Safety and Side Effects of Rifampin versus Isoniazid in Children

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dc.contributor.authorDiallo, T.
dc.contributor.authorAdjobimey, M.
dc.contributor.authorRuslami, R.
dc.contributor.authorTrajman, A.
dc.contributor.authorSow, O.
dc.contributor.authorBaah, J. Obeng
dc.contributor.authorMarks, G.B.
dc.contributor.authorLong, R.
dc.contributor.authorElwood, K.
dc.contributor.authorZielinski, D.
dc.contributor.authorGninafon, M.
dc.contributor.authorWulandari, D.A.
dc.contributor.authorApriani, L.
dc.contributor.authorValiquette, C.
dc.contributor.authorFregonese, F.
dc.contributor.authorHornby, K.
dc.contributor.authorLi, P.-Z.
dc.contributor.authorHill, P.C.
dc.contributor.authorSchwartzman, K.
dc.contributor.authorBenedetti, A.
dc.contributor.authorMenzies, D.
dc.date.accessioned2024-12-11T19:14:20Z
dc.date.available2024-12-11T19:14:20Z
dc.date.issued2018
dc.description.abstractBACKGROUND The treatment of latent infection with Mycobacterium tuberculosis is important in children because of their vulnerability to life-threatening forms of tuberculosis disease. The current standard treatment — 9 months of isoniazid — has been associated with poor adherence and toxic effects, which have hampered the ef- fectiveness of the drug. In adults, treatment with 4 months of rifampin has been shown to be safer and to have higher completion rates than 9 months of isoniazid. METHODS In this multicenter, open-label trial, we randomly assigned 844 children (<18 years of age) with latent M. tuberculosis infection to receive either 4 months of rifampin or 9 months of isoniazid. The primary outcome was adverse events of grade 1 to 5 that resulted in the permanent discontinuation of a trial drug. Secondary outcomes were treatment adherence, side-effect profile, and efficacy. Independent review panels whose members were unaware of trial-group assignments adjudicated all adverse events and progression to active tuberculosis. RESULTS Of the children who underwent randomization, 829 were eligible for inclusion in the modified intention-to-treat analysis. A total of 360 of 422 children (85.3%) in the rifampin group completed per-protocol therapy, as compared with 311 of 407 (76.4%) in the isoniazid group (adjusted difference in the rates of treatment completion, 13.4 percentage points; 95% confidence interval [CI], 7.5 to 19.3). There were no significant between-group differences in the rates of adverse events, with fewer than 5% of the children in the combined groups with grade 1 or 2 ad- verse events that were deemed to be possibly related to a trial drug. Active tuber- culosis, including 1 case with resistance to isoniazid, was diagnosed in 2 children in the isoniazid group during 542 person-years of follow-up, as compared with no cases in the rifampin group during 562 person-years (rate difference, −0.37 cases per 100 person-years; 95% CI, −0.88 to 0.14). CONCLUSIONS Among children under the age of 18 years, treatment with 4 months of rifampin had similar rates of safety and efficacy but a better rate of adherence than 9 months of treatment with isoniazid. (Funded by the Canadian Institutes of Health Research and Conselho Nacional de Pesquisa; ClinicalTrials.gov number, NCT00170209.).
dc.identifier.citationDiallo T, Adjobimey M, Ruslami R, Trajman A, Sow O, Obeng Baah J, Marks GB, Long R, Elwood K, Zielinski D, Gninafon M, Wulandari DA, Apriani L, Valiquette C, Fregonese F, Hornby K, Li PZ, Hill PC, Schwartzman K, Benedetti A, Menzies D. Safety and Side Effects of Rifampin versus Isoniazid in Children. N Engl J Med. 2018 Aug 2;379(5):454-463. doi: 10.1056/NEJMoa1714284.
dc.identifier.other10.1056/NEJMoa1714284
dc.identifier.urihttps://dspace.inc.saude.gov.br/handle/123456789/703
dc.language.isoen
dc.publisherNew England Journal of Medicine
dc.subjectAdolescenten
dc.subjectAntibiotics, Antitubercular / administration & dosage*en
dc.subjectAntibiotics, Antitubercular / adverse effects*en
dc.subjectChilden
dc.subjectChild, Preschoolen
dc.subjectDrug Administration Scheduleen
dc.subjectFemaleen
dc.subjectFollow-Up Studiesen
dc.subjectHumansen
dc.subjectInfanten
dc.subjectIntention to Treat Analysisen
dc.subjectIsoniazid / administration & dosage*en
dc.subjectIsoniazid / adverse effects*en
dc.subjectLatent Tuberculosis / drug therapy*en
dc.subjectMaleen
dc.subjectMedication Adherenceen
dc.subjectPatient Safetyen
dc.subjectRifampin / administration & dosage*en
dc.subjectRifampin / adverse effects*en
dc.subjectTreatment Outcome.en
dc.titleSafety and Side Effects of Rifampin versus Isoniazid in Children
dc.typeArticle
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