Systematic Review and Meta-Analysis on the Efficacy and Safety of Drug Prophylaxis of Contacts of Patients With Hansen's Disease

OBJECTIVES: To synthesize the evidence available in the literature in a systematic way, on prophylactic measures for contacts of confirmed cases of Hansen’s disease, with efficacy and safety for preventing the disease compared to standard therapy.

METHODS: A systematic review with meta-analysis was carried out by searching the following electronic databases: Embase, Lilacs, Medline, Cochrane Library, in addition to bibliographic citations of interest. No restrictions were made regarding language or publication period. Inclusion criteria: adults or children of both sexes, contacts of Hansen’s disease patients, undergoing chemoprophylaxis. Studies without indexed publications and conference abstracts were excluded. The quality of the studies was assessed by risk of bias using Cochrane tools and certainty in the body of evidence using the GRADE system.

RESULTS: Four studies were selected for quantitative synthesis, three randomized clinical trials and one cohort study (total n intervention = 20,659; total n comparator = 20,092). The results of the meta-analysis (four studies) were favorable to rifampicin over a two-year period (RR 0.67 95% CI 0.40- 1.12), with the studies risk of bias defined as uncertain (due to an open study and another without blinding) and certainty in the body of evidence assessed as moderate. Rifapentine, evaluated in a single study, presented better results than rifampicin with RR 0.40 (95% CI 0.08 – 2.08) in two years and 0.18 (95% CI 0.04 – 0.80) in four years, and uncertain risk of bias.

CONCLUSIONS: Rifampicin administered in a single dose as prophylaxis to contacts of Hansen’s disease patients, mainly in endemic areas, demonstrated to be effective and safe with a RR of 67% in two years, and a statistically significant protective effect maintained in six years, with low risk of bias and certainty in evidence classified as moderate. Rifapentine proved to be a promising prophylactic medication, being evaluated in a single study.