IngentaConnect Is there an increased risk of TB relapse in patients treated with...

Authors: Suryanto, A.A.¹; van den Broek, J.²; Hatta, M.³; de Soldenhoff, R.⁴; van der Werf, M.J.⁵

Source: The International Journal of Tuberculosis and Lung Disease, Volume 12, Number 2, February 2008 , pp. 174-179(6)

Publisher: International Union Against Tuberculosis and Lung Disease

Abstract:

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

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

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