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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

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



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.


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.


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.


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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