Characteristics and management of HIV-1-infected pregnant women enrolled in a randomised trial

Differences between Europe and the USA

Marie Louise Newell, Sharon Huang, Simona Fiore, Claire Thorne, Laurent Mandelbrot, John L. Sullivan, Robert Maupin, Isaac Delke, D. Heather Watts, Richard D. Gelber, Coleen K. Cunningham, Alejandro Dorenbaum, Lynne Mofenson, Mary Culnane, Brigitte Bazin, Paula Britto, Rajalakshm Balasubramanian, Yvonne Bryson, Bethann Cunningham-Schrader, Kathleen A. Kaiser & 8 others Scharla Estep, Maria Gigliotti, Adolfo Gonzalez-Garcia, Mark Mirochnick, Claire Rekacewicz, Jean Francois Delfraissy, Maureen Shannon, Savita G Pahwa

Research output: Contribution to journalArticle

18 Citations (Scopus)

Abstract

Background: Rates of mother-to-child transmission of HIV-1 (MTCT) have historically been lower in European than in American cohort studies, possibly due to differences in population characteristics. The Pediatric AIDS Clinical Trials Group Protocol (PACTG) 316 trial evaluated the effectiveness of the addition of intrapartum/neonatal nevirapine in reducing MTCT in women already receiving antiretroviral prophylaxis. Participation of large numbers of pregnant HIV-infected women from the US and Western Europe enrolling in the same clinical trial provided the opportunity to identify and explore differences in their characteristics and in the use of non-study interventions to reduce MTCT. Methods: In this secondary analysis, 1350 women were categorized according to enrollment in centres in the USA (n = 978) or in Europe (n = 372). Factors associated with receipt of highly active antiretroviral therapy and with elective caesarean delivery were identified with logistic regression. Results: In Europe, women enrolled were more likely to be white and those of black race were mainly born in Sub-Saharan Africa. Women in the US were younger and more likely to have previous pregnancies and miscarriages and a history of sexually transmitted infections. More than 90% of women did not report symptoms of their HIV infection; however, more women from the US had symptoms (8%), compared to women from Europe (4%). Women in the US were less likely to have HIV RNA levels <400 copies/ml at delivery than women enrolling in Europe, and more likely to receive highly active antiretroviral therapy, and to start therapy earlier in pregnancy. The elective caesarean delivery rate in Europe was 61%, significantly higher than that in the US (22%). Overall, 1.48% of infants were infected and there was no significant difference in the rate of transmission between Europe and the US despite the different approaches to treatment and delivery. Conclusion: These findings confirm that there are important historical differences between the HIV-infected pregnant populations in Western Europe and the USA, both in terms of the characteristics of the women and their obstetric and therapeutic management. Although highly active antiretroviral therapy predominates in pregnancy in both settings now, population differences are likely to remain.

Original languageEnglish
Article number60
JournalBMC Infectious Diseases
Volume7
DOIs
StatePublished - Jun 20 2007

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HIV-1
Pregnant Women
Highly Active Antiretroviral Therapy
Mothers
HIV
Pregnancy
Clinical Trials
Nevirapine
Africa South of the Sahara
Spontaneous Abortion
Population Characteristics
Clinical Protocols
Sexually Transmitted Diseases
Population
Obstetrics
HIV Infections
Acquired Immunodeficiency Syndrome
Cohort Studies
Therapeutics
Logistic Models

ASJC Scopus subject areas

  • Infectious Diseases

Cite this

Characteristics and management of HIV-1-infected pregnant women enrolled in a randomised trial : Differences between Europe and the USA. / Newell, Marie Louise; Huang, Sharon; Fiore, Simona; Thorne, Claire; Mandelbrot, Laurent; Sullivan, John L.; Maupin, Robert; Delke, Isaac; Watts, D. Heather; Gelber, Richard D.; Cunningham, Coleen K.; Dorenbaum, Alejandro; Mofenson, Lynne; Culnane, Mary; Bazin, Brigitte; Britto, Paula; Balasubramanian, Rajalakshm; Bryson, Yvonne; Cunningham-Schrader, Bethann; Kaiser, Kathleen A.; Estep, Scharla; Gigliotti, Maria; Gonzalez-Garcia, Adolfo; Mirochnick, Mark; Rekacewicz, Claire; Delfraissy, Jean Francois; Shannon, Maureen; Pahwa, Savita G.

In: BMC Infectious Diseases, Vol. 7, 60, 20.06.2007.

Research output: Contribution to journalArticle

Newell, ML, Huang, S, Fiore, S, Thorne, C, Mandelbrot, L, Sullivan, JL, Maupin, R, Delke, I, Watts, DH, Gelber, RD, Cunningham, CK, Dorenbaum, A, Mofenson, L, Culnane, M, Bazin, B, Britto, P, Balasubramanian, R, Bryson, Y, Cunningham-Schrader, B, Kaiser, KA, Estep, S, Gigliotti, M, Gonzalez-Garcia, A, Mirochnick, M, Rekacewicz, C, Delfraissy, JF, Shannon, M & Pahwa, SG 2007, 'Characteristics and management of HIV-1-infected pregnant women enrolled in a randomised trial: Differences between Europe and the USA', BMC Infectious Diseases, vol. 7, 60. https://doi.org/10.1186/1471-2334-7-60
Newell, Marie Louise ; Huang, Sharon ; Fiore, Simona ; Thorne, Claire ; Mandelbrot, Laurent ; Sullivan, John L. ; Maupin, Robert ; Delke, Isaac ; Watts, D. Heather ; Gelber, Richard D. ; Cunningham, Coleen K. ; Dorenbaum, Alejandro ; Mofenson, Lynne ; Culnane, Mary ; Bazin, Brigitte ; Britto, Paula ; Balasubramanian, Rajalakshm ; Bryson, Yvonne ; Cunningham-Schrader, Bethann ; Kaiser, Kathleen A. ; Estep, Scharla ; Gigliotti, Maria ; Gonzalez-Garcia, Adolfo ; Mirochnick, Mark ; Rekacewicz, Claire ; Delfraissy, Jean Francois ; Shannon, Maureen ; Pahwa, Savita G. / Characteristics and management of HIV-1-infected pregnant women enrolled in a randomised trial : Differences between Europe and the USA. In: BMC Infectious Diseases. 2007 ; Vol. 7.
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title = "Characteristics and management of HIV-1-infected pregnant women enrolled in a randomised trial: Differences between Europe and the USA",
abstract = "Background: Rates of mother-to-child transmission of HIV-1 (MTCT) have historically been lower in European than in American cohort studies, possibly due to differences in population characteristics. The Pediatric AIDS Clinical Trials Group Protocol (PACTG) 316 trial evaluated the effectiveness of the addition of intrapartum/neonatal nevirapine in reducing MTCT in women already receiving antiretroviral prophylaxis. Participation of large numbers of pregnant HIV-infected women from the US and Western Europe enrolling in the same clinical trial provided the opportunity to identify and explore differences in their characteristics and in the use of non-study interventions to reduce MTCT. Methods: In this secondary analysis, 1350 women were categorized according to enrollment in centres in the USA (n = 978) or in Europe (n = 372). Factors associated with receipt of highly active antiretroviral therapy and with elective caesarean delivery were identified with logistic regression. Results: In Europe, women enrolled were more likely to be white and those of black race were mainly born in Sub-Saharan Africa. Women in the US were younger and more likely to have previous pregnancies and miscarriages and a history of sexually transmitted infections. More than 90{\%} of women did not report symptoms of their HIV infection; however, more women from the US had symptoms (8{\%}), compared to women from Europe (4{\%}). Women in the US were less likely to have HIV RNA levels <400 copies/ml at delivery than women enrolling in Europe, and more likely to receive highly active antiretroviral therapy, and to start therapy earlier in pregnancy. The elective caesarean delivery rate in Europe was 61{\%}, significantly higher than that in the US (22{\%}). Overall, 1.48{\%} of infants were infected and there was no significant difference in the rate of transmission between Europe and the US despite the different approaches to treatment and delivery. Conclusion: These findings confirm that there are important historical differences between the HIV-infected pregnant populations in Western Europe and the USA, both in terms of the characteristics of the women and their obstetric and therapeutic management. Although highly active antiretroviral therapy predominates in pregnancy in both settings now, population differences are likely to remain.",
author = "Newell, {Marie Louise} and Sharon Huang and Simona Fiore and Claire Thorne and Laurent Mandelbrot and Sullivan, {John L.} and Robert Maupin and Isaac Delke and Watts, {D. Heather} and Gelber, {Richard D.} and Cunningham, {Coleen K.} and Alejandro Dorenbaum and Lynne Mofenson and Mary Culnane and Brigitte Bazin and Paula Britto and Rajalakshm Balasubramanian and Yvonne Bryson and Bethann Cunningham-Schrader and Kaiser, {Kathleen A.} and Scharla Estep and Maria Gigliotti and Adolfo Gonzalez-Garcia and Mark Mirochnick and Claire Rekacewicz and Delfraissy, {Jean Francois} and Maureen Shannon and Pahwa, {Savita G}",
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TY - JOUR

T1 - Characteristics and management of HIV-1-infected pregnant women enrolled in a randomised trial

T2 - Differences between Europe and the USA

AU - Newell, Marie Louise

AU - Huang, Sharon

AU - Fiore, Simona

AU - Thorne, Claire

AU - Mandelbrot, Laurent

AU - Sullivan, John L.

AU - Maupin, Robert

AU - Delke, Isaac

AU - Watts, D. Heather

AU - Gelber, Richard D.

AU - Cunningham, Coleen K.

AU - Dorenbaum, Alejandro

AU - Mofenson, Lynne

AU - Culnane, Mary

AU - Bazin, Brigitte

AU - Britto, Paula

AU - Balasubramanian, Rajalakshm

AU - Bryson, Yvonne

AU - Cunningham-Schrader, Bethann

AU - Kaiser, Kathleen A.

AU - Estep, Scharla

AU - Gigliotti, Maria

AU - Gonzalez-Garcia, Adolfo

AU - Mirochnick, Mark

AU - Rekacewicz, Claire

AU - Delfraissy, Jean Francois

AU - Shannon, Maureen

AU - Pahwa, Savita G

PY - 2007/6/20

Y1 - 2007/6/20

N2 - Background: Rates of mother-to-child transmission of HIV-1 (MTCT) have historically been lower in European than in American cohort studies, possibly due to differences in population characteristics. The Pediatric AIDS Clinical Trials Group Protocol (PACTG) 316 trial evaluated the effectiveness of the addition of intrapartum/neonatal nevirapine in reducing MTCT in women already receiving antiretroviral prophylaxis. Participation of large numbers of pregnant HIV-infected women from the US and Western Europe enrolling in the same clinical trial provided the opportunity to identify and explore differences in their characteristics and in the use of non-study interventions to reduce MTCT. Methods: In this secondary analysis, 1350 women were categorized according to enrollment in centres in the USA (n = 978) or in Europe (n = 372). Factors associated with receipt of highly active antiretroviral therapy and with elective caesarean delivery were identified with logistic regression. Results: In Europe, women enrolled were more likely to be white and those of black race were mainly born in Sub-Saharan Africa. Women in the US were younger and more likely to have previous pregnancies and miscarriages and a history of sexually transmitted infections. More than 90% of women did not report symptoms of their HIV infection; however, more women from the US had symptoms (8%), compared to women from Europe (4%). Women in the US were less likely to have HIV RNA levels <400 copies/ml at delivery than women enrolling in Europe, and more likely to receive highly active antiretroviral therapy, and to start therapy earlier in pregnancy. The elective caesarean delivery rate in Europe was 61%, significantly higher than that in the US (22%). Overall, 1.48% of infants were infected and there was no significant difference in the rate of transmission between Europe and the US despite the different approaches to treatment and delivery. Conclusion: These findings confirm that there are important historical differences between the HIV-infected pregnant populations in Western Europe and the USA, both in terms of the characteristics of the women and their obstetric and therapeutic management. Although highly active antiretroviral therapy predominates in pregnancy in both settings now, population differences are likely to remain.

AB - Background: Rates of mother-to-child transmission of HIV-1 (MTCT) have historically been lower in European than in American cohort studies, possibly due to differences in population characteristics. The Pediatric AIDS Clinical Trials Group Protocol (PACTG) 316 trial evaluated the effectiveness of the addition of intrapartum/neonatal nevirapine in reducing MTCT in women already receiving antiretroviral prophylaxis. Participation of large numbers of pregnant HIV-infected women from the US and Western Europe enrolling in the same clinical trial provided the opportunity to identify and explore differences in their characteristics and in the use of non-study interventions to reduce MTCT. Methods: In this secondary analysis, 1350 women were categorized according to enrollment in centres in the USA (n = 978) or in Europe (n = 372). Factors associated with receipt of highly active antiretroviral therapy and with elective caesarean delivery were identified with logistic regression. Results: In Europe, women enrolled were more likely to be white and those of black race were mainly born in Sub-Saharan Africa. Women in the US were younger and more likely to have previous pregnancies and miscarriages and a history of sexually transmitted infections. More than 90% of women did not report symptoms of their HIV infection; however, more women from the US had symptoms (8%), compared to women from Europe (4%). Women in the US were less likely to have HIV RNA levels <400 copies/ml at delivery than women enrolling in Europe, and more likely to receive highly active antiretroviral therapy, and to start therapy earlier in pregnancy. The elective caesarean delivery rate in Europe was 61%, significantly higher than that in the US (22%). Overall, 1.48% of infants were infected and there was no significant difference in the rate of transmission between Europe and the US despite the different approaches to treatment and delivery. Conclusion: These findings confirm that there are important historical differences between the HIV-infected pregnant populations in Western Europe and the USA, both in terms of the characteristics of the women and their obstetric and therapeutic management. Although highly active antiretroviral therapy predominates in pregnancy in both settings now, population differences are likely to remain.

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