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Meta-Analysis
. 2010 Mar 17;2010(3):CD008440.
doi: 10.1002/14651858.CD008440.

Antiretroviral therapy (ART) for treating HIV infection in ART-eligible pregnant women

Amy S Sturt  1 , Emily Kainne Dokubo, Tin Tin Sint
Affiliations
Meta-Analysis

Antiretroviral therapy (ART) for treating HIV infection in ART-eligible pregnant women

Amy S Sturt et al. Cochrane Database Syst Rev. .

Abstract

Background: This systematic review focuses on antiretroviral therapy (ART) for treating human immunodeficiency virus (HIV) infection in ART-eligible pregnant women. Mother-to-child transmission (MTCT) is the primary means by which children worldwide acquire HIV infection. MTCT occurs during three major timepoints during pregnancy and the postpartum period: in utero, intrapartum, and during breastfeeding. Strategies to reduce MTCT focus on these periods of exposure and include maternal and infant use of ART, caesarean section before onset of labour or rupture of membranes, and complete avoidance of breastfeeding. Where these combined interventions are available, the risk of MTCT is as low as 1-2%. Thus, ART used among mothers who require treatment of HIV for their own health also plays a significant role in decreasing MTCT.This review is one in a series of systematic reviews performed in preparation for the revision of the 2006 World Health Organization (WHO) Guidelines regarding "Antiretroviral Drugs for Treating Pregnant Women and Preventing HIV Infection in Infants" and "Antiretroviral therapy (ART) for HIV Infections in Adults and Adolescents." The findings from these reviews were discussed with experts, key stakeholders, and country representatives at the 2009 WHO guideline review meeting. The resulting WHO 2009 "rapid advice" preliminary guidance on adult and adolescent ART now recommends lifelong treatment for all adults with HIV infection and CD4 counts <350 cells/mm(3). These recommendations also apply to pregnant women who are HIV-infected and they place a high value on early ART to benefit the mother's own health (WHO 2009). The "rapid advice" preliminary guidance also aims to minimize side effects for mothers and their infants (WHO 2009).

Objectives: Our objective was to assess the current literature regarding the treatment of HIV infection in pregnant women who are clinically or immunologically eligible for ART. This review includes an evaluation of the optimal time to start therapy in relation to the woman's laboratory parameters and/or gestational age. It also includes an analysis of which specific antiretroviral medications to start in women who are not yet on ART and which agents to continue in women who are already on ART.

Search strategy: In June 2009, electronic searches were undertaken in these databases: Cochrane's "CENTRAL," EMBASE, PubMed, LILACS, and Web of Science/Web of Social Science. Hand searches were performed of the reference lists of all pertinent reviews and studies identified. Abstracts from relevant conferences were searched. Experts in the field were contacted to locate additional studies. The search strategy was iterative.

Selection criteria: We selected randomized controlled trials and observational studies that evaluated pregnant women with HIV infection who were eligible for ART according to criteria defined by the WHO guideline review committee. Studies were included in the systematic review when a comparison group was clearly defined and where the intervention comprised triple ART. For a study to be considered, each medication in the ART regimen needed to be clearly described.

Data collection and analysis: Two authors independently assessed the selected studies for relevance and inclusion. Relevant data was then extracted from included studies, and the risk of bias assessed. In each included study, the relative risk (RR) for the intervention versus the comparison group was calculated for each outcome, as appropriate, with 95% confidence intervals (CIs).

Main results: To our knowledge, there are no randomized controlled trials or observational studies that address the optimal time to start antiretroviral drugs in ART-eligible pregnant women in relation to the woman's laboratory parameters and/or gestational age. The medications to continue in ART-eligible pregnant women who are already receiving ART also have not been evaluated systematically in the current literature. The long-term mortality of HIV-positive pregnant women on ART for their own health, and the long-term virologic or clinical efficacy of ART in treating them, has not been evaluated in randomized clinical trials. In this review, surrogate outcomes for long-term mortality and virologic and clinical efficacy (e.g. MTCT and infant HIV transmission or death) were evaluated to determine the efficacy of specific antiretroviral regimens to start in women who are not yet on ART.Three randomized controlled trials and six observational studies were selected. No studies addressed comparative maternal mortality, which regimens to continue in women already on ART, or the laboratory parameters and gestational age at which to start therapy. The use of zidovudine (AZT), lamivudine (3TC) and lopinavir/ritonavir (LPV-r) starting at 28-36 weeks gestation in a breastfeeding population reduced infant HIV-transmission or death at 12 months compared to a short-course regimen (RR 0.64, 95% CI: 0.44-0.92) (deVincenzi, 2009). Starting AZT, 3TC, and nevirapine (NVP) at 34 weeks in a mixed-feeding population reduced infant HIV-transmission or death at 7 months compared to a short-course regimen (RR 0.39, 95% CI: 0.12-0.85) (Bae, 2008).In the Mma Bana study (a randomized controlled trial in a breastfeeding population) there was no difference in MTCT at six months between the AZT/3TC/LPV-r and AZT, 3TC, and abacavir (ABC) arms (RR 0.17, 95% CI: 0.02-1.44) (Shapiro, 2009). Both regimens also showed 92-95% efficacy in virologic suppression at delivery and during the breastfeeding period. In the Kesho Bora study there was a significant difference in MTCT at 12 months between breastfeeding women who initiated AZT/3TC/LPV-r starting between 28 and 36 weeks and those receiving a short course regimen (RR 0.58, 95% CI: 0.34-0.97) (deVincenzi, 2009). MTCT also decreased significantly when AZT/3TC/NVP was compared with a short-course regimen at seven months in a feeding intervention study (RR 0.15, 95% CI: 0.04-0.62) (Bae, 2008) and 12 months in a population where either exclusive breastfeeding or replacement feeding was encouraged (RR 0.14, CI: 0.04-0.47) (Ekouevi, 2008).In the Mma Bana study, there was increased risk of prematurity among infants born to women receiving AZT/3TC/LPV-r (RR 1.52, CI: 1.07- 2.17) compared with AZT/3TC/ABC (Shapiro, 2009). Ekouevi 2008 showed higher rates of infant low birth weight on AZT/3TC/NVP started at 24 weeks compared to a short course regimen started between 32 and 36 weeks (RR 1.81, 95% CI: 1.09- 3.0). Tonwe-Gold 2007 showed an increase in maternal severe adverse events among the women receiving AZT/3TC/NVP compared with a short-course regimen (RR 25.33, CI 1.49- 340.51).

Authors' conclusions: In ART-eligible pregnant women with HIV infection, ART is a safe and effective means of providing maternal virologic suppression, decreasing infant mortality, and reducing MTCT. Specifically, AZT/3TC/NVP, AZT/3TC/LPV-r, and AZT/3TC/ABC have been shown to decrease MTCT. More research is needed regarding the use of specific regimens and their maternal and infant side-effect profiles.

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Conflict of interest statement

There are no conflicts of interest to report.

Figures

1
1
Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.
2
2
Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
3
3
Flowsheet‐ Full‐text Articles
4
4
Flowsheet‐ Abstracts
1.1
1.1. Analysis
Comparison 1 Mma Bana (Shapiro 2009)‐ AZT/3TC/ABC vs. AZT/3TC/LPV‐r in HIV‐Infected Pregnant Women Eligible for Anti‐Retroviral Therapy, Outcome 1 Infant Mortality at 6 Months.
1.2
1.2. Analysis
Comparison 1 Mma Bana (Shapiro 2009)‐ AZT/3TC/ABC vs. AZT/3TC/LPV‐r in HIV‐Infected Pregnant Women Eligible for Anti‐Retroviral Therapy, Outcome 2 Grade 3/4 Maternal Severe Adverse Events (Laboratory).
1.3
1.3. Analysis
Comparison 1 Mma Bana (Shapiro 2009)‐ AZT/3TC/ABC vs. AZT/3TC/LPV‐r in HIV‐Infected Pregnant Women Eligible for Anti‐Retroviral Therapy, Outcome 3 Maternal Severe Adverse Events Requiring Treatment Modification.
1.4
1.4. Analysis
Comparison 1 Mma Bana (Shapiro 2009)‐ AZT/3TC/ABC vs. AZT/3TC/LPV‐r in HIV‐Infected Pregnant Women Eligible for Anti‐Retroviral Therapy, Outcome 4 Maternal Mortality at Six Months.
1.5
1.5. Analysis
Comparison 1 Mma Bana (Shapiro 2009)‐ AZT/3TC/ABC vs. AZT/3TC/LPV‐r in HIV‐Infected Pregnant Women Eligible for Anti‐Retroviral Therapy, Outcome 5 Grade 3/4 Infant Severe Adverse Events.
1.6
1.6. Analysis
Comparison 1 Mma Bana (Shapiro 2009)‐ AZT/3TC/ABC vs. AZT/3TC/LPV‐r in HIV‐Infected Pregnant Women Eligible for Anti‐Retroviral Therapy, Outcome 6 Prematurity.
1.7
1.7. Analysis
Comparison 1 Mma Bana (Shapiro 2009)‐ AZT/3TC/ABC vs. AZT/3TC/LPV‐r in HIV‐Infected Pregnant Women Eligible for Anti‐Retroviral Therapy, Outcome 7 Infant Low Birth Weight.
1.8
1.8. Analysis
Comparison 1 Mma Bana (Shapiro 2009)‐ AZT/3TC/ABC vs. AZT/3TC/LPV‐r in HIV‐Infected Pregnant Women Eligible for Anti‐Retroviral Therapy, Outcome 8 Mother to Child Transmission In Utero.
1.9
1.9. Analysis
Comparison 1 Mma Bana (Shapiro 2009)‐ AZT/3TC/ABC vs. AZT/3TC/LPV‐r in HIV‐Infected Pregnant Women Eligible for Anti‐Retroviral Therapy, Outcome 9 Mother to Child Transmission Late Post‐partum.
1.10
1.10. Analysis
Comparison 1 Mma Bana (Shapiro 2009)‐ AZT/3TC/ABC vs. AZT/3TC/LPV‐r in HIV‐Infected Pregnant Women Eligible for Anti‐Retroviral Therapy, Outcome 10 Mother to Child Transmission at Six Months Post‐Partum.
1.11
1.11. Analysis
Comparison 1 Mma Bana (Shapiro 2009)‐ AZT/3TC/ABC vs. AZT/3TC/LPV‐r in HIV‐Infected Pregnant Women Eligible for Anti‐Retroviral Therapy, Outcome 11 Stillbirths.
2.1
2.1. Analysis
Comparison 2 Kesho Bora (deVincenzi 2009)‐ AZT/3TC/LPV‐r vs. AZT (with intrapartum AZT/3TC/sd‐NVP), Outcome 1 Infant HIV Transmission or Death at 6 Months.
2.2
2.2. Analysis
Comparison 2 Kesho Bora (deVincenzi 2009)‐ AZT/3TC/LPV‐r vs. AZT (with intrapartum AZT/3TC/sd‐NVP), Outcome 2 Infant HIV Transmission or Death at 12 Months.
2.3
2.3. Analysis
Comparison 2 Kesho Bora (deVincenzi 2009)‐ AZT/3TC/LPV‐r vs. AZT (with intrapartum AZT/3TC/sd‐NVP), Outcome 3 Infant Mortality at 6 Months.
2.4
2.4. Analysis
Comparison 2 Kesho Bora (deVincenzi 2009)‐ AZT/3TC/LPV‐r vs. AZT (with intrapartum AZT/3TC/sd‐NVP), Outcome 4 Infant Mortality at 12 months.
2.5
2.5. Analysis
Comparison 2 Kesho Bora (deVincenzi 2009)‐ AZT/3TC/LPV‐r vs. AZT (with intrapartum AZT/3TC/sd‐NVP), Outcome 5 Maternal Grade 3/4 Severe Adverse Events Not Requiring Treatment Modification.
2.6
2.6. Analysis
Comparison 2 Kesho Bora (deVincenzi 2009)‐ AZT/3TC/LPV‐r vs. AZT (with intrapartum AZT/3TC/sd‐NVP), Outcome 6 Infant Grade 3/4 Severe Adverse Events.
2.7
2.7. Analysis
Comparison 2 Kesho Bora (deVincenzi 2009)‐ AZT/3TC/LPV‐r vs. AZT (with intrapartum AZT/3TC/sd‐NVP), Outcome 7 Prematurity.
2.8
2.8. Analysis
Comparison 2 Kesho Bora (deVincenzi 2009)‐ AZT/3TC/LPV‐r vs. AZT (with intrapartum AZT/3TC/sd‐NVP), Outcome 8 Low Birth Weight.
2.9
2.9. Analysis
Comparison 2 Kesho Bora (deVincenzi 2009)‐ AZT/3TC/LPV‐r vs. AZT (with intrapartum AZT/3TC/sd‐NVP), Outcome 9 Stillbirths.
2.10
2.10. Analysis
Comparison 2 Kesho Bora (deVincenzi 2009)‐ AZT/3TC/LPV‐r vs. AZT (with intrapartum AZT/3TC/sd‐NVP), Outcome 10 Mother to Child Transmission at Delivery.
2.11
2.11. Analysis
Comparison 2 Kesho Bora (deVincenzi 2009)‐ AZT/3TC/LPV‐r vs. AZT (with intrapartum AZT/3TC/sd‐NVP), Outcome 11 Mother to Child Transmission at 6 Weeks.
2.12
2.12. Analysis
Comparison 2 Kesho Bora (deVincenzi 2009)‐ AZT/3TC/LPV‐r vs. AZT (with intrapartum AZT/3TC/sd‐NVP), Outcome 12 Mother to Child Transmission at 6 Months.
2.13
2.13. Analysis
Comparison 2 Kesho Bora (deVincenzi 2009)‐ AZT/3TC/LPV‐r vs. AZT (with intrapartum AZT/3TC/sd‐NVP), Outcome 13 Mother to Child Transmission at 12 Months.
3.1
3.1. Analysis
Comparison 3 Lehman 2008‐ Resistance After AZT/3TC/NVP vs. Short Course AZT + sdNVP, Outcome 1 Maternal Resistance.
4.1
4.1. Analysis
Comparison 4 Ekouevi 2008‐ All Eligible: AZT/3TC/NVP vs. Other Short Course PMTCT Regimen, Outcome 1 Mother to Child Transmission at 12 Months.
4.2
4.2. Analysis
Comparison 4 Ekouevi 2008‐ All Eligible: AZT/3TC/NVP vs. Other Short Course PMTCT Regimen, Outcome 2 Infant Low Birth Weight.
4.3
4.3. Analysis
Comparison 4 Ekouevi 2008‐ All Eligible: AZT/3TC/NVP vs. Other Short Course PMTCT Regimen, Outcome 3 Stillbirths.
5.1
5.1. Analysis
Comparison 5 Tonwe‐Gold 2007: Eligible vs. Ineligible˜ AZT/3TC/NVP vs. Other Short Course PMTCT Regimen, Outcome 1 HIV Transmission or Death at 1 Month.
5.2
5.2. Analysis
Comparison 5 Tonwe‐Gold 2007: Eligible vs. Ineligible˜ AZT/3TC/NVP vs. Other Short Course PMTCT Regimen, Outcome 2 HIV Transmission or Death at 1 Year.
5.3
5.3. Analysis
Comparison 5 Tonwe‐Gold 2007: Eligible vs. Ineligible˜ AZT/3TC/NVP vs. Other Short Course PMTCT Regimen, Outcome 3 Infant Mortality at 1 Month.
5.4
5.4. Analysis
Comparison 5 Tonwe‐Gold 2007: Eligible vs. Ineligible˜ AZT/3TC/NVP vs. Other Short Course PMTCT Regimen, Outcome 4 Maternal Grade 3/4 Severe Adverse Events Requiring Treatment Modification.
5.5
5.5. Analysis
Comparison 5 Tonwe‐Gold 2007: Eligible vs. Ineligible˜ AZT/3TC/NVP vs. Other Short Course PMTCT Regimen, Outcome 5 Infant Low Birth Weight.
5.6
5.6. Analysis
Comparison 5 Tonwe‐Gold 2007: Eligible vs. Ineligible˜ AZT/3TC/NVP vs. Other Short Course PMTCT Regimen, Outcome 6 Stillbirths.
5.7
5.7. Analysis
Comparison 5 Tonwe‐Gold 2007: Eligible vs. Ineligible˜ AZT/3TC/NVP vs. Other Short Course PMTCT Regimen, Outcome 7 Mother to Child Tranmsission of HIV at 1 Month.
5.8
5.8. Analysis
Comparison 5 Tonwe‐Gold 2007: Eligible vs. Ineligible˜ AZT/3TC/NVP vs. Other Short Course PMTCT Regimen, Outcome 8 Mother to Child Transmission of HIV at 1 Year.
6.1
6.1. Analysis
Comparison 6 Jamisse 2007: AZT/3TC/NVP in CD4<250 vs. CD4>250, Outcome 1 Maternal Grade 3/4 Severe Adverse Events.
7.1
7.1. Analysis
Comparison 7 Jamisse 2007: AZT/3TC/NVP vs. d4T/3TC/NVP in Women With CD4<350, Outcome 1 Maternal Grade 3/4 Severe Adverse Events.
8.1
8.1. Analysis
Comparison 8 Phanuphak 2007: AZT/3TC/NVP in CD4<200 vs. CD4>200, Outcome 1 Maternal Grade 3/4 Severe Adverse Events.
9.1
9.1. Analysis
Comparison 9 Bae 2008: AZT/3TC/NVP vs. AZT in CD4<200, Outcome 1 HIV‐Transmission or Death at 7 Months.
9.2
9.2. Analysis
Comparison 9 Bae 2008: AZT/3TC/NVP vs. AZT in CD4<200, Outcome 2 Infant Grade 3/4 Severe Adverse Events at Birth.
9.3
9.3. Analysis
Comparison 9 Bae 2008: AZT/3TC/NVP vs. AZT in CD4<200, Outcome 3 Prematurity.
9.4
9.4. Analysis
Comparison 9 Bae 2008: AZT/3TC/NVP vs. AZT in CD4<200, Outcome 4 Mother to Child Transmission at Birth.
9.5
9.5. Analysis
Comparison 9 Bae 2008: AZT/3TC/NVP vs. AZT in CD4<200, Outcome 5 Mother to Child Transmission at 1 Month.
9.6
9.6. Analysis
Comparison 9 Bae 2008: AZT/3TC/NVP vs. AZT in CD4<200, Outcome 6 Mother to Child Transmission Cumulative by 7 Months.
10.1
10.1. Analysis
Comparison 10 Marazzi 2006: AZT/3TC/NVP in <250 vs. >250, Outcome 1 Hepatotoxicity in NVP‐Based Regimens With CD4>250 vs. CD4<250.
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References

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European Collaborative Study (ECS) 2005 {published data only}
    1. European Collaborative Study. Mother‐to‐child transmission of HIV infection in the era of highly active antiretroviral therapy. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 2005;40(3):458‐65. [PUBMED: 15668871] - PubMed
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    1. Fiore S, Newell ML, Trabattoni D, Thorne C, Gray L, Savasi V, et al. Antiretroviral therapy‐associated modulation of Th1 and Th2 immune responses in HIV‐infected pregnant women. Journal of reproductive immunology 2006;70(1‐2):143‐50. [PUBMED: 16423410] - PubMed
Garcia‐Tejedor 2009 {published data only}
    1. Garcia‐Tejedor A, Maiques V, Perales A, Lopez‐Aldeguer J. Influence of highly active antiretroviral treatment (HAART) on risk factors for vertical HIV transmission. Acta obstetricia et gynecologica Scandinavica 2009;88(8):882‐7. [PUBMED: 19557554] - PubMed
Giuliano 2003 {published data only}
    1. Giuliano M, Palmisano L, Galluzzo CM, Amici R, Germinario E, Okong P, et al. Selection of resistance mutations in pregnant women receiving zidovudine and lamivudine to prevent HIV perinatal transmission. AIDS (London, England) 2003;17(10):1570‐2. [PUBMED: 12824800] - PubMed
Goetghebuer 2009 {published data only}
    1. Goetghebuer T, Haelterman E, Marvillet I, Barlow P, Hainaut M, Salameh A, et al. Vertical transmission of HIV in Belgium: a 1986‐2002 retrospective analysis. European journal of pediatrics 2009;168(1):79‐85. [PUBMED: 18392638] - PubMed
Grosch‐Woerner 2008 {published data only}
    1. Grosch‐Woerner I, Puch K, Maier RF, Niehues T, Notheis G, Patel D, et al. Increased rate of prematurity associated with antenatal antiretroviral therapy in a German/Austrian cohort of HIV‐1‐infected women. HIV medicine 2008;9(1):6‐13. [PUBMED: 18199167] - PubMed
Hitti 2004 {published data only}
    1. Hitti J, Frenkel LM, Stek AM, Nachman SA, Baker D, Gonzalez‐Garcia A, et al. Maternal toxicity with continuous nevirapine in pregnancy: results from PACTG 1022. Journal of acquired immune deficiency syndromes (1999) 2004;36(3):772‐6. [PUBMED: 15213559] - PubMed
Hitti 2007 {published data only}
    1. Hitti J, Andersen J, McComsey G, Liu T, Melvin A, Smith L, et al. Protease inhibitor‐based antiretroviral therapy and glucose tolerance in pregnancy: AIDS Clinical Trials Group A5084. American journal of obstetrics and gynecology 2007;196(4):331.e1‐7. [PUBMED: 17403409] - PubMed
Hoffman 2009 {unpublished data only}
    1. Hoffman R, Black V, Technau K, Merwe K, Currier J, Chersich M, Coovadia A. Impact of highly active antiretroviral therapy regimen and duration of therapy on risk of mother‐to‐child HIV transmission in Johannesburg, South Africa. International AIDS Society Conference. Capetown, South Africa;July 2009:Abstract WEPEB260.
Jackson 2007 {published data only}
    1. Jackson DJ, Chopra M, Doherty TM, Colvin MS, Levin JB, Willumsen JF, et al. Operational effectiveness and 36 week HIV‐free survival in the South African programme to prevent mother‐to‐child transmission of HIV‐1. AIDS (London, England) 2007;21(4):509‐16. [PUBMED: 17301570] - PubMed
Justman 2003 {published data only}
    1. Justman JE, Benning L, Danoff A, Minkoff H, Levine A, Greenblatt RM, et al. Protease inhibitor use and the incidence of diabetes mellitus in a large cohort of HIV‐infected women. Journal of acquired immune deficiency syndromes (1999) 2003;32(3):298‐302. [PUBMED: 12626890] - PubMed
Kourtis 2007 {published data only}
    1. Kourtis AP, Schmid CH, Jamieson DJ, Lau J. Use of antiretroviral therapy in pregnant HIV‐infected women and the risk of premature delivery: a meta‐analysis. AIDS (London, England) 2007;21(5):607‐15. [PUBMED: 17314523] - PubMed
Kowalska 2003 {published data only}
    1. Kowalska A, Niemiec T, Midaoui A, Burkacka E. Effect of antiretroviral therapy on pregnancy outcome in HIV‐1 positive women. Medycyna wieku rozwojowego 2003;7(4 Pt 1):459‐68. [PUBMED: 15010556] - PubMed
Livingston 2007 {published data only}
    1. Livingston EG, Cohn SE, Yang Y, Watts HD, Bardeguez AD, Jones TB, et al. Lipids and lactate in human immunodeficiency virus‐1 infected pregnancies with or without protease inhibitor‐based therapy. Obstetrics and gynecology 2007;110(2 Pt 1):391‐7. [PUBMED: 17666616] - PubMed
Lopez‐Cortes 2007 {published data only}
    1. Lopez‐Cortes LF, Ruiz‐Valderas R, Rivero A, Camacho A, Marquez‐Solero M, Santos J, et al. Efficacy of low‐dose boosted saquinavir once daily plus nucleoside reverse transcriptase inhibitors in pregnant HIV‐1‐infected women with a therapeutic drug monitoring strategy. Therapeutic drug monitoring 2007;29(2):171‐6. [PUBMED: 17417070] - PubMed
Lorenzi 1998 {published data only}
    1. Lorenzi P, Spicher VM, Laubereau B, Hirschel B, Kind C, Rudin C, et al. Antiretroviral therapies in pregnancy: maternal, fetal and neonatal effects. Swiss HIV Cohort Study, the Swiss Collaborative HIV and Pregnancy Study, and the Swiss Neonatal HIV Study. AIDS (London, England) 1998;12(18):F241‐7. [PUBMED: 9875571] - PubMed
Marti 2007 {published data only}
    1. Marti C, Pena JM, Bates I, Madero R, Jose I, Pallardo LF, et al. Obstetric and perinatal complications in HIV‐infected women. Analysis of a cohort of 167 pregnancies between 1997 and 2003. Acta obstetricia et gynecologica Scandinavica 2007;86(4):409‐15. [PUBMED: 17486461] - PubMed
Martin 2006 {published data only}
    1. Martin F, Navaratne L, Khan W, Sarner L, Mercey D, Anderson J, et al. Pregnant women with HIV infection can expect healthy survival: three‐year follow‐up. Journal of acquired immune deficiency syndromes (1999) 2006;43(2):186‐92. [PUBMED: 16940856] - PubMed
Martin 2007 {published data only}
    1. Martin F, Taylor GP. Increased rates of preterm delivery are associated with the initiation of highly active antiretrovial therapy during pregnancy: a single‐center cohort study. The Journal of infectious diseases 2007;196(4):558‐61. [PUBMED: 17624841] - PubMed
McIntyre 2002 {published data only}
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McIntyre 2006 {published data only}
    1. McIntyre J. Strategies to prevent mother‐to‐child transmission of HIV. Current opinion in infectious diseases 2006;19(1):33‐8. [PUBMED: 16374215] - PubMed
Mellins 2008 {published data only}
    1. Mellins CA, Chu C, Malee K, Allison S, Smith R, Harris L, et al. Adherence to antiretroviral treatment among pregnant and postpartum HIV‐infected women. AIDS care 2008;20(8):958‐68. [PUBMED: 18608073] - PubMed
Mofenson 2002 {published data only}
    1. Mofenson LM, Munderi P. Safety of antiretroviral prophylaxis of perinatal transmission for HIV‐infected pregnant women and their infants. Journal of acquired immune deficiency syndromes (1999) 2002;30(2):200‐15. [PUBMED: 12045684] - PubMed
Mussi‐Pinhata 2007 {published data only}
    1. Mussi‐Pinhata MM, Rego MA, Freimanis L, Kakehasi FM, Machado DM, Cardoso EM, et al. Maternal antiretrovirals and hepatic enzyme, hematologic abnormalities among human immunodeficiency virus type 1‐uninfected infants: the NISDI perinatal study. The Pediatric infectious disease journal 2007;26(11):1032‐7. [PUBMED: 17984811] - PubMed
Nurutdinova 2008 {published data only}
    1. Nurutdinova D, Onen NF, Hayes E, Mondy K, Overton ET. Adverse effects of tenofovir use in HIV‐infected pregnant women and their infants. The Annals of pharmacotherapy 2008;42(11):1581‐5. [PUBMED: 18957630] - PubMed
Onen 2008 {published data only}
    1. Onen NF, Nurutdinova D, Sungkanuparph S, Gase D, Mondy K, Overton ET. Effect of postpartum HIV treatment discontinuation on long‐term maternal outcome. Journal of the International Association of Physicians in AIDS Care (Chicago, Ill. : 2002) 2008;7(5):245‐51. [PUBMED: 18812593] - PubMed
Ono 2008 {published data only}
    1. Ono E, Nunes dos Santos AM, Menezes Succi RC, Machado DM, Angelis DS, Salomao R, et al. Imbalance of naive and memory T lymphocytes with sustained high cellular activation during the first year of life from uninfected children born to HIV‐1‐infected mothers on HAART. Brazilian journal of medical and biological research = Revista brasileira de pesquisas medicas e biologicas / Sociedade Brasileira de Biofisica ... [et al.] 2008;41(8):700‐8. [PUBMED: 18797705] - PubMed
Pacheco 2006 {published data only}
    1. Pacheco SE, McIntosh K, Lu M, Mofenson LM, Diaz C, Foca M, et al. Effect of perinatal antiretroviral drug exposure on hematologic values in HIV‐uninfected children: An analysis of the women and infants transmission study. The Journal of infectious diseases 2006;194(8):1089‐97. [PUBMED: 16991083] - PubMed
Palacios 2009 {published data only}
    1. Palacios R, Senise J, Vaz M, Diaz R, Castelo A. Short‐term antiretroviral therapy to prevent mother‐to‐child transmission is safe and results in a sustained increase in CD4 T‐cell counts in HIV‐1‐infected mothers. HIV medicine 2009;10(3):157‐62. [PUBMED: 19245537] - PubMed
Peltier 2009 {published data only}
    1. Peltier CA, Ndayisaba GF, Lepage P, Griensven J, Leroy V, Pharm CO, et al. Breastfeeding with maternal antiretroviral therapy or formula feeding to prevent HIV postnatal mother‐to‐child transmission in Rwanda. AIDS (London, England) 2009;23(18):2415‐23. [PUBMED: 19730349] - PMC - PubMed
Resino 2001 {published data only}
    1. Resino Garcia S, Bellon Cano JM, Navarro Caspistegui J, Gurbindo Gutierrez D, Leon Leal JA, Munoz‐Fernandez MA. T‐cell subsets variation during clinical and immunological progression in vertically HIV‐infected children [Variacion de las subpoblaciones de celulas T segun la progresion clinica e inmunologica en ninos infectados verticalmente por HIV‐1.]. Medicina 2001;61(5 Pt 1):557‐65. [PUBMED: 11721322] - PubMed
Schulte 2007 {published data only}
    1. Schulte J, Dominguez K, Sukalac T, Bohannon B, Fowler MG. Declines in low birth weight and preterm birth among infants who were born to HIV‐infected women during an era of increased use of maternal antiretroviral drugs: Pediatric Spectrum of HIV Disease, 1989‐2004. Pediatrics 2007;119(4):e900‐6. [PUBMED: 17353299] - PubMed
Stek 2009 {published data only}
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Szyld 2006 {published data only}
    1. Szyld EG, Warley EM, Freimanis L, Gonin R, Cahn PE, Calvet GA, et al. Maternal antiretroviral drugs during pregnancy and infant low birth weight and preterm birth. AIDS (London, England) 2006;20(18):2345‐53. [PUBMED: 17117021] - PubMed
Taha 2009 {published data only}
    1. Taha TE, Kumwenda J, Cole SR, Hoover DR, Kafulafula G, Fowler MG, et al. Postnatal HIV‐1 transmission after cessation of infant extended antiretroviral prophylaxis and effect of maternal highly active antiretroviral therapy. The Journal of infectious diseases 2009;200(10):1490‐7. [PUBMED: 19832114] - PubMed
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    1. Tempelman C, Timmermans S, Godfried MH, Dieleman JP, Boer K, Ende ME. Highly active antiretroviral therapy (HAART) in HIV‐positive pregnant women in the Netherlands, 1997‐2003: safe, effective and with few side effects [Krachtige antiretrovirale therapie (HAART) bij HIV‐positieve zwangeren in Nederland, 1997‐2003: veilig, effectief en met weinig bijwerkingen.]. Nederlands tijdschrift voor geneeskunde 2004;148(41):2021‐5. [PUBMED: 15553999] - PubMed
Thomas 2008 {unpublished data only}
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Thorne 2004 {published data only}
    1. Thorne C, Patel D, Newell ML. Increased risk of adverse pregnancy outcomes in HIV‐infected women treated with highly active antiretroviral therapy in Europe. AIDS (London, England) 2004;18(17):2337‐9. [PUBMED: 15577551] - PubMed
Timmermans 2005 {published data only}
    1. Timmermans S, Tempelman C, Godfried MH, Nellen J, Dieleman J, Sprenger H, et al. Nelfinavir and nevirapine side effects during pregnancy. AIDS (London, England) 2005;19(8):795‐9. [PUBMED: 15867493] - PubMed
Townsend 2006 {published data only}
    1. Townsend CL, Tookey PA, Cortina‐Borja M, Peckham CS. Antiretroviral therapy and congenital abnormalities in infants born to HIV‐1‐infected women in the United Kingdom and Ireland, 1990 to 2003. Journal of acquired immune deficiency syndromes (1999) 2006;42(1):91‐4. [PUBMED: 16763496] - PubMed
Townsend 2007 {published data only}
    1. Townsend CL, Cortina‐Borja M, Peckham CS, Tookey PA. Antiretroviral therapy and premature delivery in diagnosed HIV‐infected women in the United Kingdom and Ireland. AIDS (London, England) 2007;21(8):1019‐26. [PUBMED: 17457096] - PubMed
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Tuomala 2005 {published data only}
    1. Tuomala RE, Watts DH, Li D, Vajaranant M, Pitt J, Hammill H, et al. Improved obstetric outcomes and few maternal toxicities are associated with antiretroviral therapy, including highly active antiretroviral therapy during pregnancy. Journal of acquired immune deficiency syndromes (1999) 2005;38(4):449‐73. [PUBMED: 15764963] - PubMed
van der Merwe 2006 {published data only}
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van Schalkwyk 2008 {published data only}
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Vithayasai 2002 {published data only}
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Volmink 2007 {published data only}
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Watts 2004 {published data only}
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Watts 2004a {published data only}
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Zorrilla 2007 {published data only}
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