Highly active antiretroviral treatment containing efavirenz or nevirapine and related toxicity in the TREAT Asia HIV Observational Database.
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ABSTRACT: Nevirapine-based therapy is associated with increased frequency of adverse events among HIV-infected pregnant women. The aim of this article was to evaluate the incidence of adverse effects in HIV-infected women who started nevirapine during pregnancy. A retrospective study was performed in our center between January 2003 and December 2006 analyzing all women prescribed nevirapine during pregnancy. Women presenting any risk factor for hepatotoxicity were excluded from the analysis. Patients were divided into two groups according to the presence or absence of adverse effects, and a correlation to CD4 counts was performed. Liver function abnormality was graded according to the Division of AIDS toxicity guidelines. A total of 170 women initiated nevirapine during pregnancy, but only 133 were included in the study. Twenty-seven women (20.3%) presented adverse effects, skin rash accounting for 77.8% (21/27 women) and liver function abnormalities for 22.2% (6/27) of the cases. Baseline CD4 counts, viral loads and transaminases were similar in both groups. All nevirapine side effects were developed in less than seven weeks. Four of 31 women with CD4 counts <250 cells/microL (12.9%) and 23 of 102 women with CD4 counts > or = 250 cells/microL (22.5%) developed adverse events. All patients who experienced hepatotoxicity had pretreatment CD4 counts > or =250 cells/microL. The incidence of adverse events with nevirapine in our study was high, but most of them were cutaneous. There was no correlation between high CD4 counts and adverse events when analyzing both cutaneous and hepatic reactions; nevertheless, hepatotoxicity occurred only in pregnant women with CD4 counts > or =250 cells/microL.Brazilian Journal of Infectious Diseases 01/2008; 11(6):544-8. DOI:10.1590/S1413-86702007000600004 · 1.10 Impact Factor
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ABSTRACT: We studied hepatic transaminases among rural Ugandans initiating highly active antiretroviral therapy (HAART) and assessed the impact of positive serology for hepatitis B surface antigen (HBsAg) and coadministration of therapy for tuberculosis. From July 2003 to December 2004, persons with symptomatic HIV disease or a CD4 count less than 250 cells/mm(3) and who had alanine transferase (ALT) or aspartate transferase (AST) less than 5 times the upper limit of normal were started on HAART including nevirapine (96%) or efavirenz (4%). Repository sera from a subset of 596 participants were analyzed for hepatic transaminase levels. A transaminase elevation was present before therapy for 249 (42%) of 596, at 3 months for 140 (25%) of 553, 12 months for 59 (11%) of 520, and 24 months for 67 (13%) of 508. In multivariate analyses, a transaminase elevation at 3 months was associated with male gender (odds ratio [OR], 1.55; 95% confidence interval [CI], 1.02-2.35), body mass index less than 18 kg/m(2) (OR, 2.10; 95% CI, 1.34-3.30), transaminase elevation at baseline (OR, 1.97; 95% CI, 1.30-2.99), and treatment for tuberculosis (OR, 4.68; 95% CI, 2.28-9.59). HBsAg status was not associated with transaminase elevations at baseline or while on HAART. The prevalence of hepatic transaminase elevations decreased during non-nucleoside reverse transcriptase inhibitor (NNRTI)-based antiretroviral therapy in this cohort of HIV-infected persons in rural Uganda.AIDS patient care and STDs 10/2008; 22(10):787-95. DOI:10.1089/apc.2008.0020 · 3.58 Impact Factor
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ABSTRACT: The aim of our study was to develop, on the basis of simple clinical data, predictive short-term risk equations for AIDS or death in Asian patients infected with human immunodeficiency virus (HIV) who were included in the TREAT Asia HIV Observational Database. Inclusion criteria were highly active antiretroviral therapy initiation and completion of required laboratory tests. Predictors of short-term AIDS or death were assessed using Poisson regression. Three different models were developed: a clinical model, a CD4 cell count model, and a CD4 cell count and HIV RNA level model. We separated patients into low-risk, high-risk, and very high-risk groups according to the key risk factors identified. In the clinical model, patients with severe anemia or a body mass index (BMI; calculated as the weight in kilograms divided by the square of the height in meters) <or= 18 were at very high risk, and patients who were aged <40 years or were male and had mild anemia were at high risk. In the CD4 cell count model, patients with a CD4 cell count <50 cells/microL, severe anemia, or a BMI <or=18 were at very high risk, and patients who had a CD4 cell count of 51-200 cells/microL, were aged <40 years, or were male and had mild anemia were at high risk. In the CD4 cell count and HIV RNA level model, patients with a CD4 cell count <50 cells/microL, a detectable viral load, severe anemia, or a BMI <or=18 were at very high risk, and patients with a CD4 cell count of 51-200 cells/microL and mild anemia were at high risk. The incidence of new AIDS or death in the clinical model was 1.3, 4.9, and 15.6 events per 100 person-years in the low-risk, high-risk, and very high-risk groups, respectively. In the CD4 cell count model the respective incidences were 0.9, 2.7, and 16.02 events per 100 person-years; in the CD4 cell count and HIV RNA level model, the respective incidences were 0.8, 1.8, and 6.2 events per 100 person-years. These models are simple enough for widespread use in busy clinics and should allow clinicians to identify patients who are at high risk of AIDS or death in Asia and the Pacific region and in resource-poor settings.Clinical Infectious Diseases 03/2009; 48(7):940-50. DOI:10.1086/597354 · 9.42 Impact Factor