ABSTRACT

Objective: In July of 2021, the Brazilian National Ministry of Health integrated three months of once-weekly isoniazid plus rifapentine (3HP) into the National Guidelines for Tuberculosis Control as a first-line tuberculosis preventive therapy (TPT) option for people living with HIV (PLHIV) and tuberculosis household contacts (HHCs). As part of the Unitaid-sponsored Increasing Market and Public Health Outcomes through Scaling up Affordable Access Models of Short Course Preventive Therapy for TB project to implement short-course TPT, we evaluated 3HP uptake, completion, and tolerability among PLHIV and pediatric HHCs in Brazil. Methods: We conducted a multicenter single-arm pragmatic project to roll out 3HP for PLHIV and HHCs in the 2- to 14-year age bracket in the cities of Rio de Janeiro and Manaus, Brazil. Participants were identified, treated, and monitored in accordance with Brazilian national tuberculosis guidelines. De-identified patient-level data on treatment initiation, adverse events, and completion were collected and analyzed. Results: From October of 2021 to March of 2023, 380 PLHIV (77.6% of whom were male; median age, 40 years [IQR, 31-51]) and 74 HHCs (54.1% of whom were male; median age, 8.6 years [IQR, 5.1-11.8]) were enrolled in the study. Treatment completion rates were 83.7% among PLHIV and 82.4% among HHCs. Completion rates were higher in Rio de Janeiro than in Manaus (PLHIV: 86.0% vs. 79.6%; HHCs: 85.2% vs. 80.9%), although completion of 10 doses was similar (PLHIV: 86.4% vs. 86.1%). Adverse event-related discontinuation was low (PLHIV: 2.4%; HHCs: 2.7%). One person living with HIV developed active tuberculosis during treatment. At six months of follow-up, 99.6% of the PLHIV remained free of tuberculosis. Conclusions: The 3HP regimen was successfully introduced, had high treatment completion rates, and was well tolerated. Widespread use of 3HP for TPT may accelerate tuberculosis elimination in Brazil.

Keywords: Tuberculosis; Latent tuberculosis; HIV infections; Isoniazid; Rifapentine; Treatment adherence and compliance.

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