Drug updated on 4/17/2024
| Dosage Form | Tablet (oral: 400 mg sofosbuvir, 100 mg velpatasvir, and 100 mg voxilaprevir) |
| Drug Class | HCV nucleotide analog NS5B polymerase inhibitor, HCV NS5A inhibitor, and HCV NS3/4A protease inhibitor |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For the treatment of adult patients with chronic HCV infection without cirrhosis or with compensated cirrhosis (Child-Pugh A) who have (1, 2.2, 14) genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an HCV regimen containing an NS5A inhibitor.
- For the treatment of adult patients with genotype 1a or 3 infection and have previously been treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor.
Summary
- Sofosbuvir, velpatasvir and voxilaprevir (Vosevi) is indicated for the treatment of adult patients with chronic HCV infection without cirrhosis or with compensated cirrhosis who have genotype 1, 2, 3, 4, 5 or 6 infection and have previously been treated with an HCV regimen containing an NS5A inhibitor.
- The document reviewed was a systematic review/meta-analysis that included one study detailing the effectiveness of Vosevi in treating hepatitis C virus (HCV) genotype-3 infected patients.
- This study found that sofosbuvir/velpatasvir/voxilaprevir had a sustained virologic response rate of approximately 85% after a treatment period ranging from twelve to twenty-four weeks.
- When compared to other regimens such as SOF+DCV±RBV; SOF+VEL±RBV; and GLE+PIB used in real-world studies on HCV GT3-infected patients across multiple countries, Vosevi's SVR rate was lower than all but still considered effective post-DAA treatment failure.
- In terms of patient subgroups: non-cirrhotic patients showed higher pooled SVR rates at around ~95%, while those suffering from cirrhosis demonstrated slightly lower success rates (~89%).
- Treatment-naive individuals also exhibited better outcomes (~94%) when compared to their counterparts who had undergone previous treatments (~88%), indicating potential considerations for prescribing this drug combination therapy for different patient populations based on disease progression and prior exposure to treatments respectively.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Vosevi (sofosbuvir, velpatasvir and voxilaprevir) Prescribing Information. | 2019 | Gilead Sciences, Inc., Foster City, CA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Real-world effectiveness of direct-acting antiviral regimens against hepatitis c virus (hcv) genotype 3 infection: a systematic review and meta-analysis. | 2021 | Annals of Hepatology |
| Assessment report: Vosevi. | 2021 | EMA |
| Clinical review report: sofosbuvir / velpatasvir / voxilaprevir (Vosevi). | 2018 | CADTH |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Hepatitis C guidance 2023 update: AASLD-IDSA recommendations for testing, managing, and treating hepatitis c virus infection. | 2023 | Infectious Disease Society of America |
| The management of chronic hepatitis C: 2018 guideline update from the Canadian Association for the Study of the Liver. | 2018 | Canadian Medical Association Journal |