# Switch to Fixed Dose of Doravirine, Lamivudine, Tenofovir Disoproxil Fumarate Versus Bictegravir, Emtricitabine, and Tenofovir Alafenamide Fumarate in Virologically Suppressed Adults on Efavirenz-Based Regimens: 48-Week Results of a Real-world, Prospective, Observational Cohort Study

## TL;DR

This study compares two HIV treatment regimens and finds both maintain virus suppression, but one has better metabolic effects.

## Contribution

A real-world comparison of two antiretroviral regimens in virologically suppressed HIV patients, showing noninferiority and metabolic benefits.

## Key findings

- Switching to DOR/3TC/TDF maintained virological suppression noninferior to BIC/FTC/TAF.
- DOR/3TC/TDF showed favorable metabolic effects, including reduced cholesterol and triglycerides.
- BIC/FTC/TAF was associated with a significant decrease in CD4 counts and increased cholesterol levels.

## Abstract

We compared the effectiveness and safety profiles of doravirine, lamivudine, tenofovir disoproxil fumarate (DOR/3TC/TDF) with bictegravir, emtricitabine, tenofovir alafenamide fumarate (BIC/FTC/TAF) in people with HIV (PWH) who had achieved virological suppression on efavirenz (EFV)-based antiretroviral regimens.

This study was a single-center, real-world, prospective observational cohort study. The main inclusion criteria: PWH aged ≥18 years who had received an EFV-containing regimen for ≥6 months and achieved confirmed virological suppression. Participants were stratified according to clinical decisions to switch to DOR/3TC/TDF or BIC/FTC/TAF. The primary effectiveness end point was the proportion of participants with HIV-1 RNA ≥50 copies/mL at week 48, with a preset 4% noninferiority margin.

A total of 349 participants received at least 1 dose of study drugs (142 in DOR group, 207 in BIC group). At 48 weeks, 2 (1.4%) in the DOR group and 1 (0.5%) in the BIC group had HIV-1 RNA ≥50 copies/mL (estimated treatment difference [ETD], 1.0%; 95% CI, −1.6% to 3.7%), establishing noninferiority. In the BIC group, mean CD4 counts decreased significantly by ∼76.5 cells/µL at week 48 (95% CI, −111.801 to −41.218; P < .001) compared with baseline. Over 48 weeks, adverse event rates were comparable between the 2 groups (P = .758). At week 48, the BIC group exhibited a baseline-adjusted mean increase of 0.269 mmol/L in total cholesterol (TC) and 0.171 mmol/L in low-density lipoprotein cholesterol (LDL-C), while the DOR group demonstrated a mean reduction of 0.453 mmol/L in triglycerides (TG), 0.412 mmol/L in TC, and 0.241 mmol/L in LDL-C relative to baseline. All β values for the group–time interaction terms were negative (P < .001). The change in body weight from baseline to week 48 in the DOR group was 1.8 kg lower than that in the BIC group (95% CI, −2.474 to −1.114; P < .001).

In previously virologically suppressed PWH on an EFV-based regimen, the switch to DOR/3TC/TDF maintained virological suppression noninferior to that of BIC/FTC/TAF, with favorable metabolic profiles.