Efficacy, Durability, and Tolerability of Bictegravir/Emtricitabine/Tenofovir Alafenamide for the Treatment of HIV in a Real-world Setting in Belgium

Rakan Nasreddine; Eric Florence; Jean Cyr Yombi; Sophie Henrard; Gilles Darcis; Jens Van Praet; Linos Vandekerckhove; Sabine D. Allard; Rémy Demeester; Peter Messiaen; Nathalie Ausselet; Marc Delforge; Stéphane De Wit


HIV Medicine. 2023;24(8):914-924. 

In This Article

Abstract and Introduction


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 (BIC/FTC/TAF) is recommended by international guidelines as a first-line option for the treatment of most people living with HIV-1.[1–4] Support for the use of BIC/FTC/TAF has come from several randomized clinical trials (RCTs) of treatment-naive[5–9] and treatment-experienced people living with HIV.[10–12] These trials showed that this regimen resulted in a rapid suppression of viraemia, was effective in maintaining virological suppression, was as tolerable as standard-of-care comparators, had a high genetic barrier to resistance, and had more favourable metabolic parameters. However, participants in RCTs are usually carefully selected, which can sometimes lead to certain groups being underrepresented. Furthermore, participants in the clinical trial setting tend to exhibit higher levels of treatment adherence than those in the real-world setting.[13] Therefore, real-world studies provide complementary information to that obtained from RCTs and ensure that those results can be generalized to broader populations seen in daily clinical practice. The aim of this study was to describe the baseline characteristics of people living with HIV in Belgium receiving BIC/FTC/TAF and to evaluate its efficacy, durability, and tolerability in a real-world setting.