ADVERSE DRUG REACTION PATTERN OF ANTI- VIRAL DRUGS USED FOR PATIENTS WITH CHRONIC HEPATITIS B IN A TERTIARY CARE HOSPITAL

Abstract

OBJECTIVE To study the pattern and severity of adverse drug reactions of anti-viral drugs in Chronic Hepatitis B patients attending the out-patient department of Hepatology at Rajiv Gandhi Government General Hospital, Madras Medical College, Chennai. METHODOLOGY The study was conducted in Chronic Hepatitis B patients attending outpatient department of Hepatology, Madras Medical College Rajiv Gandhi  Government General Hospital, Chennai between May 2015 to July 2015. Study period was 3 months. Sample size was 200. After getting approval from the Institutional ethics committee, patients with Chronic Hepatitis B receiving anti-viral drugs at the out-patient department of Hepatology were selected. 376         patients were screened, 200 patients who met the inclusion criteria were chosen for analysis. Types of drugs taken, any Adverse Drug Reaction(ADR) occurred were documented and managed as per protocol. Causality assessment of the ADR was done by WHO causality assessment scale. Severity was assessed using Modified Hartwig Siegel severity assessment scale. RESULTS Most of the patients were in the age group of 41-50 years. Males constituted 62 and females 38. The anti-viral drugs prescribed were Entecavir and Tenofovir. Entecavir was prescribed for 132(66 ) patients. 72(36) patients developed at least one Adverse Drug Reaction. Fatigue was the most  common adverse drug reaction reported in the Entecavir group and diarrhoea in the Tenofovir group. 89 of ADR were  categorized as possible using WHO causality assessment scale. Most of the ADRs were mild (96) according to Modified Hartwig Siegel severity assessment scale and did not require  discontinuation of treatment. CONCLUSION Entecavir was the most commonly prescribed anti-viral drug. 72(36) patients          developed at least one Adverse Drug Reaction. Most of ADRs were mild according to Modified Hartwig Siegel severity assessment scale and categorized as possible using WHO  causality assessment scale. None of them required discontinuation of therapy.