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Effective TB Treatment May Lie in Combination Drug Regimen
Christian Lienhardt, M.D., M.Sc., Ph.D., of the World Health Organization, Geneva, Switzerland, presented the findings of the study at a JAMA media briefing at the National Press Club. Dr. Lienhardt conducted the study while heading the Clinical Trial Division at the International Union Against Tuberculosis and Lung Disease.
"Despite the availability of a highly effective 6-month chemotherapy regimen, worldwide control of tuberculosis is severely impeded by poor treatment completion rates that threaten the emergence of multidrug resistance," according to background information in the article. "Fixed-dose combinations (FDCs) of drugs have been advocated as a way of preventing the emergence of drug resistance attributable to inappropriate drug intake. In addition, they can reduce the risk of incorrect dosage, simplify drug procurement, and aid in ensuring adherence."
Dr. Lienhardt and colleagues conducted a multicenter randomized controlled trial to evaluate the efficacy and safety of a 4-drug FDC for the treatment of tuberculosis. The study was conducted at 11 sites in Africa, Asia, and Latin America between 2003 and 2008 and included 1,585 adult patients with newly diagnosed smear-positive pulmonary tuberculosis. Patients were randomized to receive daily treatment with 4 drugs (rifampicin, isoniazid, pyrazinamide, ethambutol) given as an FDC (n = 798 patients) or separately (n = 787) in the 8-week intensive phase of treatment. A favorable treatment outcome was defined as a negative culture result at 18 months post randomization and not having already been classified as unfavorable. The FDC was assessed for noninferiority (no worse than the separate drug regimen) via several measures.
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