TOPLINE:

Patients with multidrug‑resistant HIV infection who were switched to the single‑tablet regimen bictegravir/emtricitabine/tenofovir alafenamide demonstrated sustained virologic suppression and tolerated the regimen well over 48 weeks of follow‑up.

METHODOLOGY:

• Researchers conducted a prospective cohort study of 62 patients with multidrug-resistant HIV infection (median age, 60 years; 73% men; median time since HIV diagnosis, 26.5 years) who had their regimens simplified by switching to a single tablet of bictegravir/emtricitabine/tenofovir alafenamide.
• Patients had maintained virologic suppression for at least 24 weeks on effective antiretroviral therapy, had documented resistance to two or more classes of antiretroviral therapy, and showed a contraindication to continuing one or more antiretroviral drugs.
• Clinical data were collected at baseline and every 12 weeks through week 48; the median follow-up duration was 32.5 months.
• The primary objective was to determine the probability of virologic failure after switching to bictegravir/emtricitabine/tenofovir alafenamide, defined as two consecutive episodes of viremia (> 50 HIV RNA copies/mL) or a single episode of viremia (> 200 HIV RNA copies/mL).
• Secondary endpoints included changes in laboratory measures during follow-up, including levels of triglycerides and cholesterol and estimated glomerular filtration rate.

TAKEAWAY:

• At week 48, no virologic failures were observed; the efficacy was 91% (95% CI, 81%-99%) in the intention-to-treat analysis.
• Levels of total cholesterol and low-density lipoprotein cholesterol decreased significantly (P = .011 and P = .006, respectively), whereas the mean estimated glomerular filtration rate and the protein-to-creatinine ratio remained stable.
• Five patients discontinued treatment during follow-up: two because of progression of diabetic nephropathy after more than 48 weeks of therapy and three due to sleep-related issues that led to early discontinuation.
• The probability of remaining on bictegravir/emtricitabine/tenofovir alafenamide with sustained virologic suppression was 91% at 5 years.

IN PRACTICE:

“This strategy of [switching to bictegravir/emtricitabine/tenofovir alafenamide] is an appealing one for reducing severe interactions, toxicity and pill burden in patients harbouring MDR [multidrug-resistant] strains,” the authors of the study wrote.

SOURCE:

The study was led by José L. Casado, Ramón y Cajal Hospital, Madrid, Spain. It was published online on October 3, 2025, in Journal of Antimicrobial Chemotherapy.

LIMITATIONS:

The study was limited by its observational design, the lack of a comparison group, its heterogeneous study population, and the absence of pharmacokinetic determinations. The findings should also be interpreted in the context that only about 22% of participants had high‑level resistance, with no resistance to integrase inhibitors; therefore, the results may not have been generalizable to patients with HIV infection who meet different definitions of multidrug resistance.

DISCLOSURES:

The study was not supported by any specific grant. The authors reported having no conflicts of interest.

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