ADVERSE DRUG REACTIONS IN MDR-TB PATIENTS ON CAT IV OF DOTS-PLUS AND THEIR EFFECT ON CULTURE CONVERSION

Background: Multi-Drug resistant tuberculosis, has emerged as a challenge to public health due to long duration oftreatment with high pill burden, associated adverse drug reactions. We have thus investigated the adverse drugreactions with MDR-TB Cat-IV regimen under programmatic study settings and analysed the impact of these ADR's onculture conversion.Methods: This prospective cohort observational study was conducted at DOTS-PLUS site, Amritsar, Punjab (India).Adverse drug reactions reported by Eighty consecutive MDR-TB patients,and recognized by laboratory and/or clinicalevidence were recorded after informed consent.The culture conversion rates at 6 months in patients with adverse drugreactions and without adverse drug reactions were compared using Chi2 exact test.Results: A total of eighty patients reported 76 adverse drug reactions, with a mean age 32.38± 13.60 years, male:female ratio of 5:3. Forty two (52.5%) patients experienced at least one adverse event.The adverse effects warranteddiscontinuation of the suspected offending medicine in 22(27.5%) patients. The rates of occurrence of ADR's were:Gastrointestinal side effects:31.25%, Ototoxicity:23.75%, psychiatric symptoms:11.25%, arthralgia/ hyperuricemia:10%, hepatotoxicity: 5%, nephrotoxicity: 5%, injectable related problems: 3.75%, skin rash:2.5%, peripheralneuropathy:2.5%.The difference in culture conversion rates in patients with ADR's(50%) and without ADR's(52%) was not statisticallysignificant (p value 0.6474,odds ratio 0.75,95% CI 0.3042 to 1.849)Conclusion: There is a high frequency of ADR's in MDR-TB cases.When appropriately monitored and managed,ADR'sdo not effect rates of culture conversion .Newer and less toxic drugs are urgently needed to treat MDR TB patients.