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Meta-Analysis
. 2014 Oct 4;2014(10):CD011323.
doi: 10.1002/14651858.CD011323.

Antiretroviral interventions for preventing breast milk transmission of HIV

Angela B White  1 , Joy F Mirjahangir, Hacsi Horvath, Andrew Anglemyer, Jennifer S Read
Affiliations
Meta-Analysis

Antiretroviral interventions for preventing breast milk transmission of HIV

Angela B White et al. Cochrane Database Syst Rev. .

Abstract

Background: An estimated 260,000 children under the age of 15 years acquired HIV infection in 2012. As much as 42% of mother-to-child transmission is related to breastfeeding. Antiretroviral prophylaxis for mothers or infants has the potential to prevent mother-to-child transmission of HIV through breast milk.

Objectives: To determine which antiretroviral prophylactic regimens are efficacious and safe for reducing mother-to-child transmission of HIV through breastfeeding and thereby avert child morbidity and mortality.

Search methods: Using Cochrane Collaboration search methods in conjunction with appropriate search terms, we identified relevant studies from January 1, 1994 to January 14, 2014 by searching databases including Cochrane CENTRAL, EMBASE and PubMed, LILACS, and Web of Science/Web of Social Science.

Selection criteria: Randomized controlled trials in which HIV-infected mothers breastfed their infants, and in which the mothers used antiretroviral prophylaxis while breastfeeding their children or their children received antiretroviral prophylaxis for at least four weeks while breastfeeding, were included.

Data collection and analysis: Abstracts of all trials identified were examined independently by two authors. We identified 15,922 references and examined 81 in detail. Data were abstracted independently using a standardized form.

Main results: Seven RCTs were included in the review.One trial compared triple antiretroviral prophylaxis during pregnancy and breastfeeding with short antiretroviral prophylaxis to given to the mother to prevent mother-to-child transmission of HIV. At 12 months, the risks of HIV transmission, and of HIV transmission or death, were lower, but there was no difference in infant mortality alone in the triple arm versus the short arm. Using the GRADE methodology, evidence quality for outcomes in this trial was generally low to moderate.One trial compared six months of breastfeeding using zidovudine, lamivudine, and lopinavir/ritonavir versus zidovudine, lamivudine, and abacavir from 26-34 weeks gestation. At six months, there was no difference in risk of infant HIV infection, infant death, or infant HIV infection or death between the two groups. Evidence quality for outcomes in this trial was generally very low to low.One trial of single dose nevirapine versus six weeks of infant zidovudine found the risk of HIV infection at 12 weeks to be greater in the zidovudine arm than in the single dose nevirapine arm. Evidence quality for outcomes in this trial was generally very low.One multi-country trial compared single dose nevirapine and six weeks of infant nevirapine. After 12 months, infants in the extended nevirapine group had a lower risk of infant mortality compared with the control. There was no difference in the risk of HIV infection or death or in HIV transmission alone in the extended nevirapine group compared with the control. Evidence quality for outcomes in this trial was generally low to moderate.One trial compared single dose nevirapine plus one week zidovudine; the control regimen plus nevirapine up to 14 weeks; or the control regimen with dual prophylaxis up to 14 weeks. At 24 months, the extended nevirapine regimen group had a lower risk of HIV transmission and of HIV transmission or death vs. the control. There was no difference in infant mortality alone. Compared with controls, the dual prophylaxis group had a lower risk of HIV transmission and of HIV transmission or death, but no difference in infant mortality alone. There was no difference in these outcomes between the two intervention arms. Evidence quality for outcomes in this trial was generally moderate to high.One trial compared six weeks of nevirapine with six months of nevirapine. Among infants of mothers not using highly active antiretroviral therapy, there was no difference in risk of HIV infection among the six month nevirapine group versus the six week nevirapine group. Evidence quality for outcomes in this trial was generally low to moderate.One trial compared a maternal triple-drug antiretroviral regimen, infant nevirapine, or neither intervention. Infants in the maternal prophylaxis arm were at lower risk for HIV, and HIV infection or death when compared with the control group. There was no difference in the risk of infant mortality alone. Infants with extended prophylaxis had a lower risk of HIV infection and of HIV infection or death versus the control group infants. There was no difference in the risk of infant mortality alone in the extended infant nevirapine group versus the control. There was no difference in HIV infection, infant mortality, and HIV infection or death between the maternal and extended infant prophylaxis groups. Evidence quality for outcomes in this trial was generally low to moderate.

Authors' conclusions: Antiretroviral prophylaxis, whether used by the HIV-infected mother or the HIV-exposed infant while breastfeeding, is efficacious in preventing mother-to-child transmission of HIV. Further research is needed regarding maternal resistance and response to subsequent antiretroviral therapy after maternal prophylaxis. An ongoing trial (IMPAACT 1077BF) compares the efficacy and safety of maternal triple antiretroviral prophylaxis versus daily infant nevirapine for prevention of mother-to-child transmission through breastfeeding.

PubMed Disclaimer

Conflict of interest statement

The authors declare no conflicts of interest.

Note: The conclusions and opinions expressed in this article are those of the authors and do not necessarily reflect those of the U.S. Department of Health and Human Services or the National Institutes of Health.

Figures

1
1
Methodological quality summary: review authors' judgments about each methodological quality item for each included study.
2
2
Methodological quality graph: review authors' judgments about each methodological quality item presented as percentages across all included studies.
3
3
Study flow diagram.
1.1
1.1. Analysis
Comparison 1 PEPI‐Malawi (extended NVP to infant for 14 weeks vs. sdNVP + ZDV for 1 week), Outcome 1 HIV Transmission at 9 months among those whose HIV diagnostic testing was negative within 48 hrs of birth.
1.2
1.2. Analysis
Comparison 1 PEPI‐Malawi (extended NVP to infant for 14 weeks vs. sdNVP + ZDV for 1 week), Outcome 2 Infant Mortality at 9 Months Among Those Whose HIV Diagnostic Testing was Negative Within 48 Hours of Birth.
1.3
1.3. Analysis
Comparison 1 PEPI‐Malawi (extended NVP to infant for 14 weeks vs. sdNVP + ZDV for 1 week), Outcome 3 HIV Transmission or Death at 9 Months Among Those Whose HIV Diagnostic Testing was Negative Within 48 Hours of Birth.
1.4
1.4. Analysis
Comparison 1 PEPI‐Malawi (extended NVP to infant for 14 weeks vs. sdNVP + ZDV for 1 week), Outcome 4 HIV Transmission at 24 Months Among Those Uninfected At Birth.
1.5
1.5. Analysis
Comparison 1 PEPI‐Malawi (extended NVP to infant for 14 weeks vs. sdNVP + ZDV for 1 week), Outcome 5 Infant Mortality at 24 Months Among Those Uninfected At Birth.
1.6
1.6. Analysis
Comparison 1 PEPI‐Malawi (extended NVP to infant for 14 weeks vs. sdNVP + ZDV for 1 week), Outcome 6 HIV Transmission or Death at 24 Months Among Those Uninfected At Birth.
1.7
1.7. Analysis
Comparison 1 PEPI‐Malawi (extended NVP to infant for 14 weeks vs. sdNVP + ZDV for 1 week), Outcome 7 Infants With Possible Related Severe Adverse Events‐24 Months.
1.8
1.8. Analysis
Comparison 1 PEPI‐Malawi (extended NVP to infant for 14 weeks vs. sdNVP + ZDV for 1 week), Outcome 8 Infants With Probably Related Severe Adverse Events.
2.1
2.1. Analysis
Comparison 2 PEPI‐Malawi (extended NVP + ZDV to infant for 14 weeks vs. sdNVP + ZDV for 1 week), Outcome 1 HIV Transmission at 9 months among those whose HIV diagnostic testing was negative within 48 hrs of birth.
2.2
2.2. Analysis
Comparison 2 PEPI‐Malawi (extended NVP + ZDV to infant for 14 weeks vs. sdNVP + ZDV for 1 week), Outcome 2 Infant Mortality at 9 Months Among Those Whose HIV Diagnostic Testing was Negative Within 48 Hours of Birth.
2.3
2.3. Analysis
Comparison 2 PEPI‐Malawi (extended NVP + ZDV to infant for 14 weeks vs. sdNVP + ZDV for 1 week), Outcome 3 HIV Transmission or Death at 9 Months Among Those Whose HIV Diagnostic Testing was Negative Within 48 Hours of Birth.
2.4
2.4. Analysis
Comparison 2 PEPI‐Malawi (extended NVP + ZDV to infant for 14 weeks vs. sdNVP + ZDV for 1 week), Outcome 4 HIV Transmission at 24 Months Among Those Uninfected At Birth.
2.5
2.5. Analysis
Comparison 2 PEPI‐Malawi (extended NVP + ZDV to infant for 14 weeks vs. sdNVP + ZDV for 1 week), Outcome 5 Infant Mortality at 24 Months Among Those Uninfected At Birth.
2.6
2.6. Analysis
Comparison 2 PEPI‐Malawi (extended NVP + ZDV to infant for 14 weeks vs. sdNVP + ZDV for 1 week), Outcome 6 HIV Transmission or Death at 24 Months Among Those Uninfected At Birth.
2.7
2.7. Analysis
Comparison 2 PEPI‐Malawi (extended NVP + ZDV to infant for 14 weeks vs. sdNVP + ZDV for 1 week), Outcome 7 Infants With Possible Related Severe Adverse Events‐24 Months.
2.8
2.8. Analysis
Comparison 2 PEPI‐Malawi (extended NVP + ZDV to infant for 14 weeks vs. sdNVP + ZDV for 1 week), Outcome 8 Infants With Probably Related Severe Adverse Events.
3.1
3.1. Analysis
Comparison 3 PEPI‐Malawi (extended NVP + ZDV to infant for 14 weeks vs. extended NVP for 14 weeks), Outcome 1 HIV Transmission at 9 months among those whose HIV diagnostic testing was negative within 48 hrs of birth.
3.2
3.2. Analysis
Comparison 3 PEPI‐Malawi (extended NVP + ZDV to infant for 14 weeks vs. extended NVP for 14 weeks), Outcome 2 Infant Mortality at 9 Months Among Those Whose HIV Diagnostic Testing was Negative Within 48 Hours of Birth.
3.3
3.3. Analysis
Comparison 3 PEPI‐Malawi (extended NVP + ZDV to infant for 14 weeks vs. extended NVP for 14 weeks), Outcome 3 HIV Transmission or Death at 9 Months Among Those Whose HIV Diagnostic Testing was Negative Within 48 Hours of Birth.
3.4
3.4. Analysis
Comparison 3 PEPI‐Malawi (extended NVP + ZDV to infant for 14 weeks vs. extended NVP for 14 weeks), Outcome 4 HIV Transmission at 24 Months Among Those Uninfected At Birth.
3.5
3.5. Analysis
Comparison 3 PEPI‐Malawi (extended NVP + ZDV to infant for 14 weeks vs. extended NVP for 14 weeks), Outcome 5 Infant Mortality at 24 Months Among Those Uninfected At Birth.
3.6
3.6. Analysis
Comparison 3 PEPI‐Malawi (extended NVP + ZDV to infant for 14 weeks vs. extended NVP for 14 weeks), Outcome 6 HIV Transmission or Death at 24 Months Among Those Uninfected At Birth.
3.7
3.7. Analysis
Comparison 3 PEPI‐Malawi (extended NVP + ZDV to infant for 14 weeks vs. extended NVP for 14 weeks), Outcome 7 Infants With Possible Related Severe Adverse Events‐24 Months.
3.8
3.8. Analysis
Comparison 3 PEPI‐Malawi (extended NVP + ZDV to infant for 14 weeks vs. extended NVP for 14 weeks), Outcome 8 Infants With Probably Related Severe Adverse Events.
4.1
4.1. Analysis
Comparison 4 SWEN‐Ethiopia, India, Uganda (extended NVP to infant for 6 weeks vs. sdNVP), Outcome 1 HIV Transmission at 6 Months Among Those Whose HIV Diagnostic Testing Was Negative Within 7 days of Birth.
4.2
4.2. Analysis
Comparison 4 SWEN‐Ethiopia, India, Uganda (extended NVP to infant for 6 weeks vs. sdNVP), Outcome 2 Mortality at 6 months among those whose HIV diagnostic testing was negative within 7 days of birth.
4.3
4.3. Analysis
Comparison 4 SWEN‐Ethiopia, India, Uganda (extended NVP to infant for 6 weeks vs. sdNVP), Outcome 3 HIV Transmission or Death at 6 months among those whose HIV diagnostic testing was negative within 7 days of birth.
4.4
4.4. Analysis
Comparison 4 SWEN‐Ethiopia, India, Uganda (extended NVP to infant for 6 weeks vs. sdNVP), Outcome 4 Infants with Grade 3/4 Adverse Events by 6 months.
4.5
4.5. Analysis
Comparison 4 SWEN‐Ethiopia, India, Uganda (extended NVP to infant for 6 weeks vs. sdNVP), Outcome 5 Genotypic Resistance to NVP among Ugandan infants HIV‐infected at 6 weeks.
4.6
4.6. Analysis
Comparison 4 SWEN‐Ethiopia, India, Uganda (extended NVP to infant for 6 weeks vs. sdNVP), Outcome 6 Persistance of Genotypic Resistance to NVP at 6 months among Ugandan infants found to be resistant at 6 weeks.
4.7
4.7. Analysis
Comparison 4 SWEN‐Ethiopia, India, Uganda (extended NVP to infant for 6 weeks vs. sdNVP), Outcome 7 Genotypic Resistance to NVP among Indian infants HIV‐infected in utero or through peripartum/early‐breastfeeding transmission.
4.8
4.8. Analysis
Comparison 4 SWEN‐Ethiopia, India, Uganda (extended NVP to infant for 6 weeks vs. sdNVP), Outcome 8 Genotypic Resistance to NVP among Indian infants HIV‐infected through late breastfeeding.
4.9
4.9. Analysis
Comparison 4 SWEN‐Ethiopia, India, Uganda (extended NVP to infant for 6 weeks vs. sdNVP), Outcome 9 HIV Transmission at 12 months among those whose HIV diagnostic testing was negative within 7 days of birth.
4.10
4.10. Analysis
Comparison 4 SWEN‐Ethiopia, India, Uganda (extended NVP to infant for 6 weeks vs. sdNVP), Outcome 10 Infant Mortality at 12 months among those whose HIV diagnostic testing was negative within 7 days of birth.
4.11
4.11. Analysis
Comparison 4 SWEN‐Ethiopia, India, Uganda (extended NVP to infant for 6 weeks vs. sdNVP), Outcome 11 HIV Transmission or Death at 12 months among those whose HIV diagnostic testing was negative within 7 days of birth.
4.12
4.12. Analysis
Comparison 4 SWEN‐Ethiopia, India, Uganda (extended NVP to infant for 6 weeks vs. sdNVP), Outcome 12 Infants with Grade 3/4 Adverse Events by 12 months.
6.1
6.1. Analysis
Comparison 6 PEP‐South Africa (extended ZDV to infants for 6 weeks vs. sdNVP), Outcome 1 HIV Transmission at 12 weeks among those whose HIV diagnostic testing was negative within 10 days of birth.
7.1
7.1. Analysis
Comparison 7 Mma Bana‐Botswana (extended ZDV/3TC/LPV/r vs. extended ZDV/3TC/ABC to mothers through 6 months postpartum), Outcome 1 HIV transmission at 6 months among those whose HIV diagnostic testing was negative within 96 hours of birth.
7.2
7.2. Analysis
Comparison 7 Mma Bana‐Botswana (extended ZDV/3TC/LPV/r vs. extended ZDV/3TC/ABC to mothers through 6 months postpartum), Outcome 2 Infant Mortality at 6 months.
7.3
7.3. Analysis
Comparison 7 Mma Bana‐Botswana (extended ZDV/3TC/LPV/r vs. extended ZDV/3TC/ABC to mothers through 6 months postpartum), Outcome 3 HIV Transmission or Death at 6 months among those whose HIV diagnostic testing was negative within 96 hours of birth.
7.4
7.4. Analysis
Comparison 7 Mma Bana‐Botswana (extended ZDV/3TC/LPV/r vs. extended ZDV/3TC/ABC to mothers through 6 months postpartum), Outcome 4 Infants with Grade 3/4 Severe Adverse Events.
7.5
7.5. Analysis
Comparison 7 Mma Bana‐Botswana (extended ZDV/3TC/LPV/r vs. extended ZDV/3TC/ABC to mothers through 6 months postpartum), Outcome 5 Maternal Mortality at 6 months.
7.6
7.6. Analysis
Comparison 7 Mma Bana‐Botswana (extended ZDV/3TC/LPV/r vs. extended ZDV/3TC/ABC to mothers through 6 months postpartum), Outcome 6 Mothers with any Grade 3/4 Severe Adverse Event.
7.7
7.7. Analysis
Comparison 7 Mma Bana‐Botswana (extended ZDV/3TC/LPV/r vs. extended ZDV/3TC/ABC to mothers through 6 months postpartum), Outcome 7 Mothers with Severe Adverse Events Requiring Treatment Modification.
8.1
8.1. Analysis
Comparison 8 Kesho Bora‐Burkina Faso, Kenya, South Africa (extended ZDV/3TC/LPV/r to mothers through 6.5 months postpartum vs. short course ZDV with intrapartum ZDV/3TC/sdNVP), Outcome 1 HIV transmission at 6 months among those whose diagnostic testing was negative at 6 weeks after birth.
8.2
8.2. Analysis
Comparison 8 Kesho Bora‐Burkina Faso, Kenya, South Africa (extended ZDV/3TC/LPV/r to mothers through 6.5 months postpartum vs. short course ZDV with intrapartum ZDV/3TC/sdNVP), Outcome 2 HIV transmission at 12 months among those whose diagnostic testing was negative at 6 weeks after birth.
8.3
8.3. Analysis
Comparison 8 Kesho Bora‐Burkina Faso, Kenya, South Africa (extended ZDV/3TC/LPV/r to mothers through 6.5 months postpartum vs. short course ZDV with intrapartum ZDV/3TC/sdNVP), Outcome 3 Infant Mortality at 6 months.
8.4
8.4. Analysis
Comparison 8 Kesho Bora‐Burkina Faso, Kenya, South Africa (extended ZDV/3TC/LPV/r to mothers through 6.5 months postpartum vs. short course ZDV with intrapartum ZDV/3TC/sdNVP), Outcome 4 Infant Mortality at 12 months.
8.5
8.5. Analysis
Comparison 8 Kesho Bora‐Burkina Faso, Kenya, South Africa (extended ZDV/3TC/LPV/r to mothers through 6.5 months postpartum vs. short course ZDV with intrapartum ZDV/3TC/sdNVP), Outcome 5 HIV transmission or Death at 6 months among those whose HIV diagnostic testing was negative at 6 weeks after birth.
8.6
8.6. Analysis
Comparison 8 Kesho Bora‐Burkina Faso, Kenya, South Africa (extended ZDV/3TC/LPV/r to mothers through 6.5 months postpartum vs. short course ZDV with intrapartum ZDV/3TC/sdNVP), Outcome 6 HIV transmission or Death at 12 months among those whose HIV diagnostic testing was negative at 6 weeks after birth.
8.7
8.7. Analysis
Comparison 8 Kesho Bora‐Burkina Faso, Kenya, South Africa (extended ZDV/3TC/LPV/r to mothers through 6.5 months postpartum vs. short course ZDV with intrapartum ZDV/3TC/sdNVP), Outcome 7 Maternal Grade 3/4 Severe Adverse Events.
9.1
9.1. Analysis
Comparison 9 BAN Lilongwe (an extended antiretroviral regimen administered to mothers for 28 weeks compared to 1 week of antiretroviral prophylaxis for transmission during breastfeeding), Outcome 1 HIV transmission at 28 weeks among those whose diagnostic testing was negative at 2 weeks after birth.
9.2
9.2. Analysis
Comparison 9 BAN Lilongwe (an extended antiretroviral regimen administered to mothers for 28 weeks compared to 1 week of antiretroviral prophylaxis for transmission during breastfeeding), Outcome 2 Infant mortality at 28 weeks among those whose diagnostic testing was negative at 2 weeks after birth.
9.3
9.3. Analysis
Comparison 9 BAN Lilongwe (an extended antiretroviral regimen administered to mothers for 28 weeks compared to 1 week of antiretroviral prophylaxis for transmission during breastfeeding), Outcome 3 HIV transmission or death at 28 weeks among those whose diagnostic test was negative at 2 weeks.
9.4
9.4. Analysis
Comparison 9 BAN Lilongwe (an extended antiretroviral regimen administered to mothers for 28 weeks compared to 1 week of antiretroviral prophylaxis for transmission during breastfeeding), Outcome 4 Infants with Severe Adverse Events.
9.5
9.5. Analysis
Comparison 9 BAN Lilongwe (an extended antiretroviral regimen administered to mothers for 28 weeks compared to 1 week of antiretroviral prophylaxis for transmission during breastfeeding), Outcome 5 Mothers with Severe Adverse Events.
10.1
10.1. Analysis
Comparison 10 BAN Lilongwe (an extended NVP regimen administered to infants for 28), Outcome 1 HIV transmission at 28 weeks among those whose diagnostic testing was negative at 2 weeks after birth.
10.2
10.2. Analysis
Comparison 10 BAN Lilongwe (an extended NVP regimen administered to infants for 28), Outcome 2 Infant mortality at 28 weeks among those whose diagnostic testing was negative at 2 weeks after birth.
10.3
10.3. Analysis
Comparison 10 BAN Lilongwe (an extended NVP regimen administered to infants for 28), Outcome 3 HIV transmission or death at 28 weeks among those whose diagnostic test was negative at 2 weeks.
10.4
10.4. Analysis
Comparison 10 BAN Lilongwe (an extended NVP regimen administered to infants for 28), Outcome 4 Infants with Severe Adverse Events.
11.1
11.1. Analysis
Comparison 11 BAN Lilongwe (an extended antiretroviral regimen administered to mothers for 28 weeks compared to an extended NVP regimen administered to infants for 28 weeks for preventing transmission during breastfeeding), Outcome 1 HIV transmission at 28 weeks among those whose diagnostic testing was negative at 2 weeks after birth.
11.2
11.2. Analysis
Comparison 11 BAN Lilongwe (an extended antiretroviral regimen administered to mothers for 28 weeks compared to an extended NVP regimen administered to infants for 28 weeks for preventing transmission during breastfeeding), Outcome 2 Infant mortality at 28 weeks among those whose diagnostic testing was negative at 2 weeks after birth.
11.3
11.3. Analysis
Comparison 11 BAN Lilongwe (an extended antiretroviral regimen administered to mothers for 28 weeks compared to an extended NVP regimen administered to infants for 28 weeks for preventing transmission during breastfeeding), Outcome 3 HIV transmission or death at 28 weeks among those whose diagnostic test was negative at 2 weeks.
11.4
11.4. Analysis
Comparison 11 BAN Lilongwe (an extended antiretroviral regimen administered to mothers for 28 weeks compared to an extended NVP regimen administered to infants for 28 weeks for preventing transmission during breastfeeding), Outcome 4 Infants with Severe Adverse Events.
11.5
11.5. Analysis
Comparison 11 BAN Lilongwe (an extended antiretroviral regimen administered to mothers for 28 weeks compared to an extended NVP regimen administered to infants for 28 weeks for preventing transmission during breastfeeding), Outcome 5 Mothers with Severe Adverse Events.
12.1
12.1. Analysis
Comparison 12 HPTN 046 (an extended antiretroviral regimen administered to mothers for 28 weeks vs an extended NVP regimen administered to infants for 28 weeks be used for preventing transmission), Outcome 1 HIV transmission at 12 months among infants whose HIV diagnostic testing was negative within 6 weeks of birth and whose mothers were not on HAART.
12.2
12.2. Analysis
Comparison 12 HPTN 046 (an extended antiretroviral regimen administered to mothers for 28 weeks vs an extended NVP regimen administered to infants for 28 weeks be used for preventing transmission), Outcome 2 HIV transmission at 12 months among all infants whose HIV diagnostic testing was negative within 6 weeks of birth.
12.3
12.3. Analysis
Comparison 12 HPTN 046 (an extended antiretroviral regimen administered to mothers for 28 weeks vs an extended NVP regimen administered to infants for 28 weeks be used for preventing transmission), Outcome 3 Infant mortality at 12 months among all those whose HIV diagnostic testing was negative within 6 weeks of birth.
12.4
12.4. Analysis
Comparison 12 HPTN 046 (an extended antiretroviral regimen administered to mothers for 28 weeks vs an extended NVP regimen administered to infants for 28 weeks be used for preventing transmission), Outcome 4 HIV transmission or death at 12 months among all infants whose HIV diagnostic testing was negative within 6 weeks of birth.
12.5
12.5. Analysis
Comparison 12 HPTN 046 (an extended antiretroviral regimen administered to mothers for 28 weeks vs an extended NVP regimen administered to infants for 28 weeks be used for preventing transmission), Outcome 5 Infants with Severe Adverse Events.
12.6
12.6. Analysis
Comparison 12 HPTN 046 (an extended antiretroviral regimen administered to mothers for 28 weeks vs an extended NVP regimen administered to infants for 28 weeks be used for preventing transmission), Outcome 6 HIV transmission at 6 months among infants whose HIV diagnostic testing was negative within 6 weeks of birth and whose mothers were not on HAART.
12.7
12.7. Analysis
Comparison 12 HPTN 046 (an extended antiretroviral regimen administered to mothers for 28 weeks vs an extended NVP regimen administered to infants for 28 weeks be used for preventing transmission), Outcome 7 HIV transmission at 6 months among all infants whose HIV diagnostic testing was negative within 6 weeks of birth.
12.8
12.8. Analysis
Comparison 12 HPTN 046 (an extended antiretroviral regimen administered to mothers for 28 weeks vs an extended NVP regimen administered to infants for 28 weeks be used for preventing transmission), Outcome 8 Infant mortality at 6 months among all those whose HIV diagnostic testing was negative within 6 weeks of birth.
12.9
12.9. Analysis
Comparison 12 HPTN 046 (an extended antiretroviral regimen administered to mothers for 28 weeks vs an extended NVP regimen administered to infants for 28 weeks be used for preventing transmission), Outcome 9 HIV transmission or death at 6 months among all infants whose HIV diagnostic testing was negative within 6 weeks of birth.
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References

References to studies included in this review

Chasela 2010 {published data only}
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Chimienti 2010 {published data only}
    1. Chimienti SN. More progress on preventing HIV infection in infants. Three trials this year pointed to the benefits of extending maternal antiretroviral prophylaxis throughout the breast‐feeding period. J Watch AIDS Clin Care. 2010 22:1, 6‐7. - PubMed
Chung 2008 {published data only}
    1. Chung MH, Kiarie JN, Richardson BA, Lehman DA, Overbaugh J, Kinuthia J, Njiri F, John‐Stewart GC. Highly active antiretroviral therapy versus zidovudine/nevirapine effects on early breast milk HIV type‐1 Rna: a phase II randomized clinical trial. Antivir Ther 2008;13(6):799‐807. - PMC - PubMed
Coovadia 2007 {published data only}
    1. Coovadia H, Kindra G. Breastfeeding to prevent HIV transmission in infants: balancing pros and cons. Current Opinion in Infectious Diseases 8 Feb;21(1):11‐15. - PubMed
Coovadia 2008 {published data only}
    1. Coovadia H, Kindra G. Breastfeeding to prevent HIV transmission in infants: balancing pros and cons. . Current Opinion in Infectious Diseases. 2008 Feb;21(1):11‐5. - PubMed
Coutsoudis 1999 {published data only}
    1. Coutsoudis A, Pillay K, Spooner E, Kuhn L, Coovadia HM. Influence of infant‐feeding patterns on early mother‐to‐child transmission of HIV‐1 in Durban, South Africa: a prospective cohort study. Lancet 1999 Aug 7;354(9177):471‐6. - PubMed
Coutsoudis 2000 {published data only}
    1. Coutsoudis A. Influence of infant‐feeding patterns on early mother‐to‐child transmission of HIV‐1 in Durban, South Africa: a prospective cohort study. Journal of Human Lactation 2000 Feb;16(1):73‐7. - PubMed
Coutsoudis 2001 {published data only}
    1. Coutsoudis A, Pillay K, Kuhn L, Spooner E, Tsai WY, Coovadia HM, South African Vitamin A Study Group. Method of feeding and transmission of HIV‐1 from mothers to children by 15 months of age: prospective cohort study from Durban, South Africa. AIDS 2001 Feb 16;15(3):379‐87. - PubMed
Engebretsen 2010 {published data only}
    1. Engebretsen IM, Tylleskar T. [HIV, breast feeding and antiretroviral agents]. Tidsskr Nor Laegeforen 2010;130:520‐522. - PubMed
Fao 2012 {published data only}
    1. Fao P, Ky‐Zerbo O, Gouem C, Somda P, Hien H, Ouedraogo PE, et al. Maternal HIV‐1 Disease Progression 18‐24 Months Postdelivery According to Antiretroviral Prophylaxis Regimen (Triple‐Antiretroviral Prophylaxis During Pregnancy and Breastfeeding vs Zidovudine/Single‐Dose Nevirapine Prophylaxis): The Kesho Bora Randomized Controlled Trial. Clinical Infectious Diseases. 2012:55, 3(449‐460). - PMC - PubMed
Fawzi 2002 {published data only}
    1. Fawzi W, Msamanga G, Spiegelman D, Renjifo B, Bang H, Kapiga S, et al. Transmission of HIV‐1 through breastfeeding among women in Dar es Salaam, Tanzania. Journal of Acquired Immune Deficiency Syndromes 2002 Nov 1;31(3):331‐8. - PubMed
Fogel 2011 {published data only}
    1. Fogel J, Li Q, Taha TE, Hoover DR, Kumwenda NI, Mofenson LM, et al. Initiation of antiretroviral treatment in women after delivery can induce multiclass drug resistance in breastfeeding HIV‐infected infants. Clinical Infectious Diseases. 2011 52:8, 1069‐1076. - PMC - PubMed
Fowler 2002 {published data only}
    1. Fowler MG, Newell ML. Breast‐feeding and HIV‐1 transmission in resource‐limited settings. Journal of Acquired Immune Deficiency Syndromes. 2002 Jun 1;30(2):230‐9. - PubMed
Giuliano 2007 {published data only}
    1. Giuliano M, Guidotti G, Andreotti M, Pirillo MF, Villani P, Liotta G, et al. Triple antiretroviral prophylaxis administered during pregnancy and after delivery significantly reduces breast milk viral load ‐ A study within the drug resource enhancement against AIDS and malnutrition program. Journal of Acquired Immune Deficiency Syndromes 2007 Mar 1;44(3):286‐91. - PubMed
Gray 2006 {published data only}
    1. Gray G, Violari A, McIntyre J, Jivkov B, Schnittman S, Reynolds L, Ledeine JM. Antiviral Activity of Nucleoside Analogues during short‐course monotherapy or dual therapy: Its role in preventing HIV infection in infants. J Acquir Immune Defic Syndr 2006 Jun;42(2):169‐76. - PubMed
Heidari 2011 {published data only}
    1. Heidari S, Mofenson L, Cotton MF, Marlink R, Cahn P, Katabira E. Antiretroviral drugs for preventing mother‐to‐child transmission of HIV: a review of potential effects on HIV‐exposed but uninfected children. J Acquir Immune Defic Syndr. 2011 57:4, 290‐296. - PubMed
Homsy 2010 {published data only}
    1. Homsy J, Moore D, Barasa A, Were W, Likicho C, Waiswa B, et al. Breastfeeding, mother‐to‐child HIV transmission, and mortality among infants born to HIV‐infected women on highly active antiretroviral therapy in rural Uganda. Journal of Acquired Immune Deficiency Syndromes. 2010 53:1, 28‐35. - PubMed
Horvath 2009 {published data only}
    1. Horvath T, Madi BC, Iuppa IM, Kennedy GE, Rutherford G, Read JS. Interventions for preventing late postnatal mother‐to‐child transmission of HIV. Cochrane Database Systematic Reviews. 2009 Jan 21;(1):CD006734. - PMC - PubMed
Ikechebelu 2011 {published data only}
    1. Ikechebelu JI, Ugboaja JO, Kalu SO, Ugochukwu EF. The outcome of prevention of mother to child transmission (PMTCT) of HIV infection programme in Nnewi, southeast Nigeria. Niger J Med. 2011 20:4, 421‐425. - PubMed
Iliff 2005 {published data only}
    1. Iliff PJ, Piwoz EG, Tavengwa NV, Zunguza CD, Marinda ET, Nathoo KJ, Moulton LH, Ward BJ, Humphrey JH, ZVITAMBO study group. Early exclusive breastfeeding reduces the risk of postnatal HIV‐1 transmission and increases HIV‐free survival. AIDS 2005 Apr 29;19(7):699‐708. - PubMed
John 2001 {published data only}
    1. John GC, Richardson BA, Nduati RW, Mbori‐Ngacha D, Kreiss JK. Timing of breast milk HIV‐1 transmission: a meta‐analysis. East African Medical Journal. 2001 Feb;78(2):75‐9. - PubMed
Kafulafula 2010 {published data only}
    1. Kafulafula G, Hoover DR, Taha TE, Thigpen M, Li Q, Fowler MG, et al. Frequency of Gastroenteritis and Gastroenteritis‐Associated Mortality With Early Weaning in HIV‐1‐Uninfected Children Born to HIV‐Infected Women in Malawi. Journal of Acquired Immune Deficiency Syndromes 2010;53:1:6‐13. - PubMed
Kiarie 2004 {published data only}
    1. Kiarie JN, Richardson BA, Mbori‐Ngacha D, Nduati RW, John‐Stewart GC. Infant feeding practices of women in a perinatal HIV‐1 Prevention Study in Nairobi, Kenya. Journal of Acquired Immune Deficiency Syndromes 2004 Jan 1;35(1):75‐81. - PMC - PubMed
Kilewo 2009 {published data only}
    1. Kilewo C, Karlsson K, Ngarina M, Massawe A, Lyamuya E, Swai A, Lipyoga R, Mhalu F, Biberfeld G. Prevention of mother‐to‐child transmission of HIV‐1 through breastfeeding by treating mothers with triple antiretroviral therapy in Dar es Salaam, Tanzania: The Mitra Plus study. Journal of Acquired Immune Deficiency Syndromes 2009;52:3:406‐416. - PubMed
Kourtis 2007 {published data only}
    1. Kourtis AP, Jamieson DJ, Vincenzi I, Taylor A, Thigpen MC, Dao H, et al. Prevention of human immunodeficiency virus‐1 transmission to the infant through breastfeeding: new developments. American Journal of Obstetrics Gynecology. 2007 Sep;197(3 Suppl):S113‐22. - PubMed
Kuhn 2007 {published data only}
    1. Kuhn L, Sinkala M, Kankasa C, Semrau K, Kasonde P, Scott N, Mwiya M, Vwalika C, Walter J, Tsai WY, Aldrovandi GM, Thea DM. High uptake of exclusive breastfeeding and reduced early post‐natal HIV transmission. PLoS One 2007 Dec 26;2(12):e1363. - PMC - PubMed
Lambert 2003 {published data only}
    1. Lambert JS, Nogueira SA, Abreu T, Machado ES, Costa TP, Bondarovsky M, et al. A pilot study to evaluate the safety and feasibility of the administration of ZDV/3TC fixed dose combination to HIV infected pregnant women and their infants in Rio de Janeiro, Brazil. Sexually Transmitted Infections 2003 Dec;79(6):448‐52. - PMC - PubMed
Lehman 2009 {published data only}
    1. Lehman DA, Chung MH, Mabuka JM, John‐Stewart GC, Kiarie J, Kinuthia J, et al. Lower Risk of Resistance After Short‐Course HAART Compared with Zidovudine/Single‐Dose Nevirapine Used for Prevention of HIV‐1 Mother‐to‐Child Transmission. Journal of Acquired Immune Deficiency Syndromes 2009 Aug 15;51(5):522‐9. - PMC - PubMed
Marazzi 2006 {published data only}
    1. Marazzi MC, Germano P, Liotta G, Guidotti G, Loureiro S, Cruz Gomes A, et al. Safety of nevirapine‐containing antiretroviral triple therapy regimens to prevent vertical transmission in an African cohort of HIV‐1 infected pregnant women. HIV Medicine 6 Jul;7(5):338‐44. - PubMed
Marazzi 2009 {published data only}
    1. Marazzi MC, Nielsen‐Saines K, Buonomo E, Scarcella P, GermaNoP, Majid NA, et al. Increased infant human immunodeficiency virus‐type one free survival at one year of age in sub‐saharan Africa with maternal use of highly active antiretroviral therapy during breast‐feeding. Pediatric Infectious Disease Journal 2009;28:483‐487. - PubMed
Marazzi 2011 {published data only}
    1. Marazzi MC, Palombi L, Nielsen‐Saines K, Haswell J, Zimba I, Magid NA, et al. Extended antenatal use of triple antiretroviral therapy for prevention of mother‐to‐child transmission of HIV‐1 correlates with favorable pregnancy outcomes. AIDS 2011;25:1611‐1618. - PubMed
Mbori‐Ngacha 2001 {published data only}
    1. Mbori‐Ngacha D, Nduati R, John G, Reilly M, Richardson B, Mwatha A, et al. Morbidity and mortality in breastfed and formula‐fed infants of HIV‐1‐infected women: A randomized clinical trial. JAMA 2001 Nov 21;286(19):2413‐20. - PMC - PubMed
McIntyre 2006 {published data only}
    1. McIntyre J. Strategies to prevent mother‐to‐child transmission of HIV. Current Opinion Infectious Diseases. 2006 Feb;19(1):33‐8. - PubMed
McIntyre 2010 {published data only}
    1. McIntyre J. Use of antiretrovirals during pregnancy, breastfeeding in low‐income, middle‐income countries. Current Opinion in HIV AIDS. 2010 5:1. 48‐53. - PMC - PubMed
Meda 2011 {published data only}
    1. Meda N, Fao P, Ky‐Zerbo O, Gouem C, Somda P, Hien H, et al. Triple antiretroviral compared with zidovudine and single‐dose nevirapine prophylaxis during pregnancy and breastfeeding for prevention of mother‐to‐child transmission of HIV‐1 (Kesho Bora study): a randomized controlled trial. Lancet Infectious Diseases 2011;11:171‐180. - PubMed
Miotti 1999 {published data only}
    1. Miotti PG, Taha TE, Kumwenda NI, Broadhead R, Mtimavalye LA, Hoeven L, et al. HIV transmission through breastfeeding: a study in Malawi. JAMA 1999 Aug 25;282(8):744‐9. - PubMed
Mirochnick 2009 {published data only}
    1. Mirochnick M, Thomas T, Capparelli E, Zeh C, Holland D, Masaba R, et al. Antiretroviral Concentrations in Breast‐Feeding Infants of Mothers Receiving Highly Active Antiretroviral Therapy. Antimicrobial Agents and Chemotherapy 2009 Mar;53(3):1170‐6. - PMC - PubMed
Mmiro 2009 {published data only}
    1. Mmiro FA, Aizire J, Mwatha AK, Eshleman SH, Donnell D, Fowler MG, et al. Predictors of early and late mother‐to‐child transmission of HIV in a breastfeeding population: HIV Network for Prevention Trials 012 experience, Kampala, Uganda. Journal of Acquired Immune Deficiency Syndromes 2009;52:32‐39. - PMC - PubMed
Mofenson 2003 {published data only}
    1. Mofenson LM. Advances in the prevention of vertical transmission of human immunodeficiency virus. Seminars in Pediatric Infectious Diseases. 2003 Oct;14(4):295‐308.. - PubMed
Mofenson 2008 {published data only}
    1. Mofenson LM. Antiretroviral prophylaxis to reduce breast‐milk HIV‐1 transmission oh HIV Type 1: New Data but Still Question. Journal of Acquired Immune Deficiency Syndromes 2008 Jul 1;48(3):237‐40. - PubMed
Nduati 2000 {published data only}
    1. Nduati R, John G, Mbori‐Ngacha D, Richardson B, Overbaugh J, Mwatha A, et al. Effect of breastfeeding and formula feeding on transmission of HIV‐1: a randomized clinical trial. JAMA 2000 Mar 1;283(9):1167‐74. - PubMed
Nduati 2001 {published data only}
    1. Nduati R, Richardson BA, John G, Mbori‐Ngacha D, Mwatha A, Ndinya‐Achola J, et al. Effect of breastfeeding on mortality among HIV‐1 infected women: a randomized trial. Lancet. 2001 May 26;357(9269):1651‐5.. - PMC - PubMed
Rabie 2001 {published data only}
    1. Rabie H, Pieper CH, Robson B, Cotton MF. Postnatal Zidovudine in Prevention of Vertical HIV‐1 Transmission. Journal of Tropical Pediatrics 2001 Aug;47(4):215‐9. - PubMed
Ramlal 2013 {published data only}
    1. Ramlal RT, Tembo M, Soko A, Chigwenembe M, Tohill BC, Kayira D, King CC, Chasela C, Jamieson D, Horst C, Bentley ME, Adair LS, BAN Study Team. Patterns of body composition among HIV‐infected, pregnant Malawians and the effects of famine season. Matern Child Health J. 2013 Feb;17(2):265‐7. - PMC - PubMed
Rousseau 2003 {published data only}
    1. Rousseau CM, Nduati RW, Richardson BA, Steele MS, John‐Stewart GC, Mbori‐Ngacha DA, et al. Longitudinal analysis of human immunodeficiency virus type 1 RNA in breast milk and of its relationship to infant infection and maternal disease. The Journal of Infectious Diseases 2003 Mar 1;187(5):741‐7. - PMC - PubMed
Rousseau 2004 {published data only}
    1. Rousseau CM, Nduati RW, Richardson BA, John‐Stewart GC, Mbori‐Ngacha DA, Kreiss JK, et al. Association of levels of HIV‐1‐infected breast milk cells and risk of mother‐to‐child transmission. Journal of Infectious Diseases. 2004 Nov 15;190(10):1880‐8. Epub 2004 Oct 7.. - PMC - PubMed
Sartorius 2013 {published data only}
    1. Sartorius BK, Chersich MF, Mwaura M, Meda N, Temmerman M, Newell ML, et al. Maternal anaemia and duration of zidovudine in antiretroviral regimens for preventing mother‐to‐child transmission: a randomized trial in three African countries. BMC Infect Dis. 2013:13, 1(522). - PMC - PubMed
Shapiro 2005 {published data only}
    1. Shapiro RL, Holland DT, Capparelli E, Lockman S, Thior I, Wester C, Stevens L, Peter T, Essex M, Connor JD, Mirochnick M. Antiretroviral concentrations in breast‐feeding infants of women in Botswana receiving antiretroviral treatment. Journal of Infectious Diseases 2005 Sep 1;192(5):720‐7. - PubMed
Shapiro 2006 {published data only}
    1. Shapiro RL, Thior I, Gilbert PB, Lockman S, Wester C, Smeaton LM, Stevens L, Heymann SJ, Ndung'u T, Gaseitsiwe S, Novitsky V, Makhema J, Lagakos S, Essex M. Maternal single‐dose nevirapine versus placebo as part of an antiretroviral strategy to prevent mother‐to‐child HIV transmission in Botswana. AIDS 2006 Jun 12;20(9):1281‐8. - PubMed
Shetty 2003 {published data only}
    1. Shetty AK, Coovadia HM, Mirochnick MM, Maldonado Y, Mofenson LM, Eshleman SH, et al. for the HIVNET 023 Study Team. Safety and trough concentrations of nevirapine prophylaxis given daily, twice weekly, or weekly in breast‐feeding infants from birth to 6 months. Journal of Acquired Immune Deficiency Syndromes 2003 Dec 15;34(5):482‐90. - PubMed
Siegfried 2011 {published data only}
    1. Siegfried N, Merwe L, Brocklehurst P, Sint TT. Antiretrovirals for reducing the risk of mother‐to‐child transmission of HIV infection. Cochrane Database Systematic Reviews 2011;7. - PubMed
SIMBA 2003 {published data only}
    1. Vyankandondera J, Luchters S, Hassink E, et al. Reducing risk of HIV‐1 transmission from mother to infant through breastfeeding using antiretroviral prophylaxis in infants (SIMBA study) [abstract# LB7]. Paper presented at: the 2nd International AIDS Society Conference on HIV Pathogenesis and Treatment. 2003.
Taha 2009 {published data only}
    1. Taha TE, Kumwenda J, Cole SR, Hoover DR, Kafulafula G, Fowler MG, Thigpen MC, Li Q, Kumwenda NI, Mofenson L. 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;200:1490‐1497. - PubMed
Tess 1998 {published data only}
    1. Tess BH, Rodrigues LC, Newell ML, Dunn DT, Lago TD. Infant feeding and risk of mother‐to‐child transmission of HIV‐1 in Sao Paulo State, Brazil. Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology 1998 Oct 1;19(2):189‐94. - PubMed
Thior 2006 {published data only}
    1. Thior I, Lockman S, Smeaton LM, Shapiro RL, Wester C, Heymann SJ, Gilbert PB, et al. Breastfeeding plus infant zidovudine prophylaxis for 6 months vs formula feeding plus infant zidovudine for 1 month to reduce mother‐to‐child HIV transmission in Botswana: a randomized trial: the Mashi Study. JAMA. 2006;296(7):794‐805. - PubMed
Thomas 2011 {published data only}
    1. Thomas TK, Masaba R, Borkowf CB, Ndivo R, Zeh C, Misore A, OtieNoJ, Jamieson D, Thigpen MC, Bulterys M, Slutsker L, Cock KM, Amornkul PN, Greenberg AE, Fowler MG. Triple‐antiretroviral prophylaxis to prevent mother‐to‐child HIV transmission through breastfeeding‐the Kisumu Breastfeeding Study, Kenya: A clinical trial. PLoS Medicine 2011;8:3. - PMC - PubMed
Volmink 2007 {published data only}
    1. Volmink J, Siegfried NL, Merwe L, Brocklehurst P. Antiretrovirals for reducing the risk of mother‐to‐child transmission of HIV infection. Cochrane Database Systematic Reviews. 2007 Jan 24;(1):CD003510. - PubMed
Wind‐Rotolo 2006 {published data only}
    1. Wind‐Rotolo M, Doherty MC. Viral latency and reservoirs: relevance for mother‐to‐child transmission and resistance. Current Opinion in HIV AIDS. 2006 Mar;1(2):167‐73. - PubMed

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