Aim: With modern antiretroviral therapy (ART), HIV-1 has now become a manageable chronic condition. Among treatment-experienced (TE) people with HIV-1 (PWH), ART regimens can influence metabolic and renal outcomes and adverse events such as nausea. Regimen selection increasingly prioritizes safety, tolerability and long-term acceptability. This study compared bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) with other ART regimens in TE PWH using multilevel network meta-regression (ML-NMR), focusing on lipid profile, renal function and overall safety. Materials & methods: A systematic literature review (SLR) in June 2023 identified Phase III/IV randomized controlled trials reporting safety in adult TE PWH. ML-NMR was conducted at week 48 adjusting for age, sex, race and CD4 cell count, using individual patient data from three Phase III B/F/TAF trials (GS-US-380-1844, -1878, -4030) and aggregate data from comparator trials. Results: At week 48, B/F/TAF demonstrated similar changes in total cholesterol (TC) to HDL ratio and LDL versus comparators. Compared with NNRTI (+ or /) F/TDF, changes in TC favored B/F/TAF (mean difference [MD; 95% CrI]: -12.43 [-23.26, -1.53]), but favored the NNRTI-based regimen for HDL (-4.35 [-7.76, -0.70]). Triglycerides changes favored B/F/TAF versus DTG/ABC/3TC (-15.01 [-29.18, -1.06]) and protease inhibitor (+ or /) b + 2 NRTIs (-24.48 [-41.60, -7.47]). eGFR changes favored B/F/TAF versus DTG/ABC/3TC (3.81 [1.74, 5.97]). With some exceptions of statistical differences in both directions, B/F/TAF generally had similar levels of adverse events and discontinuations as other ART. Conclusion: Switching to or remaining on B/F/TAF in TE PWH was generally well tolerated and did not worsen lipid, renal or safety outcomes versus most other contemporary ART. Improvements in select lipid parameters and stable renal function, with low rates of adverse events and discontinuation, support B/F/TAF as a safe option for long-term management in TE PWH.
Keywords: HIV-1; antiretroviral therapy; network meta-analysis; safety and tolerability; systematic literature review.
What is this article about? B/F/TAF is a single-tablet treatment for HIV-1 which combines three medications: bictegravir (B), emtricitabine (F) and tenofovir alafenamide (TAF). This medication is used by people living with HIV-1, including those who have been on other treatments before. This article examines whether B/F/TAF is as safe as other HIV-1 medications for people who have already been treated for HIV-1, looking specifically at effects on cholesterol, kidney health and side effects. Why is this important? With modern treatments, people with HIV-1 can live long, healthy lives. For those who have been on HIV-1 medication before, it is essential to ensure that any treatment remains safe over time and does not cause other health problems. What methods were used in the research? Researchers reviewed clinical trials of HIV-1 medications and compared them to assess cholesterol changes, kidney function and side effects in people who had received prior HIV-1 treatment. What were the results? B/F/TAF performed well compared with other HIV-1 medications. People taking B/F/TAF experienced favorable outcomes for certain cholesterol measurements and maintained stable kidney function. Additionally, B/F/TAF was associated with lower rates of nausea and fewer treatment-related side effects than some other options. What do the results mean? For people who have been on HIV-1 medications before, B/F/TAF appears to be a well-tolerated choice that maintains good safety outcomes. The findings support B/F/TAF as an appropriate long-term treatment option.