- In a study presented at this year’s Conference on Retroviruses & Opportunistic Infections (CROI – 2020), the single-tablet antiretroviral treatment (ART) regimen comprising bictegravir, emtricitabine, and tenofovir alafenamide (B/F/TAF) appears to be non-inferior to both dolutegravir, abacavir, and lamivudine (DTG/ABC/3TC), and dolutegravir, and tenofovir alfenamide (DTG+F/TAF) in older (ages 50+), treatment-naïve adults living with HIV.
Why this matters
- Single-tablet B/F/TAF may represent an alternative, safe, and well-tolerated HIV treatment strategy in older adults.
- Single-tablet regimens have been shown to boost adherence rates.
- 196 patients/1274 in final analysis (629 enrolled in 1st study, 645 in 2nd).
- Most participants were male (73%-92%), roughly one-third (20%-37%) were black or of African descent.
- At enrollment, 80%-90% of patients had median CD4 405-534 cells µ/mL.
- At week 144, 81% of B/F/TAF >50 years reached virologic suppression vs 83%, 88% of younger DTG/ABC/3TC, DTG+F/TAF groups, respectively, demonstrating non-inferiority.
- Similar results were observed in patients aged
- No treatment-emergent resistance observed to any components.
- Regimens did not have any clinically significant impact on renal safety; while slight hip bone mineral density declines were observed in both groups, changes were comparable between older, younger patients.
- Median weight increases ranged from 3.4 kg to 5.3 kg for older and younger patients respectively, taking DTG+F/TAF.
- Pooled data analysis of two phase 3 randomised, double-blind studies comparing single-tablet B/F/TAF to DTG/ABC/3TC in older, treatment-naive adults living with HIV. Pooled analysis assessed safety, efficacy at week 144.
- Funding: Gilead Sciences, Inc.
- Limited generalisability.
“There were no clinically significant differences in median changes from baseline to fasting lipids,” among those aged 50 and older, noted Dr Mills and associates.