ABSTRACT
Introducción: el embarazo controlado y la supresión del amamantamiento son estrategias para disminuir la transmisión vertical (TMI) del virus de inmunodeficiencia humana (VIH). La profilaxis al neonato con zidovudina o zidovudina con nevirapina se utiliza según el riesgo de TMI. Objetivo: describir la TMI entre los años 2012 y 2014 en el Centro Hospitalario Pereira Rossell (CHPR), su relación con la carga viral materna y el cumplimiento de la recomendación AZT-NVP al neonato. Material y método: estudio descriptivo en el Centro de Referencia Obstétrico - Pediátrico VIH-Sida desde 1° de setiembre de 2012 al 31de diciembre 2014. Se incluyeron los recién nacidos de mujeres con carga viral detectable o indetectable al momento del parto. Se registró la administración de zidovudina-nevirapina. Se determinó la transmisión vertical. Resultados: se incluyeron 162 mujeres, 86 con carga viral detectable o desconocida y 76 indetectable. Las primeras tuvieron 88 hijos y las segundas 76. La TMI global fue de 4,9%; 9% en el primer grupo y 0% en el segundo. Se registró asociación entre TMI y CV materna (p <0,05). La administración de AZT-NVP se indicó en 46,5% de los niños. De los ocho niños infectados, la TMI fue intraútero en cinco. En los tres restantes, dos recibieron AZT y otro ninguna profilaxis. Discusión y conclusiones: la mitad de las mujeres no controló bien su embarazo. La TMI promedio fue de 4,9%. De los ocho infectados, cinco fueron intraútero; solo un diagnóstico y tratamiento precoces lo hubiesen evitado. El protocolo AZT-NVP no se utiliza en forma adecuada. Quizá su aplicación en los tres niños restantes hubiera evitado la infección.
Introduction: controlled pregnancy and interruption of breastfeeding are strategies used to reduce vertical transmission of the immunodeficiency virus (HIV). Neonates are subject to prophylactic treatment of zidovudine or combination therapy with zidovudine and nevirapine based on the mother-to-child transmission risk. Objective: to describe mother-to-child transmission from 2012 to 2014 at the Pereira Rossell Hospital Center, its relationship with the maternal viral load and the observation of the AZT-NVP prophylactic treatment recommended for neonates. Method: descriptive study, at the Obstetric Pediatrix HIV-Aids Reference Center from September 1, 2012 until December, 31, 2014. The newborns to mother with detectable or undetectable viral loads at the time of delivery. Administration of zidovudine-nevirapine was recorded. Vertical transmission was defined. Results: 162 women were included in the study, 86 of them with a detectable or unknown viral load and 76 women with a detectable load. The first group gave birth to 88 children and the second one to 76. Global mother-to-child transmission rate was 4.9%, 9% in the first group and 0% in the second one. The association between mother-to-child transmission and maternal load was recorded (P<0.05). Administration of AZT-NVP was indicated in 45.5% of children. Intrauterine mother-to child transmission was 5 for the 8 infected children. As to the other three children: 2 received AZT and another one received no prophylactic therapy. Discussion and conclusions: fifty per cent of the women's pregnancies were not dully controlled. Average mother-to-child transmission was 4.9%. Out of the 8 infected cases, 5 happened in the uterus, only an early diagnosis and treatment would have prevented it from happening. The AZT-NVP protocol is not applied in the right way. Its application on the other 3 children may have avoided the infection.
Introdução: o controle da gravidez e a supressão do aleitamento materno são estratégias para diminuir a transmissão vertical (TMI) do Vírus da Imunodeficiência Humana (VIH). No neonato, a profilaxia com zidovudina ou zidovudina com nevirapina é utilizada de acordo com o risco de TMI. Objetivo: descrever a TMI no período 2012-2014 no CHPR, sua relação com a carga viral materna e o cumprimento da recomendação AZT-NVP no neonato. Material e métodos: estudo descritivo, realizado no Centro de Referencia Obstétrico- Pediátrico VIH-Sida no período 1° de setembro de 2012 31 de dezembro de 2014. Foram incluídos os recém-nascidos de mulheres com carga viral (CV) detectável ou indetectável no momento do parto. A administração de zidovudina nevirapina e a transmissão vertical foram registradas. Resultados: foram incluídas 162 mulheres, 86 com carga viral detectável ou desconhecida e 76 indetectável. As primeiras tiveram 88 filhos e as segundas 76. A TMI global foi de 4,9%, 9% no primeiro grupo e 0% no segundo. A associação entre TMI e CV materna (P<0.05) foi registrada. A administração de AZT-NVP foi indicada em 46.5% das crianças. Nas 8 crianças infectadas, a TMI foi intrauterina em 5 . Nas 3 restantes, duas receberam AZT e a restante não recebeu nenhum tipo de profilaxia. Discussão e conclusões: a metade das mulheres não controlou sua gravidez adequadamente. A TMI média foi de 4.9%. Das 8 infectadas, 5 foram intrauterinas; somente o diagnóstico e tratamento precoces poderiam ter evitado. O protocolo AZT-NVP, não foi utilizado de forma adequada. É possível que sua aplicação nas 3 crianças restantes tivesse evitado a infecção.
Subject(s)
Pregnancy , HIV Infections/therapy , Infectious Disease Transmission, Vertical/prevention & control , Nevirapine/therapeutic use , Zidovudine/therapeutic useABSTRACT
O presente trabalho se constitui de dois estudos clínicos realizados em Maputo, Moçambique, dos quais participaram 570 pacientes com infecção pelo HIV e tuberculose. Seus objetivos principais foram: a) determinar os parâmetros farmacocinéticos da rifampicina e da isoniazida na ausência e na presença da terapia antirretroviral (TARV) e b) comparar as concentrações plasmáticas da nevirapina e do efavirenz em vigência do tratamento para a tuberculose e após a sua descontinuação. Os dois estudos foram parte do ensaio clínicoANRS12146-CARINEMO, cujo objetivo foi comparar a eficácia e tolerância da terapia antirretroviral com base em nevirapina ou efavirenz quando coadministrada com a terapia padrão antituberculose. O tratamento para tuberculose foi composto por doses diárias de rifampicina e isoniazida, durante 6 meses, associadas a pirazinamida e etambutol nos dois primeiros meses. A TARV foi iniciada entre 4 e 6 semanas do tratamento para a tuberculose e os pacientes foram randomizados para receber nevirapina sem dose escalonada (200 mg duas vezes ao dia) ou efavirenz (600 mg dose única diária), ambos combinados com lamivudina e estavudina...
This work is composed of two clinical studies in Maputo, Mozambique, from which participated in 570 patients with co-infection with HIV and tuberculosis. Its main objectives were: a) determine the pharmacokinetic parameters of rifampicin and isoniazid in the absence and presence of antiretroviral therapy (ART) and b) compare the plasma concentrations of nevirapine and efavirenz in effectiveness of treatment for tuberculosis and after their discontinuation . The two studies were of the clínicoANRS12146-CARINEMO trial whose aim was to compare the efficacy and tolerability of antiretroviral therapy based on nevirapine or efavirenz when co-administered with the standard antituberculous therapy. The treatment for tuberculosis was composed of daily doses of rifampicin and isoniazid for 6 months, pyrazinamide and ethambutol associated with the first two months. The ART was initiated between 4 and 6 weeks of treatment for tuberculosis and patients were randomized to receive nevirapine without scaled dose (200 mg twice daily) or efavirenz (600 mg once daily), both in combination with lamivudine and stavudine...
Subject(s)
Humans , AIDS-Related Opportunistic Infections , HIV , Nevirapine , Rifampin , Tuberculosis , Antiretroviral Therapy, Highly Active , Drug Interactions , Hepatitis B virusABSTRACT
Data regarding epidemiological aspects, antiretroviral drug safety, and outcomes of HIV-infected pregnant women and their newborns are limited in Argentina. We underwent a retrospective analysis of registries of HIV-infected pregnant women assisted at Helios Salud, Buenos Aires, Argentina (1997-2006). Variables associated with preterm delivery and neonatal complications were analyzed by univariate and logistic regression analyses. A total of 204 mother-child binomium were included. Maternal age (median): 29 years; 32.5% without prior diagnosis of HIV-infection. Baseline median CD4 T-cell count: 417 cell/μl; 98% received antiretroviral drugs during pregnancy [2 nucleoside analogs plus either nevirapine (55%) or a protease inhibitor (32%)]. Overall incidence of toxicity was 12.5%: rash (8%), anemia (3.5%) and hepatotoxicity (1%). Rash was associated with exposure to nevirapine. Eighty one percent and 50% reached HIV-viral loads <1000 and <50 copies/ml at the end of pregnancy, respectively. Twenty six percent had obstetric complications and 16% had preterm delivery. Of the newborns, 1.6% had congenital defects and 9% had neonatal complications. Overall neonatal mortality was 1% and perinatal transmission was 0.7%. Protease inhibitor use and obstetric complications were associated to preterm delivery while obstetric complications were associated with neonatal complications. In our population, hepatotoxicity was low despite frequent use of nevirapine. Protease inhibitor use was associated to preterm delivery. A favorable virological response and a low rate of perinatal transmission was observed, what supports the consensus that antiretroviral therapy benefits during pregnancy outweigh risks of maternal and neonatal adverse events.
La información sobre aspectos epidemiológicos, seguridad de drogas antirretrovirales y evolución de mujeres embarazadas HIV positivas y sus hijos es limitada en la Argentina. Realizamos un análisis retrospectivo de registros de embarazadas HIV positivas asistidas en Helios Salud, Buenos Aires, Argentina (1997-2006). Las variables asociadas con parto prematuro y complicaciones neonatales se estudiaron mediante análisis univariado y regresión logística. Estudiamos 204 binomios madre-hijo. Edad materna (mediana): 29 años, 32.5% sin diagnóstico previo de HIV. Recuento de linfocitos T CD4+ (mediana): 417 células/μl. El 98% recibió tratamiento antirretroviral durante el embarazo [dos análogos de nucleósidos más nevirapina (55%) o un inhibidor de proteasa (32%)]. La incidencia global de toxicidad fue 12.5%: erupción cutánea (8%), anemia (3.5%) y hepatotoxicidad (1%). La exposición a nevirapina se asoció con rash. El 81% y 50% alcanzaron cargas virales <1000 y <50 copias/ml preparto, respectivamente. Cesárea programada: 68%; complicaciones obstétricas: 26%; parto prematuro: 16%. De los neonatos, 1.6% presentaron defectos congénitos y el 9% complicaciones neonatales. La mortalidad neonatal fue 1% y la transmisión vertical: 0.7%. Las complicaciones obstétricas y el uso de inhibidores de proteasa se asociaron a parto prematuro; las complicaciones obstétricas se asociaron con complicaciones neonatales. La tasa de hepatotoxicidad fue baja a pesar de la utilización frecuente de nevirapina; el uso de inhibidores de proteasa se asoció a parto prematuro. Se observó una respuesta virológica favorable y una baja tasa de transmisión vertical, lo que apoya el consenso de que el beneficio de las drogas antirretrovirales durante el embarazo supera el riesgo de efectos adversos maternos y neonatales.
Subject(s)
Adult , Female , Humans , Infant , Infant, Newborn , Pregnancy , HIV Infections/epidemiology , Pregnancy Complications, Infectious/epidemiology , Anti-HIV Agents/therapeutic use , Antiretroviral Therapy, Highly Active/adverse effects , Antiretroviral Therapy, Highly Active/standards , Argentina/epidemiology , Follow-Up Studies , HIV Infections/drug therapy , Infant, Premature , Maternal Age , Nevirapine/therapeutic use , Pregnancy Outcome , Pregnancy Complications, Infectious/drug therapy , Pregnancy Complications, Infectious/prevention & control , Regression Analysis , Retrospective Studies , Viral LoadABSTRACT
El Virus de inmunodeficiencia humana (VIH), es un retrovirus que afecta la inmunidad celular mediante la unión selectiva a células que expresan la molécula CD4 en su superficie, en especial los linfocitos T. Descubierto en la década de los 80, ha cobrado la vida de 20 millones de personas hasta la actualidad, con un remanente de 37.8 millones que aún quedan como portadores. De esta última cifra, más de un 50 son niños infectados perinatalmente, con una tasa de 1.500 por día a nivel mundial23. Se han realizado varios trabajos en la última década (PACTG 076, PACTG 316, entre otros), para comprobar la eficacia de la zidovudina, sola y asociada a otros inhibidores de la transcriptasa. La falta de recursos en países como el nuestro imposibilita la implementación adecuada del esquema profiláctico de transmisión perinatal utilizado en países del primer mundo, por lo que debemos utilizar otras combinaciones terapéuticas aún en estudio. Para documentar la eficacia del esquema más utilizado en nuestro medio: biterapia estándar de lamivudina (3TC) y zidovudina (AZT), más la adición de una monodosis de nevirapina justo antes del parto, se realizó un estudio de cohorte, observacional, retrospectivo y comparativo en el hospital maternidad Mariana de Jesús, de la ciudad de Guayaquil, debido a su alta incidencia de casos11. El estudio abarcó madres VIH positivo con embarazos interrumpidos por cesárea durante el año 2004, así como también datos de sus neonatos. A fin de sustentar la eficacia de la terapia, se tomaron en consideración los valores de carga viral, obtenidos por PCR y contaje celular CD4, ambos realizados en los laboratorios del Instituto Nacional de Higiene Leopoldo Izquieta Pérez, de Guayaquil. Así como también, datos de laboratorio relevantes a los efectos secundarios que pudieran haber sido ocasionados por esta asociación terapéutica, en especial valores de hemoglobina para el seguimiento del efecto secundario más común de esta terapia que es la anemia.
Human immunodeficiency virus (VIH), is a retrovirus affecting cellular immunity through selective union to cells with CD4 molecule expression in their surfaces, especially T-lymphocytes. Discovered in the 80s, it has killed 20 million up to now, with a remnant of 37.8 million carriers. From the last figure, more than 50 are children infected in perinatal stage, with a world rate of 1,500 per day23. In the last decade several papers have been made (PACTG 076, PACTG 316, among others), to check the effectiveness of zidovuline, alone, and associated to other transcriptase inhibitors. Lack of resources in countries like ours makes impossible to carry out appropriately the preventive system of perinatal transmission used in the first world countries; therefore we have to use other therapy combinations which are still object of studies. To document the effectiveness of the most used system in our country: standard lamivudine (3TC) and zidovuline (AZT) bitherapy, plus a dose of neviparine just before labor, a cohort, observational, retrospective and comparative study was carried out in the maternity hospital Mariana de Jesús in Guayaquil because of its high case incidence11. The study included positive HIV mothers with interrupted pregnancies by cesarian section during 2004, as well as their newborn data. In order to uphold the effectiveness of the therapy, viral load values, obtained by PCR and cell count CD4 (both made in the Instituto Nacionalde Higiene Leopoldo Izquieta Pérez laboratories), were considered. Laboratory data related to side effects that could be produced by this combined therapy were also considered, especially hemoglobin values to make the follow up of the most common side effect: anemia.