Phase III trial of single tablet elvitegravir + cobicistat + emtricitabine + tenofovir alafenamide meets primary endpoint in HIV/AIDS- Gilead Sciences

Gilead Sciences announced detailed 48-week data from an open-label Phase III study (Study 109) evaluating its investigational once-daily single tablet regimen (STR) of elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg (E/C/F/TAF) among 1,436 virologically suppressed adult patients with HIV/AIDS switching from tenofovir disoproxil fumarate (TDF)-containing regimens.

The study met its primary endpoint by demonstrating non-inferiority of E/C/F/TAF to the TDF-based regimens at Week 48. The study also demonstrated statistical superiority among patients with HIV-1 RNA levels less than 50 copies/mL at Week 48 and statistically significant improvements in bone and renal laboratory parameters. Among the 1,436 patients who were randomized in the study, virologic success rates at Week 48 were higher in patients taking E/C/F/TAF (97%; 93% for all TDF-based regimens). The rates of virologic failure were similar between the two arms (E/C/F/TAF, 1.0%; TDF-based regimen, 1.3%). General safety was similar between the two arms through 48 weeks of treatment, with similar percentages of patients in each group having any adverse events. These data were presented at the 8th IAS Conference on HIV Pathogenesis, Treatment & Prevention.

Comment: In November 2014, Gilead filed a New Drug Application with the FDA for E/C/F/TAF, the first investigational once-daily TAF-based STR. Tony Mills, lead author of the study, Medical Director, Southern California Men’s Medical Group, and Assistant Professor of Clinical Medicine, University of California, Los Angeles said: "This is the first large study to demonstrate that switching from a TDF-based regimen to E/C/F/TAF can help improve patients’ bone and kidney measures."