) 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
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
Apart from Gilead, companies such as
Johnson & Johnson
) are also developing therapies to combat HCV.
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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