alexa The Comparison of Conventional and Novel Fixed Dose Combination of Rifampicin and Isoniazid to Improve Bioavailability of Rifampicin for Treatment of Tuberculosis
ISSN: 2161-1068

Mycobacterial Diseases
Open Access

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Research Article

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

Sanjeev Sinha1*, Raghunandan P1, Rashmita Pradhan1, Shishoo CJ2, Manish Nivsarkar2, Padh H2, Samantaray JC3, Kamal Kishore4 and Pandey RM5

1Department of Medicine, All India Institute of Medical Sciences, New Delhi, India

2National Institute of Pharmaceutical Education and Research (NIPER), Ahmedabad and B.V.Patel Pharmaceutical Education and Research Development (PERD) Centre, Thaltej, Ahmedabad, India

3Department of Microbiology, All India Institute of Medical Sciences, New Delhi, India

4Department of Pharmacology, All India Institute of Medical Sciences, New Delhi, India

5Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India

Corresponding Author:
Sanjeev Sinha
Additional Professor, Department of Medicine
All India Institute of Medical Sciences
Ansari Nagar, New Delhi 110029, India
Tel: 91-11-26594440
Fax: 91-11-26588866
E-mail: [email protected]

Received Date: April 15, 2014; Accepted Date: June 19, 2014; Published Date: June 28, 2014

Citation: Sinha S, Raghunandan P, Pradhan R, Shishoo CJ, Nivsarkar M, et al. (2014) The Comparison of Conventional and Novel Fixed Dose Combination of Rifampicin and Isoniazid to Improve Bioavailability of Rifampicin for Treatment of Tuberculosis. J Mycobac Dis 4:157. doi:10.4172/2161-1068.1000157

Copyright: © 2014 Sinha S, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Abstract

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.

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