The US Food and Drug Administration has given the green light to a combination of Johnson & Johnson’s Olysio and Gilead Sciences’ Sovaldi for patients with hepatitis C genotype 1.
This means that Olysio (simeprevir) now has an additional approval as a once-daily, all-oral interferon- and ribavirin-free treatment option. It is second all-oral therapy that does not require interferon or ribavirin to get the FDA’s thumbs-up, as Harvoni, which combines Gilead’s ledipasvir with Sovaldi (sofosbuvir) was approved by the agency last month.
Data supporting the Olysio/Sovaldi combo are from the Phase II COSMOS study and the recommended treatment duration is 12 weeks for patients without cirrhosis or 24 weeks for those who do. Eric Lawitz of the University of Texas Health Science Center and primary investigator for the study, said “the availability of multiple treatment options is important…so optimal treatment decisions can be made, given the complexity of the disease and diversity of patient population”.
However the price of new HCV treatments, which led to cures, are still a talking point. For 12 weeks, Olysio costs $66,000 and Sovaldi $84,000, while Harvoni costs $94,500 for 12 weeks. J&J said eligible patients with commercial insurance may get an ‘Olysio Savings Card’ and pay $5 per fill, with a $50,000 annual maximum benefit.