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Comparison of anti-retroviral therapy treatment strategies in prevention of mother-to-child transmission in a teaching hospital in Ethiopia Translated title: Comparación de estrategias de tratamiento antirretroviral en prevención de transmisión madre a hijo en un hospital universitario de Etiopia

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      Abstract

      Background: More than 90% of Human immunodeficiency virus (HIV) infection in children is acquired due to mother-to-child transmission, which is spreading during pregnancy, delivery or breastfeeding. Objective: To determine the effectiveness of highly active antiretroviral and short course antiretroviral regimens in prevention of mother-to-child transmission of HIV and associated factors Jimma University Specialized Hospital (JUSH). Method: A hospital based retrospective cohort study was conducted on HIV infected pregnant mothers who gave birth and had follow up at anti-retroviral therapy (ART) clinic for at least 6 months during a time period paired with their infants. The primary and secondary outcomes were rate of infant infection by HIV at 6 weeks and 6 months respectively. The Chi-square was used for the comparison of categorical data multivariate logistic regression model was used to identify the determinants of early mother-to-child transmission of HIV at 6 weeks. Cox proportional hazard model was used to analyze factors that affect the 6 month HIV free survival of infants born to HIV infected mothers. Results: A total of 180 mother infant pairs were considered for the final analysis, 90(50%) mothers received single dose nevirapine (sdNVP) designated as regimen-3, 67 (37.2%) mothers were on different types of ARV regimens commonly AZT + 3TC + NVP (regimen-1), while the rest 23 (12.8%) mothers were on short course dual regimen AZT + 3TC + sdNVP (regimen-2). Early mother-to-child transmission rate at 6 weeks for regimens 1, 2 and 3 were 5.9% (4/67), 8.6% (2/23), and 15.5% (14/90) respectively. The late cumulative mother-to-child transmission rate of HIV at 6 months regardless of regimen type was 15.5% (28/180). Postnatal transmission at 6 months was 28.5% (8/28) of infected children. Factors that were found to be associated with high risk of early mother-to-child transmission of HIV include duration of ARV regimen shorter than 2 months during pregnancy (OR=4.3, 95%CI =1.38-13.46), base line CD4 less than 350 cells/cubic mm (OR=6.98, 95%CI=0.91-53.76), early infant infection (OR=5.4, 95%CI=2.04-14.4), infants delivered home (OR=13.1, 95%CI=2.69-63.7), infant with birth weight less than 2500 g (OR=6.41, 95%CI=2.21-18.61), and mixed infant feeding (OR=6.7, 95%CI=2.2-20.4). Antiretroviral regimen duration less than 2 months, maternal base line CD4 less than 350 cells/cubic mm and mixed infant feeding were also important risk factors for late infant infection or death. Conclusion: The effectiveness of multiple antiretroviral drugs in prevention of early mother-to-child transmission of HIV was found to be more effective than that of single dose nevirapine, although, the difference was not statistically significant. But in late transmission, a significant difference was observed in which infants born to mother who received multiple antiretroviral drugs were less likely to progress to infection or death than infants born to mothers who received single dose nevirapine.

      Translated abstract

      Antecedentes: Más del 90% de la infección por virus de inmunodeficiencia humana (VIH) en niños es adquirida debido a una transmisión madre-hijo que se establece durante el embarazo, parto o lactación. Objetivo: Determinar la efectividad de antiretrovirales altamente activos en la prevención de la transmisión madre-hijo del VIH y sus factores asociados en el Hospital Universitario de JIMMA (JUSH). Método: Se realizó un estudio de cohorte retrospectiva sobre madres que dieron a luz infectadas de VIH y tuvieron seguimiento en la Clinical de tratamiento antirretroviral (ART) por al menos un periodo de 6 meses emparejado con sus hijos. Los resultados primarios y secundarios fueron la tasa de infección por VIH en niños a las 6 semanas y 6 meses, respectivamente. Se utilizó el chi-cuadrado para comparación de los datos categóricos y un modelo de regresión logística multivariado para identificar los determinantes de transmisión temprana madre-hijo a las 6 semanas. Se usó el modelo de riesgo proporcional de Cox para analizar los factores que afectaron la supervivencia libre de VIH a 6 meses de niños nacidos de madres con VIH. Resultados: Se consideraron un total de 180 pares madre/hijo para el análisis final, 90 (50%) madres recibieron una dosis única de nevirapina (sdNVP) denominado régimen-3, 67 (37,2%) madres recibieron diferentes tipos de regímenes ARV, normalmente AZT+3TC+NVP (régimen-1), mientras que las restantes 23 (12,8%) estuvieron a tratamiento con un régimen corto de AZT + 3TC + sdNVP (régimen-2). La tasa temprana de transmisión madre-hijo a 6 semanas para los regímenes 1, 2 y 3 fue 5,9% (4/67), 8,6% (2/23), y 15,5% (14/90), respectivamente. La tasa tardía acumulativa de transmisión madre-hijo a los 6 meses, independientemente del régimen, fue del 15,5% (28/180). La transmisión postnatal a 6 meses fue del 28,5% (8/28) de los niños infectados. Los factores que se encontraron asociados a alto riesgo de transmisión de VIH madre-hijo incluían la duración del régimen ARV menor de 2 meses durante el embarazo (OR=4,3; 95%CI =1,38-13,46), CD4 al inicio de menos de 350 células/mm cubico (OR=6,98; 95%CI=0,91-53,76) , infección temprana del niño (OR=5,4, 95%CI=2,04-14,4), niños nacidos en casa (OR=13,1; 95%CI=2,69-63,7), niños nacidos con peso menor de 2500 g (OR=6,41; 95%CI=2,21-18,61), y alimentación infantil mixta (OR=6,7; 95%CI=2,2-20,4). La duración del régimen menor de 2 meses, las CD4 iniciales en menos de 350 celulas7mm cubico y la alimentación infantil mixta fueron también factores de riesgo importantes para infección infantil tardía y muerte. Conclusión: se encontró que la efectividad de los tratamientos antirretrovirales múltiples para la prevención de transmisión temprana madre-hijo de VIH era más efectiva que la dosis única de nevirapina, aunque la diferencia no era estadísticamente significativa. Pero en transmisión tardía, se observó una diferencia significativa en la que los niños nacidos de madres que recibieron tratamientos antirretrovirales múltiples tenían menos probabilidad de progresar hacia la infección que los niños de madres tratadas con una dosis única de nevirapina.

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      Most cited references 55

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      Prevention of HIV-1 infection with early antiretroviral therapy.

      Antiretroviral therapy that reduces viral replication could limit the transmission of human immunodeficiency virus type 1 (HIV-1) in serodiscordant couples. In nine countries, we enrolled 1763 couples in which one partner was HIV-1-positive and the other was HIV-1-negative; 54% of the subjects were from Africa, and 50% of infected partners were men. HIV-1-infected subjects with CD4 counts between 350 and 550 cells per cubic millimeter were randomly assigned in a 1:1 ratio to receive antiretroviral therapy either immediately (early therapy) or after a decline in the CD4 count or the onset of HIV-1-related symptoms (delayed therapy). The primary prevention end point was linked HIV-1 transmission in HIV-1-negative partners. The primary clinical end point was the earliest occurrence of pulmonary tuberculosis, severe bacterial infection, a World Health Organization stage 4 event, or death. As of February 21, 2011, a total of 39 HIV-1 transmissions were observed (incidence rate, 1.2 per 100 person-years; 95% confidence interval [CI], 0.9 to 1.7); of these, 28 were virologically linked to the infected partner (incidence rate, 0.9 per 100 person-years, 95% CI, 0.6 to 1.3). Of the 28 linked transmissions, only 1 occurred in the early-therapy group (hazard ratio, 0.04; 95% CI, 0.01 to 0.27; P<0.001). Subjects receiving early therapy had fewer treatment end points (hazard ratio, 0.59; 95% CI, 0.40 to 0.88; P=0.01). The early initiation of antiretroviral therapy reduced rates of sexual transmission of HIV-1 and clinical events, indicating both personal and public health benefits from such therapy. (Funded by the National Institute of Allergy and Infectious Diseases and others; HPTN 052 ClinicalTrials.gov number, NCT00074581.).
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        Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. Pediatric AIDS Clinical Trials Group Protocol 076 Study Group.

        Maternal-infant transmission is the primary means by which young children become infected with human immunodeficiency virus type 1 (HIV). We conducted a randomized, double-blind, placebo-controlled trial of the efficacy and safety of zidovudine in reducing the risk of maternal-infant HIV transmission. HIV-infected pregnant women (14 to 34 weeks' gestation) with CD4+ T-lymphocyte counts above 200 cells per cubic millimeter who had not received antiretroviral therapy during the current pregnancy were enrolled. The zidovudine regimen included antepartum zidovudine (100 mg orally five times daily), intrapartum zidovudine (2 mg per kilogram of body weight given intravenously over one hour, then 1 mg per kilogram per hour until delivery), and zidovudine for the newborn (2 mg per kilogram orally every six hours for six weeks). Infants with at least one positive HIV culture of peripheral-blood mononuclear cells were classified as HIV-infected. From April 1991 through December 20, 1993, the cutoff date for the first interim analysis of efficacy, 477 pregnant women were enrolled; during the study period, 409 gave birth to 415 live-born infants. HIV-infection status was known for 363 births (180 in the zidovudine group and 183 in the placebo group). Thirteen infants in the zidovudine group and 40 in the placebo group were HIV-infected. The proportions infected at 18 months, as estimated by the Kaplan-Meier method, were 8.3 percent (95 percent confidence interval, 3.9 to 12.8 percent) in the zidovudine group and 25.5 percent (95 percent confidence interval, 18.4 to 32.5 percent) in the placebo group. This corresponds to a 67.5 percent (95 percent confidence interval, 40.7 to 82.1 percent) relative reduction in the risk of HIV transmission (Z = 4.03, P = 0.00006). Minimal short-term toxic effects were observed. The level of hemoglobin at birth in the infants in the zidovudine group was significantly lower than that in the infants in the placebo group. By 12 weeks of age, hemoglobin values in the two groups were similar. In pregnant women with mildly symptomatic HIV disease and no prior treatment with antiretroviral drugs during the pregnancy, a regimen consisting of zidovudine given ante partum and intra partum to the mother and to the newborn for six weeks reduced the risk of maternal-infant HIV transmission by approximately two thirds.
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          Fundamentals of Biostatistics

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            Author and article information

            Affiliations
            [1 ] Jimma University Ethiopia
            [2 ] Jimma University Ethiopia
            [3 ] Tehran University of Medical Sciences Iran
            Contributors
            Role: ND
            Role: ND
            Role: ND
            Journal
            pharmacy
            Pharmacy Practice (Granada)
            Pharmacy Pract (Granada)
            Centro de Investigaciones y Publicaciones Farmacéuticas (Redondela )
            1885-642X
            June 2015
            : 13
            : 2
            : 0
            S1885-642X2015000200003
            10.18549/PharmPract.2015.2.539

            http://creativecommons.org/licenses/by/4.0/

            Product
            Product Information: SciELO Spain
            Categories
            PHARMACOLOGY & PHARMACY

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