FDA approves glecaprevir-pibrentasvir for HCV

Reuters

Reuters

The FDA estimates that about 75 percent of Americans with HCV have genotype 1, between 20 and 25 percent have genotypes 2 or 3, and the remaining percentage is shared by patients with genotypes 4, 5, and 6.

Mavyret (G/P), a fixed-dose combination therapy of glecaprevir/pibrentasvir has been approved by the US Food and Drug Administration (FDA) for the treatment of chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis, including patients with moderate to severe kidney disease and those who are on dialysis.

The safety and efficacy of the regimen were evaluated in clinical trials enrolling around 2,300 adults with all HCV genotypes without cirrhosis or with mild cirrhosis. The standard treatment length was previously 12 weeks or more.

"This approval provides a shorter treatment duration for many patients, and also a treatment option for certain patients. who were not successfully treated with other direct-acting antiviral treatments", said Dr. Edward Cox, director of the FDA's Office of Antimicrobial Products. Mavyret (glecaprevir/pibrentasvir) is a once-daily, ribavirin-free treatment for adults with chronic HCV.

"Treatment duration with Mavyret differs depending on treatment history, viral genotype, and cirrhosis status".

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AbbVie Inc.'s newly approved drug Mavyret can treat hepatitis C's six major strains in eight weeks.

The most common side effects reported were headache, fatigue and nausea. For AbbVie to carve out a blockbuster share of the HCV space, it will have to be aggressive.

It's also a positive steal in the hepatitis C drug world, at $26,400 for a eight-week course of treatment. "Conversely, for AbbVie, this pricing means that the revenue contribution from Mavyret is likely to be limited, and largely consistent with our existing forecast", Porges said, as cited by Endpoints.

But the figures, which reflect the various drugs' wholesale acquisition cost (WAC) - the price a drug maker offers wholesalers - matter less than the net price drugmakers actually take home, Raffat said.

As the latest entrant in a competitive market in which commercial insurers mostly have deals giving them discounts of up to 50 percent in exchange for not covering rivals' hepatitis C drugs, Maryvet is priced well below the other approved drugs. The closest is Merck (MRK)'s Zepatier at $18,200.

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