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, PACTG 316 Study Team, 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, PACTG 316 Study Team

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.

Trial registration: NCT00000869.

References

    1. European Collaborative Study Risk factors for mother-to-child transmission of HIV-1. Lancet. 1992;vol. 339:1007–1012. doi: 10.1016/0140-6736(92)90534-A.
    1. Blanche S, Rouzioux C, Moscato ML, Veber F, Mayaux MJ, Jacomet C, Tricoire J, Deville A, Vial M, Firtion G. A prospective study of infants born to women seropositive for human immunodeficiency virus type 1. HIV Infection in Newborns French Collaborative Study Group. N Engl J Med. 1989;320:1643–1648.
    1. Landesman SH, Kalish LA, Minkoff HL, Fox HE, Zorrilla C, Garcia PM, Fowler MG, Mofenson LM, Tuomala RE, The Women and Infants Transmission Study Obstetrical factors and the transmission of human immunodeficiency virus type 1 from mother-to-child. N Eng J Med. 1996;334:1617–1623. doi: 10.1056/NEJM199606203342501.
    1. Dabis F, Msellati P, Dunn DT, Lepage P, Newell ML, Perre P, Working Group on Mother-to-Child Transmission of HIV Estimating the rate of mother-to-child transmission of HIV. Report of a workshop on methodological issues, Ghent (Belgium), 17-20 February 1992. AIDS. 1993;7:1139–1148. doi: 10.1097/00002030-199308000-00027.
    1. Nair P, Alger L, Hines S, Seiden S, Hebel R, Johnson JP. Maternal and neonatal characteristics associated with HIV infection in infants of seropositive women. J Acquir Immune Defic Syndr. 1993;6:298–302.
    1. Kind C, Brandle B, Wyler CA, Calame A, Rudin C, Schaad UB, Schupbach J, Senn HP, Perrin L, Matter L, The Swiss Neonatal HIV Study Group Epidemiology of vertically transmitted HIV-1 infection in Switzerland: results of a nationwide prospective study. Eur J Pediatr. 1992;151:442–448. doi: 10.1007/BF01959360.
    1. Abrams EJ, Matheson PB, Thomas PA, Thea DM, Krasinski K, Lambert G, Shaffer N, Bamji M, Hutson DG, Grimm K, Kaur A, Rogers MF, New York City Perinatal HIV Transmission Collaborative Study Group Neonatal predictors of infection status and early death among 332 infants at risk of HIV-1 infection monitored prospectively from birth. Pediatrics. 1995;96:451–458.
    1. European Collaborative Study The mother-to-child HIV transmission epidemic in Europe: evolving in the East and established in the West. AIDS. 2006;20:1419–1427.
    1. Ryder RW, Behets F. Reasons for the wide variation in reported rates of mother-to-child transmission of HIV-1. AIDS. 1994;8:1495–1497.
    1. Cohen MH, Cook JA, Grey D, Young M, Hanau LH, Tien P, Levine AM, Wilson TE. Medically eligible women who do not use HAART: the importance of abuse, drug use, and race. Am J Public Health. 2004;94:1147–1151.
    1. Hamers FF, Batter V, Downs AM, Alix J, Cazein F, Brunet JB. The HIV epidemic associated with injecting drug use in Europe: geographic and time trends. AIDS. 1997;11:1365–1374. doi: 10.1097/00002030-199711000-00011.
    1. European Collaborative Study Vertical transmission of HIV-1: maternal immune status and obstetric factors. AIDS. 1996;10:1675–1681.
    1. Hamers FF, Downs AM. The changing face of the HIV epidemic in western Europe: what are the implications for public health policies? The Lancet. 2004;364:83–94. doi: 10.1016/S0140-6736(04)16594-X.
    1. Centers For Disease Control and Prevention HIV/AIDS Surveillance in Women. Slide Series www cdc gov/hiv/graphics/women htm. 2004;L264
    1. Dominguez KL, Lindegren ML, D'Almada PJ, Peters VB, Frederick T, Rakusan TA, Ortiz IR, Hsu HW, Melville SK, Sadek R, Fowler MG. Increasing Trend of Cesarean Deliveries in HIV-Infected Women in the United States From 1994 to 2000. J Acquir Immune Defic Syndr. 2003;33:232–238. doi: 10.1097/00126334-200306010-00019.
    1. Centers For Disease Control and Prevention . Enhanced Perinatal Surveillance - United States, 1999-2001. 4. Atlanta, US Department of Health and Human Sciences; 2004. pp. 1–22.
    1. Gebo KA, Fleishman JA, Conviser R, Reilly ED, Korthuis PT, Moore RD, Hellinger J, Keiser P, Rubin HR, Crane L, Hellinger FJ, Mathews WC, Network HIVR. Racial and gender disparities in receipt of highly active antiretroviral therapy persist in multstate sample of HIV patients in 2001. J Acquir Immune Defic Syndr. 2005;38:96–103. doi: 10.1097/00126334-200501010-00017.
    1. Palacio H, Kahn JG, Richards TA, Morin SF. Effect of race and/or ethnicity in use of antiretrovirals and prophylaxis for opportunistic infection: a review of the literature. Public Health Rep. 2002;117:233–251.
    1. European Collaborative Study Therapeutic and other interventions to reduce the risk of mother-to-child transmission of HIV-1 in Europe. Br J Obstet Gynaecol. 1998;105:704–709.
    1. Dorenbaum A, Cunningham CK, Gelber RD, Culnane M, Mofenson LM, Britto P, Rekacewicz C, Newell ML, Delfraissy JF, Cunningham-Schrader B, Mirochnick M, Sullivan JL, Team IPACTG. Two-dose intrapartum/newborn nevirapine and standard antiretroviral therapy to reduce perinatal HIV transmission. A randomised trial. JAMA. 2002;288:189–198. doi: 10.1001/jama.288.2.189.
    1. Fiore S, Thorne C, Newell ML. European involvement in an international perinatal trial. Developmental Period Medicine. 2003;7:449–458.
    1. Connor EM, Sperling RS, Gelber RD, Kiselev P, Scott GB, O'Sullivan MJ, Van Dyke R, Bey M, Shearer WT, Jacobson RL, Jimenez E, O'Neill E, Bazin B, Delfraissy JF, Culnane M, Coombs RW, Elkins MM, Moye JJ, Stratton P, Balsey J. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. N Eng J Med. 1994;331:1173–1180. doi: 10.1056/NEJM199411033311801.
    1. Hamers FF, Infuso A, Alix J, Downs AM. Current situation and regional perspective on HIV/AIDS surveillance in Europe. J Acquir Immune Defic Syndr. 2003;32:S39–S48.
    1. Mosher WD, Bachrach CA. Understanding U.S. fertility: continuity and change in the National Survey of Family Growth, 1988-1995. Fam Plann Perspect. 1996;28:4–12. doi: 10.2307/2135956.
    1. The CAESAR Coordinating Committee Randomised trial of addition of lamivudine or lamivudine plus loviride to zidovudine-containing regimens for patients with HIV-1 infection: the CAESAR trial. Lancet. 1997;349:1413–1421. doi: 10.1016/S0140-6736(97)04441-3.
    1. Carpenter CCJ, Fischl MA, Hammer SM, Hirsch MS, Jacobsen DM, Katzenstein DA, Montaner JSG, Richman DD, Saag MS, Schooley RT, Thompson MA, Vella S, Volberding PA. Antiretroviral therapy for HIV infection in 1997: updated recommendations of the International AIDS Society-USA panel. JAMA. 1997;277:1962–1969. doi: 10.1001/jama.277.24.1962.
    1. Cooper ER, Charurat M, Mofenson LM, Hanson IC, Pitt J, Diaz C, Hayani K, Handelsman E, Smeriglio V, Hoff R, Blattner WA. Combination antiretroviral strategies for the treatment of pregnant HIV-1-infected women and prevention of perinatal HIV-1 transmission. J Acquir Immune Defic Syndr. 2002;29:484–494.
    1. European Collaborative Study HIV-infected pregnant women and vertical transmission in Europe since 1986. AIDS. 2001;15:761–770. doi: 10.1097/00002030-200104130-00012.
    1. Mandelbrot L, Le Chenadec J, Berrebi A, Bongain A, Benifla JL, Delfraissy JF, Blanche S, Mayaux MJ, Cohort FP. Perinatal HIV-1 Transmission - Interaction Between Zidovudine Prophylaxis and Mode of Delivery in the French Perinatal Cohort. JAMA. 1998;280:55–60. doi: 10.1001/jama.280.1.55.
    1. European Collaborative Study Pregnancy-related changes in the longer-term management of HIV infected women in Europe. Eur J Obstet Gynecol Reprod Biol. 2003;111:3–8. doi: 10.1016/S0301-2115(03)00153-2.
    1. The Italian Register for HIV Infection in Children Determinants of mother-to-infant human immunodeficiency virus 1 transmission before and after the introduction of zidovudine prophylaxis. Arch Pediatr Adolesc Med. 2002;156:915–921.
    1. European Collaborative Study Mother-to-child transmission of HIV Infection in the era of highly active antiretroviral therapy. Clin Infect Dis. 2005;40:458–465. doi: 10.1086/427287.
    1. Warszawski J, Tubiana R, Le Chenadec J, Blanche S, Teglas JP, al Is intrapartum intravenous zidovudine still beneficial to prevent mother-to-child HIV-1 transmission? 12th Conference on Retroviruses and Opportunistic Infections, 22-25 February 2005, Boston, USA. 2005;Abstract:781.
    1. Mandelbrot L, Landreau A, Rekacewicz C, Berrebi A, Benifla JL, Burgard M, Lachassine E, Chaix ML, Bongain A, Ciraru-Vigneron N, Crenn-Herbert C, Delfraissy JF, Rouzioux C, Mayaux MJ, Blanche S, the Agence Nationale de Recherches sur le SIDA ANRSG. Lamivudine-Zidovudine Combination for Prevention of Maternal-Infant Transmission of HIV-1. JAMA. 2001;285:2083–2093. doi: 10.1001/jama.285.16.2083.
    1. Cunningham CK, Balasubramanian R, Delke I, Maupin R, Mofenson L, Dorenbaum A, Sullivan JL, Gonzalez-Garcia A, Thorpe E, Rathore M, Gelber RD. The impact of race/ethnicity on mother-to-child HIV transmission in the United States in Pediatric AIDS Clinical Trials Group Protocol 316. J Acquir Immune Defic Syndr. 2004;36:800–807. doi: 10.1097/00126334-200407010-00006.
    1. Fiscus SA, Adimora AA, Funk ML, Schoenbach VJ, Tristram D, Lim W, McKinney RE, Rupar D, Woods C, Wilfert C. Trends in interventions to reduce perinatal human immunodeficiency virus type 1 transmission in North Carolina. Pediatr Infect Dis J. 2002;21:664–668. doi: 10.1097/00006454-200207000-00012.
    1. Stringer JSA, Rouse DJ, Goldenberg RL. Prophylactic cesarean delivery for the prevention of perinatal human immunodeficiency virus transmission. The case for restraint. JAMA. 1999;281:1946–1949. doi: 10.1001/jama.281.20.1946.
    1. Brockmeyer N. German-Austrian Guidelines for HIV-therapy during pregnancy--status: May/June 1998--common statement of the Deutsche AIDS-Gesellschaft (DAIG) and the Osterreichische AIDS-Gesellschaft (OAG) Eur J Med Res. 1999;4:35–42.
    1. Taylor GP, Lyall EGH, Mercey D, Smith JR, Chester T, Newell ML, Tudor-Williams G. British HIV Association guidelines for prescribing antiretroviral therapy in pregnancy (1998) Sexually Transmitted Infections. 1999;75:90–97.
    1. Newell ML, Rogers MF. Pregnancy and HIV infection: a European Consensus on management. AIDS. 2002;16:S1–S18.
    1. British HIV Association . Guidelines for the management of HIV infection in pregnant women and the prevention of mother-to-child transmission of HIV. London, British HIV Association; 2005. p. .
    1. Hankins C, Lapointe N, Walmsley S. Participation in clinical trials among women living with HIV in Canada. Canadian Women's HIV Study Group. CMAJ. 1998;159:1359–1365.
    1. Gandhi M, Ameli N, Bacchetti P, Sharp GB, French AL, Young M, Gange SJ, Anastos K, Holman S, Levine A, Greenblatt RM. Eligibility criteria for HIV clinical trials and generalizability of results: the gap between published reports and study protocols. AIDS. 2005;19:1885–1896. doi: 10.1097/01.aids.0000189866.67182.f7.
    1. Moore DAJ, Goodall RL, Ives NJ, Hooker M, Gazzard BG, Easterbrook PJ. How generalizable are the results of large randomized controlled trials of antiretroviral therapy? HIV Medicine. 2000;1:149–154. doi: 10.1046/j.1468-1293.2000.00019.x.

Source: PubMed

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

3
Suscribir