Maternal viral load, zidovudine treatment, and the risk of transmission of human immunodeficiency virus type 1 from mother to infant

Rhoda S. Sperling, David E. Shapiro, Robert W. Coombs, John A. Todd, Steven A. Herman, George D. Mcsherry, Mary Jo O'Sullivan, Russell B. Van Dyke, Eleanor Jimenez, Christine Rouzioux, Patricia M. Flynn, John L. Sullivan, Stephen A. Spector, Clemente Diaz, James Rooney, James Balsley, Richard D. Gelber, Edward M. Connor

Research output: Contribution to journalArticle

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Abstract

Background and Methods: A placebo-controlled trial has shown that treatment with zidovudine reduces the rate at which human immunodeficiency virus type 1 (HIV-1) is transmitted from mother to infant. We present data from that trial showing the number of infected infants at 18 months of age and the relation between the maternal viral load, the risk of HIV-1 transmission, and the efficacy of zidovudine treatment. Viral cultures were obtained, and HIV-1 RNA was measured by two assays in samples of maternal blood obtained at study entry and at delivery. Results: In 402 mother-infant pairs, the rate of transmission of HIV-1 was 7.6 percent (95 percent confidence interval, 4.3 to 12.3 percent) with zidovudine treatment and 22.6 percent (95 percent confidence interval, 17.0 to 29.0 percent) with placebo (P<0.001). In the placebo group, a large viral burden at entry or delivery or a positive culture was associated with an increased risk of transmission (the transmission rate was greater than 40 percent in the highest quartile of the RNA level). In both groups, transmission occurred at a wide range of maternal plasma HIV-1 RNA levels. Zidovudine reduced plasma RNA levels somewhat (median reduction, 0.24 log). Zidovudine was effective regardless of the HIV- 1 RNA level or the CD4+ count at entry. In the zidovudine group, however, after we adjusted for the base-line HIV-1 RNA level and CD4+ count, the reduction in viral RNA from base line to delivery was not significantly associated with the risk of transmission of HIV-1. Conclusions: A high maternal plasma concentration of virus is a risk factor for the transmission of HIV-1 from an untreated mother to her infant. The reduction in such transmission after zidovudine treatment is only partly explained by the reduction in plasma levels of viral RNA. To prevent HIV-1 transmission, initiating maternal treatment with zidovudine is recommended regardless of the plasma level of HIV-1 RNA or the CD4+ count.

Original languageEnglish
Pages (from-to)1621-1629
Number of pages9
JournalNew England Journal of Medicine
Volume335
Issue number22
DOIs
StatePublished - Nov 28 1996
Externally publishedYes

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Zidovudine
Viral Load
HIV-1
Mothers
RNA
CD4 Lymphocyte Count
Therapeutics
Placebos
Viral RNA
Confidence Intervals
Viruses

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Sperling, R. S., Shapiro, D. E., Coombs, R. W., Todd, J. A., Herman, S. A., Mcsherry, G. D., ... Connor, E. M. (1996). Maternal viral load, zidovudine treatment, and the risk of transmission of human immunodeficiency virus type 1 from mother to infant. New England Journal of Medicine, 335(22), 1621-1629. https://doi.org/10.1056/NEJM199611283352201

Maternal viral load, zidovudine treatment, and the risk of transmission of human immunodeficiency virus type 1 from mother to infant. / Sperling, Rhoda S.; Shapiro, David E.; Coombs, Robert W.; Todd, John A.; Herman, Steven A.; Mcsherry, George D.; O'Sullivan, Mary Jo; Van Dyke, Russell B.; Jimenez, Eleanor; Rouzioux, Christine; Flynn, Patricia M.; Sullivan, John L.; Spector, Stephen A.; Diaz, Clemente; Rooney, James; Balsley, James; Gelber, Richard D.; Connor, Edward M.

In: New England Journal of Medicine, Vol. 335, No. 22, 28.11.1996, p. 1621-1629.

Research output: Contribution to journalArticle

Sperling, RS, Shapiro, DE, Coombs, RW, Todd, JA, Herman, SA, Mcsherry, GD, O'Sullivan, MJ, Van Dyke, RB, Jimenez, E, Rouzioux, C, Flynn, PM, Sullivan, JL, Spector, SA, Diaz, C, Rooney, J, Balsley, J, Gelber, RD & Connor, EM 1996, 'Maternal viral load, zidovudine treatment, and the risk of transmission of human immunodeficiency virus type 1 from mother to infant', New England Journal of Medicine, vol. 335, no. 22, pp. 1621-1629. https://doi.org/10.1056/NEJM199611283352201
Sperling, Rhoda S. ; Shapiro, David E. ; Coombs, Robert W. ; Todd, John A. ; Herman, Steven A. ; Mcsherry, George D. ; O'Sullivan, Mary Jo ; Van Dyke, Russell B. ; Jimenez, Eleanor ; Rouzioux, Christine ; Flynn, Patricia M. ; Sullivan, John L. ; Spector, Stephen A. ; Diaz, Clemente ; Rooney, James ; Balsley, James ; Gelber, Richard D. ; Connor, Edward M. / Maternal viral load, zidovudine treatment, and the risk of transmission of human immunodeficiency virus type 1 from mother to infant. In: New England Journal of Medicine. 1996 ; Vol. 335, No. 22. pp. 1621-1629.
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abstract = "Background and Methods: A placebo-controlled trial has shown that treatment with zidovudine reduces the rate at which human immunodeficiency virus type 1 (HIV-1) is transmitted from mother to infant. We present data from that trial showing the number of infected infants at 18 months of age and the relation between the maternal viral load, the risk of HIV-1 transmission, and the efficacy of zidovudine treatment. Viral cultures were obtained, and HIV-1 RNA was measured by two assays in samples of maternal blood obtained at study entry and at delivery. Results: In 402 mother-infant pairs, the rate of transmission of HIV-1 was 7.6 percent (95 percent confidence interval, 4.3 to 12.3 percent) with zidovudine treatment and 22.6 percent (95 percent confidence interval, 17.0 to 29.0 percent) with placebo (P<0.001). In the placebo group, a large viral burden at entry or delivery or a positive culture was associated with an increased risk of transmission (the transmission rate was greater than 40 percent in the highest quartile of the RNA level). In both groups, transmission occurred at a wide range of maternal plasma HIV-1 RNA levels. Zidovudine reduced plasma RNA levels somewhat (median reduction, 0.24 log). Zidovudine was effective regardless of the HIV- 1 RNA level or the CD4+ count at entry. In the zidovudine group, however, after we adjusted for the base-line HIV-1 RNA level and CD4+ count, the reduction in viral RNA from base line to delivery was not significantly associated with the risk of transmission of HIV-1. Conclusions: A high maternal plasma concentration of virus is a risk factor for the transmission of HIV-1 from an untreated mother to her infant. The reduction in such transmission after zidovudine treatment is only partly explained by the reduction in plasma levels of viral RNA. To prevent HIV-1 transmission, initiating maternal treatment with zidovudine is recommended regardless of the plasma level of HIV-1 RNA or the CD4+ count.",
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AU - Shapiro, David E.

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AU - Todd, John A.

AU - Herman, Steven A.

AU - Mcsherry, George D.

AU - O'Sullivan, Mary Jo

AU - Van Dyke, Russell B.

AU - Jimenez, Eleanor

AU - Rouzioux, Christine

AU - Flynn, Patricia M.

AU - Sullivan, John L.

AU - Spector, Stephen A.

AU - Diaz, Clemente

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AU - Balsley, James

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N2 - Background and Methods: A placebo-controlled trial has shown that treatment with zidovudine reduces the rate at which human immunodeficiency virus type 1 (HIV-1) is transmitted from mother to infant. We present data from that trial showing the number of infected infants at 18 months of age and the relation between the maternal viral load, the risk of HIV-1 transmission, and the efficacy of zidovudine treatment. Viral cultures were obtained, and HIV-1 RNA was measured by two assays in samples of maternal blood obtained at study entry and at delivery. Results: In 402 mother-infant pairs, the rate of transmission of HIV-1 was 7.6 percent (95 percent confidence interval, 4.3 to 12.3 percent) with zidovudine treatment and 22.6 percent (95 percent confidence interval, 17.0 to 29.0 percent) with placebo (P<0.001). In the placebo group, a large viral burden at entry or delivery or a positive culture was associated with an increased risk of transmission (the transmission rate was greater than 40 percent in the highest quartile of the RNA level). In both groups, transmission occurred at a wide range of maternal plasma HIV-1 RNA levels. Zidovudine reduced plasma RNA levels somewhat (median reduction, 0.24 log). Zidovudine was effective regardless of the HIV- 1 RNA level or the CD4+ count at entry. In the zidovudine group, however, after we adjusted for the base-line HIV-1 RNA level and CD4+ count, the reduction in viral RNA from base line to delivery was not significantly associated with the risk of transmission of HIV-1. Conclusions: A high maternal plasma concentration of virus is a risk factor for the transmission of HIV-1 from an untreated mother to her infant. The reduction in such transmission after zidovudine treatment is only partly explained by the reduction in plasma levels of viral RNA. To prevent HIV-1 transmission, initiating maternal treatment with zidovudine is recommended regardless of the plasma level of HIV-1 RNA or the CD4+ count.

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