Gilead announced results from two Phase 3 trials, Study 104 and Study 111 evaluating a once-daily single tablet regimen containing tenofovir alafenamide (TAF) for the treatment of HIV-1 infection in treatment-naïve adults. The single tablet regimen contains elvitegravir 150mg, cobicistat 150mg, emtricitabine 200mg, and TAF 10mg (E/C/F/TAF).
Both studies are randomized, double-blind, 96-week clinical trials among 1,744 treatment-naïve HIV-1 infected adults with viral load ≥1,000 copies/mL. In Study 104, 867 patients were randomized 1:1 to receive E/C/F/TAF (n=435) or Stribild (n=432). In Study 111, 866 patients were randomized 1:1 to receive E/C/F/TAF (n=431) or Stribild (n=435). The primary efficacy endpoint of the studies is the proportion of patients with viral load <50 copies/mL at 48 weeks of treatment as determined by the FDA-defined snapshot analysis.
The primary endpoints in both studies were met with E/C/F/TAF demonstrating non-inferiority to Stribild (elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir disoproxil fumarate 300mg) based on the proportion of patients with HIV RNA levels <50 copies/mL at 48 weeks of therapy. In Study 104, 93.1% (n=405/435) of patients taking E/C/F/TAF compared to 92.4% (n=399/432), of patients taking Stribild, with 95% CI from -2.6–4.5%, achieved HIV RNA <50 copies/mL at week 48. In Study 111, 91.6% (n=395/431) of E/C/F/TAF patients compared to 88.5% (n=385/435) of Stribild patients, with 95% CI from -1.0–7.1%, achieved HIV RNA <50 copies/mL at week 48.
Tenofovir alafenamide, a nucleotide reverse transcriptase inhibitor (NtRTI) is an investigational novel prodrug of tenofovir, the active agent in Viread (tenofovir disoproxil fumarate), which is also an NtRTI. Elvitegravir, an integrase inhibitor interferes with HIV replication by blocking the ability of the virus to integrate into the genetic material of human cells. Cobicistat is a cytochrome P450 3A (CYP3A) inhibitor that boosts blood levels of the HIV protease inhibitors atazanavir and darunavir by suppressing CYP3A, an enzyme that metabolizes these drugs in the body.
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