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Observational Study
. 2025 Feb 5;80(1):137-143.
doi: 10.1093/cid/ciae269.

Effectiveness of Double-Dose Dolutegravir in People Receiving Rifampin-based Tuberculosis Treatment: An Observational, Cohort Study of People With HIV From 6 Countries

N Sarita Shah  1 , Cissy Kityo  2 , Michael D Hughes  3 , Caitlyn McCarthy  3 , Carole L Wallis  4 , Mina C Hosseinipour  5 , Deborah Langat  6 , Mulinda Nyirenda  7 , Mohammed Rassool  8 , Rodney Dawson  9 , Yvetot Joseph  10 , Fatma Some  11 , Rosie Mngqibisa  12 , Pamela Grace Mukwekwerere  13 , Elizabeth Woolley  14 , Catherine Godfrey  15 , Yukari C Manabe  16 , John W Mellors  17 , Charles Flexner  16 , Gary Maartens  9 ; ACTG A5381/Hakim Study Team
Collaborators, Affiliations
Observational Study

Effectiveness of Double-Dose Dolutegravir in People Receiving Rifampin-based Tuberculosis Treatment: An Observational, Cohort Study of People With HIV From 6 Countries

N Sarita Shah et al. Clin Infect Dis. .

Abstract

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/human immunodeficiency virus (HIV).

Methods: We performed a prospective, observational cohort study at 12 sites in Haiti, Kenya, Malawi, South Africa, Uganda, and Zimbabwe. Participants starting TLD and rifampin-containing TB treatment were eligible. The primary outcome was HIV-1 RNA ≤1000 copies/mL at end of TB treatment.

Results: We enrolled 91 participants with TB/HIV: 75 (82%) ART-naive participants starting TLD after a median 15 days on TB treatment, 10 (11%) ART-naive 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% were female, the median CD4 count was 120 cells/mm3 (interquartile range, 50-295), and 87% had HIV-1 RNA >1000 copies/mL. Among 89 surviving participants, 80 were followed to TB treatment completion, including 7 who had no HIV-1 RNA result due to missed visits. The primary virologic outcome was assessed in 73 participants, 69 of whom (95%; 95% confidence interval, 89%-100%) had HIV-1 RNA ≤1000 copies/mL. No dolutegravir resistance mutations were detected among 4 participants with HIV-1 RNA >1000 copies/mL.

Conclusions: In programmatic settings, concurrent rifampin-containing TB treatment and TLD+50 was feasible, well tolerated, and achieved high viral suppression rates in a cohort of predominantly ART-naive people with TB/HIV.

Keywords: HIV; antiretroviral treatment; drug–drug interactions; tuberculosis.

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Conflict of interest statement

Potential conflicts of interest . The authors: No reported conflicts of interest. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.

Figures

Figure 1.
Figure 1.
Strengthening Reporting of Observational Studies in Epidemiology (STROBE) diagram of participant enrollment and study cohort. Abbreviations: COVID-19, coronavirus disease 2019; HIV-1, human immunodeficiency virus type 1; TB, tuberculosis; TLD, tenofovir-lamivudine-dolutegravir.
Figure 2.
Figure 2.
HIV-1 RNA at end of tuberculosis treatment among those with viral load measured within window (N = 73). Vertical bars represent exact 95% CIs. Abbreviations: CI, confidence interval; HIV-1, human immunodeficiency virus type 1. Tenofovir-lamivudine-dolutegravir (TLD) is the preferred first-line antiretroviral therapy (ART) regimen. An additional 50-mg dose of dolutegravir.
See this image and copyright information in PMC

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