Shares of Gilead Sciences (GILD) climbed 3.15% to close the trading session on Sep 24 at $108.71 following positive results from two ongoing phase III studies (104 and 111: n=1,744) on its tenofovir alafenamide (TAF)-based single tablet regimen (STR) for treating HIV patients as a first-line therapy.
Results from the randomized, double-blind studies revealed that the once-daily STR of TAF 10 mg, elvitegravir 150 mg, cobicistat 150 mg and Emtriva 200 mg (emtricitabine) was non-inferior to Gilead’s highly successful HIV treatment Stribild in reducing HIV levels at 48 weeks, thereby meeting the primary efficacy endpoint (proportion of patients with viral load less than 50 copies/mL).
Moreover, the TAF-based regimen demonstrated favorable renal and bone safety compared to Stribild. Stribild is a combination of elvitegravir 150 mg, cobicistat 150 mg, Emtriva 200 mg and Viread 300 mg (tenofovir disoproxil fumarate).
The TAF-based STR is being evaluated in other phase III studies as well. For example, Gilead is evaluating the combination in a phase IIIb study (WAVES) in HIV infected women who switched from a multi-pill regimen. Encouraged by the positive data on the TAF-based regimen, the company intends to seek approval for the same in the U.S. and EU by Dec 31, 2014. The filings will include data from studies 104 and 111 as well as the above mentioned ongoing phase III studies.
Approval of the new regimen will be crucial for Gilead, as many of its HIV drugs including Viread will lose patent exclusivity in the coming years. We expect investor focus to remain on results from the other studies on TAF-based STR.
Gilead carries a Zacks Rank #1 (Strong Buy). Equally well-ranked stocks in the health care space include Medivation (MDVN), Endo International (ENDP) and Amgen (AMGN).
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