drugset / Trial / NCT02202980
Efficacy and Safety of Oral Regimens for the Treatment of Chronic HCV Infection
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This study will evaluate the antiviral efficacy, safety, and tolerability of combination therapy with oral regimens for the treatment of chronic hepatitis C virus (HCV) infection.
Timeline
- Start
- 2014-08-04
- Primary completion
- 2016-03-16
- Completion
- 2016-05-09
Publications
- Results Gane EJ, Svarovskaia ES, Hyland RH, Stamm LM, Osinusi A, Brainard DM, Chodavarapu K, Miller MD, Mo H, Schwabe C. Resistance Analysis of Treatment-Naive and DAA-Experienced Genotype 1 Patients with and without Cirrhosis Who Received Short-Duration Treatment with Sofosbuvir/GS-5816+ GS-9857 [Poster 713]. J Hepatol 2015;62:563A
- Results Gane EJ, Schwabe C, Hyland RH, Yang Y, Svarovskaia E, Stamm LM, Brainard DM, McHutchison JG, Stedman CA. Efficacy of the Combination of Sofosbuvir, Velpatasvir, and the NS3/4A Protease Inhibitor GS-9857 in Treatment-Naive or Previously Treated Patients With Hepatitis C Virus Genotype 1 or 3 Infections. Gastroenterology. 2016 Sep;151(3):448-456.e1. doi: 10.1053/j.gastro.2016.05.021. Epub 2016 May 27.
- Results Gane EJ, Hyland RH, Yang Y, Svarovskaia E, Stamm LM, Brainard DM, McHutchison JG, Stedman CAM. Efficacy of Ledipasvir Plus Sofosbuvir for 8 or 12 Weeks in Patients With Hepatitis C Virus Genotype 2 Infection. Gastroenterology. 2017 May;152(6):1366-1371. doi: 10.1053/j.gastro.2017.01.017. Epub 2017 Jan 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LDV/SOF | Unknown | — | Oral |
| Subject | Ribavirin | Small molecule | 1000 mg | Oral |
| Subject | Ribavirin | Small molecule | 1200 mg | Oral |
| Subject | SOF/VEL | Unknown | — | Oral |
| Subject | VOX | Unknown | 100 mg | Oral |