Evaluation of a non-rifampicin continuation phase (6HE) following thrice-weekly intensive phase for the treatment of new sputum positive pulmonary tuberculosis.

ABSTRACT

SETTING: Tuberculosis Research Centre, Chennai and Madurai, South India. OBJECTIVE: To assess response to treatment, relapse and emergence of MDR TB in newly diagnosed patients with sputum-positive tuberculosis using an intermittent intensive phase followed by a non-rifampicin continuation phase. DESIGN: Patients were treated in a controlled clinical trial with 2HRZE3/6HE with thrice-weekly direct dosing in the intensive phase and once-weekly with six doses self-administered in the continuation phase. Clinical and bacteriologic evaluation was done every month for 24 months. RESULTS: The overall outcome was good, with 92% favourable response (cure) and 4.8% relapse in 450 patients including 103 who did not receive extension of intensive phase for positive smear, 38 with initial H-resistant cultures, 4 with MDR TB and 15 who received less than 75% of chemotherapy. In 392 patients with drug-susceptible cultures, 96%were cured and only 4% relapsed. There was no emergence of MDR TB among failures and relapses; toxicity was low. CONCLUSION: Newly-diagnosed Category I patients can be effectively treated with this regimen without emergence of MDR TB. It has immense potential in programmes where directly observed therapy cannot be ensured throughout, and when rifampicin is contraindicated in HIV-TB patients who require concomitant therapy with anti-retroviral