PIN147 ANTIRETROVIRAL THERAPY AND LACTIC ACIDOSIS: RISK QUANTIFICATION USING DISPROPORTIONALITY ANALYSIS IN USFDA ADVERSE EVENT REPORTING SYSTEM

Abstract

Lactic acidosis is a serious condition with poor prognosis. Antiretroviral drug class has previously been associated with lactic acidosis. This study aimed to quantify and compare the risk of lactic acidosis associated with antiretroviral drugs using disproportionality analysis of USFDA Adverse Event Reporting System (FAERS). A disproportionality analysis was performed using publicly available FAERS database from January 2010 through May 2019. Rates of lactic acidosis were calculated for each antiretroviral drug. Reporting odds ratios (RORs) and Proportional reporting ratios (PRRs) with 95% confidence intervals (CIs) were calculated. A total of 10,088 reports for lactic acidosis have been reported in the FDA database. Amongst which 702 (6.95%) reports were associated with antiretroviral drugs. The antiretroviral drugs with the highest risk estimates were Stavudine (ROR 30.15, 95% CI 18.28-44.92; PRR 29.29, 95% CI 17.93-43.04), Didanosine (ROR 29.04, 95% CI 12.42-47.74; PRR 28.19, 95% CI 12.09-45.76) and Saquinavir (ROR 22.40, 95% CI -0.165-54.14; PRR 21.78, 95% CI 0.60-49.27). Nevirapine had a ROR of 9.03 (95% CI 5.81-17.77) and PRR 9.0 (95% CI 5.76-17.70). Efavirenz (ROR 7.2, 95% CI 4.13-14.13; PRR 7.2, 95% CI 4.14-14.06), Lamivudine (ROR 5.21, 95% CI 2.98-10.43; PRR 5.24, 95% CI 2.96-10.62), Abacavir (ROR 5.70, 95% CI 3.06-11.10; PRR 5.7, 95% CI 3.07-11.04) and Ritonavir (ROR 3.01, 95% CI 2.49-5.92; PRR 3.03, 95% CI 2.51-5.99) had lower risk for lactic acidosis when compared to other antiretroviral drugs. Among antiretroviral drugs, Stavudine, Didanosine and Saquinavir have higher risk for lactic acidosis. Increased awareness of this risk among healthcare professionals, particularly variations in risk among different antiretroviral drugs may help reduce the severity and number of adverse events.