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Safety profile of the lopinavir/ritonavir combination before and during the SARS-CoV-2 pandemic

Pauline Lory1, Sandrine Combret1, Joelle Michot2

  • 1Regional Pharmacovigilance Center, Dijon University Hospital, 21079 Dijon, France.

Therapie
|November 14, 2022
PubMed
Abstract

Insights

Lopinavir/ritonavir, used for COVID-19, showed different adverse drug reactions (ADRs) compared to its HIV treatment use. COVID-19 patients experienced more liver, heart, and kidney issues, unlike earlier gastrointestinal and skin reactions.

Area of Science:

  • Pharmacovigilance and drug safety research.
  • Infectious diseases and public health.
  • Clinical pharmacology and therapeutics.

Background:

  • No established treatments for SARS-CoV-2 existed at the pandemic's start.
  • Lopinavir/ritonavir, an HIV medication, was recommended for COVID-19 in France.
  • Early identification of adverse drug reactions (ADRs) was crucial.

Purpose of the Study:

  • To compare ADRs of lopinavir/ritonavir in COVID-19 patients versus its standard HIV indication.
  • To analyze safety signals identified through pharmacovigilance.

Main Methods:

  • Extracted ADR cases from the French Pharmacovigilance Database.
  • Compared ADRs reported during pre-COVID (1985-2019) and COVID (2020) periods.

Main Results:

  • COVID-19 patients showed significantly more liver (43%), heart (10.6%), and kidney (7.1%) damage.
  • Pre-pandemic ADRs were primarily gastrointestinal and cutaneous.
  • A distinct safety profile emerged for lopinavir/ritonavir in COVID-19.

Conclusions:

  • The altered safety profile may stem from SARS-CoV-2 effects, patient factors, or co-medications.
  • Drug safety profiles can vary based on therapeutic use.
  • Pharmacovigilance is vital for detecting new ADRs with established drugs.
Keywords:
Adverse drug reactionCOVID-19LopinavirPharmacovigilanceRitonavir

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