Research Evaluates Real-World Safety, Efficacy of B/F/TAF Regimen in HIV | ACCP 2024
The first-line B/F/TAF regiment was evaluated in Hispanic/Latino patients, as well as in those with chronic kidney disease.
Although estimated HIV infections decreased 12% overall between 2018 and 2022, an estimated 1.2 million individuals in the US have HIV—a diagnosis that disproportionately impacts certain populations, including racial and ethnic minorities.1 Two posters presented at the American College of Clinical Pharmacy 2024 Annual Meeting evaluated a first-line HIV therapy—bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)—in 2 patient populations.
In the first study,2 researchers found that Hispanic/Latino people with HIV who received B/F/TAF maintained high rates of virologic suppression over 5 years. Hispanic/Latino individuals are disproportionately affected by HIV and may experience a greater risk of comorbidities compared with non-Hispanic/Latino individuals with HIV. Despite this, Hispanic/Latino individuals have been historically underrepresented in HIV clinical studies.
B/F/TAF is a first-line drug regimen to treat HIV. | Image credit: RAJCREATIONZS - stock.adobe.com
Using data from 2 phase 3, randomized, double-blind, multicenter clinical trials (NCT02607930 and NCT02607956), inclusive of 1489 and 1490 patients each, investigators conducted a pooled analysis to evaluate the safety and efficacy of B/F/TAF.
Overall, 24.5% of Hispanic/Latino and 75.5% of non-Hispanic/Latino participants received B/F/TAF over the 240-week study period (144-week randomization and 96 week open-label extension). Median ages at baseline were 30 and 33 years, respectively, and 89% and 89.1% were male at birth. A total of 11.6% and 21.2% had HIV RNA >100,000 copies/mL and 10.3% and 13.4% had CD4 <200 cells/µL. In terms of comorbidities, 4.5%, 12.9%, and 10.3% of Hispanic/Latino participants had a history of diabetes, hypertension, or hyperlipidemia, compared with 6.5%, 16.4%, and 14.7% of non-Hispanic/Latino participants.
At week 240, all Hispanic/Latino participants and 98.1% of non-Hispanic/Latino participants had HIV RNA <50 copies/mL; changes in CD4 counts were similar between groups. Changes in metabolic parameters—such as body weight and estimated glomerular filtration rate—adherence rate, and treatment-emergent adverse events were similar between groups.
“These results demonstrate the durability and safety of B/F/TAF in Hispanic/Latino [people with HIV],” the researchers concluded.
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In a second study,3 investigators evaluated the safety of B/F/TAF in the context of renal outcomes using data from the BICSTaR study.
A total of 843 participants had estimated glomerular filtration rate (eGFR) data available; of these patients, 90 had chronic kidney disease with a Modification of Diet in Renal Disease (MDRD) eGFR of <60 mL/min/1.7m2. Just over 83% of participants were men (83%) and 95% were non-Black. More participants with, rather than without, baseline chronic kidney disease were older than 50 years of age, had 1 cardiovascular condition, diabetes, and hypertension. Participants without baseline chronic kidney disease had longer prior exposure to antiretroviral therapy and time from diagnosis to initiation of B/F/TAF therapy.
A total of 16% of participants with baseline chronic kidney disease experienced drug-related adverse events, compared with 15% in patients without; 1 drug-related renal adverse event was reported in the former group. Median eGFR was stable through 24 months for individuals with baseline chronic kidney disease.
Results of this study “support the use of TAF-based regimens in people with eGFR <60 mL/min/1.73 m2,” investigators concluded.
READ MORE: Infectious Disease Resource Center
References
Fast facts: HIV in the United States. CDC. Accessed October 15, 2024. https://www.cdc.gov/hiv/data-research/facts-stats/index.html
Martorell C, Osiyemi O, Berhe M, et al. Efficacy and safety of B/F/TAF in Hispanic/Latine adults with HIV-1 initiating first-line therapy: 5 year follow-up from two phase 3 studies. Presented at: American College of Clinical Pharmacy 2024 Annual Meeting; October 12-15, 2024; Phoenix, AZ. Poster MON-64.
Rieke A, de Wet J, Esposito V, et al. Real-world effectiveness and tolerability of bictegravir/emtricitabine/tenofovir alafenamide (B/T/TAF) in treatment-experienced (TE) people with HIV with a history of CKD. Presented at: American College of Clinical Pharmacy 2024 Annual Meeting; October 12-15, 2024; Phoenix, AZ. Poster MON-65.
