BRAAVE 2020: Biktarvy Noninferior as a Switch Treatment for Black Americans Living With HIV

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Black Americans living with HIV who switched from a standard antiretroviral therapy (ART) regimen to single-dose bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF; Biktarvy®, Gilead Sciences) maintained high rates of virologic suppression through 48 weeks of the phase 3 BRAAVE 2020 study, Gilead Sciences announced at ID Week 2020.

The results support B/F/TAF as a switch option for Black Americans who are virologically suppressed, including individuals with a history of treatment failure or pre-existing resistance.

“Black and African Americans in this country have the highest rates of new HIV infections every year compared with other races,” Debbie P. Hagins, MD, FAPCR, medical director of CARE Centers of Southeast Georgia, Coastal Health District, and principal investigator of the BRAAVE 2020 study, said in a statement. “Adding to that burden are other inequalities such as lack of health insurance, difficulties navigating the healthcare system, and poverty; all of which contribute to higher rates of drug resistance.”

B/F/TAF has previously demonstrated a high barrier to resistance, and investigators sought to evaluate its efficacy and safety in Black individuals, a group that has the highest reported rates of HIV/AIDS in the United States and that may also be predisposed to pre-existing M184V/I.

Eligible participants included adults who self-identified as African American, Black, or mixed race including Black who reached HIV-1 RNA <50 copies/mL for >6 months on their baseline regimen of 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus a third agent.

Prior treatment failure was permitted (except on an integrase strand transfer inhibitor [INSTI]-containing regimen), as was documented resistance to non-nucleoside reverse transcriptase inhibitors(NNRTIs), protease inhibitors (PIs) and/or NRTIs, except for K65R/E/N, ≥ 3 thymidine analog mutations (TAMs), or T69-insertions. Other exclusion criteria included primary INSTI resistance (-R).

Investigators relied on historical genotypes and proviral DNA genotyping to identify pre-existing drug resistance.

The phase 3, randomized, open-label, multicenter, active-controlled US study ultimately enrolled 495 participants. Subjects were randomized 2:1 to switch to the study drug B/F/TAF (330) or stay on their baseline regimen (SBR) for 24 weeks with a delayed switch to B/F/TAF until week 48 (165).

The primary end point was HIV-1 RNA >50 c/mL, with a secondary outcome of HIV-1 RNA > and < 50 c/mL.

After 48 weeks of study, outcomes for 489 participants demonstrated that nearly all subjects (99%; 324/327) who received B/F/TAF maintained HIV-1 RNA <50 c/mL, compared with 100% of subjects in the delayed switch group (162/162).

In terms of pre-existing resistance, primary NRTI-R, NNRTI-R, and PI-R substitutions were observed in 14% (70/495), 21% (102/495), and 13% (62/495), respectively. Investigators determined that similar virologic suppression rates were achieved regardless of resistance substitutions.

“M184V/I and TAMs were detected in 10% (51/495) and 7% (34/495), respectively. Primary INSTI-R was detected post-randomization in 2% (11/495); all continued on study and were included in efficacy analyses [and] no participant had treatment emergent resistance to study drugs,” the research team reported.

B/F/TAF represents an effective treatment option for virologically suppressed Black Americans, the trial concluded.

The study, “Preexisting Resistance and Week 48 Virologic Outcomes After Switching to B/F/TAF in African American Adults with HIV,” was presented virtually at ID Week 2020.