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% confidence intervals (CI). Among 397 charts reviewed, 377 (95.0%) 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% (N = 130) of the medical charts (0.17 adverse reactions/100 person-day), while nausea (14.5%) and vomiting (13.1%) were the most common ones. Variables independently associated with adverse reactions were: regimens with nevirapine (RH = 1.78; 95% CI = 1.07-2.96), indinavir or indinavir/ritonavir combinations (RH = 2.05; 95% CI = 1.15-3.64), female patients (RH = 1.93; 95% CI = 1.31-2.83), 5 or more outpatient visits (RH = 1.94; 95% CI = 1.25-3.01), non-adherence to antiretroviral therapy (RH = 2.38; 95% CI = 1.62-3.51), and a CD4+ count of 200 to 500 cells/mm 3 (RH = 2.66; 95% CI = 1. 19-5.90). An independent and negative association was also found for alcohol use (RH = 0.55; 95% 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.

Pharmaceutical care to pregnant women carrying human immunodeficiency virus

“…The data found were similar to those from other works (Lignani Júnior, Greco, Carneiro, 2001;Menezes de Pádua et al, 2006), in which adverse reactions appearance was detected, such as: nauseas, vomits, diarrhea, allergies, anemia, abdominal pains, fatigue, headache, insomnia, pruritus, exanthema, among others.…”

Prevalence and Extent of Adverse Drug Reactions in Sudanese Patients in Highly Active Anti-retroviral Therapy Regimens

“…Adverse reactions have been described as single symptoms (e.g., nausea, headache, anemia), or as symptoms involving organs or systems (e.g., gastrointestinal, hematological reactions), classified according to severity or intensity, or estimated using scales or absolute numbers [44,45]. Additionally, medical charts and interviews with patients represent the most commonly used sources of information in such studies [37,38,41,44,46,47].…”

“…In addition, factors positively associated with adverse reactions include female gender [44,46,48], ritonavir use compared to other PI [44,46], progressive increase in age, hemophilia, hepatotoxicity, injecting drug use [46], and immunosuppressed patients receiving NRTI [45].…”

“…Many of the ADRs (46.2%) were considered preventable, although less likely to be preventable in HIV-infected patients than in those with negative or unknown HIV status (community-acquired ADRs; P-value 0.0001); hospitalacquired ADRs; P = 0.003). Patients admitted with ADRs were older than patients not admitted with an ADR (P-value 0.003), but 60% of community-acquired ADRs at hospital admission were in patients more than 60 years old [46]. Among patients 60 years old and above, those HIV infected were more likely to be admitted with an ADR [odds ratio (OR) 2.32, 95% confidence interval P-value 0.017.…”

Adverse Drug Reactions in Children Living with HIV/AIDS Receiving First Line ART

“…This value is higher than that reported from Eastern India on children undergoing first line ART (28%; Chatterjee et al, 2012) (6) , and another that reported 30% in HIV-positive children from the age group of 5 months to 14 years (Shah, 2006) (7) . (8)(9)(10) . It is possible that the spectrum of ADRs to ART varies from one country to another.…”