Antiretroviral therapies in women after single-dose nevirapine exposure

S. Lockman, M. D. Hughes, J. McIntyre, Y. Zheng, T. Chipato, F. Conradie, F. Sawe, A. Asmelash, M. C. Hosseinipour, L. Mohapi, E. Stringer, R. Mngqibisa, A. Siika, D. Atwine, J. Hakim, D. Shaffer, C. Kanyama, Kara Wools-Kaloustian, R. A. Salata, E. Hogg & 9 others B. Alston-Smith, A. Walawander, E. Purcelle-Smith, S. Eshleman, J. Rooney, S. Rahim, J. W. Mellors, R. T. Schooley, J. S. Currier

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Abstract

Background: Peripartum administration of single-dose nevirapine reduces mother-to-child transmission of human immunodeficiency virus type 1 (HIV-1) but selects for nevirapineresistant virus. Methods: In seven African countries, women infected with HIV-1 whose CD4+ T-cell counts were below 200 per cubic millimeter and who either had or had not taken singledose nevirapine at least 6 months before enrollment were randomly assigned to receive antiretroviral therapy with tenofovir - emtricitabine plus nevirapine or tenofovir- emtricitabine plus lopinavir boosted by a low dose of ritonavir. The primary end point was the time to confirmed virologic failure or death. Results: A total of 241 women who had been exposed to single-dose nevirapine began the study treatments (121 received nevirapine and 120 received ritonavir-boosted lopin avir). Significantly more women in the nevirapine group reached the primary end point than in the ritonavir-boosted lopinavir group (26% vs. 8%) (adjusted P = 0.001). Virologic failure occurred in 37 (28 in the nevirapine group and 9 in the ritonavir-boosted lopinavir group), and 5 died without prior virologic failure (4 in the nevirapine group and 1 in the ritonavir-boosted lopinavir group). The group differences appeared to decrease as the interval between single-dose nevirapine exposure and the start of antiretroviral therapy increased. Retrospective bulk sequencing of baseline plasma samples showed nevirapine resistance in 33 of 239 women tested (14%). Among 500 women without prior exposure to single-dose nevirapine, 34 of 249 in the nevirapine group (14%) and 36 of 251 in the ritonavir-boosted lopinavir group (14%) had virologic failure or died. Conclusions: In women with prior exposure to peripartum single-dose nevirapine (but not in those without prior exposure), ritonavir-boosted lopinavir plus tenofovir - emtricitabine was superior to nevirapine plus tenofovir - emtricitabine for initial antiretroviral therapy.

Original languageEnglish
Pages (from-to)1499-1509
Number of pages11
JournalNew England Journal of Medicine
Volume363
Issue number16
DOIs
StatePublished - Oct 14 2010

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Nevirapine
Tenofovir
Ritonavir
Lopinavir
Therapeutics
Peripartum Period
HIV-1
CD4 Lymphocyte Count

ASJC Scopus subject areas

  • Medicine(all)

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Lockman, S., Hughes, M. D., McIntyre, J., Zheng, Y., Chipato, T., Conradie, F., ... Currier, J. S. (2010). Antiretroviral therapies in women after single-dose nevirapine exposure. New England Journal of Medicine, 363(16), 1499-1509. https://doi.org/10.1056/NEJMoa0906626

Antiretroviral therapies in women after single-dose nevirapine exposure. / Lockman, S.; Hughes, M. D.; McIntyre, J.; Zheng, Y.; Chipato, T.; Conradie, F.; Sawe, F.; Asmelash, A.; Hosseinipour, M. C.; Mohapi, L.; Stringer, E.; Mngqibisa, R.; Siika, A.; Atwine, D.; Hakim, J.; Shaffer, D.; Kanyama, C.; Wools-Kaloustian, Kara; Salata, R. A.; Hogg, E.; Alston-Smith, B.; Walawander, A.; Purcelle-Smith, E.; Eshleman, S.; Rooney, J.; Rahim, S.; Mellors, J. W.; Schooley, R. T.; Currier, J. S.

In: New England Journal of Medicine, Vol. 363, No. 16, 14.10.2010, p. 1499-1509.

Research output: Contribution to journalArticle

Lockman, S, Hughes, MD, McIntyre, J, Zheng, Y, Chipato, T, Conradie, F, Sawe, F, Asmelash, A, Hosseinipour, MC, Mohapi, L, Stringer, E, Mngqibisa, R, Siika, A, Atwine, D, Hakim, J, Shaffer, D, Kanyama, C, Wools-Kaloustian, K, Salata, RA, Hogg, E, Alston-Smith, B, Walawander, A, Purcelle-Smith, E, Eshleman, S, Rooney, J, Rahim, S, Mellors, JW, Schooley, RT & Currier, JS 2010, 'Antiretroviral therapies in women after single-dose nevirapine exposure', New England Journal of Medicine, vol. 363, no. 16, pp. 1499-1509. https://doi.org/10.1056/NEJMoa0906626
Lockman S, Hughes MD, McIntyre J, Zheng Y, Chipato T, Conradie F et al. Antiretroviral therapies in women after single-dose nevirapine exposure. New England Journal of Medicine. 2010 Oct 14;363(16):1499-1509. https://doi.org/10.1056/NEJMoa0906626
Lockman, S. ; Hughes, M. D. ; McIntyre, J. ; Zheng, Y. ; Chipato, T. ; Conradie, F. ; Sawe, F. ; Asmelash, A. ; Hosseinipour, M. C. ; Mohapi, L. ; Stringer, E. ; Mngqibisa, R. ; Siika, A. ; Atwine, D. ; Hakim, J. ; Shaffer, D. ; Kanyama, C. ; Wools-Kaloustian, Kara ; Salata, R. A. ; Hogg, E. ; Alston-Smith, B. ; Walawander, A. ; Purcelle-Smith, E. ; Eshleman, S. ; Rooney, J. ; Rahim, S. ; Mellors, J. W. ; Schooley, R. T. ; Currier, J. S. / Antiretroviral therapies in women after single-dose nevirapine exposure. In: New England Journal of Medicine. 2010 ; Vol. 363, No. 16. pp. 1499-1509.
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title = "Antiretroviral therapies in women after single-dose nevirapine exposure",
abstract = "Background: Peripartum administration of single-dose nevirapine reduces mother-to-child transmission of human immunodeficiency virus type 1 (HIV-1) but selects for nevirapineresistant virus. Methods: In seven African countries, women infected with HIV-1 whose CD4+ T-cell counts were below 200 per cubic millimeter and who either had or had not taken singledose nevirapine at least 6 months before enrollment were randomly assigned to receive antiretroviral therapy with tenofovir - emtricitabine plus nevirapine or tenofovir- emtricitabine plus lopinavir boosted by a low dose of ritonavir. The primary end point was the time to confirmed virologic failure or death. Results: A total of 241 women who had been exposed to single-dose nevirapine began the study treatments (121 received nevirapine and 120 received ritonavir-boosted lopin avir). Significantly more women in the nevirapine group reached the primary end point than in the ritonavir-boosted lopinavir group (26{\%} vs. 8{\%}) (adjusted P = 0.001). Virologic failure occurred in 37 (28 in the nevirapine group and 9 in the ritonavir-boosted lopinavir group), and 5 died without prior virologic failure (4 in the nevirapine group and 1 in the ritonavir-boosted lopinavir group). The group differences appeared to decrease as the interval between single-dose nevirapine exposure and the start of antiretroviral therapy increased. Retrospective bulk sequencing of baseline plasma samples showed nevirapine resistance in 33 of 239 women tested (14{\%}). Among 500 women without prior exposure to single-dose nevirapine, 34 of 249 in the nevirapine group (14{\%}) and 36 of 251 in the ritonavir-boosted lopinavir group (14{\%}) had virologic failure or died. Conclusions: In women with prior exposure to peripartum single-dose nevirapine (but not in those without prior exposure), ritonavir-boosted lopinavir plus tenofovir - emtricitabine was superior to nevirapine plus tenofovir - emtricitabine for initial antiretroviral therapy.",
author = "S. Lockman and Hughes, {M. D.} and J. McIntyre and Y. Zheng and T. Chipato and F. Conradie and F. Sawe and A. Asmelash and Hosseinipour, {M. C.} and L. Mohapi and E. Stringer and R. Mngqibisa and A. Siika and D. Atwine and J. Hakim and D. Shaffer and C. Kanyama and Kara Wools-Kaloustian and Salata, {R. A.} and E. Hogg and B. Alston-Smith and A. Walawander and E. Purcelle-Smith and S. Eshleman and J. Rooney and S. Rahim and Mellors, {J. W.} and Schooley, {R. T.} and Currier, {J. S.}",
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T1 - Antiretroviral therapies in women after single-dose nevirapine exposure

AU - Lockman, S.

AU - Hughes, M. D.

AU - McIntyre, J.

AU - Zheng, Y.

AU - Chipato, T.

AU - Conradie, F.

AU - Sawe, F.

AU - Asmelash, A.

AU - Hosseinipour, M. C.

AU - Mohapi, L.

AU - Stringer, E.

AU - Mngqibisa, R.

AU - Siika, A.

AU - Atwine, D.

AU - Hakim, J.

AU - Shaffer, D.

AU - Kanyama, C.

AU - Wools-Kaloustian, Kara

AU - Salata, R. A.

AU - Hogg, E.

AU - Alston-Smith, B.

AU - Walawander, A.

AU - Purcelle-Smith, E.

AU - Eshleman, S.

AU - Rooney, J.

AU - Rahim, S.

AU - Mellors, J. W.

AU - Schooley, R. T.

AU - Currier, J. S.

PY - 2010/10/14

Y1 - 2010/10/14

N2 - Background: Peripartum administration of single-dose nevirapine reduces mother-to-child transmission of human immunodeficiency virus type 1 (HIV-1) but selects for nevirapineresistant virus. Methods: In seven African countries, women infected with HIV-1 whose CD4+ T-cell counts were below 200 per cubic millimeter and who either had or had not taken singledose nevirapine at least 6 months before enrollment were randomly assigned to receive antiretroviral therapy with tenofovir - emtricitabine plus nevirapine or tenofovir- emtricitabine plus lopinavir boosted by a low dose of ritonavir. The primary end point was the time to confirmed virologic failure or death. Results: A total of 241 women who had been exposed to single-dose nevirapine began the study treatments (121 received nevirapine and 120 received ritonavir-boosted lopin avir). Significantly more women in the nevirapine group reached the primary end point than in the ritonavir-boosted lopinavir group (26% vs. 8%) (adjusted P = 0.001). Virologic failure occurred in 37 (28 in the nevirapine group and 9 in the ritonavir-boosted lopinavir group), and 5 died without prior virologic failure (4 in the nevirapine group and 1 in the ritonavir-boosted lopinavir group). The group differences appeared to decrease as the interval between single-dose nevirapine exposure and the start of antiretroviral therapy increased. Retrospective bulk sequencing of baseline plasma samples showed nevirapine resistance in 33 of 239 women tested (14%). Among 500 women without prior exposure to single-dose nevirapine, 34 of 249 in the nevirapine group (14%) and 36 of 251 in the ritonavir-boosted lopinavir group (14%) had virologic failure or died. Conclusions: In women with prior exposure to peripartum single-dose nevirapine (but not in those without prior exposure), ritonavir-boosted lopinavir plus tenofovir - emtricitabine was superior to nevirapine plus tenofovir - emtricitabine for initial antiretroviral therapy.

AB - Background: Peripartum administration of single-dose nevirapine reduces mother-to-child transmission of human immunodeficiency virus type 1 (HIV-1) but selects for nevirapineresistant virus. Methods: In seven African countries, women infected with HIV-1 whose CD4+ T-cell counts were below 200 per cubic millimeter and who either had or had not taken singledose nevirapine at least 6 months before enrollment were randomly assigned to receive antiretroviral therapy with tenofovir - emtricitabine plus nevirapine or tenofovir- emtricitabine plus lopinavir boosted by a low dose of ritonavir. The primary end point was the time to confirmed virologic failure or death. Results: A total of 241 women who had been exposed to single-dose nevirapine began the study treatments (121 received nevirapine and 120 received ritonavir-boosted lopin avir). Significantly more women in the nevirapine group reached the primary end point than in the ritonavir-boosted lopinavir group (26% vs. 8%) (adjusted P = 0.001). Virologic failure occurred in 37 (28 in the nevirapine group and 9 in the ritonavir-boosted lopinavir group), and 5 died without prior virologic failure (4 in the nevirapine group and 1 in the ritonavir-boosted lopinavir group). The group differences appeared to decrease as the interval between single-dose nevirapine exposure and the start of antiretroviral therapy increased. Retrospective bulk sequencing of baseline plasma samples showed nevirapine resistance in 33 of 239 women tested (14%). Among 500 women without prior exposure to single-dose nevirapine, 34 of 249 in the nevirapine group (14%) and 36 of 251 in the ritonavir-boosted lopinavir group (14%) had virologic failure or died. Conclusions: In women with prior exposure to peripartum single-dose nevirapine (but not in those without prior exposure), ritonavir-boosted lopinavir plus tenofovir - emtricitabine was superior to nevirapine plus tenofovir - emtricitabine for initial antiretroviral therapy.

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