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Adverse Reactions to Antiretrovirals in Cuban Patients Living with HIV/AIDS

Mayasil Morales-Pérez1

  • 1Medical University of Havana, Havana, Cuba.

MEDICC Review
|May 11, 2021
PubMed

Insights

Adverse reactions to antiretrovirals in Cuban HIV/AIDS patients are common and moderate. Nevirapine and zidovudine were most implicated, with hypersensitivity being the most frequent reaction. Over half of these reactions were preventable, often due to prescription errors.

Area of Science:

  • Pharmacovigilance
  • Infectious Diseases
  • Clinical Pharmacy

Background:

  • Antiretroviral therapy (ART) has significantly reduced HIV/AIDS mortality globally since 1996.
  • Cuba has reported 26,952 HIV/AIDS cases, with a notable decline in mortality rates since ART became available in 2002.
  • Understanding antiretroviral safety profiles is crucial for maintaining treatment adherence due to potential toxicities.

Purpose of the Study:

  • To describe the adverse reactions associated with antiretroviral drugs used in Cuban patients diagnosed with HIV/AIDS.
  • To analyze the types, frequency, and severity of these adverse reactions.
  • To identify preventable adverse reactions and their primary causes.

Main Methods:

  • A retrospective study of 352 adverse reaction notifications to antiretrovirals in the Cuban National Pharmacovigilance Database (2003-2017).
  • Analysis of variables including patient demographics, notification year, specific antiretroviral drug, and characteristics of adverse reactions (type, frequency, severity, preventability).

Main Results:

  • The average adverse reaction rate was 2.1 per million population annually, constituting 24.2% of all antiviral drug reactions.
  • Nevirapine (29.0%) and zidovudine (26.7%) were the most frequently implicated drugs.
  • Common reactions included hypersensitivity (24.4%), digestive disorders (15.9%), and anemia (15.6%), predominantly in adult males.
  • Over half (52.6%) of reactions were preventable, mainly due to drug interactions (68.1%) and improper dosage/prescription errors (16.2%).

Conclusions:

  • Adverse reactions to antiretrovirals in Cuban HIV/AIDS patients are frequent and of moderate severity.
  • Nevirapine and hypersensitivity were the most commonly reported drug and reaction, respectively.
  • A significant proportion of adverse reactions are preventable, highlighting the need for improved prescription practices and management of drug interactions.
Abstract

Keywords:
CubaDrug-related side effects and adverse reactionsantiretroviral agentssecondary preventiontertiary prevention

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