# Effectiveness and safety of tenofovir alafenamide/emtricitabine/bictegravir as a first-line regimen in people with HIV: A retrospective observational study

## TL;DR

This study shows that TAF/FTC/BIC is effective and well-tolerated as a first-line treatment for newly diagnosed HIV patients.

## Contribution

The study provides real-world evidence of TAF/FTC/BIC's effectiveness and safety in newly diagnosed HIV patients.

## Key findings

- TAF/FTC/BIC had a low virological failure rate of 3.1 per 1000 person-years.
- Only 2.5% of patients discontinued the regimen due to toxicity.
- Estimated durability was 84.8% at 12 months and 75.5% at 24 months.

## Abstract

•Tenofovir alafenamide/emtricitabine/bictegravir (TAF/FTC/BIC) is recommended by international guidelines as a first-line regimen.•TAF/FTC/BIC showed low virological failure in newly diagnosed people with HIV.•Estimated TAF/FTC/BIC durability was 84.8% at 12 months, 75.5% at 24 months.•Few toxicities led to TAF/FTC/BIC interruptions among the study cohort.

Tenofovir alafenamide/emtricitabine/bictegravir (TAF/FTC/BIC) is recommended by international guidelines as a first-line regimen.

TAF/FTC/BIC showed low virological failure in newly diagnosed people with HIV.

Estimated TAF/FTC/BIC durability was 84.8% at 12 months, 75.5% at 24 months.

Few toxicities led to TAF/FTC/BIC interruptions among the study cohort.

To assess the effectiveness and safety of tenofovir alafenamide/emtricitabine/bictegravir (TAF/FTC/BIC) in patients newly diagnosed with HIV (PWH) in a non-experimental setting.

We conducted a single-center, retrospective observational study that included all newly diagnosed PWH treated with TAF/FTC/BIC at our institution. Virological failure was defined as two consecutive HIV-RNA values of >50 cp/ml after 48 weeks of treatment. Reasons for TAF/FTC/BIC interruption were also collected. The durability of TAF/FTC/BIC was estimated using Kaplan-Meier curves.

A total of 236 PWH started TAF/FTC/BIC, with a median follow-up time of 13 months (interquartile range [IQR] 4-27 months). Most PWH were cisgender men (178/236, 75.4%) with a median age at diagnosis of 37 years (IQR 29-48) and a median cluster of differentiation 4 cell counts of 302 cells/mm³ (IQR 117-467). One protocol-defined virological failure was observed, without the development of drug resistance, resulting in an incidence of 3.1 per 1000 person-years of follow-up (95% confidence interval [CI] 0.8-17.3). Six (2.5%) PWH discontinued TAF/FTC/BIC because of toxicity. The estimated durabilities of TAF/FTC/BIC at 12 and 24 months were 84.8% (95% CI 78.6-89.3%) and 75.5% (95% CI 67.6-82.6%), respectively.

In our cohort of newly diagnosed PWH treated with TAF/FTC/BIC, the low occurrence of virological failure and discontinuation related to drug toxicities underscores the effectiveness and tolerability of the regimen.