Selected adverse events and HAART regimens: Incidence, predictors, and consequences
Description
Background. The adverse events of highly active antiretroviral therapy (HAART) have been associated with discontinuation of HAART and nonadherence. Studies of adverse events in observational cohorts reveal higher incidence of adverse events than those found in clinical trials Methods. The medical records of 345 patients who initiated HAART at the HIV Outpatient Clinic in New Orleans, LA with one of the six most common initial regimens were reviewed to ascertain the incidence of selected adverse events, factors associated with experiencing an adverse event, and consequences of experiencing an adverse event Results. Gastrointestinal events (diarrhea, nausea, vomiting) were frequent among all regimens examined. Incidence of adverse events was highest in the first three months of HAART. Factors associated with experiencing an incident gastrointestinal adverse event were: use of zidovudine, use of nelfinavir or indinavir, a concurrent high viral load, being on HAART for less than three months, and for patients taking dapsone, a lower CD4 cell count. After a median follow-up of 8.1 months, 61% of patients changed or discontinued their initial HAART regimen; 24% did so because of an adverse event. The events most commonly cited as the cause for discontinuation were nausea, vomiting, and diarrhea. Factors associated with time to discontinuation due to an adverse event were concurrent nausea or vomiting, dizziness, anorexia/weight loss, and a higher viral load. Patients with a history of Pneumocystis carinii pneumonia (PCP) were less likely to discontinue their initial HAART regimen than patients who did not have a history of PCP Conclusions. Gastrointestinal adverse events of HAART are the most frequent complaints for patients on an initial regimen and are the most frequently cited reason for discontinuation of HAART. An effort should be made to educate patients about the early incidence of these events and to encourage continued adherence. Additionally, appropriate prophylaxes for these events are warranted