TOPLINE:

Twice-daily bictegravir/emtricitabine/tenofovir alafenamide resulted in high sustained viral suppression rates over 48 weeks in patients with HIV infection receiving rifampicin-based treatment for tuberculosis (TB). The regimen was safe and well tolerated, with no discontinuations or drug switches due to adverse events.

METHODOLOGY:

• Researchers conducted a phase 2b randomized trial to examine the efficacy, safety, and pharmacokinetics of a twice-daily single-pill bictegravir/emtricitabine/tenofovir alafenamide regimen vs standard care in people with HIV infection receiving rifampicin-based treatment for TB.
• Overall, 122 patients with HIV infection (median age, 35 years; 65% men) were randomly assigned to one of the following groups while receiving treatment for TB:
  • Bictegravir group (n = 80): twice daily bictegravir 50 mg, emtricitabine 200 mg, tenofovir alafenamide 25 mg
  • Dolutegravir group (n = 42): twice-daily dolutegravir 50 mg with once-daily tenofovir 300 mg and lamivudine 300 mg
• The primary endpoint was viral suppression, defined as the proportion of patients with < 50 HIV-1 RNA copies/mL, at week 24 in the bictegravir group.
• Secondary outcomes included viral suppression rates at weeks 24 and 48 in the dolutegravir group and at week 48 in the bictegravir group; the incidence of TB-associated immune reconstitution inflammatory syndrome through week 24, adverse events of grade 3 or higher, or serious adverse events; and clinician-initiated treatment interruptions or switches through week 48.

TAKEAWAY:

• Viral suppression rates were 94% (95% CI, 86-98) at week 24 and 95% (95% CI, 88-99) at week 48 in the bictegravir group and 95% (95% CI, 84-99) at week 24 and 93% (95% CI, 81-99) at week 48 in the dolutegravir group.
• Serious adverse events were reported in 14% of patients in the bictegravir group and 7% of those in the dolutegravir group; adverse events of grade 3 or higher occurred in 45% and 55% of patients, respectively.
• TB-associated immune reconstitution inflammatory syndrome occurred in 28% of patients in the bictegravir group and 36% of those in the dolutegravir group.
• Three treatment interruptions due to hepatotoxicity or hyperbilirubinemia were reported; all patients successfully resumed therapy after temporary holds.

IN PRACTICE:

“Our findings support the use of this regimen among people with HIV and TB in settings in which the drug is available and opens a pathway for expanded access to this treatment option in Africa and other low-income and middle-income countries where the drug is not yet available, and to be included in the current WHO [World Health Organization] guidelines for the treatment of HIV as an alternate INSTI [integrase strand transfer inhibitors] option,” the authors wrote.

SOURCE:

This study was led by Anushka Naidoo, PhD, Nelson R. Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa. It was published online on December 01, 2025, in The Lancet HIV.

LIMITATIONS:

The noncomparative design was not powered to detect differences between study groups. Individuals with CD4 counts < 50 cells/μL and those who did not previously respond to second-line antiretroviral therapy were excluded, potentially limiting generalizability to these groups. Reliance on self-reported dose timing and adherence before pharmacokinetics visits may have affected the accuracy of measured drug concentrations.

DISCLOSURES:

This study was funded by the National Institutes of Health and the South African Medical Research Council. One author reported being an employee of the biopharmaceutical company Gilead Sciences and holding stock in it.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.