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Post–liver transplant results similar in acute alcoholic hepatitis, stage 1a
WASHINGTON – Patients with acute alcoholic hepatitis (AAH) have similar early post–liver transplant outcomes to those listed with fulminant hepatic failure, according to a study presented at the annual meeting of the American Association for the Study of Liver Diseases.
Patients with severe AAH have high mortality, but many are unable to survive the 6 months of sobriety required to be accepted as liver transplant candidates, said George Cholankeril, MD, of the gastroenterology and hepatology department at Stanford (Calif.) University.
He and his associates studied wait-list mortality and post–liver transplant survival among 1,912 patients listed for either AAH or fulminant hepatic failure on the United Network for Organ Sharing (UNOS) registry between 2011 and 2016.
A total of 193 patients were listed with AAH, 314 were listed with drug-induced liver injury including acetaminophen (DILI-APAP), and 1,405 were listed as non-DILI patients.
One-year post–liver transplant survival among AAH patients was 93.3%, compared with 87.75% for DILI-APAP patients and 88.4% among non-DILI patients (P less than .001). Survival remained the same among AAH patients 3 years following transplantation, but rates dropped for both the DILI-APAP group (80.8%) and the non-DILI group (81.4%), Dr. Cholankeril reported.
Patients were a median age of 45, 33, and 46 years among the AAH, DILI-APAP, and non-DILI, groups respectively. Patients were majority white among all three groups, with a significantly larger female population among the DILI-APAP group (80.6%) than the AAH (34.7%) or non-DILI (59.4%) groups. Patients in the AAH group had a median Model for End-Stage Liver Disease (MELD) score of 32, compared with 34 for DILI-APAP and 21 for non-DILI.
AAH patients could potentially see significant improvement with a liver transplant, according to investigators; however, the current standards for candidacy have created treatment barriers.
“Patients with AAH have comparable early post-transplant outcomes to those with hepatic liver failure,” said Dr. Cholankeril. “However, there is no consensus or national guidelines for liver transplantation within this patient population.”
Wait-list trends have already started to shift toward more AAH patient acceptance. The number of AAH patients added to the transplant wait lists increased from 14 in 2011 to 58 in 2016. Investigators also found that the number of liver transplant centers accepting AAH patients to their transplant lists increased from 3 to 26.
Investigators were limited by the variations in protocols for each transplant center, as well as by the inconsistency of pre–liver transplant psychosocial metrics. The diagnostic criteria of AAH through UNOS was also a limitation for investigators, according to Dr. Cholankeril.
Although liver transplantation may be able to help some patients, it is only a small fix for a much larger problem. “This is only a solution for a minority of patients with the rising epidemic of alcoholic intoxication in the U.S.,” he said. “As the increasing mortality trends show alcohol-related mortality, and alcoholic liver disease is a contributor to it, we must recognize alcoholic liver disease remains an orphan disease and there is still an unmet need.”
Dr. Cholankeril reported no relevant financial disclosures.
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
Transplanting patients with alcohol induced liver disease has been controversial since the earliest days of liver transplantation. Initially some programs were reluctant to transplant patients with a disease that was “self-inflicted” based on an ethical concern about using a scarce resource to save the lives of those whose disease was their own fault, while other patients may die waiting. There was also a concern that transplanting alcoholics would be bad publicity for organ donation and reduce the public’s willingness to donate organs. The highly publicized transplantation of baseball legend and known alcoholic Mickey Mantle in 1995 intensified this debate.
Over time it became clear that the concerns regarding transplanting alcoholics were unfounded. The outcomes were equal or better than for other diseases. Liver transplantation was termed “the ultimate eye opening experience” as serious recidivism turned out to be very uncommon. It was realized that a large percentage of all reasons for seeking medical care can be attributed to self-inflicted harm when one considers cigarette induced malignancy and cardiovascular disease and dietary indiscretion leading to obesity and diabetes. It also became clear that from a practical standpoint prohibiting transplantation of alcoholics simply drove patients to programs that would accept such patients, or caused them and their family to withhold disclosure of alcohol use.
While transplantation of patients with chronic liver disease due to alcohol use has become standard of care, transplanting patients with acute alcoholic hepatitis remains controversial and relatively uncommon. Many programs require a period of abstinence, which is impossible in the setting of acute alcoholic hepatitis. The concern is that it is impossible to discern among actively drinking candidates which ones will be able to achieve sobriety after the transplant. The report by Cholankeril and colleagues documents that the tide is changing. There are increasing numbers of patients being transplanted for acute alcoholic hepatitis, and outcomes are acceptable. However, as the authors point out, the numbers are small and represent a highly selected group of patients. Nevertheless, the pressure on programs to modify rigid abstinence criteria is likely to grow as the evidence accumulates showing selected patients with acute alcoholic hepatitis can do well.
Jeffrey Punch, MD, FACS, is transplant specialist at the University of Michigan in Ann Arbor, and on the Editorial Advisory Board of ACS Surgery News.
Transplanting patients with alcohol induced liver disease has been controversial since the earliest days of liver transplantation. Initially some programs were reluctant to transplant patients with a disease that was “self-inflicted” based on an ethical concern about using a scarce resource to save the lives of those whose disease was their own fault, while other patients may die waiting. There was also a concern that transplanting alcoholics would be bad publicity for organ donation and reduce the public’s willingness to donate organs. The highly publicized transplantation of baseball legend and known alcoholic Mickey Mantle in 1995 intensified this debate.
Over time it became clear that the concerns regarding transplanting alcoholics were unfounded. The outcomes were equal or better than for other diseases. Liver transplantation was termed “the ultimate eye opening experience” as serious recidivism turned out to be very uncommon. It was realized that a large percentage of all reasons for seeking medical care can be attributed to self-inflicted harm when one considers cigarette induced malignancy and cardiovascular disease and dietary indiscretion leading to obesity and diabetes. It also became clear that from a practical standpoint prohibiting transplantation of alcoholics simply drove patients to programs that would accept such patients, or caused them and their family to withhold disclosure of alcohol use.
While transplantation of patients with chronic liver disease due to alcohol use has become standard of care, transplanting patients with acute alcoholic hepatitis remains controversial and relatively uncommon. Many programs require a period of abstinence, which is impossible in the setting of acute alcoholic hepatitis. The concern is that it is impossible to discern among actively drinking candidates which ones will be able to achieve sobriety after the transplant. The report by Cholankeril and colleagues documents that the tide is changing. There are increasing numbers of patients being transplanted for acute alcoholic hepatitis, and outcomes are acceptable. However, as the authors point out, the numbers are small and represent a highly selected group of patients. Nevertheless, the pressure on programs to modify rigid abstinence criteria is likely to grow as the evidence accumulates showing selected patients with acute alcoholic hepatitis can do well.
Jeffrey Punch, MD, FACS, is transplant specialist at the University of Michigan in Ann Arbor, and on the Editorial Advisory Board of ACS Surgery News.
Transplanting patients with alcohol induced liver disease has been controversial since the earliest days of liver transplantation. Initially some programs were reluctant to transplant patients with a disease that was “self-inflicted” based on an ethical concern about using a scarce resource to save the lives of those whose disease was their own fault, while other patients may die waiting. There was also a concern that transplanting alcoholics would be bad publicity for organ donation and reduce the public’s willingness to donate organs. The highly publicized transplantation of baseball legend and known alcoholic Mickey Mantle in 1995 intensified this debate.
Over time it became clear that the concerns regarding transplanting alcoholics were unfounded. The outcomes were equal or better than for other diseases. Liver transplantation was termed “the ultimate eye opening experience” as serious recidivism turned out to be very uncommon. It was realized that a large percentage of all reasons for seeking medical care can be attributed to self-inflicted harm when one considers cigarette induced malignancy and cardiovascular disease and dietary indiscretion leading to obesity and diabetes. It also became clear that from a practical standpoint prohibiting transplantation of alcoholics simply drove patients to programs that would accept such patients, or caused them and their family to withhold disclosure of alcohol use.
While transplantation of patients with chronic liver disease due to alcohol use has become standard of care, transplanting patients with acute alcoholic hepatitis remains controversial and relatively uncommon. Many programs require a period of abstinence, which is impossible in the setting of acute alcoholic hepatitis. The concern is that it is impossible to discern among actively drinking candidates which ones will be able to achieve sobriety after the transplant. The report by Cholankeril and colleagues documents that the tide is changing. There are increasing numbers of patients being transplanted for acute alcoholic hepatitis, and outcomes are acceptable. However, as the authors point out, the numbers are small and represent a highly selected group of patients. Nevertheless, the pressure on programs to modify rigid abstinence criteria is likely to grow as the evidence accumulates showing selected patients with acute alcoholic hepatitis can do well.
Jeffrey Punch, MD, FACS, is transplant specialist at the University of Michigan in Ann Arbor, and on the Editorial Advisory Board of ACS Surgery News.
WASHINGTON – Patients with acute alcoholic hepatitis (AAH) have similar early post–liver transplant outcomes to those listed with fulminant hepatic failure, according to a study presented at the annual meeting of the American Association for the Study of Liver Diseases.
Patients with severe AAH have high mortality, but many are unable to survive the 6 months of sobriety required to be accepted as liver transplant candidates, said George Cholankeril, MD, of the gastroenterology and hepatology department at Stanford (Calif.) University.
He and his associates studied wait-list mortality and post–liver transplant survival among 1,912 patients listed for either AAH or fulminant hepatic failure on the United Network for Organ Sharing (UNOS) registry between 2011 and 2016.
A total of 193 patients were listed with AAH, 314 were listed with drug-induced liver injury including acetaminophen (DILI-APAP), and 1,405 were listed as non-DILI patients.
One-year post–liver transplant survival among AAH patients was 93.3%, compared with 87.75% for DILI-APAP patients and 88.4% among non-DILI patients (P less than .001). Survival remained the same among AAH patients 3 years following transplantation, but rates dropped for both the DILI-APAP group (80.8%) and the non-DILI group (81.4%), Dr. Cholankeril reported.
Patients were a median age of 45, 33, and 46 years among the AAH, DILI-APAP, and non-DILI, groups respectively. Patients were majority white among all three groups, with a significantly larger female population among the DILI-APAP group (80.6%) than the AAH (34.7%) or non-DILI (59.4%) groups. Patients in the AAH group had a median Model for End-Stage Liver Disease (MELD) score of 32, compared with 34 for DILI-APAP and 21 for non-DILI.
AAH patients could potentially see significant improvement with a liver transplant, according to investigators; however, the current standards for candidacy have created treatment barriers.
“Patients with AAH have comparable early post-transplant outcomes to those with hepatic liver failure,” said Dr. Cholankeril. “However, there is no consensus or national guidelines for liver transplantation within this patient population.”
Wait-list trends have already started to shift toward more AAH patient acceptance. The number of AAH patients added to the transplant wait lists increased from 14 in 2011 to 58 in 2016. Investigators also found that the number of liver transplant centers accepting AAH patients to their transplant lists increased from 3 to 26.
Investigators were limited by the variations in protocols for each transplant center, as well as by the inconsistency of pre–liver transplant psychosocial metrics. The diagnostic criteria of AAH through UNOS was also a limitation for investigators, according to Dr. Cholankeril.
Although liver transplantation may be able to help some patients, it is only a small fix for a much larger problem. “This is only a solution for a minority of patients with the rising epidemic of alcoholic intoxication in the U.S.,” he said. “As the increasing mortality trends show alcohol-related mortality, and alcoholic liver disease is a contributor to it, we must recognize alcoholic liver disease remains an orphan disease and there is still an unmet need.”
Dr. Cholankeril reported no relevant financial disclosures.
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
WASHINGTON – Patients with acute alcoholic hepatitis (AAH) have similar early post–liver transplant outcomes to those listed with fulminant hepatic failure, according to a study presented at the annual meeting of the American Association for the Study of Liver Diseases.
Patients with severe AAH have high mortality, but many are unable to survive the 6 months of sobriety required to be accepted as liver transplant candidates, said George Cholankeril, MD, of the gastroenterology and hepatology department at Stanford (Calif.) University.
He and his associates studied wait-list mortality and post–liver transplant survival among 1,912 patients listed for either AAH or fulminant hepatic failure on the United Network for Organ Sharing (UNOS) registry between 2011 and 2016.
A total of 193 patients were listed with AAH, 314 were listed with drug-induced liver injury including acetaminophen (DILI-APAP), and 1,405 were listed as non-DILI patients.
One-year post–liver transplant survival among AAH patients was 93.3%, compared with 87.75% for DILI-APAP patients and 88.4% among non-DILI patients (P less than .001). Survival remained the same among AAH patients 3 years following transplantation, but rates dropped for both the DILI-APAP group (80.8%) and the non-DILI group (81.4%), Dr. Cholankeril reported.
Patients were a median age of 45, 33, and 46 years among the AAH, DILI-APAP, and non-DILI, groups respectively. Patients were majority white among all three groups, with a significantly larger female population among the DILI-APAP group (80.6%) than the AAH (34.7%) or non-DILI (59.4%) groups. Patients in the AAH group had a median Model for End-Stage Liver Disease (MELD) score of 32, compared with 34 for DILI-APAP and 21 for non-DILI.
AAH patients could potentially see significant improvement with a liver transplant, according to investigators; however, the current standards for candidacy have created treatment barriers.
“Patients with AAH have comparable early post-transplant outcomes to those with hepatic liver failure,” said Dr. Cholankeril. “However, there is no consensus or national guidelines for liver transplantation within this patient population.”
Wait-list trends have already started to shift toward more AAH patient acceptance. The number of AAH patients added to the transplant wait lists increased from 14 in 2011 to 58 in 2016. Investigators also found that the number of liver transplant centers accepting AAH patients to their transplant lists increased from 3 to 26.
Investigators were limited by the variations in protocols for each transplant center, as well as by the inconsistency of pre–liver transplant psychosocial metrics. The diagnostic criteria of AAH through UNOS was also a limitation for investigators, according to Dr. Cholankeril.
Although liver transplantation may be able to help some patients, it is only a small fix for a much larger problem. “This is only a solution for a minority of patients with the rising epidemic of alcoholic intoxication in the U.S.,” he said. “As the increasing mortality trends show alcohol-related mortality, and alcoholic liver disease is a contributor to it, we must recognize alcoholic liver disease remains an orphan disease and there is still an unmet need.”
Dr. Cholankeril reported no relevant financial disclosures.
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
AT THE LIVER MEETING 2017
Key clinical point:
Major finding: Survival 1 and 3 years after liver transplant was comparable in patients with drug-induced liver injury including acetaminophen (P = .10) and significantly higher than other chronic alcoholic liver disease patients (P less that .001).
Data source: Retrospective study of 1,912 liver transplant patients listed for either AAH or status 1A registered on the UNOS registry between 2011 and 2016.
Disclosures: Presenter reported no relevant financial disclosures.
VIDEO: Fibrosis biomarkers show promise to replace liver biopsy
WASHINGTON – The concentrations of three biomarkers successfully identified the severity of fibrosis in patients with nonalcoholic steatohepatitis (NASH), according to a study presented at the annual meeting of the American Association for the Study of Liver Diseases.
This noninvasive diagnostic method could replace liver biopsy, the current standard used to diagnose patients with NASH.
Liver biopsies are associated with high cost, high rates of complications like infection, and minimal association with morbidity and mortality, Manal Abdelmalek, MD, a hepatologist and liver transplant specialist at Duke University, Durham, N.C., said in a video interview.
Investigators measured serum concentrations of a2-macroglobulin, hyaluronic acid, and metalloproteinase-1 collected from 792 patients with NASH on the same day as patients’ liver biopsies.
Dr. Abdelmalek and her fellow investigators randomly assigned half of the samples to a training group and half the samples to a validation group.
Investigators found that samples in the training group showed a sensitivity of 84.4% (95% confidence interval, 75.5%-91.0%), compared with 81.1% (95% CI, 71.7%-88.4%) in the validation group. Among patients with liver fibrosis, the biomarker test correctly diagnosed 76.5%-100% of patients, with variations depending on placement in the four classifications based on severity.
Investigators feel optimistic that, with more testing, this biomarker test can be used in collaboration with imaging or used independently, minimizing possible patient complications.
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
WASHINGTON – The concentrations of three biomarkers successfully identified the severity of fibrosis in patients with nonalcoholic steatohepatitis (NASH), according to a study presented at the annual meeting of the American Association for the Study of Liver Diseases.
This noninvasive diagnostic method could replace liver biopsy, the current standard used to diagnose patients with NASH.
Liver biopsies are associated with high cost, high rates of complications like infection, and minimal association with morbidity and mortality, Manal Abdelmalek, MD, a hepatologist and liver transplant specialist at Duke University, Durham, N.C., said in a video interview.
Investigators measured serum concentrations of a2-macroglobulin, hyaluronic acid, and metalloproteinase-1 collected from 792 patients with NASH on the same day as patients’ liver biopsies.
Dr. Abdelmalek and her fellow investigators randomly assigned half of the samples to a training group and half the samples to a validation group.
Investigators found that samples in the training group showed a sensitivity of 84.4% (95% confidence interval, 75.5%-91.0%), compared with 81.1% (95% CI, 71.7%-88.4%) in the validation group. Among patients with liver fibrosis, the biomarker test correctly diagnosed 76.5%-100% of patients, with variations depending on placement in the four classifications based on severity.
Investigators feel optimistic that, with more testing, this biomarker test can be used in collaboration with imaging or used independently, minimizing possible patient complications.
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
WASHINGTON – The concentrations of three biomarkers successfully identified the severity of fibrosis in patients with nonalcoholic steatohepatitis (NASH), according to a study presented at the annual meeting of the American Association for the Study of Liver Diseases.
This noninvasive diagnostic method could replace liver biopsy, the current standard used to diagnose patients with NASH.
Liver biopsies are associated with high cost, high rates of complications like infection, and minimal association with morbidity and mortality, Manal Abdelmalek, MD, a hepatologist and liver transplant specialist at Duke University, Durham, N.C., said in a video interview.
Investigators measured serum concentrations of a2-macroglobulin, hyaluronic acid, and metalloproteinase-1 collected from 792 patients with NASH on the same day as patients’ liver biopsies.
Dr. Abdelmalek and her fellow investigators randomly assigned half of the samples to a training group and half the samples to a validation group.
Investigators found that samples in the training group showed a sensitivity of 84.4% (95% confidence interval, 75.5%-91.0%), compared with 81.1% (95% CI, 71.7%-88.4%) in the validation group. Among patients with liver fibrosis, the biomarker test correctly diagnosed 76.5%-100% of patients, with variations depending on placement in the four classifications based on severity.
Investigators feel optimistic that, with more testing, this biomarker test can be used in collaboration with imaging or used independently, minimizing possible patient complications.
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
AT THE LIVER MEETING 2017
Bilirubin levels associated with transplant-free survival in PBC patients
Normal serum bilirubin concentrations in patients with primary biliary cholangitis (PBC) were associated with improved odds of transplant-free survival, according to a study presented at the annual meeting of the American Association for the Study of Liver Diseases.
In a retrospective analysis of data from the Global PBC Study group, PBC patients who had bilirubin levels between normal and the upper limit of normal at baseline (n = 2,795), at 1 year (n = 3,082), at 3 years (n = 1,657), or at 5 years (n = 1,339) were included in the study. Both ursodeoxycholic acid–treated and untreated patients were included, according to Carla Murillo Perez of Toronto General Hospital and her associates.
Each cohort was organized into quartiles, with Q1 having the lowest bilirubin levels and Q4 having the highest. In the baseline cohort, 5-year transplant-free survival rates were 97% in Q1, 95% in Q2, 96% in Q3, and 91% in Q4; similarly improved odds for transplant-free survival in lower quartiles were seen in the later cohorts.
Higher bilirubin (per 0.1 × upper limit of normal increase) was associated with an increased chance for death or transplantation, with hazard ratios of 1.14 in the baseline cohort, 1.21 in the 1-year cohort, 1.19 in the 3-year cohort, and 1.17 in the 5-year cohort, Ms. Perez and her associates said.
Dr. Cyriel Ponsioen, Dr. Christophe Corpechot, Dr. Marlyn Mayo, Dr. Annarosa Floreani, Dr. Albert Pares, Dr. Frederik Nevens, Dr. Kris Kowdley, Dr. Tony Bruns, Dr. Gideon Hirschfield, Dr. Keith Lindor, and Dr. Harry Janssen reported conflicts of interest.
Normal serum bilirubin concentrations in patients with primary biliary cholangitis (PBC) were associated with improved odds of transplant-free survival, according to a study presented at the annual meeting of the American Association for the Study of Liver Diseases.
In a retrospective analysis of data from the Global PBC Study group, PBC patients who had bilirubin levels between normal and the upper limit of normal at baseline (n = 2,795), at 1 year (n = 3,082), at 3 years (n = 1,657), or at 5 years (n = 1,339) were included in the study. Both ursodeoxycholic acid–treated and untreated patients were included, according to Carla Murillo Perez of Toronto General Hospital and her associates.
Each cohort was organized into quartiles, with Q1 having the lowest bilirubin levels and Q4 having the highest. In the baseline cohort, 5-year transplant-free survival rates were 97% in Q1, 95% in Q2, 96% in Q3, and 91% in Q4; similarly improved odds for transplant-free survival in lower quartiles were seen in the later cohorts.
Higher bilirubin (per 0.1 × upper limit of normal increase) was associated with an increased chance for death or transplantation, with hazard ratios of 1.14 in the baseline cohort, 1.21 in the 1-year cohort, 1.19 in the 3-year cohort, and 1.17 in the 5-year cohort, Ms. Perez and her associates said.
Dr. Cyriel Ponsioen, Dr. Christophe Corpechot, Dr. Marlyn Mayo, Dr. Annarosa Floreani, Dr. Albert Pares, Dr. Frederik Nevens, Dr. Kris Kowdley, Dr. Tony Bruns, Dr. Gideon Hirschfield, Dr. Keith Lindor, and Dr. Harry Janssen reported conflicts of interest.
Normal serum bilirubin concentrations in patients with primary biliary cholangitis (PBC) were associated with improved odds of transplant-free survival, according to a study presented at the annual meeting of the American Association for the Study of Liver Diseases.
In a retrospective analysis of data from the Global PBC Study group, PBC patients who had bilirubin levels between normal and the upper limit of normal at baseline (n = 2,795), at 1 year (n = 3,082), at 3 years (n = 1,657), or at 5 years (n = 1,339) were included in the study. Both ursodeoxycholic acid–treated and untreated patients were included, according to Carla Murillo Perez of Toronto General Hospital and her associates.
Each cohort was organized into quartiles, with Q1 having the lowest bilirubin levels and Q4 having the highest. In the baseline cohort, 5-year transplant-free survival rates were 97% in Q1, 95% in Q2, 96% in Q3, and 91% in Q4; similarly improved odds for transplant-free survival in lower quartiles were seen in the later cohorts.
Higher bilirubin (per 0.1 × upper limit of normal increase) was associated with an increased chance for death or transplantation, with hazard ratios of 1.14 in the baseline cohort, 1.21 in the 1-year cohort, 1.19 in the 3-year cohort, and 1.17 in the 5-year cohort, Ms. Perez and her associates said.
Dr. Cyriel Ponsioen, Dr. Christophe Corpechot, Dr. Marlyn Mayo, Dr. Annarosa Floreani, Dr. Albert Pares, Dr. Frederik Nevens, Dr. Kris Kowdley, Dr. Tony Bruns, Dr. Gideon Hirschfield, Dr. Keith Lindor, and Dr. Harry Janssen reported conflicts of interest.
FROM THE LIVER MEETING 2017
Key clinical point:
Major finding: In a baseline cohort, 5-year transplant-free survival rates were 97% in patients with the lowest bilirubin levels and 91% in patients with the highest.
Data source: A retrospective analysis of data from the Global PBC Study group database.
Disclosures: Dr. Cyriel Ponsioen, Dr. Christophe Corpechot, Dr. Marlyn Mayo, Dr. Annarosa Floreani, Dr. Albert Pares, Dr. Frederik Nevens, Dr. Kris Kowdley, Dr. Tony Bruns, Dr. Gideon Hirschfield, Dr. Keith Lindor, and Dr. Harry Janssen reported conflicts of interest.
Early liver transplant good for patients with severe alcoholic hepatitis
Early liver transplantation was associated with good short-term survival in patients with severe alcoholic hepatitis, but a significant number of patients started consuming alcohol again, according to a study presented at the annual meeting of the American Association for the Study of Liver Diseases.
The study was a retrospective review of the ACCELERATE-AH trial, utilizing a cohort of 147 patients with severe AH who underwent liver transplant prior to a 6-month abstinence period and were discharged home after surgery, said Dr. Brian Lee of the University of California, San Francisco, and his colleagues. Patients also underwent a follow-up period with a median time of 1.6 years.
Pretransplant abstinence time was a median of 55 days, and 54% received steroids for alcoholic hepatitis before the surgery. A total of 141 patients were discharged home after surgery, and 132 survived past 3 months. Of the nine patients who died within 3 months of their liver transplant, eight had received steroid therapy, and five died from sepsis.
No deaths were reported between 3 months and 1 year post transplant, but nine deaths were reported after 1 year, seven of which were alcohol related. The probability of alcohol use after 1 year was 25% and was 34% after 3 years.
After adjustment, a lack of self-admission into a hospital was associated with alcohol usage post transplant, with a hazard ratio of 4.3. In multivariate analysis, any alcohol use post transplant was associated with death, with a hazard ratio of 3.9, Dr. Lee and his colleagues noted.
Dr. Lee, Dr. Mehta, Dr. Platt, Dr. Gurakar, Dr. Im, Dr. Han, Dr. Victor, Dr. Rinella, Dr. Maddur, Dr. Eswaran, Dr. Hause, Dr. Foley, Dr. Dodge, Dr. Li, and Dr. Terrault reported conflicts of interest.
Early liver transplantation was associated with good short-term survival in patients with severe alcoholic hepatitis, but a significant number of patients started consuming alcohol again, according to a study presented at the annual meeting of the American Association for the Study of Liver Diseases.
The study was a retrospective review of the ACCELERATE-AH trial, utilizing a cohort of 147 patients with severe AH who underwent liver transplant prior to a 6-month abstinence period and were discharged home after surgery, said Dr. Brian Lee of the University of California, San Francisco, and his colleagues. Patients also underwent a follow-up period with a median time of 1.6 years.
Pretransplant abstinence time was a median of 55 days, and 54% received steroids for alcoholic hepatitis before the surgery. A total of 141 patients were discharged home after surgery, and 132 survived past 3 months. Of the nine patients who died within 3 months of their liver transplant, eight had received steroid therapy, and five died from sepsis.
No deaths were reported between 3 months and 1 year post transplant, but nine deaths were reported after 1 year, seven of which were alcohol related. The probability of alcohol use after 1 year was 25% and was 34% after 3 years.
After adjustment, a lack of self-admission into a hospital was associated with alcohol usage post transplant, with a hazard ratio of 4.3. In multivariate analysis, any alcohol use post transplant was associated with death, with a hazard ratio of 3.9, Dr. Lee and his colleagues noted.
Dr. Lee, Dr. Mehta, Dr. Platt, Dr. Gurakar, Dr. Im, Dr. Han, Dr. Victor, Dr. Rinella, Dr. Maddur, Dr. Eswaran, Dr. Hause, Dr. Foley, Dr. Dodge, Dr. Li, and Dr. Terrault reported conflicts of interest.
Early liver transplantation was associated with good short-term survival in patients with severe alcoholic hepatitis, but a significant number of patients started consuming alcohol again, according to a study presented at the annual meeting of the American Association for the Study of Liver Diseases.
The study was a retrospective review of the ACCELERATE-AH trial, utilizing a cohort of 147 patients with severe AH who underwent liver transplant prior to a 6-month abstinence period and were discharged home after surgery, said Dr. Brian Lee of the University of California, San Francisco, and his colleagues. Patients also underwent a follow-up period with a median time of 1.6 years.
Pretransplant abstinence time was a median of 55 days, and 54% received steroids for alcoholic hepatitis before the surgery. A total of 141 patients were discharged home after surgery, and 132 survived past 3 months. Of the nine patients who died within 3 months of their liver transplant, eight had received steroid therapy, and five died from sepsis.
No deaths were reported between 3 months and 1 year post transplant, but nine deaths were reported after 1 year, seven of which were alcohol related. The probability of alcohol use after 1 year was 25% and was 34% after 3 years.
After adjustment, a lack of self-admission into a hospital was associated with alcohol usage post transplant, with a hazard ratio of 4.3. In multivariate analysis, any alcohol use post transplant was associated with death, with a hazard ratio of 3.9, Dr. Lee and his colleagues noted.
Dr. Lee, Dr. Mehta, Dr. Platt, Dr. Gurakar, Dr. Im, Dr. Han, Dr. Victor, Dr. Rinella, Dr. Maddur, Dr. Eswaran, Dr. Hause, Dr. Foley, Dr. Dodge, Dr. Li, and Dr. Terrault reported conflicts of interest.
FROM THE LIVER MEETING 2017
Key clinical point:
Major finding: The survival rate post transplant was 94% after 1 year.
Data source: A retrospective review from the ACCELERATE-AH trial of 147 alcoholic hepatitis patients who received liver transplants.
Disclosures: Dr. Lee, Dr. Mehta, Dr. Platt, Dr. Gurakar, Dr. Im, Dr. Han, Dr. Victor, Dr. Rinella, Dr. Maddur, Dr. Eswaran, Dr. Hause, Dr. Foley, Dr. Dodge, Dr. Li, and Dr. Terrault reported conflicts of interest.
Asians have highest rate of herbal dietary supplement DILI liver transplantations
There is a significant relationship between race/ethnicity and drug-induced liver disease requiring liver transplantation caused by herbal and dietary supplements (HDS), according to a study presented at the annual meeting of the American Association for the Study of Liver Diseases.
Asian people had significantly higher rates of HDS DILI that required transplant than did blacks, Hispanics, whites, and others (American Indian/Alaskan native, multiracial, and native Hawaii/Pacific Islander). White people had significantly lower rates of HDS DILI than did blacks, Hispanics, and others.
While the proportion of white people with HDS DILI requiring transplant was much lower than other races/ethnicities, the rate from 2005 to 2015 was significantly higher in this population than in 1995-2005, Dr. Kesar and his colleagues noted.
Dr. Odin is a member of Intercept Pharmaceuticals advisory committees or review panels and is an AASLD member. Dr. Ahmad is an AASLD member.
There is a significant relationship between race/ethnicity and drug-induced liver disease requiring liver transplantation caused by herbal and dietary supplements (HDS), according to a study presented at the annual meeting of the American Association for the Study of Liver Diseases.
Asian people had significantly higher rates of HDS DILI that required transplant than did blacks, Hispanics, whites, and others (American Indian/Alaskan native, multiracial, and native Hawaii/Pacific Islander). White people had significantly lower rates of HDS DILI than did blacks, Hispanics, and others.
While the proportion of white people with HDS DILI requiring transplant was much lower than other races/ethnicities, the rate from 2005 to 2015 was significantly higher in this population than in 1995-2005, Dr. Kesar and his colleagues noted.
Dr. Odin is a member of Intercept Pharmaceuticals advisory committees or review panels and is an AASLD member. Dr. Ahmad is an AASLD member.
There is a significant relationship between race/ethnicity and drug-induced liver disease requiring liver transplantation caused by herbal and dietary supplements (HDS), according to a study presented at the annual meeting of the American Association for the Study of Liver Diseases.
Asian people had significantly higher rates of HDS DILI that required transplant than did blacks, Hispanics, whites, and others (American Indian/Alaskan native, multiracial, and native Hawaii/Pacific Islander). White people had significantly lower rates of HDS DILI than did blacks, Hispanics, and others.
While the proportion of white people with HDS DILI requiring transplant was much lower than other races/ethnicities, the rate from 2005 to 2015 was significantly higher in this population than in 1995-2005, Dr. Kesar and his colleagues noted.
Dr. Odin is a member of Intercept Pharmaceuticals advisory committees or review panels and is an AASLD member. Dr. Ahmad is an AASLD member.
FROM THE LIVER MEETING 2017
Key clinical point:
Major finding: People of Asian descent were most likely to require transplantation because of drug-induced liver injury from herbal dietary supplements.
Data source: Retrospective data analysis of 645 patients from the Organ Procurement and Transplantation Network database.
Disclosures: Dr. Odin is a member of Intercept Pharmaceuticals advisory committees or review panels and is an AASLD member. Dr. Ahmad is an AASLD member.
We’ll be there, covering the news
GI & Hepatology News reporters are geared up to cover the Liver Meeting® at the Walter E. Washington Convention Center, in Washington, starting this weekend. The annual meeting of the American Association for the Study of Liver Diseases is a worldwide meeting of liver specialists that will include presentations of new information on every level of knowledge about the liver from the hepatocyte to organ transplantation.
Onsite reporters will cover new biomarkers for nonalcoholic fatty liver disease, surveillance and treatments for hepatocellular carcinoma, and pre- and posttransplant factors that affect morbidity and mortality.
Highly anticipated presentations include:
- Early liver transplant good for patients with severe alcoholic hepatitis.
- Asians have highest rate of herbal dietary supplement DILI liver transplantations.
- Bilirubin levels associated with transplant-free survival in PBS patients.
GI & Hepatology News reporters are geared up to cover the Liver Meeting® at the Walter E. Washington Convention Center, in Washington, starting this weekend. The annual meeting of the American Association for the Study of Liver Diseases is a worldwide meeting of liver specialists that will include presentations of new information on every level of knowledge about the liver from the hepatocyte to organ transplantation.
Onsite reporters will cover new biomarkers for nonalcoholic fatty liver disease, surveillance and treatments for hepatocellular carcinoma, and pre- and posttransplant factors that affect morbidity and mortality.
Highly anticipated presentations include:
- Early liver transplant good for patients with severe alcoholic hepatitis.
- Asians have highest rate of herbal dietary supplement DILI liver transplantations.
- Bilirubin levels associated with transplant-free survival in PBS patients.
GI & Hepatology News reporters are geared up to cover the Liver Meeting® at the Walter E. Washington Convention Center, in Washington, starting this weekend. The annual meeting of the American Association for the Study of Liver Diseases is a worldwide meeting of liver specialists that will include presentations of new information on every level of knowledge about the liver from the hepatocyte to organ transplantation.
Onsite reporters will cover new biomarkers for nonalcoholic fatty liver disease, surveillance and treatments for hepatocellular carcinoma, and pre- and posttransplant factors that affect morbidity and mortality.
Highly anticipated presentations include:
- Early liver transplant good for patients with severe alcoholic hepatitis.
- Asians have highest rate of herbal dietary supplement DILI liver transplantations.
- Bilirubin levels associated with transplant-free survival in PBS patients.
Study supports routine rapid HCV testing for at-risk youth
Routine finger-stick testing for hepatitis C virus infection is the best screening strategy for 15- to 30-year-olds, provided that at least 6 in every 1,000 have injected drugs, according to the results of a modeling study.
“Currently, nearly all hepatitis C virus (HCV) transmission in the United States occurs among young persons who inject drugs,” wrote Sabrina A. Assoumou, MD, of Boston Medical Center and Boston University and her associates. “We show that routine testing provides the most clinical benefit and best value for money in an urban community health setting where HCV prevalence is high.”
Rapid routine testing consistently yielded more quality-adjusted life years (QALYs) at a lower cost than did the current practice of reflexive, risk-based venipuncture testing, the researchers said. They recommended that urban health centers either replace venipuncture diagnostics with routine finger-stick testing or that they ensure follow-up RNA testing when needed so they can link HCV-positive patients to treatment (Clin Infect Dis. 2017 Sep 9. doi: 10.1093/cid/cix798).
The Centers for Disease Control and Prevention has recommended risk-based HCV testing, but studies indicate that primary care providers often miss the chance to test and have trouble identifying high-risk patients, Dr. Assoumou and her associates said. The standard HCV test is a blood draw for antibody testing followed by confirmatory RNA testing, but a two-step process complicates follow-up.
To compare one-time HCV screening strategies in high-risk settings, the researchers created a decision analytic model using TreeAge Pro 2014 software and input data on prevalence, mortality, treatment costs, and efficacy from an extensive literature review.
Compared with targeted risk-based HCV testing, routine rapid testing performed by dedicated counselors yielded an incremental cost-effectiveness ratio of less than $100,000 per quality-adjusted life year unless the prevalence of injection drug use was less than 0.59%, the prevalence of HCV infection among injection drug users was less than 16%, the reinfection rate exceeded 26 cases per 100 person-years, or all venipuncture antibody tests were followed by confirmatory testing. Routine rapid testing identified 20% of HCV infections in the model, which is four times the rate under current practice. Rates of sustained virologic response were 18% with routine rapid testing and 2% with standard practice.
Routine rapid testing did not dramatically boost QALYs at a population level, the researchers acknowledged, but diagnosing and treating an injection drug user increased life span by an average of 2 years and saved $214,000 per patient in additional costs.
“Rapid testing always provided greater life expectancy than venipuncture testing at either a lower lifetime medical cost or a lower cost/QALY gained,” the investigators concluded. “Future studies are needed to define the programmatic effectiveness of HCV treatment among youth, and testing and treatment acceptability in this population.”
The National Institute on Drug Abuse and the National Institute of Allergy and Infectious Diseases provided funding. The researchers reported having no conflicts of interest.
Routine finger-stick testing for hepatitis C virus infection is the best screening strategy for 15- to 30-year-olds, provided that at least 6 in every 1,000 have injected drugs, according to the results of a modeling study.
“Currently, nearly all hepatitis C virus (HCV) transmission in the United States occurs among young persons who inject drugs,” wrote Sabrina A. Assoumou, MD, of Boston Medical Center and Boston University and her associates. “We show that routine testing provides the most clinical benefit and best value for money in an urban community health setting where HCV prevalence is high.”
Rapid routine testing consistently yielded more quality-adjusted life years (QALYs) at a lower cost than did the current practice of reflexive, risk-based venipuncture testing, the researchers said. They recommended that urban health centers either replace venipuncture diagnostics with routine finger-stick testing or that they ensure follow-up RNA testing when needed so they can link HCV-positive patients to treatment (Clin Infect Dis. 2017 Sep 9. doi: 10.1093/cid/cix798).
The Centers for Disease Control and Prevention has recommended risk-based HCV testing, but studies indicate that primary care providers often miss the chance to test and have trouble identifying high-risk patients, Dr. Assoumou and her associates said. The standard HCV test is a blood draw for antibody testing followed by confirmatory RNA testing, but a two-step process complicates follow-up.
To compare one-time HCV screening strategies in high-risk settings, the researchers created a decision analytic model using TreeAge Pro 2014 software and input data on prevalence, mortality, treatment costs, and efficacy from an extensive literature review.
Compared with targeted risk-based HCV testing, routine rapid testing performed by dedicated counselors yielded an incremental cost-effectiveness ratio of less than $100,000 per quality-adjusted life year unless the prevalence of injection drug use was less than 0.59%, the prevalence of HCV infection among injection drug users was less than 16%, the reinfection rate exceeded 26 cases per 100 person-years, or all venipuncture antibody tests were followed by confirmatory testing. Routine rapid testing identified 20% of HCV infections in the model, which is four times the rate under current practice. Rates of sustained virologic response were 18% with routine rapid testing and 2% with standard practice.
Routine rapid testing did not dramatically boost QALYs at a population level, the researchers acknowledged, but diagnosing and treating an injection drug user increased life span by an average of 2 years and saved $214,000 per patient in additional costs.
“Rapid testing always provided greater life expectancy than venipuncture testing at either a lower lifetime medical cost or a lower cost/QALY gained,” the investigators concluded. “Future studies are needed to define the programmatic effectiveness of HCV treatment among youth, and testing and treatment acceptability in this population.”
The National Institute on Drug Abuse and the National Institute of Allergy and Infectious Diseases provided funding. The researchers reported having no conflicts of interest.
Routine finger-stick testing for hepatitis C virus infection is the best screening strategy for 15- to 30-year-olds, provided that at least 6 in every 1,000 have injected drugs, according to the results of a modeling study.
“Currently, nearly all hepatitis C virus (HCV) transmission in the United States occurs among young persons who inject drugs,” wrote Sabrina A. Assoumou, MD, of Boston Medical Center and Boston University and her associates. “We show that routine testing provides the most clinical benefit and best value for money in an urban community health setting where HCV prevalence is high.”
Rapid routine testing consistently yielded more quality-adjusted life years (QALYs) at a lower cost than did the current practice of reflexive, risk-based venipuncture testing, the researchers said. They recommended that urban health centers either replace venipuncture diagnostics with routine finger-stick testing or that they ensure follow-up RNA testing when needed so they can link HCV-positive patients to treatment (Clin Infect Dis. 2017 Sep 9. doi: 10.1093/cid/cix798).
The Centers for Disease Control and Prevention has recommended risk-based HCV testing, but studies indicate that primary care providers often miss the chance to test and have trouble identifying high-risk patients, Dr. Assoumou and her associates said. The standard HCV test is a blood draw for antibody testing followed by confirmatory RNA testing, but a two-step process complicates follow-up.
To compare one-time HCV screening strategies in high-risk settings, the researchers created a decision analytic model using TreeAge Pro 2014 software and input data on prevalence, mortality, treatment costs, and efficacy from an extensive literature review.
Compared with targeted risk-based HCV testing, routine rapid testing performed by dedicated counselors yielded an incremental cost-effectiveness ratio of less than $100,000 per quality-adjusted life year unless the prevalence of injection drug use was less than 0.59%, the prevalence of HCV infection among injection drug users was less than 16%, the reinfection rate exceeded 26 cases per 100 person-years, or all venipuncture antibody tests were followed by confirmatory testing. Routine rapid testing identified 20% of HCV infections in the model, which is four times the rate under current practice. Rates of sustained virologic response were 18% with routine rapid testing and 2% with standard practice.
Routine rapid testing did not dramatically boost QALYs at a population level, the researchers acknowledged, but diagnosing and treating an injection drug user increased life span by an average of 2 years and saved $214,000 per patient in additional costs.
“Rapid testing always provided greater life expectancy than venipuncture testing at either a lower lifetime medical cost or a lower cost/QALY gained,” the investigators concluded. “Future studies are needed to define the programmatic effectiveness of HCV treatment among youth, and testing and treatment acceptability in this population.”
The National Institute on Drug Abuse and the National Institute of Allergy and Infectious Diseases provided funding. The researchers reported having no conflicts of interest.
FROM CLINICAL INFECTIOUS DISEASES
Key clinical point: Routine finger-stick testing was the most cost-effective way to screen urban adolescents and young adults for hepatitis C virus infection.
Major finding: The incremental cost-effectiveness ratio was less than $100,000 per quality-adjusted life year unless prevalence of injection drug use was less than 0.59%, less than 16% of injection drug users had HCV infection, the reinfection rate exceeded 26 cases per 100 person-years, or all venipuncture antibody tests were followed by confirmatory testing.
Data source: A decision analytic model created with TreeAge Pro 2014 and data from an extensive literature review.
Disclosures: The National Institute on Drug Abuse and the National Institute of Allergy and Infectious Diseases provided funding. The researchers reported having no conflicts of interest.
To boost HCV testing in baby boomers, offer the option
Rates of hepatitis C testing increased among New York adults born between 1945 and 1965 after the state passed a law mandating that health care providers offer HCV testing to people of that age, according to a report from the Centers for Disease Control and Prevention.
In 2013, the year before the new law became effective on Jan. 1, 2014, the total of specimens collected for HCV testing from the 106 clinics that reported data for both 2013 and 2014 was 538,229. In the following year after the law became effective, 813,492 samples were collected from the same clinics, an increase of 51.1% over 2013. The rate of increase for New York Medicaid recipients was similar at 52%.
“This report highlights the potential for state laws to promote HCV testing and the utility of HCV surveillance and Medicaid claims data to monitor the quality of HCV testing and linkage to care for HCV-infected persons,” the CDC investigators concluded.
Find the full report in the MMWR (doi: 10.15585/mmwr.mm6638a3).
Rates of hepatitis C testing increased among New York adults born between 1945 and 1965 after the state passed a law mandating that health care providers offer HCV testing to people of that age, according to a report from the Centers for Disease Control and Prevention.
In 2013, the year before the new law became effective on Jan. 1, 2014, the total of specimens collected for HCV testing from the 106 clinics that reported data for both 2013 and 2014 was 538,229. In the following year after the law became effective, 813,492 samples were collected from the same clinics, an increase of 51.1% over 2013. The rate of increase for New York Medicaid recipients was similar at 52%.
“This report highlights the potential for state laws to promote HCV testing and the utility of HCV surveillance and Medicaid claims data to monitor the quality of HCV testing and linkage to care for HCV-infected persons,” the CDC investigators concluded.
Find the full report in the MMWR (doi: 10.15585/mmwr.mm6638a3).
Rates of hepatitis C testing increased among New York adults born between 1945 and 1965 after the state passed a law mandating that health care providers offer HCV testing to people of that age, according to a report from the Centers for Disease Control and Prevention.
In 2013, the year before the new law became effective on Jan. 1, 2014, the total of specimens collected for HCV testing from the 106 clinics that reported data for both 2013 and 2014 was 538,229. In the following year after the law became effective, 813,492 samples were collected from the same clinics, an increase of 51.1% over 2013. The rate of increase for New York Medicaid recipients was similar at 52%.
“This report highlights the potential for state laws to promote HCV testing and the utility of HCV surveillance and Medicaid claims data to monitor the quality of HCV testing and linkage to care for HCV-infected persons,” the CDC investigators concluded.
Find the full report in the MMWR (doi: 10.15585/mmwr.mm6638a3).
FROM THE MMWR
Hepatitis C drug’s lower cost paves way for Medicaid, prisons to expand treatment
Valerie Green is still waiting to be cured.
The Delaware resident was diagnosed with hepatitis C more than two years ago, but she doesn’t qualify yet for the Medicaid program’s criteria for treatment with a new class of highly effective but pricey drugs. The recent approval of a less expensive drug that generally cures hepatitis C in just eight weeks may make it easier for more insurers and correctional facilities to expand treatment.
The drug, Mavyret, is the first to be approved by the Food and Drug Administration that can cure all six genetic types of hepatitis C in about two months in patients who haven’t previously been treated. Other approved drugs generally require 12 weeks to treat the disease and often aren’t effective for all types of hepatitis C.
In addition, Mavyret’s price tag of $26,400 for a course of treatment is significantly below that of other hepatitis C drugs whose sticker price ranges from about $55,000 to $95,000 to beat the disease. Patients and insurers often pay less, however, through negotiated insurance discounts and rebates.
“It certainly stands to reason that the continual march downwards on cost would lead to continual opening up of criteria,” said Matt Salo, executive director of the National Association of Medicaid Directors.
Hepatitis C is a viral liver infection spread through blood that affects an estimated 3.5 million people in the United States. It can take years to cause problems. Many baby boomers who contracted it decades ago before blood was screened for the virus don’t realize they have it until they develop liver disease. In addition, the growing heroin epidemic is adding to the problem as people become infected by sharing contaminated needles.
“Direct acting antiviral” therapies like Harvoni, a once-a-day pill introduced in 2014 that generally cured hepatitis C in 12 weeks, are much more effective than earlier treatments that required weekly interferon injections and multiple daily pills for nearly a year. But the newer regimens came at a price: $94,500, in Harvoni’s case.
State Medicaid programs, which cover a high proportion of people with hepatitis C, balked at the high prices, even with the 23 percent drug discount the programs typically receive. Many threw up roadblocks to limit drug approval until the disease was advanced. Some required people to be drug- and alcohol-free for six months or more before treatment would be approved.
Those moves prompted advocates to push for better access, in some cases filing suit to force the programs to cover more people.
Faced with a lawsuit in Delaware, the state Medicaid program began loosening up treatment criteria this year, and in January will begin approving enrollees regardless of the severity of their disease.
The state joins more than a dozen others that no longer (or never did) restrict hepatitis C treatment based on disease severity, said Kevin Costello, director of litigation at Harvard Law School’s Center for Health Law and Policy Innovation, which has been a key player in litigation in Delaware and other states.
It can’t happen soon enough, said Green, 58, who believes she contracted the disease 31 years ago when she suffered complications during childbirth and required a blood transfusion. Although her liver isn’t damaged, Green said, she’s suffered with abdominal and joint pain, weight loss and fatigue for decades, symptoms that doctors attribute to the hepatitis C virus.
“It’s been a difficult fight for us Medicaid patients,” she said.
People who are incarcerated face an even tougher battle to get treatment for hepatitis C. Roughly 17 percent of prisoners are infected with hepatitis C, compared with about 1 percent of the general population.
Prisons have a duty not to be deliberately indifferent to the medical needs of incarcerated people. Prisons don’t get the price discounts that the Medicaid programs have, and their budgets are fixed.
“Administrators have to make do with what is there,” said Dr. Anne Spaulding, an associate professor at Emory University’s public health school who has worked as a medical director in corrections and published research on hepatitis C among prisoners.
Lawyers in a handful of states are pursuing class action lawsuits to force prisons to provide hepatitis C treatment. Mavyret may make a difference, said David Rudovsky, a civil rights lawyer who’s litigating a class action lawsuit against the Pennsylvania Department of Corrections.
“Everyone recognizes that it’s going to make it easier to cover people,” he said.
People with regular private insurance may face some obstacles to coverage of hepatitis C, but coverage is typically less problematic. For example, Mavyret is one of seven hepatitis C drugs that are included in the 2018 national preferred formulary by Express Scripts, which manages the pharmacy benefits for 83 million people.
“The benefit to patients and payers is the additional competition, which brings down costs across the class, thus resulting in greater access and affordability,” said Jennifer Luddy, director of corporate communications at Express Scripts.
Please visit khn.org/columnists to send comments or ideas for future topics for the Insuring Your Health column.
KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.
Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
Valerie Green is still waiting to be cured.
The Delaware resident was diagnosed with hepatitis C more than two years ago, but she doesn’t qualify yet for the Medicaid program’s criteria for treatment with a new class of highly effective but pricey drugs. The recent approval of a less expensive drug that generally cures hepatitis C in just eight weeks may make it easier for more insurers and correctional facilities to expand treatment.
The drug, Mavyret, is the first to be approved by the Food and Drug Administration that can cure all six genetic types of hepatitis C in about two months in patients who haven’t previously been treated. Other approved drugs generally require 12 weeks to treat the disease and often aren’t effective for all types of hepatitis C.
In addition, Mavyret’s price tag of $26,400 for a course of treatment is significantly below that of other hepatitis C drugs whose sticker price ranges from about $55,000 to $95,000 to beat the disease. Patients and insurers often pay less, however, through negotiated insurance discounts and rebates.
“It certainly stands to reason that the continual march downwards on cost would lead to continual opening up of criteria,” said Matt Salo, executive director of the National Association of Medicaid Directors.
Hepatitis C is a viral liver infection spread through blood that affects an estimated 3.5 million people in the United States. It can take years to cause problems. Many baby boomers who contracted it decades ago before blood was screened for the virus don’t realize they have it until they develop liver disease. In addition, the growing heroin epidemic is adding to the problem as people become infected by sharing contaminated needles.
“Direct acting antiviral” therapies like Harvoni, a once-a-day pill introduced in 2014 that generally cured hepatitis C in 12 weeks, are much more effective than earlier treatments that required weekly interferon injections and multiple daily pills for nearly a year. But the newer regimens came at a price: $94,500, in Harvoni’s case.
State Medicaid programs, which cover a high proportion of people with hepatitis C, balked at the high prices, even with the 23 percent drug discount the programs typically receive. Many threw up roadblocks to limit drug approval until the disease was advanced. Some required people to be drug- and alcohol-free for six months or more before treatment would be approved.
Those moves prompted advocates to push for better access, in some cases filing suit to force the programs to cover more people.
Faced with a lawsuit in Delaware, the state Medicaid program began loosening up treatment criteria this year, and in January will begin approving enrollees regardless of the severity of their disease.
The state joins more than a dozen others that no longer (or never did) restrict hepatitis C treatment based on disease severity, said Kevin Costello, director of litigation at Harvard Law School’s Center for Health Law and Policy Innovation, which has been a key player in litigation in Delaware and other states.
It can’t happen soon enough, said Green, 58, who believes she contracted the disease 31 years ago when she suffered complications during childbirth and required a blood transfusion. Although her liver isn’t damaged, Green said, she’s suffered with abdominal and joint pain, weight loss and fatigue for decades, symptoms that doctors attribute to the hepatitis C virus.
“It’s been a difficult fight for us Medicaid patients,” she said.
People who are incarcerated face an even tougher battle to get treatment for hepatitis C. Roughly 17 percent of prisoners are infected with hepatitis C, compared with about 1 percent of the general population.
Prisons have a duty not to be deliberately indifferent to the medical needs of incarcerated people. Prisons don’t get the price discounts that the Medicaid programs have, and their budgets are fixed.
“Administrators have to make do with what is there,” said Dr. Anne Spaulding, an associate professor at Emory University’s public health school who has worked as a medical director in corrections and published research on hepatitis C among prisoners.
Lawyers in a handful of states are pursuing class action lawsuits to force prisons to provide hepatitis C treatment. Mavyret may make a difference, said David Rudovsky, a civil rights lawyer who’s litigating a class action lawsuit against the Pennsylvania Department of Corrections.
“Everyone recognizes that it’s going to make it easier to cover people,” he said.
People with regular private insurance may face some obstacles to coverage of hepatitis C, but coverage is typically less problematic. For example, Mavyret is one of seven hepatitis C drugs that are included in the 2018 national preferred formulary by Express Scripts, which manages the pharmacy benefits for 83 million people.
“The benefit to patients and payers is the additional competition, which brings down costs across the class, thus resulting in greater access and affordability,” said Jennifer Luddy, director of corporate communications at Express Scripts.
Please visit khn.org/columnists to send comments or ideas for future topics for the Insuring Your Health column.
KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.
Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
Valerie Green is still waiting to be cured.
The Delaware resident was diagnosed with hepatitis C more than two years ago, but she doesn’t qualify yet for the Medicaid program’s criteria for treatment with a new class of highly effective but pricey drugs. The recent approval of a less expensive drug that generally cures hepatitis C in just eight weeks may make it easier for more insurers and correctional facilities to expand treatment.
The drug, Mavyret, is the first to be approved by the Food and Drug Administration that can cure all six genetic types of hepatitis C in about two months in patients who haven’t previously been treated. Other approved drugs generally require 12 weeks to treat the disease and often aren’t effective for all types of hepatitis C.
In addition, Mavyret’s price tag of $26,400 for a course of treatment is significantly below that of other hepatitis C drugs whose sticker price ranges from about $55,000 to $95,000 to beat the disease. Patients and insurers often pay less, however, through negotiated insurance discounts and rebates.
“It certainly stands to reason that the continual march downwards on cost would lead to continual opening up of criteria,” said Matt Salo, executive director of the National Association of Medicaid Directors.
Hepatitis C is a viral liver infection spread through blood that affects an estimated 3.5 million people in the United States. It can take years to cause problems. Many baby boomers who contracted it decades ago before blood was screened for the virus don’t realize they have it until they develop liver disease. In addition, the growing heroin epidemic is adding to the problem as people become infected by sharing contaminated needles.
“Direct acting antiviral” therapies like Harvoni, a once-a-day pill introduced in 2014 that generally cured hepatitis C in 12 weeks, are much more effective than earlier treatments that required weekly interferon injections and multiple daily pills for nearly a year. But the newer regimens came at a price: $94,500, in Harvoni’s case.
State Medicaid programs, which cover a high proportion of people with hepatitis C, balked at the high prices, even with the 23 percent drug discount the programs typically receive. Many threw up roadblocks to limit drug approval until the disease was advanced. Some required people to be drug- and alcohol-free for six months or more before treatment would be approved.
Those moves prompted advocates to push for better access, in some cases filing suit to force the programs to cover more people.
Faced with a lawsuit in Delaware, the state Medicaid program began loosening up treatment criteria this year, and in January will begin approving enrollees regardless of the severity of their disease.
The state joins more than a dozen others that no longer (or never did) restrict hepatitis C treatment based on disease severity, said Kevin Costello, director of litigation at Harvard Law School’s Center for Health Law and Policy Innovation, which has been a key player in litigation in Delaware and other states.
It can’t happen soon enough, said Green, 58, who believes she contracted the disease 31 years ago when she suffered complications during childbirth and required a blood transfusion. Although her liver isn’t damaged, Green said, she’s suffered with abdominal and joint pain, weight loss and fatigue for decades, symptoms that doctors attribute to the hepatitis C virus.
“It’s been a difficult fight for us Medicaid patients,” she said.
People who are incarcerated face an even tougher battle to get treatment for hepatitis C. Roughly 17 percent of prisoners are infected with hepatitis C, compared with about 1 percent of the general population.
Prisons have a duty not to be deliberately indifferent to the medical needs of incarcerated people. Prisons don’t get the price discounts that the Medicaid programs have, and their budgets are fixed.
“Administrators have to make do with what is there,” said Dr. Anne Spaulding, an associate professor at Emory University’s public health school who has worked as a medical director in corrections and published research on hepatitis C among prisoners.
Lawyers in a handful of states are pursuing class action lawsuits to force prisons to provide hepatitis C treatment. Mavyret may make a difference, said David Rudovsky, a civil rights lawyer who’s litigating a class action lawsuit against the Pennsylvania Department of Corrections.
“Everyone recognizes that it’s going to make it easier to cover people,” he said.
People with regular private insurance may face some obstacles to coverage of hepatitis C, but coverage is typically less problematic. For example, Mavyret is one of seven hepatitis C drugs that are included in the 2018 national preferred formulary by Express Scripts, which manages the pharmacy benefits for 83 million people.
“The benefit to patients and payers is the additional competition, which brings down costs across the class, thus resulting in greater access and affordability,” said Jennifer Luddy, director of corporate communications at Express Scripts.
Please visit khn.org/columnists to send comments or ideas for future topics for the Insuring Your Health column.
KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.
Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
Alcohol showed no cardiovascular benefits in nonalcoholic fatty liver disease
Alcohol consumption produced no apparent cardiovascular benefits among individuals with nonalcoholic fatty liver disease, according to a study of 570 white and black adults from the Coronary Artery Risk Development in Young Adults (CARDIA) longitudinal cohort.
After researchers controlled for multiple demographic and clinical confounders, alcohol use was not associated with cardiovascular risk factors such as diabetes, hypertension, or hyperlipidemia, nor with homeostatic model assessment of insulin resistance, C-reactive protein level, total cholesterol, systolic or diastolic blood pressure, coronary artery calcification, E/A ratio, or global longitudinal strain among individuals with nonalcoholic fatty liver disease (NAFLD), reported Lisa B. VanWagner, MD, of Northwestern University, Chicago, and her associates. “[A] recommendation of cardiovascular disease risk benefit of alcohol use in persons with NAFLD cannot be made based on the current findings,” they wrote. They advocated for prospective, long-term studies to better understand how various types and doses of alcohol affect hard cardiovascular endpoints in patients with NAFLD. Their study was published in Gastroenterology.
CARDIA enrolled 5,115 black and white adults aged 18-30 years from four cities in the United States, and followed them long term. Participants were asked about alcohol consumption at study entry and again at 15, 20, and 25 years of follow-up. At year 25, participants underwent computed tomography (CT) examinations of the thorax and abdomen and tissue Doppler echocardiography with myocardial strain measured by speckle tracking (Gastroenterology. 2017 Aug 9. doi: 10.1053/j.gastro.2017.08.012).
The 570 participants with NAFLD averaged 50 years of age, 54% were black, 46% were female, and 58% consumed at least one alcoholic drink per week, said the researchers. Compared with nondrinkers, drinkers had attained significantly higher education levels, were significantly more likely to be white and male, and had a significantly lower average body mass index (34.4 kg/m2 vs. 37.3 kg/m2) and C-reactive protein level (4.2 vs. 6.1 mg per L), and a significantly lower prevalence of diabetes (23% vs. 37%), impaired glucose tolerance (42% vs. 49%), obesity (75% vs. 83%) and metabolic syndrome (55% vs. 66%) (P less than .05 for all comparisons). Drinkers and nondrinkers resembled each other in terms of lipid profiles, use of lipid-lowering medications, liver attenuation scores, and systolic and diastolic blood pressures, although significantly more nondrinkers used antihypertensive medications (46% vs.35%; P = .005).
Drinkers had a higher prevalence of coronary artery calcification, defined as Agatston score above 0 (42% vs. 34%), and the difference approached statistical significance (P = .05). However, after they adjusted for multiple potential confounders, the researchers found no link between alcohol consumption and risk factors for cardiovascular disease or between alcohol consumption and measures of subclinical cardiovascular disease. This finding persisted in sensitivity analyses that examined alcohol dose, binge drinking, history of cardiovascular events, and former heavy alcohol use.
SOURCE: AMERICAN GASTROENTEROLOGICAL ASSOCIATION
Taken together, the findings “challenge the belief that alcohol use may reduce cardiovascular disease risk in persons with nonalcoholic fatty liver disease,” the investigators concluded. Clinical heart failure was too rare to reliably assess, but “we failed to observe an association between alcohol use and multiple markers of subclinical changes in cardiac structure and function that may be precursors of incident heart failure in NAFLD,” they wrote. More longitudinal studies would be needed to clarify how moderate alcohol use in NAFLD affects coronary artery calcification or changes in myocardial structure and function, they cautioned.
The National Institutes of Health supported the work. The investigators reported having no relevant conflicts of interest.
Alcohol consumption produced no apparent cardiovascular benefits among individuals with nonalcoholic fatty liver disease, according to a study of 570 white and black adults from the Coronary Artery Risk Development in Young Adults (CARDIA) longitudinal cohort.
After researchers controlled for multiple demographic and clinical confounders, alcohol use was not associated with cardiovascular risk factors such as diabetes, hypertension, or hyperlipidemia, nor with homeostatic model assessment of insulin resistance, C-reactive protein level, total cholesterol, systolic or diastolic blood pressure, coronary artery calcification, E/A ratio, or global longitudinal strain among individuals with nonalcoholic fatty liver disease (NAFLD), reported Lisa B. VanWagner, MD, of Northwestern University, Chicago, and her associates. “[A] recommendation of cardiovascular disease risk benefit of alcohol use in persons with NAFLD cannot be made based on the current findings,” they wrote. They advocated for prospective, long-term studies to better understand how various types and doses of alcohol affect hard cardiovascular endpoints in patients with NAFLD. Their study was published in Gastroenterology.
CARDIA enrolled 5,115 black and white adults aged 18-30 years from four cities in the United States, and followed them long term. Participants were asked about alcohol consumption at study entry and again at 15, 20, and 25 years of follow-up. At year 25, participants underwent computed tomography (CT) examinations of the thorax and abdomen and tissue Doppler echocardiography with myocardial strain measured by speckle tracking (Gastroenterology. 2017 Aug 9. doi: 10.1053/j.gastro.2017.08.012).
The 570 participants with NAFLD averaged 50 years of age, 54% were black, 46% were female, and 58% consumed at least one alcoholic drink per week, said the researchers. Compared with nondrinkers, drinkers had attained significantly higher education levels, were significantly more likely to be white and male, and had a significantly lower average body mass index (34.4 kg/m2 vs. 37.3 kg/m2) and C-reactive protein level (4.2 vs. 6.1 mg per L), and a significantly lower prevalence of diabetes (23% vs. 37%), impaired glucose tolerance (42% vs. 49%), obesity (75% vs. 83%) and metabolic syndrome (55% vs. 66%) (P less than .05 for all comparisons). Drinkers and nondrinkers resembled each other in terms of lipid profiles, use of lipid-lowering medications, liver attenuation scores, and systolic and diastolic blood pressures, although significantly more nondrinkers used antihypertensive medications (46% vs.35%; P = .005).
Drinkers had a higher prevalence of coronary artery calcification, defined as Agatston score above 0 (42% vs. 34%), and the difference approached statistical significance (P = .05). However, after they adjusted for multiple potential confounders, the researchers found no link between alcohol consumption and risk factors for cardiovascular disease or between alcohol consumption and measures of subclinical cardiovascular disease. This finding persisted in sensitivity analyses that examined alcohol dose, binge drinking, history of cardiovascular events, and former heavy alcohol use.
SOURCE: AMERICAN GASTROENTEROLOGICAL ASSOCIATION
Taken together, the findings “challenge the belief that alcohol use may reduce cardiovascular disease risk in persons with nonalcoholic fatty liver disease,” the investigators concluded. Clinical heart failure was too rare to reliably assess, but “we failed to observe an association between alcohol use and multiple markers of subclinical changes in cardiac structure and function that may be precursors of incident heart failure in NAFLD,” they wrote. More longitudinal studies would be needed to clarify how moderate alcohol use in NAFLD affects coronary artery calcification or changes in myocardial structure and function, they cautioned.
The National Institutes of Health supported the work. The investigators reported having no relevant conflicts of interest.
Alcohol consumption produced no apparent cardiovascular benefits among individuals with nonalcoholic fatty liver disease, according to a study of 570 white and black adults from the Coronary Artery Risk Development in Young Adults (CARDIA) longitudinal cohort.
After researchers controlled for multiple demographic and clinical confounders, alcohol use was not associated with cardiovascular risk factors such as diabetes, hypertension, or hyperlipidemia, nor with homeostatic model assessment of insulin resistance, C-reactive protein level, total cholesterol, systolic or diastolic blood pressure, coronary artery calcification, E/A ratio, or global longitudinal strain among individuals with nonalcoholic fatty liver disease (NAFLD), reported Lisa B. VanWagner, MD, of Northwestern University, Chicago, and her associates. “[A] recommendation of cardiovascular disease risk benefit of alcohol use in persons with NAFLD cannot be made based on the current findings,” they wrote. They advocated for prospective, long-term studies to better understand how various types and doses of alcohol affect hard cardiovascular endpoints in patients with NAFLD. Their study was published in Gastroenterology.
CARDIA enrolled 5,115 black and white adults aged 18-30 years from four cities in the United States, and followed them long term. Participants were asked about alcohol consumption at study entry and again at 15, 20, and 25 years of follow-up. At year 25, participants underwent computed tomography (CT) examinations of the thorax and abdomen and tissue Doppler echocardiography with myocardial strain measured by speckle tracking (Gastroenterology. 2017 Aug 9. doi: 10.1053/j.gastro.2017.08.012).
The 570 participants with NAFLD averaged 50 years of age, 54% were black, 46% were female, and 58% consumed at least one alcoholic drink per week, said the researchers. Compared with nondrinkers, drinkers had attained significantly higher education levels, were significantly more likely to be white and male, and had a significantly lower average body mass index (34.4 kg/m2 vs. 37.3 kg/m2) and C-reactive protein level (4.2 vs. 6.1 mg per L), and a significantly lower prevalence of diabetes (23% vs. 37%), impaired glucose tolerance (42% vs. 49%), obesity (75% vs. 83%) and metabolic syndrome (55% vs. 66%) (P less than .05 for all comparisons). Drinkers and nondrinkers resembled each other in terms of lipid profiles, use of lipid-lowering medications, liver attenuation scores, and systolic and diastolic blood pressures, although significantly more nondrinkers used antihypertensive medications (46% vs.35%; P = .005).
Drinkers had a higher prevalence of coronary artery calcification, defined as Agatston score above 0 (42% vs. 34%), and the difference approached statistical significance (P = .05). However, after they adjusted for multiple potential confounders, the researchers found no link between alcohol consumption and risk factors for cardiovascular disease or between alcohol consumption and measures of subclinical cardiovascular disease. This finding persisted in sensitivity analyses that examined alcohol dose, binge drinking, history of cardiovascular events, and former heavy alcohol use.
SOURCE: AMERICAN GASTROENTEROLOGICAL ASSOCIATION
Taken together, the findings “challenge the belief that alcohol use may reduce cardiovascular disease risk in persons with nonalcoholic fatty liver disease,” the investigators concluded. Clinical heart failure was too rare to reliably assess, but “we failed to observe an association between alcohol use and multiple markers of subclinical changes in cardiac structure and function that may be precursors of incident heart failure in NAFLD,” they wrote. More longitudinal studies would be needed to clarify how moderate alcohol use in NAFLD affects coronary artery calcification or changes in myocardial structure and function, they cautioned.
The National Institutes of Health supported the work. The investigators reported having no relevant conflicts of interest.
FROM GASTROENTEROLOGY
Key clinical point: No cardioprotective effects were shown with alcohol consumption in adults with nonalcoholic fatty liver disease.
Major finding: After researchers adjusted for multiple confounders, alcohol use was not associated with risk factors for cardiovascular disease or with indicators of subclinical cardiovascular disease.
Data source: A longitudinal, population-based study of 570 individuals with nonalcoholic fatty liver disease.
Disclosures: The National Institutes of Health supported the work. The investigators reported having no relevant conflicts of interest.