GS-7340 is a nucleotide reverse transcriptase inhibitor (NtRTI) similar to the company’s HIV drug Viread.
The double-blind 48-week clinical trial will include150 patients, who are randomized (2:1) to receive a once-daily tablet containing GS-7340 10 mg/cobicistat 150 mg/elvitegravir 150 mg/emtricitabine 200 mg or the Quad (tenofovir disoproxil fumarate 300 mg/cobicistat 150 mg/elvitegravir 150 mg/emtricitabine 200 mg).
The study is designed to evaluate GS-7340 as part of a once-daily, co-formulated single-tablet regimen that will also contain cobicistat, the integrase inhibitor elvitegravir, and Emtriva.
The primary objective of the trial will be the proportion of patients with viral load less than 50 copies/mL at 24 weeks of treatment, while secondary endpoints will include the proportion of patients who achieve viral load of less than 50 copies/mL at 48 weeks of therapy, and change from baseline in HIV-1 RNA and in CD4+ cell count to Weeks 24 and 48.
The company intends to initiate a second Phase 2 trial for GS-7340 later in 2012 which will investigate GS-7340 as part of another single-tablet regimen containing cobicistat, Emtriva and Tibotec Pharmaceuticals’ Prezista (darunavir).
In earlier studies, GS-7340 has demonstrated the ability to provide greater antiviral efficacy at a dose that is ten times lower than Viread.