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Maternal and infant antiretroviral regimens to prevent postnatal HIV-1 transmission: 48-week follow-up of the BAN randomised controlled trial.
Lancet. 2012 Jun 30; 379(9835):2449-2458.Lct

Abstract

BACKGROUND

In resource-limited settings where no safe alternative to breastfeeding exists, WHO recommends that antiretroviral prophylaxis be given to either HIV-infected mothers or infants throughout breastfeeding. We assessed the effect of 28 weeks of maternal or infant antiretroviral prophylaxis on postnatal HIV infection at 48 weeks.

METHODS

The Breastfeeding, Antiretrovirals, and Nutrition (BAN) Study was undertaken in Lilongwe, Malawi, between April 21, 2004, and Jan 28, 2010. 2369 HIV-infected breastfeeding mothers with a CD4 count of 250 cells per μL or more and their newborn babies were randomly assigned with a variable-block design to one of three, 28-week regimens: maternal triple antiretroviral (n=849); daily infant nevirapine (n=852); or control (n=668). Patients and local clinical staff were not masked to treatment allocation, but other study investigators were. All mothers and infants received one dose of nevirapine (mother 200 mg; infant 2 mg/kg) and 7 days of zidovudine (mother 300 mg; infants 2 mg/kg) and lamivudine (mothers 150 mg; infants 4 mg/kg) twice a day. Mothers were advised to wean between 24 weeks and 28 weeks after birth. The primary endpoint was HIV infection by 48 weeks in infants who were not infected at 2 weeks and in all infants randomly assigned with censoring at loss to follow-up. This trial is registered with ClinicalTrials.gov, number NCT00164736.

FINDINGS

676 mother-infant pairs completed follow-up to 48 weeks or reached an endpoint in the maternal-antiretroviral group, 680 in the infant-nevirapine group, and 542 in the control group. By 32 weeks post partum, 96% of women in the intervention groups and 88% of those in the control group reported no breastfeeding since their 28-week visit. 30 infants in the maternal-antiretroviral group, 25 in the infant-nevirapine group, and 38 in the control group became HIV infected between 2 weeks and 48 weeks of life; 28 (30%) infections occurred after 28 weeks (nine in maternal-antiretroviral, 13 in infant-nevirapine, and six in control groups). The cumulative risk of HIV-1 transmission by 48 weeks was significantly higher in the control group (7%, 95% CI 5-9) than in the maternal-antiretroviral (4%, 3-6; p=0·0273) or the infant-nevirapine (4%, 2-5; p=0·0027) groups. The rate of serious adverse events in infants was significantly higher during 29-48 weeks than during the intervention phase (1·1 [95% CI 1·0-1·2] vs 0·7 [0·7-0·8] per 100 person-weeks; p<0·0001), with increased risk of diarrhoea, malaria, growth faltering, tuberculosis, and death. Nine women died between 2 weeks and 48 weeks post partum (one in maternal-antiretroviral group, two in infant-nevirapine group, six in control group).

INTERPRETATION

In resource-limited settings where no suitable alternative to breastfeeding is available, antiretroviral prophylaxis given to mothers or infants might decrease HIV transmission. Weaning at 6 months might increase infant morbidity.

FUNDING

US Centers for Disease Control and Prevention.

Authors+Show Affiliations

US Centers for Disease Control and Prevention, Atlanta, GA, USA. Electronic address: djj0@cdc.gov.UNC Project, Lilongwe, Malawi.University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.US Centers for Disease Control and Prevention, Atlanta, GA, USA.US Centers for Disease Control and Prevention, Atlanta, GA, USA.UNC Project, Lilongwe, Malawi.UNC Project, Lilongwe, Malawi; University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.UNC Project, Lilongwe, Malawi.US Centers for Disease Control and Prevention, Atlanta, GA, USA.US Centers for Disease Control and Prevention, Atlanta, GA, USA.University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.UNC Project, Lilongwe, Malawi.UNC Project, Lilongwe, Malawi.UNC Project, Lilongwe, Malawi.University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.Principia International, Chapel Hill, NC, USA.UNC Project, Lilongwe, Malawi; University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.UNC Project, Lilongwe, Malawi.UNC Project, Lilongwe, Malawi.University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.No affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, American Recovery and Reinvestment Act
Research Support, N.I.H., Extramural
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

22541418

Citation

Jamieson, Denise J., et al. "Maternal and Infant Antiretroviral Regimens to Prevent Postnatal HIV-1 Transmission: 48-week Follow-up of the BAN Randomised Controlled Trial." Lancet (London, England), vol. 379, no. 9835, 2012, pp. 2449-2458.
Jamieson DJ, Chasela CS, Hudgens MG, et al. Maternal and infant antiretroviral regimens to prevent postnatal HIV-1 transmission: 48-week follow-up of the BAN randomised controlled trial. Lancet. 2012;379(9835):2449-2458.
Jamieson, D. J., Chasela, C. S., Hudgens, M. G., King, C. C., Kourtis, A. P., Kayira, D., Hosseinipour, M. C., Kamwendo, D. D., Ellington, S. R., Wiener, J. B., Fiscus, S. A., Tegha, G., Mofolo, I. A., Sichali, D. S., Adair, L. S., Knight, R. J., Martinson, F., Kacheche, Z., Soko, A., ... van der Horst, C. (2012). Maternal and infant antiretroviral regimens to prevent postnatal HIV-1 transmission: 48-week follow-up of the BAN randomised controlled trial. Lancet (London, England), 379(9835), 2449-2458. https://doi.org/10.1016/S0140-6736(12)60321-3
Jamieson DJ, et al. Maternal and Infant Antiretroviral Regimens to Prevent Postnatal HIV-1 Transmission: 48-week Follow-up of the BAN Randomised Controlled Trial. Lancet. 2012 Jun 30;379(9835):2449-2458. PubMed PMID: 22541418.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Maternal and infant antiretroviral regimens to prevent postnatal HIV-1 transmission: 48-week follow-up of the BAN randomised controlled trial. AU - Jamieson,Denise J, AU - Chasela,Charles S, AU - Hudgens,Michael G, AU - King,Caroline C, AU - Kourtis,Athena P, AU - Kayira,Dumbani, AU - Hosseinipour,Mina C, AU - Kamwendo,Deborah D, AU - Ellington,Sascha R, AU - Wiener,Jeffrey B, AU - Fiscus,Susan A, AU - Tegha,Gerald, AU - Mofolo,Innocent A, AU - Sichali,Dorothy S, AU - Adair,Linda S, AU - Knight,Rodney J, AU - Martinson,Francis, AU - Kacheche,Zebrone, AU - Soko,Alice, AU - Hoffman,Irving, AU - van der Horst,Charles, AU - ,, Y1 - 2012/04/26/ PY - 2012/5/1/entrez PY - 2012/5/1/pubmed PY - 2012/8/2/medline SP - 2449 EP - 2458 JF - Lancet (London, England) JO - Lancet VL - 379 IS - 9835 N2 - BACKGROUND: In resource-limited settings where no safe alternative to breastfeeding exists, WHO recommends that antiretroviral prophylaxis be given to either HIV-infected mothers or infants throughout breastfeeding. We assessed the effect of 28 weeks of maternal or infant antiretroviral prophylaxis on postnatal HIV infection at 48 weeks. METHODS: The Breastfeeding, Antiretrovirals, and Nutrition (BAN) Study was undertaken in Lilongwe, Malawi, between April 21, 2004, and Jan 28, 2010. 2369 HIV-infected breastfeeding mothers with a CD4 count of 250 cells per μL or more and their newborn babies were randomly assigned with a variable-block design to one of three, 28-week regimens: maternal triple antiretroviral (n=849); daily infant nevirapine (n=852); or control (n=668). Patients and local clinical staff were not masked to treatment allocation, but other study investigators were. All mothers and infants received one dose of nevirapine (mother 200 mg; infant 2 mg/kg) and 7 days of zidovudine (mother 300 mg; infants 2 mg/kg) and lamivudine (mothers 150 mg; infants 4 mg/kg) twice a day. Mothers were advised to wean between 24 weeks and 28 weeks after birth. The primary endpoint was HIV infection by 48 weeks in infants who were not infected at 2 weeks and in all infants randomly assigned with censoring at loss to follow-up. This trial is registered with ClinicalTrials.gov, number NCT00164736. FINDINGS: 676 mother-infant pairs completed follow-up to 48 weeks or reached an endpoint in the maternal-antiretroviral group, 680 in the infant-nevirapine group, and 542 in the control group. By 32 weeks post partum, 96% of women in the intervention groups and 88% of those in the control group reported no breastfeeding since their 28-week visit. 30 infants in the maternal-antiretroviral group, 25 in the infant-nevirapine group, and 38 in the control group became HIV infected between 2 weeks and 48 weeks of life; 28 (30%) infections occurred after 28 weeks (nine in maternal-antiretroviral, 13 in infant-nevirapine, and six in control groups). The cumulative risk of HIV-1 transmission by 48 weeks was significantly higher in the control group (7%, 95% CI 5-9) than in the maternal-antiretroviral (4%, 3-6; p=0·0273) or the infant-nevirapine (4%, 2-5; p=0·0027) groups. The rate of serious adverse events in infants was significantly higher during 29-48 weeks than during the intervention phase (1·1 [95% CI 1·0-1·2] vs 0·7 [0·7-0·8] per 100 person-weeks; p<0·0001), with increased risk of diarrhoea, malaria, growth faltering, tuberculosis, and death. Nine women died between 2 weeks and 48 weeks post partum (one in maternal-antiretroviral group, two in infant-nevirapine group, six in control group). INTERPRETATION: In resource-limited settings where no suitable alternative to breastfeeding is available, antiretroviral prophylaxis given to mothers or infants might decrease HIV transmission. Weaning at 6 months might increase infant morbidity. FUNDING: US Centers for Disease Control and Prevention. SN - 1474-547X UR - https://www.unboundmedicine.com/medline/citation/22541418/Maternal_and_infant_antiretroviral_regimens_to_prevent_postnatal_HIV_1_transmission:_48_week_follow_up_of_the_BAN_randomised_controlled_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0140-6736(12)60321-3 DB - PRIME DP - Unbound Medicine ER -