- Email: [email protected]
Efficacy and Patient-Reported Outcomes in Decompensated Cirrhotic with Chronic Hepatitis C Treated with Sofosbuvir and Velpatasvir with or without Ribavirin: Results from Astral-4 Clinical Trial
POSTER PRESENTATIONS patients, 73/114 (64%) F3 patients, 59/86 (69%) F2 patients, and remained stable in 250/260 (96%) F0-1 patients (Table). In patients achieving SVR subgrouped by baseline METAVIR score, FibroTest least square mean changes from baseline were significantly different from no change. Additionally, these changes were statistically different from those in patients that did not achieve SVR (F4: −0.17 vs −0.11; F3: −0.15 vs +0.05; F2: −0.13 vs +0.23; F0-1: −0.05 vs +0.07 for SVRs vs non-SVRs respectively). Achievement of SVR was identified to be strongly associated with FibroTest score improvement and was particularly pronounced in patients with higher fibrosis stage at baseline.
(13.5%), ( p < 0.01 and p < 0.01, respectively). Presence of cirrhosis (hazard ratio [HR], 9.92, p < 0.01), older age (HR 1.03, p < 0.01), achievement of SVR (−) (HR 7.02, p < 0.01), and no-treatment (HR 6.76, p < 0.01) were independent factors for HCC development in chronic HCV patients. In treatment group, older age, presence of cirrhosis, and SVR (−) were independent factors for HCC, and in notreatment group, older age, male, and presence of cirrhosis were independent factors for HCC development. Conclusions: The risk of HCC increased in chronic hepatitis C patients with older age, cirrhotic background, SVR (−), and no-treatment. Moreover, SVR (−) group showed lower HCC development rate than no-treatment group. Therefore, active antiviral therapy with highly effective oral antiviral drugs such as sofosfovir or daclatasvir/ asunaprevir needs to be recommended in these patients if there is no contraindication. SAT-285 EFFICACY AND PATIENT-REPORTED OUTCOMES IN DECOMPENSATED CIRRHOTIC WITH CHRONIC HEPATITIS C TREATED WITH SOFOSBUVIR AND VELPATASVIR WITH OR WITHOUT RIBAVIRIN: RESULTS FROM ASTRAL-4 CLINICAL TRIAL Z.M. Younossi1, M. Stepanova2, M. Charlton3, J.G. O’Leary4, M.P. Curry5, R.S. Brown6, S. Hunt7. 1Center for Liver Diseaes, Department of Medicine, Fairafx Hospital, Falls Church; 2Center for Outcomes Research in Liver Disease, Washington, D.C.; 3Intermountain Medical Center, Salt Lake City; 4Beth Israel Deaconess Medical Center, Boston; 5Baylor University Medical Center, Dallas; 6Weill Cornell Medical College, New York; 7Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, United States E-mail: [email protected]
Conclusions: Improvements in mean FibroTest score were observed in patients treated with OBV/PTV/r + DSV ± RBV and achieving SVR, irrespective of their baseline score. Achievement of SVR was a strong predictor of fibrosis regression and led to FibroTest-derived fibrosis stage regression for the majority of patients with baseline F2–F4 fibrosis. SAT-284 ACTIVE ANTIVIRAL TREATMENT FOR CHRONIC HEPATITIS C VIRUS INFECTION NEEDS TO BE RECOMMENDED FOR DECREASING HEPATITIS C-ASSOCIATED HEPATOCELLULAR CARCINOMA RISK IN THE NEW ERA OF HIGHLY EFFECTIVE ORAL ANTIVIRAL DRUGS Y.-J. Jin1, J.T. Hong1, J.-W. Lee1. 1Internal Medicine, Inha University Hospital, Inha University School of Medicine, Incheon, South Korea E-mail: [email protected] Background and Aims: There is still under research for whether active antiviral therapy should be recommended for all patients with chronic hepatitis C virus (HCV) infection. The aim of this study was to determine the suppressive effect of antiviral therapy on the development of HCC in chronic HCV patients. Methods: This large-scale, retrospective study consisted of 1,013 Korean chronic hepatitis C patients with no history of HCC (treatment group, n = 489 and no-treatment group, n = 687). Anti-HCV antibody was positive for at least 6 months and HCV-RNA was also positive for all. In treatment group, patients were treated with pegylated interferon (PEG-IFN) plus ribavirin, and they were dichotomized as those with and without sustained virologic response (SVR). Followup period was measured from the end of the antiviral treatment in treatment group, and after diagnosis of chronic HCV infection in notreatment group. The cumulative HCC development rate was estimated using the Kaplan–Meier method according to three groups: SVR (+), SVR (−), and no-treatment. Results: During the median follow-up period of 45 months after antiviral therapy, HCC developed in 20 (4.1%) patients. The 3-year cumulative HCC incidence rates for SVR (+) (1.1%) and SVR (−) (8.6%) groups were significantly lower than those of the no-treatment group S830
Background and Aims: HCV treatment regimens with direct-acting antivirals have not been extensively studied in patients with decompensated cirrhosis. The aim of this study is to assess patientreported outcomes (PROs) in patients with decompensated cirrhosis who were treated with a fixed-dose combination of sofosbuvir/ velpatasvir (SOF/VEL) with and without ribavirin (RBV). Methods: Four PRO questionnaires (SF-36, CLDQ-HCV, FACIT-F, WPAI: HCV) were administered prospectively in a phase 3 clinical trial of SOF/VEL in decompensated patients with HCV (ASTRAL-4). Results: A total of 267 patients with decompensated cirrhosis were enrolled (57.8 ± 6.4 years, 70% male, 78% HCV genotype 1, 15% HCV genotype 3, 45% treatment-naïve, 80% with baseline ascites, 62% baseline encephalopathy, 6% with Child-Pugh score of 5–6, 90% with 7–9, 4% with 10–12). The SVR-12 rates were 84.4% in SOF/VEL and 94.3% in SOF/VEL + RBV ( p = 0.02). Baseline clinico-demographic characteristics and PRO scores were similar (all p > 0.05). In both SOF/VEL and SOF/VEL + RBV groups, statistically significant improvements in some of the PROs, including general health, emotional well-being and worry scores (up to +11.9 points on a universal 0–100 PRO scale in SOF/VEL + RBV, up to +16.6 in SOF/VEL, p < 0.05), were observed shortly after the start of treatment (4 to 8 weeks), and continued throughout the duration of treatment. At week 12 and 24 follow-ups, no differences in PROs were noted between the treatment arms (all p > 0.05), and improvements in most of the PROs were observed in SOF/VEL both with and without RBV (up to +19.3 points, average across all studied PRO domains +8.5 points). In multivariate analysis, the major baseline predictors of PRO impairment were the presence of ascites, encephalopathy, pretreatment history of insomnia and depression. Conclusions: Patients with HCV-related decompensated cirrhosis treated with SOF/VEL+RBV achieved 94.3% SVR-12. Furthermore, there is significant early and sustained improvement of PROs posttreatment with SOF/VEL with or without RBV in patients with HCVrelated decompensated cirrhosis.
Journal of Hepatology 2016 vol. 64 | S631–S832
(13.5%), ( p < 0.01 and p < 0.01, respectively). Presence of cirrhosis (hazard ratio [HR], 9.92, p < 0.01), older age (HR 1.03, p < 0.01), achievement of SVR (−) (HR 7.02, p < 0.01), and no-treatment (HR 6.76, p < 0.01) were independent factors for HCC development in chronic HCV patients. In treatment group, older age, presence of cirrhosis, and SVR (−) were independent factors for HCC, and in notreatment group, older age, male, and presence of cirrhosis were independent factors for HCC development. Conclusions: The risk of HCC increased in chronic hepatitis C patients with older age, cirrhotic background, SVR (−), and no-treatment. Moreover, SVR (−) group showed lower HCC development rate than no-treatment group. Therefore, active antiviral therapy with highly effective oral antiviral drugs such as sofosfovir or daclatasvir/ asunaprevir needs to be recommended in these patients if there is no contraindication. SAT-285 EFFICACY AND PATIENT-REPORTED OUTCOMES IN DECOMPENSATED CIRRHOTIC WITH CHRONIC HEPATITIS C TREATED WITH SOFOSBUVIR AND VELPATASVIR WITH OR WITHOUT RIBAVIRIN: RESULTS FROM ASTRAL-4 CLINICAL TRIAL Z.M. Younossi1, M. Stepanova2, M. Charlton3, J.G. O’Leary4, M.P. Curry5, R.S. Brown6, S. Hunt7. 1Center for Liver Diseaes, Department of Medicine, Fairafx Hospital, Falls Church; 2Center for Outcomes Research in Liver Disease, Washington, D.C.; 3Intermountain Medical Center, Salt Lake City; 4Beth Israel Deaconess Medical Center, Boston; 5Baylor University Medical Center, Dallas; 6Weill Cornell Medical College, New York; 7Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, United States E-mail: [email protected]
Conclusions: Improvements in mean FibroTest score were observed in patients treated with OBV/PTV/r + DSV ± RBV and achieving SVR, irrespective of their baseline score. Achievement of SVR was a strong predictor of fibrosis regression and led to FibroTest-derived fibrosis stage regression for the majority of patients with baseline F2–F4 fibrosis. SAT-284 ACTIVE ANTIVIRAL TREATMENT FOR CHRONIC HEPATITIS C VIRUS INFECTION NEEDS TO BE RECOMMENDED FOR DECREASING HEPATITIS C-ASSOCIATED HEPATOCELLULAR CARCINOMA RISK IN THE NEW ERA OF HIGHLY EFFECTIVE ORAL ANTIVIRAL DRUGS Y.-J. Jin1, J.T. Hong1, J.-W. Lee1. 1Internal Medicine, Inha University Hospital, Inha University School of Medicine, Incheon, South Korea E-mail: [email protected] Background and Aims: There is still under research for whether active antiviral therapy should be recommended for all patients with chronic hepatitis C virus (HCV) infection. The aim of this study was to determine the suppressive effect of antiviral therapy on the development of HCC in chronic HCV patients. Methods: This large-scale, retrospective study consisted of 1,013 Korean chronic hepatitis C patients with no history of HCC (treatment group, n = 489 and no-treatment group, n = 687). Anti-HCV antibody was positive for at least 6 months and HCV-RNA was also positive for all. In treatment group, patients were treated with pegylated interferon (PEG-IFN) plus ribavirin, and they were dichotomized as those with and without sustained virologic response (SVR). Followup period was measured from the end of the antiviral treatment in treatment group, and after diagnosis of chronic HCV infection in notreatment group. The cumulative HCC development rate was estimated using the Kaplan–Meier method according to three groups: SVR (+), SVR (−), and no-treatment. Results: During the median follow-up period of 45 months after antiviral therapy, HCC developed in 20 (4.1%) patients. The 3-year cumulative HCC incidence rates for SVR (+) (1.1%) and SVR (−) (8.6%) groups were significantly lower than those of the no-treatment group S830
Background and Aims: HCV treatment regimens with direct-acting antivirals have not been extensively studied in patients with decompensated cirrhosis. The aim of this study is to assess patientreported outcomes (PROs) in patients with decompensated cirrhosis who were treated with a fixed-dose combination of sofosbuvir/ velpatasvir (SOF/VEL) with and without ribavirin (RBV). Methods: Four PRO questionnaires (SF-36, CLDQ-HCV, FACIT-F, WPAI: HCV) were administered prospectively in a phase 3 clinical trial of SOF/VEL in decompensated patients with HCV (ASTRAL-4). Results: A total of 267 patients with decompensated cirrhosis were enrolled (57.8 ± 6.4 years, 70% male, 78% HCV genotype 1, 15% HCV genotype 3, 45% treatment-naïve, 80% with baseline ascites, 62% baseline encephalopathy, 6% with Child-Pugh score of 5–6, 90% with 7–9, 4% with 10–12). The SVR-12 rates were 84.4% in SOF/VEL and 94.3% in SOF/VEL + RBV ( p = 0.02). Baseline clinico-demographic characteristics and PRO scores were similar (all p > 0.05). In both SOF/VEL and SOF/VEL + RBV groups, statistically significant improvements in some of the PROs, including general health, emotional well-being and worry scores (up to +11.9 points on a universal 0–100 PRO scale in SOF/VEL + RBV, up to +16.6 in SOF/VEL, p < 0.05), were observed shortly after the start of treatment (4 to 8 weeks), and continued throughout the duration of treatment. At week 12 and 24 follow-ups, no differences in PROs were noted between the treatment arms (all p > 0.05), and improvements in most of the PROs were observed in SOF/VEL both with and without RBV (up to +19.3 points, average across all studied PRO domains +8.5 points). In multivariate analysis, the major baseline predictors of PRO impairment were the presence of ascites, encephalopathy, pretreatment history of insomnia and depression. Conclusions: Patients with HCV-related decompensated cirrhosis treated with SOF/VEL+RBV achieved 94.3% SVR-12. Furthermore, there is significant early and sustained improvement of PROs posttreatment with SOF/VEL with or without RBV in patients with HCVrelated decompensated cirrhosis.
Journal of Hepatology 2016 vol. 64 | S631–S832