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

Mary L Windle, PharmD

Disclosures

January 11, 2018

In This Article

Mavyret (glecaprevir/pibrentasvir)

Indication:

Treatment-naive adults with chronic hepatitis C virus (HCV) infection with genotypes 1-6 without cirrhosis or with compensated cirrhosis. Also indicated for treatment-experienced patients with HCV genotype 1 who have been previously treated with a regimen containing either an NS5A inhibitor or an NS3/4A protease inhibitor, but not both.

Mechanism:

Combination product that includes 2 new drugs, glecaprevir (HCV protease inhibitor) and pibrentasvir (NS5A inhibitor).

Dosage:

3 tablets (ie, 300 mg/120 mg total dose) PO once daily with food. Treatment duration ranges from 8 to 16 weeks and is dependent on treatment status, genotype, and presence of cirrhosis.

Approval:

Approval was based on clinical trials involving nearly 2300 adults with chronic HCV. Sustained viral response at 12 weeks after treatment with glecaprevir/pibrentasvir ranged from 92-100%, indicative of a cure–regardless of whether treatment lasted 8, 12, or 16 weeks.

Reference:

Mavyret (glecaprevir/pibrentasvir) prescribing information. AbbVie Inc. Chicago, IL. August, 2017.

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