Sofosbuvir plus velpatasvir combination therapy for treatment- Experienced patients with genotype 1 or 3 Hepatitis c virus infection

Stephen Pianko, Steven L Flamm, Mitchell L Shiffman, Sonal Kumar, Simone I Strasser, Gregory J Dore, John McNally, Diana Brainard, Lingling Han, Brian Doehle, Erik Mogalian, John G McHutchison, Mordechai Rabinovitz, William J Towner, Edward J Gane, Catherine A M Stedman, Kuchikula Rajender Reddy, Stuart Keith Roberts

Research output: Contribution to journalArticleResearchpeer-review

Abstract

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
Original languageEnglish
Pages (from-to)809 - 817
Number of pages9
JournalAnnals of Internal Medicine
Volume163
Issue number11
DOIs
Publication statusPublished - 2015

Cite this

Pianko, Stephen ; Flamm, Steven L ; Shiffman, Mitchell L ; Kumar, Sonal ; Strasser, Simone I ; Dore, Gregory J ; McNally, John ; Brainard, Diana ; Han, Lingling ; Doehle, Brian ; Mogalian, Erik ; McHutchison, John G ; Rabinovitz, Mordechai ; Towner, William J ; Gane, Edward J ; Stedman, Catherine A M ; Reddy, Kuchikula Rajender ; Roberts, Stuart Keith. / Sofosbuvir plus velpatasvir combination therapy for treatment- Experienced patients with genotype 1 or 3 Hepatitis c virus infection. In: Annals of Internal Medicine. 2015 ; Vol. 163, No. 11. pp. 809 - 817.
@article{e1757c0ea71948e8a8bc57c6972b4fee,
title = "Sofosbuvir plus velpatasvir combination therapy for treatment- Experienced patients with genotype 1 or 3 Hepatitis c virus infection",
abstract = "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",
author = "Stephen Pianko and Flamm, {Steven L} and Shiffman, {Mitchell L} and Sonal Kumar and Strasser, {Simone I} and Dore, {Gregory J} and John McNally and Diana Brainard and Lingling Han and Brian Doehle and Erik Mogalian and McHutchison, {John G} and Mordechai Rabinovitz and Towner, {William J} and Gane, {Edward J} and Stedman, {Catherine A M} and Reddy, {Kuchikula Rajender} and Roberts, {Stuart Keith}",
year = "2015",
doi = "10.7326/M15-1014",
language = "English",
volume = "163",
pages = "809 -- 817",
journal = "Annals of Internal Medicine",
issn = "0003-4819",
publisher = "American College of Physicians",
number = "11",

}

Pianko, S, Flamm, SL, Shiffman, ML, Kumar, S, Strasser, SI, Dore, GJ, McNally, J, Brainard, D, Han, L, Doehle, B, Mogalian, E, McHutchison, JG, Rabinovitz, M, Towner, WJ, Gane, EJ, Stedman, CAM, Reddy, KR & Roberts, SK 2015, 'Sofosbuvir plus velpatasvir combination therapy for treatment- Experienced patients with genotype 1 or 3 Hepatitis c virus infection' Annals of Internal Medicine, vol. 163, no. 11, pp. 809 - 817. https://doi.org/10.7326/M15-1014

Sofosbuvir plus velpatasvir combination therapy for treatment- Experienced patients with genotype 1 or 3 Hepatitis c virus infection. / Pianko, Stephen; Flamm, Steven L; Shiffman, Mitchell L; Kumar, Sonal; Strasser, Simone I; Dore, Gregory J; McNally, John; Brainard, Diana; Han, Lingling; Doehle, Brian; Mogalian, Erik; McHutchison, John G; Rabinovitz, Mordechai; Towner, William J; Gane, Edward J; Stedman, Catherine A M; Reddy, Kuchikula Rajender; Roberts, Stuart Keith.

In: Annals of Internal Medicine, Vol. 163, No. 11, 2015, p. 809 - 817.

Research output: Contribution to journalArticleResearchpeer-review

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

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