AbbVie investigational hep C drug boasts 97.5% response rate
pharmafile | November 15, 2016 | News story | Manufacturing and Production, Medical Communications, Research and Development |Â Â AbbVie, hepatitis C, pan-genotypicÂ
AbbVie released details on their latest trials for their investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530). In an eight week trial of chronic HCV infected patients without cirrhosis and who are new to treatment, 97.5% were found to have a sustained virologic response at 12 weeks post treatment.
There were 711 patients spread across three different Phase III trials, with all trials displaying similar levels of efficacy. The rate of virologic failure was only 1% when spread across all trials. The treatment itself is a combination of two antiviral agents, which are taken as part of a once-daily regimen.
The timeframe in which the treatment can be shown to effective, in this case eight weeks, is a particular bonus on top of the successful trials. Though it’s a boon for AbbVie, it will cause worries over at their nearest competitor; Gilead were given approval for their hepatitis C treatment in June but their treatment takes 12 weeks to be effective.
“The results we announced today bring us closer to providing a potential pan-genotypic, once-daily treatment option with 8 weeks of therapy for people living without cirrhosis and who are new to treatment,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. “With our registrational program nearing completion, we’re on track to submit our next generation, pan-genotypic regimen to regulatory authorities by the end of this year in the U.S. and early 2017 in the European Union and Japan.”
Ben Hargreaves
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