Nelfinavir and nevirapine side effects during pregnancy

Timmermans, Sarah; Tempelman, C; Godfried, Mieke H.; Nellen, J F J B; Dieleman, Jeanne P.; Sprenger, Herman; Schneider, Margriet E. E.; Wolf, Frank de; Boer, Kees; Ende, Marchina E. van der

doi:10.1097/01.aids.0000168973.59466.14

Cited by 64 publications

(48 citation statements)

References 18 publications

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“…Some authors suggested that antiretroviral-drug-related side effects are more frequent for some AIDS-associated retroviruses in pregnant than in nonpregnant HIV-infected women (14). Our study regimen was well tolerated, with no severe adverse events reported.…”

mentioning

confidence: 62%

Antiretroviral Therapy with a Twice-Daily Regimen Containing 400 Milligrams of Indinavir and 100 Milligrams of Ritonavir in Human Immunodeficiency Virus Type 1-Infected Women during Pregnancy

Ghosn

Montgolfier

Cornélie

et al. 2008

Antimicrob Agents Chemother

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We evaluated the safety and efficacy of a twice daily regimen containing 400 mg of indinavir and 100 mg of ritonavir in 32 human immunodeficiency virus (HIV)-infected women during pregnancy. The median indinavir trough concentration was 208 ng/ml during the third trimester. At delivery, 26 of 28 women on indinavirritonavir had HIV RNA levels of <200 copies/ml. No infant was HIV infected. These data are encouraging for the use of this combination for prevention of mother-to-child transmission of HIV.Protease inhibitor (PI)-based combinations are the current standard of care for human immunodeficiency virus type 1 (HIV-1)-infected pregnant women in France (18). Published data describing indinavir (IDV) pharmacokinetic parameters for pregnant women are limited and suggest that IDV plasma concentrations may be suboptimal in pregnant women taking standard doses of IDV (7; D. Wara, R. Tuomala, and Y. Bryson, presented at the 2nd Conference on Global Strategies for the Prevention of HIV Transmission from Mothers to Infants, Montreal, Canada, 1999). Thus, use of unboosted IDV should be avoided during pregnancy (12, 15). We have previously shown the good efficacy and tolerability of a twice daily (BID) regimen containing 400 mg of IDV and 100 mg of ritonavir (hereafter referred to as IDV/r 400/100 mg BID) in patients switching from a standard IDV-containing regimen (6) and in patients initiating a first-line treatment (4). The objective of this study was to describe, in terms of effects on mothers and newborns, the safety and tolerability of and responses to an IDV/r 400/100 mg BID regimen during the antenatal period in HIV-1-infected pregnant women.In a prospective, observational, pilot, open-label, single-center, noncomparative study, the efficacy and tolerability of a triple combination of two nucleoside reverse transcriptase inhibitors and IDV/r 400/100 mg BID were evaluated for consecutive HIV-1-infected women in whom pregnancy was diagnosed before the third trimester. The patients were followed monthly with clinical examinations and biological assessments, including plasma HIV RNA (lower limit of quantification [LOQ], 200 copies/ml; Amplicor HIV monitor kit; Roche, Meylan, France) and CD4 cell counts. Steady-state IDV plasma trough concentrations (C trough values) were determined during the third trimester by high-performance liquid chromatography coupled with UV detection (LOQ, 5 ng/ml) (17). IDV C trough was determined during the month following delivery for a subset of women. The expected efficient IDV C trough was 120 ng/ml (1).The mode of delivery was determined according to plasma viral load (VL), obstetrical history, and personal decision. All women received intravenous zidovudine (ZDV) infusions initiated during labor or 2 h before elective caesarean section, and newborns received a 6-week course of ZDV (0.2 mg/kg of body weight four times a day), as recommended by French guidelines (18). All women received counseling on the risk of HIV-1 transmission through breastfeeding, and no woman reported breastfeedi...

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confidence: 62%

Antiretroviral Therapy with a Twice-Daily Regimen Containing 400 Milligrams of Indinavir and 100 Milligrams of Ritonavir in Human Immunodeficiency Virus Type 1-Infected Women during Pregnancy

Ghosn

Montgolfier

Cornélie

et al. 2008

Antimicrob Agents Chemother

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“…The careful monitoring for hepatotoxicity after initiation of ARV therapy is important since it has been demonstrated that the side effects of ARV therapy are more frequent in pregnant than in non-pregnant women. This situation is more often demonstrated with the use of nevirapine [12,13].…”

Section: Discussionmentioning

confidence: 98%

Effects of antiretroviral agents during pregnancy on liver enzymes and amylase in HIV-exposed, uninfected newborn infants

Beitune¹,

Duarte²,

Campbell³

et al. 2007

Braz J Infect Dis

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This study assessed the effect of antiretroviral drugs administered to pregnant women on amylase and liver enzymes of the neonate. A prospective study was conducted on 52 neonates divided into three groups: infants born to HIVinfected mothers taking zidovudine (ZDV group, n = 18), infants born to mothers taking zidovudine + lamivudine + nelfinavir (TT group, n = 22) and infants born to normal women (control group, n = 12). Umbilical cord blood from the newborn infant was used to determine liver transaminases and amylase. Data were analyzed statistically by nonparametric tests, with the level of significance set at p<0.05. The median levels for TT group newborns were 33.3 U/L for oxaloacetic transaminase, 21.5 U/L for pyruvic transaminase, 1.9 mg/dL for total bilirubin, 153 mg/dL for alkaline phosphatase, and 9.6 U/L for amylase. These results did not differ from those obtained for Control newborns or newborns exposed to ZDV alone. No association was observed between the use of antiretroviral drugs during pregnancy and adverse effects on neonatal amylase and hepatic parameters at birth.

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“…Las reacciones tóxi-cas pueden aparecer entre los 10 y los 280 días de iniciado el tratamiento (23)(24)(25)(26). La hepatotoxicidad se ha presentado en pacientes con edad entre los 18 y 45 años (21, 24-27), con elevación de las transaminasas y rash (23,(26)(27)(28)(29)(30)(31)(32)(33)(34)(35)(36)(37). Se presentó 1 caso de ductopenia, caracterizado por un tipo de lesión colestásica (25).…”

Section: Valoración De La Aparición De Hepatotoxicidadunclassified

“…Se presentó 1 caso de ductopenia, caracterizado por un tipo de lesión colestásica (25). El manejo se fundamenta en la suspensión de la nevirapina y cambio en la farmacoterapia (23,(26)(27)(28)(29). La frecuencia de hepatotoxicidad por este medicamento es variable, entre el 0,5% y el 20% (24,30,31,34,(37)(38)(39).…”

Section: Valoración De La Aparición De Hepatotoxicidadunclassified

Medicamentos causantes de hepatotoxicidad en el embarazo: revisión estructurada

Amariles

2017

Rev. Colomb. Gastroenterol.

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Objetivo: identificar los medicamentos y determinar las principales características asociadas con hepatotoxicidad por medicamentos en el embarazo.Método: revisión estructurada en PubMed/Medline, EMBASE y Web of Science utilizando los términos: Drug induced liver injury OR Hepatotoxicity AND Pregnancy. La búsqueda incluyó artículos en inglés, español, humanos, entre 2005 y 2015, con información sobre hepatotoxicidad por medicamentos en el embarazo. Fueron excluidos los artículos sin relación con embarazo o hepatotoxicidad, asociados con otras causas de enfermedad hepática o con hepatotoxicidad por otras sustancias. La información del medicamento y las características de los pacientes fueron registradas en una tabla. La probabilidad de la aparición de hepatotoxicidad fue valorada y agrupada en tres categorías: definida, probable y posible; para algunos medicamentos fue determinada por el método RUCAM.Resultados: fueron identificados 488 artículos, de los cuales 46 fueron seleccionados. Fueron identificados también 12 medicamentos (acetaminofeno, alfametildopa, labetalol, metotrexato, saquinavir, nevirapina, propiltiouracilo, metimazol, carbimazol, nitrofurantoína, ácido acetilsalicílico y piperidolato) con probabilidad de causar hepatotoxicidad en el embarazo. Algunas características asociadas con los fármacos fueron: tiempo de aparición de las reacciones, semanas de embarazo (3-36), factores de riesgo (edad y enfermedades crónicas), manifestaciones clínicas (elevación de transaminasas, prurito, ictericia) y desenlaces (trasplante de hígado, muertes materna y fetal).Conclusión: los medicamentos acetaminofeno, alfametildopa, labetalol, metotrexato, saquinavir, nevirapina, propiltiouracilo, metimazol, carbimazol, nitrofurantoína, ácido acetilsalicílico y piperidolato podrían causar hepatotoxicidad en pacientes embarazadas. Además de la dosis y del tiempo de exposición al fármaco, la edad y el tiempo de gestación podrían influir en la presentación y gravedad de la hepatotoxicidad.

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Nelfinavir and nevirapine side effects during pregnancy

Abstract: Nelfinavir- or nevirapine-containing HAART regimens during pregnancy are well tolerated. Side effects of antiretroviral therapy are more frequent in pregnant than in non-pregnant women.

Cited by 64 publications

References 18 publications

Antiretroviral Therapy with a Twice-Daily Regimen Containing 400 Milligrams of Indinavir and 100 Milligrams of Ritonavir in Human Immunodeficiency Virus Type 1-Infected Women during Pregnancy

Antiretroviral Therapy with a Twice-Daily Regimen Containing 400 Milligrams of Indinavir and 100 Milligrams of Ritonavir in Human Immunodeficiency Virus Type 1-Infected Women during Pregnancy

Effects of antiretroviral agents during pregnancy on liver enzymes and amylase in HIV-exposed, uninfected newborn infants

Medicamentos causantes de hepatotoxicidad en el embarazo: revisión estructurada

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