Evaluation of a new fixed duration (12 weeks) multi-drug regimen of bactericidal drugs in multibacillary leprosy.

ABSTRACT

Leprosy still remains a public health problem mainly in Asia, Africa and South America. The WHO Expert Committee on Leprosy recommended, in 1997, the simplified treatment of leprosy for multibacillary (MB) cases, by reducing the duration of treatment from 24 to 12 months. From the operational point of view even this reduced duration is still long and monthly supervised drug administration may not always be practical in those areas where the accessibility is difficult and health infrastructure weak. The present study was carried out to compare the safety and efficacy of a new fixed duration regimen consisting of four bactericidal drugs with WHO/MDT (MB). METHODS: Thirty adult patients were randomly allocated to two groups. Group 1 (18 patients) received a new regimen of daily rifampicin 600 mg, sparfloxacin 200 mg, clarithromycin 500 mg and minocycline 100 mg for 12 weeks. Group 2 (12 patients) received WHO/MDT (MB) for 12 months. A detailed clinical evaluation and laboratory investigations, BI and MI were done at the baseline, every 4 weeks for 12 weeks, and thereafter every 8 weeks till 48 weeks. Skin biopsies were taken and chest X-rays were done at 0, 12 and 48 weeks. RESULTS: At 48 weeks, the net percentage clinical improvement in group 1 was 73.92% and in group 2 it was 66.66%. The net percentage reduction (NPR) in BI in group 1 was 19.17% and in group 2 it was 18.87% (p = 0.09). NPR in MI in both groups was 100% by 8 weeks, and somewhat faster in group 1. In group 1, 8 patients had mild gastrointestinal side-effect, and 16 had minocycline-induced hyperpigmentation. Three patients in group 1 developed type I reversal reactions. CONCLUSION: The regimen containing daily doses of rifampicin 600 mg, sparfloxacin 200 mg, minocycline 100 mg and clarithromycin 500 mg for 12 weeks was found to be an acceptable, effective and safe alternative regimen for MB leprosy with an additional operational advantage of shorter duration of treatment.