Rifampicin plus isoniazid for the prevention of tuberculosis in an immigrant population

Correspondence to: Maria Angeles Jimenez-Fuentes, Unidad de Prevencion y Control de la Tuberculosis de Barcelona, Servei d’Atencio Primaria Suport al Diagnostic i al Tractament, Institut Catala Salut, Centre d’Atencio Primaria Drassanes, Av Drassanes 17-21, 08001 Barcelona, Spain. Tel: (+34) 933 012 424. Fax: (+34) 933 186 186. e-mail: ajimenezf.bcn.ics@ gencat.cat Article submitted 3 July 2012. Final version accepted 7 October 2012. O B J E C T I V E S : To compare the tolerance, adherence and effectiveness of two approaches for the treatment of latent tuberculosis infection (LTBI): 6 months of isoniazid (6H) vs. 3 months of isoniazid plus rifampicin (3RH). P O P U L AT I O N : Immigrants with LTBI. M E T H O D S : Participants were enrolled in a controlled, randomised clinical trial in Barcelona, Spain, from April 2001 to April 2005. Monthly follow-up was done to assess tolerance, side effects and adherence. Effectiveness was evaluated at 5 years. R E S U LT S : In the 590 subjects enrolled, the rate of adherence was greater in the 3RH than in the 6H arm (72% vs. 52.4%, P = 0.001). No differences between study arms were observed with respect to hepatotoxicity or side effects. Variables associated with nonadherence were diagnosis by screening (OR 1.88, 95%CI 1.26– 2.82, P = 0.001), illegal immigration status (OR 1.48, 95%CI 1.01–2.15, P = 0.03), unemployment (OR 1.91, 95%CI 1.28–2.85, P = 0.0008), illiteracy (OR 1.73, 95%CI 1.04–2.88, P = 0.02), lack of family support (OR 3.7, 95%CI 2.54–5.4, P = 0.001) and the 6-month treatment regimen (OR 2.45, 95%CI 1.68–3.57, P = 0.0001). None of the patients who completed either treatment developed tuberculosis. C O N C L U S I O N S : The 3RH regimen facilitates adherence to LTBI treatment and offers a safe, well-tolerated and effective alternative. K E Y W O R D S : randomised clinical trial; latent tuberculosis infection; immigration; isoniazid; rifampicin