Real-world data in a low-resource region show high treatment persistence and sustained virologic suppression with fixed-dose B/F/TAF
Presenter: Diego Martín Cecchini, MD, PhD, Helios Salud, Buenos Aires, Argentina
Effectiveness and safety of bictegravir/emtricitabine/tenofovir alafenamide fixed-dose combination for the treatment of people living with HIV in Argentina: first interim report of the BICTARG cohort. Presented July 24, 2023.
One year of follow-up of a Latin American cohort living with HIV who were being treated with bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in a fixed-dose combination shows high levels of treatment persistence and high rates of virologic suppression.
Findings from the observational, retrospective BICTARG cohort, composed of 2,671 treatment-naïve (n = 315) and treatment-experienced (n = 2,356) people living with HIV in a real-world clinical setting in Argentina, showed persistence rates of 99% or higher at 24 weeks for both the treatment-naïve and treatment-experienced patients treated with B/F/TAF, and more than 99% in each category remained on therapy at 48 weeks. The researchers, led by Diego Martín Cecchini, MD, PhD, Helios Salud, Buenos Aires, Argentina, note that “real-world data for this fixed-dose combination emerge from cohorts from high-income settings with no reports from resource-constrained settings, such as Latin America.”
At baseline, 35% of the treatment-naïve population and 63.8% of the treatment-experienced population had comorbidities. Dyslipidemia (37.3%), hypertension (17.1%), and obesity (16.5%) were the most common comorbidities in the treatment-experienced group, while dyslipidemia (10.2%), obesity (9%), and hypertension (7.2%) were most common in the treatment-naïve patients. The median baseline viral load in the treatment-naïve group was 39,750 copies/mL and the median CD4 count was 329 cells/µL. In the treatment-experienced group, 89% had a baseline viral load less than 50 copies/mL and the median CD4 T-cell count was 621 cells/µL.
At 24 weeks, 97.4% of the treatment-naïve and 99% of the treatment-experienced patients achieved a viral load less than 200 copies/mL, which improved to 100% and 99%, respectively, at 48 weeks. Viral load suppression to less than 50 copies/mL was achieved by 88% and 97% of treatment-naïve and treatment-experienced patients, respectively, at 24 weeks, which improved to 92% and 97%, respectively, at 48 weeks.
The median CD4 T-cell count improved from 468 cells/µL at 24 weeks to 550 cells/µL at 48 weeks in the treatment-naïve population, and from 628 cells/µL to 642 cells/µL in the treatment-experienced population.
The median number of prior antiretroviral regimens in the treatment-experienced cohort was 2. Among this cohort, 54.8% cited simplification of the regimen as the reason for switching to B/F/TAF, 24.1% indicated prevention of toxicity, 19.6% cited toxicity with antiretroviral therapy, and 2% indicated virologic failure.
Adverse events were infrequent and no cases of virologic failure were documented. Overall, the prevalence of adverse events (predominantly weight gain) was less than 1% at 48 weeks. Eight patients (7 treatment-experienced and 1 treatment-naïve) had discontinued fixed-dose combination B/F/TAF at 24 weeks: 1 because of intolerance, 1 because of renal toxicity, 1 because of weight gain, 1 because of patient preference, and 4 for other reasons. A total of 10 patients (9 treatment-experienced and 1 treatment-naïve) had discontinued at 48 weeks: 2 because of weight gain, 1 because of hepatic toxicity, 1 because of patient preference, 4 for other causes, and 3 for unknown reasons.
The authors conclude that the data support B/F/TAF FDC as a therapeutic option for naïve and switching populations.
The research was sponsored by Gilead Sciences, Inc.