Dolutegravir-based Antiretroviral Therapy for Patients Coinfected With Tuberculosis and Human Immunodeficiency Virus: A Multicenter, Noncomparative, Open-label, Randomized Trial

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dc.contributor.authorDooley, Kelly E
dc.contributor.authorKaplan, Richard
dc.contributor.authorMwelase, Noluthando
dc.contributor.authorGrinsztejn, Beatriz
dc.contributor.authorTicona, Eduardo
dc.contributor.authorLacerda, Marcus
dc.contributor.authorSued, Omar
dc.contributor.authorBelonosova, Elena
dc.contributor.authorAit-Khaled, Mounir
dc.contributor.authorAngelis, Konstantinos
dc.contributor.authorBrown, Dannae
dc.contributor.authorSingh, Rajendra
dc.contributor.authorTalarico, Christine L
dc.contributor.authorTenorio, Allan R
dc.contributor.authorKeegan, Michael R
dc.contributor.authorAboud, Michael
dc.contributor.authorInternational Study of Patients with HIV on Rifampicin ING study group
dc.date.accessioned2024-05-23T23:49:21Z
dc.date.available2024-05-23T23:49:21Z
dc.date.issued2019-03-28
dc.descriptionFil: Sued O. Fundación Huésped, Buenos Aires; Argentinaes_ES
dc.description.abstractBackground The concurrent treatment of tuberculosis and human immunodeficiency virus (HIV) is challenging, owing to drug interactions, overlapping toxicities, and immune reconstitution inflammatory syndrome (IRIS). The efficacy and safety of dolutegravir (DTG) were assessed in adults with HIV and drug-susceptible tuberculosis. Methods International Study of Patients with HIV on Rifampicin ING is a noncomparative, active-control, randomized, open-label study in HIV-1–infected antiretroviral therapy–naive adults (CD4+ ≥50 cells/mm3). Participants on rifampicin-based tuberculosis treatment ≤8 weeks were randomized (3:2) to receive DTG (50 mg twice daily both during and 2 weeks after tuberculosis therapy, then 50 mg once daily) or efavirenz (EFV; 600 mg daily) with 2 nucleoside reverse transcriptase inhibitors for 52 weeks. The primary endpoint was the proportion of DTG-arm participants with plasma HIV-1-RNA <50 copies/mL (responders) by the Food and Drug Administration Snapshot algorithm (intent-to-treat exposed population) at Week 48. The study was not powered to compare arms. Results For DTG (n = 69), the baseline HIV-1 RNA was >100 000 copies/mL in 64% of participants, with a median CD4+ count of 208 cells/mm3; for EFV (n = 44), 55% of participants had HIV-1 RNA >100 000 copies/mL, with a median CD4+ count of 202 cells/mm3. The Week 48 response rates were 75% (52/69, 95% confidence interval [CI] 65–86%) for DTG and 82% (36/44, 95% CI 70–93%) for EFV. The DTG nonresponses were driven by non–treatment related discontinuations (n = 10 lost to follow-up). There were no deaths or study drug switches. There were 2 discontinuations for toxicity (EFV). There were 3 protocol-defined virological failures (2 DTG, no acquired resistance; 1 EFV, emergent resistance to nucleoside reverse transcriptase inhibitors and nonnucleoside reverse transcriptase inhibitors). The tuberculosis treatment success rate was high. Tuberculosis-associated IRIS was uncommon (4/arm), with no discontinuations for IRIS. Conclusions Among adults with HIV receiving rifampicin-based tuberculosis treatment, twice-daily DTG was effective and well tolerated. Clinical Trials Registration NCT02178592.es_ES
dc.formatapplication/pdfes_ES
dc.identifier.doihttps://doi.org/10.1093/cid/ciz256
dc.identifier.urihttps://repositorio.huesped.org.ar/handle/123456789/1344
dc.languageENGes_ES
dc.provenancePublishedes_ES
dc.relation.ispartofseriesClinical Infectious Diseases;Volume 70, Issue 4, 15 February 2020, Pages 549–556
dc.rightsopenAccesses_ES
dc.subjectHIVes_ES
dc.subjectTuberculosises_ES
dc.subjectImmune Reconstitutiones_ES
dc.titleDolutegravir-based Antiretroviral Therapy for Patients Coinfected With Tuberculosis and Human Immunodeficiency Virus: A Multicenter, Noncomparative, Open-label, Randomized Triales_ES
dc.typeArticuloes_ES

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