FDA New Drug and Biologic Approvals -- 2017 Year-in-Review

Vosevi (sofosbuvir/velpatasvir/voxilaprevir)

Indication:

Re-treatment of hepatitis C virus (HCV) infection in adults with genotype 1, 2, 3, 4, 5, or 6 previously treated with an NS5A inhibitor-containing regimen. Also indicated for genotypes 1a or 3 in patients previously treated with a sofosbuvir-containing regimen without an NS5A inhibitor.

Mechanism:

Voxilaprevir is new to the U.S. market.

Sofosbuvir: Inhibitor of HCV NS5B RNA-dependent polymerase; its inhibition, in turn, suppresses viral replication.

Velpatasvir: Pangenotypic HCV NS5A inhibitor; the NS5A protein is required for viral replication.

Voxilaprevir: Pangenotypic NS3/4A protease inhibitor, which is needed for proteolytic cleavage of the HCV-encoded polyprotein into mature forms and is essential for viral replication.

Dosage:

1 tablet (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg) PO once daily for 12 weeks.

Approval:

Approval was based on two phase 3 clinical trials, POLARIS-1 and POLARIS-4 (n=728) in adults with chronic HCV infection without cirrhosis or with compensated cirrhosis. Results of both trials demonstrated a sustained viral response of 96-98% at 12 weeks following treatment in patients who received sofosbuvir/velpatasvir/voxilaprevir.

Reference:

Bourlière M, et al. Sofosbuvir, velpatasvir, and voxilaprevir for previously treated HCV infection. N Engl J Med. 2017 Jun 1;376(22):2134-46.

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Cite this: Mary L Windle. FDA New Drug and Biologic Approvals -- 2017 Year-in-Review - Medscape - Jan 11, 2018.