Medical Advocates

Nevirapine
(Viramune)
 
Perinatal/Neonate Efficacy Data

Monotherapy
NVP vs ZDV
NVP/ZDV
NVP/
HIVIGLOB

NVP/TNF/EMT
NVP vs 3TC/ZDV
NVP vs LPN
NVP vs ZDV/NVP
NVP-Based HAART
National Studies


 

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Last Update:  April 15, 2012
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Monotherapy
 

          Journal Papers, Abstracts, and Commentaries  

 
Role of low-frequency HIV-1 variants in failure of nevirapine-containing antiviral therapy in women
previously exposed to single-dose nevirapine.
Boltz VF, Zheng Y, Lockman S, et al
Proc Natl Acad Sci U S A. 2011 May 31;108(22):9202-7.
Abstract

'Twelve-month follow-up of Six Week Extended Dose Nevirapine randomized controlled trials:
differential impact of extended-dose nevirapine on mother-to-child transmission and infant death
by maternal CD4 cell count.
Omer SB; for the Six Week Extended Dose Nevirapine (SWEN) Study Team.
AIDS
. 2011 Feb 16
Abstract

Lack of effect from a previous single dose of nevirapine on virologic and immunologic responses after 6 months
of antiretroviral regimens containing either efavirenz or lopinavir-ritonavir.
Dlamini JN, Hu Z, Somaroo H, Highbarger HC,  et al
Pharmacotherapy. 2011 Feb;31(2):158-63
Abstract

Independent effects of nevirapine prophylaxis and HIV-1 RNA suppression in breast milk on
early perinatal HIV-1 transmission.

Chung MH, Kiarie JN, Richardson BA, et al 
J Acquir Immune Defic Syndr.
2007 Dec 1;46(4):472-8
Abstract
 

Response to Antiretroviral Therapy after a Single, Peripartum Dose of Nevirapine.
Lockman S, Shapiro RL, Smeaton LM, et al 
N Engl J Med. 2007 Jan 11;356(2):135-147.
Abstract
 
Intrapartum Transmission After Mucosal Exposure to HIV Was Not Observed With Single-Dose
Nevirapine for Mother and Child.
Kunz A, Mugenyi K, Karcher H, et al 
J Acquir Immune Defic Syndr.
2006 Dec 21;
Abstract
 
Maternal single-dose nevirapine versus placebo as part of an antiretroviral strategy to prevent
mother-to-child HIV transmission in Botswana.
Shapiro RL, Thior I, Gilbert PB, Lockman S 
AIDS. 2006 Jun 12;20(9):1281-1288.
Abstract

Timing of maternal and neonatal dosing of nevirapine and the risk of mother-to-child transmission
of HIV-1: HIVNET 024*

Chi BH, Wang L, Read JS, et al;  
AIDS
. 2005 Nov 4;19(16):1857-1864.
Abstract

Comparison of Mother-to-Child Transmission Rates in Ugandan Women With Subtype
A Versus D HIV-1 Who Received Single-Dose Nevirapine Prophylaxis: HIV Network for
Prevention Trials 012.
Eshleman SH, Guay LA, Mwatha A, et al 
J Acquir Immune Defic Syndr. 2005 Aug 15;39(5):593-597.
Abstract
 
A randomized trial of two postexposure prophylaxis regimens to reduce mother-to-child
HIV-1 transmission in infants of untreated mothers.
Gray GE, Urban M, Chersich MF, et al 
AIDS. 2005 Aug 12;19(12):1289-97.
Abstract
 
Nevirapine and zidovudine at birth to reduce perinatal transmission of HIV in an African
setting: a randomized controlled trial.
Taha TE, Kumwenda NI, Hoover DR et al 
JAMA. 2004 Jul 14;292(2):202-9.

Abstract

Timing of the maternal drug dose and risk of perinatal HIV transmission in the setting
of intrapartum and neonatal single-dose nevirapine.
Stringer JS, Sinkala M, Chapman V, et al.
AIDS. 2003 Jul 25;17(11):1659-1665.
Abstract

Predose infant nevirapine concentration with the two-dose intrapartum neonatal nevirapine
regimen: association with timing of maternal intrapartum nevirapine dose.
Mirochnick M, Dorenbaum A, Blanchard S
Acquir Immune Defic Syndr. 2003 Jun 1;33(2):153-6.
Abstract

Comparison of Two Strategies for Administering Nevirapine to Prevent Perinatal HIV
Transmission in High-Prevalence, Resource-Poor Settings.

Stringer JS, Sinkala M, Stout JP, et al. 

J Acquir Immune Defic Syndr
2003 Apr 15;32(5):506-513
Abstract

Survival of Ugandan Infants with Subtype A and D HIV-1 Infection (HIVNET 012).
Eshleman SH, Guay LA, Fleming T, et al.  
J Acquir Immune Defic Syndr 2002 Nov 1;31(3):327-30
Abstract
 
Impact of human immunodeficiency virus type 1 (hiv-1) subtype on women receiving
single-dose nevirapine prophylaxis to prevent hiv-1 vertical transmission (hiv network
for prevention trials 012 study).
Eshleman SH, Becker-Pergola G, Deseyve M, et al.
J Infect Dis 2001 Oct 1;184(7):914-917
Abstract
 
Impact of Human Immunodeficiency Virus Type 1 (HIV-1) Subtype on Women Receiving
Single-Dose Nevirapine Prophylaxis to Prevent HIV-1 Vertical Transmission

Eshleman SH, Becker-Pergola G, Deseyve M, et al
J Infect Dis 2001 Aug 13;184(7)
Abstract
 
Nevirapine: a review of its use in the prevention and treatment of paediatric
HIV infection
.
Bardsley-Elliot A, Perry CM
Paediatr Drugs 2000 Sep-Oct;2(5):373-407  
Abstract

        Conference Reports, Abstracts, and Posters

 
Pooled analysis of five randomized trials of infant nevirapine prophylaxis to prevent breast-milk
HIV-1 transmission

M. Hudgens, T. Taha, S.B. Omer, et al
(6th IAS Conference)
Abstract

POSTER
4-Year Clinical and Therapeutic Consequences of Intra-partum Single-dose Nevirapine for the Prevention of
Perinatal HIV in Women Who Subsequently Initiated a Nevirapine-based ART

G Jourdain, N Ngo-Giang-huong, S Le Coeur,  et al
(16 CROI)
PDF Poster    Abstract

POSTER
Administration of Infant-only Single-dose Nevirapine within Minutes of Birth Results in More Variable and Lower
Nevirapine Blood Concentrations

S Dross, S Rossi, I Beck, et al
(16 CROI)
PDF Poster
    Abstract
 
POSTER
Long-term Maternal and Pediatric Virologic Outcomes on Nevirapine-based HAART following Receipt of
Peripartum Single-dose Nevirapine or Placebo, Botswana

S Lockman, L Smeaton, A Ogwu
, et al
(16 CROI)
PDF Poster
     Abstract

Short-course Zidovudine and Lamivudine or single-dose Nevirapine-containing PMTCT
Compromises 12-Month Response to HAART in African Women, Abidjan, Côte d’Ivoire
(2003-2006)

P Coffie, D Ekouevi, M L Chaix. et al
(14 CROI)
Abstract
 

  Maternal immune response and clinical outcomes on NNRTI-based antiretroviral therapy (ART)
following exposure to single-dose nevirapine (NVP) for prevention of mother-to-child HIV
transmission (PMTCT)

Chi B., Sinkala M., Levy J., et al    
(
XVI International AIDS Conference)
Abstract
 
  Infant Nevirapine Dosing for the Prevention of Mother-to-Child Transmission in
Association with Timing of Maternal Intrapartum Nevirapine Dose: Initiatives of

the United States Pharmacopeia Drug Quality and Information Program (USP DQI)
Seyoum D., Primo-Carpenter J.

(3rd IAS)
Abstract

 
  NNRTI-resistant mutations in HIV-1 infected infants following single dose
Nevirapine (Sd-NVP) are reduced by the addition of short course zidovudine
and 3TC.

Gray G., McIntyre J., Hopley M., et al
(3rd IAS)
Abstract

 
  Frequency of nevirapine resistance (NVPR) after single dose nevirapine (sdNVP)
use to prevent HIV-1 vertical transmission: a meta-analysis

Arrivé E., Dabis F., Newell M.-L.,, et a
l
(3rd IAS)
Abstract

 
  Timing of maternal and infant nevirapine and the risk of mother-to-child transmission
of HIV-1: HIVNET 024

Chi B.H., Wang L., Read J.S., et al
(3rd IAS)
Abstract
 
  6-month immunological response with HAART containing Nevirapine in HIV infected
women post exposure to single dose of Nevirapine for PMTCT. The MTCT-Plus Initiative
in Abidjan, Côte d’Ivoire (2003-2005).

G Bedikou,  I Viho,  B Tonwe-Gold, et al 
(
3rd IA
S)
Abstract
 
Effectiveness of Nevirapine in reducing mother-to-child transmission of HIV in formula-fed infants
L Rivera, M Pena, E Perez-Then, M Tavarez-Rojas
((15IAC)
Abstract
 
GROWTH OF BREAST AND FORMULA FED BABIES BORN TO NEVIRAPINE TREATED
HIV-1 POSITIVE MOTHERS IN YAOUNDE, CAMEROON

G. Tene, M. Tejiokem, F. Tietche, et al
(2nd IAS)
Abstract
 
Uptake of interventions to reduce mother-to-child HIV transmission: nevirapine and
exclusive breastfeeding in the Zambia exclusive breastfeeding study (ZEBS)

L Kuhn, P Kasonde, C Vwalika,  et al
(14IAC)
Abstract

NVP vs ZDV
 

      Journal Papers, Abstracts, and Commentaries

 
Is there a difference in the efficacy of peripartum antiretroviral regimens in reducing mother-
to-child transmission of HIV in Africa?
Leroy V, Sakarovitch C, Cortina-Borja M,
AIDS. 2005 Nov 4;19(16):1865-1875.
Abstract
 
Breast milk HIV-1 suppression and decreased transmission: a randomized trial comparing
HIVNET 012 nevirapine versus short-course zidovudine.
Chung MH, Kiarie JN, Richardson BA, et al  
AIDS.
2005 Sep 2;19(13):1415-1422.
Abstract
 
Intrapartum and neonatal single-dose nevirapine compared with zidovudine for
prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: 18-month
follow-up of the HIVNET 012 randomised trial.
Jackson JB, Musoke P, Fleming T, et al  
Lancet. 2003 Sep 13;362(9387):859-68
Abstract

Intrapartum and Neonatal Single-Dose Nevirapine Compared with Zidovudine for
Prevention of Mother-to-Child Transmission of HIV-1 in Kampala, Uganda:
Randomized Trial (HIVNET 012)

Guay LA, Musoke P, Fleming T, et al.
Lancet 1999 Sep 4;354(9181):795-802  
Abstract

        Conference Reports, Abstracts, and Posters

 
Routine use of combined zidovudine and nevirapine regimen in MTCT-Plus program
O Marcy,  A Mafoua , G Halembokaka
(3rd IAS)
Abstract

Immunologic and virologic responses to generic highly active antiretroviral therapy of patients
with single dose nevirapine or short course AZT pre-exposure

L S Zijenah, G Kadzirange, O Tobaiwa, et al
(15IAC)
Abstract
 
Suppression of HIV-1 RNA levels in breast milk after randomization to perinatal nevirapine vs.
AZT

MH Chung, D Lehman, J Kiarie, et al
(15IAC)
Abstract

 
Prevention of vertical HIV-1 transmission by Zidovudine and Nevirapine
SN Kurle, SP Tripathy, PL Joshi, et al
(15IAC)
Abstract

NVP/ZDV

         Journal Papers, Abstracts, and Commentaries
 
 
Effects of short-course zidovudine on the selection of nevirapine-resistant HIV-1 in women taking single-dose nevirapine.
Micek MA, Blanco AJ, Carlsson J,  et al
J Infect Dis
. 2012 Apr 5.
Abstract

Addition of extended zidovudine to extended nevirapine prophylaxis reduces nevirapine
resistance in infants who were HIV-infected in utero.
Lidström J, Li Q, Hoover DR, Kafulafula G,
et al
AIDS
. 2010 Jan 28;24(3):381-6.
Abstract

A randomized, double-blind, placebo-controlled trial of combined nevirapine and zidovudine
compared with nevirapine alone in the prevention of perinatal transmission of HIV in Zimbabwe.
Thistle P, Spitzer RF, Glazier RH, et al
Clin Infect Dis.
2007 Jan 1;44(1):111-9
Abstract
 

Nevirapine and zidovudine at birth to reduce perinatal transmission of HIV in an African
setting: a randomized controlled trial.
Taha TE, Kumwenda NI, Hoover DR et al 
JAMA. 2004 Jul 14;292(2):202-9.

Abstract
 
FULL-TEXT ARTICLE
Single-Dose Perinatal Nevirapine plus Standard Zidovudine to Prevent Mother-to-Child
Transmission of HIV-1 in Thailand.
Lallemant M, Jourdain G, Le Coeur S, et al
N Engl J Med. 2004 Jul 9
Paper
 
Short postexposure prophylaxis in newborn babies to reduce mother-to-child transmission
of HIV-1: NVAZ randomised clinical trial.
Taha TE, Kumwenda NI, Gibbons A, et al.
Lancet. 2003 Oct 11;362(9391):1171-7.
Abstract

Intrapartum and Neonatal Single-Dose Nevirapine Compared with Zidovudine for
Prevention of Mother-to-Child Transmission of HIV-1 in
Kampala, Uganda:
Randomized Trial (HIVNET 012)

Guay LA, Musoke P, Fleming T, et al.
Lancet 1999 Sep 4;354(9181):795-802  
Abstract
 

 
         Conference Reports, Abstracts, and Posters
 
 
Pooled analysis of five randomized trials of infant nevirapine prophylaxis to prevent breast-milk
HIV-1 transmission

M. Hudgens, T. Taha, S.B. Omer, et al
(6th IAS Conference)
Abstract

Efficacy of Peripartum Nevirapine to Prevent Mother to Child HIV Transmission in
Women Presenting Late for Antenatal Care in Thailand
G Jourdain, S Le Coeur, N Ngo-Giang-Huong, et al
(12 CROI)
Abstract

Maternal Single-dose Nevirapine May Not Be Needed to Reduce Mother-to-Child HIV
Transmission in the Setting of Maternal and Infant Zidovudine and Infant Single-dose
Nevirapine: Results of a Randomized Clinical Trial in Botswana
R Shapiro, I Thior, P Gilbert, et al
(12 CROI)
Abstract
 
Duration of nevirapine (NVP) postpartum exposure in women who received single
dose NVP during labor in addition to standard zidovudine (ZDV) prophylaxis for the
prevention of mother-to-child transmission of HIV-1 in Thailand

T R Cressey, S Kunkeaw, P N Ruttana-Aroongorn., et al
(15IAC)
Abstract
 
Multicentre, Randomized Controlled Trial, Assessing the Safety and Efficacy of Nevirapine
in Addition to Zidovudine for the Prevention of Perinatal HIV In Thailand: PHPT-2 Update

M Lallemant, G Jourdain, S Le Coeur, et al.
(2nd IAS)
Abstract
 
Genotypic resistance analysis following single-dose administration of nevirapine to HIV-infected
women and their infants receiving short-course zidovudine

W Leelawiwat, P Wirachsilp, R Sutthent,et al
(14IAC)
Abstract

A Randomized Trial of Single Dose Nevirapine to Mother and Infant Versus
Azidothymidine in Kampala, Uganda for Prevention of Mother-To-Infant Transmission
of HIV-1 (HIVNET 012
)  
Abstract

 

NVP/HIVIGLOB

         Journal Papers, Abstracts, and Commentaries
 
  Safety and Efficacy of HIV Hyperimmune Globulin (HIVIGLOB) for Prevention of Mother-to-Child HIV Transmission in HIV-1 infected Pregnant Women and their Infants in Kampala, Uganda (HIVIGLOB/NVP STUDY).
Onyango-Makumbi C, Omer SB, Mubiru M, et al
J Acquir Immune Defic Syndr. 2011 Aug 4
Abstract

NVP/TNF/EMT
 

          Journal Papers, Abstracts, and Commentaries
 
  Addition of Single-Dose Tenofovir and Emtricitabine to Intrapartum Nevirapine to Reduce Perinatal
HIV Transmission.

Chi BH, Chintu N, Cantrell RA, et al
J Acquir Immune Defic Syndr.
2008 Jun 1;48(2):220-223.

Abstract
 

NVP vs LPN
 

          Conference Reports, Abstracts, and Posters
 
  Nevirapine (NVP) vs lopinavir-ritonavir (LPV/r)-based antiretroviral therapy (ART) in single dose nevirapine (sdNVP)-exposed HIV-infected infants: preliminary results from the IMPAACT P1060 trial
P. Palumbo, A. Violari J. Lindsey,  et al 
(5th IAS Conference)

Abstract
 

NVP vs 3TC/ZDV
 

          Journal Papers, Abstracts, and Commentaries
 
  A Multicenter Randomized Controlled Trial of Nevirapine Versus a Combination of
Zidovudine and Lamivudine to Reduce Intrapartum and Early Postpartum Mother-
to-Child Transmission of Human Immunodeficiency Virus Type 1
.

Moodley D, Moodley J, Coovadia H, et al.
J Infect Dis 2003 Mar 1;187(5):725-35
Abstract
 

NVP vs ZDV/NVP
 

          Journal Papers, Abstracts, and Commentaries
 
 
FULL-TEXT PDF ARTICLE
Comparing two service delivery models for the Prevention of Mother-to-Child Transmission (PMTCT)
of HIV during transition from single-dose Nevirapine to multi-drug antiretroviral regimens.

Tsague L, Tsiouri FO, Carter RJ, et al
BMC Public Health
. 2010 Dec 6;10(1):753.
Abstract

FULL TEXT ARTICLE
Extended Antiretroviral Prophylaxis to Reduce Breast-Milk HIV-1 Transmission.
Kumwenda NI, Hoover DR, Mofenson LM, et al
N Engl J Med.
2008 Jun 4.

Paper
 

          Conference Reports, Abstracts, and Posters
 
  Single dose nevirapine versus combination zidovudine-nevirapine for PMTCT of HIV:
An outcomes-oriented policy review for developing countries

Megazzini K., Chi B., Sinkala M., et al
(3rd IAS )
Abstract

NVP-Based HAART
 

          Journal Papers, Abstracts, and Commentaries
 
  Peripartum nevirapine exposure and subsequent clinical outcomes among
HIV-infected women receiving antiretroviral therapy for at least 12 months.
Chintu N, Giganti MJ, Putta NB, et al
Trop Med Int Health. 2010 May 7.
Abstract

          Conference Reports, Abstracts, and Posters
 

 
POSTER
Equally low mother-to-child transmission (MTCT) rates with single-dose nevirapine (sd-NVP) plus
 sd-Truvada compared to sd-NVP and 7 days of combivir
Z.P. Theilgaard, M.G. Chiduo, L. Flamholc, et al
(6th IAS Conference)
Poster     Abstract

Efficacy and safety of nevirapine versus efavirenz when combined in ART regimens in
HIV-infected antiretroviral-naïve persons (the NNRTI substudy of FIRST-CPCRA 058)

van den Berg-Wolf M., Peng G., Xiang Y., et al
(XVI International AIDS Conference)
Abstract
 

24 month outcome of nevirapine based highly active antiretroviral therapy (HAART) in women
during the postpartum period: a PMTCT+ pilot program supported by the global fund in Thailand

Jourdain G., Briand N., Fregonese F  
(XVI International AIDS Conference)
Abstract
 
6-month immunological response with HAART containing Nevirapine in HIV infected
women post exposure to single dose of Nevirapine for PMTCT. The MTCT-Plus Initiative
in Abidjan, Côte d’Ivoire (2003-2005).

(3rd IAS)
Abstract

Safety of Nevirapine in pregnant women (PW): A report of 143 cases
Rolon M.J., Coll P., Lattner J., Cahn P.
(3rd IAS)
Abstract
 


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Nevirapine Perinatal/Neonate Efficacy Data