Efficacy, durability, and tolerability of bictegravir/emtricitabine/tenofovir alafenamide for the treatment of HIV in a real‐world setting in Belgium

Abstract

Objectives Our objective was to evaluate the efficacy, durability, and tolerability of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in a real‐world setting in Belgium. Methods This was a retrospective, multicentre cohort study involving adult treatment‐naïve (TN) and treatment‐experienced (TE) people living with HIV receiving BIC/FTC/TAF between 1 January 2019 and 30 September 2020. The primary outcome was rate of virological suppression (plasma HIV‐1 viral load <50 copies/mL; on‐treatment analysis) at weeks 24 and 48. The main secondary outcomes included loss of virological suppression (LVS; two consecutive viral loads of >200 copies/mL after being virologically suppressed) by week 48 and analysis of resistance‐associated mutations at time of LVS; tolerability of BIC/FTC/TAF over the 48‐week study period; and change in weight and proportion of participants reporting a >10% weight gain at week 48. Results Overall, 2001 participants were included. Through 48 weeks, overall rate of virological suppression was 93.5%, with similar results observed in the following subgroups: age ≥50 years (92.7%), women (92.8%), Black sub‐Saharan African (91%), TN (94%), TE (93.2%), and non‐suppressed at baseline (86.6%). LVS was observed in 0.7% (n = 14) of participants, with one participant developing resistance‐associated mutations to nucleoside reverse transcriptase inhibitors (184 V) and integrase strand transfer inhibitors (263KR). Of the 131 (6.5%) treatment discontinuations, the most common reason was an adverse event (2.4%), with the most frequent being central nervous system/psychiatric (0.4%) and gastrointestinal (0.4%) toxicity. Median weight gain at week 48 was 2 kg (interquartile range −1 to 5), and a >10% weight increase was observed in 11.6% of participants. Conclusion In this large real‐world cohort, BIC/FTC/TAF showed excellent virological efficacy in a diverse population of patients with HIV. Rare occurrence of emergent drug resistance was observed, and treatment was well tolerated.

Bictegravir/emtricitabine/tenofovir alafenamide in paediatrics: Real‐life experience from a French cohort (2019–2023)

“…The BIC/FTC/TAF co‐formulation was well tolerated, with only one participant (1.4%) discontinuing his treatment during the follow‐up because of a suspected adverse event. This finding is consistent with the results of trials and cohorts in adults receiving BIC/FTC/TAF, in which discontinuation rates due to an adverse event were 1–3% [8, 9, 12]. Of note, our study population had been mostly exposed to ART, and more specifically INSTIs, before BIC/FTC/TAF initiation and would potentially be less likely to experience or more likely to tolerate adverse events, thereby leading to few treatment discontinuations.…”

“…Previous studies of BIC/FTC/TAF have demonstrated no or very rare treatment‐emergent resistance in adults [8, 9, 12], even in the case of baseline NRTI resistance [17], and in those dosed only 4–5 days/week [18]. In our cohort with high rate of VF and, in patients experiencing VF, long duration of unsuppressed viraemia on ART, we have demonstrated viral re‐suppression in half of the patients and evidenced only one case of treatment‐emergent NRTI RAM (1.4% of subjects, 3.6% of those with VF) with no INSTI RAM.…”

“…In clinical trials and real‐world studies including adults treated with BIC/FTC/TAF (first‐line or switch), very low rates of VF (<2%) were observed [8, 9, 12]. Similarly, the recent phase 2/3 paediatric trial, where all participants were virologically suppressed on a stable ART regimen at baseline, viral suppression was maintained by 98/100 (98%) subjects at week 48 after BIC/FTC/TAF initiation [10].…”

Real-world prevalence of integrase inhibitor resistance and virological failure since adoption as guideline-preferred therapy

“…This study found similar or lower estimated rates of INSTI-R in a real-world population compared with those found in RCTs and previous observational studies ( Table 4 ), despite a numerically higher incidence of VF. 3 – 12 , 22 – 41 …”

Long-Term Treatment Success with Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF)

“…Simple patient and therapy management and the best possible HRQoL are crucial for long-term treatment success. 10,15 To achieve this, the tolerability of ART plays a crucial role. BIC/FTC/TAF has also demonstrated good tolerability in real-world clinical practice, with most drug-related adverse events (DRAEs) documented in the first six months.…”