Drug updated on 9/4/2024
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
Summary
- Vosevi (sofosbuvir, velpatasvir, and voxilaprevir) is 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; and for the treatment of adult patients with genotype 1a or 3 infection who have previously been treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor.
- This summary is based on the review of four systematic review(s)/meta-analysis(es). [1-4]
- SOF/VEL/VOX achieved a sustained virologic response at 12 weeks (SVR12) of 93% in the intention-to-treat (ITT) populations and 96% in the per-protocol (PP) populations. Genotype 3-infected and cirrhotic patients, as well as those with prior SOF/VEL exposure, showed lower SVR12 rates.
- In genotype 3 (GT3)-infected patients, SOF/VEL/VOX demonstrated an SVR rate of 84.97%, which was lower compared to GLE+PIB (98.54%), SOF+VEL±RBV (95.08%), and SOF+DCV±RBV (91.17%) in the same population.
- SVR12 rates varied by region, with higher rates observed in the Eastern Mediterranean compared to the Americas and Europe. Non-cirrhotic patients and those without prior SOF/VEL treatment also exhibited higher SVR12 rates.
- Treatment discontinuation due to drug-related adverse events was rare (0.2%), while adverse events were reported in 30% of patients, with serious adverse events occurring in 3.82%. The most common adverse events were headache, asthenia, nausea, fatigue, and diarrhea. Adverse event-related discontinuations were low (0.66%).
- Grade 3 hyperglycemia incidence was 0.015, with a higher incidence in cirrhotic patients and those with the GT3 genotype, and SOF/VEL/VOX was specifically noted for this adverse effect compared to other direct-acting antivirals (DAAs).
- There is no population type or subgroup 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 |
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 |