Bictegravir/Emtricitabine/Tenofovir Alafenamide Effective for Advanced HIV

Data from 2 Phase 3 clinical trials indicated that initial treatment with bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) was safe and effective at 5 years among patients with advanced HIV infection. These study results were presented at IDWeek 2022, held from October 19 to 23, in Washington, DC.

Data for this analysis were sourced from previous analyses in which patients with HIV infection were randomly assigned to receive initial therapy with either B/F/TAF, dolutegravir (DTG)/abacavir/lamivudine, or DTG plus F/TAF for 144 weeks. At week 144, patients could switch to open-label B/F/TAF for 96 weeks. This analysis comprised only patients who were randomly assigned to receive B/F/TAF and had CD4 counts below 200 cells/µL at baseline.

Among 634 patients included in the final analysis, the median age was 32 years, 89% were men, and 33% were Black. At baseline, 80 patients had a CD4 count below 200 cells/µL, and 119 had an HIV viral load above 100,000 cells/mL.

In the analysis that excluded patients with missing data, the efficacy of B/F/TAF in achieving virologic suppression (HIV-1 RNA <50 copies/mL) at week 240 was 93%, 97%, and 99% among those with viral loads below 100,000, between 100,000 and 400,000, and above 400,000 copies/mL at baseline, respectively.

For patients with a CD4 count below 200 cells/µL at baseline and those with HIV viral loads above 100,000 cells/mL and CD4 counts below 200 cells/µL at baseline, 98% and 95% achieved virologic suppression through week 240.

The rate of any drug-related adverse event (AE) ranged between 20% and 30% among the patient groups. The most common AEs included headache, diarrhea, nausea, dizziness, fatigue, and insomnia. Five patients experienced severe drug-related adverse AEs, all of whom had an HIV viral load of less than100,000 copies/mL at baseline. Twelve patients discontinued treatment due to AEs, of whom 6 experienced a drug-related AEs.

“These outcomes provide additional evidence that B/F/TAF is an effective and durable regimen for a broad range of PWH [patients with HIV], including those with advanced disease,” the researchers concluded.