by Jeffrey T. Kirchner, DO, AAHIVS, AAHIVM Chief Medical Officer
November 26, 2019
Kityo, C et al. Switching to Fixed-Dose Bictegravir, Emtricitabine, and Tenofovir Alafenamide (B/F/TAF) in Virologically Suppressed HIV-1 Infected Women. A Randomized, Open-Label, Multicenter, Active-Controlled, Phase 3, Non-inferiority Trial.
JAIDS November 1, 2019 – Volume 82(3):321–328.
Bictegravir, co-formulated with emtricitabine/tenofovir alafenamide (B/F/TAF) is one of the “recommended initial regimens” by the DHHS and IAS-USA guidelines for the treatment of HIV infection. Multiple clinical trials of these three agents in both treatment naive and virologically suppressed patients have shown good efficacy and tolerability with no treatment-emergent resistance. This study was an international, randomized, open-label, noninferiority trial, specifically of HIV-infected women. All were virologically suppressed with HIV-1 RNA levels of <50 copies/mL. Baseline regimens included boosted elvitegravir/F/TDF, boosted elvitegravir/F/TAF or atazanavir/ritonavir + F/TDF. The study randomized 472 women to either continue their baseline ART regimen or change to fixed-dose B/F/TAF. The primary endpoint was the proportion of participants with plasma viral loads of more than 50 copies/mL. At the end of week 48, only 4 women from each group had viral loads greater than 50 copies/mL. None of the women in the B/F/TAF group who failed therapy developed treatment-emergent resistance and there were no discontinuations due to adverse events. Changes from baseline in renal function as well as lipid parameters were similar between both treatment arms and generally not significant.
The 24-week data from this study were originally presented at CROI in 2018 (abstract #500). The 48-week results of this study are reassuring as we transition more of our patients to better-tolerated and safer single-tablet regimens such as B/F/TAF. The declining need for boosting with cobicistat or ritonavir also limits the risk of drug-drug interactions. As the authors note in their discussion, this study contributes to the growing body of data on safety, tolerability and outcomes of ART in women living with HIV.
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