MAVIRET

What it is

MAVIRET contains glecaprevir and pibrentasvir. MAVIRET is available as a fixed-dose combination tablet containing glecaprevir 100 mg and pibrentasvir 40 mg, or as granules in sachets containing glecaprevir 50 mg and pibrentasvir 20 mg. MAVIRET tablets and granules do not contain gluten but contain lactose.

Approved indications

— Treatment of adult and paediatric patients 3 years and older with acute or chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection with or without compensated cirrhosis. — Treatment of patients with HCV genotype 1 infection who were previously treated with either a regimen of an NS5A inhibitor or with an NS3/4A protease inhibitor but not both classes of inhibitors.

Dosing overview

Recommended MAVIRET treatment duration is based on the patient population in HCV mono-infected and HCV/HIV-1 coinfected patients with compensated liver disease with or without cirrhosis and with or without renal impairment including patients receiving dialysis.

Regulatory history

MAVIRET glecaprevir/pibrentasvir 100 mg/40 mg film-coated tablet blister pack was first listed on the ARTG on 2 January 2018. In November 2017, PBAC recommended listing MAVIRET for chronic hepatitis C virus infection with Authority Required General Schedule and Section 100 (Highly Specialised Drug) listing for treatment naïve and treatment experienced patients including those with prior NS5A treatment with genotypes 1–6 with or without cirrhosis. MAVIRET glecaprevir/pibrentasvir 100 mg/40 mg film-coated tablet bottle was first listed on the ARTG on 16 January 2020. In December 2020, PBAC recommended amending the listing to include an 8-week treatment option for treatment-naïve patients with chronic hepatitis C with compensated cirrhosis. MAVIRET glecaprevir 50 mg / pibrentasvir 20 mg granules sachet was first listed on the ARTG on 7 February 2022. On 25 January 2022, the TGA approved extension of indication for MAVIRET to include paediatric patients 3 years and older with chronic hepatitis C virus genotype 1, 2, 3, 4, 5, or 6 infection with or without compensated cirrhosis, including patients with HCV genotype 1 infection previously treated with either an NS5A inhibitor or an NS3/4A protease inhibitor but not both classes of inhibitors.