Preliminary appraisal of a WHO-recommended multiple drug regimen in paucibacillary leprosy patients in Malawi.

A study was undertaken within the framework of the LEPRA Evaluation Project and the LEPRA Control Project in Malawi (Central Africa) to study the incidence rates of type 1 reactions and of relapses in paucibacillary leprosy patients treated with the current World Health Organization-recommended multiple drug regimen (WHO/MDT). Of 503 patients recruited into the study, 488 were reviewed at the end of treatment and 480 have now been followed for 1 year after completion of treatment. At the end of treatment the skin lesions had completely disappeared in 27.4%, but were judged to be still active in 4.3%. During the follow-up period two patients were found with new active skin lesions, giving a relapse rate of 4.17 (2 of 480) per 1000 person years during the first year after completion of WHO/MDT (95% confidence interval 1.14 to 15.06 per 1000 person years). The incidence rate of marked type 1 reaction (renewed inflammation in previously inactive lesions) during the first year after completion of WHO/MDT was 47.8 per 1000 person years in self-reporting patients but zero in patients identified by active case finding. Data are presented which suggest that the incidence rate of late type 1 reactions is closely related to the classification and stage of the disease at detection.