Antiretroviral-Related Adverse Reactions: A Cause for Concern

Abstract

Felix Tetteh Dadebo41767, Ebenezer Wiafe41768*, Neelaveni Padayachee41769, Celenkosini Thembelenkosini Nxumalo41770, Frasia Oosthuizen41771, Varsha Bangalee41772 and Berko Panyin Anto41773

Background: Safety monitoring of medicines is key to the overall quality of care for Persons Living with HIV on Antiretroviral Therapy. As Ghana scales up access to Antiretroviral treatment towards ending the global AIDS pandemic by the year 2030, there is a need to monitor and evaluate treatment-related Adverse Drug Reactions amongst Persons Living with HIV at all levels, including district hospitals.

Objective: To determine the prevalence, types, causes, and outcomes of Adverse Drug Reactions in patients being managed with Antiretrovirals at a secondary health facility in Ghana.

Method: A quantitative retrospective study was conducted to collect data on Adverse Drug Reactions that had occurred amongst HIV-positive patients on Antiretroviral Therapy (ART). A total of 350 active HIV-positive adults on ART were interviewed at the Antiretroviral Center from June 2020 to August 2020. The results of 109 out of 350 patients who reported ADRs were analyzed using Statistical Package for Social Sciences (SPSS) version 20. Naranjo’s and Hartwig’s assessment scales were used for causality and severity assessments of ADRs, respectively. Prevalence was determined as a proportion of the study population with ADRs.

Results: The prevalence of Adverse Drug Reactions (ADRs) was 31%. More females (84%) than males (16%) reported ADRs with the highest number of ADRs reported amongst the middle age group (41-50 years). Dizziness (32.5%) was the most common type of ADR reported, followed by abnormal dreams (7.7%), palpitations (7.1%), and vomiting (5.9%). The fixed-dose combination, Tenofovir/Lamivudine/Efavirenz, was the Antiretroviral most frequently associated with ADRs (49.1%); followed by Zidovudine/Lamivudine/Nevirapine (14.7%) and the single-dose Efavirenz (8.6%). Most of the ADRs were mild (55%) to moderate (32%). Almost 12% of ADRs were severe and 8% were life-threatening. ADRs were categorized as “possible” (84%) and “probable” (16%) according to Naranjo’s probability scale. Actions taken in response to ADRs included no change of active medications (73%); changing of medications to a new regimen (22%) and withdrawal of the suspected drug(s) (5%).

Conclusion: The prevalence of ADRs is high amongst HIV-positive patients being managed on Antiretroviral Therapy at the study facility. This calls for pragmatic steps to enforce pharmacovigilance at all levels of HIV treatment centers to forestall non-adherence and reduce mortality.