Unanswered questions on the safety of MDT-U - Reply.

Dear Dr. Barve,

Thank you very much for your comments regarding our paper “Clinical trial for uniform multidrug therapy for leprosy patients in Brazil (U-MDT/CT-BR): adverse effects approach”.[1]

Let us clarify some points:

Indeed, both pigmentation and xerosis are caused by clofazimine. We definitely did not imply that these were due to rifampicin and/or dapsone.

It is clear that paucibacillary (PB) patients treated with R-MDT do not use clofazimine. However, as mentioned in reference 2, the inclusion of clofazimine in the treatment of PB patients did not lead to an increase in non-compliance when we used U-MDT.[2]

Definitely, we cannot compare data from leprosy control programs with a randomized and controlled clinical trial.[3] It would be a fundamental and serious mistake. However, it is very important to stress that only 24 patients had to interrupt treatment due to adverse effects (AE).[1]

Despite your question about the moment of AE onset, for us it is clear and elementary that the shorter the treatment is, the less AE we are likely to find.