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
