HHS Panel Recommends New Combo Tab as Initial Therapy for HIV
A recommendation from the panel of the Department of Health & Human Services (HHS) states that based on safety and efficacy data, the fixed-dose combination tablet consisting of elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide (EVG/c/FTC/TAF) will be added as one of the recommended initial regimens for antiretroviral therapy (ART)-naive adults and adolescents with estimated creatinine clearance ≥30mL/min.
The Food and Drug Administration (FDA) recently approved tenofovir alafenamide as a component of the EVG/c/FTC/TAF fixed-dose combination tablet for use in some ART-naive and ART-experienced patients.
Tenofovir alafenamide, an oral prodrug of tenofovir, works as a reverse transcriptase inhibitor. Different from tenofovir disoproxil fumarate (TDF), TAF remains stable in plasma resulting in higher intracellular tenofovir concentrations. The lower tenofovir plasma concentration means a lower potential for adverse renal and bone effects with TAF than TDF.
The safety and efficacy of EVG/c/FTC/TDF vs. EVG/c/FTC/TAF in ART-naive HIV-infected adults with estimated glomerular filtration rate (eGFR) ≥50mL/min were evaluated in two randomized, double-blind Phase 3 studies. At 48 weeks, 92% (800/866) of the study patients randomized to TAF and 90% (784/867) of the study patients randomized to TDF achieved plasma HIV RNA <50 copies/mL. This showed TAF was noninferior to TDF when combined with EVG/c/FTC (95% CI: 0.7%–4.7%).
The safety and efficacy of EVG/c/FTC/TAF were further supported in an open-label study that evaluated virologically-suppressed patients with mild-moderate renal impairment (eGFR 30–69mL/min).
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