Positive Results for New HIV Single Tablet Regimen

Gilead Sciences announced results from two Phase 3 trials, Studies 104 and 111, evaluating the once daily single tablet regimen (STR), Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide; E/C/F/TAF), for the treatment of HIV-1 infection in treatment-naïve adults.

Studies 104 and 111 are randomized, double-blind, controlled Phase 3 trials which enrolled 1,733 treatment-naïve adults with HIV. Patients were randomized 1:1 to receive an STR of Genvoya (elvitegravir 150mg, cobicistat 150mg, emtricitabine 200mg and tenofovir alafenamide 10mg) or Stribild (elvitegravir 150mg, cobicistat 150 mg, emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; E/C/F/TDF). The primary endpoint was non-inferior efficacy to Stribild, defined as the proportion of participants who had HIV-1 RNA <50 copies/mL using the FDA Snapshot Algorithm. The study was originally planned for 96 weeks but recently extended to 144 weeks.

Genvoya met the primary endpoint, showing statistical non-inferiority to Stribild. After 48 weeks, high rates of viral suppression were observed in both study arms (Genvoya 92% vs. Stribild 90%). At 96 weeks, 86.6% (n=750/866) in the Genvoya arm and 85.2% (n=739/867) in the Stribild arm achieved HIV-1 RNA levels <50 copies/mL (CI -1.8% to +4.8%, P=0.36). The analysis found that the virologic success rate between the two regimens was similar across patient subgroups (age, gender, race, baseline HIV-1 RNA level and baseline CD4 count).

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Patients receiving Genvoya also had improved renal and bone laboratory parameters compared to Stribild over the 96-week period. There was a statistically significant difference in the median change in estimated glomerular filtration rate (eGFR) from baseline to week 96, favoring Genvoya (-2mL/min for Genvoya vs. -7.5mL/min for Stribild, P<0.001). Patients taking Genvoya had smaller declines in bone mineral density (BMD) compared to patients taking Stribild, as assessed by DXA (spine: -0.96 vs. -2.79, P<0.001; hip: -0.67 vs. -3.28, P<0.001).

Tenofovir alafenamide (TAF) is a novel, investigational nucleotide reverse transcriptase inhibitor (NRTI) that has demonstrated high antiviral efficacy at a dose less than one-tenth that of Gilead’s Viread (TDF), as well as improved renal and bone laboratory parameters compared to TDF in combination with other antiretroviral agents.

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