Product Dossier
VOSEVI
Product Dossier for VOSEVI (sofosbuvir, velpatasvir, voxilaprevir, Gilead Sciences). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by…
- Sponsor: Gilead Sciences
- Active ingredient: sofosbuvir, velpatasvir, voxilaprevir
- Therapeutic area: Hepatology
- Related brand: EPCLUSA
- Related brand: HARVONI
- Same area: URSODOX
- Same area: PEGASYS
What it is
VOSEVI is a fixed-dose combination tablet containing sofosbuvir 400 mg, velpatasvir 100 mg, and voxilaprevir 100 mg.
Approved indications —
Chronic hepatitis C virus (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 been treated with an HCV regimen containing an NS5A inhibitor. — Chronic hepatitis C virus (HCV) infection in adult patients, without cirrhosis or with compensated cirrhosis, with genotype 1a or 3 infection who have previously been treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor.
Key safety warnings
The safety profile is generally consistent with the known profiles of sofosbuvir and velpatasvir, with no new or unexpected safety concerns identified for the fixed-dose combination.
Regulatory history
VOSEVI was first listed on the ARTG on 16 March 2018. The TGA approved registration for the treatment of chronic hepatitis C virus (HCV) infection in adult patients, without cirrhosis or with compensated cirrhosis, who have previously been treated with an HCV regimen containing an NS5A inhibitor, or genotype 1a or 3 infection and have previously been treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor, based on demonstrated efficacy and acceptable safety profile of the fixed-dose combination in this difficult-to-treat patient population. In July 2018, the PBAC recommended VOSEVI for listing on the General Schedule and Section 100 (Highly Specialised Drugs Program) on a cost minimisation basis with glecaprevir with pibrentasvir, for chronic hepatitis C virus (HCV) infection in patients who have failed treatment with an NS5A-based direct acting antiviral treatment regimen, regardless of genotype.