Maternal anaemia and duration of zidovudine in antiretroviral regimens for preventing mother-to-child transmission: A randomized trial in three African countries

Benn K.D. Sartorius; Matthew F. Chersich; Mary Mwaura; Nicolas Meda; Marleen Temmerman; Marie L. Newell; Timothy M.M. Farley; Stanley Luchters; Bobo Dioulasso; Burkina Faso; Nicolas Meda; Paulin Fao; Odette Ky-Zerbo; Clarisse Gouem; Paulin Somda; Hervé Hien; Patrice Elysée Ouedraogo; Dramane Kania; Armande Sanou; Ida Ayassou Kossiwavi; Bintou Sanogo; Moussa Ouedraogo; Issa Siribie; Diane Valéa; Sayouba Ouedraogo; Roseline Somé; François Rouet; Nigel Rollins; Lynne McFetridge; Kevi Naidu; Marcel Reyners; Eunice Irungu; Christine Katingima; Mary Mwaura; Gina Ouattara; Kishor Mandaliya; Sammy Wambua; Mary Thiongo; Ruth Nduati; Judith Kose; Ephantus Njagi; Peter Mwaura; Marie Louise Newell; Stephen Mepham; Johannes Viljoen; Ruth Bland; Londiwe Mthethwa

doi:10.1186/1471-2334-13-522

Maternal anaemia and duration of zidovudine in antiretroviral regimens for preventing mother-to-child transmission: A randomized trial in three African countries

Benn K.D. Sartorius, Matthew F. Chersich, Mary Mwaura, Nicolas Meda, Marleen Temmerman, Marie L. Newell, Timothy M.M. Farley, Stanley Luchters, Bobo Dioulasso, Burkina Faso, Nicolas Meda, Paulin Fao, Odette Ky-Zerbo, Clarisse Gouem, Paulin Somda, Hervé Hien, Patrice Elysée Ouedraogo, Dramane Kania, Armande Sanou, Ida Ayassou KossiwaviBintou Sanogo, Moussa Ouedraogo, Issa Siribie, Diane Valéa, Sayouba Ouedraogo, Roseline Somé, François Rouet, Nigel Rollins, Lynne McFetridge, Kevi Naidu, Marcel Reyners, Eunice Irungu, Christine Katingima, Mary Mwaura, Gina Ouattara, Kishor Mandaliya, Sammy Wambua, Mary Thiongo, Ruth Nduati, Judith Kose, Ephantus Njagi, Peter Mwaura, Marie Louise Newell, Stephen Mepham, Johannes Viljoen, Ruth Bland, Londiwe Mthethwa

Research output: Contribution to journal › Article › peer-review

13 Citations (Scopus)

Abstract

Background: Although substantiated by little evidence, concerns about zidovudine-related anaemia in pregnancy have influenced antiretroviral (ARV) regimen choice for preventing mother-to-child transmission of HIV-1, especially in settings where anaemia is common.Methods: Eligible HIV-infected pregnant women in Burkina Faso, Kenya and South Africa were followed from 28 weeks of pregnancy until 12-24 months after delivery (n = 1070). Women with a CD4 count of 200-500cells/mm³ and gestational age 28-36 weeks were randomly assigned to zidovudine-containing triple-ARV prophylaxis continued during breastfeeding up to 6-months, or to zidovudine during pregnancy plus single-dose nevirapine (sd-NVP) at labour. Additionally, two cohorts were established, women with CD4 counts: <200 cells/mm³ initiated antiretroviral therapy, and >500 cells/mm³ received zidovudine during pregnancy plus sd-NVP at labour. Mild (haemoglobin 8.0-10.9 g/dl) and severe anaemia (haemoglobin < 8.0 g/dl) occurrence were assessed across study arms, using Kaplan-Meier and multivariable Cox proportional hazards models.Results: At enrolment (corresponded to a median 32 weeks gestation), median haemoglobin was 10.3 g/dl (IQR = 9.2-11.1). Severe anaemia occurred subsequently in 194 (18.1%) women, mostly in those with low baseline haemoglobin, lowest socio-economic category, advanced HIV disease, prolonged breastfeeding (≥6 months) and shorter ARV exposure. Severe anaemia incidence was similar in the randomized arms (equivalence P-value = 0.32). After 1-2 months of ARV's, severe anaemia was significantly reduced in all groups, though remained highest in the low CD4 cohort.Conclusions: Severe anaemia occurs at a similar rate in women receiving longer triple zidovudine-containing regimens or shorter prophylaxis. Pregnant women with pre-existing anaemia and advanced HIV disease require close monitoring. Trial registration number: ISRCTN71468401.

Original language	English
Article number	522
Journal	BMC Infectious Diseases
Volume	13
Issue number	1
DOIs	https://doi.org/10.1186/1471-2334-13-522
Publication status	Published - 6 Nov 2013
Externally published	Yes

Keywords

Anaemia
Drug toxicity
HIV
Pregnancy
Sub-Saharan Africa
Zidovudine

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1186/1471-2334-13-522

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Sartorius, B. K. D., Chersich, M. F., Mwaura, M., Meda, N., Temmerman, M., Newell, M. L., Farley, T. M. M., Luchters, S., Dioulasso, B., Faso, B., Meda, N., Fao, P., Ky-Zerbo, O., Gouem, C., Somda, P., Hien, H., Ouedraogo, P. E., Kania, D., Sanou, A., ... Mthethwa, L. (2013). Maternal anaemia and duration of zidovudine in antiretroviral regimens for preventing mother-to-child transmission: A randomized trial in three African countries. BMC Infectious Diseases, 13(1), Article 522. https://doi.org/10.1186/1471-2334-13-522

@article{e7445ba9871d4f2195b2842fd2a222db,

title = "Maternal anaemia and duration of zidovudine in antiretroviral regimens for preventing mother-to-child transmission: A randomized trial in three African countries",

abstract = "Background: Although substantiated by little evidence, concerns about zidovudine-related anaemia in pregnancy have influenced antiretroviral (ARV) regimen choice for preventing mother-to-child transmission of HIV-1, especially in settings where anaemia is common.Methods: Eligible HIV-infected pregnant women in Burkina Faso, Kenya and South Africa were followed from 28 weeks of pregnancy until 12-24 months after delivery (n = 1070). Women with a CD4 count of 200-500cells/mm3 and gestational age 28-36 weeks were randomly assigned to zidovudine-containing triple-ARV prophylaxis continued during breastfeeding up to 6-months, or to zidovudine during pregnancy plus single-dose nevirapine (sd-NVP) at labour. Additionally, two cohorts were established, women with CD4 counts: <200 cells/mm3 initiated antiretroviral therapy, and >500 cells/mm3 received zidovudine during pregnancy plus sd-NVP at labour. Mild (haemoglobin 8.0-10.9 g/dl) and severe anaemia (haemoglobin < 8.0 g/dl) occurrence were assessed across study arms, using Kaplan-Meier and multivariable Cox proportional hazards models.Results: At enrolment (corresponded to a median 32 weeks gestation), median haemoglobin was 10.3 g/dl (IQR = 9.2-11.1). Severe anaemia occurred subsequently in 194 (18.1%) women, mostly in those with low baseline haemoglobin, lowest socio-economic category, advanced HIV disease, prolonged breastfeeding (≥6 months) and shorter ARV exposure. Severe anaemia incidence was similar in the randomized arms (equivalence P-value = 0.32). After 1-2 months of ARV's, severe anaemia was significantly reduced in all groups, though remained highest in the low CD4 cohort.Conclusions: Severe anaemia occurs at a similar rate in women receiving longer triple zidovudine-containing regimens or shorter prophylaxis. Pregnant women with pre-existing anaemia and advanced HIV disease require close monitoring. Trial registration number: ISRCTN71468401.",

keywords = "Anaemia, Drug toxicity, HIV, Pregnancy, Sub-Saharan Africa, Zidovudine",

author = "Sartorius, {Benn K.D.} and Chersich, {Matthew F.} and Mary Mwaura and Nicolas Meda and Marleen Temmerman and Newell, {Marie L.} and Farley, {Timothy M.M.} and Stanley Luchters and Bobo Dioulasso and Burkina Faso and Nicolas Meda and Paulin Fao and Odette Ky-Zerbo and Clarisse Gouem and Paulin Somda and Herv{\'e} Hien and Ouedraogo, {Patrice Elys{\'e}e} and Dramane Kania and Armande Sanou and Kossiwavi, {Ida Ayassou} and Bintou Sanogo and Moussa Ouedraogo and Issa Siribie and Diane Val{\'e}a and Sayouba Ouedraogo and Roseline Som{\'e} and Fran{\c c}ois Rouet and Nigel Rollins and Lynne McFetridge and Kevi Naidu and Marcel Reyners and Eunice Irungu and Christine Katingima and Mary Mwaura and Gina Ouattara and Kishor Mandaliya and Sammy Wambua and Mary Thiongo and Ruth Nduati and Judith Kose and Ephantus Njagi and Peter Mwaura and Newell, {Marie Louise} and Stephen Mepham and Johannes Viljoen and Ruth Bland and Londiwe Mthethwa",

note = "Funding Information: The Bobo-Dioulasso site was funded by l'Agence Natio-nale de Recherches sur le Sida et les H{\'e}patites Virales (ANRS) and UNDP/UNFPA/World Bank/WHO Special Programme of Research, Development and Research Training in Human Reproduction (WHO/HRP). Funding Information: The Nairobi site was funded by the Centers for Disease Control and Prevention (CDC) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) through a cooperative agreement. Funding Information: The South-African sites were funded by the Department for International Development (DFID), EDCTP, UNICEF and WHO/HRP. Funding Information: The Mombasa site was funded by ANRS, WHO/HRP, European and Developing Countries Clinical Trials Partnership (EDCTP), Thrasher Research Fund, Belgian Directorate General for International Cooperation. Funding Information: The Nutrition and laboratory coordination were funded by ANRS. Funding Information: The overall coordination and external monitoring was funded by WHO/HRP.",

year = "2013",

month = nov,

day = "6",

doi = "10.1186/1471-2334-13-522",

language = "English",

volume = "13",

journal = "BMC Infectious Diseases",

issn = "1471-2334",

publisher = "BioMed Central Ltd.",

number = "1",

}

Sartorius, BKD, Chersich, MF, Mwaura, M, Meda, N, Temmerman, M, Newell, ML, Farley, TMM, Luchters, S, Dioulasso, B, Faso, B, Meda, N, Fao, P, Ky-Zerbo, O, Gouem, C, Somda, P, Hien, H, Ouedraogo, PE, Kania, D, Sanou, A, Kossiwavi, IA, Sanogo, B, Ouedraogo, M, Siribie, I, Valéa, D, Ouedraogo, S, Somé, R, Rouet, F, Rollins, N, McFetridge, L, Naidu, K, Reyners, M, Irungu, E, Katingima, C, Mwaura, M, Ouattara, G, Mandaliya, K, Wambua, S, Thiongo, M, Nduati, R, Kose, J, Njagi, E, Mwaura, P, Newell, ML, Mepham, S, Viljoen, J, Bland, R & Mthethwa, L 2013, 'Maternal anaemia and duration of zidovudine in antiretroviral regimens for preventing mother-to-child transmission: A randomized trial in three African countries', BMC Infectious Diseases, vol. 13, no. 1, 522. https://doi.org/10.1186/1471-2334-13-522

TY - JOUR

T1 - Maternal anaemia and duration of zidovudine in antiretroviral regimens for preventing mother-to-child transmission

T2 - A randomized trial in three African countries

AU - Sartorius, Benn K.D.

AU - Chersich, Matthew F.

AU - Mwaura, Mary

AU - Meda, Nicolas

AU - Temmerman, Marleen

AU - Newell, Marie L.

AU - Farley, Timothy M.M.

AU - Luchters, Stanley

AU - Dioulasso, Bobo

AU - Faso, Burkina

AU - Meda, Nicolas

AU - Fao, Paulin

AU - Ky-Zerbo, Odette

AU - Gouem, Clarisse

AU - Somda, Paulin

AU - Hien, Hervé

AU - Ouedraogo, Patrice Elysée

AU - Kania, Dramane

AU - Sanou, Armande

AU - Kossiwavi, Ida Ayassou

AU - Sanogo, Bintou

AU - Ouedraogo, Moussa

AU - Siribie, Issa

AU - Valéa, Diane

AU - Ouedraogo, Sayouba

AU - Somé, Roseline

AU - Rouet, François

AU - Rollins, Nigel

AU - McFetridge, Lynne

AU - Naidu, Kevi

AU - Reyners, Marcel

AU - Irungu, Eunice

AU - Katingima, Christine

AU - Mwaura, Mary

AU - Ouattara, Gina

AU - Mandaliya, Kishor

AU - Wambua, Sammy

AU - Thiongo, Mary

AU - Nduati, Ruth

AU - Kose, Judith

AU - Njagi, Ephantus

AU - Mwaura, Peter

AU - Newell, Marie Louise

AU - Mepham, Stephen

AU - Viljoen, Johannes

AU - Bland, Ruth

AU - Mthethwa, Londiwe

N1 - Funding Information: The Bobo-Dioulasso site was funded by l'Agence Natio-nale de Recherches sur le Sida et les Hépatites Virales (ANRS) and UNDP/UNFPA/World Bank/WHO Special Programme of Research, Development and Research Training in Human Reproduction (WHO/HRP). Funding Information: The Nairobi site was funded by the Centers for Disease Control and Prevention (CDC) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) through a cooperative agreement. Funding Information: The South-African sites were funded by the Department for International Development (DFID), EDCTP, UNICEF and WHO/HRP. Funding Information: The Mombasa site was funded by ANRS, WHO/HRP, European and Developing Countries Clinical Trials Partnership (EDCTP), Thrasher Research Fund, Belgian Directorate General for International Cooperation. Funding Information: The Nutrition and laboratory coordination were funded by ANRS. Funding Information: The overall coordination and external monitoring was funded by WHO/HRP.

PY - 2013/11/6

Y1 - 2013/11/6

N2 - Background: Although substantiated by little evidence, concerns about zidovudine-related anaemia in pregnancy have influenced antiretroviral (ARV) regimen choice for preventing mother-to-child transmission of HIV-1, especially in settings where anaemia is common.Methods: Eligible HIV-infected pregnant women in Burkina Faso, Kenya and South Africa were followed from 28 weeks of pregnancy until 12-24 months after delivery (n = 1070). Women with a CD4 count of 200-500cells/mm3 and gestational age 28-36 weeks were randomly assigned to zidovudine-containing triple-ARV prophylaxis continued during breastfeeding up to 6-months, or to zidovudine during pregnancy plus single-dose nevirapine (sd-NVP) at labour. Additionally, two cohorts were established, women with CD4 counts: <200 cells/mm3 initiated antiretroviral therapy, and >500 cells/mm3 received zidovudine during pregnancy plus sd-NVP at labour. Mild (haemoglobin 8.0-10.9 g/dl) and severe anaemia (haemoglobin < 8.0 g/dl) occurrence were assessed across study arms, using Kaplan-Meier and multivariable Cox proportional hazards models.Results: At enrolment (corresponded to a median 32 weeks gestation), median haemoglobin was 10.3 g/dl (IQR = 9.2-11.1). Severe anaemia occurred subsequently in 194 (18.1%) women, mostly in those with low baseline haemoglobin, lowest socio-economic category, advanced HIV disease, prolonged breastfeeding (≥6 months) and shorter ARV exposure. Severe anaemia incidence was similar in the randomized arms (equivalence P-value = 0.32). After 1-2 months of ARV's, severe anaemia was significantly reduced in all groups, though remained highest in the low CD4 cohort.Conclusions: Severe anaemia occurs at a similar rate in women receiving longer triple zidovudine-containing regimens or shorter prophylaxis. Pregnant women with pre-existing anaemia and advanced HIV disease require close monitoring. Trial registration number: ISRCTN71468401.

AB - Background: Although substantiated by little evidence, concerns about zidovudine-related anaemia in pregnancy have influenced antiretroviral (ARV) regimen choice for preventing mother-to-child transmission of HIV-1, especially in settings where anaemia is common.Methods: Eligible HIV-infected pregnant women in Burkina Faso, Kenya and South Africa were followed from 28 weeks of pregnancy until 12-24 months after delivery (n = 1070). Women with a CD4 count of 200-500cells/mm3 and gestational age 28-36 weeks were randomly assigned to zidovudine-containing triple-ARV prophylaxis continued during breastfeeding up to 6-months, or to zidovudine during pregnancy plus single-dose nevirapine (sd-NVP) at labour. Additionally, two cohorts were established, women with CD4 counts: <200 cells/mm3 initiated antiretroviral therapy, and >500 cells/mm3 received zidovudine during pregnancy plus sd-NVP at labour. Mild (haemoglobin 8.0-10.9 g/dl) and severe anaemia (haemoglobin < 8.0 g/dl) occurrence were assessed across study arms, using Kaplan-Meier and multivariable Cox proportional hazards models.Results: At enrolment (corresponded to a median 32 weeks gestation), median haemoglobin was 10.3 g/dl (IQR = 9.2-11.1). Severe anaemia occurred subsequently in 194 (18.1%) women, mostly in those with low baseline haemoglobin, lowest socio-economic category, advanced HIV disease, prolonged breastfeeding (≥6 months) and shorter ARV exposure. Severe anaemia incidence was similar in the randomized arms (equivalence P-value = 0.32). After 1-2 months of ARV's, severe anaemia was significantly reduced in all groups, though remained highest in the low CD4 cohort.Conclusions: Severe anaemia occurs at a similar rate in women receiving longer triple zidovudine-containing regimens or shorter prophylaxis. Pregnant women with pre-existing anaemia and advanced HIV disease require close monitoring. Trial registration number: ISRCTN71468401.

KW - Anaemia

KW - Drug toxicity

KW - HIV

KW - Pregnancy

KW - Sub-Saharan Africa

KW - Zidovudine

UR - http://www.scopus.com/inward/record.url?scp=84887027905&partnerID=8YFLogxK

U2 - 10.1186/1471-2334-13-522

DO - 10.1186/1471-2334-13-522

M3 - Article

C2 - 24192332

AN - SCOPUS:84887027905

SN - 1471-2334

VL - 13

JO - BMC Infectious Diseases

JF - BMC Infectious Diseases

IS - 1

M1 - 522

ER -

Maternal anaemia and duration of zidovudine in antiretroviral regimens for preventing mother-to-child transmission: A randomized trial in three African countries

Abstract

Keywords

UN SDGs

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