Gilead Reports Full 24-Week Phase 2 Results for Once-Daily Single Tablet HIV Regimen Containing Novel TAF

Gilead Sciences, Inc.

today announced detailed 24-week results from a Phase 2 study (Study 102) evaluating a once-daily single tablet regimen containing tenofovir alafenamide (TAF) for the treatment of HIV-1 infection. A regimen of TAF 10 mg/elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg was found to be similar to Stribild^® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) based on the percentage of patients with HIV RNA levels less than 50 copies/mL at 24 weeks of treatment. These findings were presented today in a latebreaker session (Abstract #99LB) at the 20th Conference on Retroviruses and Opportunistic Infections (CROI 2013) taking place in Atlanta. “Given that HIV is now a chronic disease that can be managed with life-long therapy, there remains a need for new treatment options that are well tolerated,” said Andrew Zolopa, MD, Professor of Medicine, Infectious Diseases, Stanford University School of Medicine and an investigator for Study 102. “In this study, a TAF-based single tablet regimen achieved comparable viral suppression to Stribild while demonstrating improvement in renal and bone safety indicators.” In Study 102, HIV-positive treatment-naïve adult patients were randomized (2:1) to receive the investigational TAF-based regimen or Stribild. At 24 weeks, 87 percent (n=97/112) of patients taking TAF and 90 percent (n=52/58) of patients taking Stribild achieved HIV RNA (viral load) less than 50 copies/mL, based on the FDA snapshot algorithm (95 percent CI for the difference: -15.7 percent to 5.9 percent for TAF vs. Stribild; p=0.36). There were no statistically significant differences in the frequency and nature of Grades 3-4 laboratory abnormalities, and the frequency and nature of adverse events were similar between the two arms. Both regimens were generally well tolerated. “We are pleased with these positive Phase 2 data, which we believe demonstrate that TAF-based single tablet regimens have the potential to play an important role in HIV therapy,” said Norbert W. Bischofberger, PhD, Gilead's Executive Vice President, Research and Development and Chief Scientific Officer. “Our Phase 3 program for TAF is enrolling rapidly, and we look forward to sharing initial results from the first pivotal study in 2014.” In January 2013, Gilead announced the initiation of two Phase 3 trials, Studies 104 and 111, which are examining TAF/elvitegravir/cobicistat/emtricitabine compared to Stribild among HIV patients new to therapy. Topline results from Study 102 were announced in October 2012.