Drug updated on 5/17/2024
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
- Indicated 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.
- Indicated 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.
Latest News
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Summary
- Sofosbuvir, velpatasvir, and voxilaprevir (Vosevi) is recommended for the management of chronic HCV infection in adult patients without cirrhosis or with compensated cirrhosis who have genotype 1, 2, 3, 4, 5, or 6 infection and have previously received an HCV regimen containing an NS5A inhibitor. It is also effective in managing adults with genotype 1a or 3 infections previously treated using a sofosbuvir-based regimen without an NS5A inhibitor.
- Four systematic reviews/meta-analyses provided insights into its efficacy as a salvage treatment for Chronic Hepatitis C patients who had previous treatments fail.
- The medication has demonstrated high effectiveness as a rescue therapy among Chronic Hepatitis C patients whose prior direct-acting antiviral treatments failed. Predictors of treatment failure include active hepatocellular carcinoma (HCC), baseline cirrhosis, and prior exposure to SOF/VEL combination drugs.
- Regarding the safety profile across different population types, including diabetic patients managing HCV treatment failure, rare instances of grade three hyperglycemia necessitate careful monitoring during administration among this subgroup.
- Real-world effectiveness studies indicate SVR12 rates between 93%-96% among HCV-infected individuals experiencing previous therapeutic failures. Adverse events are generally mild, but serious adverse events occur at a rate of approximately four percent.
- In comparison to other regimens like GLE+PIB specifically for GT3 infected individuals post-treatment failure, while Vosevi remains an effective option with a lower SVR rate at around eighty-five percent, GLE+PIB shows higher success rates nearing ninety-nine percent, indicating potential superiority in such cases.
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
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Hepatitis c guidance 2023 update: American Association for the Study of Liver Diseases– Infectious Diseases Society of America recommendations for testing, managing, and treating hepatitis c virus infection. | 2023 | Clinical Infectious Diseases |
The management of chronic hepatitis C: 2018 guideline update from the Canadian Association for the Study of the Liver. | 2018 | Canadian Medical Association Journal |