Six months fixed duration multidrug therapy in paucibacillary leprosy: risk of relapse and disability in Agra PB cohort study.

BACKGROUND

Many studies have focused on multidrug therapy (MDT) for multibacillary (MB) leprosy and rarely on long-term outcome of paucibacillary (PB) leprosy having recommendation of therapy for 6 months fixed duration therapy for PB patients. Studies on measuring risk of disability are rare. The present study is to assess the cure; default, relapse and disability in a prospective cohort of PB leprosy during follow-up of >4 years after treatment.

DESIGN

Prospective.

SETTING

Primary in our field area of Agra District.

PARTICIPANTS

920 PB leprosy patients entered the study, 621 completed treatment, 599 followed finally including 271 males, no ethnic differentiation, patients of all age groups except for children below 5 years and old persons above 70 years were not included.

TREATMENT

6 months fixed duration MDT as recommended by WHO.

PRIMARY AND SECONDARY OUTCOMES

Treatment completion, cure, relapse and development of disability based on clinical assessment by well-experienced doctors.

STATISTICAL METHODS

Data have been analysed using SPSS software, risk is computed as incidence per 100 person-years (PY) and test of significance used.

RESULTS

Study reports 91% cure rate. Incidence of relapse was 1.3/100 PY with no significant variation by age, sex, delay in detection, patches and nerves. Crude incidence of disability was 2.2% and varied significantly by age and nerve thickening but not by sex, number of patches, nerves and delay in treatment. Incidence of disability was 0.50/100 PY in treatment completed and 0.43 among defaulters.

CONCLUSION

The study concludes that relapses do occur after MDT treatment but at the level of 1-2%, incidence of disability remains low (<1/100 PY) in PB leprosy. Low incidence of relapse and disability suggests that 6 months therapy is quite effective. However, further improvement may help to improve its efficacy. Longer follow-up may add to efficacy measures.