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Sofosbuvir, velpatasvir and voxilaprevir

(Vosevi®)

Vosevi®

Drug updated on 10/30/2024

Dosage FormTablet (oral: 400 mg sofosbuvir, 100 mg velpatasvir, and 100 mg voxilaprevir)
Drug ClassHepatitis 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).

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Summary
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  • 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 ITT populations and 96% in PP populations, with higher rates in non-GT3-infected and non-cirrhotic patients.
  • Subgroup analysis showed lower SVR12 rates in GT3-infected, cirrhotic patients, and those with previous SOF/VEL treatment failure.
  • Treatment-related adverse events were reported with SOF/VEL/VOX in DAA-experienced 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.