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Nelfinavir (Viracept)
 
Perinatal Index

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Last Update:  February 25, 2015
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New and Noteworthy
     
March 2012
 
 
Drug Alerts
     
Prevention Guidelines and Recommendations
United States
United States

     Internet Documents

  FULL TEXT 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
 
  FULL TEXT 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

Nelfinavir and its active metabolite, hydroxyl-t-butylamidenelfinavir (M8), are transferred in low quantities
to breast milk and do not result in biologically significant concentrations in breast-feeding infants whose
mothers are taking nelfinavir.
Weidle PJ, Zeh C, Martin A, Lando R, et al
Antimicrob Agents Chemother. 2011 Aug 29.
Abstract

Contribution and limit of the model of perfused cotyledon to the study of placental transfer of
drugs. Example of a protease inhibitor of HIV: Nelfinavir.
 Gavard L, Beghin D, Forestier F,et al  
 Eur J Obstet Gynecol Reprod Biol. 2009 Sep 19.
Abstract

     Conference Reports, Abstracts, and Posters

 
Safety and efficacy of lopinavir/ritonavir compared to nelfinavir-based HAART during pregnancy
 Peña JM, González MI, Pascual-Pareja JF, et al 
(Ninth International Congress on Drug Therapy in HIV Infection)
 Abstract
 
Safety
                    
      Journal Papers, Abstracts, and Commentaries
 
  Safety and pharmacokinetics of nelfinavir during the second and third trimesters of pregnancy
and postpartum.
Fang A, Valluri SR, O'Sullivan MJ,  et al
HIV Clin Trials. 2012 Jan-Feb;13(1):46-59.
 Abstract

     Conference Reports, Abstracts, and Posters

 
Safety and efficacy of lopinavir/ritonavir compared to nelfinavir-based HAART during pregnancy
 Peña JM, González MI, Pascual-Pareja JF, et al 
(Ninth International Congress on Drug Therapy in HIV Infection)
 Abstract
 
A Review of Protease Inhibitors (PI) Use in 89 Pregnancies
(6 CROI)
Abstract
Pharmacokinetics
                    
      Journal Papers, Abstracts, and Commentaries
 
 
Safety and pharmacokinetics of nelfinavir during the second and third trimesters of pregnancy
and postpartum.
Fang A, Valluri SR, O'Sullivan MJ,  et al
HIV Clin Trials. 2012 Jan-Feb;13(1):46-59.
 Abstract

Pharmacokinetics of new 625 mg nelfinavir formulation during pregnancy and postpartum.
 Read J, Best B, Stek A, et al   
 HIV Med. 2008 Sep 14.
Abstract
 
Pharmacokinetics and Safety of Nelfinavir When Used in Combination with Zidovudine and Lamivudine in
HIV-Infected Pregnant Women: Pediatric AIDS Clinical Trials Group (PACTG) Protocol 353.
 Bryson , Mirochnick , Stek, et al
HIV Clin Trials. 2008 Jan 1;9(2):115-125.
 Abstract
 
Pharmacokinetics of nelfinavir in HIV-1-infected pregnant and nonpregnant women.
Villani P, Floridia M, Pirillo MF, et al
Br J Clin Pharmacol. 2006 Sep;62(3):309-15
 Abstract

Nelfinavir Plasma Concentrations Are Low during Pregnancy.
 Nellen JF, Schillevoort I, Wit FW, Bergshoeff AS,et al
Clin Infect Dis. 2004 Sep 1;39(5):736-40.
Abstract

        Conference Reports, Abstracts, and Posters

 
Nelfinavir Pharmacokinetics with an Increased Dose during the First 2 Weeks of Life
 M Mirochnick, K Nielsen-Saines, J Pilotto, et al
 (14 CROI)
Abstract
 
Nelfinavir Pharmacokinetics (625-mg Tablets) during the Third Trimester of Pregnancy
and Post-partum
J Read, B Best, A Stek, et al
(14 CROI)
Abstract

Pharmacokinetics (PK) of Nelfinavir and Its Metabolite (M8) in HIV-Infected Infants
Following BID TID Administration.
E. Capparelli, J. Sullivan, L. Mofenson, et al
(8 CROI)
Abstract
Resistance
                    
     Journal Papers, Abstracts, and Commentaries
 
 
Persistence of Genotypic Resistance to Nelfinavir among Women Exposed to
Prophylactic Antiretroviral Therapy during Pregnancy.
 Kakehasi FM, Tupinambás U, Cleto S, et al 
AIDS Res Hum Retroviruses. 2007 Dec;23(12):1515-20
 Abstract

High prevalence of primary lamivudine and nelfinavir resistance in HIV-1-infected pregnant
women in the United States, 1998-2004.
 Paredes R, Cheng I, Kuritzkes DR, Tuomala RE. 
AIDS. 2007 Oct 1;21(15):2103-6
 Abstract
 

     Conference Reports, Abstracts, and Posters

 
POSTER
 High Prevalence of Primary Lamivudine and Nelfinavir Resistance in HIV-1-infected Pregnant
Women in the United Stated, 1998-2003
R Paredes, I Cheng, D Kuritzke, et al
(14 CROI)
 PDF Poster    Abstract
Adverse Events
                    
      News Releases
 
  VIRACEPT Studies Suggest No Apparent Increase in Birth Defects and Drug Levels
Boosted When Taken with Food
(10 CROI)		  

     Journal Papers, Abstracts, and Commentaries

 
Nelfinavir and nevirapine side effects during pregnancy.
Timmermans S, Tempelman C, Godfried MH 
AIDS. 2005 May 20;19(8):795-799.
Abstract

Risk of birth defects associated with nelfinavir exposure during pregnancy.
Covington DL, Conner SD, Doi PA, et al
bstet Gynecol. 2004 Jun;103(6):1181-9.
 Abstract
Monotherapy
 

Efficacy

        Conference Reports, Abstracts, and Posters

 
Prevention of mother to child transmission of HIV-1 with antiretroviral regimens
containing nelfinavir
R Marques, S Silva, A Ferreira, et al
 (15IAC)
 Abstract
 
PLASMA NELFINAVIR CONCENTRATIONS ARE SIGNIFICANTLY LOWER IN
PREGNANCY
F. Wit, J. Nellen, A. Bergshoeff,  et al
 [2 IAS)
 Abstract

Cord Blood Protease Inhibitor (PI) Concentrations in Infants Born to Mothers
Receiving PIs.
M. Mirochnick, A. Dorenbaum, B. Cunningham-Schrader, et al.
[8 CROI]
Abstract

Resistance

I

        Conference Reports, Abstracts, and Posters

  High rate of nelfinavir-associated mutations observed among women exposed to prophylactic
antiretroviral during pregnancy
Kakehasi F.M., Tupinanmbas U., Cleto S., et al
XVI International AIDS Conference
 Abstract

Combination Therapy

I

NFV/Multiple ART
 
          Journal Papers, Abstracts, and Commentaries
 
  Comparison of dual nucleoside-analogue reverse-transcriptase inhibitor regimens with
and without  nelfinavir in children withHIV-1 who have not previously been treated: the
PENTA 5 randomised trial.
Gibb DM.
Lancet 2002 Mar 2;359(9308):733-40
Abstract     
   
  Nucleoside-analogue reverse-transcriptase inhibitors plus nevirapine, nelfinavir, or ritonavir for
pretreated children infected with human immunodeficiency virus type 1.
 Krogstad P, Lee S, Johnson G, Stanley K,. et al.
Clin Infect Dis 2002 Apr 1;34(7):991-1001
 Abstract
 
NVP/IND

Pharmacokinetics

         Journal Papers, Abstracts, and Commentaries

  Pharmacokinetics of nelfinavir and indinavir in HIV-1-infected pregnant women.
Kosel BW, Beckerman KP, Hayashi S, et al. 
AIDS. 2003 May 23;17(8):1195-1199.
Abstract  

NFV/3TC/ZDV

Safety/Pharmacokinetics/Efficacy

         Journal Papers, Abstracts, and Commentaries

 
Pharmacokinetics and Safety of Nelfinavir When Used in Combination with Zidovudine and Lamivudine
in HIV-Infected Pregnant Women: Pediatric AIDS Clinical Trials Group (PACTG) Protocol 353.
 Bryson , Mirochnick , Stek , et al
 HIV Clin Trials. 2008 Jan 1;9(2):115-125.
 Abstract
 

Safety and Pharmacokinetics of Nelfinavir Coadministered With Zidovudine and
Lamivudine in Infants During the First 6 Weks of Life.
Mirochnick M, Stek A, Acevedo M, et al
J Acquir Immune Defic Syndr. 2005 Jun 1;39(2):189-194.
Abstract

  Conference Reports, Abstracts, and Posters
 
POSTER
 Discontinuation or Modification of Study Drug Regimen among Women in a Trial of HAART
for Prevention of Mother-to-Child Transmission in Kisumu, Kenya
 P Odhiambo, R Masaba, L Ochieng, et al 
15th CROI
 PDF Poster     Abstract

Pharmacokinetics, Antiviral Activity, and Safety of Nelfinavir (NFV) with ZDV/3TC in
Pregnant HIV-Infected Women and Their Infants: PACTG 353 Cohort 2
(9 CROI)
 Abstract

   
  PACTG 353 A Phase I Study of Safety, Pharmacokinetics, and Antiviral Activity of Combination
(7 CROI)
Abstract
   
  Nelfinavir (NFV), ZDV, and 3TC in HIV-Infected Pregnant Women and Their Infants                
(7 CROI)
Abstract

NFV/D4T/DDI

Safety/Pharmacokinetics

        Journal Papers, Abstracts, and Commentaries

  Pharmacokinetics of Stavudine and Didanosine coadministered with nelfinavir in human
immunodeficiency virus-exposed neonates.
Rongkavilit C, Thaithumyanon P, Chuenyam, T, et al.
Antimicrob Agents Chemother. 2001 Dec;45(12):3585-90.
Abstract
Discontinuation
 
        Journal Papers, Abstracts, and Commentaries
 
  Clinicians' Knowledge of 2007 Food and Drug Administration Recommendation to
Discontinue Nelfinavir Use During Pregnancy.
Fogler J, Weber S, Mahoney MR, Goldschmidt RH. J
 Int Assoc Physicians AIDS Care (Chic Ill). 2009 Jun 8.
 Abstract

        Conference Reports, Abstracts and Posters
 
  POSTER
 Increased Resistance to Lamivudine Detected in HIV+ Pregnant Women Discontinuing Zidovudine, Lamivudine,
and Nelfinavir: Results of PACTG 1022
G Ellis, J Hitti, L Frenke, PACTG 1022 
(16 CROI)
PDF Poster     Abstract		  

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