Phase II trial of recombinant interferon-alpha 2b in patients with advanced intractable multidrug-resistant pulmonary tuberculosis: long-term follow-up

SETTING: Multidrug-resistant tuberculosis patients without human immunodefi ciency virus (HIV) infection, with Mycobacterium tuberculosis resistant to almost all of the available drugs. OBJECTIVE: Limited phase II trial with recombinant interferon-alpha 2b in f ive chronic multidrug-resistant tuberculosis patients. METHODS: Three million units of r-IFN-alpha 2b were administered subcutaneo usly every week for 12 weeks. Before and after treatment, and during a 30-m onth follow-up period, the patients underwent clinical and radiological exa mination, together with bacteriological, immunological and routine laborato ry testing. RESULTS: Two Of the five patients became long-term sputum smear and culture negative after r-IFN-alpha 2b therapy; one of the patients showed clinical improvement and negative smear after therapy, but remained culture positiv e. The other two patients showed no response. CONCLUSION: The results of this trial suggest that IFN-alpha 2b should be e valuated further in multidrug-resistant tuberculosis ill prospective contro lled trials.