Background
Antiretroviral options for older adults are limited by age-related co-morbidities and drug toxicities. We evaluated whether a first line switch strategy in older adults maintains viral suppression while minimizing contribution to comorbidities.
Methods
The bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)-elderly study was an open-label, randomized, non-inferiority trial conducted at two sites in Kenya. HIV-1 positive adults ≥60 years old with HIV viral load (VL) <50 copies/mL for at least 12 weeks prior to enrollment while on any first line regimen were randomized 1:1 to switch to B/F/TAF or continue current ARV regimen (CAR). We report the key secondary outcomes at week 96 including proportion of participants with VL ≥50 copies/mL using the FDA snapshot algorithm with a 4% non-inferiority margin, the mean percentage change in lumbar spine BMD, safety and incident co-morbidities.
ClinicalTrials.gov NCT05243602.
Results
Between Feb and May 2022, 520 participants were randomized (260 B/F/TAF, 260 CAR) and a subset of 296 had BMD monitoring (143 B/F/TAF, 153 CAR). All participants were black African, 267 (51%) were female and the median age was 64 years (range 60-79). Baseline characteristics were balanced between arms. At enrolment, 495 (95%) participants were on tenofovir disoproxil fumarate (TDF) and 179 (60%) of the BMD population had osteoporosis. At week 96, 7/260 participants (2.7%) in each arm had VL ≥50 copies/mL (difference [95% CI], 0% [-2.8 to 2.8]), meeting non-inferiority (Figure). The mean percentage change in lumbar spine BMD was +3.98% (SD 6.10) on B/F/TAF and +2.29% (SD 6.02) on CAR (difference [95% CI], 1.70 [0.25 to 3.14], p=0.021). There were no treatment-related serious adverse events (AEs) in either arm. Participants discontinuing study drug due to any AE were 1 (0.4%, due to Tuberculosis) on B/F/TAF and 30 (11.5%, due to declining kidney function) on CAR. Percentage change in creatinine clearance was 1.7 on B/F/TAF and -3.5 on CAR. Percentage change in weight was 0 on B/F/TAF and -2.6 on CAR, 13.4% and 6.4% of participants on B/F/TAF and CAR respectively had >5% weight gain, 60/166 (51.7%) on B/F/TAF and 46/100 (49.1%) on CAR had incident hypertension, 69/207 (33%) on B/F/TAF and 58/218 (26.6%) on CAR had incident dyslipidemia.
Conclusions
A first line switch strategy to B/F/TAF was effective and safe in a population of older African adults and associated with less requirement for treatment modification due to declining kidney function compared to CAR.