Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01783678 | A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Adults | PHASE3 | COMPLETED | 275 | — | — | Jan 1, 2013 | Jul 1, 2014 | Apr 30, 2015 | 24 | Australia, France +4 |
| NCT01641640 | Sofosbuvir With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1, 4, 5, or 6 HCV Infection | PHASE3 | COMPLETED | 328 | — | — | Jun 1, 2012 | Apr 1, 2013 | May 8, 2014 | 56 | United States, Puerto Rico |
| NCT02745535 | Safety, Tolerability and Efficacy of Sofosbuvir, Velpatasvir, and Voxilaprevir in Subjects With Previous DAA Experience | PHASE2 | COMPLETED | 77 | — | — | May 1, 2016 | Oct 24, 2018 | Mar 10, 2022 | 1 | United States |
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ, ie, \< 25 IU/mL) 12 weeks following the last dose of study drug.
The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized.
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks after cessation of therapy.
The number of participants experiencing adverse events leading to permanent discontinuation of study drug was summarized. Adverse events may or may not have been related to study treatment. Participants discontinuing study drug were permitted to remain on the study for further assessments.
Number of participants with grade 3 and 4 adverse events during treatment with and/or within 30 of completion of SOF/VEL/VOX in HCV infected
Intention to treat (ITT) analysis. Sustained Virologic Response as measure by an undetectable HCV RNA level 12 weeks after completion of therapy.
| Arm | Type | Description |
|---|---|---|
| Genotype 2 treatment-naive | EXPERIMENTAL | Treatment-naive (TN) participants with HIV-1 and genotype 2 HCV coinfection will receive sofosbuvir plus RBV for 12 weeks. |
| Genotype 2/3 treatment-experienced | EXPERIMENTAL | Treatment-experienced (TE) participants with HIV-1 and genotype 2 or 3 HCV co-infection will receive sofosbuvir plus RBV for 24 weeks. |
| Genotype 1/3/4 treatment-naive | EXPERIMENTAL | Treatment naive (TN) participants with HIV-1 and genotype 1, 3, or 4 HCV co-infection will receive sofosbuvir plus RBV for 24 weeks. |
| Sofosbuvir+PEG+RBV | EXPERIMENTAL | - |
| SOF/VEL/VOX | EXPERIMENTAL | Fixed dose combination of SOF/VEL/VOX (Sofosbuvir 400mg/Velpatasvir 100mg/ Voxilaprevir 100mg) dosed once daily for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| Sofosbuvir | DRUG | Sofosbuvir 400 mg tablet administered orally once daily |
| RBV | DRUG | Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg) |
| PEG | DRUG | Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection |
| Sofosbuvir/Velpatasvir/Voxilaprevir | DRUG | - |
Inclusion Criteria: * Age ≥ 18 years with HIV-1 and chronic HCV genotype 1, 2, 3, or 4 co-infection * HCV RNA \> 10,000 IU/mL at screening * HCV treatment history: * Treatment-naive for HCV genotypes 1, 2, 3, or 4, or * Treatment-experienced for HCV genotypes 2 or 3 * HIV antiretroviral (ARV) ...