Retrospective evaluation of the efficacy and safety of the multidrug regimen (RiMoxClaMin) for leprosy patients

Abstract

Medicinal resistance in leprosy is related to: changes in drug absorption, inconsistency in treatment by patients, re-exposure to high bacillary loads, and metabolic and structural characteristics inherent to M. leprae, allowing for bacillary persistence after treatment, as well as genetic factors that lead to the occurrence of mutations in genes related to resistance. Considering the increasing number of leprosy patients with unsatisfactory response to conventional treatment with PQT (Rifampicin, Clofazimine, Dapsone); the increase in longevity and comorbidities increases the side effects to PQT, such as hepatopathy with rifampicin (the only bactericidal drug in the PQT scheme), severe anemia with dapsone and cutaneous hyperpigmentation with clofazimine, leading to more discrimination and stigmas associated with leprosy, a considerable number of patients from our National Reference Center for Leprosy at HCFMRP-USP have begun to require substitute schemes since 2015, schemes that are more bactericidal based on moxifloxacin, associated with rifampicin, clarithromycin and minocycline (RIMOXCLAMIN scheme) with significant results in terms of improving clinical lesions and reaction frames. Therefore, the project aims to retrospectively compare the medical records of leprosy patients who have used the new RIMOXCLAMIN scheme in the last 5 years to those who used the standard scheme (PQT-multibacillary), aiming to evaluate efficacy and safety. Medical records of patients treated in the leprosy outpatient clinic of dermatology at HCFMRP-USP from 2015 to 2022 will be evaluated, seeking clinical data such as age, gender, origin, diagnosis, clinical classification, specific and general laboratory data (hematological and biochemical) initial and during clinical follow-up, esthesiometry, drug-related side effects. The study is expected to demonstrate the efficacy of the RiMoxClaMin scheme and identify improvements in clinical and functional patients, reduction of laboratory bacillary load, change in esthesiometric profile, and listing of side effects occurred during treatment. In short, the study aims to answer the important need of the Ministry of Health to implement and offer a new therapeutic scheme to cases resistant to leprosy treatment and or unable to use the scarce conventional drugs used.