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Lopinavir/Ritonavir (Kaletra/Aluvia)
 
Perinatal Data

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Last Update:  April 02, 2012
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New and Noteworthy
       
March 2012
 
Guidelines
       
United States

     Internet Documents

  PDF DOCUMENT
 Public Health Service Task Force Recommendations for Use of Antiretroviral Drugs
in Pregnant HIV-Infected Women for Maternal Health and Interventions to Reduce
Perinatal HIV  Transmission in the United States.
Perinatal HIV Guidelines Working Group.
November 2, 2007
Guidelines
 
  PDF DOCUMENT
 Safety and Toxicity of Individual Antiretroviral Agents in Pregnancy
 Perinatal HIV Guidelines Working Group.
November 2, 2007
Guidelines
General Reports
 
       Journal Papers, Abstracts, and Commentaries
 
 
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

A WEEK-IN-REVIEW FEATURED REPORT
 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
 
      Conference Reports, Abstracts, and Posters 
 
 

Lopinavir/Ritonavir Concentrations in Breast Milk and Breast-feeding Infants
A Corbett, F Martinson, N Rezk, et al
(16th CROI)
 Abstract
 
POSTER
Lopinavir/ritonavir (LPV/r) in Pregnancy
SS Roberts, M Martinez, DL.Covington, et al  
(XVII International AIDS Conference)
 PDF Poster    Abstract
 
Plasma lopinavir levels in a group of pregnant women on lopinavir, ritonavir, zidovudine, and
lamivudine
 K Manavi, A McDonald, Al Al-Sharqui
(8th Int Congress on Drug Therapy in HIV Infection)
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
 
 
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
 
      Conference Reports, Abstracts, and Posters 
 
 
Pharmacokinetics of the LPV/r Tablet in HIV-infected Pregnant Women: A Longitudinal Investigation
of Protein Bound and Unbound Drug Exposure with Empiric Dosage Adjustment
 K Patterson, J Dumond, H Prince, et al
(18 CROI)
 Abstract

POSTER
 Comparison of total and unbound lopinavir (LPV) pharmacokinetics (PK) in HIV-infected pregnant
women receiving lopinavir/ritonavir (LPV/r) soft-gel capsules (SGC) or tablets
 G.P. Taylor, L. Else, L. Dickenson, et al
(XVIII IAS Conference)
 PDF Poster     Abstract

POSTER
 Pharmacokinetics of Lopinavir Boosted with Ritonavir (400/100 mg, Twice Daily)
Initiated during the Third Trimester of Pregnancy in HIV-1-infected Thai Women
T Cressey, G Jourdain, B Rawangban, et al  
(17 CROI)
PDF Poster     Abstract

Pharmacokinetics, placental transfer and infant outcome in 56 LPV/r exposed pregnancies
M. Sovric, A. Gingelmaier, R. Kaestner, et al
 (5th IAS Conference)
 Abstract

Lopinavir/Ritonavir Population Pharmacokinetics in Neonates
S Urien, G Firtion, S Anderson, et al 
(16th CROI)
 Abstract

Total and Unbound Lopinavir/Ritonavir Pharmacokinetics in a Concentration-guided Study of HIV-infected
Women throughout Pregnancy and Post-partum
J Kiser, S Mawhinney, K Kinzie, et al
(16th CROI)
 Abstract
 
Lopinavir Population Pharmacokinetics on HIV-infected Pregnant Women
 M Bouillon Pichault, V Jullien, E Azria, et al
 (15 CROI)
 Abstract

POSTER
Adequate Lopinavir Exposure Achieved with a Higher Dose during the Third Trimester of
Pregnancy
M Mirochnick, A Stek, E Capparelli, et al
(13 CROI)
 PDF Poster     Abstract

Adequate Trough Lopinavir Levels with Standard Dosing in Pregnancy
F Lyons, M Lechelt, V Magaya, et al
 (13 CROI)
Abstract
 
Reduced lopinavir exposure during pregnancy: preliminary pharmacokinetic
results from PACTG 1026
A Stek, M Mirochnick, E Capparelli,  et al
(15IAC)
Abstract
Efficacy
       
       Journal Papers, Abstracts, and Commentaries
 
 
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
 
      Conference Reports, Abstracts, and Posters 
 
 
Use of a protease inhibitor based highly active antiretroviral treatment (HAART) for the prevention of HIV mother to child transmission (MTCT) at hospital Roosevelt ID clinic in Guatemala: the role of lopinavir/ritonavir (LPV/r) standard dose (SD) of 400/100mg BID
C. Mejia Villatoro, M.E. Luarte, J. Juárez, et al
(6th IAS Conference)
 Abstract

LPV/r Monotherapy during Pregnancy for PMTCT of HIV-1: The PRIMEVA/ANRS 135 Randomized Trial,
Pregnancy Outcomes
 R Tubiana, L Mandelbrot,.S Delmas, et al
(18 CROI)
 Abstract

LPV/r+TDF/FTC Is Associated with Less Favorable Changes in Lipids Compared to NVP+TDF/FTC
in Women Initiating ART in Sub-Saharan Africa: A5208 (OCTANE)
D Shaffer, Y Bao, A Moses, et al
(18 CROI)
 Abstract

Pharmacokinetics, placental transfer and infant outcome in 56 LPV/r exposed pregnancies
M. Sovric, A. Gingelmaier, R. Kaestner, et al
 (5th IAS Conference)
 Abstract

Lopinavir/ritonavir (LPV/r)- compared to nevirapine (NVP)-based ART following receipt of single-dose
nevirapine (sdNVP) for prevention of mother-to-child HIV transmission in South Africa: a
cost-effectiveness analysis of the OCTANE (ACTG A5208) trial
 A. Ciaranello. K. Freedberg, J. Chu, et al |
(5th IAS Conference)
 Abstract

Safety and efficacy of lopinavir/ritonavir compared to nelfinavir-based HAART during pregnancy
JM Peña, MI González, JF Pascual-Parejam et al
(Ninth International Congress on Drug Therapy in HIV Infection)
 Abstract
 
POSTER
Lopinavir/ritonavir (LPV/r) in Pregnancy
SS Roberts, M Martinez, DL.Covington, et al 
(XVII International AIDS Conference)
PDF Poster

 High-dose Lopinavir and Standard-dose Emtricitabine Pharmacokinetics during Pregnancy
and Postpartum
 B Best, A Stek, C Hu, et al
 (15 CROI)
 Abstract
 
Pharmacokinetics and 24-Week Efficacy and Safety of Lopinavir/Ritonavir in HIV-1-infected
Infants <6 Weeks of Age
J Pinto, B Robbins, J Chen, et al
 (14 CROI)
 Abstract
 
Reduced Lopinavir Exposure during Pregnancy: A Case Control Study
G Peytavin, S Pierre-François, B Cassard, et
(14 CROI)
 Abstract
 
Different rates of early viral load reduction with nevirapine or lopinavir/ritonavir-based combination
antiretroviral therapies in pregnant women
 C Bell, N Desmond, GP Taylor
(8th Int Congress on Drug Therapy in HIV Infection)
 Abstract

Lopinavir/ritonavir during the pregnancy of HIV-infected women
Sovric M., Gingelmaier A., Kaestner R., et al
(XVI  International AIDS Conference)
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

      Conference Reports, Abstracts, and Posters 
 

 
Therapeutic drug monitoring of new formulation Kaletra in pregnancy
V Jackson, LJ Else, SH Khoo, et al 
(Ninth International Congress on Drug Therapy in HIV Infection)
 Abstract
 
Lopinavir Drug Monitoring in 36 Pregnant Women
Marie-Aude Khuong-Josses, A Boussaïri, C Palette, D Méchali
 (14 CROI)
 Abstract
 
Therapeutic Drug Monitoring of Lopinavir/ritonavir (LPV/r) Containing Regimen in
Pregnant HIV-infected Women
 Cassard B, Rouault A, Damond F, et al
(3rd IAS Conference)
Abstract
 
Adverse Events
       
       Journal Papers, Abstracts, and Commentaries
 
 
A WEEK-IN-REVIEW FEATURED REPORT
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

      Conference Reports, Abstracts, and Posters 

 
POSTER
 Neonatal Toxicity of Kaletra Oral Solution—LPV, Ethanol, or Propylene Glycol?
 D Boxwell, K Cao, L Lewis, et al
 (18 CROI)
 PDF Poster     Abstract
Economics
       
      Conference Reports, Abstracts, and Posters 
 
 
Lopinavir/ritonavir (LPV/r)- compared to nevirapine (NVP)-based ART following receipt of single-dose
nevirapine (sdNVP) for prevention of mother-to-child HIV transmission in South Africa: a
cost-effectiveness analysis of the OCTANE (ACTG A5208) trial
 A. Ciaranello. K. Freedberg, J. Chu, et al 
 (5th IAS Conference)
 Abstract

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Lopinavir/Ritonavir
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