FDA OKs 8-Week Mavyret for Hepatitis C

August 03, 2017

The US Food and Drug Administration (FDA) today approved the combination of glecaprevir and pibrentasvir (Mavyret, AbbVie) for the treatment of chronic hepatitis C virus (HCV). The drug reduces by 4 weeks the time needed for a cure.

Glecaprevir/pibrentasvir is indicated for adults with chronic HCV genotypes 1 through 6 without cirrhosis, or with mild cirrhosis, including those with moderate-to-severe kidney disease and those on dialysis. It's also indicated for adults infected with HCV genotype 1 who were previously treated with either an NS5A inhibitor or an NS3/4A protease inhibitor, but not both.

Glecaprevir is a pangenotypic NS3/4A protease inhibitor, while pibrentasvir is a pangenotypic inhibitor of the NS5A replication complex.

The treatment regimen for glecaprevir/pibrentasvir lasts 8 weeks. The new HCV drug is the first of this duration approved for genotypes 1 through 6 in adults without cirrhosis who haven't been treated before, the FDA said in a news release. The standard treatment length previously was at least 12 weeks.

The FDA determined that glecaprevir/pibrentasvir was safe and effective based on clinical trials involving roughly 2300 adults with chronic HCV (genotypes 1 through 6) without cirrhosis, or with mild cirrhosis. Between 92% and 100% of patients receiving the new drug had no virus detected in their blood 12 weeks after treatment ceased — indicative of a cure — regardless of whether treatment lasted 8, 12, or 16 weeks. How long patients took the new drug hinged on treatment history, viral genotype, and cirrhosis status.

Headache, fatigue, and nausea were the most common adverse events observed in the studies.

Glecaprevir/pibrentasvir is contraindicated for patients with severe cirrhosis, and not recommended for those with moderate cirrhosis. In addition, it's contraindicated for anyone taking atazanavir and rifampin.

The FDA advises clinicians to screen all patients for evidence of current or prior infection with hepatitis B virus (HBV) before initiating treatment with glecaprevir/pibrentasvir. That precaution is necessary because HCV direct-acting antivirals can reactivate HBV infection in patients with both viruses.

More information on today's announcement is available on the FDA website.

Follow Robert Lowes on Twitter @LowesRobert

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