A RANDOMIZED CLINICAL-TRIAL OF 2 SINGLE-DOSE TREATMENTS FOR PAUCIBACILLARY LEPROSY

We compared 2 single-dose regimens for the treatment of paucibacillary leprosy in a randomized clinical trial in Zaire. The regimens were : C2 (rifampicin 40 mg/kg and 1200 mg clofazimine once) and C4 (rifampic in 40 mg/kg, clofazimine 100 mg, DDS 100 mg and ethionamide 500 mg onc e). An analysis of the results of patients enrolled between May 1987 a nd December 1988, with a maximum follow-up of 4 years, is presented. A total of 622 patients were enrolled and 14 paucibacillary and 1 multi bacillary relapses occurred. The overall paucibacillary relapse rate w as 2.4 per 100 person years. This relapse rate was higher for older pa tients as well as for patients with 3 or more lesions. The probability of cure at 3 years is 0.816 for C2 and 0.823 for C4, the difference n ot being statistically significant. The probability of cure at 3 years with either regimen is higher for patients with 1 or 2 lesions (0-872 ) than for patients with 3 or more lesions (0.787), and it is higher f or patients with a bacterial index of 0 (0.831) than for patients with a bacterial index of 1 (0.699). These results are compared to other s tudies. We also discuss the potential of single-dose treatment regimen s for paucibacillary leprosy.