Use of Dispersible Fixed-Dose Combinations in Chemotherapy of Drug Susceptible Tuberculosis: Results of the Observational Study

The objective: to assess effectiveness, safety and pharmacoeconomic feasibility of using a dispersible fixed-dose combination (isoniazid 150 mg, rifampicin 150 mg, pyrazinamide 375 mg) in patients with respiratory tuberculosis and preserved susceptibility of Mycobacterium tuberculosis (MTB) to anti-tuberculosis drugs. Subjects and Methods. A post-registration observational study was conducted to assess treatment effectiveness of pulmonary tuberculosis in 60 adult patients with drug susceptible tuberculosis. In Main Group, patients received the fixed-dose combination (isoniazid 150 mg, rifampicin 150 mg, pyrazinamide 375 mg), while in Control Group, patients were treated with the regimen consisting of single anti-tuberculosis drugs. Results. Sputum conversion rate made 76.7% by the end of the intensive phase (60 doses) when replacing isoniazid, rifampicin and pyrazinamide with the dispersible fixed-dose combination, while with the standard choice of drugs, it was 66.7%. The incidence of adverse reactions was 7-fold lower when using the investigational drug which contributed to a high level of adherence and high effectiveness of therapy. Pharmacoeconomic analysis convincingly demonstrated advantages and economic benefits of the dispersible fixed-dose combination (isoniazid 150 mg, rifampicin 150 mg, pyrazinamide 375 mg), which was more costly than the combination of single drugs.