Adverse Drug Reactions during COVID-19 Treatment: A Comprehensive Analysis Focused on Hospitalized Patients, with the Use of a Survey in Cuba in 2020

Lizette Gil-Del-Valle; Rosario Gravier-Hernández; Waldemar Baldoquin-Rodríguez; Beatriz Sierra-Vázquez; Ana Beatriz Perez-Díaz; Pablo Sariol-Resik; Tatiana Prieto-Dominguez; Mario Manuel Delgado-Guerra; Joniel Arnoldo Sánchez-Márquez; Olga Elena López-Fernández; Faustina Fonseca-Betancourt; Liana Valdés-Lanza; Odalys Orraca-Castillo; Xaveer Van Ostade; Wim Vanden Berghe; Veerle Vanlerberghe; M Guadalupe Guzmán-Tirado

doi:10.1155/2023/1995642

Adverse Drug Reactions during COVID-19 Treatment: A Comprehensive Analysis Focused on Hospitalized Patients, with the Use of a Survey in Cuba in 2020

Adv Pharmacol Pharm Sci. 2023 Feb 1:2023:1995642. doi: 10.1155/2023/1995642. eCollection 2023.

Authors

Lizette Gil-Del-Valle¹, Rosario Gravier-Hernández¹, Waldemar Baldoquin-Rodríguez¹, Beatriz Sierra-Vázquez¹, Ana Beatriz Perez-Díaz¹, Pablo Sariol-Resik¹, Tatiana Prieto-Dominguez¹, Mario Manuel Delgado-Guerra², Joniel Arnoldo Sánchez-Márquez², Olga Elena López-Fernández², Faustina Fonseca-Betancourt², Liana Valdés-Lanza³, Odalys Orraca-Castillo³, Xaveer Van Ostade⁴, Wim Vanden Berghe⁴, Veerle Vanlerberghe⁵, M Guadalupe Guzmán-Tirado¹

Affiliations

¹ Institute "Pedro Kourí" (IPK), Havana, Cuba.
² Hospital Ernesto Guevara, University of Informatics Science, Havana, Cuba.
³ Universidad de Ciencias Médicas de Pinar del Río, Pinar del Río, Cuba.
⁴ University of Antwerp, Department of Biomedical Sciences (BMW), Faculty of Pharmaceutical, Biomedical and Veterinary Sciences (FBD), Antwerp, Belgium.
⁵ Institute of Tropical Medicine, Antwerp, Belgium.

Abstract

Aims: To evaluate the prevalence and type of adverse drug reactions (ADRs), together with associated risk factors, among Cuban COVID-19 patients treated with chloroquine (CQ), lopinavir/ritonavir (LPV/r), or interferon α2b (IFN α2b), according to the Cuban protocol.

Materials and methods: A prospective descriptive analysis of ADRs was performed on 200 COVID-19 patients who were admitted consecutively to three hospitals in Havana and Pinar del Río from April to July 2020. Information on demographics, ADRs, outcomes, behavioral, and health-related factors was collected using a validated questionnaire and clinical records. Each potential ADR case was assessed for causality based on the WHO-UMC algorithm, concomitant drug influences, and the presence of any drug-drug interactions (DDI).

Results: The total frequency of ADRs was 55%, with predominantly gastrointestinal disorders and general symptoms (23% vs 20%). 95.1% of ADRs occurred within 10 days after treatment and 42 potential DDI in 55.5% of patients (61/110) were observed. The prevalence of ADRs was: 44%, 30.4%, and 26.4% for IFN α2b, LPV/r, and CQ, respectively. Sex (odds ratio (OR): 0.40 (95% confidence interval (CI): 0.211-0.742), age (OR: 2.36 (95% CI: 1.02-5.44)), and underlying diseases (OR: 0.12 (95% CI: 0.06-0.23)) were independently associated factors for ADRs (P < 0.05).

Conclusions: The frequency of ADRs and potential DDI was high compared to their use during nonpandemic times (e.g., for malaria, HIV, or inflammatory diseases). The safety profile of these drugs when used for COVID-19 treatment showed similar characteristics. Comorbidities, age >37 years old, and female sex were associated with ADRs.