This article is part of Infectious Disease Advisor’s In-Depth HIV coverage of the IDWeek 2020 meeting.
Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) was a well-tolerated and effective treatment in older people living with HIV (PLWH), and switching to B/F/TAF was associated with high virologic suppression, lipid improvements, and lower drug-drug interactions (DDIs) in a large proportion of patients, according to research presented at IDWeek, held virtually from October 21 to 25, 2020.
With approximately 50% of PLWH in the United States being at least 50 years of age, there is a need to identify antiretrovirals (ARV) that are associated with fewer drug-drug interactions and long-term side effects in this population. This retrospective cohort study assessed the efficacy, safety, and tolerability of B/F/TAF for 48 weeks when switched from an alternative therapy in adults aged 50 years of age or older.
In total, 350 PLWH aged 50 years or older who were switched to daily B/F/TAF as a completed ARV regimen between February 2018 and August 2019 were included in the study. Additional inclusion criteria included 2 documentations of plasma HIV-1 RNA less than 50 copies/mL at least three months apart, attended at least 2 clinic visits in the year prior, and had no prior history of virologic failure or resistance on an integrase strand transfer inhibitor regimen. Of the patients who were included, 281 (80%) were men, 199 (57%) were White, median baseline CD4+ cell count was 664 (range, 58-2327) cells/mm3, and the median duration of HIV infection was 19.5 years.
The primary endpoint of this study was the proportion of patients with plasma HIV-1 RNA less than 50 copies/mL at Week 48. Secondary endpoints of this study included subgroup analyses of virologic outcomes at Week 48 by baseline regimen prior to switch, change in CD4+ cell count through Week 48, change in lipids through Week 48, and the impact of switching to B/F/TAF on DDIs. The safety and tolerability of B/F/TAF were also assessed through Week 48.
Results support the use of B/F/TAF as a treatment option in older PLWH. Switching to B/F/TAF was associated with high virologic suppression in 330 (94%) patients. High virologic suppression was also seen in subgroup analyses when compared to different ARV regimens prior to switch, presence of M184V/1 mutation, and different numbers of nucleoside reverse transcriptase inhibitor resistance-associated mutations.
At Week 48, switching to B/F/TAF was also associated with significant declines in total cholesterol by 15.5 mg/dL (95% CI, 9.5-21.5), LDL cholesterol by 9.5 mg/dL (95% CI, 4-15.5), and triglycerides by 20 mg/dL (95% CI, 9.5-32.5). Median weight increased by 2.5 pounds (95% CI, 1.5-3.5). No significant change in median CD4+ cell count from baseline to Week 48 was observed. A total of 123 potential DDIs were identified in 103 (34%) patients who were on ritonavir, cobicistat, or rilpivirine at baseline that resolved upon the switch to B/F/TAF. Common DDIs include statins (23%), phosphodiesterase type 5 inhibitors (7%), and inhaled or intranasal steroids (5%).
The B/F/TAF regimen was well tolerated among patients. No deaths or serious adverse events (AE) occurred during the study. Drug-related AEs occurred in 51 (15%) patients, with 8 leading to discontinuation from.
Overall, the study authors conclude that, “In this real-world cohort, switching to B/F/TAF was associated with maintenance of virologic control, improvement in lipid parameters, and avoidance of DDIs in a large proportion of patients.”
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Rolle CM, Nguyen V, Patel K, Cruz D, Hinestrosa F, DeJesus E. Efficacy, safety and tolerability of switching to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in HIV-1 infected virologically-suppressed older adults in a real-world setting. Presented at: IDWeek 2020; October 21-25, 2020. Poster 1012.