HHS Panel Recommends New Combo Tab as Initial Therapy for HIV

HHS Panel Recommends New Combo Tab as Initial Therapy for HIV
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.

RELATED: Genvoya Approved for the Treatment of HIV

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). 

The fixed-dose tablet EVG/c/FTC/TAF is currently marketed as Genvoya (Gilead) in 150mg/150mg/200mg/10mg strength tablets.

For more information call (800) 448-0440 or visit NIH.gov.

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