AbbVie’s hepatitis C blockbuster Mavyret could soon also be an eight-week treatment for patients with compensated cirrhosis, thanks to positive new phase 3b data. That would give it more firepower as AbbVie battles Gilead's HCV drugs for marketshare.
The data showed that, with just eight weeks of treatment, the drug achieved sustained virologic response in all genotype 1, 2, 4, 5 and 6 HCV patients with compensated cirrhosis when they were evaluated at 12 weeks post treatment—a common standard used to imply the disease has been cured. That’s compared with 12 weeks of treatment for which the drug is currently approved in that patient group.
The second cohort of the study, which evaluates genotype 3 patients with compensated cirrhosis, is still ongoing.
Mavyret made a splash in the HCV world last year when it was approved as the first pan-genotypic HCV therapy that only requires eight weeks of treatment, whereas Gilead’s Epclusa and others are 12-week regimens. If Mavyret is eventually approved as an eight-week therapy for the compensated cirrhosis population, AbbVie could steal more market share from Gilead.
As Mavyret has gobbled up market share, Gilead's HCV sales fell to $891 million in the third quarter of this year from $1.4 billion a year earlier. That was on top of a 31% decline as Gilead and other HCV drugmakers have faced tough pricing and a shrinking patient pool.
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As patients are being cured, the shrinking HCV patient population has affected AbbVie as well. Its third-quarter HCV sales declined 11% sequentially, to $862 million, even though Mavyret continues to hold around 50% of global market share, said AbbVie finance chief Bill Chase on the company’s third-quarter earnings call in late October.
Both AbbVie and Gilead are vying to expand their influence in whatever is left with the HCV market. Starting from January 2019, Gilead will market authorized generics to Epclusa and Harvoni in the U.S. at a huge discount to their originals. It will be about the same time that PBM major Express Scripts kicks Mavyret off its national preferred formulary in favor of drugs from Merck & Co. and Gilead.
In contrast, AbbVie has its eyes on the ex-U.S. market, having inked a deal to allow generics makers to develop cheap Mavyret copycats in about 100 low- and middle-income countries.