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.
Highlights
Tuberculosis constitutes a major public health problem with an estimated 8.7 million new cases and 1.4 million deaths every year
Baseline characteristics (Table 1) were similar in the 2 groups except for sex where a significantly higher proportion of men were found to be in the patients receiving the novel Fixed-dose combinations (FDCs) dosage form
Of the 105 participants, 51 (48.6%) had PTB with the rest having extrapulmonary tuberculosis (EPTB). 26 of the 51 (51.0%) PTB patients tested positive for tuberculosis either in culture or in sputum microscopy
Summary
Tuberculosis constitutes a major public health problem with an estimated 8.7 million new cases and 1.4 million deaths every year. 3.7% of new cases and 20% of previously treated cases were estimated to have multi drug resistance tuberculosis (MDR-TB) [1]. This emergence of drug resistant tuberculosis presents a major threat to the future success of TB control. As a solution to this problem World Health Organization (WHO) and International Union Against Tuberculosis Lung Disease (IUATLD), together with their partners, recommend the use of fixed-dose combination (FDC) formulations of the essential anti-tuberculosis drugs as one further step to ensure adequate treatment of patients. 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)
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