Fw: Ref.: (LML) Does Rifampicin PEP for household contacts alter the risk of multibacillary HD?

 

Leprosy Mailing List –  July 24,  2024

 

Ref.:  (LML) Does Rifampicin PEP for household contacts alter the risk of multibacillary HD?

From:  Epco Hasker, Antwerp, Belgium

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Dear Pieter,

 

I would like to respond to the posting by Joel Almeida on the LML on 23 June. He presents a sub group analysis of data from the PEOPLE trial on single dose rifampicin post-exposure prophylaxis (SDR-PEP) for leprosy. He compares arm 2, in which SDR-PEP was provided to household contacts, to arm 1, the comparator arm, in which no PEP was provided. The analysis is restricted to MB cases only and conclusions focus on SDR-PEP provided to household contacts. Indeed in arm 2 there were 42 incident MB cases versus 27 in arm 1, while total follow-up time was comparable between the two arms. Almeida then concludes that SDR-PEP has caused an increase in incidence of MB leprosy.

As can be seen from the trial profile figure presented in the article [1], only seven incident patients in arm 2 had received SDR-PEP. Out of those four were PB, three were MB. So even if the theory that SDR-PEP given to household contacts would increase the risk of developing MB leprosy, how could it ever explain the 39 MB cases in arm 2 that had not received any PEP?

In addition, SDR-PEP was provided to household contacts not only in arm 2 but also in arms 3 and 4 of the PEOPLE trial. In these arms numbers and proportions of MB incident cases were substantially lower than in arm 1 (19/68 in arm 3 and 13/44 in arm 4). If we run the individual model comparing those who did and did not receive SDR-PEP, restricted to household contacts only and with MB-leprosy as outcome, the incidence rate ratio among SDR-PEP recipients is still 0.49, though not statistically significant because of the much smaller study population (p=0.34).

I strongly recommend that this discussion is continued in the peer reviewed literature, where inconsistencies in argumentation would have been flagged by reviewers before publication.

 

Kind regards,

 

Epco Hasker

 

1. Hasker E, Assoumani Y, Randrianantoandro A, Ramboarina S, Braet SM, Cauchoix B, et al. Post-exposure prophylaxis in leprosy (PEOPLE): a cluster randomised trial. Lancet Glob Health. 2024;12(6):e1017-e26. doi: 10.1016/S2214-109X(24)00062-7. PubMed PMID: 38762282.

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LML - S Deepak, B Naafs, S Noto and P Schreuder

LML blog link: http://leprosymailinglist.blogspot.it/

Contact: Dr Pieter Schreuder << editorlml@gmail.com

 

 

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