User login
HCV patients with early-stage hepatocellular carcinoma can achieve SVR
BOSTON – Among patients with hepatocellular carcinoma (HCC), rates of sustained viral response (SVR) to direct-acting regimens for hepatitis C virus were 79% for genotype 1, 69% for genotype 2, and 47% for genotype 3 infections, reported George N. Ioannou, MD.
“These rates are lower than in patients who do not have hepatocellular carcinoma [HCC], but are still remarkably high,” Dr. Ioannou said during an oral presentation at the annual meeting of the American Association for the Study of Liver Diseases. “Antiviral therapy should be considered in patients with early-stage hepatocellular carcinoma, ideally after adequate locoregional treatments.”
The study included Veterans Affairs Health Care System data on 17,487 recipients of direct-acting anti-HCV regimens. When patients did not have HCC, SVR rates were 93% for genotype 1 infection, 87% for genotype 2 (GT2), and 76% for GT3. Among the 624 (3.6%) patients with a history of HCC, 142 underwent antiviral treatment after transplantation and 482 received other types of cancer therapy.
Why HCC is associated with lower SVR in HCV patients remains unclear, Dr. Ioannou noted. Age does not seem to explain the effect, and neither does sex, race, or ethnicity; cirrhosis or decompensated cirrhosis; renal disease; diabetes; HCV viral load; genotype or subgenotype; HCV regimen; or treatment experience, he said.
Dr. Ioannou noted several study limitations. Nine percent of patients lacked data on SVR, and the imputation to correct for this lowered SVR rates by about 1%-2%. The dataset also did not include information on HCC tumor size or number, and the researchers have not yet examined how antiviral therapy affects the likelihood of de novo HCC, recurrent HCC, or progression of cirrhosis and liver dysfunction.
The Veterans Affairs Office of Research and Development sponsored the study. Dr. Ioannou had no disclosures.
BOSTON – Among patients with hepatocellular carcinoma (HCC), rates of sustained viral response (SVR) to direct-acting regimens for hepatitis C virus were 79% for genotype 1, 69% for genotype 2, and 47% for genotype 3 infections, reported George N. Ioannou, MD.
“These rates are lower than in patients who do not have hepatocellular carcinoma [HCC], but are still remarkably high,” Dr. Ioannou said during an oral presentation at the annual meeting of the American Association for the Study of Liver Diseases. “Antiviral therapy should be considered in patients with early-stage hepatocellular carcinoma, ideally after adequate locoregional treatments.”
The study included Veterans Affairs Health Care System data on 17,487 recipients of direct-acting anti-HCV regimens. When patients did not have HCC, SVR rates were 93% for genotype 1 infection, 87% for genotype 2 (GT2), and 76% for GT3. Among the 624 (3.6%) patients with a history of HCC, 142 underwent antiviral treatment after transplantation and 482 received other types of cancer therapy.
Why HCC is associated with lower SVR in HCV patients remains unclear, Dr. Ioannou noted. Age does not seem to explain the effect, and neither does sex, race, or ethnicity; cirrhosis or decompensated cirrhosis; renal disease; diabetes; HCV viral load; genotype or subgenotype; HCV regimen; or treatment experience, he said.
Dr. Ioannou noted several study limitations. Nine percent of patients lacked data on SVR, and the imputation to correct for this lowered SVR rates by about 1%-2%. The dataset also did not include information on HCC tumor size or number, and the researchers have not yet examined how antiviral therapy affects the likelihood of de novo HCC, recurrent HCC, or progression of cirrhosis and liver dysfunction.
The Veterans Affairs Office of Research and Development sponsored the study. Dr. Ioannou had no disclosures.
BOSTON – Among patients with hepatocellular carcinoma (HCC), rates of sustained viral response (SVR) to direct-acting regimens for hepatitis C virus were 79% for genotype 1, 69% for genotype 2, and 47% for genotype 3 infections, reported George N. Ioannou, MD.
“These rates are lower than in patients who do not have hepatocellular carcinoma [HCC], but are still remarkably high,” Dr. Ioannou said during an oral presentation at the annual meeting of the American Association for the Study of Liver Diseases. “Antiviral therapy should be considered in patients with early-stage hepatocellular carcinoma, ideally after adequate locoregional treatments.”
The study included Veterans Affairs Health Care System data on 17,487 recipients of direct-acting anti-HCV regimens. When patients did not have HCC, SVR rates were 93% for genotype 1 infection, 87% for genotype 2 (GT2), and 76% for GT3. Among the 624 (3.6%) patients with a history of HCC, 142 underwent antiviral treatment after transplantation and 482 received other types of cancer therapy.
Why HCC is associated with lower SVR in HCV patients remains unclear, Dr. Ioannou noted. Age does not seem to explain the effect, and neither does sex, race, or ethnicity; cirrhosis or decompensated cirrhosis; renal disease; diabetes; HCV viral load; genotype or subgenotype; HCV regimen; or treatment experience, he said.
Dr. Ioannou noted several study limitations. Nine percent of patients lacked data on SVR, and the imputation to correct for this lowered SVR rates by about 1%-2%. The dataset also did not include information on HCC tumor size or number, and the researchers have not yet examined how antiviral therapy affects the likelihood of de novo HCC, recurrent HCC, or progression of cirrhosis and liver dysfunction.
The Veterans Affairs Office of Research and Development sponsored the study. Dr. Ioannou had no disclosures.
AT THE LIVER MEETING
Key clinical point: Consider direct-acting antiviral therapy in HCV-infected patients with early-stage HCC.
Major finding: Rates of sustained viral response were 79% in HCC patients with GT1 HCV infection, 69% in GT2 patients, and 47% in GT3 patients.
Data source: An analysis of Veterans Affairs Health Care System data on 17,487 recipients of direct-acting antiviral regimens, including 624 patients with HCC.
Disclosures: The Veterans Affairs Office of Research and Development sponsored the study.
Early TIPS effective in high-risk cirrhosis patients, but still underutilized
BOSTON – High-risk cirrhosis patients treated early with a transjugular intrahepatic portosystemic shunt (TIPS) showed increased survival rates and reduced rates of adverse events, according to a study.
The data were presented at the American Association for the Study of Liver Diseases by Virginia Hernandez-Gea, MD, a hepatologist at the Hospital Clinic in Barcelona.
In each study arm, three-quarters were men in their mid-50s. Cirrhosis in the non-TIPS group was alcohol-related in 57.4% of the cohort, compared with 71.2% of the group given early TIPS; roughly half of each group mentioned alcohol use in the past 3 months.
Also similar were Model for End-stage Liver Disease (MELD) scores: an average of 15.5 in the non-TIPS group, compared with 15 on average in the TIPS group. Nearly three-quarters of the TIPS group had a Child-Pugh C score, compared with 64% in the non-TIPS group. A Child-Pugh score with active bleeding was recorded in 28.8% of the TIPS group, compared with 36% in the non-TIPS group.
The transplant-free survival rate at 1 year in the standard care group was 61%, compared with 76% in the early TIPS group (P = .0175). The failure and bleeding rate at 1 year was significantly higher in the standard care group: 91%, compared with 68% in the early TIPS group (P = .004). Failure and bleeding rates in the Child-Pugh B and C groups across the study were similar.
Ascites at 1 year was seen in 88% of the standard care group, compared with in 64% of the study group. Rates of hepatic encephalopathy were similar in those with Child-Pugh B with active bleeding, and Child-Pugh C across both groups: 22% in the standard care group vs. 25% in the early TIPS group.
That there was no associated significant risk of hepatic encephalopathy in persons with acute variceal bleeding who were given early TIPS “strongly suggests that early TIPS should be included in clinical practice,” Dr. Hernandez-Gea said, noting that only 10% of the 34 sites in the study had used early TIPS. “We don’t really know why centers are not using this, since it is very difficult to find treatments that extend survival rates in this population.”
[email protected]
On Twitter @whitneymcknight
BOSTON – High-risk cirrhosis patients treated early with a transjugular intrahepatic portosystemic shunt (TIPS) showed increased survival rates and reduced rates of adverse events, according to a study.
The data were presented at the American Association for the Study of Liver Diseases by Virginia Hernandez-Gea, MD, a hepatologist at the Hospital Clinic in Barcelona.
In each study arm, three-quarters were men in their mid-50s. Cirrhosis in the non-TIPS group was alcohol-related in 57.4% of the cohort, compared with 71.2% of the group given early TIPS; roughly half of each group mentioned alcohol use in the past 3 months.
Also similar were Model for End-stage Liver Disease (MELD) scores: an average of 15.5 in the non-TIPS group, compared with 15 on average in the TIPS group. Nearly three-quarters of the TIPS group had a Child-Pugh C score, compared with 64% in the non-TIPS group. A Child-Pugh score with active bleeding was recorded in 28.8% of the TIPS group, compared with 36% in the non-TIPS group.
The transplant-free survival rate at 1 year in the standard care group was 61%, compared with 76% in the early TIPS group (P = .0175). The failure and bleeding rate at 1 year was significantly higher in the standard care group: 91%, compared with 68% in the early TIPS group (P = .004). Failure and bleeding rates in the Child-Pugh B and C groups across the study were similar.
Ascites at 1 year was seen in 88% of the standard care group, compared with in 64% of the study group. Rates of hepatic encephalopathy were similar in those with Child-Pugh B with active bleeding, and Child-Pugh C across both groups: 22% in the standard care group vs. 25% in the early TIPS group.
That there was no associated significant risk of hepatic encephalopathy in persons with acute variceal bleeding who were given early TIPS “strongly suggests that early TIPS should be included in clinical practice,” Dr. Hernandez-Gea said, noting that only 10% of the 34 sites in the study had used early TIPS. “We don’t really know why centers are not using this, since it is very difficult to find treatments that extend survival rates in this population.”
[email protected]
On Twitter @whitneymcknight
BOSTON – High-risk cirrhosis patients treated early with a transjugular intrahepatic portosystemic shunt (TIPS) showed increased survival rates and reduced rates of adverse events, according to a study.
The data were presented at the American Association for the Study of Liver Diseases by Virginia Hernandez-Gea, MD, a hepatologist at the Hospital Clinic in Barcelona.
In each study arm, three-quarters were men in their mid-50s. Cirrhosis in the non-TIPS group was alcohol-related in 57.4% of the cohort, compared with 71.2% of the group given early TIPS; roughly half of each group mentioned alcohol use in the past 3 months.
Also similar were Model for End-stage Liver Disease (MELD) scores: an average of 15.5 in the non-TIPS group, compared with 15 on average in the TIPS group. Nearly three-quarters of the TIPS group had a Child-Pugh C score, compared with 64% in the non-TIPS group. A Child-Pugh score with active bleeding was recorded in 28.8% of the TIPS group, compared with 36% in the non-TIPS group.
The transplant-free survival rate at 1 year in the standard care group was 61%, compared with 76% in the early TIPS group (P = .0175). The failure and bleeding rate at 1 year was significantly higher in the standard care group: 91%, compared with 68% in the early TIPS group (P = .004). Failure and bleeding rates in the Child-Pugh B and C groups across the study were similar.
Ascites at 1 year was seen in 88% of the standard care group, compared with in 64% of the study group. Rates of hepatic encephalopathy were similar in those with Child-Pugh B with active bleeding, and Child-Pugh C across both groups: 22% in the standard care group vs. 25% in the early TIPS group.
That there was no associated significant risk of hepatic encephalopathy in persons with acute variceal bleeding who were given early TIPS “strongly suggests that early TIPS should be included in clinical practice,” Dr. Hernandez-Gea said, noting that only 10% of the 34 sites in the study had used early TIPS. “We don’t really know why centers are not using this, since it is very difficult to find treatments that extend survival rates in this population.”
[email protected]
On Twitter @whitneymcknight
AT THE LIVER MEETING
Key clinical point:
Major finding: At 1 year post procedure, early TIPS was associated with better rates of survival and lower rates of adverse events, compared with those who did not receive early TIPS.
Data source: Multicenter, international observational study between 2011 and 2015 of 671 high-risk patients with cirrhosis managed according to current guidelines.
Disclosures: Dr. Hernandez-Gea did not have any relevant disclosures.
Metabolomics of liquid biopsies offer a comprehensive look at NAFLD
BOSTON – Metabolomics of liquid biopsies noninvasively identified nonalcoholic fatty liver disease (NAFLD) with and without steatosis, and assessed the severity of both steatosis and fibrosis, Puneet Puri, MD, reported at the annual meeting of the American Association for the Study of Liver Diseases.
“These data provide proof of concept that liquid biopsy metabolomics can be used to resolve diagnostic questions in NAFLD management,” said Dr. Puri of Virginia Commonwealth University Medical Center in Richmond.
The researchers first developed a model that distinguished NAFLD patients from controls based on body mass index and the relative plasma concentrations of 11 triglycerides. This model correctly classified patients and controls 90% of the time (area under the receiver operating characteristic curve [AUROC], 0.90; standard deviation, 0.02) in the discovery cohort, and 93% of the time in the validation cohort (AUROC, 0.93; SD, 0.03). The sensitivity of the model was 98% in the discovery cohort and 97% in the validation cohort, and its specificity was 78% in the discovery cohort and 82% in the validation cohort.
The investigators then developed a lipodomic signature to assess the severity of steatosis in NAFLD patients, using magnetic resonance (MR) hepatic fat fraction data as the standard. This lipodomic signature correlated with MR with an r value of 0.81 (P less than .0001).
Next, they evaluated metabolomics for diagnosing nonalcoholic steatohepatitis (NASH). A model that accounted for body mass index (BMI) and the relative concentrations of 20 triglycerides distinguished biopsy-confirmed nonalcoholic fatty liver without steatosis from NASH with an AUROC of 0.95, a sensitivity of 0.83, and a specificity of 0.94 in the discovery cohort. In the validation cohort, the AUROC was 0.84, sensitivity was 79%, and specificity was 92%.
Finally, the researchers developed a way to use metabolomics to evaluate the severity of fibrosis. An algorithm that incorporated 16 variables for phospholipids, triacylglycerols, and nonesterified fatty acids distinguished F0 from F1 through F4 fibrosis with an AUROC of 0.92. Its sensitivity was 90%, and its specificity was 77%. A separate algorithm that incorporated five variables for phospholipids, triacylglycerols, acylcarnitines, sphingolipids, and sterols distinguished F1/F2 fibrosis from F3/F4 fibrosis with an AUROC of 0.89. Its sensitivity was only 62%, but its specificity was 93%.
This proof-of-concept study supports the idea that NAFLD and NASH cause metabolic changes, which in turn alter the circulating metabolome and can be noninvasively measured for diagnostic purposes, Dr. Puri concluded.
Dr. Puri did not list funding sources. He reported having no relevant financial conflicts of interest.
BOSTON – Metabolomics of liquid biopsies noninvasively identified nonalcoholic fatty liver disease (NAFLD) with and without steatosis, and assessed the severity of both steatosis and fibrosis, Puneet Puri, MD, reported at the annual meeting of the American Association for the Study of Liver Diseases.
“These data provide proof of concept that liquid biopsy metabolomics can be used to resolve diagnostic questions in NAFLD management,” said Dr. Puri of Virginia Commonwealth University Medical Center in Richmond.
The researchers first developed a model that distinguished NAFLD patients from controls based on body mass index and the relative plasma concentrations of 11 triglycerides. This model correctly classified patients and controls 90% of the time (area under the receiver operating characteristic curve [AUROC], 0.90; standard deviation, 0.02) in the discovery cohort, and 93% of the time in the validation cohort (AUROC, 0.93; SD, 0.03). The sensitivity of the model was 98% in the discovery cohort and 97% in the validation cohort, and its specificity was 78% in the discovery cohort and 82% in the validation cohort.
The investigators then developed a lipodomic signature to assess the severity of steatosis in NAFLD patients, using magnetic resonance (MR) hepatic fat fraction data as the standard. This lipodomic signature correlated with MR with an r value of 0.81 (P less than .0001).
Next, they evaluated metabolomics for diagnosing nonalcoholic steatohepatitis (NASH). A model that accounted for body mass index (BMI) and the relative concentrations of 20 triglycerides distinguished biopsy-confirmed nonalcoholic fatty liver without steatosis from NASH with an AUROC of 0.95, a sensitivity of 0.83, and a specificity of 0.94 in the discovery cohort. In the validation cohort, the AUROC was 0.84, sensitivity was 79%, and specificity was 92%.
Finally, the researchers developed a way to use metabolomics to evaluate the severity of fibrosis. An algorithm that incorporated 16 variables for phospholipids, triacylglycerols, and nonesterified fatty acids distinguished F0 from F1 through F4 fibrosis with an AUROC of 0.92. Its sensitivity was 90%, and its specificity was 77%. A separate algorithm that incorporated five variables for phospholipids, triacylglycerols, acylcarnitines, sphingolipids, and sterols distinguished F1/F2 fibrosis from F3/F4 fibrosis with an AUROC of 0.89. Its sensitivity was only 62%, but its specificity was 93%.
This proof-of-concept study supports the idea that NAFLD and NASH cause metabolic changes, which in turn alter the circulating metabolome and can be noninvasively measured for diagnostic purposes, Dr. Puri concluded.
Dr. Puri did not list funding sources. He reported having no relevant financial conflicts of interest.
BOSTON – Metabolomics of liquid biopsies noninvasively identified nonalcoholic fatty liver disease (NAFLD) with and without steatosis, and assessed the severity of both steatosis and fibrosis, Puneet Puri, MD, reported at the annual meeting of the American Association for the Study of Liver Diseases.
“These data provide proof of concept that liquid biopsy metabolomics can be used to resolve diagnostic questions in NAFLD management,” said Dr. Puri of Virginia Commonwealth University Medical Center in Richmond.
The researchers first developed a model that distinguished NAFLD patients from controls based on body mass index and the relative plasma concentrations of 11 triglycerides. This model correctly classified patients and controls 90% of the time (area under the receiver operating characteristic curve [AUROC], 0.90; standard deviation, 0.02) in the discovery cohort, and 93% of the time in the validation cohort (AUROC, 0.93; SD, 0.03). The sensitivity of the model was 98% in the discovery cohort and 97% in the validation cohort, and its specificity was 78% in the discovery cohort and 82% in the validation cohort.
The investigators then developed a lipodomic signature to assess the severity of steatosis in NAFLD patients, using magnetic resonance (MR) hepatic fat fraction data as the standard. This lipodomic signature correlated with MR with an r value of 0.81 (P less than .0001).
Next, they evaluated metabolomics for diagnosing nonalcoholic steatohepatitis (NASH). A model that accounted for body mass index (BMI) and the relative concentrations of 20 triglycerides distinguished biopsy-confirmed nonalcoholic fatty liver without steatosis from NASH with an AUROC of 0.95, a sensitivity of 0.83, and a specificity of 0.94 in the discovery cohort. In the validation cohort, the AUROC was 0.84, sensitivity was 79%, and specificity was 92%.
Finally, the researchers developed a way to use metabolomics to evaluate the severity of fibrosis. An algorithm that incorporated 16 variables for phospholipids, triacylglycerols, and nonesterified fatty acids distinguished F0 from F1 through F4 fibrosis with an AUROC of 0.92. Its sensitivity was 90%, and its specificity was 77%. A separate algorithm that incorporated five variables for phospholipids, triacylglycerols, acylcarnitines, sphingolipids, and sterols distinguished F1/F2 fibrosis from F3/F4 fibrosis with an AUROC of 0.89. Its sensitivity was only 62%, but its specificity was 93%.
This proof-of-concept study supports the idea that NAFLD and NASH cause metabolic changes, which in turn alter the circulating metabolome and can be noninvasively measured for diagnostic purposes, Dr. Puri concluded.
Dr. Puri did not list funding sources. He reported having no relevant financial conflicts of interest.
AT THE LIVER MEETING 2016
Key clinical point: Metabolomics of liquid biopsies identified and characterized nonalcoholic fatty liver disease in a proof-of-concept study.
Major finding: Four distinct models diagnosed NAFLD, diagnosed NASH, and characterized the severity of steatosis and fibrosis.
Data source: A multicenter study of 817 patients with biopsy-confirmed NAFLD and 130 biopsy-confirmed controls.
Disclosures: Dr. Puri did not list funding sources. He reported having no relevant financial conflicts of interest.
Time to consider cirrhosis medical homes
BOSTON – As part of the push to create value-based care across the specialties, hepatologists should consider medical homes for their patients, such as those with cirrhosis, according to experts.
“Cirrhosis is a chronic condition, highly symptomatic, and occurs in highly comorbid individuals. Treating them in a medical home scenario means we can offer services that we don’t otherwise do, but which are associated with better outcomes for our patients,” Fasiha Kanwal, MD, of the department of medicine at Baylor College of Medicine, Houston, said in a panel presentation at the annual meeting of the American Association for the Study of Liver Diseases.
Essentially, value-based care is the evolution of evidence-based medicine, according to Zobair M. Younossi, MD, AGAF, FAASLD, chair of the department of medicine at Inova Fairfax (Va.) Hospital. With value-based care, aligned incentives across all the specialties will lead to more precise accounting and efficiencies of care, said Dr. Younossi, who was also on the panel. “It would be very difficult right now to ask a hospital to tell you exactly what the cost of their liver care would be,” he said.
However, at present there are no true value-based models for hepatology in the United States, according to Dr. Kanwal, so clinicians should start by defining what will “truly constitute value for our patients.”
Because psychosocial support is essential to improved outcomes in patients with cirrhosis, she suggested adding case managers in practice, as they can help coordinate with services in the community at large. Other suggestions she offered included extending office hours, operating an after-hours hotline, and building teams that include general internists, additional nursing staff, and nutritionists.
Even though such changes in clinical practice models now are inevitable, Dr. Kanwal said there are few data at present that support how to innovate care in hospitalized patients with cirrhosis. This matters, as how patients present for outpatient follow-up care will impact reimbursements to the clinicians who treat them.
Some possible ways to improve hospital outcomes for patients with cirrhosis include creating a “best practice alert” that prompts a hepatology consult and triggers the implementation of a standardized set of guidelines for addressing ascites, bleeding, acute kidney injury, encephalopathy, and hepatorenal syndrome. For those with decompensated cirrhosis or for those who need transplants, a similar standardized checklist can be systematized between the hospital and clinic, emphasizing inpatient rifaximin and prophylactic antibiotics in case of spontaneous bacterial peritonitis.
With an overt emphasis on the needs of patients and payers, clinicians now must compete with one another to offer the most comprehensive, cost-effective care supported by information technology structures that can assess real time costs and outcomes, said Dr. Younossi. “Hepatology is lagging behind other fields in all this,” he added.
This worries Dr. Kanwal: “We should be the ones to determine what the value should be. We should be the ones to decide what the model will be and to engage with other fields, and the payers. Otherwise we will not have a seat at the table.”
Dr. Kanwal and Dr. Younossi did not have any relevant financial disclosures.
On Twitter @whitneymcknight
BOSTON – As part of the push to create value-based care across the specialties, hepatologists should consider medical homes for their patients, such as those with cirrhosis, according to experts.
“Cirrhosis is a chronic condition, highly symptomatic, and occurs in highly comorbid individuals. Treating them in a medical home scenario means we can offer services that we don’t otherwise do, but which are associated with better outcomes for our patients,” Fasiha Kanwal, MD, of the department of medicine at Baylor College of Medicine, Houston, said in a panel presentation at the annual meeting of the American Association for the Study of Liver Diseases.
Essentially, value-based care is the evolution of evidence-based medicine, according to Zobair M. Younossi, MD, AGAF, FAASLD, chair of the department of medicine at Inova Fairfax (Va.) Hospital. With value-based care, aligned incentives across all the specialties will lead to more precise accounting and efficiencies of care, said Dr. Younossi, who was also on the panel. “It would be very difficult right now to ask a hospital to tell you exactly what the cost of their liver care would be,” he said.
However, at present there are no true value-based models for hepatology in the United States, according to Dr. Kanwal, so clinicians should start by defining what will “truly constitute value for our patients.”
Because psychosocial support is essential to improved outcomes in patients with cirrhosis, she suggested adding case managers in practice, as they can help coordinate with services in the community at large. Other suggestions she offered included extending office hours, operating an after-hours hotline, and building teams that include general internists, additional nursing staff, and nutritionists.
Even though such changes in clinical practice models now are inevitable, Dr. Kanwal said there are few data at present that support how to innovate care in hospitalized patients with cirrhosis. This matters, as how patients present for outpatient follow-up care will impact reimbursements to the clinicians who treat them.
Some possible ways to improve hospital outcomes for patients with cirrhosis include creating a “best practice alert” that prompts a hepatology consult and triggers the implementation of a standardized set of guidelines for addressing ascites, bleeding, acute kidney injury, encephalopathy, and hepatorenal syndrome. For those with decompensated cirrhosis or for those who need transplants, a similar standardized checklist can be systematized between the hospital and clinic, emphasizing inpatient rifaximin and prophylactic antibiotics in case of spontaneous bacterial peritonitis.
With an overt emphasis on the needs of patients and payers, clinicians now must compete with one another to offer the most comprehensive, cost-effective care supported by information technology structures that can assess real time costs and outcomes, said Dr. Younossi. “Hepatology is lagging behind other fields in all this,” he added.
This worries Dr. Kanwal: “We should be the ones to determine what the value should be. We should be the ones to decide what the model will be and to engage with other fields, and the payers. Otherwise we will not have a seat at the table.”
Dr. Kanwal and Dr. Younossi did not have any relevant financial disclosures.
On Twitter @whitneymcknight
BOSTON – As part of the push to create value-based care across the specialties, hepatologists should consider medical homes for their patients, such as those with cirrhosis, according to experts.
“Cirrhosis is a chronic condition, highly symptomatic, and occurs in highly comorbid individuals. Treating them in a medical home scenario means we can offer services that we don’t otherwise do, but which are associated with better outcomes for our patients,” Fasiha Kanwal, MD, of the department of medicine at Baylor College of Medicine, Houston, said in a panel presentation at the annual meeting of the American Association for the Study of Liver Diseases.
Essentially, value-based care is the evolution of evidence-based medicine, according to Zobair M. Younossi, MD, AGAF, FAASLD, chair of the department of medicine at Inova Fairfax (Va.) Hospital. With value-based care, aligned incentives across all the specialties will lead to more precise accounting and efficiencies of care, said Dr. Younossi, who was also on the panel. “It would be very difficult right now to ask a hospital to tell you exactly what the cost of their liver care would be,” he said.
However, at present there are no true value-based models for hepatology in the United States, according to Dr. Kanwal, so clinicians should start by defining what will “truly constitute value for our patients.”
Because psychosocial support is essential to improved outcomes in patients with cirrhosis, she suggested adding case managers in practice, as they can help coordinate with services in the community at large. Other suggestions she offered included extending office hours, operating an after-hours hotline, and building teams that include general internists, additional nursing staff, and nutritionists.
Even though such changes in clinical practice models now are inevitable, Dr. Kanwal said there are few data at present that support how to innovate care in hospitalized patients with cirrhosis. This matters, as how patients present for outpatient follow-up care will impact reimbursements to the clinicians who treat them.
Some possible ways to improve hospital outcomes for patients with cirrhosis include creating a “best practice alert” that prompts a hepatology consult and triggers the implementation of a standardized set of guidelines for addressing ascites, bleeding, acute kidney injury, encephalopathy, and hepatorenal syndrome. For those with decompensated cirrhosis or for those who need transplants, a similar standardized checklist can be systematized between the hospital and clinic, emphasizing inpatient rifaximin and prophylactic antibiotics in case of spontaneous bacterial peritonitis.
With an overt emphasis on the needs of patients and payers, clinicians now must compete with one another to offer the most comprehensive, cost-effective care supported by information technology structures that can assess real time costs and outcomes, said Dr. Younossi. “Hepatology is lagging behind other fields in all this,” he added.
This worries Dr. Kanwal: “We should be the ones to determine what the value should be. We should be the ones to decide what the model will be and to engage with other fields, and the payers. Otherwise we will not have a seat at the table.”
Dr. Kanwal and Dr. Younossi did not have any relevant financial disclosures.
On Twitter @whitneymcknight
EXPERT ANALYSIS FROM THE LIVER MEETING 2016
Sofosbuvir/velpatasvir improved patient-reported outcomes, knocked out HCV genotypes 1-6
BOSTON – When given with ribavirin, a fixed-dose combination of sofosbuvir/velpatasvir (Epclusa) achieved a sustained viral response at 12 weeks (SVR-12) in 94% of decompensated cirrhotic patients with hepatitis C virus (HCV) genotypes 1-6 infection, according to Zobair M. Younossi, MD.
Patients with and without cirrhosis also reported meaningful improvements across a variety of outcome measures after successfully completing treatment with Epclusa or sofosbuvir (Harvoni), said Dr. Younossi of Inova Fairfax Hospital in Falls Church, Va. “Although on-treatment patient-reported outcomes improved more with ribavirin-free regimens, post-SVR improvements were similar,” regardless of whether patients had received ribavirin, he reported at the annual meeting of the American Association for the Study of Liver Diseases.
Epclusa without ribavirin led to SVR-12 in 85% of decompensated cirrhotic patients and nearly 99% of noncirrhotic patients of all HCV genotypes, Dr. Younossi reported. For sofosbuvir with ribavirin, rates of SVR-12 were 66% in genotype 3 cirrhotic patients and 95% in cirrhotic patients of other HCV genotypes.
At baseline, cirrhotic patients scored up to 33.5 points worse than noncirrhotics on a universal 100-point scale covering 26 patient-reported domains (P less than .05 for all but 3 domains). Decompensated cirrhotics reported more baseline depression and fatigue than other patients (P less than .002 for each comparison), while patients without cirrhosis were more likely to be treatment naive and employed (both P less than .0001). But after the investigators controlled for these differences, decompensated cirrhotics who received Epclusa reported an additional 5.5-9 points of improvement in treatment-emergent outcomes than those who received sofosbuvir plus ribavirin (P less than .002). Patients with compensated cirrhosis reported 2.3-5 points more improvement in treatment-emergent outcomes on Epclusa than on sofosbuvir plus ribavirin (P less than .05). “Decompensated cirrhotics experienced the best and greatest improvement of patient-reported outcome scores during treatment with sofosbuvir/velpatasvir,” Dr. Younossi said.
Patients who received ribavirin reported similar changes across domains at the end of treatment, regardless of cirrhosis status. Among patients who achieved SVR-12, decompensated cirrhotics reported significantly more improvement 12 weeks later than did patients with less severe liver disease, although both groups showed long-term improvements (5.8 points vs. 4.1 points, P less than .05). Clearly, patients continue to report improvements in various domains as time goes on, “suggesting that all the benefit of cure is not achieved by 12 weeks of follow-up,” said Dr. Younossi.
Gilead Sciences makes Epclusa and Harvoni and funded the study. Dr. Younossi reported having no relevant financial conflicts.
BOSTON – When given with ribavirin, a fixed-dose combination of sofosbuvir/velpatasvir (Epclusa) achieved a sustained viral response at 12 weeks (SVR-12) in 94% of decompensated cirrhotic patients with hepatitis C virus (HCV) genotypes 1-6 infection, according to Zobair M. Younossi, MD.
Patients with and without cirrhosis also reported meaningful improvements across a variety of outcome measures after successfully completing treatment with Epclusa or sofosbuvir (Harvoni), said Dr. Younossi of Inova Fairfax Hospital in Falls Church, Va. “Although on-treatment patient-reported outcomes improved more with ribavirin-free regimens, post-SVR improvements were similar,” regardless of whether patients had received ribavirin, he reported at the annual meeting of the American Association for the Study of Liver Diseases.
Epclusa without ribavirin led to SVR-12 in 85% of decompensated cirrhotic patients and nearly 99% of noncirrhotic patients of all HCV genotypes, Dr. Younossi reported. For sofosbuvir with ribavirin, rates of SVR-12 were 66% in genotype 3 cirrhotic patients and 95% in cirrhotic patients of other HCV genotypes.
At baseline, cirrhotic patients scored up to 33.5 points worse than noncirrhotics on a universal 100-point scale covering 26 patient-reported domains (P less than .05 for all but 3 domains). Decompensated cirrhotics reported more baseline depression and fatigue than other patients (P less than .002 for each comparison), while patients without cirrhosis were more likely to be treatment naive and employed (both P less than .0001). But after the investigators controlled for these differences, decompensated cirrhotics who received Epclusa reported an additional 5.5-9 points of improvement in treatment-emergent outcomes than those who received sofosbuvir plus ribavirin (P less than .002). Patients with compensated cirrhosis reported 2.3-5 points more improvement in treatment-emergent outcomes on Epclusa than on sofosbuvir plus ribavirin (P less than .05). “Decompensated cirrhotics experienced the best and greatest improvement of patient-reported outcome scores during treatment with sofosbuvir/velpatasvir,” Dr. Younossi said.
Patients who received ribavirin reported similar changes across domains at the end of treatment, regardless of cirrhosis status. Among patients who achieved SVR-12, decompensated cirrhotics reported significantly more improvement 12 weeks later than did patients with less severe liver disease, although both groups showed long-term improvements (5.8 points vs. 4.1 points, P less than .05). Clearly, patients continue to report improvements in various domains as time goes on, “suggesting that all the benefit of cure is not achieved by 12 weeks of follow-up,” said Dr. Younossi.
Gilead Sciences makes Epclusa and Harvoni and funded the study. Dr. Younossi reported having no relevant financial conflicts.
BOSTON – When given with ribavirin, a fixed-dose combination of sofosbuvir/velpatasvir (Epclusa) achieved a sustained viral response at 12 weeks (SVR-12) in 94% of decompensated cirrhotic patients with hepatitis C virus (HCV) genotypes 1-6 infection, according to Zobair M. Younossi, MD.
Patients with and without cirrhosis also reported meaningful improvements across a variety of outcome measures after successfully completing treatment with Epclusa or sofosbuvir (Harvoni), said Dr. Younossi of Inova Fairfax Hospital in Falls Church, Va. “Although on-treatment patient-reported outcomes improved more with ribavirin-free regimens, post-SVR improvements were similar,” regardless of whether patients had received ribavirin, he reported at the annual meeting of the American Association for the Study of Liver Diseases.
Epclusa without ribavirin led to SVR-12 in 85% of decompensated cirrhotic patients and nearly 99% of noncirrhotic patients of all HCV genotypes, Dr. Younossi reported. For sofosbuvir with ribavirin, rates of SVR-12 were 66% in genotype 3 cirrhotic patients and 95% in cirrhotic patients of other HCV genotypes.
At baseline, cirrhotic patients scored up to 33.5 points worse than noncirrhotics on a universal 100-point scale covering 26 patient-reported domains (P less than .05 for all but 3 domains). Decompensated cirrhotics reported more baseline depression and fatigue than other patients (P less than .002 for each comparison), while patients without cirrhosis were more likely to be treatment naive and employed (both P less than .0001). But after the investigators controlled for these differences, decompensated cirrhotics who received Epclusa reported an additional 5.5-9 points of improvement in treatment-emergent outcomes than those who received sofosbuvir plus ribavirin (P less than .002). Patients with compensated cirrhosis reported 2.3-5 points more improvement in treatment-emergent outcomes on Epclusa than on sofosbuvir plus ribavirin (P less than .05). “Decompensated cirrhotics experienced the best and greatest improvement of patient-reported outcome scores during treatment with sofosbuvir/velpatasvir,” Dr. Younossi said.
Patients who received ribavirin reported similar changes across domains at the end of treatment, regardless of cirrhosis status. Among patients who achieved SVR-12, decompensated cirrhotics reported significantly more improvement 12 weeks later than did patients with less severe liver disease, although both groups showed long-term improvements (5.8 points vs. 4.1 points, P less than .05). Clearly, patients continue to report improvements in various domains as time goes on, “suggesting that all the benefit of cure is not achieved by 12 weeks of follow-up,” said Dr. Younossi.
Gilead Sciences makes Epclusa and Harvoni and funded the study. Dr. Younossi reported having no relevant financial conflicts.
AT THE LIVER MEETING 2016
Key clinical point: Sofosbuvir/velpatasvir with ribavirin effectively cured most hepatitis C virus–infected patients with decompensated cirrhosis.
Major finding: In all, 94% of patients achieved a sustained viral response at 12 weeks, regardless of HCV genotype.
Data source: The phase III ASTRAL trials involving 1,701 patients with pangenotypic hepatitis C virus infections.
Disclosures: Gilead Sciences makes Epclusa and Harvoni and funded the study. Dr. Younossi reported having no relevant financial conflicts.
NAFLD can regress with weight loss, activity
BOSTON – All phenotypes of nonalcoholic fatty liver disease (NAFLD) can progress or regress even without pharmacologic intervention, according to a prospective longitudinal study of 394 patients.
Weight loss and baseline NAFLD Activity Score predicted resolution of NAFLD, while weight gain and rising serum transaminases predicted progression to nonalcoholic steatohepatitis (NASH), Arun J. Sanyal, MD, said at the annual meeting of the American Association for the Study of Liver Diseases. Baseline and subsequent NAFLD Activity Score also was “a strong predictor of fibrosis progression or regression,” as was AST, portal inflammation, and baseline fibrosis stage, said Dr. Sanyal of Virginia Commonwealth University in Richmond, Va.
NAFLD comprises two main phenotypes, fatty liver and steatohepatitis. “The phenotype can change over time, and both phenotypes can be associated with fibrosis,” Dr. Sanyal noted. To better understand trends and clinical correlates for these phenotypes, he and his associates analyzed prospectively collected clinical and biopsy data from the NASH Clinical Research Network of the National Institutes of Diabetes and Digestive and Kidney Diseases. Each patient attended multiple clinic visits and underwent two liver biopsies at least 1 year and usually 4-5 years apart, which were interpreted by a masked central pathology review committee.
At baseline, 75 patients had fatty liver without steatohepatitis, of which only 13% resolved and 44% progressed to borderline or definite steatohepatitis. Similarly, among 74 patients with borderline steatohepatitis at baseline, only 22% regressed to fatty liver disease without steatohepatitis, while 43% progressed to definite steatohepatitis. The remaining 245 patients had definite steatohepatitis at baseline, of which 58% failed to regress at all, 20% regressed to borderline, 11% regressed to fatty liver disease without steatohepatitis, and 11% regressed to normal.
The investigators also performed a multivariable analysis of 197 patients with complete data. After the investigators controlled for serum insulin level, alkaline phosphatase level, NAS, and the presence of metabolic syndrome, each 10-U/L increase in ALT more than doubled the odds of progression from fatty liver without steatohepatitis to NASH (odds ratio, 2.2; 95% confidence interval, 1.1 to 4.1; P = .02). The association was even stronger for AST (OR, 3.5; 95% CI, 1.2 to 10.4; P = .03), and each 1-kg gain in body weight increased the odds of progression to NASH by 70% (OR, 1.7; 95% CI, 1.1 to 2.5; P = .01). In contrast, resolution of NAFLD was associated with weight loss (OR per 1 kg, 0.9; P less than .001) and lower baseline NAFLD Activity Score (OR, 0.7; P = .04).
About one in four patients had evidence of fibrosis at baseline, and 44% had at least stage 1 fibrosis at follow-up biopsy. Patients whose NAFLD progressed to a more severe phenotype were much more likely to have evidence of progressive fibrosis than were those whose NAFLD did not progress (OR, 7.2; 95% CI, 2.1 to 21.5; P less than .001), and there was no evidence that time between liver biopsies influenced this relationship. Among patients with definite NASH who had stage 0 fibrosis at baseline, 50% progressed to at least 1 fibrosis stage over the next 6.8 years, and 50% progressed to at least 2 stages over 9.6 years. Patients whose baseline NAFLD Activity Scores were between 1 and 4 were most likely to experience regression of fibrosis, while those with scores between 5 and 8 were more likely to have worsening fibrosis. Patients with severe baseline NAFLD Activity Score component scores for steatosis, lobular inflammation, and ballooning also were significantly more likely to have progressive fibrosis than were those with baseline NAFLD Activity Scores of 0 or 1. Furthermore, increasing NAFLD Activity Score over time predicted fibrosis progression.
Diabetes did not seem to affect fibrosis progression or regression, Dr. Sanyal noted. However, baseline portal inflammation predicted worsening fibrosis (P less than .01), as did baseline and subsequent elevations in AST (P less than .001), insulin (P = .03), and NAS (P less than 001), and baseline ballooning (P less than .01).
The investigators reported that the study had no sponsors. Dr. Sanyal disclosed ties to a wide number of drug companies.
BOSTON – All phenotypes of nonalcoholic fatty liver disease (NAFLD) can progress or regress even without pharmacologic intervention, according to a prospective longitudinal study of 394 patients.
Weight loss and baseline NAFLD Activity Score predicted resolution of NAFLD, while weight gain and rising serum transaminases predicted progression to nonalcoholic steatohepatitis (NASH), Arun J. Sanyal, MD, said at the annual meeting of the American Association for the Study of Liver Diseases. Baseline and subsequent NAFLD Activity Score also was “a strong predictor of fibrosis progression or regression,” as was AST, portal inflammation, and baseline fibrosis stage, said Dr. Sanyal of Virginia Commonwealth University in Richmond, Va.
NAFLD comprises two main phenotypes, fatty liver and steatohepatitis. “The phenotype can change over time, and both phenotypes can be associated with fibrosis,” Dr. Sanyal noted. To better understand trends and clinical correlates for these phenotypes, he and his associates analyzed prospectively collected clinical and biopsy data from the NASH Clinical Research Network of the National Institutes of Diabetes and Digestive and Kidney Diseases. Each patient attended multiple clinic visits and underwent two liver biopsies at least 1 year and usually 4-5 years apart, which were interpreted by a masked central pathology review committee.
At baseline, 75 patients had fatty liver without steatohepatitis, of which only 13% resolved and 44% progressed to borderline or definite steatohepatitis. Similarly, among 74 patients with borderline steatohepatitis at baseline, only 22% regressed to fatty liver disease without steatohepatitis, while 43% progressed to definite steatohepatitis. The remaining 245 patients had definite steatohepatitis at baseline, of which 58% failed to regress at all, 20% regressed to borderline, 11% regressed to fatty liver disease without steatohepatitis, and 11% regressed to normal.
The investigators also performed a multivariable analysis of 197 patients with complete data. After the investigators controlled for serum insulin level, alkaline phosphatase level, NAS, and the presence of metabolic syndrome, each 10-U/L increase in ALT more than doubled the odds of progression from fatty liver without steatohepatitis to NASH (odds ratio, 2.2; 95% confidence interval, 1.1 to 4.1; P = .02). The association was even stronger for AST (OR, 3.5; 95% CI, 1.2 to 10.4; P = .03), and each 1-kg gain in body weight increased the odds of progression to NASH by 70% (OR, 1.7; 95% CI, 1.1 to 2.5; P = .01). In contrast, resolution of NAFLD was associated with weight loss (OR per 1 kg, 0.9; P less than .001) and lower baseline NAFLD Activity Score (OR, 0.7; P = .04).
About one in four patients had evidence of fibrosis at baseline, and 44% had at least stage 1 fibrosis at follow-up biopsy. Patients whose NAFLD progressed to a more severe phenotype were much more likely to have evidence of progressive fibrosis than were those whose NAFLD did not progress (OR, 7.2; 95% CI, 2.1 to 21.5; P less than .001), and there was no evidence that time between liver biopsies influenced this relationship. Among patients with definite NASH who had stage 0 fibrosis at baseline, 50% progressed to at least 1 fibrosis stage over the next 6.8 years, and 50% progressed to at least 2 stages over 9.6 years. Patients whose baseline NAFLD Activity Scores were between 1 and 4 were most likely to experience regression of fibrosis, while those with scores between 5 and 8 were more likely to have worsening fibrosis. Patients with severe baseline NAFLD Activity Score component scores for steatosis, lobular inflammation, and ballooning also were significantly more likely to have progressive fibrosis than were those with baseline NAFLD Activity Scores of 0 or 1. Furthermore, increasing NAFLD Activity Score over time predicted fibrosis progression.
Diabetes did not seem to affect fibrosis progression or regression, Dr. Sanyal noted. However, baseline portal inflammation predicted worsening fibrosis (P less than .01), as did baseline and subsequent elevations in AST (P less than .001), insulin (P = .03), and NAS (P less than 001), and baseline ballooning (P less than .01).
The investigators reported that the study had no sponsors. Dr. Sanyal disclosed ties to a wide number of drug companies.
BOSTON – All phenotypes of nonalcoholic fatty liver disease (NAFLD) can progress or regress even without pharmacologic intervention, according to a prospective longitudinal study of 394 patients.
Weight loss and baseline NAFLD Activity Score predicted resolution of NAFLD, while weight gain and rising serum transaminases predicted progression to nonalcoholic steatohepatitis (NASH), Arun J. Sanyal, MD, said at the annual meeting of the American Association for the Study of Liver Diseases. Baseline and subsequent NAFLD Activity Score also was “a strong predictor of fibrosis progression or regression,” as was AST, portal inflammation, and baseline fibrosis stage, said Dr. Sanyal of Virginia Commonwealth University in Richmond, Va.
NAFLD comprises two main phenotypes, fatty liver and steatohepatitis. “The phenotype can change over time, and both phenotypes can be associated with fibrosis,” Dr. Sanyal noted. To better understand trends and clinical correlates for these phenotypes, he and his associates analyzed prospectively collected clinical and biopsy data from the NASH Clinical Research Network of the National Institutes of Diabetes and Digestive and Kidney Diseases. Each patient attended multiple clinic visits and underwent two liver biopsies at least 1 year and usually 4-5 years apart, which were interpreted by a masked central pathology review committee.
At baseline, 75 patients had fatty liver without steatohepatitis, of which only 13% resolved and 44% progressed to borderline or definite steatohepatitis. Similarly, among 74 patients with borderline steatohepatitis at baseline, only 22% regressed to fatty liver disease without steatohepatitis, while 43% progressed to definite steatohepatitis. The remaining 245 patients had definite steatohepatitis at baseline, of which 58% failed to regress at all, 20% regressed to borderline, 11% regressed to fatty liver disease without steatohepatitis, and 11% regressed to normal.
The investigators also performed a multivariable analysis of 197 patients with complete data. After the investigators controlled for serum insulin level, alkaline phosphatase level, NAS, and the presence of metabolic syndrome, each 10-U/L increase in ALT more than doubled the odds of progression from fatty liver without steatohepatitis to NASH (odds ratio, 2.2; 95% confidence interval, 1.1 to 4.1; P = .02). The association was even stronger for AST (OR, 3.5; 95% CI, 1.2 to 10.4; P = .03), and each 1-kg gain in body weight increased the odds of progression to NASH by 70% (OR, 1.7; 95% CI, 1.1 to 2.5; P = .01). In contrast, resolution of NAFLD was associated with weight loss (OR per 1 kg, 0.9; P less than .001) and lower baseline NAFLD Activity Score (OR, 0.7; P = .04).
About one in four patients had evidence of fibrosis at baseline, and 44% had at least stage 1 fibrosis at follow-up biopsy. Patients whose NAFLD progressed to a more severe phenotype were much more likely to have evidence of progressive fibrosis than were those whose NAFLD did not progress (OR, 7.2; 95% CI, 2.1 to 21.5; P less than .001), and there was no evidence that time between liver biopsies influenced this relationship. Among patients with definite NASH who had stage 0 fibrosis at baseline, 50% progressed to at least 1 fibrosis stage over the next 6.8 years, and 50% progressed to at least 2 stages over 9.6 years. Patients whose baseline NAFLD Activity Scores were between 1 and 4 were most likely to experience regression of fibrosis, while those with scores between 5 and 8 were more likely to have worsening fibrosis. Patients with severe baseline NAFLD Activity Score component scores for steatosis, lobular inflammation, and ballooning also were significantly more likely to have progressive fibrosis than were those with baseline NAFLD Activity Scores of 0 or 1. Furthermore, increasing NAFLD Activity Score over time predicted fibrosis progression.
Diabetes did not seem to affect fibrosis progression or regression, Dr. Sanyal noted. However, baseline portal inflammation predicted worsening fibrosis (P less than .01), as did baseline and subsequent elevations in AST (P less than .001), insulin (P = .03), and NAS (P less than 001), and baseline ballooning (P less than .01).
The investigators reported that the study had no sponsors. Dr. Sanyal disclosed ties to a wide number of drug companies.
AT THE LIVER MEETING 2016
Key clinical point: Phenotypes of nonalcoholic fatty liver disease can progress or regress over time.
Major finding: Resolution of NAFLD was associated with weight loss (OR per 1 kg, 0.9; P less than .001) and lower baseline NAFLD Activity Score (OR, 0.7; P = .04).
Data source: A prospective study of 394 patients with nonalcoholic fatty liver disease.
Disclosures: The investigators reported that the study had no sponsors. Dr. Sanyal disclosed ties to several drug companies.
Tumor boards linked to improved survival in hepatocellular carcinoma
BOSTON – Veterans were about 13% less likely to die within 5 years of hepatocellular carcinoma diagnosis when multidisciplinary tumor boards managed their care than if they did not, according to a large, multicenter observational study.
Seeing a hepatologist or surgeon within 30 days of diagnosis also significantly improved 5-year overall survival, even after controlling for age, race, Charlson-Deyo comorbidity index, Barcelona Clinic Liver Cancer (BCLC) stage, academic center and geographic region of care, and the distance patients lived from the nearest Veterans Affairs transplant center, Marina Serper, MD, reported at the annual meeting of the American Association for the Study of Liver Diseases. “More studies are needed to understand how to best use multidisciplinary tumor boards to improve the care of patients with hepatocellular carcinoma,” she said.
Outcomes data for hepatocellular carcinoma mostly come from clinical trials; transplant centers; and Surveillance, Epidemiology, and End Results-Medicare analyses, noted Dr. Serper of the University of Pennsylvania in Philadelphia.
For a better look at veterans, she and her associates combined administrative, laboratory, and death data with medical chart reviews and information from the Organ Procurement and Transplantation Network’s Standard Transplant Analysis and Research file. The initial cohort included more than 6,800 veterans whose ICD-9CM diagnosis code indicated a malignant hepatic neoplasm. Excluding patients with neoplasms such as cholangiocarcinoma and those managed outside the VA left 3,989 VA patients with hepatocellular carcinoma.
In the multivariable analysis, use of multidisciplinary tumor boards was associated with a statistically significant 13% improvement in 5-year overall survival (hazard ratio, 0.87; 95% confidence interval, 0.81-0.94; P less than .001). Improved survival also was linked with seeing certain specialists within 30 days of diagnosis, including hepatologists (HR, 0.77; P less than .001) and surgeons (HR, 0.72; P less than .001). Consulting with a hepatologist within 30 days of diagnosis, however, did not improve the chances of receiving curative therapy, such as liver transplantation, resection, local ablation, transarterial chemoembolization, or Y-90 radioembolization.
Care also varied substantially geographically and by academic affiliation, Dr. Serper noted. “Treatment of hepatocellular carcinoma is complex, as it depends as much on liver function as it does on tumor staging,” she emphasized. “Studies to improve multidisciplinary approaches for hepatocellular carcinoma in the community are needed to increase rates of curative therapy and improve clinical outcomes.”
Patients in this study averaged 62 years of age at diagnosis, 54% were white, 36% were within Milan criteria, and 45% had a Child-Turcotte-Pugh score of B or higher. Nearly 18% had macrovascular invasion at diagnosis, and 7% had metastatic disease. Nearly two-thirds of patients were BCLC stage A or B at diagnosis, and more than a third had underlying alcohol misuse and chronic hepatitis C virus infection.
The work was funded by unrestricted grants from Bayer Healthcare Pharmaceuticals and the VA’s HIV, Hepatitis and Public Health Pathogens Programs. The investigators had no relevant financial disclosures.
BOSTON – Veterans were about 13% less likely to die within 5 years of hepatocellular carcinoma diagnosis when multidisciplinary tumor boards managed their care than if they did not, according to a large, multicenter observational study.
Seeing a hepatologist or surgeon within 30 days of diagnosis also significantly improved 5-year overall survival, even after controlling for age, race, Charlson-Deyo comorbidity index, Barcelona Clinic Liver Cancer (BCLC) stage, academic center and geographic region of care, and the distance patients lived from the nearest Veterans Affairs transplant center, Marina Serper, MD, reported at the annual meeting of the American Association for the Study of Liver Diseases. “More studies are needed to understand how to best use multidisciplinary tumor boards to improve the care of patients with hepatocellular carcinoma,” she said.
Outcomes data for hepatocellular carcinoma mostly come from clinical trials; transplant centers; and Surveillance, Epidemiology, and End Results-Medicare analyses, noted Dr. Serper of the University of Pennsylvania in Philadelphia.
For a better look at veterans, she and her associates combined administrative, laboratory, and death data with medical chart reviews and information from the Organ Procurement and Transplantation Network’s Standard Transplant Analysis and Research file. The initial cohort included more than 6,800 veterans whose ICD-9CM diagnosis code indicated a malignant hepatic neoplasm. Excluding patients with neoplasms such as cholangiocarcinoma and those managed outside the VA left 3,989 VA patients with hepatocellular carcinoma.
In the multivariable analysis, use of multidisciplinary tumor boards was associated with a statistically significant 13% improvement in 5-year overall survival (hazard ratio, 0.87; 95% confidence interval, 0.81-0.94; P less than .001). Improved survival also was linked with seeing certain specialists within 30 days of diagnosis, including hepatologists (HR, 0.77; P less than .001) and surgeons (HR, 0.72; P less than .001). Consulting with a hepatologist within 30 days of diagnosis, however, did not improve the chances of receiving curative therapy, such as liver transplantation, resection, local ablation, transarterial chemoembolization, or Y-90 radioembolization.
Care also varied substantially geographically and by academic affiliation, Dr. Serper noted. “Treatment of hepatocellular carcinoma is complex, as it depends as much on liver function as it does on tumor staging,” she emphasized. “Studies to improve multidisciplinary approaches for hepatocellular carcinoma in the community are needed to increase rates of curative therapy and improve clinical outcomes.”
Patients in this study averaged 62 years of age at diagnosis, 54% were white, 36% were within Milan criteria, and 45% had a Child-Turcotte-Pugh score of B or higher. Nearly 18% had macrovascular invasion at diagnosis, and 7% had metastatic disease. Nearly two-thirds of patients were BCLC stage A or B at diagnosis, and more than a third had underlying alcohol misuse and chronic hepatitis C virus infection.
The work was funded by unrestricted grants from Bayer Healthcare Pharmaceuticals and the VA’s HIV, Hepatitis and Public Health Pathogens Programs. The investigators had no relevant financial disclosures.
BOSTON – Veterans were about 13% less likely to die within 5 years of hepatocellular carcinoma diagnosis when multidisciplinary tumor boards managed their care than if they did not, according to a large, multicenter observational study.
Seeing a hepatologist or surgeon within 30 days of diagnosis also significantly improved 5-year overall survival, even after controlling for age, race, Charlson-Deyo comorbidity index, Barcelona Clinic Liver Cancer (BCLC) stage, academic center and geographic region of care, and the distance patients lived from the nearest Veterans Affairs transplant center, Marina Serper, MD, reported at the annual meeting of the American Association for the Study of Liver Diseases. “More studies are needed to understand how to best use multidisciplinary tumor boards to improve the care of patients with hepatocellular carcinoma,” she said.
Outcomes data for hepatocellular carcinoma mostly come from clinical trials; transplant centers; and Surveillance, Epidemiology, and End Results-Medicare analyses, noted Dr. Serper of the University of Pennsylvania in Philadelphia.
For a better look at veterans, she and her associates combined administrative, laboratory, and death data with medical chart reviews and information from the Organ Procurement and Transplantation Network’s Standard Transplant Analysis and Research file. The initial cohort included more than 6,800 veterans whose ICD-9CM diagnosis code indicated a malignant hepatic neoplasm. Excluding patients with neoplasms such as cholangiocarcinoma and those managed outside the VA left 3,989 VA patients with hepatocellular carcinoma.
In the multivariable analysis, use of multidisciplinary tumor boards was associated with a statistically significant 13% improvement in 5-year overall survival (hazard ratio, 0.87; 95% confidence interval, 0.81-0.94; P less than .001). Improved survival also was linked with seeing certain specialists within 30 days of diagnosis, including hepatologists (HR, 0.77; P less than .001) and surgeons (HR, 0.72; P less than .001). Consulting with a hepatologist within 30 days of diagnosis, however, did not improve the chances of receiving curative therapy, such as liver transplantation, resection, local ablation, transarterial chemoembolization, or Y-90 radioembolization.
Care also varied substantially geographically and by academic affiliation, Dr. Serper noted. “Treatment of hepatocellular carcinoma is complex, as it depends as much on liver function as it does on tumor staging,” she emphasized. “Studies to improve multidisciplinary approaches for hepatocellular carcinoma in the community are needed to increase rates of curative therapy and improve clinical outcomes.”
Patients in this study averaged 62 years of age at diagnosis, 54% were white, 36% were within Milan criteria, and 45% had a Child-Turcotte-Pugh score of B or higher. Nearly 18% had macrovascular invasion at diagnosis, and 7% had metastatic disease. Nearly two-thirds of patients were BCLC stage A or B at diagnosis, and more than a third had underlying alcohol misuse and chronic hepatitis C virus infection.
The work was funded by unrestricted grants from Bayer Healthcare Pharmaceuticals and the VA’s HIV, Hepatitis and Public Health Pathogens Programs. The investigators had no relevant financial disclosures.
AT THE LIVER MEETING 2016
Key clinical point: The use of multidisciplinary tumor boards was associated with significantly improved overall survival in patients with hepatocellular carcinoma.
Major finding: The risk of death within 5 years dropped by about 13% (hazard ratio, 0.87; 95% confidence interval, 0.81-0.94; P less than .001).
Data source: A retrospective study of 3,989 Veterans Affairs patients with hepatocellular carcinoma.
Disclosures: The work was funded by unrestricted grants from Bayer Healthcare Pharmaceuticals and the VA’s HIV, Hepatitis and Public Health Pathogens Programs. The investigators had no relevant financial disclosures.
Direct-acting antiretrovirals in genotype 1 HCV patients with mental health conditions safe, well tolerated
BOSTON – Direct-acting antiretroviral therapies are safe and well tolerated in hepatitis C virus patients with comorbid psychiatric conditions, a study showed.
The finding that sustained virologic response (SVR) rates at 1 year were similar in genotype 1 HCV patients with and without psychiatric comorbidities could help end the stigma against treating this patient subgroup, stemming from when treatment with interferon risked psychiatric decompensation. That’s according to nurse practitioner Anne Moore, winner of this year’s Poster of Distinction Award at the American Association for the Study of Liver Diseases annual meeting.
She and her colleagues reviewed patient records for 588 adults diagnosed with genotype 1 HCV in Arizona between 2013 and 2016. They found 389 patients who’d been treated with either a combination of sofosbuvir and ledipasvir (with or without ribavirin) or sofosbuvir and simeprevir. Patients coinfected with HIV were included in this group; those who’d had a liver transplant were not. Just over three-quarters of the patients were white, 60% were male, 10% were Hispanic, and the average age was 59 years. A third of the patients had been diagnosed with cirrhosis.
Because medical and mental health records typically are not integrated, Ms. Moore and her colleagues instead used medical records to evaluate which medications had been prescribed, in order to determine likely psychiatric diagnoses. They determined that 27% of the 389 patients had a comorbid psychiatric diagnosis. Of these, 68% had depression and 28% had anxiety. Only one person was considered to have bipolar disorder; Ms. Moore said it was possible this group was underrepresented in the study, but that some persons considered to have depression might have had bipolar disorder instead.
Rates of SVR at 1 year were similar across the study – 82.3% in those without a comorbid psychiatric diagnosis vs. 79.4% of those who did have one – with no additional risk of patients with psychiatric diagnoses being lost to follow-up. DAA therapy was well tolerated in both groups.
Ms. Moore said that winning the award was a “huge surprise” but interpreted it to mean that liver specialists are struggling to find the best treatment algorithms for HCV, partly because of the number of restrictions often placed by payers on access to DAAs, but also because it is often difficult to know who will adhere to treatment.
“Gastroenterologists and hepatologists are not used to dealing with patients who have psychiatric conditions. They don’t understand them well, and so there is a reluctance to ‘go there.’ If that’s what has been holding you back, it doesn’t have to. You can treat these patients successfully,” Ms. Moore said.
She had no relevant financial disclosures.
[email protected]
On Twitter @whitneymcknight
BOSTON – Direct-acting antiretroviral therapies are safe and well tolerated in hepatitis C virus patients with comorbid psychiatric conditions, a study showed.
The finding that sustained virologic response (SVR) rates at 1 year were similar in genotype 1 HCV patients with and without psychiatric comorbidities could help end the stigma against treating this patient subgroup, stemming from when treatment with interferon risked psychiatric decompensation. That’s according to nurse practitioner Anne Moore, winner of this year’s Poster of Distinction Award at the American Association for the Study of Liver Diseases annual meeting.
She and her colleagues reviewed patient records for 588 adults diagnosed with genotype 1 HCV in Arizona between 2013 and 2016. They found 389 patients who’d been treated with either a combination of sofosbuvir and ledipasvir (with or without ribavirin) or sofosbuvir and simeprevir. Patients coinfected with HIV were included in this group; those who’d had a liver transplant were not. Just over three-quarters of the patients were white, 60% were male, 10% were Hispanic, and the average age was 59 years. A third of the patients had been diagnosed with cirrhosis.
Because medical and mental health records typically are not integrated, Ms. Moore and her colleagues instead used medical records to evaluate which medications had been prescribed, in order to determine likely psychiatric diagnoses. They determined that 27% of the 389 patients had a comorbid psychiatric diagnosis. Of these, 68% had depression and 28% had anxiety. Only one person was considered to have bipolar disorder; Ms. Moore said it was possible this group was underrepresented in the study, but that some persons considered to have depression might have had bipolar disorder instead.
Rates of SVR at 1 year were similar across the study – 82.3% in those without a comorbid psychiatric diagnosis vs. 79.4% of those who did have one – with no additional risk of patients with psychiatric diagnoses being lost to follow-up. DAA therapy was well tolerated in both groups.
Ms. Moore said that winning the award was a “huge surprise” but interpreted it to mean that liver specialists are struggling to find the best treatment algorithms for HCV, partly because of the number of restrictions often placed by payers on access to DAAs, but also because it is often difficult to know who will adhere to treatment.
“Gastroenterologists and hepatologists are not used to dealing with patients who have psychiatric conditions. They don’t understand them well, and so there is a reluctance to ‘go there.’ If that’s what has been holding you back, it doesn’t have to. You can treat these patients successfully,” Ms. Moore said.
She had no relevant financial disclosures.
[email protected]
On Twitter @whitneymcknight
BOSTON – Direct-acting antiretroviral therapies are safe and well tolerated in hepatitis C virus patients with comorbid psychiatric conditions, a study showed.
The finding that sustained virologic response (SVR) rates at 1 year were similar in genotype 1 HCV patients with and without psychiatric comorbidities could help end the stigma against treating this patient subgroup, stemming from when treatment with interferon risked psychiatric decompensation. That’s according to nurse practitioner Anne Moore, winner of this year’s Poster of Distinction Award at the American Association for the Study of Liver Diseases annual meeting.
She and her colleagues reviewed patient records for 588 adults diagnosed with genotype 1 HCV in Arizona between 2013 and 2016. They found 389 patients who’d been treated with either a combination of sofosbuvir and ledipasvir (with or without ribavirin) or sofosbuvir and simeprevir. Patients coinfected with HIV were included in this group; those who’d had a liver transplant were not. Just over three-quarters of the patients were white, 60% were male, 10% were Hispanic, and the average age was 59 years. A third of the patients had been diagnosed with cirrhosis.
Because medical and mental health records typically are not integrated, Ms. Moore and her colleagues instead used medical records to evaluate which medications had been prescribed, in order to determine likely psychiatric diagnoses. They determined that 27% of the 389 patients had a comorbid psychiatric diagnosis. Of these, 68% had depression and 28% had anxiety. Only one person was considered to have bipolar disorder; Ms. Moore said it was possible this group was underrepresented in the study, but that some persons considered to have depression might have had bipolar disorder instead.
Rates of SVR at 1 year were similar across the study – 82.3% in those without a comorbid psychiatric diagnosis vs. 79.4% of those who did have one – with no additional risk of patients with psychiatric diagnoses being lost to follow-up. DAA therapy was well tolerated in both groups.
Ms. Moore said that winning the award was a “huge surprise” but interpreted it to mean that liver specialists are struggling to find the best treatment algorithms for HCV, partly because of the number of restrictions often placed by payers on access to DAAs, but also because it is often difficult to know who will adhere to treatment.
“Gastroenterologists and hepatologists are not used to dealing with patients who have psychiatric conditions. They don’t understand them well, and so there is a reluctance to ‘go there.’ If that’s what has been holding you back, it doesn’t have to. You can treat these patients successfully,” Ms. Moore said.
She had no relevant financial disclosures.
[email protected]
On Twitter @whitneymcknight
AT THE LIVER MEETING 2016
Key clinical point:
Major finding: Sustained virologic response rates at 1 year were similar between genotype 1 HCV patients with and without a comorbid psychiatric diagnosis.
Data source: A retrospective analysis of medical records from 2013 to 2016 for 588 adults with genotype 1 hepatitis C virus.
Disclosures: Ms. Moore had no relevant financial disclosures.
VIDEO: PBC patients with compensated cirrhosis fare well on obeticholic acid
BOSTON – Patients with primary biliary cholangitis (PBC) who have compensated cirrhosis fared just as well on obeticholic acid (OCA) as did PBC patients without cirrhosis, according to an analysis of data from POISE, the pivotal clinical trial for approval of OCA for PBC.
The POISE trial included 36 individuals with PBC and compensated cirrhosis, since cirrhosis “is an endpoint for virtually all liver diseases,” John Vierling, MD, said in a video interview at the meeting.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
To see how this group fared, Dr. Vierling and his coinvestigators performed a post hoc analysis of the POISE data to examine OCA’s safety and efficacy for patients with compensated cirrhosis. Patients with decompensated cirrhosis were not included in the trial.
Dr. Vierling, chief of hepatology at Baylor College of Medicine, Houston, noted that investigators worked hard to set the bar high for inclusion in the group with cirrhosis, to achieve very high specificity. “We did this by using very stringent criteria of liver biopsy, or transient elastography adjusted for a very high range of kilopascals required to diagnose cirrhosis in cholestatic patients,” he said. To be included, patients also had to have elevated total bilirubin levels and a baseline alkaline phosphatase level greater than five times the upper limit of normal.
Statistically, the patients were evenly distributed across the placebo arm and the two treatment arms, one of which dosed OCA at 10 mg/day; the other treatment arm had flexible dosing at 5-10 mg/day.
The POISE trial used a composite primary efficacy endpoint of achieving an alkaline phosphatase (ALP) less than 1.67 times the upper limit of normal, with total bilirubin within normal limits, and at least a 15% reduction in ALP.
“Significantly more OCA-treated patients with cirrhosis achieved the primary composite endpoint compared to placebo,” Dr. Vierling and his coauthors wrote in a poster presented at the annual meeting for the American Association for the Study of Liver Diseases. The difference was individually significant for all three values that made up the composite primary endpoint as well.
Secondary endpoints included gamma-glutamyltransferase, alanine aminotrasferase, and aspartate aminotransferase, all of which were significantly reduced among patients taking OCA. Patients on placebo saw these values rise over the time period of the study.
There were no new safety signals seen in the post hoc analysis of the group with cirrhosis that were not seen in the trial at large, said Dr. Vierling. Two individuals in the subgroup dropped out of the trial because of pruritis, a similar proportion to that seen in the full trial population.
The drug’s manufacturer, Intercept Pharmaceuticals, is working with the Food and Drug Administration to establish appropriate doses and intervals for obeticholic acid so it may be used safely in individuals with decompensated cirrhosis, said Dr. Vierling.
Obeticholic acid, a farnesoid-X receptor agonist, is an approved agent to use as add-on therapy to ursodeoxycholic acid (UDCA), or as monotherapy for patients who can’t tolerate UDCA.
Dr. Vierling disclosed financial relationships with Intercept Pharmaceuticals and with several other pharmaceutical companies. The study was funded by Intercept Pharmaceuticals.
[email protected]
On Twitter @karioakes
BOSTON – Patients with primary biliary cholangitis (PBC) who have compensated cirrhosis fared just as well on obeticholic acid (OCA) as did PBC patients without cirrhosis, according to an analysis of data from POISE, the pivotal clinical trial for approval of OCA for PBC.
The POISE trial included 36 individuals with PBC and compensated cirrhosis, since cirrhosis “is an endpoint for virtually all liver diseases,” John Vierling, MD, said in a video interview at the meeting.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
To see how this group fared, Dr. Vierling and his coinvestigators performed a post hoc analysis of the POISE data to examine OCA’s safety and efficacy for patients with compensated cirrhosis. Patients with decompensated cirrhosis were not included in the trial.
Dr. Vierling, chief of hepatology at Baylor College of Medicine, Houston, noted that investigators worked hard to set the bar high for inclusion in the group with cirrhosis, to achieve very high specificity. “We did this by using very stringent criteria of liver biopsy, or transient elastography adjusted for a very high range of kilopascals required to diagnose cirrhosis in cholestatic patients,” he said. To be included, patients also had to have elevated total bilirubin levels and a baseline alkaline phosphatase level greater than five times the upper limit of normal.
Statistically, the patients were evenly distributed across the placebo arm and the two treatment arms, one of which dosed OCA at 10 mg/day; the other treatment arm had flexible dosing at 5-10 mg/day.
The POISE trial used a composite primary efficacy endpoint of achieving an alkaline phosphatase (ALP) less than 1.67 times the upper limit of normal, with total bilirubin within normal limits, and at least a 15% reduction in ALP.
“Significantly more OCA-treated patients with cirrhosis achieved the primary composite endpoint compared to placebo,” Dr. Vierling and his coauthors wrote in a poster presented at the annual meeting for the American Association for the Study of Liver Diseases. The difference was individually significant for all three values that made up the composite primary endpoint as well.
Secondary endpoints included gamma-glutamyltransferase, alanine aminotrasferase, and aspartate aminotransferase, all of which were significantly reduced among patients taking OCA. Patients on placebo saw these values rise over the time period of the study.
There were no new safety signals seen in the post hoc analysis of the group with cirrhosis that were not seen in the trial at large, said Dr. Vierling. Two individuals in the subgroup dropped out of the trial because of pruritis, a similar proportion to that seen in the full trial population.
The drug’s manufacturer, Intercept Pharmaceuticals, is working with the Food and Drug Administration to establish appropriate doses and intervals for obeticholic acid so it may be used safely in individuals with decompensated cirrhosis, said Dr. Vierling.
Obeticholic acid, a farnesoid-X receptor agonist, is an approved agent to use as add-on therapy to ursodeoxycholic acid (UDCA), or as monotherapy for patients who can’t tolerate UDCA.
Dr. Vierling disclosed financial relationships with Intercept Pharmaceuticals and with several other pharmaceutical companies. The study was funded by Intercept Pharmaceuticals.
[email protected]
On Twitter @karioakes
BOSTON – Patients with primary biliary cholangitis (PBC) who have compensated cirrhosis fared just as well on obeticholic acid (OCA) as did PBC patients without cirrhosis, according to an analysis of data from POISE, the pivotal clinical trial for approval of OCA for PBC.
The POISE trial included 36 individuals with PBC and compensated cirrhosis, since cirrhosis “is an endpoint for virtually all liver diseases,” John Vierling, MD, said in a video interview at the meeting.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
To see how this group fared, Dr. Vierling and his coinvestigators performed a post hoc analysis of the POISE data to examine OCA’s safety and efficacy for patients with compensated cirrhosis. Patients with decompensated cirrhosis were not included in the trial.
Dr. Vierling, chief of hepatology at Baylor College of Medicine, Houston, noted that investigators worked hard to set the bar high for inclusion in the group with cirrhosis, to achieve very high specificity. “We did this by using very stringent criteria of liver biopsy, or transient elastography adjusted for a very high range of kilopascals required to diagnose cirrhosis in cholestatic patients,” he said. To be included, patients also had to have elevated total bilirubin levels and a baseline alkaline phosphatase level greater than five times the upper limit of normal.
Statistically, the patients were evenly distributed across the placebo arm and the two treatment arms, one of which dosed OCA at 10 mg/day; the other treatment arm had flexible dosing at 5-10 mg/day.
The POISE trial used a composite primary efficacy endpoint of achieving an alkaline phosphatase (ALP) less than 1.67 times the upper limit of normal, with total bilirubin within normal limits, and at least a 15% reduction in ALP.
“Significantly more OCA-treated patients with cirrhosis achieved the primary composite endpoint compared to placebo,” Dr. Vierling and his coauthors wrote in a poster presented at the annual meeting for the American Association for the Study of Liver Diseases. The difference was individually significant for all three values that made up the composite primary endpoint as well.
Secondary endpoints included gamma-glutamyltransferase, alanine aminotrasferase, and aspartate aminotransferase, all of which were significantly reduced among patients taking OCA. Patients on placebo saw these values rise over the time period of the study.
There were no new safety signals seen in the post hoc analysis of the group with cirrhosis that were not seen in the trial at large, said Dr. Vierling. Two individuals in the subgroup dropped out of the trial because of pruritis, a similar proportion to that seen in the full trial population.
The drug’s manufacturer, Intercept Pharmaceuticals, is working with the Food and Drug Administration to establish appropriate doses and intervals for obeticholic acid so it may be used safely in individuals with decompensated cirrhosis, said Dr. Vierling.
Obeticholic acid, a farnesoid-X receptor agonist, is an approved agent to use as add-on therapy to ursodeoxycholic acid (UDCA), or as monotherapy for patients who can’t tolerate UDCA.
Dr. Vierling disclosed financial relationships with Intercept Pharmaceuticals and with several other pharmaceutical companies. The study was funded by Intercept Pharmaceuticals.
[email protected]
On Twitter @karioakes
EXPERT ANALYSIS FROM THE LIVER MEETING
SNP predicts liver cancer in hepatitis C patients regardless of SVR
BOSTON – rs4836493, a single nucleotide polymorphism of the gene encoding chondroitin sulfate synthase-3, significantly predicted hepatocellular carcinoma among patients with HCV even when they achieved sustained virologic response on pegylated interferon, according to a genome-wide association study.
The next step is to determine whether rs4836493 predicts liver cancer after SVR on the new direct-acting antiviral regimens, Basile Njei, MD, MPH, said during an oral presentation at the annual meeting of the American Association for the Study of Liver Diseases.
Cirrhotic patients face about a 2%-7% annual risk of hepatocellular carcinoma, noted Dr. Njei of Yale University, New Haven, Conn. “Recent studies show that people with HCV may still develop hepatocellular carcinoma even after achieving SVR,” he said.
To look for genetic predictors of this outcome, he and his associates genotyped 958 patients with HCV and advanced hepatic fibrosis from the Hepatitis C Antiviral Long-term Treatment against Cirrhosis (HALT-C) study. This trial had evaluated long-term, low-dose pegylated interferon therapy (90 mcg per week for 3.5 years) as a means of keeping fibrosis from progressing among HCV patients who had failed peginterferon and ribavirin therapy.
A total of 63% of patients had cirrhosis, and 55 (5.7%) developed biopsy or imaging-confirmed hepatocellular carcinoma over a median of 80 months of follow-up, Dr. Njei said. After the researchers controlled for age, sex, Ishak fibrosis score, and SVR status, rs4836493 predicted hepatocellular carcinoma with a highly significant P value of .000004.
This SNP is located on the CHSY3 gene, which plays a role in the chondroitin polymerization, tissue development, and morphogenesis, according to Dr. Njei. Notably, the gene has been implicated in the biology of colorectal tumors, he added.
Dr. Njei and his associates genotyped patients by using the 610-Quad platform, which contains more than 600,000 SNPs. They double-checked results and conducted more genetic analyses using PLINK 1.9, a free, open-source software program for genome-wide association data. Three-quarters of patients in the study were white, 72% were male, and median age at enrollment was 50 years, he noted.
Linking a single SNP to liver cancer despite SVR is a striking finding, but it is also preliminary, Dr. Njei cautioned. “The SNP identified in our discovery genome-wide association study needs future replication and validation in patients who achieve SVR after receiving the new direct-acting antiviral therapies,” he said.
The National Institutes of Health provided partial funding. Dr. Njei and his coinvestigators had no relevant financial conflicts of interest.
BOSTON – rs4836493, a single nucleotide polymorphism of the gene encoding chondroitin sulfate synthase-3, significantly predicted hepatocellular carcinoma among patients with HCV even when they achieved sustained virologic response on pegylated interferon, according to a genome-wide association study.
The next step is to determine whether rs4836493 predicts liver cancer after SVR on the new direct-acting antiviral regimens, Basile Njei, MD, MPH, said during an oral presentation at the annual meeting of the American Association for the Study of Liver Diseases.
Cirrhotic patients face about a 2%-7% annual risk of hepatocellular carcinoma, noted Dr. Njei of Yale University, New Haven, Conn. “Recent studies show that people with HCV may still develop hepatocellular carcinoma even after achieving SVR,” he said.
To look for genetic predictors of this outcome, he and his associates genotyped 958 patients with HCV and advanced hepatic fibrosis from the Hepatitis C Antiviral Long-term Treatment against Cirrhosis (HALT-C) study. This trial had evaluated long-term, low-dose pegylated interferon therapy (90 mcg per week for 3.5 years) as a means of keeping fibrosis from progressing among HCV patients who had failed peginterferon and ribavirin therapy.
A total of 63% of patients had cirrhosis, and 55 (5.7%) developed biopsy or imaging-confirmed hepatocellular carcinoma over a median of 80 months of follow-up, Dr. Njei said. After the researchers controlled for age, sex, Ishak fibrosis score, and SVR status, rs4836493 predicted hepatocellular carcinoma with a highly significant P value of .000004.
This SNP is located on the CHSY3 gene, which plays a role in the chondroitin polymerization, tissue development, and morphogenesis, according to Dr. Njei. Notably, the gene has been implicated in the biology of colorectal tumors, he added.
Dr. Njei and his associates genotyped patients by using the 610-Quad platform, which contains more than 600,000 SNPs. They double-checked results and conducted more genetic analyses using PLINK 1.9, a free, open-source software program for genome-wide association data. Three-quarters of patients in the study were white, 72% were male, and median age at enrollment was 50 years, he noted.
Linking a single SNP to liver cancer despite SVR is a striking finding, but it is also preliminary, Dr. Njei cautioned. “The SNP identified in our discovery genome-wide association study needs future replication and validation in patients who achieve SVR after receiving the new direct-acting antiviral therapies,” he said.
The National Institutes of Health provided partial funding. Dr. Njei and his coinvestigators had no relevant financial conflicts of interest.
BOSTON – rs4836493, a single nucleotide polymorphism of the gene encoding chondroitin sulfate synthase-3, significantly predicted hepatocellular carcinoma among patients with HCV even when they achieved sustained virologic response on pegylated interferon, according to a genome-wide association study.
The next step is to determine whether rs4836493 predicts liver cancer after SVR on the new direct-acting antiviral regimens, Basile Njei, MD, MPH, said during an oral presentation at the annual meeting of the American Association for the Study of Liver Diseases.
Cirrhotic patients face about a 2%-7% annual risk of hepatocellular carcinoma, noted Dr. Njei of Yale University, New Haven, Conn. “Recent studies show that people with HCV may still develop hepatocellular carcinoma even after achieving SVR,” he said.
To look for genetic predictors of this outcome, he and his associates genotyped 958 patients with HCV and advanced hepatic fibrosis from the Hepatitis C Antiviral Long-term Treatment against Cirrhosis (HALT-C) study. This trial had evaluated long-term, low-dose pegylated interferon therapy (90 mcg per week for 3.5 years) as a means of keeping fibrosis from progressing among HCV patients who had failed peginterferon and ribavirin therapy.
A total of 63% of patients had cirrhosis, and 55 (5.7%) developed biopsy or imaging-confirmed hepatocellular carcinoma over a median of 80 months of follow-up, Dr. Njei said. After the researchers controlled for age, sex, Ishak fibrosis score, and SVR status, rs4836493 predicted hepatocellular carcinoma with a highly significant P value of .000004.
This SNP is located on the CHSY3 gene, which plays a role in the chondroitin polymerization, tissue development, and morphogenesis, according to Dr. Njei. Notably, the gene has been implicated in the biology of colorectal tumors, he added.
Dr. Njei and his associates genotyped patients by using the 610-Quad platform, which contains more than 600,000 SNPs. They double-checked results and conducted more genetic analyses using PLINK 1.9, a free, open-source software program for genome-wide association data. Three-quarters of patients in the study were white, 72% were male, and median age at enrollment was 50 years, he noted.
Linking a single SNP to liver cancer despite SVR is a striking finding, but it is also preliminary, Dr. Njei cautioned. “The SNP identified in our discovery genome-wide association study needs future replication and validation in patients who achieve SVR after receiving the new direct-acting antiviral therapies,” he said.
The National Institutes of Health provided partial funding. Dr. Njei and his coinvestigators had no relevant financial conflicts of interest.
AT THE LIVER MEETING 2016
Key clinical point: A single nucleotide polymorphism of the CHSY3 gene predicted liver cancer in patients who successfully completed treatment for chronic hepatitis C virus infection.
Major finding: After researchers controlled for sustained virologic response and other confounders, the rs4836493 variant predicted hepatocellular carcinoma with a P value of .000004.
Data source: A genome-wide association study of 958 HCV patients with advanced hepatic fibrosis from the HALT-C trial.
Disclosures: The National Institutes of Health provided partial funding. Dr. Njei and his coinvestigators had no relevant financial conflicts of interest.