Drug Information Update- Mavyret (glecaprevir/pibrentasvir)
New Drug Approval:
On August 3, 2017 the FDA approved Mavyret for the treatment of adult patients with chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis (Child-Pugh A) who have genotype 1, 2, 3, 4, 5, or 6 infection. Mavyret is approved for 1) treatment naïve patients (genotypes 1-6), 2) treatment experienced patients (previous treatment with peginteferon/ribavirin and/or Sovaldi, genotypes 1-6) and for 3) treatment experienced patients (previous treatment with NS5A inhibitor OR NS3/4A inhibitor, genotype 1 only).
Prescribing information is available here.
Drug Overview & Place in Therapy:
A number of effective and well-tolerated regimens for treatment of chronic HCV have been approved in the past 4 years. Prescribers now have a variety of treatment options that are likely to provide sustained virologic response (SVR) rates of 90-100% for most patients. Mavyret adds an effective new treatment option for many patients and is the only HCV treatment approved for patients with chronic kidney disease (CKD) with HCV genotype 2, 3, 5 or 6 infection.
Mavyret, a combination of glecaprevir (NS3/4A protease inhibitor) and pibrentasvir (NS5A inhibitor), is the third pan-genotypic HCV agent approved. It is approved for the majority of patients with chronic HCV infection, including patients with severe renal impairment and patients with prior treatment with NS5A inhibitors or NS3/4A protease inhibitors. Treatment naïve patients with no cirrhosis and a subset of treatment experienced patients qualify for a short 8-week treatment. However, treatment regimens vary depending on patient type; Mavyret requires 12 or 16 weeks of treatment for patients with cirrhosis and patients previously treated with NS5A inhibitor or NS4/4A protease inhibitor.
Mavyret is a novel double combination therapy that offers an all-oral, interferon-free, once-daily regimen. Clinical trials demonstrate that Mavyret is an extremely effective treatment for many types of patients. The approval is based on data from nine major clinical studies. The ENDURANCE-1 and EXPEDITION-1 trials showed overall SVR rates of 99% with 8 and 12 weeks of Mavyret, respectively. Mavyret also showed excellent efficacy in patients with the difficult-to-treat genotype 3 (SVR rates of 95-98%).
Mavyret is generally well-tolerated; the most commonly reported adverse events in clinical trials were headache and fatigue.