Effectiveness of MDT in multibacillary leprosy.

The study on the use of World Health Organization multidrug therapy (WHO/MDT) under field conditions was initiated in December 1981, and included 1067 multibacillary (MB) patients treated with two MDT regimens. The first was a THELEP-recommended regimen which consisted of 600 mg of rifampin (RFP) and 600 mg of clofazimine (CLO) given under supervision on two consecutive days monthly and 225 mg of diacetyl diaminodiphenylsulfone (DADDS) bimonthly plus dapsone (DDS) 100 mg daily unsupervised. The second regimen was the conventional MDT: patients received RFP 600 mg and CLO 300 mg supervised once a month, daily 100 mg of DDS and 50 mg of CLO unsupervised. A zero relapse rate was obtained after more than 10 years (a total of 8244 person-years) of follow up. Both regimens were well tolerated with few complications and a high acceptability, even among women. The fall in the bacterial index (BI) was 0.5 - 1.0+ in positive patients. CLO discoloration began to decrease after 3 months and disappeared within 1 year after it was discontinued. Seventy-two patients (67%) developed reactions during the treatment period; a further 12 patients developed post-treatment reactions during the surveillance period. This study vindicates MDT treatment for MB patients as recommended by WHO under field conditions.