Uniform multidrug therapy for leprosy patients in Brazil (U-MDT/CT-BR): Results of an open label, randomized and controlled clinical trial, among multibacillary patients

Abstract

BackgroundLeprosy control is based on early diagnosis and multidrug therapy. For treatment purposes, leprosy patients can be classified as paucibacillary (PB) or multibacillary (MB), according to the number of skin lesions. Studies regarding a uniform treatment regimen (U-MDT) for all leprosy patients have been encouraged by the WHO, rendering disease classification unnecessary.Methodology and findingsAn independent, randomized, controlled clinical trial conducted from 2007 to 2015 in Brazil, compared main outcomes (frequency of reactions, bacilloscopic index trend, disability progression and relapse rates) among MB patients treated with a uniform regimen/U-MDT (dapsone+rifampicin+clofazimine for six months) versus WHO regular-MDT/R-MDT (dapsone+rifampicin+clofazimine for 12 months). A total of 613 newly diagnosed, untreated MB patients with high bacterial load were included. There was no statistically significant difference in Kaplan-Meyer survival function regarding reaction or disability progression among patients in the U-MDT and R-MDT groups, with more than 25% disability progression in both groups. The full mixed effects model adjusted for the bacilloscopic index average trend in time showed no statistically significant difference for the regression coefficient in both groups and for interaction variables that included treatment group.During active follow up, four patients in U-MDT group relapsed representing a relapse rate of 2.6 per 1000 patients per year of active follow up (95% CI [0·81, 6·2] per 1000). During passive follow up three patients relapsed in U-MDT and one in R-MTD. As this period corresponds to passive follow up, sensitivity analysis estimated the relapse rate for the entire follow up period between 2·9- and 4·5 per 1000 people per year.ConclusionOur results on the first randomized and controlled study on U-MDT together with the results from three previous studies performed in China, India and Bangladesh, support the hypothesis that UMDT is an acceptable option to be adopted in endemic countries to treat leprosy patients in the field worldwide.Trial registrationClinicalTrials.gov: NCT00669643

World Health Organization (WHO) antibiotic regimen against other regimens for the treatment of leprosy: a systematic review and meta-analysis

“…The decision was taken based in only one study [27] which, although it shows an interesting design, its non-randomized and has a very low quality of evidence [44]. Also, the study has not been valued in comparison with other studies, and besides these, its findings had not been supported by a RCT [35].…”

Epidemiology of Leprosy in Vietnam and the Effectiveness of Multidrug Therapy (MDT) in the Management of the Disease

“…To this date, there is nothing in short period of time to replace MDT [28]. Recently, the recommendation of the WHO about the implementation of U-MDT among central strategies for leprosy control in the quadrennium 2017/2020 was published [29,30]. In Vietnam, there was no controlled clinical study, comparing the efficacy of U-MDT and WHO-MDT for PB and MB patients.…”

Conquistas do SUS no enfrentamento das doenças transmissíveis

“…This was partially due to a break in the paradigm that leprosy patients do not re-infect, since the decoding of the complete genome of M. leprae isolated from patients with a relapse of the disease revealed that the same patient could be infected at different times with different strains of this bacillus 12 . Following the rationale for the treatment of tuberculosis, a new single therapeutic regimen (U-MDT) for leprosy will be adopted in 2018, which includes three drugs, for all patients regardless of clinical classification for a period of only six months 13 .…”