• Le Wang, Hongsheng Wang, Liangbin Yan, Meiwen Yu, Jun Yang, Jinlan Li, Junhua Li, Yong Ning, Haiqin Jiang, Ying Shi, Wenyue Zhang, Li Xiong, Jie Liu, Yanfei Kuang, Hao Wang, Jun He, De Wang, Bin Li, Yangying Liu, Tiejun Shui, Ying Wang, Huan Chen, Xiaowei Sha, Heng Long, Xiaojin Yu, Chong Shen, Jianping Shen, Xueyuan Yang, Heng Gu, Guocheng Zhang, and Baoxi Wang.
• From the Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College, and the National Center for Leprosy Control, Chinese Center for Disease Control and Prevention (CDC) (L.W., Hongsheng Wang, L.Y., M.Y., H.J., Y.S., W.Z., J.S., X. Yang, H.G., G.Z., B.W.), Key Laboratory of Basic and Translational Research on Immune-Mediated Skin Diseases, Chinese Academy of Medical Sciences, and Jiangsu Key Laboratory of Molecular Biology for Skin Diseases and Sexually Transmitted Infections (Hongsheng Wang), the Department of Epidemiology and Health Statistics, School of Public Health, Southeast University (X. Yu), and the Department of Epidemiology, School of Public Health, Nanjing Medical University (C.S.), Nanjing, Yunnan Provincial CDC, Kunming (J.Y., L.X., J.H., T.S.), Guizhou Provincial CDC, Guiyang (Jinlan Li, J. Liu, D.W., Y.W.), Hunan Provincial CDC, Changsha (Junhua Li, Y.K., B.L., H.C.), Sichuan Provincial People's Hospital, Chengdu (Y.N., Hao Wang, Y. Liu, X.S.), WenShan Prefecture Institute of Dermatology, Wenshan (H.L.), and Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (B.W.) - all in China.
• N. Engl. J. Med. 2023 May 18; 388 (20): 184318521843-1852.

BackgroundPrevious studies have suggested that a single dose of rifampin has protective effects against leprosy in close contacts of patients with the disease. Rifapentine was shown to have greater bactericidal activity against Mycobacterium leprae than rifampin in murine models of leprosy, but data regarding its effectiveness in preventing leprosy are lacking.MethodsWe conducted a cluster-randomized, controlled trial to investigate whether single-dose rifapentine is effective in preventing leprosy in household contacts of patients with leprosy. The clusters (counties or districts in Southwest China) were assigned to one of three trial groups: single-dose rifapentine, single-dose rifampin, or control (no intervention). The primary outcome was the 4-year cumulative incidence of leprosy among household contacts.ResultsA total of 207 clusters comprising 7450 household contacts underwent randomization; 68 clusters (2331 household contacts) were assigned to the rifapentine group, 71 (2760) to the rifampin group, and 68 (2359) to the control group. A total of 24 new cases of leprosy occurred over the 4-year follow-up, for a cumulative incidence of 0.09% (95% confidence interval [CI], 0.02 to 0.34) with rifapentine (2 cases), 0.33% (95% CI, 0.17 to 0.63) with rifampin (9 cases), and 0.55% (95% CI, 0.32 to 0.95) with no intervention (13 cases). In an intention-to-treat analysis, the cumulative incidence in the rifapentine group was 84% lower than that in the control group (cumulative incidence ratio, 0.16; multiplicity-adjusted 95% CI, 0.03 to 0.87; P = 0.02); the cumulative incidence did not differ significantly between the rifampin group and the control group (cumulative incidence ratio, 0.59; multiplicity-adjusted 95% CI, 0.22 to 1.57; P = 0.23). In a per-protocol analysis, the cumulative incidence was 0.05% with rifapentine, 0.19% with rifampin, and 0.63% with no intervention. No severe adverse events were observed.ConclusionsThe incidence of leprosy among household contacts over 4 years was lower with single-dose rifapentine than with no intervention. (Funded by the Ministry of Health of China and the Chinese Academy of Medical Sciences; Chinese Clinical Trial Registry number, ChiCTR-IPR-15007075.).Copyright © 2023 Massachusetts Medical Society.

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