Gilead Sciences Inc.
) recently initiated the first of two phase III studies on
tenofovir alafenamide (TAF). The study (104) is evaluating a
single tablet regimen of TAF for treatment-naïve adults suffering
from HIV-1 infection. TAF is a prodrug of tenofovir which is the
active agent in Gilead's Viread (tenofovir disoproxil
Gilead has designed its phase III study to evaluate a
once-daily single tablet regimen of TAF with its HIV drug,
Stribild among new HIV patients. The company expects to initiate
the second phase III study (111) on the candidate soon.
In Oct 2012, Gilead reported positive top line results from a
phase II study on TAF. The study compared TAF single tablet
regimen with Stribild. The TAF based regimen demonstrated
statistically significant smaller reductions in HIV RNA levels in
comparison to Stribild.
We note that in Aug 2012 the US Food and Drug Administration
(FDA) approved Gilead's Stribild as a first-line therapy for
treating adults with HIV-1 infection. Stribild is Gilead's third
single tablet regimen for HIV after Truvada and Atripla.
Stribild is a combination of elvitegravir, cobicistat and
Truvada. We note that Truvada itself is a combination of Viread
and Emtriva. The company is also looking to approve Stribild in
We remain optimistic on the growth prospects of Gilead's HIV
drugs, Truvada and Atripla. We are also encouraged by the sales
ramp of the newly launched Complera/Eviplera, which together with
Stribild, will further fortify the HIV franchise and help
mitigate the impact of upcoming patent expirations.
Gilead carries a Zacks Rank #4 (Sell). Pharma stocks, which
appear to be favorably placed, include
Valeant Pharmaceuticals International Inc.
). All these companies carry a Zacks Rank #1 (Strong Buy).
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