Medical Advocates
Lopinavir/Ritonavir (Kaletra/Aluvia)

Perinatal Data

New and Noteworthy
General Reports
Animal Studies
Pharmacokinetics
Efficacy
Monitoring
Adverse Events

Last Update: April 10, 2018
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New and Noteworthy

April 2018

Raltegravir versus lopinavir/ritonavir for treatment of HIV-infected late-presenting pregnant women.
Brites C, Nóbrega I, Luz E, et al HIV Clin Trials. 2018 Apr 9:1

General Reports

Journal Papers, Abstracts, and Commentaries

Low Third-Trimester Serum Levels of Lamivudine/Zidovudine and Lopinavir/Ritonavir in an HIV-Infected Pregnant Woman with Gastric Bypass
Michalik DE, Jackson-Alvarez JT, Flores R, et al
J Int Assoc Provid AIDS Care. 2014 Oct 31
Abstract
Impact of body weight and missed doses on lopinavir concentrations with standard and increased lopinavir/ritonavir doses during late pregnancy.
Cressey TR, Urien S, Capparelli EV, et al
J Antimicrob Chemother. 2014 Sep 25
Abstract

Atazanavir and lopinavir profile in pregnant women with HIV: tolerability, activity and pregnancy outcomes in an observational national study.
Floridia M, Ravizza M, Masuelli G, et al
J Antimicrob Chemother. 2013 Dec 25
Abstract

A Randomized Controlled Trial to Assess Safety, Tolerability, and Antepartum Viral Load with Increased Lopinavir/Ritonavir Dosage in Pregnancy.
Bonafe SM, Costa DA, Vaz MJ, et al
AIDS Patient Care STDS. 2013 Oct 19.
Abstract

Hair and Plasma Data Show That Lopinavir, Ritonavir, and Efavirenz All Transfer From Mother to Infant In Utero, But Only Efavirenz Transfers via Breastfeeding.
Gandhi M, Mwesigwa J, Aweeka F, et al
J Acquir Immune Defic Syndr. 2013 Aug 15;63(5):578-584
Abstract

Administration of lopinavir/ritonavir association during rat pregnancy: maternal and fetal effects.
Kulay L Jr, Hagemann CC, Nakamura MU
Clin Exp Obstet Gynecol. 2013;40(1):151-
Abstract

Protein Binding of Lopinavir and Ritonavir During Four Phases of Pregnancy: Implications for Treatment Guidelines.
Patterson KB, Dumond JB, Prince HA, et al
J Acquir Immune Defic Syndr. 2012 Dec 6.
Abstract

Therapeutic levels of lopinavir in late pregnancy and abacavir passage into breast milk, in the Mma Bana Study, Botswana.
Shapiro RL, Rossi S, Ogwu A, et al
Antivir Ther. 2012 Nov 26.
Abstract

Free and total plasma levels of lopinavir during pregnancy, at delivery and in postpartum: implication for dosage adjustments in pregnant women.
Fayet-Mello A, Buclin T, Guignard N, et al
Antivir Ther. 2012 Aug 22.
Abstract

FULL-TEXT PDF LETTER
Transplacental passage of nevirapine, nelfinavir and lopinavir.
van Hoog S, Boer K, Nellen J, et al
J Med. 2012 Mar;70(2):102-103.
Commentary

Improved oral bioavailability of lopinavir in melt-extruded tablet formulation reduces impact of third trimester on lopinavir plasma concentrations.
Else LJ, Douglas M, Dickinson L, et al
Antimicrob Agents Chemother. 2011 Nov 21
Abstract
FULL-TEXT ARTICLE
Lopinavir/ritonavir dosing during pregnancy in Brazil and maternal/infant laboratory abnormalities.
Peixoto MF, Pilotto JH, Stoszek SK, et al
Braz J Infect Dis. 2011 Jun;15(3):253-61.
Paper
Thai HIV-1 infected women do not require a dose increase of lopinavir/ritonavir during the third trimester of pregnancy.
Ramautarsing RA, van der Lugt J, Gorowara M, et al
AIDS. 2011 Apr 21.
Abstract
Lopinavir/Ritonavir in Pregnancy.
Roberts SS, Martinez M, Covington DL, et al
J Acquir Immune Defic Syndr. 2009 Apr 18.
Abstract

Reduced lopinavir exposure during pregnancy.
Stek AM, Mirochnick M, Capparelli E, et al
AIDS. 2006 Oct 3;20(15):1931-1939.
Abstract

Placental transfer of lopinavir/ritonavir in the ex vivo human cotyledon perfusion model.
Gavard L, Gil S, Peytavin G, et al
Am J Obstet Gynecol. 2006 May 4;
Abstract

Animal Studies

Journal Papers, Abstracts, and Commentaries

Effects of lopinavir-ritonavir combined therapy during the rat pregnancy
Morphological and biochemical aspects.
Cunha AM, Hagemann CC, Simoes RS, et al
Eur J Obstet Gynecol Reprod Biol. 2006 Sep 18;
Abstract

Pharmacokinetics

Journal Papers, Abstracts, and Commentaries

Free And Total Lopinavir Pharmacokinetics in HIV-Infected Pregnant Women Using A Population Approach: Consequences On Dose Adjustment.
Fauchet F, Treluyer JM, Illamola SM, et al
Antimicrob Agents Chemother. 2015 Jul 6
Abstract

A Comparison of the Pharmacokinetics of Standard and Increased Dosage Lopinavir/Ritonavir Co-formulation Tablets in HIV-positive Pregnant Women: a randomized clinical trial.
Santini-Oliveira M, Estrela RD, et al
Antimicrob Agents Chemother. 2014 Mar 10.
Abstract

Pharmacokinetics of lopinavir/ritonavir and efavirenz in food insecure HIV-infected pregnant and breastfeeding women in Tororo, Uganda.
Bartelink IH, Savic RM, Mwesigwa J, et al
J Clin Pharmacol. 2013 Aug 23.
Abstract

Lopinavir/ritonavir Monotherapy as a Nucleoside Analogue-Sparing Strategy to Prevent HIV-1 Mother-to-Child Transmission. The ANRS 135 PRIMEVA phase II/III Randomized Trial.
Tubiana R, Mandelbrot L, Le Chenadec J, et al
Clin Infect Dis. 2013 Jun 12
Abstract

Lopinavir tablet pharmacokinetics with an increased dose during pregnancy.
Best BM, Stek AM, Mirochnick M, et al
J Acquir Immune Defic Syndr. 2010 Aug 1;54(4):381-8
Abstract

Population analysis of the pregnancy-related modifications in lopinavir pharmacokinetics and their possible consequences for dose adjustment.
Bouillon-Pichault M, Jullien V.et al,
J Antimicrob Chemother. 2009 Apr 22.
Abstract

Early Postpartum Pharmacokinetics (PK) of Lopinavir (LPV) when Initiated Intrapartum in Thai Women: a substudy of the International Maternal Pediatric Adolescent AIDS Clinical Trial (IMPAACT) Group
P1032 study.
Cressey TR, Van Dyke R, Jourdain G, et al
Antimicrob Agents Chemother. 2009 Feb 23
Abstract

Placental transfer and pharmacokinetics of lopinavir and other protease inhibitors in combination with nevirapine at delivery.
Gingelmaier A, Kurowski M, Kastner R, et al
AIDS. 2006 Aug 22;20(13):1737-1743
Abstract

Efficacy

Journal Papers, Abstracts, and Commentaries

Raltegravir versus lopinavir/ritonavir for treatment of HIV-infected late-presenting pregnant women.
Brites C, Nóbrega I, Luz E, et al
HIV Clin Trials. 2018 Apr 9:1
Abstract

FULL-TEXT ARTICLE
Maternal and foetal outcomes among 4118 women with HIV infection treated with lopinavir/ritonavir during pregnancy: analysis of population-based surveillance data from the national study of HIV in pregnancy and childhood in the United Kingdom and Ireland.
Tookey PA, Thorne C, van Wyk J, Norton M.
BMC Infect Dis. 2016 Feb 4;16(1):65.
Paper

Lopinavir and atazanavir in pregnancy: comparable infant outcomes, virological efficacies and preterm delivery rates
Perry M, Taylor GP, Sabin CA, et al
HIV Med. 2015 Jul 22.
Abstract

Efficacy and safety of lopinavir/ritonavir versus efavirenz-based antiretroviral therapy in HIV-infected pregnant Ugandan women.
Cohan D, Natureeba P, Koss CA, et al
AIDS. 2015 Jan 14;29(2):183-91
Abstract

Randomized Clinical Trial Comparing the Pharmacokinetics of Standard- and Increased-Dosage Lopinavir-Ritonavir Coformulation Tablets in HIV-Positive Pregnant Women.
Santini-Oliveira M, Estrela Rde C, Veloso VG, et al
Antimicrob Agents Chemother. 2014 May;58(5):2884-93.
Abstract

FULL-TEXT PDF ARTICLE
Lopinavir/Ritonavir versus Lamivudine peri-exposure prophylaxis to prevent HIV-1 transmission by breastfeeding: the PROMISE-PEP trial Protocol ANRS 12174.
Nagot N, Kankasa C, Meda N, et al |
BMC Infect Dis. 2012 Oct 6;12(1):246
Paper

Pharmacokinetics and virologic response of zidovudine/lopinavir/ritonavir initiated during the third trimester of pregnancy.
Cressey TR, Jourdain G, Rawangban B, et al
AIDS. 2010 Jul 9
Abstract

Pregnancy outcomes in women with HIV type-1 receiving a lopinavir/ritonavir-containing regimen.
Azria E, Moutafoff C, Schmitz T, et al
Antivir Ther. 2009;14(3):423-32.
Abstract

Early Initiation of Lopinavir/Ritonavir in Infants Less Than 6 Weeks of Age: Pharmacokinetics and 24-Week Safety and Efficacy.
Chadwick EG, Pinto J, Yogev R, et al
Pediatr Infect Dis J. 2009 Feb 9.
Abstract

Lopinavir Exposure With an Increased Dose During Pregnancy.
Mirochnick M, Best BM, Stek AM,et al
J Acquir Immune Defic Syndr. 2008 Nov 4.
Abstract

FULL-TEXT ARTICLE
DSMB Finds Ritonavir-boosted Lopinavir Superior to Nevirapine in HIV-positive Women Who Previously Took Single-dose Nevirapine
NIAID Bulletin
October 28, 2008
Paper

Plasma lopinavir trough levels in a group of pregnant women on lopinavir, ritonavir, zidovudine,and lamivudine.
Manavi K, McDonald A, Al-Sharqui A.
AIDS. 2007 Mar 12;21(5):643-5.
Abstract

Monitoring

Journal Papers, Abstracts, and Commentaries
	Utility of therapeutic drug monitoring in the management of HIV-infected pregnant women in receipt of lopinavir. Caswell RJ, Phillips D, Chaponda M, et al Int J STD AIDS. 2011 Jan;22(1):11-4. Abstract Therapeutic drug monitoring of lopinavir/ritonavir in pregnancy. Lambert JS, Else LJ, Jackson V, et al HIV Med. 2010 Aug 18. Abstract

Adverse Events

Journal Papers, Abstracts, and Commentaries

Maternal Lopinavir/Ritonavir Is Associated with Fewer Adverse Events in Infants than Nelfinavir or Atazanavir.
Smith C, Weinberg A, Forster JE, et al
Infect Dis Obstet Gynecol. 2016;2016:9848041
Abstract
Risk Factors for Preterm Birth among HIV-Infected Pregnant Ugandan Women Randomized to Lopinavir/ritonavir- or Efavirenz-based Antiretroviral Therapy.
Koss CA, Natureeba P, Plenty A, et al
J Acquir Immune Defic Syndr. 2014 Jul 26
Abstract

Association of prenatal and postnatal exposure to lopinavir-ritonavir and adrenal dysfunction among uninfected infants of HIV-infected mothers.
Simon A, Warszawski J, Kariyawasam D, et al
JAMA. 2011 Jul 6;306(1):70-8.
Abstract

Twin Preterm Neonates with Cardiac Toxicity Related to Lopinavir/Ritonavir Therapy.
McArthur MA, Kalu SU, Foulks AR, et al
Pediatr Infect Dis J. 2009 Oct 8.
Abstract

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