A STUDY ON ADVERSE DRUG REACTIONS OF BEDAQUILINE CONTAINING REGIMEN IN PATIENTS WITH DRUG RESISTANT TUBERCULOSIS.

Abstract

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Context: Newer drugs like Bedaquiline and Delamanid are expected to improve treatment outcomes among selected population. Bedaquiline has serious side effects include QT prolongation, liver dysfunction, and an increased risk of death.

Aims: Due to paucity of study on the adverse effects of Bedaquiline containing regimen we have conducted this study to find out the side effect profile of patients treated with Bedaquiline.

Settings and Design: A prospective study involving 55 patients of Drug Resistant TB on a regimen containing Bedaquiline fulfilling the criteria that they are above 18 years of age and all genders with biological specimen showing phenotypically or genotypically confirmed drug resistant tuberculosis.

 Statistical Analysis Used: All data were entered in Microsoft Excel and appropriate simple descriptive statistical methods were used.

Results: Most common adverse effect was nausea followed by diarrhoea, joint pain , anorexia and itching. No hepatotoxic effect was found.

Conclusion: Bedaquiline containing regimen is associated with early sputum smear and culture conversion and is relatively safe and well tolerated with no derangement in liver function. This could be considered as an effective treatment for MDR and XDR patients.

Keywords: Adverse Drug Reactions, Antitubercular Agents, Drug-resistant tuberculosis