Efficacy of single-dose ROM therapy plus low-dose convit vaccine as an adjuvant for treatment of paucibacillary leprosy patients with a single skin lesion

The recent World Health Organization multicentric field study on the treatm ent of paucibacillary (PB) leprosy patients with single skin lesion (SSL) a nd a single dose of rifampin-ofloxacin-minocycline (ROM) brought new hope t o those who are engaged in the eradication of leprosy from India. Being enc ouraged by the WHO report, we undertook the present hospital-based study an d found that PB leprosy patients with SSL were morphologically and histopat hologically heterogeneous. The histological spectrum of SSL ranged From ind eterminate through tuberculoid (TT) to borderline tuberculoid (BT) leprosy, and most patients had active BT leprosy. Ninety new, untreated PB leprosy patients with SSL were included in the present study for comparative assess ment of the efficacies of ROM and ROM plus Convit vaccine therapies. Childr en, pregnant women, lactating mothers and patients with any thickening of n erves were excluded. All patients were bacteriologically negative (skin-sme ar test) but lepromin reactive. The patients were divided into two groups a fter proper matching for morphological and histological status of SSL, a) T he test group included 60 patients and the control group included 30 patien ts. The test group was given a single dose of ROM initially and two injecti ons of low-dose Convit vaccine, one initially and the other at the end of 3 months, b) The control group was given only a single dose of ROM initially , Both groups were followed clinically every 2 weeks for 6 months and retes ted for histological, bacteriological and lepromin status at the end of 6 m onths. Thereafter, they were followed clinically every month for another 6 months. In the test group, the SSL resolved in 33.3%, regressed in 48.3%, a nd remained active in 18.3% of the patients, while the granuloma disappeare d in 70% of the cases. Only one patient developed neuritis, and in another patient the disease relapsed on the eighth month. On the other hand, the SS L in the control patients resolved, regressed and remained active in 13.3%, 63.3% and 23.3% of the cases, respectively, while the granuloma disappeare d in 53.3% of the cases. In the seven patients who remained active, the dis ease course was progressive, and two of them developed neuritis. The clinic al outcome of the patients treated with ROM plus low-dose Convit vaccine wa s statistically superior to those treated with single-dose ROM therapy alon e,