drugset / Trial / NCT02074514
Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Chronic Genotype 1 or 3 HCV Infection
RandomizedParallel-groupOpen-labelTreatment
Summary
This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + ribavirin (RBV) in treatment-naive adults with chronic genotype 1 or 3 hepatitis C virus (HCV) infection.
Timeline
- Start
- 2014-03
- Primary completion
- 2015-09
- Completion
- 2015-11
Publications
- Results Shah S, Acharya SK, Mehta R., Kapoor D, Duseja A, Koshy A, et al. (2016) "Sofosbuvir Plus Ribavirin in the Treatment of Chronic HCV Infection in India." Hepatol Int. 10 (Suppl 1): S15.
- Results Shah S, Chowdhury A, Mehta R, Kapoor D, Duseja A, Koshy A, et al. Sofosbuvir plus Ribavirin Results in High SVR4 Rates in Patients with Chronic HCV Genotype 1 or 3 Infection in India (Poster L-47). 56th Annual Conference of Indian Society of Gastroenterology; 2015, November, 19-22 Indore, India.
- Shah SR, Chowdhury A, Mehta R, Kapoor D, Duseja A, Koshy A, Shukla A, Sood A, Madan K, Sud R, Nijhawan S, Pawan R, Prasad M, Kersey K, Jiang D, Svarovskaia E, Doehle B, Kanwar B, Subramanian M, Acharya SK, Sarin S. Sofosbuvir plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 or 3 infection in India. J Viral Hepat. 2017 May;24(5):371-379. doi: 10.1111/jvh.12654. Epub 2016 Dec 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | RBV | Unknown | 1000 mg | Oral |
| Subject | RBV | Unknown | 1200 mg | Oral |
| Subject | Sofosbuvir | Small molecule | 400 mg | Oral |