drugset / Trial / NCT01826981
Efficacy and Safety of Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection in Participants With Chronic Genotype 1, 2, 3, or 6 HCV Infection
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the antiviral efficacy, safety, tolerability of combination therapy with sofosbuvir (SOF) containing regimens for the treatment of chronic hepatitis C virus (HCV) infection.
Timeline
- Start
- 2013-04
- Primary completion
- 2015-03
- Completion
- 2015-05
Outcome
Met primary endpoint
paper All eight patients (100%; 95% CI 63%, 100%) reached the primary end point of HCV RNA <15 IU/ml 12 weeks after treatment. PMID 27367295 ↗
Publications
- Results Gane EJ, Hyland RH, An D, Svarovskaia E, Pang PS, Brainard D, Stedman CA. Efficacy of ledipasvir and sofosbuvir, with or without ribavirin, for 12 weeks in patients with HCV genotype 3 or 6 infection. Gastroenterology. 2015 Nov;149(6):1454-1461.e1. doi: 10.1053/j.gastro.2015.07.063. Epub 2015 Aug 7.
- Results Gane EJ, Hyland RH, An D, Svarovskaia ES, Brainard D, McHutchison JG. Ledipasvir and sofosbuvir for HCV infection in patients coinfected with HBV. Antivir Ther. 2016;21(7):605-609. doi: 10.3851/IMP3066. Epub 2016 Jul 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ledipasvir/sofosbuvir | Unknown | 90 mg | Oral |
| Subject | Ledipasvir/sofosbuvir | Unknown | 400 mg | Oral |
| Subject | Pegylated Interferon | Unknown | 180 ug | Subcutaneous |
| Subject | RADALBUVIR | Small molecule | 500 mg | Oral |
| Subject | Ribavirin | Small molecule | 1000 mg | Oral |
| Subject | Ribavirin | Small molecule | 1200 mg | Oral |
| Subject | Sofosbuvir | Small molecule | 400 mg | Oral |
| Subject | velpatasvir | Other / unclassified | 25 mg | Oral |
| Subject | velpatasvir | Other / unclassified | 100 mg | Oral |