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.
Subject(s)
Adult , Female , Humans , Male , Anti-HIV Agents/adverse effects , Antiretroviral Therapy, Highly Active/adverse effects , HIV Infections/drug therapy , Adverse Drug Reaction Reporting Systems/statistics & numerical data , Anti-HIV Agents/therapeutic use , Brazil/epidemiology , Epidemiologic MethodsABSTRACT
PURPOSE: To perform a comprehensive, multifactorial analysis of potential risk factors (demographic and clinical) for contact allergy to neomycin sulfate, a common adverse reaction resulting from the topical use of this drug; especially in some subgroups of the population. METHODS: Retrospective analysis of allergy test data of the Information Network of Departments of Dermatology (IVDK, www.ivdk.org) between 1998 and 2003, including all patients patch tested with a standard screening series because of suspected allergic contact dermatitis (ACD). As one outcome, a positive (allergic) test reaction to neomycin sulfate was considered. An alternative outcome included only those patients with a positive test to neomycin sulfate and a final diagnosis of ACD. The association between outcome and potential risk factors was analyzed with Poisson regression analysis, deriving prevalence ratios (PR) as risk estimates. RESULTS: Of the 47,559 patients tested, 2.5% had positive reactions to neomycin sulfate, while in 1.1% ACD was additionally diagnosed. The results of the multifactorial analysis indicated that the risk of both outcomes decreased slightly during the period covered; was higher among patients with leg dermatitis; varied significantly with age and increased progressively with the number of additional positive reactions to other standard series allergens. Cross-reactivity to other, selectively tested, aminoglycoside antibiotics was substantial (kappa = 0.67; 95%CI: 0.63-0.71) for framycetin sulfate, to low (kappa = 0.33; 95%CI: 0.27-0.37) for gentamicin sulfate. CONCLUSIONS: The prevalence of contact sensitization to neomycin sulfate was noteworthy among patients patch tested in the IVDK centers. Supplementing clinical epidemiology, neomycin contact allergy has been estimated to be relatively common even on the level of the unselected population (prevalence approx. 1%). Hence, the topical use of neomycin sulfate by patients should be carefully monitored, considering its potential to induce ACD, with emphasis on subgroups at risk.
