Routine data underestimates the incidence of first-line antiretroviral drug discontinuations due to adverse drug reactions: Observational study in two South African cohorts

By Renee de Waal, Karen Cohen, Andrew Boulle  Matthew Fox  Gary Maartens, Ehimario U Igumbor, Mary-Ann Davies  |  | 

Estimating the incidence of antiretroviral discontinuations due to adverse drug reactions (ADRs) is important to inform antiretroviral treatment (ART) regimen recommendations, and to guide prescribing and monitoring policies. Routinely collected clinical data is a useful source of pharmacovigilance data. We estimated the incidences of first-line antiretroviral discontinuations due to ADRs using routine clinical data, and compared them with incidences estimated using data enhanced by folder review, in two South African cohorts.