Drug updated on 12/11/2024
| Dosage Form | Tablet (oral: 400 mg sofosbuvir, 100 mg velpatasvir, and 100 mg voxilaprevir) |
| Drug Class | Hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitors, HCV NS5A inhibitors, and HCV NS3/4A protease inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult patients with chronic HCV infection without cirrhosis or with compensated cirrhosis (Child-Pugh A) who have genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an HCV regimen containing an NS5A inhibitor
- Indicated for the treatment of adult patients with chronic HCV infection without cirrhosis or with compensated cirrhosis (Child-Pugh A) who have genotype 1a or 3 infection and have previously been treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor (Additional benefit of VOSEVI over sofosbuvir/velpatasvir was not shown in adults with genotype 1b, 2, 4, 5, or 6 infection previously treated with sofosbuvir without an NS5A inhibitor).
Latest News
Summary
- This summary is based on the review of four systematic review(s)/meta-analysis(es). [1-4]
- SVR12 rates varied by region, with Eastern Mediterranean showing significantly higher pooled SVR12 rates than America and Europe (p < 0.05).
- Predictors of treatment failure included genotype 3, active hepatocellular carcinoma (HCC), baseline cirrhosis, and prior SOF/VEL exposure.
- Real-world studies reported SVR12 rates of 93% in intention-to-treat (ITT) populations and 96% in per-protocol (PP) populations, with higher rates in non-genotype 3 (GT3)-infected and non-cirrhotic patients.
- Subgroup analysis showed lower SVR12 rates in GT3-infected, cirrhotic patients, and those with previous sofosbuvir/velpatasvir (SOF/VEL) treatment failure.
- Treatment-related adverse events were reported with SOF/VEL/voxilaprevir (VOX) in direct-acting antiviral (DAA)-experienced hepatitis C (CHC) patients, with a 0.2% rate of treatment discontinuation due to adverse events.
- In real-world studies, 30% of patients reported adverse events, with serious adverse events occurring in 3.82% of patients and AE-related treatment discontinuations reported in 0.66% of cases. Common adverse events included headache, asthenia, nausea, fatigue, and diarrhea, mostly mild.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Vosevi (sofosbuvir, velpatasvir and voxilaprevir) Prescribing Information. | 2019 | Gilead Sciences, Inc., Foster City, CA |