High incidence of adverse reactions to initial antiretroviral therapy in Brazil

ABSTRACT

A concurrent prospective study was conducted from 2001 to 2003 to assess factors associated with adverse reactions among individuals initiating antiretroviral therapy at two public referral HIV/AIDS centers in Belo Horizonte, MG, Brazil. Adverse reactions were obtained from medical charts reviewed up to 12 months after the first antiretroviral prescription. Cox proportional hazard model was used to perform univariate and multivariate analyses. Relative hazards (RH) were estimated with 95 percent confidence intervals (CI). Among 397 charts reviewed, 377 (95.0 percent) had precise information on adverse reactions and initial antiretroviral treatment. Most patients received triple combination regimens including nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors and protease inhibitors. At least one adverse reaction was recorded on 34.5 percent (N = 130) of the medical charts (0.17 adverse reactions/100 person-day), while nausea (14.5 percent) and vomiting (13.1 percent) were the most common ones. Variables independently associated with adverse reactions were regimens with nevirapine (RH = 1.78; 95 percent CI = 1.07-2.96), indinavir or indinavir/ritonavir combinations (RH = 2.05; 95 percent CI = 1.15-3.64), female patients (RH = 1.93; 95 percent CI = 1.31-2.83), 5 or more outpatient visits (RH = 1.94; 95 percent CI = 1.25-3.01), non-adherence to antiretroviral therapy (RH = 2.38; 95 percent CI = 1.62-3.51), and a CD4+ count of 200 to 500 cells/mm³ (RH = 2.66; 95 percent CI = 1.19-5.90). An independent and negative association was also found for alcohol use (RH = 0.55; 95 percent CI = 0.33-0.90). Adverse reactions were substantial among participants initiating antiretroviral therapy. Specially elaborated protocols in HIV/AIDS referral centers may improve the diagnosis, management and prevention of adverse reactions, thus contributing to improving adherence to antiretroviral therapy among HIV-infected patients.