Hep C combo clears virus at 12 weeks
- AbbVie's Phase 3 12-week data for the combination of glecaprevir and pibrentasvir (G/P) has come up positive in patients across the genotypes of hepatitis C infection and compensated cirrhosis in a presentation at the International Liver Congress (EASL), currently underway in the Netherlands.
- Almost all (145 of 146 patients) showed sustained virologic response at 12 weeks in the EXPEDITION-1 study of patients with genotype 1, 2, 4, 5 or 6 and compensated cirrhosis, including those with virus strains linked to resistance or high levels of virus in their bloodstream. Most adverse events were mild; the most common were fatigue and headache.
- The glecaprevir and pibrentasvir combination is under review worldwide, with accelerated assessments in Europe, the U.S. and Japan. It has an estimated approval date in the U.S. of early August.
Chronic hepatitis C virus infection affects around 130 to 150 million people worldwide, with a 15-30% risk of cirrhosis within 20 years. However, since the launch of the initial near-curative therapies, such as Gilead's Harvoni (ledipasvir/sofosbuvir) and Sovaldi (sofosbuvir) and others since then, the market has become crowded, the patient pool, dwindling. Earlier in 2017, Merck & Co marked down the value of its clinical hepatitis C candidate uprifosbuvir, taking a $2.9 billion charge ($1.9 billion after taxes), as a result of the competitive changes in the market dynamic.
One of the advantages touted by AbbVie for its glecaprevir and pibrentasvir (G/P) combination is that it covers five of the six genotypes. However, Gilead's Epclusa (sofosbuvir/velpatasvir) was approved in 2016 for patients with all six genotypes of hepatitis C, potentially undermining AbbVie's competitive advantage intent.
Has AbbVie and its partner Enanta simply missed the boat? AbbVie's share price, trading only 0.5% higher on the news, may speak to the likelihood of it. Glecaprevir and pibrentasvir, however, could still have potential in the niche of hard-to-treat patients with compensated cirrhosis, as well as patients with chronic kidney disease, HIV-1 co-infection, post-transplant patients, and non-responders. It also avoids the use of ribavirin, which has been associated with long term side effects, such as hemolytic anemia, and worsening heart disease.
"With our G/P clinical development program, our goal is to provide a cure for as many patients living with HCV as possible, across all genotypes and regardless of whether their disease has progressed to compensated cirrhosis," said Michael Severino, chief scientific officer of AbbVie.
- AbbVie Statement
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