tested again after 6 months, with 243 of those (23.2%) having a further radiologic or histologic examination done. The final cohort comprised 222 subjects, of which CLD was found in 147 (66.2%), while only 75 (33.8%) had no CLD despite having elevated ALT and HIV. CLD was determined to be “clinically significant” in one out of every four subjects who had it.

“Potential risk factors for CLD included alcohol use (44.2%), one or more feature of the [metabolic syndrome] (68%) and [antiretroviral] use (74.1%), with 68.7% having [more than one] risk factor [and] serum triglyceride (odds ratio, 1.482; 95% confidence interval. 1.053-2.086; P = .024) was the only independent predictor of CLD,” the investigators noted.

Furthermore, the study shows that “the most striking observation [is] that only 23% with persistently elevated ALT were investigated further, with only 58/1,047 (5.5%) undergoing objective assessment of hepatic fibrosis and 45/1,047 (4.3%) being referred to Hepatology.”

Dr. Verma and her coauthors did not report any relevant financial disclosures.

dchitnis@frontlinemedcom.com

Adults with irritable bowel syndrome (IBS) who underwent psychotherapy improved more than about 75% of controls, and the effect “remained significant and medium in magnitude” for at least 6-12 months, according to a meta-analysis of 41 randomized, controlled trials reported in the July issue of Clinical Gastroenterology and Hepatology.

The finding “is particularly noteworthy because of the typically recurrent, persistent nature of IBS symptoms,” said Kelsey Laird, a doctoral student of clinical psychology at Vanderbilt University in Nashville, Tenn., together with her associates there. “Future research is needed to compare the longevity of treatment effects for psychotherapy with pharmacologic therapies, such as antidepressants,” they added. “Although it is beyond the scope of this review, it is also important to consider the mechanisms by which psychotherapies improve GI symptoms and to determine the ‘active ingredients’ responsible for this effect.”

©MacXever/Thinkstock

Up to 16% of individuals in the United States have IBS, and treating it costs anywhere from $950 million to $1.35 billion per year, the researchers noted. Other meta-analyses found psychotherapy about as effective as antidepressants for treating IBS-related GI symptoms over the short term, but its long-term efficacy was unknown, they added. Therefore, they searched PubMed, PsycINFO, Science Direct, and ProQuest through Aug. 15, 2015, identifying randomized controlled trials of psychological therapy and active or nonactive comparators. Psychotherapy included not only traditional psychodynamic and cognitive-behavioral therapies, but also mind-body approaches, such as relaxation training, biofeedback, and yoga, “which can be conceptualized as mindful movement,” Ms. Laird and her associates said. Comparators included support groups, education, sham treatments for hypnosis or biofeedback, online discussion forums, enhanced medical care, treatment as usual, symptom monitoring, and being wait-listed for psychological treatment (Clin Gastroenterol Hepatol. 2016 Jan 21. doi: 10.1016/j.cgh.2015.11.020). The 41 trials included 2,290 patients, comprising 1,183 assigned to the psychological modalities and 1,107 assigned to the various comparators. Taken together, the psychological modalities were associated with greater improvements in GI symptoms immediately after treatment, as compared with the grouped comparators. The Cohen’s d value was 0.69 (95% confidence interval, 0.52-0.86; P less than .001), indicating a medium effect size, the researchers said. Moreover, Cohen’s d values were 0.76 and 0.73, respectively, at short-term follow-up (1-6 months) and long-term follow-up (6-12 months). “On average, individuals who received psychotherapy had a greater reduction in GI symptoms after treatment than 75% of individuals assigned to a control condition,” the researchers concluded.

Effect sizes were similar among cognitive, cognitive-behavioral, and relaxation and hypnosis interventions, and between interventions delivered online and in person, the investigators also reported. Furthermore, longer durations or sessions of psychotherapy did not appear to further improve symptoms.

Study limitations included substantial variability between trials, and the fact that none of the 41 trials could be seen as having a low risk of bias in every domain assessed, the investigators said. “This was partially a result of the difficulty in blinding participants in psychological trials,” they noted. “However, even after excluding this domain, only nine trials were rated as low risk of bias in all remaining domains. Future studies should follow the CONSORT guidelines for [randomized controlled trials], use [intention-to-treat] designs, use active control conditions to control for nonspecific treatment effects, and assess treatment credibility and expectancy.”

The authors reported no funding sources and had no disclosures.

Adults with irritable bowel syndrome (IBS) who underwent psychotherapy improved more than about 75% of controls, and the effect “remained significant and medium in magnitude” for at least 6-12 months, according to a meta-analysis of 41 randomized, controlled trials reported in the July issue of Clinical Gastroenterology and Hepatology.

The finding “is particularly noteworthy because of the typically recurrent, persistent nature of IBS symptoms,” said Kelsey Laird, a doctoral student of clinical psychology at Vanderbilt University in Nashville, Tenn., together with her associates there. “Future research is needed to compare the longevity of treatment effects for psychotherapy with pharmacologic therapies, such as antidepressants,” they added. “Although it is beyond the scope of this review, it is also important to consider the mechanisms by which psychotherapies improve GI symptoms and to determine the ‘active ingredients’ responsible for this effect.”

©MacXever/Thinkstock

Up to 16% of individuals in the United States have IBS, and treating it costs anywhere from $950 million to $1.35 billion per year, the researchers noted. Other meta-analyses found psychotherapy about as effective as antidepressants for treating IBS-related GI symptoms over the short term, but its long-term efficacy was unknown, they added. Therefore, they searched PubMed, PsycINFO, Science Direct, and ProQuest through Aug. 15, 2015, identifying randomized controlled trials of psychological therapy and active or nonactive comparators. Psychotherapy included not only traditional psychodynamic and cognitive-behavioral therapies, but also mind-body approaches, such as relaxation training, biofeedback, and yoga, “which can be conceptualized as mindful movement,” Ms. Laird and her associates said. Comparators included support groups, education, sham treatments for hypnosis or biofeedback, online discussion forums, enhanced medical care, treatment as usual, symptom monitoring, and being wait-listed for psychological treatment (Clin Gastroenterol Hepatol. 2016 Jan 21. doi: 10.1016/j.cgh.2015.11.020). The 41 trials included 2,290 patients, comprising 1,183 assigned to the psychological modalities and 1,107 assigned to the various comparators. Taken together, the psychological modalities were associated with greater improvements in GI symptoms immediately after treatment, as compared with the grouped comparators. The Cohen’s d value was 0.69 (95% confidence interval, 0.52-0.86; P less than .001), indicating a medium effect size, the researchers said. Moreover, Cohen’s d values were 0.76 and 0.73, respectively, at short-term follow-up (1-6 months) and long-term follow-up (6-12 months). “On average, individuals who received psychotherapy had a greater reduction in GI symptoms after treatment than 75% of individuals assigned to a control condition,” the researchers concluded.

Effect sizes were similar among cognitive, cognitive-behavioral, and relaxation and hypnosis interventions, and between interventions delivered online and in person, the investigators also reported. Furthermore, longer durations or sessions of psychotherapy did not appear to further improve symptoms.

Study limitations included substantial variability between trials, and the fact that none of the 41 trials could be seen as having a low risk of bias in every domain assessed, the investigators said. “This was partially a result of the difficulty in blinding participants in psychological trials,” they noted. “However, even after excluding this domain, only nine trials were rated as low risk of bias in all remaining domains. Future studies should follow the CONSORT guidelines for [randomized controlled trials], use [intention-to-treat] designs, use active control conditions to control for nonspecific treatment effects, and assess treatment credibility and expectancy.”

The authors reported no funding sources and had no disclosures.

Adults with irritable bowel syndrome (IBS) who underwent psychotherapy improved more than about 75% of controls, and the effect “remained significant and medium in magnitude” for at least 6-12 months, according to a meta-analysis of 41 randomized, controlled trials reported in the July issue of Clinical Gastroenterology and Hepatology.

The finding “is particularly noteworthy because of the typically recurrent, persistent nature of IBS symptoms,” said Kelsey Laird, a doctoral student of clinical psychology at Vanderbilt University in Nashville, Tenn., together with her associates there. “Future research is needed to compare the longevity of treatment effects for psychotherapy with pharmacologic therapies, such as antidepressants,” they added. “Although it is beyond the scope of this review, it is also important to consider the mechanisms by which psychotherapies improve GI symptoms and to determine the ‘active ingredients’ responsible for this effect.”

©MacXever/Thinkstock

Up to 16% of individuals in the United States have IBS, and treating it costs anywhere from $950 million to $1.35 billion per year, the researchers noted. Other meta-analyses found psychotherapy about as effective as antidepressants for treating IBS-related GI symptoms over the short term, but its long-term efficacy was unknown, they added. Therefore, they searched PubMed, PsycINFO, Science Direct, and ProQuest through Aug. 15, 2015, identifying randomized controlled trials of psychological therapy and active or nonactive comparators. Psychotherapy included not only traditional psychodynamic and cognitive-behavioral therapies, but also mind-body approaches, such as relaxation training, biofeedback, and yoga, “which can be conceptualized as mindful movement,” Ms. Laird and her associates said. Comparators included support groups, education, sham treatments for hypnosis or biofeedback, online discussion forums, enhanced medical care, treatment as usual, symptom monitoring, and being wait-listed for psychological treatment (Clin Gastroenterol Hepatol. 2016 Jan 21. doi: 10.1016/j.cgh.2015.11.020). The 41 trials included 2,290 patients, comprising 1,183 assigned to the psychological modalities and 1,107 assigned to the various comparators. Taken together, the psychological modalities were associated with greater improvements in GI symptoms immediately after treatment, as compared with the grouped comparators. The Cohen’s d value was 0.69 (95% confidence interval, 0.52-0.86; P less than .001), indicating a medium effect size, the researchers said. Moreover, Cohen’s d values were 0.76 and 0.73, respectively, at short-term follow-up (1-6 months) and long-term follow-up (6-12 months). “On average, individuals who received psychotherapy had a greater reduction in GI symptoms after treatment than 75% of individuals assigned to a control condition,” the researchers concluded.

Effect sizes were similar among cognitive, cognitive-behavioral, and relaxation and hypnosis interventions, and between interventions delivered online and in person, the investigators also reported. Furthermore, longer durations or sessions of psychotherapy did not appear to further improve symptoms.

Study limitations included substantial variability between trials, and the fact that none of the 41 trials could be seen as having a low risk of bias in every domain assessed, the investigators said. “This was partially a result of the difficulty in blinding participants in psychological trials,” they noted. “However, even after excluding this domain, only nine trials were rated as low risk of bias in all remaining domains. Future studies should follow the CONSORT guidelines for [randomized controlled trials], use [intention-to-treat] designs, use active control conditions to control for nonspecific treatment effects, and assess treatment credibility and expectancy.”

The authors reported no funding sources and had no disclosures.