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Sofosbuvir/ledipasvir co-formulation cures more than 90% of treatment-naive and retreated genotype 1 patients
Liz Highleyman, 2014-04-14 10:30:00
A co-formulation of sofosbuvir and ledipasvir taken for as little as eight weeks produced high sustained response rates across the board for participants in the phase 3 ION trials, including people with genotype 1 hepatitis C virus (HCV) starting treatment for the first time, prior non-responders and people with liver cirrhosis, according to findings presented last week at the 49th Annual Meeting of the European Association for the Study of the Liver (EASL) in London. Results were also published online in the New England Journal of Medicine.
Sofosbuvir (Sovaldi) is an HCV polymerase inhibitor recently approved in the European Union and the US. Ledipasvir is an NS5A replication complex inhibitor. Phase 2 studies have shown that ledipasvir works better than ribavirin in interferon-free therapy for people with HCV genotype 1. Gilead Sciences is in the final stages of developing a co-formulation of the two drugs taken as a single once-daily pill (400/900mg). The US Food and Drug Administration has granted it priority review status, with a decision expected in mid-October.
The ION studies were open-label, randomised phase 3 clinical trials evaluating the safety and effectiveness of the once-daily sofosbuvir/ledipasvir fixed-dose combination taken for 8, 12 or 24 weeks, either with or without ribavirin. The programme was funded by Gilead.
The primary endpoint for all three trials was sustained virological response, or continued undetectable HCV viral load at 12 weeks after completing therapy (SVR12), which is considered a cure.
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