Микобактериальные заболевания
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The Comparison of Conventional and Novel Fixed Dose Combination of Rifampicin and Isoniazid to Improve Bioavailability of Rifampicin for Treatment of Tuberculosis

Sanjeev Sinha, Raghunandan P, Rashmita Pradhan, Shishoo CJ, Manish Nivsarkar, Padh H, Samantaray JC, Kamal Kishore and Pandey RM

Background: Fixed-dose combinations (FDCs) of anti-tubercular drugs have been recommended as a step towards ensuring better treatment and compliance of patients receiving anti-tubercular therapy (ATT).

Methods: The study was an open-label and randomized controlled trial. Patients were randomized to receive daily treatment with the conventional FDC dosage formulation or the novel FDC formulation of rifampicin and isoniazid as a part of 4 drug ATT regimen. The outcome measures were sputum conversion rates, radiological response and clinical response.

Results: Of the 105 patients who were randomized 55 received the conventional FDC formulation while 50 received the novel FDC formulation. Of the 105 participants, 51 (48.6%) had PTB with the rest having extrapulmonary tuberculosis (EPTB). Of the 87 patients could be assessed at the end of 6 months treatment,10/42 (23.8%) of the patients in group A and 13/45 (28.9%) of the patients in group B had some evidence of disease activity at the end of 6 months of treatment on the CT scan or in the Chest X-Ray. A total of 6 (5.8%) patients, three in each group (5.6% in group A and 6.4% in Group B) experienced treatment failure. Of these 3 were classified as treatment failure due to radiological deterioration and 3 due to persistent culture positivity. There was no significant difference in the microbiological, clinical or radiological response rates between the two groups. There was no significant difference in the plasma concentrations of rifampicin and isoniazid at various time points between the two groups.

Conclusion: In conclusion, we found no difference in the clinical efficacy of rifampicin and isoniazid drug levels of the novel FDC formulation as compared to the conventional FDC formulation. Further studies are required with larger sample size to study the usefulness of novel FDC formulation.