Clinical and bacteriological progress of highly bacillated BL-LL patients discontinuing treatment after different periods of MDT.

Highly bacillated lepromatous patients (BL/LL) with an initial bacterial index (BI) of 4 to 6+ are being treated with a modified World Health Organization-recommended multiple-drug therapy (WHO/MDT) regimen consisting of rifampin 600 mg once a month, clofazimine 100 mg on alternate days, and dapsone 100 mg daily. The clinical and bacteriological profiles of the patients who had discontinued treatment at different durations have been compared with patients who took the same treatment until attainment of smear negativity. All six of the patients who had discontinued treatment at 12-18 months had worsened clinically and bacteriologically, and viable bacilli could be demonstrated in those tested for ATP. In four patients who had stopped treatment at 24-30 months, the BI continued to fall and there was no clinical or bacteriological worsening in 1 to 2 years of follow-up. The fall in the BI in five cases who had discontinued treatment at 36-44 months was comparable to those on continuous treatment, and there was no worsening. These observations indicate that with the conventional MDT regimen it is not advisable to stop treatment at 12 and 18 months. It appears that treatment should be continued for at least 2 years, and longer in the untreated highly bacillated cases. Prospective clinical trials with a sufficient number of cases and long-term follow-up need to be carried out to ascertain the optimum duration.