Three months of weekly rifapentine plus isoniazid for TB prevention among people with HIV.

R Borse, B Randive, S Mattoo, P Malik, H Solanki, A Gupta, R E Chaisson, V Mave, N Suryavanshi
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Abstract

Background: Evidence on implementation of three months of weekly isoniazid (H, INH) and rifapentine (P, RPT) (3HP) as a TB preventive therapy (TPT) for at-risk groups in Indian programmatic conditions is limited.

Methods: A prospective demonstration study assessing scale-up, safety, and effectiveness of 3HP TPT among people living with HIV (PLHIV) in Indian programmatic settings was conducted.

Results: Of 656 screened PLHIV, 502 (77%) received 3HP. Of these, 20 (4%) discontinued TPT due to toxicity,17 (3.8%) lost to follow-up, one (0.2%) had breakthrough rifampicin-sensitive TB, and 464 (92%) completed 3 HP TPT. Of 288 (57%) overall adverse events (AEs), 46 (9%) had Grade 2 or above AEs. The median time to AE was 14 days (IQR 7-42). Serious adverse events (SAEs) were reported in 9 (2%) participants; of these, 7 (78%) were not related to 3HP. No TB episodes occurred during the 1-year follow-up period.

Conclusion: 3HP TPT completion rate of 92%, with few adverse events leading to 3HP discontinuation, providing evidence of the scalability and safety of 3HP TPT among PLHIV in Indian health program settings.

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为预防艾滋病病毒感染者感染结核病,每周服用利福喷丁加异烟肼三个月。
背景:在印度计划条件下,对高危人群实施为期三个月的每周异烟肼(H,INH)和利福喷汀(P,RPT)(3HP)结核病预防疗法(TPT)的证据有限:方法:开展了一项前瞻性示范研究,评估 3HP TPT 在印度计划环境中艾滋病毒感染者(PLHIV)中的推广、安全性和有效性:在 656 名经过筛查的艾滋病毒感染者中,502 人(77%)接受了 3HP 治疗。其中,20 人(4%)因毒性中止了 TPT,17 人(3.8%)失去了随访,1 人(0.2%)出现了突破性利福平敏感结核病,464 人(92%)完成了 3HP TPT。在288例(57%)总体不良事件(AEs)中,46例(9%)为2级或2级以上不良事件。发生 AE 的中位时间为 14 天(IQR 7-42)。9名参与者(2%)报告了严重不良事件(SAE),其中7名(78%)与3HP无关。结论:3HP TPT 的完成率为 92%,导致停用 3HP 的不良事件很少,证明了 3HP TPT 在印度卫生项目环境中的 PLHIV 中的可扩展性和安全性。
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