ADVERSE DRUG REACTIONS WITH COMMON ANTIVIRALS IN VIRAL HEPATITIS: A PROSPECTIVE OBSERVATIONAL STUDY FROM A NORTH-INDIAN TERTIARY-CARE OPD
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Keywords
Viral hepatitis, Antiviral agents, Adverse drug reactions, Pharmacovigilance, Tenofovir, Entecavir, Sofosbuvir
Abstract
Background: Antiviral therapy is central to viral hepatitis care, yet real-world adverse drug reaction (ADR) patterns in busy outpatient settings remain incompletely characterised.
Aim: To evaluate ADRs associated with antivirals used for viral hepatitis, focusing on frequency, severity, time-to-onset, and causality.
Materials and Methods: A prospective, observational study conducted in the Gastroenterology and Medicine outpatient departments of KGMU, Lucknow after ethics approval (IEC 3006/Ethics/2024, 23-01-2024). Adults with viral hepatitis receiving antivirals were enrolled (n = 95) after consent. ADRs were captured using a pre-designed case-record form and assessed by WHO-UMC causality and Hartwig severity scales; follow-up was scheduled at ~1 month and thereafter per protocol, with review after any ADR. Statistical analyses included paired t-tests, chi-square tests, and Kruskal–Wallis (two-sided p < 0.05).
Results: Antivirals prescribed were tenofovir, entecavir, sofosbuvir+daclatasvir and sofosbuvir+velpatasvir. From baseline to follow-up, there were significant improvement in biochemical parameters, decrease in AST/SGOT, ALT/SGPT, ALP, urea, creatinine, and INR, and increase in serum protein and albumin. ADRs occurred in 31/95 (32.6%); Most frequent ADRs were nausea, headache, and fatigue. Most ADRs were mild. Causality was probable/possible in all cases.
Conclusion: In tertiary-care practice, antiviral therapy for viral hepatitis was associated with favourable biochemical trajectories & mild ADRs. ADR type & onset timing differ, supporting early monitoring & standardised documentation to optimise safety.
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Dr Shilpi Rani Biswas
MD PHARMACOLOGY, Junior Resident KGMU, Lucknow, UP, India
Dr Rahul Soni
MD PHARMACOLOGY, Junior Resident KGMU, Lucknow, UP, India
Dr Ayush Jain
MD, DNB PHARMACOLOGY, Assistant Professor, KGMU, Lucknow, UP, India
Dr Sumit Rungta
MD, DM MEDICAL GASTROENTEROLOGY, Additional Professor, KGMU, Lucknow, UP, India
Prof Ajay Kumar Patwa
MD, DM MEDICINE, Professor, KGMU, Lucknow, UP, India
Dr Suyog Sindhu
MD PHARMACOLOGY, Associate Professor, KGMU, Lucknow, UP, India
Prof Narendra Kumar
MD PHARMACOLOGY, Professor, KGMU, Lucknow, UP, India