Gilead Sciences (GILD) recently presented encouraging top-line data from a phase III study (Positron) which evaluated its candidate sofosbuvir (formerly GS-7977) combined with ribavirin in patients suffering from genotypes 2 or 3 of the chronic hepatitis C virus (:HCV). The study evaluated patients, who were unable or unwilling to take interferon, a standard HCV therapy characterized by unpleasant side effects. Through this study, Gilead is aiming to develop an all-oral treatment regimen to combat HCV.
Data from the study revealed that after 12 weeks of completion of treatment, no traces of the HCV virus were detected in 78% patients in the sofosbuvir arm. Moreover, the candidate exhibited a safety profile similar to that witnessed in earlier studies. Furthermore, only a few patients discontinued treatment due to adverse events. Gilead intends to present full data from the phase III study at an upcoming scientific conference.
We note that Positron is the first of three phase III studies evaluating sofosbuvir in patients with genotypes 2/3 of the virus. Another phase III study is evaluating the candidate in patients with genotypes 1, 4, 5 and 6 of the virus. Gilead intends to seek regulatory approvals for the candidate in mid-2013.
Successful development of sofosbuvir would not only boost Gilead’s top line but also strengthen its position in the lucrative HCV market. A huge population suffers from HCV infection across the world. However, the treated population is much lower. This leaves the field open for new treatments. Moreover, the current standard of care comes with several side effects which make it difficult for patients to remain on treatment.
We currently have a Neutral recommendation on Gilead. The stock carries a Zacks #3 Rank (Hold rating) in the short run.
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