Hepatitis

Among patients with adult congenital heart disease (ACHD), hepatitis C virus antibody positivity was significantly associated with a composite end point that comprised cardiac death, heart failure hospitalization, lethal ventricular arrhythmias, and cardiac reoperation, according to a report published online in the American Journal of Cardiology.

American Heart Association

The study retrospectively enrolled 243 ACHD patients (mean age 26 years) who underwent cardiac surgery before 1992 and visited a single hospital during 1995-2015. Clinical characteristics, including cardiac function and long-term prognosis, were compared between HCV antibody–positive (48) and –negative (195) patients, according to Ryo Konno, MD, of Tohoku University, Sendai, Japan, and his colleagues.

They found that the prevalence of reduced systemic ventricular ejection fraction less than 50% was significantly higher in the HCV antibody–positive group than in the HCV antibody–negative group (17 vs. 5.4%; P = .014), and that during a mean follow-up of 10 years the composite end point occurred in 51 patients.

Overall, Kaplan-Meier analysis showed the HCV antibody–positive group had significantly poorer event-free survival than the HCV antibody–negative group (P = .002). In addition, HCV antibody positivity was significantly associated with the composite end point in both univariable and multivariable Cox regression models (hazard ratio, 2.37; P = .005 and HR, 1.96; P = .032, respectively).

“These results indicate that screening for HCV should be performed in all ACHD patients with a history of heart surgery before 1992. Further, cardiac functions should be monitored more frequently to detect [stroke volume] dysfunction earlier in case of a positive result. These management strategies may have a beneficial impact on the long-term prognosis in this population,” Dr. Konno and his colleagues concluded.

The research was supported by the Japan Agency for Medical Research and the authors had no conflicts of interest to disclose.

[email protected]

SOURCE: Konno R. et al. Am J Card. 2018;122:1965-71.

Among patients with adult congenital heart disease (ACHD), hepatitis C virus antibody positivity was significantly associated with a composite end point that comprised cardiac death, heart failure hospitalization, lethal ventricular arrhythmias, and cardiac reoperation, according to a report published online in the American Journal of Cardiology.

American Heart Association

The study retrospectively enrolled 243 ACHD patients (mean age 26 years) who underwent cardiac surgery before 1992 and visited a single hospital during 1995-2015. Clinical characteristics, including cardiac function and long-term prognosis, were compared between HCV antibody–positive (48) and –negative (195) patients, according to Ryo Konno, MD, of Tohoku University, Sendai, Japan, and his colleagues.

They found that the prevalence of reduced systemic ventricular ejection fraction less than 50% was significantly higher in the HCV antibody–positive group than in the HCV antibody–negative group (17 vs. 5.4%; P = .014), and that during a mean follow-up of 10 years the composite end point occurred in 51 patients.

Overall, Kaplan-Meier analysis showed the HCV antibody–positive group had significantly poorer event-free survival than the HCV antibody–negative group (P = .002). In addition, HCV antibody positivity was significantly associated with the composite end point in both univariable and multivariable Cox regression models (hazard ratio, 2.37; P = .005 and HR, 1.96; P = .032, respectively).

“These results indicate that screening for HCV should be performed in all ACHD patients with a history of heart surgery before 1992. Further, cardiac functions should be monitored more frequently to detect [stroke volume] dysfunction earlier in case of a positive result. These management strategies may have a beneficial impact on the long-term prognosis in this population,” Dr. Konno and his colleagues concluded.

The research was supported by the Japan Agency for Medical Research and the authors had no conflicts of interest to disclose.

[email protected]

SOURCE: Konno R. et al. Am J Card. 2018;122:1965-71.

Among patients with adult congenital heart disease (ACHD), hepatitis C virus antibody positivity was significantly associated with a composite end point that comprised cardiac death, heart failure hospitalization, lethal ventricular arrhythmias, and cardiac reoperation, according to a report published online in the American Journal of Cardiology.

American Heart Association

The study retrospectively enrolled 243 ACHD patients (mean age 26 years) who underwent cardiac surgery before 1992 and visited a single hospital during 1995-2015. Clinical characteristics, including cardiac function and long-term prognosis, were compared between HCV antibody–positive (48) and –negative (195) patients, according to Ryo Konno, MD, of Tohoku University, Sendai, Japan, and his colleagues.

They found that the prevalence of reduced systemic ventricular ejection fraction less than 50% was significantly higher in the HCV antibody–positive group than in the HCV antibody–negative group (17 vs. 5.4%; P = .014), and that during a mean follow-up of 10 years the composite end point occurred in 51 patients.

Overall, Kaplan-Meier analysis showed the HCV antibody–positive group had significantly poorer event-free survival than the HCV antibody–negative group (P = .002). In addition, HCV antibody positivity was significantly associated with the composite end point in both univariable and multivariable Cox regression models (hazard ratio, 2.37; P = .005 and HR, 1.96; P = .032, respectively).

“These results indicate that screening for HCV should be performed in all ACHD patients with a history of heart surgery before 1992. Further, cardiac functions should be monitored more frequently to detect [stroke volume] dysfunction earlier in case of a positive result. These management strategies may have a beneficial impact on the long-term prognosis in this population,” Dr. Konno and his colleagues concluded.

The research was supported by the Japan Agency for Medical Research and the authors had no conflicts of interest to disclose.

[email protected]

SOURCE: Konno R. et al. Am J Card. 2018;122:1965-71.

SAN FRANCISCO – People who inject drugs, including those with ongoing injection drug use and challenging demographic characteristics, have high rates of hepatitis C virus treatment completion and cure, preliminary results from an ongoing study showed.

“Both from a public health and a human rights perspective, hepatitis C elimination in people who inject drugs is critical,” study coauthor Elana Rosenthal, MD, said during a press briefing at the annual meeting of the American Association for the Study of Liver Diseases. “People who inject drugs are the main progenitors of ongoing transmission of hepatitis C. However, they are often denied access to hepatitis C treatment due to concerns about their ability to take medication consistently and achieve cure. This is especially true amongst patients with challenging demographic factors, frequent drug use, and those not on treatment for opioid use disorder. However, there are limited data on hepatitis C adherence in people who inject drugs outside of vigorous clinical trial settings.”

In an effort to understand whether a marginalized population with ongoing injection drug use could adhere to HCV treatment, and how this adherence would impact cure, Dr. Rosenthal and her associates enrolled 100 subjects in ANCHOR, a single-center study evaluating HCV treatment in patients who have chronic HCV, opioid use disorder, and ongoing injection drug use. “We did not preferentially enroll patients who we thought we would be most likely to cure, and we did not exclude patients who seemed unlikely to adhere to treatment,” said Dr. Rosenthal, codirector of the DC Partnership for HIV/AIDS Progress hepatitis clinical research program at the University of Maryland, Baltimore. “All patients were treated with sofosbuvir/velpatasvir, with a plan to complete 12 weeks of treatment.” Medication was dispensed monthly in bottles containing 28 pills, and patients were seen for monthly visits, mirroring standard clinical care for HCV. The researchers monitored patients for medication adherence through pill counts and evaluated them for hepatitis C cure 12 weeks after treatment.

The median age of the 100 patients was 57 years, 76% were black, 33% had cirrhosis, 51% were unstably housed, 92% had a history of incarceration, and 92% had no income source or relied exclusively on government benefits. “The patients represent an incredibly marginalized population,” she said. At baseline, 58% reported daily or more frequent injection drug use, 33% reported medication-assisted treatment, 29% shared injection drug use equipment within the past 3 months, and 40% met criteria for hazardous drinking based on the Alcohol Use Disorders Identification Test (AUDIT-C).

Of the 100 patients, 59 received 12 weeks of treatment. Of these 59 patients, 28 finished 1-7 days after the anticipated end date, 9 finished between 8 and 14 days late, and 9 patients finished more than 14 days late.

Of the 58 patients who attended an office visit at week 24 of their treatment, 52 (90%) achieved a sustained virologic response. This cure rate was associated with having an HCV viral load less than 200 IU/mL at week 4, and with taking 12 weeks of treatment. Nonsustained virologic response was driven by virologic failure, loss to follow-up, and death.

When the researchers compared subjects who achieved sustained virologic response with those who did not, baseline demographics including frequent drug use, unstable housing status, and not being on medication to treat opioid use disorder were not associated with decreased cure rates. “While we found high rates of treatment completion in this population, because of external factors such as incarceration, hospitalization, and having medications stolen, 13 patients had interruptions in treatment,” Dr. Rosenthal said. “Further, while 21 patients had near-perfect medication adherence, 46 patients took longer than 12 weeks to complete the full treatment course due to intermittent missed doses. However, as long as patients completed the prescribed amount, imperfect adherence was not associated with decreased cure rates.”

Based on ANCHOR’s preliminary results, Dr. Rosenthal concluded that concerns about HCV treatment adherence such as baseline housing status, drug use frequency, and being on medication for opioid use disorder “are not likely to influence treatment outcome of HCV and should not be used to justify exclusion from treatment in this population. The ANCHOR investigation adds to the growing body of literature supporting expansion of HCV treatment to all patients, including people who inject drugs. Treatment of people who inject drugs is a critical factor in HCV elimination and, most importantly, reducing morbidity and mortality in this population.”

Dr. Rosenthal disclosed that she has received grant/research support from Gilead Sciences and from Merck.

[email protected]

Source: Rosenthal E et al. Hepatol. 2018;68[S1], Abstract 18.

SAN FRANCISCO – People who inject drugs, including those with ongoing injection drug use and challenging demographic characteristics, have high rates of hepatitis C virus treatment completion and cure, preliminary results from an ongoing study showed.

“Both from a public health and a human rights perspective, hepatitis C elimination in people who inject drugs is critical,” study coauthor Elana Rosenthal, MD, said during a press briefing at the annual meeting of the American Association for the Study of Liver Diseases. “People who inject drugs are the main progenitors of ongoing transmission of hepatitis C. However, they are often denied access to hepatitis C treatment due to concerns about their ability to take medication consistently and achieve cure. This is especially true amongst patients with challenging demographic factors, frequent drug use, and those not on treatment for opioid use disorder. However, there are limited data on hepatitis C adherence in people who inject drugs outside of vigorous clinical trial settings.”

In an effort to understand whether a marginalized population with ongoing injection drug use could adhere to HCV treatment, and how this adherence would impact cure, Dr. Rosenthal and her associates enrolled 100 subjects in ANCHOR, a single-center study evaluating HCV treatment in patients who have chronic HCV, opioid use disorder, and ongoing injection drug use. “We did not preferentially enroll patients who we thought we would be most likely to cure, and we did not exclude patients who seemed unlikely to adhere to treatment,” said Dr. Rosenthal, codirector of the DC Partnership for HIV/AIDS Progress hepatitis clinical research program at the University of Maryland, Baltimore. “All patients were treated with sofosbuvir/velpatasvir, with a plan to complete 12 weeks of treatment.” Medication was dispensed monthly in bottles containing 28 pills, and patients were seen for monthly visits, mirroring standard clinical care for HCV. The researchers monitored patients for medication adherence through pill counts and evaluated them for hepatitis C cure 12 weeks after treatment.

The median age of the 100 patients was 57 years, 76% were black, 33% had cirrhosis, 51% were unstably housed, 92% had a history of incarceration, and 92% had no income source or relied exclusively on government benefits. “The patients represent an incredibly marginalized population,” she said. At baseline, 58% reported daily or more frequent injection drug use, 33% reported medication-assisted treatment, 29% shared injection drug use equipment within the past 3 months, and 40% met criteria for hazardous drinking based on the Alcohol Use Disorders Identification Test (AUDIT-C).

Of the 100 patients, 59 received 12 weeks of treatment. Of these 59 patients, 28 finished 1-7 days after the anticipated end date, 9 finished between 8 and 14 days late, and 9 patients finished more than 14 days late.

Of the 58 patients who attended an office visit at week 24 of their treatment, 52 (90%) achieved a sustained virologic response. This cure rate was associated with having an HCV viral load less than 200 IU/mL at week 4, and with taking 12 weeks of treatment. Nonsustained virologic response was driven by virologic failure, loss to follow-up, and death.

When the researchers compared subjects who achieved sustained virologic response with those who did not, baseline demographics including frequent drug use, unstable housing status, and not being on medication to treat opioid use disorder were not associated with decreased cure rates. “While we found high rates of treatment completion in this population, because of external factors such as incarceration, hospitalization, and having medications stolen, 13 patients had interruptions in treatment,” Dr. Rosenthal said. “Further, while 21 patients had near-perfect medication adherence, 46 patients took longer than 12 weeks to complete the full treatment course due to intermittent missed doses. However, as long as patients completed the prescribed amount, imperfect adherence was not associated with decreased cure rates.”

Based on ANCHOR’s preliminary results, Dr. Rosenthal concluded that concerns about HCV treatment adherence such as baseline housing status, drug use frequency, and being on medication for opioid use disorder “are not likely to influence treatment outcome of HCV and should not be used to justify exclusion from treatment in this population. The ANCHOR investigation adds to the growing body of literature supporting expansion of HCV treatment to all patients, including people who inject drugs. Treatment of people who inject drugs is a critical factor in HCV elimination and, most importantly, reducing morbidity and mortality in this population.”

Dr. Rosenthal disclosed that she has received grant/research support from Gilead Sciences and from Merck.

[email protected]

Source: Rosenthal E et al. Hepatol. 2018;68[S1], Abstract 18.

SAN FRANCISCO – People who inject drugs, including those with ongoing injection drug use and challenging demographic characteristics, have high rates of hepatitis C virus treatment completion and cure, preliminary results from an ongoing study showed.

“Both from a public health and a human rights perspective, hepatitis C elimination in people who inject drugs is critical,” study coauthor Elana Rosenthal, MD, said during a press briefing at the annual meeting of the American Association for the Study of Liver Diseases. “People who inject drugs are the main progenitors of ongoing transmission of hepatitis C. However, they are often denied access to hepatitis C treatment due to concerns about their ability to take medication consistently and achieve cure. This is especially true amongst patients with challenging demographic factors, frequent drug use, and those not on treatment for opioid use disorder. However, there are limited data on hepatitis C adherence in people who inject drugs outside of vigorous clinical trial settings.”

In an effort to understand whether a marginalized population with ongoing injection drug use could adhere to HCV treatment, and how this adherence would impact cure, Dr. Rosenthal and her associates enrolled 100 subjects in ANCHOR, a single-center study evaluating HCV treatment in patients who have chronic HCV, opioid use disorder, and ongoing injection drug use. “We did not preferentially enroll patients who we thought we would be most likely to cure, and we did not exclude patients who seemed unlikely to adhere to treatment,” said Dr. Rosenthal, codirector of the DC Partnership for HIV/AIDS Progress hepatitis clinical research program at the University of Maryland, Baltimore. “All patients were treated with sofosbuvir/velpatasvir, with a plan to complete 12 weeks of treatment.” Medication was dispensed monthly in bottles containing 28 pills, and patients were seen for monthly visits, mirroring standard clinical care for HCV. The researchers monitored patients for medication adherence through pill counts and evaluated them for hepatitis C cure 12 weeks after treatment.

The median age of the 100 patients was 57 years, 76% were black, 33% had cirrhosis, 51% were unstably housed, 92% had a history of incarceration, and 92% had no income source or relied exclusively on government benefits. “The patients represent an incredibly marginalized population,” she said. At baseline, 58% reported daily or more frequent injection drug use, 33% reported medication-assisted treatment, 29% shared injection drug use equipment within the past 3 months, and 40% met criteria for hazardous drinking based on the Alcohol Use Disorders Identification Test (AUDIT-C).

Of the 100 patients, 59 received 12 weeks of treatment. Of these 59 patients, 28 finished 1-7 days after the anticipated end date, 9 finished between 8 and 14 days late, and 9 patients finished more than 14 days late.

Of the 58 patients who attended an office visit at week 24 of their treatment, 52 (90%) achieved a sustained virologic response. This cure rate was associated with having an HCV viral load less than 200 IU/mL at week 4, and with taking 12 weeks of treatment. Nonsustained virologic response was driven by virologic failure, loss to follow-up, and death.

When the researchers compared subjects who achieved sustained virologic response with those who did not, baseline demographics including frequent drug use, unstable housing status, and not being on medication to treat opioid use disorder were not associated with decreased cure rates. “While we found high rates of treatment completion in this population, because of external factors such as incarceration, hospitalization, and having medications stolen, 13 patients had interruptions in treatment,” Dr. Rosenthal said. “Further, while 21 patients had near-perfect medication adherence, 46 patients took longer than 12 weeks to complete the full treatment course due to intermittent missed doses. However, as long as patients completed the prescribed amount, imperfect adherence was not associated with decreased cure rates.”

Based on ANCHOR’s preliminary results, Dr. Rosenthal concluded that concerns about HCV treatment adherence such as baseline housing status, drug use frequency, and being on medication for opioid use disorder “are not likely to influence treatment outcome of HCV and should not be used to justify exclusion from treatment in this population. The ANCHOR investigation adds to the growing body of literature supporting expansion of HCV treatment to all patients, including people who inject drugs. Treatment of people who inject drugs is a critical factor in HCV elimination and, most importantly, reducing morbidity and mortality in this population.”

Dr. Rosenthal disclosed that she has received grant/research support from Gilead Sciences and from Merck.

[email protected]

Source: Rosenthal E et al. Hepatol. 2018;68[S1], Abstract 18.

SAN FRANCISCO – Chronic liver disease (CLD) is independently associated with an increased risk of falls and fall injuries, results from a large study of nationally representative data showed.

Doug Brunk/MDedge News

“We have previously known that having cirrhosis, for example, is associated with the risk of falling, but we didn’t have any data from a nationally representative sample,” lead study author Maria Camila Pérez-Matos, MD, said in an interview at the annual meeting of the American Association for the Study of Liver Diseases. “What surprised us is that just by having chronic liver disease – any subtype – you’re more likely to fall, and also to have a fracture after you have fallen.”

In an effort to define the association between CLD and fall history and its related injuries, Dr. Pérez-Matos of the division of gastroenterology and hepatology at Beth Israel Deaconess Medical Center, Boston, and her associates examined data from 5,363 subjects aged 60 years and older in the Third National Health and Nutrition Examination Survey, which represents the noninstitutionalized civilian population in the United States. Their outcomes of interest were one or more falls occurring in the previous 12 months and fall-related injuries. The main exposure was definitive CLD, defined by chronic viral hepatitis (hepatitis C RNA or hepatitis B surface antigen), nonalcoholic steatohepatitis (NASH; hepatosteatosis by ultrasound with abnormal transaminases), and alcohol-related liver disease (females consuming more than 7 drinks/week and males consuming 14 drinks/week among, plus having abnormal transaminases). Suspected CLD was defined as having abnormal alanine aminotransferase levels (males greater than 30 IU/L, females greater than 19 IU/L), aspartate aminotransferase levels above 33 IU/L, or alkaline phosphatase levels above 100 IU/L. The researchers used univariate and multivariate logistic regression to examine associations.

The average age of subjects was 70 years, and 59% were female. Of the 5,363 subjects, 340 had definitive CLD. Of these, 234 (69%) had NASH, 85 (25%) had viral hepatitis, and 21 (6%) had alcoholic liver disease. Subjects with definitive CLD were more likely to be female and have diabetes mellitus, a higher body mass index, and physical/functional impairment. Dr. Pérez-Matos and her colleagues found that definitive CLD was associated with a 52% increase in the odds of having a history of falls (odds ratio, 1.52; P = .01). The association remained significant after controlling for age, sex, smoking, race, physical or functional impairment, impaired vision, polypharmacy, and body mass index. The degree of excess falling risk posed by CLD was similar to that of having impaired vision (OR, 1.48; P less than .001).

Of the CLD subtypes, subjects with viral hepatitis had the strongest association with a history of falls (OR, 2.2; P = .001). In addition, definitive CLD was found to have significant association with any physical impairment, even after adjusting for relevant covariates (OR, 1.63; P = .001).

Finally, multivariate logistic regression revealed that both suspected and definitive CLD were associated with injurious falls (OR, 1.40 and OR of 1.67, respectively). “Everyone is interested in preventing falls because of its public health impact, and predictors of falls are relatively limited,” said Elliott B. Tapper, MD, the study’s principal investigator, who is with the division of gastroenterology and hepatology at the University of Michigan, Ann Arbor. “Because chronic liver disease is increasingly common, our data is speaking to a hitherto unknown risk factor: one which if you apply it to other data sets might help figure out why more people are falling. The lesson is, there’s something about chronic liver disease; it’s a sign. If it’s fatty liver disease, it’s a sign that diabetes has taken its toll on the body – its nerves and muscles. There’s something about what’s going on in that person that’s worse than it is for other people. We don’t know cause or effect, but the association is strong and deserves further study, particularly when it comes to determining [which patients] in our clinics are at higher risk and making sure they’re doing physical therapy to prevent falls in the future.”

Dr. Tapper disclosed that she has a career development award from the National Institutes of Health. Dr. Pérez-Matos reported having no monetary conflicts.

[email protected]

Source: Hepatol. 2018;68[S1], Abstract 756.

SAN FRANCISCO – Chronic liver disease (CLD) is independently associated with an increased risk of falls and fall injuries, results from a large study of nationally representative data showed.

Doug Brunk/MDedge News

“We have previously known that having cirrhosis, for example, is associated with the risk of falling, but we didn’t have any data from a nationally representative sample,” lead study author Maria Camila Pérez-Matos, MD, said in an interview at the annual meeting of the American Association for the Study of Liver Diseases. “What surprised us is that just by having chronic liver disease – any subtype – you’re more likely to fall, and also to have a fracture after you have fallen.”

In an effort to define the association between CLD and fall history and its related injuries, Dr. Pérez-Matos of the division of gastroenterology and hepatology at Beth Israel Deaconess Medical Center, Boston, and her associates examined data from 5,363 subjects aged 60 years and older in the Third National Health and Nutrition Examination Survey, which represents the noninstitutionalized civilian population in the United States. Their outcomes of interest were one or more falls occurring in the previous 12 months and fall-related injuries. The main exposure was definitive CLD, defined by chronic viral hepatitis (hepatitis C RNA or hepatitis B surface antigen), nonalcoholic steatohepatitis (NASH; hepatosteatosis by ultrasound with abnormal transaminases), and alcohol-related liver disease (females consuming more than 7 drinks/week and males consuming 14 drinks/week among, plus having abnormal transaminases). Suspected CLD was defined as having abnormal alanine aminotransferase levels (males greater than 30 IU/L, females greater than 19 IU/L), aspartate aminotransferase levels above 33 IU/L, or alkaline phosphatase levels above 100 IU/L. The researchers used univariate and multivariate logistic regression to examine associations.

The average age of subjects was 70 years, and 59% were female. Of the 5,363 subjects, 340 had definitive CLD. Of these, 234 (69%) had NASH, 85 (25%) had viral hepatitis, and 21 (6%) had alcoholic liver disease. Subjects with definitive CLD were more likely to be female and have diabetes mellitus, a higher body mass index, and physical/functional impairment. Dr. Pérez-Matos and her colleagues found that definitive CLD was associated with a 52% increase in the odds of having a history of falls (odds ratio, 1.52; P = .01). The association remained significant after controlling for age, sex, smoking, race, physical or functional impairment, impaired vision, polypharmacy, and body mass index. The degree of excess falling risk posed by CLD was similar to that of having impaired vision (OR, 1.48; P less than .001).

Of the CLD subtypes, subjects with viral hepatitis had the strongest association with a history of falls (OR, 2.2; P = .001). In addition, definitive CLD was found to have significant association with any physical impairment, even after adjusting for relevant covariates (OR, 1.63; P = .001).

Finally, multivariate logistic regression revealed that both suspected and definitive CLD were associated with injurious falls (OR, 1.40 and OR of 1.67, respectively). “Everyone is interested in preventing falls because of its public health impact, and predictors of falls are relatively limited,” said Elliott B. Tapper, MD, the study’s principal investigator, who is with the division of gastroenterology and hepatology at the University of Michigan, Ann Arbor. “Because chronic liver disease is increasingly common, our data is speaking to a hitherto unknown risk factor: one which if you apply it to other data sets might help figure out why more people are falling. The lesson is, there’s something about chronic liver disease; it’s a sign. If it’s fatty liver disease, it’s a sign that diabetes has taken its toll on the body – its nerves and muscles. There’s something about what’s going on in that person that’s worse than it is for other people. We don’t know cause or effect, but the association is strong and deserves further study, particularly when it comes to determining [which patients] in our clinics are at higher risk and making sure they’re doing physical therapy to prevent falls in the future.”

Dr. Tapper disclosed that she has a career development award from the National Institutes of Health. Dr. Pérez-Matos reported having no monetary conflicts.

[email protected]

Source: Hepatol. 2018;68[S1], Abstract 756.

SAN FRANCISCO – Chronic liver disease (CLD) is independently associated with an increased risk of falls and fall injuries, results from a large study of nationally representative data showed.

Doug Brunk/MDedge News

“We have previously known that having cirrhosis, for example, is associated with the risk of falling, but we didn’t have any data from a nationally representative sample,” lead study author Maria Camila Pérez-Matos, MD, said in an interview at the annual meeting of the American Association for the Study of Liver Diseases. “What surprised us is that just by having chronic liver disease – any subtype – you’re more likely to fall, and also to have a fracture after you have fallen.”

In an effort to define the association between CLD and fall history and its related injuries, Dr. Pérez-Matos of the division of gastroenterology and hepatology at Beth Israel Deaconess Medical Center, Boston, and her associates examined data from 5,363 subjects aged 60 years and older in the Third National Health and Nutrition Examination Survey, which represents the noninstitutionalized civilian population in the United States. Their outcomes of interest were one or more falls occurring in the previous 12 months and fall-related injuries. The main exposure was definitive CLD, defined by chronic viral hepatitis (hepatitis C RNA or hepatitis B surface antigen), nonalcoholic steatohepatitis (NASH; hepatosteatosis by ultrasound with abnormal transaminases), and alcohol-related liver disease (females consuming more than 7 drinks/week and males consuming 14 drinks/week among, plus having abnormal transaminases). Suspected CLD was defined as having abnormal alanine aminotransferase levels (males greater than 30 IU/L, females greater than 19 IU/L), aspartate aminotransferase levels above 33 IU/L, or alkaline phosphatase levels above 100 IU/L. The researchers used univariate and multivariate logistic regression to examine associations.

The average age of subjects was 70 years, and 59% were female. Of the 5,363 subjects, 340 had definitive CLD. Of these, 234 (69%) had NASH, 85 (25%) had viral hepatitis, and 21 (6%) had alcoholic liver disease. Subjects with definitive CLD were more likely to be female and have diabetes mellitus, a higher body mass index, and physical/functional impairment. Dr. Pérez-Matos and her colleagues found that definitive CLD was associated with a 52% increase in the odds of having a history of falls (odds ratio, 1.52; P = .01). The association remained significant after controlling for age, sex, smoking, race, physical or functional impairment, impaired vision, polypharmacy, and body mass index. The degree of excess falling risk posed by CLD was similar to that of having impaired vision (OR, 1.48; P less than .001).

Of the CLD subtypes, subjects with viral hepatitis had the strongest association with a history of falls (OR, 2.2; P = .001). In addition, definitive CLD was found to have significant association with any physical impairment, even after adjusting for relevant covariates (OR, 1.63; P = .001).

Finally, multivariate logistic regression revealed that both suspected and definitive CLD were associated with injurious falls (OR, 1.40 and OR of 1.67, respectively). “Everyone is interested in preventing falls because of its public health impact, and predictors of falls are relatively limited,” said Elliott B. Tapper, MD, the study’s principal investigator, who is with the division of gastroenterology and hepatology at the University of Michigan, Ann Arbor. “Because chronic liver disease is increasingly common, our data is speaking to a hitherto unknown risk factor: one which if you apply it to other data sets might help figure out why more people are falling. The lesson is, there’s something about chronic liver disease; it’s a sign. If it’s fatty liver disease, it’s a sign that diabetes has taken its toll on the body – its nerves and muscles. There’s something about what’s going on in that person that’s worse than it is for other people. We don’t know cause or effect, but the association is strong and deserves further study, particularly when it comes to determining [which patients] in our clinics are at higher risk and making sure they’re doing physical therapy to prevent falls in the future.”

Dr. Tapper disclosed that she has a career development award from the National Institutes of Health. Dr. Pérez-Matos reported having no monetary conflicts.

[email protected]

Source: Hepatol. 2018;68[S1], Abstract 756.

SAN FRANCISCO – Patients with chronic liver disease are prescribed opioids and benzodiazepines at very high rates, despite risk for adverse consequences because of hepatic metabolism, according to results from a large longitudinal study of national data.

“Middle-aged individuals and those with a background of substance abuse and mental health conditions appear to have highest rates of use and represent populations for which targeted interventions to curb use could be highest yield,” lead study author Monica Konerman, MD, said in an interview in advance of the annual meeting of the American Association for the Study of Liver Diseases.

In an effort to better understand the rates of prescription opioid and benzodiazepine use in chronic liver disease, Dr. Konerman, director of the Michigan Medicine NAFLD Clinic at the University of Michigan, Ann Arbor, and her colleagues drew from the Truven Health Analytics Marketscan databases from 2009 to 2015. They limited the analysis to individuals with drug coverage who had chronic hepatitis C (HCV) without cirrhosis, cirrhosis, congestive heart failure (CHF), or chronic obstructive pulmonary disease (COPD), and examined pharmacy files for outpatient prescriptions.

Dr. Konerman reported data from 210,191 patients with HCV, 79,332 with cirrhosis, 766,840 with CHF, and 1,438,798 with COPD. Their median age was 59 years, and 51% were female. In per person-years, the prevalence of prescription opioid use was 25% among patients with chronic HCV, 53% among patients with cirrhosis, 26% among those with CHF, and 24% among those with COPD. At the same time, in per person-years, the prevalence of benzodiazepine use was 12% among patients with chronic HCV, 21% among patients with cirrhosis, 12% among those with CHF, and 13% among those with COPD. Use of opioids was greatest in adults 40-59 years of age (P less than .001). High-dose opioid use, defined as 100 opioid morphine equivalents per day or greater, occurred in 23% of those with cirrhosis and in 22% of those with HCV.

“The significant increase in rates of use in chronic liver disease, compared to other chronic conditions was remarkable, particularly given that patients with liver disease are at higher risk for adverse consequences of use due to hepatic metabolism of these medications,” Dr. Konerman said.

She went on to acknowledge “inherent limitations to studies that are secondary database analyses that rely on diagnosis codes for categorization of disease with potential for both over and under classification. We also did not capture inpatient prescriptions,” she said.

Dr. Konerman reported having no financial disclosures.

[email protected]

SAN FRANCISCO – Patients with chronic liver disease are prescribed opioids and benzodiazepines at very high rates, despite risk for adverse consequences because of hepatic metabolism, according to results from a large longitudinal study of national data.

“Middle-aged individuals and those with a background of substance abuse and mental health conditions appear to have highest rates of use and represent populations for which targeted interventions to curb use could be highest yield,” lead study author Monica Konerman, MD, said in an interview in advance of the annual meeting of the American Association for the Study of Liver Diseases.

In an effort to better understand the rates of prescription opioid and benzodiazepine use in chronic liver disease, Dr. Konerman, director of the Michigan Medicine NAFLD Clinic at the University of Michigan, Ann Arbor, and her colleagues drew from the Truven Health Analytics Marketscan databases from 2009 to 2015. They limited the analysis to individuals with drug coverage who had chronic hepatitis C (HCV) without cirrhosis, cirrhosis, congestive heart failure (CHF), or chronic obstructive pulmonary disease (COPD), and examined pharmacy files for outpatient prescriptions.

Dr. Konerman reported data from 210,191 patients with HCV, 79,332 with cirrhosis, 766,840 with CHF, and 1,438,798 with COPD. Their median age was 59 years, and 51% were female. In per person-years, the prevalence of prescription opioid use was 25% among patients with chronic HCV, 53% among patients with cirrhosis, 26% among those with CHF, and 24% among those with COPD. At the same time, in per person-years, the prevalence of benzodiazepine use was 12% among patients with chronic HCV, 21% among patients with cirrhosis, 12% among those with CHF, and 13% among those with COPD. Use of opioids was greatest in adults 40-59 years of age (P less than .001). High-dose opioid use, defined as 100 opioid morphine equivalents per day or greater, occurred in 23% of those with cirrhosis and in 22% of those with HCV.

“The significant increase in rates of use in chronic liver disease, compared to other chronic conditions was remarkable, particularly given that patients with liver disease are at higher risk for adverse consequences of use due to hepatic metabolism of these medications,” Dr. Konerman said.

She went on to acknowledge “inherent limitations to studies that are secondary database analyses that rely on diagnosis codes for categorization of disease with potential for both over and under classification. We also did not capture inpatient prescriptions,” she said.

Dr. Konerman reported having no financial disclosures.

[email protected]

SAN FRANCISCO – Patients with chronic liver disease are prescribed opioids and benzodiazepines at very high rates, despite risk for adverse consequences because of hepatic metabolism, according to results from a large longitudinal study of national data.

“Middle-aged individuals and those with a background of substance abuse and mental health conditions appear to have highest rates of use and represent populations for which targeted interventions to curb use could be highest yield,” lead study author Monica Konerman, MD, said in an interview in advance of the annual meeting of the American Association for the Study of Liver Diseases.

In an effort to better understand the rates of prescription opioid and benzodiazepine use in chronic liver disease, Dr. Konerman, director of the Michigan Medicine NAFLD Clinic at the University of Michigan, Ann Arbor, and her colleagues drew from the Truven Health Analytics Marketscan databases from 2009 to 2015. They limited the analysis to individuals with drug coverage who had chronic hepatitis C (HCV) without cirrhosis, cirrhosis, congestive heart failure (CHF), or chronic obstructive pulmonary disease (COPD), and examined pharmacy files for outpatient prescriptions.

Dr. Konerman reported data from 210,191 patients with HCV, 79,332 with cirrhosis, 766,840 with CHF, and 1,438,798 with COPD. Their median age was 59 years, and 51% were female. In per person-years, the prevalence of prescription opioid use was 25% among patients with chronic HCV, 53% among patients with cirrhosis, 26% among those with CHF, and 24% among those with COPD. At the same time, in per person-years, the prevalence of benzodiazepine use was 12% among patients with chronic HCV, 21% among patients with cirrhosis, 12% among those with CHF, and 13% among those with COPD. Use of opioids was greatest in adults 40-59 years of age (P less than .001). High-dose opioid use, defined as 100 opioid morphine equivalents per day or greater, occurred in 23% of those with cirrhosis and in 22% of those with HCV.

“The significant increase in rates of use in chronic liver disease, compared to other chronic conditions was remarkable, particularly given that patients with liver disease are at higher risk for adverse consequences of use due to hepatic metabolism of these medications,” Dr. Konerman said.

She went on to acknowledge “inherent limitations to studies that are secondary database analyses that rely on diagnosis codes for categorization of disease with potential for both over and under classification. We also did not capture inpatient prescriptions,” she said.

Dr. Konerman reported having no financial disclosures.

[email protected]

SAN DIEGO – There’s good news and bad news about hepatitis C virus (HCV) in patients with chronic kidney disease (CKD): The new generation of drugs that cures HCV is effective in this population, but outbreaks of infection are still plaguing the nation’s dialysis clinics.

These perspectives came in a presentation about infections in CKD at Kidney Week 2018, sponsored by the American Society of Nephrology.

First, the good news about HCV. “Treatment is now feasible for all stages of chronic kidney disease,” said gastroenterologist Paul Martin, MD, of the University of Miami. “It was possible to achieve biological cure in 99% of patients, which is truly remarkable considering what a problem kidney patients were for hepatitis C until very recently.”

The key is to treat HCV with drug combinations that lower the risk of viral resistance. “These drugs are extremely well tolerated. They’re not like interferon or ribavirin,” he said, referring to a drug combo that was formerly used to treat HCV. “We can anticipate curing hepatitis C with a finite amount of therapy in virtually every patient we see, including those with kidney disease.”

In patients with CKD, all the new drugs are approved for glomerular filtration rates greater than 30 mL/min. Sofosbuvir (Sovaldi) is not approved for patients with a filtration rate under 30 mL/min, he said, but other options are available.

Ribavirin, he added, is no longer needed with current regimens.

Dr. Martin pointed to two studies that reveal the power of the new regimens against HCV in patients with CKD. One of the studies, a 2015 industry-funded report in the Lancet, found that “once-daily grazoprevir and elbasvir for 12 weeks had a low rate of adverse events and was effective in patients infected with HCV genotype 1 and stage 4-5 chronic kidney disease.” The other study, also funded by industry and published in 2017 in the New England Journal of Medicine, found that “treatment with glecaprevir and pibrentasvir for 12 weeks resulted in a high rate of sustained virologic response in patients with stage 4 or 5 chronic kidney disease and HCV infection.”

Meanwhile, there are signs that HCV treatment may boost survival in CKD patients on dialysis, Dr. Martin said.

In terms of bad news, Priti R. Patel, MD, MPH, a medical officer with the Centers for Disease Control and Prevention, warned that dialysis clinics are still seeing HCV outbreaks. “It’s a continuing problem,” she said. “What we hear about at the CDC is the tip of the iceberg.”

The CDC says it received word of 21 HCV outbreaks of two or more cases in dialysis clinics during 2008-2017. These affected 102 patients, and more than 3,000 patients were notified that they were at risk and should be screened.

One dialysis clinic in Philadelphia had 18 cases of HCV during 2008-2013; they were blamed on “multiple lapses in infection control ... including hand hygiene and glove use, vascular access care, medication preparation, cleaning, and disinfection.”

“There should be no more than one case that has to happen for a facility to detect that it has a problem and identify a solution,” Dr. Patel said.

Since acute HCV can appear without symptoms, every dialysis patients should be tested for HCV antibodies, she added. “If it’s positive, confirm it. If confirmed, they should be informed of their infection status and have an evaluation for treatment.”

Dr. Martin reported consulting for Bristol-Myers Squibb and AbbVie and receiving research funding from Gilead, Bristol-Myers Squibb, AbbVie, and Merck. Dr. Patel reported no disclosures.
 

SAN DIEGO – There’s good news and bad news about hepatitis C virus (HCV) in patients with chronic kidney disease (CKD): The new generation of drugs that cures HCV is effective in this population, but outbreaks of infection are still plaguing the nation’s dialysis clinics.

These perspectives came in a presentation about infections in CKD at Kidney Week 2018, sponsored by the American Society of Nephrology.

First, the good news about HCV. “Treatment is now feasible for all stages of chronic kidney disease,” said gastroenterologist Paul Martin, MD, of the University of Miami. “It was possible to achieve biological cure in 99% of patients, which is truly remarkable considering what a problem kidney patients were for hepatitis C until very recently.”

The key is to treat HCV with drug combinations that lower the risk of viral resistance. “These drugs are extremely well tolerated. They’re not like interferon or ribavirin,” he said, referring to a drug combo that was formerly used to treat HCV. “We can anticipate curing hepatitis C with a finite amount of therapy in virtually every patient we see, including those with kidney disease.”

In patients with CKD, all the new drugs are approved for glomerular filtration rates greater than 30 mL/min. Sofosbuvir (Sovaldi) is not approved for patients with a filtration rate under 30 mL/min, he said, but other options are available.

Ribavirin, he added, is no longer needed with current regimens.

Dr. Martin pointed to two studies that reveal the power of the new regimens against HCV in patients with CKD. One of the studies, a 2015 industry-funded report in the Lancet, found that “once-daily grazoprevir and elbasvir for 12 weeks had a low rate of adverse events and was effective in patients infected with HCV genotype 1 and stage 4-5 chronic kidney disease.” The other study, also funded by industry and published in 2017 in the New England Journal of Medicine, found that “treatment with glecaprevir and pibrentasvir for 12 weeks resulted in a high rate of sustained virologic response in patients with stage 4 or 5 chronic kidney disease and HCV infection.”

Meanwhile, there are signs that HCV treatment may boost survival in CKD patients on dialysis, Dr. Martin said.

In terms of bad news, Priti R. Patel, MD, MPH, a medical officer with the Centers for Disease Control and Prevention, warned that dialysis clinics are still seeing HCV outbreaks. “It’s a continuing problem,” she said. “What we hear about at the CDC is the tip of the iceberg.”

The CDC says it received word of 21 HCV outbreaks of two or more cases in dialysis clinics during 2008-2017. These affected 102 patients, and more than 3,000 patients were notified that they were at risk and should be screened.

One dialysis clinic in Philadelphia had 18 cases of HCV during 2008-2013; they were blamed on “multiple lapses in infection control ... including hand hygiene and glove use, vascular access care, medication preparation, cleaning, and disinfection.”

“There should be no more than one case that has to happen for a facility to detect that it has a problem and identify a solution,” Dr. Patel said.

Since acute HCV can appear without symptoms, every dialysis patients should be tested for HCV antibodies, she added. “If it’s positive, confirm it. If confirmed, they should be informed of their infection status and have an evaluation for treatment.”

Dr. Martin reported consulting for Bristol-Myers Squibb and AbbVie and receiving research funding from Gilead, Bristol-Myers Squibb, AbbVie, and Merck. Dr. Patel reported no disclosures.
 

SAN DIEGO – There’s good news and bad news about hepatitis C virus (HCV) in patients with chronic kidney disease (CKD): The new generation of drugs that cures HCV is effective in this population, but outbreaks of infection are still plaguing the nation’s dialysis clinics.

These perspectives came in a presentation about infections in CKD at Kidney Week 2018, sponsored by the American Society of Nephrology.

First, the good news about HCV. “Treatment is now feasible for all stages of chronic kidney disease,” said gastroenterologist Paul Martin, MD, of the University of Miami. “It was possible to achieve biological cure in 99% of patients, which is truly remarkable considering what a problem kidney patients were for hepatitis C until very recently.”

The key is to treat HCV with drug combinations that lower the risk of viral resistance. “These drugs are extremely well tolerated. They’re not like interferon or ribavirin,” he said, referring to a drug combo that was formerly used to treat HCV. “We can anticipate curing hepatitis C with a finite amount of therapy in virtually every patient we see, including those with kidney disease.”

In patients with CKD, all the new drugs are approved for glomerular filtration rates greater than 30 mL/min. Sofosbuvir (Sovaldi) is not approved for patients with a filtration rate under 30 mL/min, he said, but other options are available.

Ribavirin, he added, is no longer needed with current regimens.

Dr. Martin pointed to two studies that reveal the power of the new regimens against HCV in patients with CKD. One of the studies, a 2015 industry-funded report in the Lancet, found that “once-daily grazoprevir and elbasvir for 12 weeks had a low rate of adverse events and was effective in patients infected with HCV genotype 1 and stage 4-5 chronic kidney disease.” The other study, also funded by industry and published in 2017 in the New England Journal of Medicine, found that “treatment with glecaprevir and pibrentasvir for 12 weeks resulted in a high rate of sustained virologic response in patients with stage 4 or 5 chronic kidney disease and HCV infection.”

Meanwhile, there are signs that HCV treatment may boost survival in CKD patients on dialysis, Dr. Martin said.

In terms of bad news, Priti R. Patel, MD, MPH, a medical officer with the Centers for Disease Control and Prevention, warned that dialysis clinics are still seeing HCV outbreaks. “It’s a continuing problem,” she said. “What we hear about at the CDC is the tip of the iceberg.”

The CDC says it received word of 21 HCV outbreaks of two or more cases in dialysis clinics during 2008-2017. These affected 102 patients, and more than 3,000 patients were notified that they were at risk and should be screened.

One dialysis clinic in Philadelphia had 18 cases of HCV during 2008-2013; they were blamed on “multiple lapses in infection control ... including hand hygiene and glove use, vascular access care, medication preparation, cleaning, and disinfection.”

“There should be no more than one case that has to happen for a facility to detect that it has a problem and identify a solution,” Dr. Patel said.

Since acute HCV can appear without symptoms, every dialysis patients should be tested for HCV antibodies, she added. “If it’s positive, confirm it. If confirmed, they should be informed of their infection status and have an evaluation for treatment.”

Dr. Martin reported consulting for Bristol-Myers Squibb and AbbVie and receiving research funding from Gilead, Bristol-Myers Squibb, AbbVie, and Merck. Dr. Patel reported no disclosures.
 

SAN FRANCISCO – Chronic liver disease mortality continues to rise in the United States, driven largely by a spike in nonalcoholic fatty liver disease (NAFLD), according to results from an analysis of national data.

“I believe it’s all related to a big increase in obesity and type 2 diabetes in this country,” lead study author Zobair M. Younossi, MD, MPH, said in an interview in advance of the annual meeting of the American Association for the Study of Liver Diseases. “Those two risk factors drive NAFLD and its progressive type, nonalcoholic steatohepatitis (NASH). That accounts for at least part of the increase in mortality related to liver disease.”

In an effort to evaluate recent mortality trends in chronic liver disease in the United States, Dr. Younossi and his colleagues drew from National Vital Statistics Data during 2007-2016. They used ICD-10 codes to select mortality data for alcoholic liver disease, chronic hepatitis B and C, iron overload, NAFLD, cirrhosis, and hepatocellular carcinoma. NAFLD cases were defined as those having an ICD-10 code for NAFLD/NASH or an ICD-10 code for “cirrhosis of unknown etiology.” Next, the researchers adjusted age-standardized death rates to the 2000 U.S. Census population and used logistic regression and propensity scores to estimate predictors of chronic liver disease-related deaths.

Dr. Younossi, who chairs the department of medicine at Inova Fairfax Medical Campus, in Falls Church, Va., and his colleagues reported findings from 838,809 chronic liver disease–related deaths during the study period. They found that the age-standardized death rate for chronic liver disease increased from 21.9/100,000 population in 2007 to 24.9/100,000 population in 2016, which translated into an annual percentage change of 1.3% for males and 2.5% for females. Chronic liver disease–related deaths increased with age and were highest among those aged 55-64 years, followed by those aged 65-74 years – an average annual percentage change of 3.4% and 3.1% in each group.

Among chronic liver disease–related deaths, the most common diagnostic etiology was NAFLD (34.7%), followed by alcoholic liver disease (28.8%) and chronic hepatitis C (21.1%). Between 2007 and 2016, death rates increased from 7.6 to 9.0 per 100,000 population for NAFLD (an average annual percentage change of 2.1%) and from 6.1 to 7.9 per 100,000 population for alcoholic liver disease (an average annual percentage change of 3.1%). “What surprised me was that, despite highly effective treatment for HCV, we still have a burden of hepatitis C in this country,” Dr. Younossi said. “It’s still the most common cause of liver disease in the U.S. But it seems like hepatitis C–related liver disease is being replaced quickly by liver disease from nonalcoholic steatohepatitis. This transition between hepatitis C as the most important cause of liver disease and liver mortality to NASH or obesity-related NASH is becoming more rapid than I expected.”

On multivariate analysis, three factors were independently associated with an increased risk of death in NAFLD: the presence of type 2 diabetes (odds ratio, 1.78), cardiovascular disease (OR, 1.07), and renal failure (OR, 1.08).

“One important message from this study is that NASH is very common in the U.S. population,” said Dr. Younossi, who is also a professor of medicine at Virginia Commonwealth University, Richmond. “These patients are underrecognized and underdiagnosed because they are asymptomatic. The second message is that there is a subtype of patients with fatty liver disease – even a subtype of NASH – that can progress to cirrhosis and its complications. We have to pay attention to this silent disease to identify patients who are at risk for progressive liver disease and try to address some of the risk issues, such as tight control of diabetes, obesity, and control of hypertension and hyperlipidemia. Short of that, right now we have very few medical treatments such as vitamin E and pioglitazone recommended for a very selected group. In contrast, there are plenty of new medications that are being developed. The first step in tackling this disease is to identify who the patients are with fatty liver disease who are at risk for bad outcomes and make sure they’re linked to care by a knowledgeable caregiver [who] understands the importance of NASH.”

Dr. Younossi acknowledged certain limitations of the study, including the fact that liver disease diagnoses were based on ICD-10 coding. He disclosed that he is a consultant for Gilead, Intercept, Novo Nordisk, BMS, AbbVie, Viking, Term Quest Diagnostics, Echosens,and Shionogi. He has also received grant/research support from Gilead, Intercept, and BMS.

[email protected]

Source: Hepatol. 2018;68[S1], Abstract 763.

SAN FRANCISCO – Chronic liver disease mortality continues to rise in the United States, driven largely by a spike in nonalcoholic fatty liver disease (NAFLD), according to results from an analysis of national data.

“I believe it’s all related to a big increase in obesity and type 2 diabetes in this country,” lead study author Zobair M. Younossi, MD, MPH, said in an interview in advance of the annual meeting of the American Association for the Study of Liver Diseases. “Those two risk factors drive NAFLD and its progressive type, nonalcoholic steatohepatitis (NASH). That accounts for at least part of the increase in mortality related to liver disease.”

In an effort to evaluate recent mortality trends in chronic liver disease in the United States, Dr. Younossi and his colleagues drew from National Vital Statistics Data during 2007-2016. They used ICD-10 codes to select mortality data for alcoholic liver disease, chronic hepatitis B and C, iron overload, NAFLD, cirrhosis, and hepatocellular carcinoma. NAFLD cases were defined as those having an ICD-10 code for NAFLD/NASH or an ICD-10 code for “cirrhosis of unknown etiology.” Next, the researchers adjusted age-standardized death rates to the 2000 U.S. Census population and used logistic regression and propensity scores to estimate predictors of chronic liver disease-related deaths.

Dr. Younossi, who chairs the department of medicine at Inova Fairfax Medical Campus, in Falls Church, Va., and his colleagues reported findings from 838,809 chronic liver disease–related deaths during the study period. They found that the age-standardized death rate for chronic liver disease increased from 21.9/100,000 population in 2007 to 24.9/100,000 population in 2016, which translated into an annual percentage change of 1.3% for males and 2.5% for females. Chronic liver disease–related deaths increased with age and were highest among those aged 55-64 years, followed by those aged 65-74 years – an average annual percentage change of 3.4% and 3.1% in each group.

Among chronic liver disease–related deaths, the most common diagnostic etiology was NAFLD (34.7%), followed by alcoholic liver disease (28.8%) and chronic hepatitis C (21.1%). Between 2007 and 2016, death rates increased from 7.6 to 9.0 per 100,000 population for NAFLD (an average annual percentage change of 2.1%) and from 6.1 to 7.9 per 100,000 population for alcoholic liver disease (an average annual percentage change of 3.1%). “What surprised me was that, despite highly effective treatment for HCV, we still have a burden of hepatitis C in this country,” Dr. Younossi said. “It’s still the most common cause of liver disease in the U.S. But it seems like hepatitis C–related liver disease is being replaced quickly by liver disease from nonalcoholic steatohepatitis. This transition between hepatitis C as the most important cause of liver disease and liver mortality to NASH or obesity-related NASH is becoming more rapid than I expected.”

On multivariate analysis, three factors were independently associated with an increased risk of death in NAFLD: the presence of type 2 diabetes (odds ratio, 1.78), cardiovascular disease (OR, 1.07), and renal failure (OR, 1.08).

“One important message from this study is that NASH is very common in the U.S. population,” said Dr. Younossi, who is also a professor of medicine at Virginia Commonwealth University, Richmond. “These patients are underrecognized and underdiagnosed because they are asymptomatic. The second message is that there is a subtype of patients with fatty liver disease – even a subtype of NASH – that can progress to cirrhosis and its complications. We have to pay attention to this silent disease to identify patients who are at risk for progressive liver disease and try to address some of the risk issues, such as tight control of diabetes, obesity, and control of hypertension and hyperlipidemia. Short of that, right now we have very few medical treatments such as vitamin E and pioglitazone recommended for a very selected group. In contrast, there are plenty of new medications that are being developed. The first step in tackling this disease is to identify who the patients are with fatty liver disease who are at risk for bad outcomes and make sure they’re linked to care by a knowledgeable caregiver [who] understands the importance of NASH.”

Dr. Younossi acknowledged certain limitations of the study, including the fact that liver disease diagnoses were based on ICD-10 coding. He disclosed that he is a consultant for Gilead, Intercept, Novo Nordisk, BMS, AbbVie, Viking, Term Quest Diagnostics, Echosens,and Shionogi. He has also received grant/research support from Gilead, Intercept, and BMS.

[email protected]

Source: Hepatol. 2018;68[S1], Abstract 763.

SAN FRANCISCO – Chronic liver disease mortality continues to rise in the United States, driven largely by a spike in nonalcoholic fatty liver disease (NAFLD), according to results from an analysis of national data.

“I believe it’s all related to a big increase in obesity and type 2 diabetes in this country,” lead study author Zobair M. Younossi, MD, MPH, said in an interview in advance of the annual meeting of the American Association for the Study of Liver Diseases. “Those two risk factors drive NAFLD and its progressive type, nonalcoholic steatohepatitis (NASH). That accounts for at least part of the increase in mortality related to liver disease.”

In an effort to evaluate recent mortality trends in chronic liver disease in the United States, Dr. Younossi and his colleagues drew from National Vital Statistics Data during 2007-2016. They used ICD-10 codes to select mortality data for alcoholic liver disease, chronic hepatitis B and C, iron overload, NAFLD, cirrhosis, and hepatocellular carcinoma. NAFLD cases were defined as those having an ICD-10 code for NAFLD/NASH or an ICD-10 code for “cirrhosis of unknown etiology.” Next, the researchers adjusted age-standardized death rates to the 2000 U.S. Census population and used logistic regression and propensity scores to estimate predictors of chronic liver disease-related deaths.

Dr. Younossi, who chairs the department of medicine at Inova Fairfax Medical Campus, in Falls Church, Va., and his colleagues reported findings from 838,809 chronic liver disease–related deaths during the study period. They found that the age-standardized death rate for chronic liver disease increased from 21.9/100,000 population in 2007 to 24.9/100,000 population in 2016, which translated into an annual percentage change of 1.3% for males and 2.5% for females. Chronic liver disease–related deaths increased with age and were highest among those aged 55-64 years, followed by those aged 65-74 years – an average annual percentage change of 3.4% and 3.1% in each group.

Among chronic liver disease–related deaths, the most common diagnostic etiology was NAFLD (34.7%), followed by alcoholic liver disease (28.8%) and chronic hepatitis C (21.1%). Between 2007 and 2016, death rates increased from 7.6 to 9.0 per 100,000 population for NAFLD (an average annual percentage change of 2.1%) and from 6.1 to 7.9 per 100,000 population for alcoholic liver disease (an average annual percentage change of 3.1%). “What surprised me was that, despite highly effective treatment for HCV, we still have a burden of hepatitis C in this country,” Dr. Younossi said. “It’s still the most common cause of liver disease in the U.S. But it seems like hepatitis C–related liver disease is being replaced quickly by liver disease from nonalcoholic steatohepatitis. This transition between hepatitis C as the most important cause of liver disease and liver mortality to NASH or obesity-related NASH is becoming more rapid than I expected.”

On multivariate analysis, three factors were independently associated with an increased risk of death in NAFLD: the presence of type 2 diabetes (odds ratio, 1.78), cardiovascular disease (OR, 1.07), and renal failure (OR, 1.08).

“One important message from this study is that NASH is very common in the U.S. population,” said Dr. Younossi, who is also a professor of medicine at Virginia Commonwealth University, Richmond. “These patients are underrecognized and underdiagnosed because they are asymptomatic. The second message is that there is a subtype of patients with fatty liver disease – even a subtype of NASH – that can progress to cirrhosis and its complications. We have to pay attention to this silent disease to identify patients who are at risk for progressive liver disease and try to address some of the risk issues, such as tight control of diabetes, obesity, and control of hypertension and hyperlipidemia. Short of that, right now we have very few medical treatments such as vitamin E and pioglitazone recommended for a very selected group. In contrast, there are plenty of new medications that are being developed. The first step in tackling this disease is to identify who the patients are with fatty liver disease who are at risk for bad outcomes and make sure they’re linked to care by a knowledgeable caregiver [who] understands the importance of NASH.”

Dr. Younossi acknowledged certain limitations of the study, including the fact that liver disease diagnoses were based on ICD-10 coding. He disclosed that he is a consultant for Gilead, Intercept, Novo Nordisk, BMS, AbbVie, Viking, Term Quest Diagnostics, Echosens,and Shionogi. He has also received grant/research support from Gilead, Intercept, and BMS.

[email protected]

Source: Hepatol. 2018;68[S1], Abstract 763.

Currently, there is no effective hepatitis C virus (HCV) vaccine available despite numerous ongoing studies, according to the results of a review published in Gastroenterology.

copyright itsmejust/Thinkstock

In their article, Justin R. Bailey, MD, of Johns Hopkins University, Baltimore, and his colleagues reviewed the limited feasibility of applying traditional vaccine design to HCV and the problem of genetic diversity in the virus, as well as trials of vaccines designed to elicit T-cell responses.

One profound difficulty in the development and testing of an HCV vaccine is that the cohort most predictably at risk for high infection levels, people who inject drugs, are notoriously difficult to recruit, maintain consistent treatment, and follow up on – all necessary aspects of an appropriate vaccine trial.

Thus, at present, adjuvant envelope or core protein and virus-vectored nonstructural antigen vaccines have been tested only in healthy volunteers who are not at risk for HCV infection; viral vectors encoding nonstructural proteins remain the only vaccine strategy tested in truly at-risk individuals, according to Dr. Bailey and his colleagues.

“Although pharmaceutical companies invest in drug development, vaccine development requires investment from sources beyond government and charitable foundations. A prophylactic HCV vaccine is an important part of a successful strategy for global control. Although development is not easy, the quest is a worthy challenge,” Dr. Bailey and his colleagues concluded.

The authors reported having no conflicts.

[email protected]

SOURCE: Bailey JR et al. Gastroenterology. 2018 Sep 27. doi: 10.1053/j.gastro.2018.08.060.

Currently, there is no effective hepatitis C virus (HCV) vaccine available despite numerous ongoing studies, according to the results of a review published in Gastroenterology.

copyright itsmejust/Thinkstock

In their article, Justin R. Bailey, MD, of Johns Hopkins University, Baltimore, and his colleagues reviewed the limited feasibility of applying traditional vaccine design to HCV and the problem of genetic diversity in the virus, as well as trials of vaccines designed to elicit T-cell responses.

One profound difficulty in the development and testing of an HCV vaccine is that the cohort most predictably at risk for high infection levels, people who inject drugs, are notoriously difficult to recruit, maintain consistent treatment, and follow up on – all necessary aspects of an appropriate vaccine trial.

Thus, at present, adjuvant envelope or core protein and virus-vectored nonstructural antigen vaccines have been tested only in healthy volunteers who are not at risk for HCV infection; viral vectors encoding nonstructural proteins remain the only vaccine strategy tested in truly at-risk individuals, according to Dr. Bailey and his colleagues.

“Although pharmaceutical companies invest in drug development, vaccine development requires investment from sources beyond government and charitable foundations. A prophylactic HCV vaccine is an important part of a successful strategy for global control. Although development is not easy, the quest is a worthy challenge,” Dr. Bailey and his colleagues concluded.

The authors reported having no conflicts.

[email protected]

SOURCE: Bailey JR et al. Gastroenterology. 2018 Sep 27. doi: 10.1053/j.gastro.2018.08.060.

Currently, there is no effective hepatitis C virus (HCV) vaccine available despite numerous ongoing studies, according to the results of a review published in Gastroenterology.

copyright itsmejust/Thinkstock

In their article, Justin R. Bailey, MD, of Johns Hopkins University, Baltimore, and his colleagues reviewed the limited feasibility of applying traditional vaccine design to HCV and the problem of genetic diversity in the virus, as well as trials of vaccines designed to elicit T-cell responses.

One profound difficulty in the development and testing of an HCV vaccine is that the cohort most predictably at risk for high infection levels, people who inject drugs, are notoriously difficult to recruit, maintain consistent treatment, and follow up on – all necessary aspects of an appropriate vaccine trial.

Thus, at present, adjuvant envelope or core protein and virus-vectored nonstructural antigen vaccines have been tested only in healthy volunteers who are not at risk for HCV infection; viral vectors encoding nonstructural proteins remain the only vaccine strategy tested in truly at-risk individuals, according to Dr. Bailey and his colleagues.

“Although pharmaceutical companies invest in drug development, vaccine development requires investment from sources beyond government and charitable foundations. A prophylactic HCV vaccine is an important part of a successful strategy for global control. Although development is not easy, the quest is a worthy challenge,” Dr. Bailey and his colleagues concluded.

The authors reported having no conflicts.

[email protected]

SOURCE: Bailey JR et al. Gastroenterology. 2018 Sep 27. doi: 10.1053/j.gastro.2018.08.060.

The natural histories of hepatitis B virus (HBV) and hepatitis C virus (HCV) are very different in children, compared with their progress in adults, and depends on age at time of infection, mode of acquisition, ethnicity, and genotype, according to a review in a special pediatric issue of Clinics in Liver Disease.

Courtesy NIH

Most children infected perinatally or vertically continue to be asymptomatic but are at uniquely higher risk of developing chronic viral hepatitis and progressing to liver cirrhosis and hepatocellular carcinoma (HCC), according to Krupa R. Mysore, MD, and Daniel H. Leung, MD, both of the Baylor College of Medicine, Houston. In addition, because the risk of progression to cancer along with such other liver damage is high in children, the reviewers stated that HCV and HBV can be classified as oncoviruses.

Their article assessed overall epidemiology, viral characteristics, and immune responses, as well as prevention, clinical manifestations, and current advances in the treatment of hepatitis B and C in children.

Because of the introduction of universal infant vaccination for HBV in the United States in 1991, the incidence of acute hepatitis B in U.S. children (those aged less than 19 years) has decreased from approximately 13.80/100,000 population (in children aged 10-19 years) in the 1980s to 0.34/100,000 population in 2002, Dr. Mysore and Dr. Leung wrote.

However, they added that those children who have chronic HBV remain at high risk for HCC, with a 100-fold greater incidence, compared with the HBV-negative population.

Similarly, HCV is a significant problem in children, with an estimated prevalence in the United States of 0.2% and 0.4% for children aged 6-11 years and 12-19 years, respectively. Vertical transmission from the mother is responsible for more than 60% of pediatric HCV infection and adds approximately 7,200 new cases in the United States yearly. Older children can acquire the virus through intravenous and intranasal drug use and high-risk sexual activity, they stated.

“Our understanding of the pathobiology and immunology of hepatitis B and C is unprecedented. As new antiviral therapies are being developed for the pediatric population, the differences in management and monitoring between children and adults with HBV and HCV are beginning to narrow but are still important,” the authors wrote.

They pointed out that soon-to-be-available treatments for HCV will be curative in children aged as young as 3 years. “[T]his will change the natural history of HCV and the prevalence of hepatocellular carcinoma over the next several decades for the better,” Dr. Mysore and Dr. Leung concluded.

They reported that they had no conflicts of interest to disclose.

[email protected]

SOURCE: Mysore KR et al. Clin Liver Dis. 2018; 22:703-22.

The natural histories of hepatitis B virus (HBV) and hepatitis C virus (HCV) are very different in children, compared with their progress in adults, and depends on age at time of infection, mode of acquisition, ethnicity, and genotype, according to a review in a special pediatric issue of Clinics in Liver Disease.

Courtesy NIH

Most children infected perinatally or vertically continue to be asymptomatic but are at uniquely higher risk of developing chronic viral hepatitis and progressing to liver cirrhosis and hepatocellular carcinoma (HCC), according to Krupa R. Mysore, MD, and Daniel H. Leung, MD, both of the Baylor College of Medicine, Houston. In addition, because the risk of progression to cancer along with such other liver damage is high in children, the reviewers stated that HCV and HBV can be classified as oncoviruses.

Their article assessed overall epidemiology, viral characteristics, and immune responses, as well as prevention, clinical manifestations, and current advances in the treatment of hepatitis B and C in children.

Because of the introduction of universal infant vaccination for HBV in the United States in 1991, the incidence of acute hepatitis B in U.S. children (those aged less than 19 years) has decreased from approximately 13.80/100,000 population (in children aged 10-19 years) in the 1980s to 0.34/100,000 population in 2002, Dr. Mysore and Dr. Leung wrote.

However, they added that those children who have chronic HBV remain at high risk for HCC, with a 100-fold greater incidence, compared with the HBV-negative population.

Similarly, HCV is a significant problem in children, with an estimated prevalence in the United States of 0.2% and 0.4% for children aged 6-11 years and 12-19 years, respectively. Vertical transmission from the mother is responsible for more than 60% of pediatric HCV infection and adds approximately 7,200 new cases in the United States yearly. Older children can acquire the virus through intravenous and intranasal drug use and high-risk sexual activity, they stated.

“Our understanding of the pathobiology and immunology of hepatitis B and C is unprecedented. As new antiviral therapies are being developed for the pediatric population, the differences in management and monitoring between children and adults with HBV and HCV are beginning to narrow but are still important,” the authors wrote.

They pointed out that soon-to-be-available treatments for HCV will be curative in children aged as young as 3 years. “[T]his will change the natural history of HCV and the prevalence of hepatocellular carcinoma over the next several decades for the better,” Dr. Mysore and Dr. Leung concluded.

They reported that they had no conflicts of interest to disclose.

[email protected]

SOURCE: Mysore KR et al. Clin Liver Dis. 2018; 22:703-22.

The natural histories of hepatitis B virus (HBV) and hepatitis C virus (HCV) are very different in children, compared with their progress in adults, and depends on age at time of infection, mode of acquisition, ethnicity, and genotype, according to a review in a special pediatric issue of Clinics in Liver Disease.

Courtesy NIH

Most children infected perinatally or vertically continue to be asymptomatic but are at uniquely higher risk of developing chronic viral hepatitis and progressing to liver cirrhosis and hepatocellular carcinoma (HCC), according to Krupa R. Mysore, MD, and Daniel H. Leung, MD, both of the Baylor College of Medicine, Houston. In addition, because the risk of progression to cancer along with such other liver damage is high in children, the reviewers stated that HCV and HBV can be classified as oncoviruses.

Their article assessed overall epidemiology, viral characteristics, and immune responses, as well as prevention, clinical manifestations, and current advances in the treatment of hepatitis B and C in children.

Because of the introduction of universal infant vaccination for HBV in the United States in 1991, the incidence of acute hepatitis B in U.S. children (those aged less than 19 years) has decreased from approximately 13.80/100,000 population (in children aged 10-19 years) in the 1980s to 0.34/100,000 population in 2002, Dr. Mysore and Dr. Leung wrote.

However, they added that those children who have chronic HBV remain at high risk for HCC, with a 100-fold greater incidence, compared with the HBV-negative population.

Similarly, HCV is a significant problem in children, with an estimated prevalence in the United States of 0.2% and 0.4% for children aged 6-11 years and 12-19 years, respectively. Vertical transmission from the mother is responsible for more than 60% of pediatric HCV infection and adds approximately 7,200 new cases in the United States yearly. Older children can acquire the virus through intravenous and intranasal drug use and high-risk sexual activity, they stated.

“Our understanding of the pathobiology and immunology of hepatitis B and C is unprecedented. As new antiviral therapies are being developed for the pediatric population, the differences in management and monitoring between children and adults with HBV and HCV are beginning to narrow but are still important,” the authors wrote.

They pointed out that soon-to-be-available treatments for HCV will be curative in children aged as young as 3 years. “[T]his will change the natural history of HCV and the prevalence of hepatocellular carcinoma over the next several decades for the better,” Dr. Mysore and Dr. Leung concluded.

They reported that they had no conflicts of interest to disclose.

[email protected]

SOURCE: Mysore KR et al. Clin Liver Dis. 2018; 22:703-22.

Patients with chronic hepatitis B virus infection and decompensated cirrhosis who immediately initiated entecavir or lamivudine therapy and maintained a virologic response (MVR) had significantly longer transplant-free survival than did nonresponders, according to the results of a multicenter observational study published in the December issue of Clinical Gastroenterology and Hepatology.

CDC/Dr. Erskine Palmer

Survival times were “excellent” if patients survived the first 6 months of antiviral therapy and did not develop hepatocellular carcinoma, said Jeong Won Jang, MD, of the Catholic University of Korea College of Medicine in Seoul, South Korea, and his associates. Patients who developed hepatocellular carcinoma had persistent declines in survival over time, they said. Predictors of short-term mortality included a baseline Model for End-Stage Liver Disease score above 20 and multiple complications.

Chronic hepatitis B virus (HBV) infection is the most common cause of liver-related disease and death in Asia, and complications such as decompensated cirrhosis affect up to 40% of chronically infected persons. Five-year survival rates are as low as 14% if patients develop decompensated cirrhosis.

To explore whether virologic suppression with oral nucleoside or nucleotide analog therapy improves outcomes in these decompensated patients, the researchers studied 295 such individuals from the Epidemiology and Natural History of Liver Cirrhosis in Korea Study. At baseline, these patients did not have documented chronic hepatitis C virus infection, hepatocellular carcinoma, other cancers, autoimmune hepatitis, or alcohol use disorders. All patients initiated entecavir or lamivudine therapy immediately after their cirrhosis became decompensated. The primary outcome was transplant-free survival.

A total of 60.1% of patients survived 5 years and 45.7% survived 10 years without undergoing transplantation, for a median transplant-free survival time of 7.7 years. The 116 patients (39%) who consistently had undetectable HBV DNA levels (less than 20 IU/mL) throughout treatment had significantly longer transplant-free survival than did patients who did not maintain a virologic response (P less than .001). In addition, a maintained virologic response (MVR) was the strongest predictor of long-term transplant-free survival, the researchers said.

A significantly greater proportion of patients who received entecavir survived 10 years compared with patients who received lamivudine. However, there was no significant difference in long-term survival among patients with MVRs to either drug. “Importantly, it appears that improvement in patient survival is attained by antiviral response, not by the type of nucleos(t)ide analogue per se,” the researchers wrote.

Patients who achieved MVR also showed significant improvements in hepatic function, but “the preventive effects of MVR on the incidence of hepatocellular carcinoma appeared only modest,” the investigators said. “Survival of patients without hepatocellular carcinoma who survived the first 6 months after initiation of antiviral therapy was excellent, with only a 25.3% mortality rate occurring between 6 months and 10 years.”

Based on their findings, Dr. Jang and his associates recommended aiming for an HBV DNA load less than 20 IU/mL in patients with decompensated cirrhosis to significantly improve the chances of long-term survival. Survival curves were similar regardless of whether patients had HBV DNA levels less than 10 IU/mL or between and 10 and 20 IU/mL, they noted.

Funders included Korea Healthcare Technology R&D Project and the Catholic Research Coordinating Center of the Korea Health 21 R&D Project, both of the Ministry of Health and Welfare, Republic of Korea. Dr. Jang disclosed ties to Bristol-Myers Squibb, Gilead, and Merck Sharp & Dohme. Three coinvestigators also disclosed ties to Gilead, MSD, and several other pharmaceutical companies.

SOURCE: Jang JW et al. Clin Gastroenterol Hepatol. 2018 May 18. doi: 10.1016/j.cgh.2018.04.063

Patients with chronic hepatitis B virus infection and decompensated cirrhosis who immediately initiated entecavir or lamivudine therapy and maintained a virologic response (MVR) had significantly longer transplant-free survival than did nonresponders, according to the results of a multicenter observational study published in the December issue of Clinical Gastroenterology and Hepatology.

CDC/Dr. Erskine Palmer

Survival times were “excellent” if patients survived the first 6 months of antiviral therapy and did not develop hepatocellular carcinoma, said Jeong Won Jang, MD, of the Catholic University of Korea College of Medicine in Seoul, South Korea, and his associates. Patients who developed hepatocellular carcinoma had persistent declines in survival over time, they said. Predictors of short-term mortality included a baseline Model for End-Stage Liver Disease score above 20 and multiple complications.

Chronic hepatitis B virus (HBV) infection is the most common cause of liver-related disease and death in Asia, and complications such as decompensated cirrhosis affect up to 40% of chronically infected persons. Five-year survival rates are as low as 14% if patients develop decompensated cirrhosis.

To explore whether virologic suppression with oral nucleoside or nucleotide analog therapy improves outcomes in these decompensated patients, the researchers studied 295 such individuals from the Epidemiology and Natural History of Liver Cirrhosis in Korea Study. At baseline, these patients did not have documented chronic hepatitis C virus infection, hepatocellular carcinoma, other cancers, autoimmune hepatitis, or alcohol use disorders. All patients initiated entecavir or lamivudine therapy immediately after their cirrhosis became decompensated. The primary outcome was transplant-free survival.

A total of 60.1% of patients survived 5 years and 45.7% survived 10 years without undergoing transplantation, for a median transplant-free survival time of 7.7 years. The 116 patients (39%) who consistently had undetectable HBV DNA levels (less than 20 IU/mL) throughout treatment had significantly longer transplant-free survival than did patients who did not maintain a virologic response (P less than .001). In addition, a maintained virologic response (MVR) was the strongest predictor of long-term transplant-free survival, the researchers said.

A significantly greater proportion of patients who received entecavir survived 10 years compared with patients who received lamivudine. However, there was no significant difference in long-term survival among patients with MVRs to either drug. “Importantly, it appears that improvement in patient survival is attained by antiviral response, not by the type of nucleos(t)ide analogue per se,” the researchers wrote.

Patients who achieved MVR also showed significant improvements in hepatic function, but “the preventive effects of MVR on the incidence of hepatocellular carcinoma appeared only modest,” the investigators said. “Survival of patients without hepatocellular carcinoma who survived the first 6 months after initiation of antiviral therapy was excellent, with only a 25.3% mortality rate occurring between 6 months and 10 years.”

Based on their findings, Dr. Jang and his associates recommended aiming for an HBV DNA load less than 20 IU/mL in patients with decompensated cirrhosis to significantly improve the chances of long-term survival. Survival curves were similar regardless of whether patients had HBV DNA levels less than 10 IU/mL or between and 10 and 20 IU/mL, they noted.

Funders included Korea Healthcare Technology R&D Project and the Catholic Research Coordinating Center of the Korea Health 21 R&D Project, both of the Ministry of Health and Welfare, Republic of Korea. Dr. Jang disclosed ties to Bristol-Myers Squibb, Gilead, and Merck Sharp & Dohme. Three coinvestigators also disclosed ties to Gilead, MSD, and several other pharmaceutical companies.

SOURCE: Jang JW et al. Clin Gastroenterol Hepatol. 2018 May 18. doi: 10.1016/j.cgh.2018.04.063

Patients with chronic hepatitis B virus infection and decompensated cirrhosis who immediately initiated entecavir or lamivudine therapy and maintained a virologic response (MVR) had significantly longer transplant-free survival than did nonresponders, according to the results of a multicenter observational study published in the December issue of Clinical Gastroenterology and Hepatology.

CDC/Dr. Erskine Palmer

Survival times were “excellent” if patients survived the first 6 months of antiviral therapy and did not develop hepatocellular carcinoma, said Jeong Won Jang, MD, of the Catholic University of Korea College of Medicine in Seoul, South Korea, and his associates. Patients who developed hepatocellular carcinoma had persistent declines in survival over time, they said. Predictors of short-term mortality included a baseline Model for End-Stage Liver Disease score above 20 and multiple complications.

Chronic hepatitis B virus (HBV) infection is the most common cause of liver-related disease and death in Asia, and complications such as decompensated cirrhosis affect up to 40% of chronically infected persons. Five-year survival rates are as low as 14% if patients develop decompensated cirrhosis.

To explore whether virologic suppression with oral nucleoside or nucleotide analog therapy improves outcomes in these decompensated patients, the researchers studied 295 such individuals from the Epidemiology and Natural History of Liver Cirrhosis in Korea Study. At baseline, these patients did not have documented chronic hepatitis C virus infection, hepatocellular carcinoma, other cancers, autoimmune hepatitis, or alcohol use disorders. All patients initiated entecavir or lamivudine therapy immediately after their cirrhosis became decompensated. The primary outcome was transplant-free survival.

A total of 60.1% of patients survived 5 years and 45.7% survived 10 years without undergoing transplantation, for a median transplant-free survival time of 7.7 years. The 116 patients (39%) who consistently had undetectable HBV DNA levels (less than 20 IU/mL) throughout treatment had significantly longer transplant-free survival than did patients who did not maintain a virologic response (P less than .001). In addition, a maintained virologic response (MVR) was the strongest predictor of long-term transplant-free survival, the researchers said.

A significantly greater proportion of patients who received entecavir survived 10 years compared with patients who received lamivudine. However, there was no significant difference in long-term survival among patients with MVRs to either drug. “Importantly, it appears that improvement in patient survival is attained by antiviral response, not by the type of nucleos(t)ide analogue per se,” the researchers wrote.

Patients who achieved MVR also showed significant improvements in hepatic function, but “the preventive effects of MVR on the incidence of hepatocellular carcinoma appeared only modest,” the investigators said. “Survival of patients without hepatocellular carcinoma who survived the first 6 months after initiation of antiviral therapy was excellent, with only a 25.3% mortality rate occurring between 6 months and 10 years.”

Based on their findings, Dr. Jang and his associates recommended aiming for an HBV DNA load less than 20 IU/mL in patients with decompensated cirrhosis to significantly improve the chances of long-term survival. Survival curves were similar regardless of whether patients had HBV DNA levels less than 10 IU/mL or between and 10 and 20 IU/mL, they noted.

Funders included Korea Healthcare Technology R&D Project and the Catholic Research Coordinating Center of the Korea Health 21 R&D Project, both of the Ministry of Health and Welfare, Republic of Korea. Dr. Jang disclosed ties to Bristol-Myers Squibb, Gilead, and Merck Sharp & Dohme. Three coinvestigators also disclosed ties to Gilead, MSD, and several other pharmaceutical companies.

SOURCE: Jang JW et al. Clin Gastroenterol Hepatol. 2018 May 18. doi: 10.1016/j.cgh.2018.04.063

Crohn’s disease was significantly associated with anal canal high-risk human papillomavirus (HPV) infection in a prospective, single-center study of patients undergoing colonoscopy for various indications.

xrender/Thinkstock

High-risk HPV and HPV strain 16 were detected in 30% of patients with Crohn’s disease and 18% of patients without Crohn’s disease (P = .005), said Lucine Vuitton, MD, of University Hospital of Besançon (France) and her associates. “Increasing our knowledge of HPV infection of anal tissues could help physicians identify populations at risk and promote prophylaxis with vaccination and adequate screening,” the investigators wrote in the November issue of Clinical Gastroenterology and Hepatology.

Most anal cancers are squamous cell carcinomas, for which infection with high-risk HPV (especially high-risk HPV16) is a driving risk factor. Case studies and literature reviews have linked Crohn’s disease to increased rates of anal canal cancers, but population-based data were lacking, the researchers wrote. Therefore, they prospectively analyzed anal tissue samples from 467 consecutive patients undergoing colonoscopy at a tertiary care center in France. Median age was 54 years (interquartile range, 18-86 years), and 52% of patients were women. No patient had detectable macroscopic neoplastic lesions at the anal margin at baseline.

The researchers used the QIAamp DNA Blood minikit (Qiagen) for DNA extraction and the INNO-LiPA HPV Genotyping Extra kit (Fujirebio Diagnostics) for HPV DNA detection and genotyping. These methods identified HPV DNA in anal tissue samples from 34% of the patients and high-risk HPV DNA in 18% of patients. The most prevalent genotype was HPV16 (detected in 7% of samples), followed by HPV51, HPV52, and HPV39.

A total of 112 patients were receiving at least one immunosuppressive treatment for inflammatory bowel disease or another condition. Seventy patients had Crohn’s disease, and 29 patients had ulcerative colitis. The prevalence of anal canal high-risk HPV and HPV16 infection in patients with ulcerative colitis was similar to that seen in those without inflammatory bowel disease. However, patients with Crohn’s disease were more likely to have anal canal high-risk HPV infection (30%) and HPV16 infection (14%), compared with patients without Crohn’s disease (18% and 7%, respectively). Additionally, among 22 patients with Crohn’s disease and perianal involvement, 11 had HPV DNA in the anal canal versus 30% of other patients with inflammatory bowel disease.

Women were more likely to have anal canal high-risk HPV (23%) infection than were men (13%; P = .004). In a multivariable analysis of self-reported data and medical data, significant risk factors for high-risk HPV infection included female sex, a history of sexually transmitted infections, having more than 10 sexual partners over the life course, having at least one sexual partner during the past year, current smoking, and immunosuppressive therapy. The multivariable analysis also linked Crohn’s disease with anal canal high-risk HPV16 infection (odds ratio, 3.8), but the association did not reach statistical significance (95% confidence interval, 0.9-16.9).

Most patients with Crohn’s disease were on immunosuppressive therapy, “which markedly affected statistical power,” the researchers commented. Nonetheless, their findings support HPV vaccination for patients with Crohn’s disease, as well as efforts to target high-risk patients who could benefit from anal cancer screening, they said.

The work was funded by the APICHU research grant from Besançon (France) University Hospital and by the Région de Franche-Comté. Dr. Vuitton disclosed ties to AbbVie, Ferring, MSD, Hospira, Janssen, and Takeda. Three coinvestigators disclosed relationships with AbbVie, MSD, Hospira, Mayoli, and Roche.

SOURCE: Vuitton L et al. Clin Gastroenterol Hepatol. 2018 Nov. doi: 10.1016/j.cgh.2018.03.008.

Crohn’s disease was significantly associated with anal canal high-risk human papillomavirus (HPV) infection in a prospective, single-center study of patients undergoing colonoscopy for various indications.

xrender/Thinkstock

High-risk HPV and HPV strain 16 were detected in 30% of patients with Crohn’s disease and 18% of patients without Crohn’s disease (P = .005), said Lucine Vuitton, MD, of University Hospital of Besançon (France) and her associates. “Increasing our knowledge of HPV infection of anal tissues could help physicians identify populations at risk and promote prophylaxis with vaccination and adequate screening,” the investigators wrote in the November issue of Clinical Gastroenterology and Hepatology.

Most anal cancers are squamous cell carcinomas, for which infection with high-risk HPV (especially high-risk HPV16) is a driving risk factor. Case studies and literature reviews have linked Crohn’s disease to increased rates of anal canal cancers, but population-based data were lacking, the researchers wrote. Therefore, they prospectively analyzed anal tissue samples from 467 consecutive patients undergoing colonoscopy at a tertiary care center in France. Median age was 54 years (interquartile range, 18-86 years), and 52% of patients were women. No patient had detectable macroscopic neoplastic lesions at the anal margin at baseline.

The researchers used the QIAamp DNA Blood minikit (Qiagen) for DNA extraction and the INNO-LiPA HPV Genotyping Extra kit (Fujirebio Diagnostics) for HPV DNA detection and genotyping. These methods identified HPV DNA in anal tissue samples from 34% of the patients and high-risk HPV DNA in 18% of patients. The most prevalent genotype was HPV16 (detected in 7% of samples), followed by HPV51, HPV52, and HPV39.

A total of 112 patients were receiving at least one immunosuppressive treatment for inflammatory bowel disease or another condition. Seventy patients had Crohn’s disease, and 29 patients had ulcerative colitis. The prevalence of anal canal high-risk HPV and HPV16 infection in patients with ulcerative colitis was similar to that seen in those without inflammatory bowel disease. However, patients with Crohn’s disease were more likely to have anal canal high-risk HPV infection (30%) and HPV16 infection (14%), compared with patients without Crohn’s disease (18% and 7%, respectively). Additionally, among 22 patients with Crohn’s disease and perianal involvement, 11 had HPV DNA in the anal canal versus 30% of other patients with inflammatory bowel disease.

Women were more likely to have anal canal high-risk HPV (23%) infection than were men (13%; P = .004). In a multivariable analysis of self-reported data and medical data, significant risk factors for high-risk HPV infection included female sex, a history of sexually transmitted infections, having more than 10 sexual partners over the life course, having at least one sexual partner during the past year, current smoking, and immunosuppressive therapy. The multivariable analysis also linked Crohn’s disease with anal canal high-risk HPV16 infection (odds ratio, 3.8), but the association did not reach statistical significance (95% confidence interval, 0.9-16.9).

Most patients with Crohn’s disease were on immunosuppressive therapy, “which markedly affected statistical power,” the researchers commented. Nonetheless, their findings support HPV vaccination for patients with Crohn’s disease, as well as efforts to target high-risk patients who could benefit from anal cancer screening, they said.

The work was funded by the APICHU research grant from Besançon (France) University Hospital and by the Région de Franche-Comté. Dr. Vuitton disclosed ties to AbbVie, Ferring, MSD, Hospira, Janssen, and Takeda. Three coinvestigators disclosed relationships with AbbVie, MSD, Hospira, Mayoli, and Roche.

SOURCE: Vuitton L et al. Clin Gastroenterol Hepatol. 2018 Nov. doi: 10.1016/j.cgh.2018.03.008.

Crohn’s disease was significantly associated with anal canal high-risk human papillomavirus (HPV) infection in a prospective, single-center study of patients undergoing colonoscopy for various indications.

xrender/Thinkstock

High-risk HPV and HPV strain 16 were detected in 30% of patients with Crohn’s disease and 18% of patients without Crohn’s disease (P = .005), said Lucine Vuitton, MD, of University Hospital of Besançon (France) and her associates. “Increasing our knowledge of HPV infection of anal tissues could help physicians identify populations at risk and promote prophylaxis with vaccination and adequate screening,” the investigators wrote in the November issue of Clinical Gastroenterology and Hepatology.

Most anal cancers are squamous cell carcinomas, for which infection with high-risk HPV (especially high-risk HPV16) is a driving risk factor. Case studies and literature reviews have linked Crohn’s disease to increased rates of anal canal cancers, but population-based data were lacking, the researchers wrote. Therefore, they prospectively analyzed anal tissue samples from 467 consecutive patients undergoing colonoscopy at a tertiary care center in France. Median age was 54 years (interquartile range, 18-86 years), and 52% of patients were women. No patient had detectable macroscopic neoplastic lesions at the anal margin at baseline.

The researchers used the QIAamp DNA Blood minikit (Qiagen) for DNA extraction and the INNO-LiPA HPV Genotyping Extra kit (Fujirebio Diagnostics) for HPV DNA detection and genotyping. These methods identified HPV DNA in anal tissue samples from 34% of the patients and high-risk HPV DNA in 18% of patients. The most prevalent genotype was HPV16 (detected in 7% of samples), followed by HPV51, HPV52, and HPV39.

A total of 112 patients were receiving at least one immunosuppressive treatment for inflammatory bowel disease or another condition. Seventy patients had Crohn’s disease, and 29 patients had ulcerative colitis. The prevalence of anal canal high-risk HPV and HPV16 infection in patients with ulcerative colitis was similar to that seen in those without inflammatory bowel disease. However, patients with Crohn’s disease were more likely to have anal canal high-risk HPV infection (30%) and HPV16 infection (14%), compared with patients without Crohn’s disease (18% and 7%, respectively). Additionally, among 22 patients with Crohn’s disease and perianal involvement, 11 had HPV DNA in the anal canal versus 30% of other patients with inflammatory bowel disease.

Women were more likely to have anal canal high-risk HPV (23%) infection than were men (13%; P = .004). In a multivariable analysis of self-reported data and medical data, significant risk factors for high-risk HPV infection included female sex, a history of sexually transmitted infections, having more than 10 sexual partners over the life course, having at least one sexual partner during the past year, current smoking, and immunosuppressive therapy. The multivariable analysis also linked Crohn’s disease with anal canal high-risk HPV16 infection (odds ratio, 3.8), but the association did not reach statistical significance (95% confidence interval, 0.9-16.9).

Most patients with Crohn’s disease were on immunosuppressive therapy, “which markedly affected statistical power,” the researchers commented. Nonetheless, their findings support HPV vaccination for patients with Crohn’s disease, as well as efforts to target high-risk patients who could benefit from anal cancer screening, they said.

The work was funded by the APICHU research grant from Besançon (France) University Hospital and by the Région de Franche-Comté. Dr. Vuitton disclosed ties to AbbVie, Ferring, MSD, Hospira, Janssen, and Takeda. Three coinvestigators disclosed relationships with AbbVie, MSD, Hospira, Mayoli, and Roche.

SOURCE: Vuitton L et al. Clin Gastroenterol Hepatol. 2018 Nov. doi: 10.1016/j.cgh.2018.03.008.