Effectiveness of double-dose dolutegravir in people receiving rifampin-based tuberculosis treatment: an observational, cohort study of people with HIV from six countries.

Autor:	Shah NS; Emory Rollins School of Public Health, Emory University, Atlanta, GA, USA., Kityo C; Joint Clinical Research Centre, Kampala, Uganda., Hughes MD; Harvard TH Chan School of Public Health, Boston, MA, USA., McCarthy C; Harvard TH Chan School of Public Health, Boston, MA, USA., Wallis C; Lancet Laboratories and BARC-SA, Johannesburg, South Africa., Hosseinipour M; University of North Carolina at Chapel Hill, NC, USA., Langat D; Walter Reed Project-Kericho, Kericho, Kenya., Nyirenda M; College of Medicine- Johns Hopkins Research Project, Blantyre, Malawi., Rassool M; Clinical HIV Research Unit, Helen Joseph Hospital, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa., Dawson R; Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa., Joseph Y; GHESKIO Institute of Infectious Diseases and Reproductive Health, Port-au-Prince, Haiti., Some F; Moi University Clinical Research Centre, Eldoret, Kenya., Mngqbisa R; Durban Clinical Research Site, Durban, South Africa., Mukwekwerere PG; Milton Park Clinical Research Site, University of Zimbabwe, Harare, Zimbabwe., Woolley E; Social & Scientific Systems, Inc., A DLH Holdings Company, Silver Spring, MD, USA., Godfrey C; Office of the Global AIDS Coordinator, U.S. Department of State, Washington DC, USA., Manabe YC; The Johns Hopkins University School of Medicine, Baltimore, MD, USA., Mellors JW; University of Pittsburgh, Pittsburgh, PA, USA., Flexner C; The Johns Hopkins University School of Medicine, Baltimore, MD, USA., Maartens G; Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
Jazyk:	angličtina
Zdroj:	Clinical infectious diseases : an official publication of the Infectious Diseases Society of America [Clin Infect Dis] 2024 May 13. Date of Electronic Publication: 2024 May 13.
DOI:	10.1093/cid/ciae269
Abstrakt:	Background: Tenofovir-lamivudine-dolutegravir (TLD) is the preferred first-line antiretroviral therapy (ART) regimen. An additional 50 mg dose of dolutegravir (TLD + 50) is required with rifampin-containing tuberculosis (TB) co-treatment. There are limited data on the effectiveness of TLD + 50 in individuals with TB/HIV. Methods: Prospective, observational cohort study at 12 sites in Haiti, Kenya, Malawi, South Africa, Uganda, Zimbabwe. Participants starting TLD and rifampin-containing TB treatment were eligible. Primary outcome was HIV-1 RNA ≤1000 copies/mL at end of TB treatment. Findings: We enrolled 91 participants with TB/HIV: 75 (82%) ART-naïve participants starting TLD after a median 15 days on TB treatment, 10 (11%) ART-naïve participants starting TLD and TB treatment, 5 (5%) starting TB treatment after a median 3.3 years on TLD, and 1 (1%) starting TB treatment and TLD after changing from efavirenz/lamivudine/tenofovir. Median age was 37 years, 35% female, median CD4 count 120 cells/mm3 (IQR 50-295), 87% had HIV-1 RNA >1000 copies/mL. Two participants died during TB treatment. Among 89 surviving participants, 80 were followed to TB treatment completion, including 7 who had no HIV-1 RNA result due to missed visits. Primary virologic outcome was assessed in 73 participants, of whom 69 (95%, 95% CI 89-100%) had HIV-1 RNA ≤1000 copies/mL. No dolutegravir resistance mutations were detected among four participants with HIV-1 RNA >1000 copies/mL. Interpretation: In routine programmatic settings, concurrent rifampin-containing TB treatment and TLD + 50 was feasible, well-tolerated, and achieved high rates of viral suppression in a cohort of predominantly ART-naïve people with TB/HIV. (© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)
Databáze:	MEDLINE
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