Gilead Sciences has announced promising, newly updated data on its hepatitis C virus (HCV) triple therapy, meaning that the combo of the nucleotide sofosbuvir, the NS5A inhibitor GS-5885 and ribavirin is headed toward imminent regulatory filing, HIVandHepatitis reports. Gilead also provided updates on various studies of sofosbuvir/GS-5885 as a fixed-dose, single-pill combination therapy taken with or without ribavirin for periods ranging between eight and 24 weeks.
In November, Gilead reported preliminary results from its Phase II ELECTRON study of sofosbuvir, GS-5885 and ribavirin in participants with HCV genotype 1 who had previously failed an interferon-based treatment. (This category of hep C patient is particularly difficult to treat.) At the time, three out of nine participants had reached a sustained virologic response four weeks after finishing a 12-week treatment (SVR4, considered a cure). Now Gilead has announced that all nine participants have reached SVR4. Researchers will continue to monitor these patients through SVR12 and SVR24.
Gilead reports that it is on track to submit initial regulatory filing to the Food and Drug Administration (FDA) for approval for sofosbuvir mid-2013 and for the fixed-dose combination in 2014.
To read the HIVandHepatitis report, click here.
To read the Gilead release, click here.