Three postpartum antiretroviral regimens to prevent intrapartum HIV infection

Karin Nielsen-Saines, D. Heather Watts, Valdilea G. Veloso, Yvonne J. Bryson, Esau C. Joao, Jose Henrique Pilotto, Glenda Gray, Gerhard Theron, Breno Santos, Rosana Fonseca, Regis Kreitchmann, Jorge Pinto, Marisa M. Mussi-Pinhata, Mariana Ceriotto, Daisy Machado, James Bethel, Marisa G. Morgado, Ruth Dickover, Margaret Camarca, Mark MirochnickGeorge Siberry, Beatriz Grinsztejn, Ronaldo I. Moreira, Francisco I. Bastos, Jiahong Xu, Jack Moye, Lynne M. Mofenson

Research output: Contribution to journalArticle

Abstract

BACKGROUND: The safety and efficacy of adding antiretroviral drugs to standard zidovudine prophylaxis in infants of mothers with human immunodeficiency virus (HIV) infection who did not receive antenatal antiretroviral therapy (ART) because of late identification are unclear. We evaluated three ART regimens in such infants. METHODS:Within 48 hours after their birth, we randomly assigned formula-fed infants born to women with a peripartum diagnosis of HIV type 1 (HIV-1) infection to one of three regimens: zidovudine for 6 weeks (zidovudine-alone group), zidovudine for 6 weeks plus three doses of nevirapine during the first 8 days of life (two-drug group), or zidovudine for 6 weeks plus nelfinavir and lamivudine for 2 weeks (three-drug group). The primary outcome was HIV-1 infection at 3 months in infants uninfected at birth. RESULTS:A total of 1684 infants were enrolled in the Americas and South Africa (566 in the zidovudine-alone group, 562 in the two-drug group, and 556 in the three-drug group). The overall rate of in utero transmission of HIV-1 on the basis of Kaplan-Meier estimates was 5.7% (93 infants), with no significant differences among the groups. Intrapartum transmission occurred in 24 infants in the zidovudine-alone group (4.8%; 95% confidence interval [CI], 3.2 to 7.1), as compared with 11 infants in the two-drug group (2.2%; 95% CI, 1.2 to 3.9; P = 0.046) and 12 in the three-drug group (2.4%; 95% CI, 1.4 to 4.3; P = 0.046). The overall transmission rate was 8.5% (140 infants), with an increased rate in the zidovudine-alone group (P = 0.03 for the comparisons with the two- and three-drug groups). On multivariate analysis, zidovudine monotherapy, a higher maternal viral load, and maternal use of illegal substances were significantly associated with transmission. The rate of neutropenia was significantly increased in the three-drug group (P

Original languageEnglish (US)
Pages (from-to)2368-2379
Number of pages12
JournalNew England Journal of Medicine
Volume366
Issue number25
DOIs
StatePublished - Jun 21 2012
Externally publishedYes

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Virus Diseases
Zidovudine
Postpartum Period
HIV
Pharmaceutical Preparations
HIV-1
Mothers
Confidence Intervals
Parturition
Nelfinavir
Peripartum Period
Nevirapine
Infant Formula
Lamivudine
Kaplan-Meier Estimate
South Africa
Neutropenia
Viral Load
Multivariate Analysis
Safety

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Nielsen-Saines, K., Watts, D. H., Veloso, V. G., Bryson, Y. J., Joao, E. C., Pilotto, J. H., ... Mofenson, L. M. (2012). Three postpartum antiretroviral regimens to prevent intrapartum HIV infection. New England Journal of Medicine, 366(25), 2368-2379. https://doi.org/10.1056/NEJMoa1108275

Three postpartum antiretroviral regimens to prevent intrapartum HIV infection. / Nielsen-Saines, Karin; Watts, D. Heather; Veloso, Valdilea G.; Bryson, Yvonne J.; Joao, Esau C.; Pilotto, Jose Henrique; Gray, Glenda; Theron, Gerhard; Santos, Breno; Fonseca, Rosana; Kreitchmann, Regis; Pinto, Jorge; Mussi-Pinhata, Marisa M.; Ceriotto, Mariana; Machado, Daisy; Bethel, James; Morgado, Marisa G.; Dickover, Ruth; Camarca, Margaret; Mirochnick, Mark; Siberry, George; Grinsztejn, Beatriz; Moreira, Ronaldo I.; Bastos, Francisco I.; Xu, Jiahong; Moye, Jack; Mofenson, Lynne M.

In: New England Journal of Medicine, Vol. 366, No. 25, 21.06.2012, p. 2368-2379.

Research output: Contribution to journalArticle

Nielsen-Saines, K, Watts, DH, Veloso, VG, Bryson, YJ, Joao, EC, Pilotto, JH, Gray, G, Theron, G, Santos, B, Fonseca, R, Kreitchmann, R, Pinto, J, Mussi-Pinhata, MM, Ceriotto, M, Machado, D, Bethel, J, Morgado, MG, Dickover, R, Camarca, M, Mirochnick, M, Siberry, G, Grinsztejn, B, Moreira, RI, Bastos, FI, Xu, J, Moye, J & Mofenson, LM 2012, 'Three postpartum antiretroviral regimens to prevent intrapartum HIV infection', New England Journal of Medicine, vol. 366, no. 25, pp. 2368-2379. https://doi.org/10.1056/NEJMoa1108275
Nielsen-Saines K, Watts DH, Veloso VG, Bryson YJ, Joao EC, Pilotto JH et al. Three postpartum antiretroviral regimens to prevent intrapartum HIV infection. New England Journal of Medicine. 2012 Jun 21;366(25):2368-2379. https://doi.org/10.1056/NEJMoa1108275
Nielsen-Saines, Karin ; Watts, D. Heather ; Veloso, Valdilea G. ; Bryson, Yvonne J. ; Joao, Esau C. ; Pilotto, Jose Henrique ; Gray, Glenda ; Theron, Gerhard ; Santos, Breno ; Fonseca, Rosana ; Kreitchmann, Regis ; Pinto, Jorge ; Mussi-Pinhata, Marisa M. ; Ceriotto, Mariana ; Machado, Daisy ; Bethel, James ; Morgado, Marisa G. ; Dickover, Ruth ; Camarca, Margaret ; Mirochnick, Mark ; Siberry, George ; Grinsztejn, Beatriz ; Moreira, Ronaldo I. ; Bastos, Francisco I. ; Xu, Jiahong ; Moye, Jack ; Mofenson, Lynne M. / Three postpartum antiretroviral regimens to prevent intrapartum HIV infection. In: New England Journal of Medicine. 2012 ; Vol. 366, No. 25. pp. 2368-2379.
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T1 - Three postpartum antiretroviral regimens to prevent intrapartum HIV infection

AU - Nielsen-Saines, Karin

AU - Watts, D. Heather

AU - Veloso, Valdilea G.

AU - Bryson, Yvonne J.

AU - Joao, Esau C.

AU - Pilotto, Jose Henrique

AU - Gray, Glenda

AU - Theron, Gerhard

AU - Santos, Breno

AU - Fonseca, Rosana

AU - Kreitchmann, Regis

AU - Pinto, Jorge

AU - Mussi-Pinhata, Marisa M.

AU - Ceriotto, Mariana

AU - Machado, Daisy

AU - Bethel, James

AU - Morgado, Marisa G.

AU - Dickover, Ruth

AU - Camarca, Margaret

AU - Mirochnick, Mark

AU - Siberry, George

AU - Grinsztejn, Beatriz

AU - Moreira, Ronaldo I.

AU - Bastos, Francisco I.

AU - Xu, Jiahong

AU - Moye, Jack

AU - Mofenson, Lynne M.

PY - 2012/6/21

Y1 - 2012/6/21

N2 - BACKGROUND: The safety and efficacy of adding antiretroviral drugs to standard zidovudine prophylaxis in infants of mothers with human immunodeficiency virus (HIV) infection who did not receive antenatal antiretroviral therapy (ART) because of late identification are unclear. We evaluated three ART regimens in such infants. METHODS:Within 48 hours after their birth, we randomly assigned formula-fed infants born to women with a peripartum diagnosis of HIV type 1 (HIV-1) infection to one of three regimens: zidovudine for 6 weeks (zidovudine-alone group), zidovudine for 6 weeks plus three doses of nevirapine during the first 8 days of life (two-drug group), or zidovudine for 6 weeks plus nelfinavir and lamivudine for 2 weeks (three-drug group). The primary outcome was HIV-1 infection at 3 months in infants uninfected at birth. RESULTS:A total of 1684 infants were enrolled in the Americas and South Africa (566 in the zidovudine-alone group, 562 in the two-drug group, and 556 in the three-drug group). The overall rate of in utero transmission of HIV-1 on the basis of Kaplan-Meier estimates was 5.7% (93 infants), with no significant differences among the groups. Intrapartum transmission occurred in 24 infants in the zidovudine-alone group (4.8%; 95% confidence interval [CI], 3.2 to 7.1), as compared with 11 infants in the two-drug group (2.2%; 95% CI, 1.2 to 3.9; P = 0.046) and 12 in the three-drug group (2.4%; 95% CI, 1.4 to 4.3; P = 0.046). The overall transmission rate was 8.5% (140 infants), with an increased rate in the zidovudine-alone group (P = 0.03 for the comparisons with the two- and three-drug groups). On multivariate analysis, zidovudine monotherapy, a higher maternal viral load, and maternal use of illegal substances were significantly associated with transmission. The rate of neutropenia was significantly increased in the three-drug group (P

AB - BACKGROUND: The safety and efficacy of adding antiretroviral drugs to standard zidovudine prophylaxis in infants of mothers with human immunodeficiency virus (HIV) infection who did not receive antenatal antiretroviral therapy (ART) because of late identification are unclear. We evaluated three ART regimens in such infants. METHODS:Within 48 hours after their birth, we randomly assigned formula-fed infants born to women with a peripartum diagnosis of HIV type 1 (HIV-1) infection to one of three regimens: zidovudine for 6 weeks (zidovudine-alone group), zidovudine for 6 weeks plus three doses of nevirapine during the first 8 days of life (two-drug group), or zidovudine for 6 weeks plus nelfinavir and lamivudine for 2 weeks (three-drug group). The primary outcome was HIV-1 infection at 3 months in infants uninfected at birth. RESULTS:A total of 1684 infants were enrolled in the Americas and South Africa (566 in the zidovudine-alone group, 562 in the two-drug group, and 556 in the three-drug group). The overall rate of in utero transmission of HIV-1 on the basis of Kaplan-Meier estimates was 5.7% (93 infants), with no significant differences among the groups. Intrapartum transmission occurred in 24 infants in the zidovudine-alone group (4.8%; 95% confidence interval [CI], 3.2 to 7.1), as compared with 11 infants in the two-drug group (2.2%; 95% CI, 1.2 to 3.9; P = 0.046) and 12 in the three-drug group (2.4%; 95% CI, 1.4 to 4.3; P = 0.046). The overall transmission rate was 8.5% (140 infants), with an increased rate in the zidovudine-alone group (P = 0.03 for the comparisons with the two- and three-drug groups). On multivariate analysis, zidovudine monotherapy, a higher maternal viral load, and maternal use of illegal substances were significantly associated with transmission. The rate of neutropenia was significantly increased in the three-drug group (P

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