Borse R, Randive B, Mattoo S, Malik P, Solanki H, Gupta A, Chaisson R E, Mave V, Suryavanshi N
Byramjee Jeejeebhoy Government Medical College, Pune, India.
Byramjee Jeejeebhoy Government Medical College-Johns Hopkins University Clinical Research Site, Pune, India.
IJTLD Open. 2024 Sep 1;1(9):404-409. doi: 10.5588/ijtldopen.23.0609. eCollection 2024 Sep.
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.
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.
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.
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.
在印度的项目实施条件下，关于将三个月每周一次的异烟肼（H，INH）和利福喷汀（P，RPT）（3HP）作为高危人群结核病预防治疗（TPT）的实施证据有限。
开展了一项前瞻性示范研究，评估印度项目环境中HIV感染者（PLHIV）接受3HP TPT的扩大规模、安全性和有效性。
在656名接受筛查的PLHIV中，502名（77%）接受了3HP治疗。其中，20名（4%）因毒性反应停止TPT治疗，17名（3.8%）失访，1名（0.2%）发生利福平敏感结核病突破，464名（92%）完成了3HP TPT治疗。在288例（57%）总体不良事件（AE）中，46例（9%）发生2级或以上AE。AE发生的中位时间为14天（IQR 7 - 42）。9名（2%）参与者报告了严重不良事件（SAE）；其中，7名（78%）与3HP无关。在1年随访期内未发生结核病发作。
3HP TPT完成率为92%，因不良事件导致3HP停药的情况很少，这为印度卫生项目环境中PLHIV接受3HP TPT的可扩展性和安全性提供了证据。
