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Post-Marketing Pharmacovigilance Study of Darunavir in the United Kingdom: An Analysis of Adverse Drug Reactions Reported to the MHRA

Pono Pono,V. Cheng,V. Skerrett,Alan M. Jones

Published 2025 in Pharmacoepidemiology

ABSTRACT

Background/Objectives: Human immunodeficiency virus (HIV) continues to be a global public health concern. Several antiretroviral drugs have been approved for the treatment, post-exposure, and pre-exposure prophylaxis of HIV. Darunavir (DRV) is a protease inhibitor (PI) approved for the management of HIV globally. This study aims to generate safety signals for DRV through data mining and analysis of adverse events (AEs) reported to the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card Scheme. Methods: Disproportionality analysis was conducted using reporting odds ratio (ROR), proportional reporting ratio (PRR), and Bayesian confidence propagation neural network (BCPNN) approaches to identify potential safety signals. Results: The MHRA database contained n = 779 reports (n = 1791 AEs) attributed to DRV. The majority of AEs were reported for males. Positive safety signals were identified at both the system organ class (SOC, n = 5) and preferred term level (PT, n = 95). At SOC level, endocrine disorders emerged as a signal of interest n = 33 cases (ROR: 8.17, 95% CI: 5.78–11.56; PRR:7.96, 95% CI: 5.68–11.15; and IC: 2.85, IC025: 2.51). Among the results, 40 new potential safety signals are not listed on the product labelling in the UK. These include serious AEs such as cerebrovascular accident, brain injury, thrombosis, and pregnancy, puerperium, and perinatal AEs. Conclusions: This study provides additional real-world safety data for DRV in the UK and paves the way for future observational studies to investigate the identified safety signals.

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