Gilead Announces Preliminary Data From Study 934

Gilead Sciences has announced preliminary 48-week data from the company's Study 934, which was designed to compare a regimen of Viread, Emtriva and Bristol-Myers Squibb's Sustiva to Combivir and Sustiva in treatment-naive patients with HIV.

Results from this analysis of 487 patients show a statistically significant difference favoring Viread (tenofovir disoproxil fumarate)/Emtriva (emtricitabine) in the percentage of patients who achieved and maintained HIV RNA less than 400 copies/mL at 48 weeks, based on the FDA Time to Loss of Virologic Response algorithm (TLOVR). Data from this analysis have not been reviewed by the FDA.

Study 934 is a Phase III, multicenter, open-label 96-week clinical trial that enrolled 517 HIV-infected patients in the U.S. and Europe. The study's primary endpoint is at 48 weeks. The prespecified intent-to-treat population includes 487 patients.

Participants in one arm of the study receive Viread 300 mg, Emtriva 200 mg and Sustiva (efavirenz) 600 mg, all dosed once daily. Patients in the comparator arm receive Combivir (lamivudine 150 mg/zidovudine 300 mg) twice daily and Sustiva 600 mg once daily. At study entry, patients had not previously received antiretroviral therapy and had HIV RNA greater than 10,000 copies/mL. The study is planned to continue in a subset of patients through 96 weeks.

Based on the 48-week analysis, data show 84 percent of patients in the Viread/Emtriva arm compared to 73 percent of patients in the Combivir arm achieved and maintained HIV RNA less than 400 copies/mL at Week 48 using the TLOVR algorithm. Similarly, 80 percent of patients in the Viread/Emtriva arm compared to 71 percent of patients in the Combivir arm achieved and maintained HIV RNA less than 50 copies/mL at Week 48 using the TLOVR algorithm. Patients receiving Viread/Emtriva had a significantly greater increase from baseline in CD4 cell count at Week 48 compared to those receiving Combivir.

The incidence of adverse events leading to permanent discontinuation of study regimen was 4 percent in the Viread/Emtriva arm and 9 percent in the Combivir arm, and the most common of these adverse events were anemia, nausea, vomiting and fatigue in the Viread/Emtriva and Combivir arms, respectively. Gilead expects to present these data at a scientific conference later this year.