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Efficacy and safety of three antiretroviral therapy regimens for treatment-naive African adults living with HIV-2 (FIT-2): a pilot, phase 2, non-comparative, open-label, randomised controlled trial

dc.rights.licenseopenen_US
dc.contributor.authorEHOLIE, Serge P
hal.structure.identifierBordeaux population health [BPH]
hal.structure.identifierGlobal Health in the Global South [GHiGS]
dc.contributor.authorEKOUEVI, Didier Koumavi
hal.structure.identifierBordeaux population health [BPH]
hal.structure.identifierGlobal Health in the Global South [GHiGS]
dc.contributor.authorCHAZALLON, Corine
dc.contributor.authorCHARPENTIER, Charlotte
dc.contributor.authorMESSOU, Eugene
dc.contributor.authorDIALLO, Zelica
dc.contributor.authorZOUNGRANA, Jacques
dc.contributor.authorMINGA, Albert
dc.contributor.authorNGOM GUEYE, Ndeye Fatou
dc.contributor.authorHAWERLANDER, Denise
dc.contributor.authorDEMBELE, Fassery
hal.structure.identifierBordeaux population health [BPH]
hal.structure.identifierGlobal Health in the Global South [GHiGS]
dc.contributor.authorCOLIN, Geraldine
hal.structure.identifierBordeaux population health [BPH]
hal.structure.identifierGlobal Health in the Global South [GHiGS]
dc.contributor.authorTCHOUNGA, Boris
hal.structure.identifierBordeaux population health [BPH]
hal.structure.identifierGlobal Health in the Global South [GHiGS]
dc.contributor.authorKARCHER, Sophie
hal.structure.identifierBordeaux population health [BPH]
hal.structure.identifierGlobal Health in the Global South [GHiGS]
dc.contributor.authorLE CARROU, Jerome
dc.contributor.authorTCHABERT-GUIE, Annick
dc.contributor.authorTONI, Thomas-D'Aquin
dc.contributor.authorOUEDRAOGO, Abdoul-Salam
dc.contributor.authorBADO, Guillaume
dc.contributor.authorTOURE KANE, Coumba
dc.contributor.authorSEYDI, Moussa
dc.contributor.authorPODA, Armel
dc.contributor.authorMENSAH, Ephrem
dc.contributor.authorDIALLO, Illah
dc.contributor.authorDRABO, Youssouf Joseph
hal.structure.identifierBordeaux population health [BPH]
hal.structure.identifierGlobal Health in the Global South [GHiGS]
dc.contributor.authorANGLARET, Xavier
dc.contributor.authorBRUN-VEZINET, Francoise
dc.date.accessioned2024-08-22T12:14:26Z
dc.date.available2024-08-22T12:14:26Z
dc.date.issued2024-06-01
dc.identifier.issn2352-3018en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/201257
dc.description.abstractEnBackground Due to the low number of individuals with HIV-2, no randomised trials of HIV-2 treatment have ever been done. We hypothesised that a non-comparative study describing the outcomes of several antiretroviral therapy (ART) regimens in parallel groups would improve understanding of how differences between HIV-1 and HIV-2 might lead to different therapeutic approaches. Methods This pilot, phase 2, non-comparative, open-label, randomised controlled trial was done in Burkina Faso, C & ocirc;te d'Ivoire, Senegal, and Togo. Adults with HIV-2 who were ART naive with CD4 counts of 200 cells per mu L or greater were randomly assigned 1:1:1 to one of three treatment groups. A computer-generated sequentially numbered block randomisation list stratified by country was used for online allocation to the next available treatment group. In all groups, tenofovir disoproxil fumarate (henceforth tenofovir) was dosed at 245 mg once daily with either emtricitabine at 200 mg once daily or lamivudine at 300 mg once daily. The triple nucleoside reverse transcriptase inhibitor (NRTI) group received zidovudine at 250 mg twice daily. The ritonavir-boosted lopinavir group received lopinavir at 400 mg twice daily boosted with ritonavir at 100 mg twice daily. The raltegravir group received raltegravir at 400 mg twice daily. The primary outcome was the rate of treatment success at week 96, defined as an absence of serious morbidity event during follow-up, plasma HIV-2 RNA less than 50 copies per mL at week 96, and a substantial increase in CD4 cells between baseline and week 96. This trial is registered at ClinicalTrials.gov, NCT02150993, and is closed to new participants. Findings Between Jan 26, 2016, and June 29, 2017, 210 participants were randomly assigned to treatment groups. Five participants died during the 96 weeks of follow-up (triple NRTI group, n=2; ritonavir-boosted lopinavir group, n=2; and raltegravir group, n=1), eight had a serious morbidity event (triple NRTI group, n=4; ritonavir-boosted lopinavir group, n=3; and raltegravir group, n=1), 17 had plasma HIV-2 RNA of 50 copies per mL or greater at least once (triple NRTI group, n=11; ritonavir-boosted lopinavir group, n=4; and raltegravir group, n=2), 32 (all in the triple NRTI group) switched to another ART regimen, and 18 permanently discontinued ART (triple NRTI group, n=5; ritonavir-boosted lopinavir group, n=7; and raltegravir group, n=6). The Data Safety Monitoring Board recommended premature termination of the triple NRTI regimen for safety reasons. The overall treatment success rate was 57% (95% CI 47-66) in the ritonavir-boosted lopinavir group and 59% (49-68) in the raltegravir group. Interpretation The raltegravir and ritonavir-boosted lopinavir regimens were efficient and safe in adults with HIV-2. Both regimens could be compared in future phase 3 trials. The results of this pilot study suggest a trend towards better virological and immunological efficacy in the raltegravir-based regimen.
dc.language.isoENen_US
dc.rightsAttribution-NonCommercial-NoDerivs 3.0 United States*
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/3.0/us/*
dc.title.enEfficacy and safety of three antiretroviral therapy regimens for treatment-naive African adults living with HIV-2 (FIT-2): a pilot, phase 2, non-comparative, open-label, randomised controlled trial
dc.title.alternativeLancet HIVen_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1016/s2352-3018(24)00085-7en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed38740027en_US
bordeaux.journalLancet HIVen_US
bordeaux.pagee380-e388en_US
bordeaux.volume11en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.issue6en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.teamGHIGS_BPHen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
bordeaux.identifier.funderIDAgence Nationale de Recherches sur le Sida et les Hépatites Viralesen_US
bordeaux.identifier.funderIDInstitut de Recherche pour le Développementen_US
hal.identifierhal-04675385
hal.version1
hal.date.transferred2024-08-22T12:14:30Z
hal.popularnonen_US
hal.audienceInternationaleen_US
hal.exporttrue
dc.rights.ccPas de Licence CCen_US
bordeaux.COinSctx_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.jtitle=Lancet%20HIV&rft.date=2024-06-01&rft.volume=11&rft.issue=6&rft.spage=e380-e388&rft.epage=e380-e388&rft.eissn=2352-3018&rft.issn=2352-3018&rft.au=EHOLIE,%20Serge%20P&EKOUEVI,%20Didier%20Koumavi&CHAZALLON,%20Corine&CHARPENTIER,%20Charlotte&MESSOU,%20Eugene&rft.genre=article


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