Background: No large studies have demonstrated the effectiveness of a 6-month regimen for all forms of extra-pulmonary tuberculosis (EPTB).

Methods: Retrospective, observational analysis to evaluate the effectiveness of a 6-month treatment regimen (2HRZE/4H3R3) for all patients diagnosed with EPTB in Caracas, Venezuela, from 1 January 1998 to 31 December 2000, using direct observation.

Results: Of 679 patients enrolled, 101 (14.9%) had AIDS. In 83.2% the diagnosis was based on microbiological, histological or genetic amplification information. Of 612 (90.1%) patients who took more than 90% of the doses, treatment had to be altered in six (1%) due to drug side effects. Of the remaining 606 patients who took more than 90% of the doses, 603 (99.5%) were cured and three failed. In the follow-up conducted 2 years after the end of treatment, only 6 relapsed (1%). Cures without relapse were achieved in 24 cases of central nervous system involvement, 27 cases of osteoarticular involvement and in the 42 who had miliary and/or disseminated TB.

Conclusion: A 6-month treatment regimen for all forms of EPTB, with treatment three times a week during the continuation phase, was highly effective.

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