Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sofosbuvir/Velpatasvir/Voxilaprevir · 3 trials · 2 indications
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) ...
Sofosbuvir is an investigational small molecule being developed for the treatment of chronic Hepatitis C virus (HCV) infection, including genotypes 1, 3, 4, 5, and 6, as well as Hepatitis B. It is studied in combination with other antiviral agents such as ribavirin and pegylated interferon.
Sofosbuvir is a nucleotide analog inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is essential for viral replication. By targeting this enzyme, sofosbuvir interferes with the Hepatitis C virus's ability to multiply, thereby reducing viral load in infected patients.
Sofosbuvir is developed by Gilead Sciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol GILD. Gilead is responsible for the clinical development and regulatory strategy for this compound across multiple Hepatitis C indications.
Sofosbuvir is in Phase 3 clinical development for chronic Hepatitis C virus infection. It has completed five clinical trials, including Phase 2 and Phase 3 studies, with a total enrollment of 825 participants. Sofosbuvir is not yet approved and remains an investigational drug.
Sofosbuvir has completed several clinical trials, including NCT01329978, a Phase 2 study in HCV genotypes 1, 4, 5, and 6; NCT01435044, a Phase 2 safety study; NCT02021643, a Phase 3 trial in chronic HCV; and NCT02074514, a Phase 3 study in treatment-naive adults with genotype 1 or 3 HCV.
Sofosbuvir is the generic name for the drug also known as Sovaldi, which is a brand name used by Gilead Sciences. In clinical trials and regulatory documents, the compound is referred to as sofosbuvir, while Sovaldi is the commercial name under which it is marketed.