Recently, Gilead Sciences (GILD) initiated the phase III program of Quad, which is a fixed dose combination of four drugs: elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate. The phase III program consists of two trials (Studies 102 and 103), which will compare Quad with a standard HIV therapy in treatment-naïve patients.

In addition, Gilead is examining the efficacy of cobicistat as a boosting agent for other antiretrovirals. The company also plans to initiate a phase III trial to evaluate the impact of cobicistat-boosted atazanavir as against ritonavir-boosted atazanavir, both in combination with Truvada (emtricitabine and tenofovir disoproxil fumarate).

In the phase II trial, it was observed that after 24 weeks, about 90% of the patients in the Quad arm experienced a reduction in the viral load factor (less than 50 copies/mL) compared to 83% in the Atripla arm.

Study 102 has been designed to compare Quad with Atripla in the U.S. and Puerto Rico. About 700 HIV-infected treatment naïve adults with HIV RNA levels greater than or equal to 5,000 copies/mL will participate in the trial. They will receive either Quad or Atripla over a 96-week period.

The patient profile for study 103 will be similar to study 102. This study will compare Quad with ritonavir-boosted atazanavir and Truvada over a 96-week period across more than 200 study sites in multiple locations in North America, South America, Europe and Asia Pacific.

For both trials, the lowering of HIV RNA levels (below 50 copies/mL) after 48 weeks of treatment will act as the primary endpoint. Secondary objectives will evaluate the impact of the Quad therapy through 96 weeks of treatment.

Gilead is one of the leading players in the area of HIV treatment. Its strategy of creating fixed-dose combinations of existing HIV drugs has been an enormous success. We believe Quad holds immense potential for the company, which can generate strong revenues on successful commercialization. We are Neutral on the stock.
Read the full analyst report on “GILD”
Zacks Investment Research