TY - JOUR
T1 - Sofosbuvir plus velpatasvir combination therapy for treatment- Experienced patients with genotype 1 or 3 Hepatitis c virus infection
AU - Pianko, Stephen
AU - Flamm, Steven L
AU - Shiffman, Mitchell L
AU - Kumar, Sonal
AU - Strasser, Simone I
AU - Dore, Gregory J
AU - McNally, John
AU - Brainard, Diana
AU - Han, Lingling
AU - Doehle, Brian
AU - Mogalian, Erik
AU - McHutchison, John G
AU - Rabinovitz, Mordechai
AU - Towner, William J
AU - Gane, Edward J
AU - Stedman, Catherine A M
AU - Reddy, Kuchikula Rajender
AU - Roberts, Stuart Keith
PY - 2015
Y1 - 2015
N2 - Effective treatment options are needed for patients with genotype 1 or 3 hepatitis C virus (HCV) infection in whom previous therapy has failed. Objective: To assess the efficacy and safety of sofosbuvir plus velpatasvir, with and without ribavirin, in treatment-experienced patients. Design: Randomized, phase 2, open-label study. (ClinicalTrials .gov: NCT01909804) Setting: 58 sites in Australia, New Zealand, and the United States. Patients: Treatment-experienced adults with genotype 3 HCV infection without cirrhosis (cohort 1) and with compensated cirrhosis (cohort 2) and patients with genotype 1 HCV infection that was unsuccessfully treated with a protease inhibitor with peginterferon and ribavirin (50 could have compensated cirrhosis) (cohort 3). Intervention: All patients received 12 weeks of treatment that included 400 mg of sofosbuvir once daily. Patients in each cohort were randomly assigned to 25 mg of velpatasvir once daily with or without ribavirin or 100 mg of velpatasvir once daily with or without ribavirin. Measurements: Proportion of patients with sustained virologic response at week 12 after treatment (SVR12). Results: In cohort 1, SVR12 rates were 85 with 25 mg of velpatasvir, 96 with 25 mg of velpatasvir plus ribavirin, 100 with 100 mg of velpatasvir, and 100 with 100 mg of velpatasvir plus ribavirin. In cohort 2, SVR12 rates were 58 with 25 mg of velpatasvir, 84 with 25 mg of velpatasvir plus ribavirin, 88 with 100 mg of velpatasvir, and 96 with 100 mg of velpatasvir plus ribavirin. In cohort 3, SVR12 rates were 100 with 25 mg of velpatasvir, 97 with 25 mg of velpatasvir plus ribavirin, 100 with 100 mg of velpatasvir, and 96 with 100 mg of velpatasvir plus ribavirin. The most common adverse events were headache, fatigue, and nausea. Limitation: Treatment assignments were not blinded, and no inferential statistics were planned. Conclusion: Treatment with 400 mg of sofosbuvir plus 100 mg of velpatasvir for 12 weeks was well-Tol
AB - Effective treatment options are needed for patients with genotype 1 or 3 hepatitis C virus (HCV) infection in whom previous therapy has failed. Objective: To assess the efficacy and safety of sofosbuvir plus velpatasvir, with and without ribavirin, in treatment-experienced patients. Design: Randomized, phase 2, open-label study. (ClinicalTrials .gov: NCT01909804) Setting: 58 sites in Australia, New Zealand, and the United States. Patients: Treatment-experienced adults with genotype 3 HCV infection without cirrhosis (cohort 1) and with compensated cirrhosis (cohort 2) and patients with genotype 1 HCV infection that was unsuccessfully treated with a protease inhibitor with peginterferon and ribavirin (50 could have compensated cirrhosis) (cohort 3). Intervention: All patients received 12 weeks of treatment that included 400 mg of sofosbuvir once daily. Patients in each cohort were randomly assigned to 25 mg of velpatasvir once daily with or without ribavirin or 100 mg of velpatasvir once daily with or without ribavirin. Measurements: Proportion of patients with sustained virologic response at week 12 after treatment (SVR12). Results: In cohort 1, SVR12 rates were 85 with 25 mg of velpatasvir, 96 with 25 mg of velpatasvir plus ribavirin, 100 with 100 mg of velpatasvir, and 100 with 100 mg of velpatasvir plus ribavirin. In cohort 2, SVR12 rates were 58 with 25 mg of velpatasvir, 84 with 25 mg of velpatasvir plus ribavirin, 88 with 100 mg of velpatasvir, and 96 with 100 mg of velpatasvir plus ribavirin. In cohort 3, SVR12 rates were 100 with 25 mg of velpatasvir, 97 with 25 mg of velpatasvir plus ribavirin, 100 with 100 mg of velpatasvir, and 96 with 100 mg of velpatasvir plus ribavirin. The most common adverse events were headache, fatigue, and nausea. Limitation: Treatment assignments were not blinded, and no inferential statistics were planned. Conclusion: Treatment with 400 mg of sofosbuvir plus 100 mg of velpatasvir for 12 weeks was well-Tol
UR - http://annals.org/article.aspx?articleid=2468807
U2 - 10.7326/M15-1014
DO - 10.7326/M15-1014
M3 - Article
SN - 0003-4819
VL - 163
SP - 809
EP - 817
JO - Annals of Internal Medicine
JF - Annals of Internal Medicine
IS - 11
ER -
