Free Content Is there an increased risk of TB relapse in patients treated with fixed-dose combination drugs in Indonesia?

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SETTING: South Sulawesi Province, Republic of Indonesia.

OBJECTIVE: To compare relapse rates among tuberculosis (TB) patients treated with fixed-dose combination drugs (FDCs) and patients treated with the same regimen using loose drugs.

METHODOLOGY: Between 1999 and 2001, new smear-positive TB patients were randomly allocated to treatment with four-drug FDCs or loose drugs to study differences in treatment outcomes. Although it was not in the original study design, in 2004–2005 we performed a follow-up study by home visit of cured patients. We conducted an interview and tried to collect a sputum sample from each patient. If the patient was absent or had died, a proxy interview was conducted. The sputum samples were examined by microscopy and culture.

RESULTS: The overall relapse rate was 7.0% in patients who were able to produce a sputum sample. Relapse appeared to be more frequent in the FDC group compared to the loose drug group (10.1% vs. 2.7%, P = 0.074).

CONCLUSION: This is the first documented long-term follow-up study of patients treated with four-drug FDCs. There is an indication that treatment of new sputum smear-positive TB patients with FDCs provides an increased risk of relapse compared to treatment with loose drugs. The long-term results of treatment with FDCs should be carefully evaluated in other settings.

Keywords: Indonesia; four-drug FDC; relapse; treatment; tuberculosis

Document Type: Regular Paper

Affiliations: 1: Directly Communicable Diseases Section, Provincial Health Services, Makassar, Indonesia 2: KNCV Tuberculosis Foundation, Den Haag, The Netherlands 3: Department of Microbiology, Molecular Biology and Immunology Laboratory, Faculty of Medicine, Hasanuddin University, Makassar, Indonesia 4: Netherlands Leprosy Relief (NLR), Makassar, Indonesia 5: KNCV Tuberculosis Foundation, Den Haag, The Netherlands; and Department of Infectious Diseases, Tropical Medicine & AIDS, Center for Infection and Immunity Amsterdam (CINIMA), University of Amsterdam, Amsterdam, The Netherlands

Publication date: February 1, 2008

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  • The International Journal of Tuberculosis and Lung Disease publishes articles on all aspects of lung health, including public health-related issues such as training programmes, cost-benefit analysis, legislation, epidemiology, intervention studies and health systems research. The IJTLD is dedicated to the continuing education of physicians and health personnel and the dissemination of information on tuberculosis and lung health world-wide.

    Certain IJTLD articles are selected for translation into French, Spanish, Chinese or Russian. They are available on the Union website

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