OBJECTIVES

The purpose of this study is to identify the trends in adverse drug reaction (ADR) reporting most commonly associated with medication used to treat HIV-1 infection.

METHODS

Reports of adverse events related to the administration of medication used to treat HIV/AID were acquired from the FDA’s Adverse Event Reporting System (FAERS) database between January 2001 and November 2017. Reports of HIV treatment-related events were identified by searching for the brand and generic names of all FDA-approved HIV medications. Descriptive statistics were utilized in summarizing AE trends based upon drug class, reporting period, reporter type and seriousness of the reported event.

RESULTS

According to the FAERS, more than 100,000 reports of HAART-related adverse events were received between 2001 and 2017. Of those events reported through August 2017, 83% were classified as serious with an additional 9.44% resulting in death. Upon stratification by drug class it was noted that nucleoside reverse transcriptase inhibitors (NRTIs) were the class most frequently associated with total reported cases (43.72%), serious events (46.98%), and deaths (46.96%).

CONCLUSIONS

This study showed that adverse drug reactions were more commonly noted following administration of NRTIs which should be cause for concern. There were also peaks in reporting of adverse events that did not correspond to any known changes in policy, yet a more thorough search may highlight changes not observed following a cursory policy review. Overall, the results may be used to inform monitoring, risk management assessment and planning activities by various stakeholders in order to assess mediation safety and effectiveness for patients receiving ART.