A phase 3 randomized controlled clinical trial of bictegravir in a fixed dose combination, B/F/TAF, vs ABC/DTG/3TC in treatment-naive adults at Week 48

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Conference Proceeding

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J Int AIDS Soc


Background : Integrase strand transfer inhibitors (INSTIs) are recommended as first-line antiretroviral therapy in combination with 2 nucleoside reverse transcriptase inhibitors. Bictegravir (B), a novel, potent INSTI with a high in vitro barrier to resistance and low potential for drug interactions, has been coformulated with emtricitabine (F) and tenofovir alafenamide (TAF) as a fixed-dose combination (B/F/TAF). We report results from a blinded Phase 3 study comparing B/F/TAF to coformulated abacavir, dolutegravir and lamivudine (ABC/DTG/3TC).

Methods : HIV-infected, treatment-naive, HLA-B*5701-negative, HBV-uninfected adults with estimated glomerular filtration rate (eGFR) ≥ 50 mL/min were randomized 1:1 to receive blinded treat- ment with fixed-dose combination B/F/TAF (50/200/25mg) or ABC/ DTG/3TC (600/50/300mg) with matching placebos once daily. The primary endpoint was proportion of participants with HIV-1 RNA (VL)/mL at W48 (FDA snapshot). Noninferiority was assessed through 95.002% confidence intervals (CI) (12% margin). Secondary endpoints were safety (adverse events (AEs) and laboratory abnormalities) and pre-defined analyses of changes from baseline in bone mineral density (BMD) and measures of renal function, including eGFR and proteinuria.

Results : 629 participants were randomized and treated (314 B/F/ TAF, 315 ABC/DTG/3TC): 10% women, 36% Black, 16% VL >100,000 c/mL, 11% CD4/mL. Median baseline charac- teristics: age 32 yrs, CD4 count 444 cells/μL and VL 4.47 log10 c/ mL. At W48, B/F/TAF was non-inferior to ABC/DTG/3TC, with 92.4% on B/F/TAF and 93.0% on ABC/DTG/3TC achieving HIV-1 RNA/mL (difference − 0.6%; 95.002% CI − 4.8% to 3.6%, p = 0.78). No resistance mutations emerged in either group. Comparing B/F/TAF to ABC/DTG/3TC throughout, the most com- mon AEs were diarrhoea (13%, 13%), headache (11%, 14%) and nausea (10%, 23%). Few participants (0 vs. 4 (1%)) had any AEs leading to premature study drug discontinuation. At W48, mean percentage changes from baseline in BMD were − 0.83% versus − 0.60% ( p = 0.39) (lumbar spine) and − 0.78% versus − 1.02% ( p = 0.23) (total hip). No differences between treatments were noted in changes from baseline for eGFR and proteinuria at W48.

Conclusions : At W48, B/F/TAF achieved virologic suppression in 92.4% of treatment-naive adults and was noninferior to ABC/ DTG/3TC, with no emergent resistance. B/F/TAF was safe and well tolerated with less nausea than ABC/DTG/3TC. Bone and renal safety profiles were similar between groups.




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