Use of darunavir and enfuvirtide in a pregnant woman

Sued, Omar; Lattner, Jorge; Gun, Ana; Patterson, Patricia; Abusamra, Lorena; César, Carina; Fink, Valeria; Krolewiecki, Alejandro; Cahn, Pedro

doi:10.1258/ijsa.2008.008075

Cited by 9 publications

(3 citation statements)

References 9 publications

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“…Data on the pharmacology of darunavir/ritonavir during pregnancy are limited to case reports [1][2][3][4][5][6][7][8], few of which examined pharmacokinetics [1][2][3][5][6][7]9]. The effects of pregnancy on the pharmacokinetics of darunavir remain unclear; therefore, further pharmacokinetic studies are needed.…”

Section: Introductionmentioning

confidence: 99%

Total and unbound darunavir pharmacokinetics in pregnant women infected with HIV‐1: results of a study of darunavir/ritonavir 600/100 mg administered twice daily

Wright

Osiyemi

et al. 2013

HIV Medicine

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ObjectivesAntiretroviral therapy during pregnancy is recommended to reduce the risk of mother-to-child transmission of HIV and for maternal care management. Physiological changes during pregnancy can affect pharmacokinetics, potentially altering pharmacological activity. We therefore evaluated the pharmacokinetics of twice-daily (bid) darunavir in HIV-1-infected pregnant women.MethodsHIV-1-infected pregnant women receiving an antiretroviral regimen containing darunavir/ritonavir 600/100 mg bid were enrolled in this study. Total and unbound darunavir and total ritonavir plasma concentrations were obtained over 12 h during the second and third trimesters and postpartum. Total darunavir and ritonavir plasma concentrations were determined using a validated high-performance liquid chromatography tandem mass spectrometry assay and unbound darunavir was determined using 14C-darunavir-fortified plasma. Pharmacokinetic parameters were derived using noncompartmental analysis.ResultsData were available for 14 women. The area under the plasma concentration–time curve from 0 to 12 h (AUC12h) for total darunavir was 17–24% lower during pregnancy than postpartum. The AUC12h for unbound darunavir was minimally reduced during pregnancy vs. postpartum. The minimum plasma concentration (Cmin) of total and unbound darunavir was on average 43–86% and 10–14% higher, respectively, during pregnancy vs. postpartum. The antiviral response (< 50 HIV-1 RNA copies/mL) was 33% at baseline and increased to 73–90% during treatment; the percentage CD4 count increased over time. One serious adverse event was reported (increased transaminase). All 12 infants born to women remaining in the study at delivery were HIV-1-negative; four of these infants were premature.ConclusionsTotal darunavir exposure decreased during pregnancy. No clinically relevant change in unbound (active) darunavir occurred during pregnancy, suggesting that no dose adjustment is required for darunavir/ritonavir 600/100 mg bid in pregnant women.

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Section: Introductionmentioning

confidence: 99%

Total and unbound darunavir pharmacokinetics in pregnant women infected with HIV‐1: results of a study of darunavir/ritonavir 600/100 mg administered twice daily

Wright

Osiyemi

et al. 2013

HIV Medicine

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“…Three of these involved ritonavir-boosted darunavir;132–134 the other included ritonavir-boosted tipranavir 135. All births were by cesarean delivery; in none of the cases was there transmission of HIV to the newborn.…”

Section: Antiretroviral Therapy In Pregnancymentioning

confidence: 99%

Pharmacologic and nonpharmacologic options for the management of HIV infection during pregnancy

Zorrilla

Tamayo-Agrait²

2009

HIV

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Over the past decade, significant advances have been made in the treatment of HIV-1 infection using both pharmacologic and nonpharmacologic strategies to prevent mother-to-child transmission (MTCT). Optimal prevention of the MTCT of HIV requires antiretroviral drugs (ARV) during pregnancy, during labor, and to the infant. ARVs reduce viral replication, lowering maternal plasma viral load and thus the likelihood of MTCT. Postexposure prophylaxis of ARV agents in newborns protect against infection following potential exposure to maternal HIV during birth. In general, the choice of an ARV for treatment of HIV-infected women during pregnancy is complicated by the need to consider the effectiveness of the therapy for the maternal disease as well as the teratogenic or teratotoxic potential of these drugs. Clinicians managing HIV in pregnancy need to discuss the potential risks and benefits of available therapy options so that mothers can make informed decisions in choosing the best treatment regimen for themselves and for their children.

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“…(9) Few studies published until now, mostly case reports, have evaluated the reduction in maternal-fetal transmission of HIV in multidrug-resistant pregnant women using enfuvirtide. (10)(11)(12) Furthermore, the chronic effects of this drug on maternal organs are unknown.…”

Section: ❚ Introductionmentioning

confidence: 99%

Action of enfuvirtide on the pregnancy of albino rats (Rattus norvegicus albinus, Rodentia, Mammalia): biological assay and functional and histological analyses of exposed maternal-fetal organs

Moraes¹,

Júnior²,

Castelo³

et al. 2023

Einstein (São Paulo)

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Objective: To assess the effects of enfuvirtide on pregnancy in albino rats and their fetuses. Methods: Forty pregnant EPM 1 Wistar rats were randomly allocated into four groups: control (E) (distilled water twice/day), G1 (4mg/kg/day enfuvirtide), G2 (12mg/kg/day enfuvirtide), and G3 (36mg/kg/day enfuvirtide) groups. On the 20th day of gestation, the rats were anesthetized and subjected to cesarean section. Their blood was collected for laboratory analysis, and they were sacrificed. The offspring's fragments of their kidneys, liver, and placentas and the maternal rats' fragments of their lungs, kidneys, and liver were separated in the immediate postpartum period for light microscopy analysis. Results: No maternal deaths occurred. In the second week at the end of pregnancy, the mean weight of the G3 Group was significantly lower than that of the G2 Group (p=0.029 and p=0.028, respectively). Analyzing blood laboratory parameters, the G1 Group had the lowest mean amylase level, and the G2 Group had the lowest mean hemoglobin level and the highest mean platelet count. In the morphological analysis, there were no changes in organs, such as the kidneys and liver, in both the maternal rats and offspring. Three maternal rats in the G3 Group had pulmonary inflammation in the lungs. Conclusion: Enfuvirtide has no significant adverse effects on pregnancy, conceptual products, or functional alterations in maternal rats.

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Use of darunavir and enfuvirtide in a pregnant woman

Cited by 9 publications

References 9 publications

Total and unbound darunavir pharmacokinetics in pregnant women infected with HIV‐1: results of a study of darunavir/ritonavir 600/100 mg administered twice daily

Total and unbound darunavir pharmacokinetics in pregnant women infected with HIV‐1: results of a study of darunavir/ritonavir 600/100 mg administered twice daily

Pharmacologic and nonpharmacologic options for the management of HIV infection during pregnancy

Action of enfuvirtide on the pregnancy of albino rats (Rattus norvegicus albinus, Rodentia, Mammalia): biological assay and functional and histological analyses of exposed maternal-fetal organs

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