Gilead's (GILD) HIV Drug Positive in 2 Phase III Studies - Analyst Blog
Pipeline updates are highly awaited events in the pharma/biotech sector as they play an important role in deciding whether or not to invest in a particular company. These updates provide information on experimental drugs and at times give an insight into the commercial potential of the candidate once it is successfully developed and commercialized.
With the commencement of 2015, several companies have been providing an update on their pipelines. Late last week, Gilead Sciences, Inc. GILD announced detailed 48-week results from two phase III studies − Studies 104 and 111 − on an investigational once-daily single-tablet regimen containing tenofovir alafenamide (TAF). Both studies evaluated the TAF-containing tablets for the treatment of HIV-1 infection in treatment-naïve patients.
Studies 104 and 111 (in which altogether 1,733 treatment-naïve HIV patients were randomized 1:1 to either E/C/F/TAF combination or Stribild) evaluated whether the E/C/F/TAF combination was non-inferior to Stribild with respect to the proportion of patients with HIV RNA less than 50 copies/mL at week 48.
In these studies, a combination of elvitegravir (150 mg), cobicistat (150 mg), emtricitabine (200 mg) and TAF (10 mg) (E/C/F/TAF) was found to be statistically non-inferior to Stribild, which contains tenofovir disoproxil fumarate (300 mg) along with the elvitegravirm, cobicistat and emtricitabine in similar proportions. A separate in-depth analysis investigated the effect of the two regimens on laboratory parameters of the kidney, bone and plasma lipid levels to find statistically significant results in favor of the E/C/F/TAF regimen.
Results also showed high antiviral efficacy of TAF and improved renal and bone laboratory parameters at a dose 10 times lower than Viread, containing tenofovir disoproxil fumarate.
Based on these results, Gilead stated that its tenofovir alafenamide-containing investigational therapy was the first TAF-based regimen that was found to be non-inferior to Stribild and also enhanced in terms of renal and bone parameters. The company added that a TAF-based single-tablet regimen has the potential to address the needs of HIV patients undergoing life-long antiretroviral therapy.
Meanwhile, Gilead filed a new drug application for the E/C/F/TAF combination with the FDA in Nov 2014. An action from the agency is expected by Nov 2015. The combination therapy is also under review in the EU.
Gilead carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are ANI Pharmaceuticals, Inc. ANIP, Cytokinetics, Inc. CYTK and Isis Pharmaceuticals, Inc. ISIS. All these carry a Zacks Rank #1 (Strong Buy).
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