Dive Brief:
- A clinical study of treatment-naive hepatitis C patients with compensated cirrhosis found that, after receiving AbbVie's Mavyret for eight weeks, all had reached sustained virologic responses at week 12 — meaning they're considered cured.
- Notably, the responses were seen across hep C patients with genotypes 1, 2, 4, 5 and 6. A second cohort testing the drug in genotype 3 patients is ongoing. Research has shown genotype 3 hep C is especially prominent in Western countries.
- Mavyret first gained Food and Drug Administration approval in August 2017 as a pan-genomic treatment for adults with chronic hep C virus who either don't have cirrhosis or, if they do, have mild forms. While new to the market, the drug is already racking up sales, with $839 million during third quarter 2018 and $2.75 billion year-to-date.
Dive Insight:
The entrance of essentially curative direct-acting antivirals like Sovaldi (sofosbuvir) and Daklinza (daclatasvir) made the hep C drug market harder to crack, as the backlog of patients with easier-to-treat forms of the infection, or who can access the costly drugs, were cleared from the system.
While there are fewer opportunities now, there is a place for companies willing to work in harder-to-treat patients, such as those with liver cirrhosis, and across a broad array of genotypes.
Mavyret combines glecaprevir, an NS3/4A protease inhibitor, with pibrentasvir, an NS5A inhibitor, to address a wide variety of hep C genotypes. Regulators approved the drug for both treatment-experienced and treatment-naive patients, with regimens for the latter group ranging from eight weeks to 12 weeks depending on the level of liver cirrhosis.
The aim of EXPEDITION-8, a Phase 3b study, was to see if a shorter regimen would work in patients with liver disease and make treatment easier without lowering response rates. AbbVie noted in a Nov. 13 statement the study identified no new safety signals.
AbbVie was late to the party with Mavyret, coming almost three years after Sovaldi. However, it has captured a reasonable market share quite rapidly, due at least in part to its competitive wholesale acquisition cost of $26,400 for an 8-week course of treatment and its label that covered all six genotypes.
The drug hasn't been without setbacks, though. It recently lost out on inclusion to Express Scripts' 2019 formulary, an income source that would have helped AbbVie as the hep C patient pool continues to shrink and the date when Humira (adalimumab) biosimilars hit the U.S. market draws closer.