Gilead Sciences Inc. (GILD) announced today that Phase 3 clinical trials of their fixed dose “QUAD” treatment for HIV patients, has exceeded expectations and improved on other available treatments. Quad which is a combination of four drugs : elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate, demonstrated a 90 percent response rate compared to 87 percent in the ritonavir-boosted atazanavir plus Truvada.
Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, confirmed that they were happy with the results and expected to move regulatory filing forwards to before year end.
The study, which was carried out over 96 weeks at more than 200 locations, was a randomized double blind clinical trial comparing efficacy, safety and tolerability of the Quad treatment versus ritonavir-boosted atazanavir plus Truvada.
The trials were also encouraging because the discontinuation rate for Quad was only 3.1 percent when compared to ritonavir-boosted atazanavir plus Truvada rate of above 5 percent.
The participants were HIV-infected adults with HIV RNA levels greater than or equal to 5,000 copies/mL. Trial participants were randomized (1:1) to receive a once-daily tablet containing elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200mg/tenofovir disoproxil fumarate 300 mg (n=353) or ritonavir 100 mg and atazanavir 300 mg plus Truvada (emtricitabine/tenofovir disoproxil fumarate).
The percentage results are based on subjects who after treatment tested with HIV RNA levels (viral load) of less than 50 copies/mL a hundredfold drop from before treatment after 48 weeks. The secondary goal was to assess for tolerance, safety and efficacy and continued until the 96 week mark. Once the treatments were un-blinded subjects were given the option to continue the QUAD treatment openly.
Written by Rupert Shepherd BSc.