Switching to B/F/TAF as Initial Therapy for HIV in Older Adults in Kenya
Overview
In a randomized trial of 520 virally suppressed adults aged ≥60 years in Kenya, switching to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) was non-inferior to continuing current antiretroviral regimens (CAR) for viral suppression at 48 weeks. The B/F/TAF group showed significant improvement in lumbar spine bone mineral density (BMD) and fewer discontinuations due to kidney function decline, though incident dyslipidemia was more common.
Background
Older people living with HIV (PWH) face increased comorbidities including cardiovascular, kidney, and bone diseases, complicating antiretroviral therapy (ART) management. Tenofovir disoproxil fumarate (TDF), commonly used in ART, is associated with renal toxicity and bone mineral density loss, limiting its use in older adults. Tenofovir alafenamide (TAF) offers a potentially safer alternative with less kidney and bone toxicity but may increase lipid levels and weight. Data on switching to TAF-based regimens in older African populations are limited, prompting this trial to assess efficacy, safety, and bone health outcomes.
Data Highlights
Outcome
B/F/TAF Arm (n=260)
CAR Arm (n=260)
Difference (95% CI)
P-value
HIV-1 RNA ≥50 copies/mL at Week 48
1.9% (5/260)
2.7% (7/260)
−0.8% (−3.4 to 1.8)
Non-inferior
Change in Lumbar Spine BMD at Week 48
+2.18%
+0.68%
1.51% (0.27 to 2.76)
0.017
Grade 3 or 4 Treatment-Related Adverse Events
16.9%
14.2%
Not specified
Not specified
Grade 3 or 4 AEs Leading to Drug Discontinuation
0 (none)
15 (all due to kidney function decline)
Not specified
Not specified
Incident Dyslipidemia
23%
14%
Not specified
0.015
Key Findings
Switching to B/F/TAF was non-inferior to continuing current ART for maintaining viral suppression at 48 weeks in adults aged ≥60 years.
Participants on B/F/TAF experienced a statistically significant increase in lumbar spine bone mineral density compared to those continuing CAR.
Grade 3 or 4 adverse events were similar between groups, but all drug discontinuations due to adverse events occurred in the CAR arm, primarily from declining kidney function.
Incident dyslipidemia was more frequent in the B/F/TAF arm, raising considerations for cardiovascular risk monitoring.
Calcium and vitamin D supplementation was introduced during the study due to high baseline osteoporosis rates, highlighting bone health concerns in this population.
Clinical Implications
Switching older adults with HIV to B/F/TAF is an effective and safe strategy that may improve bone mineral density and reduce kidney-related adverse events compared to continuing existing regimens. However, clinicians should monitor lipid profiles closely due to increased dyslipidemia risk. Bone health assessment and supplementation should be considered in this population to address osteoporosis risk.
Conclusion
In older Kenyan adults with HIV, switching to B/F/TAF maintains viral suppression, improves bone density, and has a favorable renal safety profile, though lipid changes warrant monitoring. This supports B/F/TAF as a viable treatment option in resource-limited settings for aging PWH.
References
B/F/TAF-Elderly Trial Investigators 2023 -- Switching to B/F/TAF as Initial Therapy for HIV in Older Adults Aged 60 and Above in Kenya
by Loice Achieng Ombajo, Jeremy Penner, Joseph Nkuranga, Victor Omodi, Edwin Otieno, Jared Ongechi Mecha, Simon Wahome, Florentius Ndinya, Rukia Aksam, Sanjay Bhagani, Rose Wafula, Anton Pozniak, Diana Nyakoe, On behalf of, the B/F/TAF-Elderly Study Group, Ruth Wanjohi, Arnold Onyango, Foram Bhogayata, Janet Oyoo, Susan Onywera, Martha Atandi, Agatha Theuri, Beryl Handa, Elizabeth Kamau, Susan Wanjiru, Eunice Karuoya, Amos Ongubo, Gerald Kiambi, Sheila Eshiwani Juliet, Lillian Gekonge, Florence Kinyanjui, Betty Chepchumba, Alex Morwabe, Kevin Wauna, Felix Hinga
