Safety Profile of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Hepatitis C in Romania: an Analysis Conducted in VigiBase®/ WHO

Authors

  • Irina Cazacu Department of Pharmacology, Physiology and Pathophysiology, Faculty of Pharmacy, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania
  • Roxana Stroe Pharmacovigilance and Risk Management Service. National Agency for Medicines and Medical Devices of Romania, Bucharest, Romania
  • Roxana Dondera Pharmacovigilance and Risk Management Service. National Agency for Medicines and Medical Devices of Romania, Bucharest, Romania
  • Bogdan Apan Department of Pharmacology, Toxicology and Clinical pharmacology, Functional Sciences, Faculty of Medicine, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania
  • Andreea Farcas Drug Information Research Centre, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania
  • Anamaria Cristina Department of Pharmacology, Physiology and Pathophysiology, Faculty of Pharmacy, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania
  • Camelia Bucsa Drug Information Research Centre, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania
  • Cristina Mogosan Department of Pharmacology, Physiology and Pathophysiology, Faculty of Pharmacy, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca; Drug Information Research Centre, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania

DOI:

https://doi.org/10.15403/jgld-2889

Keywords:

hepatitis C, direct antiviral agents, Romania, drug-related side effects, adverse reactions, drug interactions, ombitasvir/paritaprevir/ritonavir, dasabuvir

Abstract

Background and Aims: Due to the increasing number of hepatitis C virus (HCV)-infected patients being treated with direct antiviral agents (DAAs) in Romania, we aimed to conduct a pharmacovigilance study in order to comprehensively evaluate the safety profile for the ombitasvir/paritaprevir/ritonavir and dasabuvir (Om/Pa/Ri+Da) regimen.

Methods: A retrospective analysis was conducted on the individual case safety reports (ICSRs), extracted from VigiBase® on 1 st February 2018, which included the Om/Pa/Ri+Da regimen as suspected for causing adverse drug reactions (ADRs). Potential drug-drug interactions (DDIs) were checked for all concomitant medication using the IBM Micromedex® tool.

Results: Among the 1,102 ICSRs retrieved, 260 were serious (23.5%). Ribavirin was significantly associated with more ADRs reported per case (on average 5.1 vs. 3.2 ADRs/case, p<0.001). Most commonly reported ADRs were pruritus (6.8%), fatigue (5.4%), dizziness (4.3%) and headache (3.8%). For the serious ICSRs, a significant relationship was found between age and renal and urinary disorders, and between gender and neoplasms, injury, poisonings and procedural complications. Hepatotoxicity was identified in six ICSRs, four of them being serious. Potential contraindicated DDIs were identified in 1.9% of all ICSRs and major DDIs in 20.4%.

Conclusions: About a third of the ICSRs related to Om/Pa/Ri+Da regimen were serious. Pruritus, fatigue, dizziness and headache were the most commonly reported ADRs. The frequent use of multiple co- medications in HCV-infected patients requires the consideration of potential DDIs when using the Om/ Pa/Ri+Da regimen.

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Published

2020-10-27

How to Cite

1.
Cazacu I, Stroe R, Dondera R, Apan B, Farcas A, Cristina A, Bucsa C, Mogosan C. Safety Profile of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Hepatitis C in Romania: an Analysis Conducted in VigiBase®/ WHO. JGLD [Internet]. 2020 Oct. 27 [cited 2025 Jul. 15];29(4):603-10. Available from: https://jgld.ro/jgld/index.php/jgld/article/view/2889

Issue

Vol. 29 No. 4: December 2020

Section

Original Article