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Published on: April 9, 2012
Single-Dose Rifapentine in Household Contacts of Patients with Leprosy
Le Wang1, Hongsheng Wang1, Liangbin Yan1
1From 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.
Background:
Previous 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.
Methods:
We 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.
Results:
A 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.
Conclusions:
The 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.).
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