Pamela S Belperio1, Troy A Shahoumian1, Timothy P Loomis1, Larry A Mole1, Lisa I Backus2. 1. Department of Veterans Affairs, Population Health Services, Palo Alto Health Care System, Palo Alto, CA, USA. 2. Department of Veterans Affairs, Population Health Services, Palo Alto Health Care System, Palo Alto, CA, USA. Electronic address: Lisa.Backus@va.gov.
Abstract
BACKGROUND & AIM: Understanding the real-world effectiveness of all-oral hepatitis C virus (HCV) regimens informs treatment decisions. We evaluated the effectiveness of daclatasvir + sofosbuvir ± ribavirin (DCV + SOF ± RBV) and velpatasvir/sofosbuvir (VEL/SOF) ± RBV in patients with genotype 2 and genotype 3 infection treated in routine practice. METHODS: This observational analysis was carried out in an intent-to-treat cohort of patients with HCV genotype 2 and genotype 3. Sustained virologic response (SVR) analysis was performed in 5,400 patients initiated on DCV + SOF ± RBV or VEL/SOF ± RBV at any Department of Veterans Affairs facility. RESULTS: For genotype 2, SVR rates did not differ between DCV + SOF (94.5%) and VEL/SOF (94.4%) or between DCV + SOF + RBV (88.1%) and VEL/SOF + RBV (89.5%). For genotype 3, SVR rates did not differ between DCV + SOF (90.8%) and VEL/SOF (92.0%) or between DCV + SOF + RBV (88.1%) and VEL/SOF + RBV (86.4%). In multivariate models of patients with genotype 2 and 3 infection, the treatment regimen was not a significant predictor of the odds of SVR. For genotype 3, significant predictors of reduced odds of SVR were prior HCV treatment-experience (odds ratio [OR] 0.51, 95% CI 0.36-0.72; p <0.001), FIB-4 >3.25 (OR 0.60; 95%CI 0.43-0.84; p = 0.002) and a history of decompensated liver disease (OR 0.68; 95%CI 0.47-0.98; p = 0.04). For patients with genotype 2 and 3, treated with VEL/SOF ± RBV, 89% and 85% received 12-weeks of treatment, respectively. For DCV + SOF ± RBV, 56% and 20% of patients with HCV genotype 2 received 12-weeks and 24-weeks of treatment, respectively; while 53% and 23% of patients with HCV genotype 3 received 12-weeks and 24-weeks, with most direct-acting antiviral experienced patients receiving 24-weeks. CONCLUSIONS: In patients infected with HCV genotype 2 and 3, DCV + SOF ± RBV and VEL/SOF ± RBV produced similar SVR rates within each genotype, and the regimen did not have a significant impact on the odds of SVR. For patients with genotype 3, prior treatment-experience and advanced liver disease were significant predictors of reduced odds of SVR regardless of regimen. LAY SUMMARY: In clinical practice, cure rates for hepatitis C virus (HCV) genotype 2 were 94% and cure rates for HCV genotype 3 were 90%. The chance of achieving cure was the same whether a person received daclatasvir plus sofosbuvir or velpatasvir/sofosbuvir. Ribavirin did not affect cure rates. The chance of a cure was lowest in people who had received HCV medication in the past. Published by Elsevier B.V.
BACKGROUND & AIM: Understanding the real-world effectiveness of all-oral hepatitis C virus (HCV) regimens informs treatment decisions. We evaluated the effectiveness of daclatasvir + sofosbuvir ± ribavirin (DCV + SOF ± RBV) and velpatasvir/sofosbuvir (VEL/SOF) ± RBV in patients with genotype 2 and genotype 3 infection treated in routine practice. METHODS: This observational analysis was carried out in an intent-to-treat cohort of patients with HCV genotype 2 and genotype 3. Sustained virologic response (SVR) analysis was performed in 5,400 patients initiated on DCV + SOF ± RBV or VEL/SOF ± RBV at any Department of Veterans Affairs facility. RESULTS: For genotype 2, SVR rates did not differ between DCV + SOF (94.5%) and VEL/SOF (94.4%) or between DCV + SOF + RBV (88.1%) and VEL/SOF + RBV (89.5%). For genotype 3, SVR rates did not differ between DCV + SOF (90.8%) and VEL/SOF (92.0%) or between DCV + SOF + RBV (88.1%) and VEL/SOF + RBV (86.4%). In multivariate models of patients with genotype 2 and 3 infection, the treatment regimen was not a significant predictor of the odds of SVR. For genotype 3, significant predictors of reduced odds of SVR were prior HCV treatment-experience (odds ratio [OR] 0.51, 95% CI 0.36-0.72; p <0.001), FIB-4 >3.25 (OR 0.60; 95%CI 0.43-0.84; p = 0.002) and a history of decompensated liver disease (OR 0.68; 95%CI 0.47-0.98; p = 0.04). For patients with genotype 2 and 3, treated with VEL/SOF ± RBV, 89% and 85% received 12-weeks of treatment, respectively. For DCV + SOF ± RBV, 56% and 20% of patients with HCV genotype 2 received 12-weeks and 24-weeks of treatment, respectively; while 53% and 23% of patients with HCV genotype 3 received 12-weeks and 24-weeks, with most direct-acting antiviral experienced patients receiving 24-weeks. CONCLUSIONS: In patientsinfected with HCV genotype 2 and 3, DCV + SOF ± RBV and VEL/SOF ± RBV produced similar SVR rates within each genotype, and the regimen did not have a significant impact on the odds of SVR. For patients with genotype 3, prior treatment-experience and advanced liver disease were significant predictors of reduced odds of SVR regardless of regimen. LAY SUMMARY: In clinical practice, cure rates for hepatitis C virus (HCV) genotype 2 were 94% and cure rates for HCV genotype 3 were 90%. The chance of achieving cure was the same whether a person received daclatasvir plus sofosbuvir or velpatasvir/sofosbuvir. Ribavirin did not affect cure rates. The chance of a cure was lowest in people who had received HCV medication in the past. Published by Elsevier B.V.
Authors: Sunil S Solomon; Sandra Wagner-Cardoso; Laura Smeaton; Leonard A Sowah; Chanelle Wimbish; Gregory Robbins; Irena Brates; Christine Scello; Annie Son; Anchalee Avihingsanon; Benjamin Linas; Donald Anthony; Estevão Portela Nunes; Dimas A Kliemann; Khuanchai Supparatpinyo; Cissy Kityo; Pablo Tebas; Jaclyn Ann Bennet; Jorge Santana-Bagur; Constance A Benson; Marije Van Schalkwyk; Nelson Cheinquer; Susanna Naggie; David Wyles; Mark Sulkowski Journal: Lancet Gastroenterol Hepatol Date: 2022-01-10
Authors: Alessandra Mangia; Scott Milligan; Mandana Khalili; Stefano Fagiuoli; Stephen D Shafran; Fabrice Carrat; Denis Ouzan; George Papatheodoridis; Alnoor Ramji; Sergio M Borgia; Heiner Wedemeyer; Ruggero Losappio; Francisco Pérez-Hernandez; Nicole Wick; Robert S Brown; Pietro Lampertico; Karen Doucette; Ioanna Ntalla; Heribert Ramroth; Michael Mertens; Kim Vanstraelen; Juan Turnes Journal: Liver Int Date: 2020-06-09 Impact factor: 5.828