Gilead Sciences, Inc.
) recently announced encouraging 48-week data from a phase II
study (study 102) on its HIV single tablet regimen (STR). The STR
includes tenofovir alafenamide (TAF), a pro drug of Gilead's HIV
drug Viread. The randomized, double-blind study compared the
safety and efficacy of a once-daily STR of TAF 10 mg,
elvitegravir 150 mg, cobicistat 150 mg and Emtriva 200 mg with
We remind investors that Gilead gained approval from the U.S.
Food and Drug Administration (FDA) for Stribild in Aug 2012 as a
first-line therapy for treating adults with HIV-1 infection.
European approval came in May 2013.
Stribild is a combination of elvitegravir, cobicistat and
Truvada. We note that Truvada itself is a combination of Viread
and Emtriva. Data from the above study revealed that the
TAF-based regimen worked as effectively as Stribild for treating
treatment-naïve HIV infected adults. Moreover, the candidate was
found to be safe in the study.
We are impressed with the encouraging data on the HIV candidate.
Successful development and commercialization of the TAF-based
regimen would further strengthen its HIV portfolio.
Although pleased with the progress of the TAF-based regimen, we
believe that investor focus will remain on sofosbuvir, which is
being developed for treating patients suffering from chronic
hepatitis C virus (HCV). The HCV candidate is under priority
review in the U.S. (target date: Dec 8, 2013). Sofosbuvir is also
under review in the EU. Gilead is also seeking approval for the
candidate in other countries such as Canada, Switzerland, Turkey
Approval of sofosbuvir would not only boost Gilead's top line but
also strengthen its position in the lucrative HCV market. A
sizeable population suffers from HCV globally. However, the
treated population is much lower, thus leaving the field open for
Gilead carries a Zacks Rank #1 (Strong Buy). Companies like
Biogen Idec Inc.
) too are Zacks #1 Ranked stocks.
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