Long‑Term Effectiveness and Safety of Doravirine‑Based Antiretroviral Regimens in Virologically Suppressed People with HIV: The French Dat'AIDS Cohort.

INTRODUCTION

Doravirine (DOR)-based regimens are recommended as alternative options for virologically suppressed people with HIV (VS-PWH). However, data supporting their long-term use in real-world settings are scarce. This large study described the long-term effectiveness and safety of DOR-based regimens following treatment switch in routine clinical practice.

METHODS

Retrospective cohort study using data from Dat'AIDS, a French standardized database that collects real-world medical data from PWH across France. All treatment-experienced adults with confirmed plasma HIV-1 RNA < 50 copies/ml who initiated a DOR-based regimen for the first time between April 2019 and June 2024 were included. Baseline demographic and clinical characteristics, proportions of PWH receiving a DOR-based regimen and maintaining virologic suppression, and reasons for treatment discontinuation were collected. PWH were censored at the time of discontinuing DOR, death, or end of study (December 2024).

RESULTS

Data from 1666 VS-PWH (median age 56 years, interquartile range: 47-63; 65% male; 31% with obesity) were analyzed. Just before switching, 49% and 38% were receiving an integrase strand transfer inhibitor (INSTI) or non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimen combined with at least one nucleo(t)side reverse transcriptase inhibitor (NRTI). Most (80%) switched to a triple therapy, mainly DOR/3TC/TDF (74%). Virologic suppression was maintained in 97% of PWH at 12 months (96% at 48 months). Only small changes in body weight, lipid parameters, and renal or hepatic function were observed during follow-up. Among the 45 discontinuations of DOR-based regimens, 11 were due to adverse events and two due to protocol-defined virologic failure, with no observed resistance to antiretroviral treatments.

CONCLUSIONS

In this study, reporting the largest cohort of people receiving DOR-based regimens to date, DOR-based regimens demonstrated durable virologic effectiveness and a very favorable safety profile in treatment-experienced people with HIV and multiple comorbidities.

TRIAL REGISTRATION: ClinicalTrials.gov NCT02898987.