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Clin Infect Dis. 2018 Sep 28;67(8):1161-1167. doi: 10.1093/cid/ciy245.

First-line Raltegravir/Emtricitabine/Tenofovir Combination in Human Immunodeficiency Virus Type 2 (HIV-2) Infection: A Phase 2, Noncomparative Trial (ANRS 159 HIV-2).

Author information

1
Hopital Bichat-Claude Bernard, Assistance Publique-Hôpitaux de Paris (AP-HP).
2
Institut national de la santé et de la recherche médicale (INSERM), Infection, Antimicrobiens, Modélisation, Evolution, Unité Mixte de Recherche (UMR) 1137.
3
Université Paris Diderot, Sorbonne Paris Cité.
4
Hopital Saint Louis, AP-HP, Paris.
5
INSERM, Bordeaux Population Health Research Center, UMR 1219, Université Bordeaux, Institut de santé publique, d'épidémiologie et de développement, Centre Hospitalier Universitaire Bordeaux.
6
Hopital Lariboisière, AP-HP, Paris.
7
Centre Hospitalier René Dubos, Pontoise.
8
Hôpital Louis Mourier, AP-HP, Colombes.
9
Hopital Pitié-Salpetriere, AP-HP, Université Paris 6, INSERM, Institut Pierre-Louis Epidémiologie et Santé Publique, UMR en Santé 1136, Paris, France.

Abstract

Background:

New options for first-line treatment of human immunodeficiency virus type 2 (HIV-2) infection are needed. We evaluated an integrase inhibitor (raltegravir)-containing regimen.

Methods:

Antiretroviral therapy (ART)-naive adults with symptomatic infection by HIV-2 only, CD4 count <500 cells/μL or CD4 decrease >50 cells/μL/year over the past 3 years, or a confirmed plasma HIV-2 RNA (pVL) load ≥100 copies/mL were eligible for this noncomparative trial. The composite primary endpoint was survival at 48 weeks without any of the following: CD4 gain from baseline <100 cells/μL, confirmed pVL ≥40 copies/mL from week 24, raltegravir permanent discontinuation, or incident B or C event. HIV-2 ultrasensitive pVL (uspVL) and total DNA were assessed using in-house polymerase chain reaction (PCR) assays.

Results:

Baseline median CD4 count of 30 enrolled individuals (67% women) was 436 cells/µL (interquartile range [IQR], 314-507 cells/µL); pVL was ≥40 copies/mL in 67% of them, uspVL was ≥5 copies/mL in 92%, and total DNA was >6 copies by PCR in 32%. At week 48, the composite endpoint of success was reached in 40% [95% confidence interval, 22.7%-59.4%]. Failure was mainly (50%) due to CD4 gain <100 cells/µL; uspVL was <5 copies/mL in 87% and total DNA >6 copies by PCR in 12% of participants. Median CD4 gain was 87 cells/µL (IQR, 38-213 cells/µL; n = 28). No serious adverse reactions were reported.

Conclusions:

Raltegravir-containing ART is a safe option for first-line treatment of HIV-2 infection, yielding a comparable success rate to protease inhibitors.

Clinical Trials Registration:

NCT 01605890.

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