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Observational Study
. 2023 Jan 3;20(1):1.
doi: 10.1186/s12981-022-00499-4.

Safety and efficacy of switching to elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate in treatment-experienced people with HIV: a multicenter cohort study

Nathalie De Castro  1 , Alexandre Brun  2 , Pierre Sellier  3 , Gwenn Hamet  2 , Frédéric Mechaï  4 , Valérie Garrait  5 , Amélie Chabrol  6 , Marie-Anne Bouldouyre  7 , Eric Froguel  8 , Didier Troisvallets  9 , Pauline Caraux-Paz  10 , Constance Delaugerre  11   12 , Willy Rozenbaum  11   2 , Jean-Michel Molina  11   12
Affiliations
Observational Study

Safety and efficacy of switching to elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate in treatment-experienced people with HIV: a multicenter cohort study

Nathalie De Castro et al. AIDS Res Ther. .

Abstract

Objectives: We assessed the virologic efficacy of switching to co-formulated elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate (E/C/F/TDF) in patients with controlled HIV infection.

Methods: We conducted a retrospective multicenter observational cohort study including adult patients with controlled HIV-1 infection on any stable antiretroviral (ART) regimen, who switched to E/C/F/TDF. Success was measured by the proportion of patients with plasma viral load < 50 copies/ml at W48 using the FDA snapshot algorithm. We also assessed risk factors associated with virological failure (VF).

Results: 382 patients with HIV RNA < 50 copies/mL who switched to E/C/F/TDF were included in the study. Most patients (69.9%) were male, with median age 44 years (IQR 38-51), who had been on ART for a median of 7 years (IQR 4-13). Median CD4 count was 614/mm3 and 24.6% of the patients had a history of previous virological failure. The reasons for switching were simplification (67.0%) and tolerance issues (22.0%). At week 48, 314 (82.0% [95% CI 78.4-86.0]) patients had HIV RNA < 50 copies/mL, 13 (3.5% [95% CI 3.64-8.41]) experienced virological failure. Genotype at failure was available in 6/13 patients with detection of resistance-associated mutations to integrase inhibitors and NRTIs in 5/6 (83.3%) patients. We found no predictive factor associated with virological failure except for a borderline significance with the duration of viral suppression before the switch. Tolerability of E/C/F/TDF was good with 23/382 (6.0%) patients experiencing mild adverse reactions.

Conclusion: In our cohort, switching well-suppressed patients to E/C/F/TDF resulted in few virologic failures and was well tolerated. However, resistance to integrase inhibitors emerged in patients with virological failure.

Keywords: E/C/F/TDF; integrase resistance; switch; virologic efficacy.

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Conflict of interest statement

NDC received a research Grant from Gilead in 2015 for the present work. JMM has acted as a consultant, participated in advisory boards, has received speaker fees and has been an investigator for clinical trials for Janssen, ViiV Healthcare, Gilead Sciences, Bristol-Myers Squibb, Abbott Laboratories, Boehringer Ingelheim, and Merck, Sharp & Dohme. He has also received research grants from Merck. CD participated in advisory boards for ViiV Healthcare, Gilead Sciences, BMS, and Merck, and has also received research grants from Gilead, and MAD. DT received fees for travel and conferences by Gilead and MSD.

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