Maternal health outcomes among HIV-infected breastfeeding women with high CD4 counts: results of a treatment strategy trial

被引：11

作者：

Hoffman, Risa M. ^{[1
]}

Angelidou, Konstantia Nadia ^{[2
]}

Brummel, Sean S. ^{[2
]}

Saidi, Friday ^{[3
]}

Violari, Avy ^{[4
]}

Dula, Dingase ^{[5
]}

Mave, Vidya ^{[6
,7
]}

Fairlie, Lee ^{[8
]}

Theron, Gerhard ^{[9
]}

Kamateeka, Moreen ^{[10
]}

Chipato, Tsungai ^{[11
]}

Chi, Benjamin H. ^{[12
]}

Stranix-Chibanda, Lynda ^{[13
,35
]}

Nematadziraw, Leader ^{[14
]}

Moodley, Dhayendre ^{[15
,16
]}

Bhattacharya, Debika ^{[1
]}

Gupta, Amita ^{[6
,7
]}

Coletti, Anne ^{[17
]}

McIntyre, James A. ^{[18
,19
]}

Klingman, Karin L. ^{[20
]}

Chakhtoura, Nahida ^{[21
]}

Shapiro, David E. ^{[2
]}

Fowler, Mary Glenn ^{[22
]}

Currier, Judith S. ^{[1
]}

Mmbaga, Blandina T. ^{[23
]}

Mlay, Pendo ^{[23
]}

Njau, Boniface ^{[23
]}

Masenya, Masebole ^{[24
]}

Grab, Janet ^{[24
]}

Abrahams, Nasreen ^{[25
]}

Nyati, Mandisa ^{[25
]}

Dittmer, Sylvia ^{[25
]}

Rossouw, Magdel E. ^{[26
]}

Rossouw, Lindie ^{[26
]}

Martinson, Francis ^{[27
]}

Makina, Ezylia ^{[27
]}

Milala, Beteniko ^{[27
]}

Bobat, Raziya ^{[28
]}

Skosana, Nozibusiso Rejoice ^{[28
]}

Mawlana, Sajeeda ^{[28
]}

Mwalukanga, Martin ^{[29
]}

Mbewe, Felistus ^{[30
]}

Mubiana-Mbewe, Mwangelwa ^{[30
]}

Owor, Maxie ^{[31
]}

Sebikari, Dorothy ^{[31
]}

Atuhaire, Patience ^{[31
]}

Moodley, Daya ^{[32
]}

Chetty, Vani ^{[32
]}

Naidoo, Megeshinee ^{[32
]}

Desmond, Alicia Catherine ^{[32
]}

机构：

[1] Univ Calif Los Angeles, David Geffen Sch Med, Dept Med, Div Infect Dis, 10833 Le Conte Ave,37-121 CHS, Los Angeles, CA 90095 USA

[2] Harvard TH Chan Sch Publ Hlth, Ctr Biostat AIDS Res, Boston, MA USA

[3] Univ North Carolina Project Malawi, Lilongwe, Malawi

[4] Chris Hani Baragwanath Hosp, Perinatal HIV Res Unit, Soweto, South Africa

[5] Malawi Coll Med, Johns Hopkins Project, Chichiri, Malawi

[6] BJGMC Clin Trials Unit, Pune, Maharashtra, India

[7] Johns Hopkins Sch Med, Div Infect Dis, Baltimore, MD USA

[8] Wits Reprod Hlth & HIV Inst, Johannesburg, South Africa

[9] Stellenbosch Univ, Cape Town, South Africa

[10] Makerere Univ, Johns Hopkins Univ Res Collaborat, Mulago Kampala, Uganda

[11] Univ Zimbabwe, Dept Obstet & Gynecol, Harare, Zimbabwe

[12] Univ N Carolina, Sch Med, Dept Obstet & Gynecol, Chapel Hill, NC USA

[13] Univ Zimbabwe, Harare, Zimbabwe

[14] Univ Zimbabwe, Coll Hlth Sci, Clin Trials Res Ctr, Harare, Zimbabwe

[15] Univ KwaZulu Natal, Ctr AIDS Programme Res South Africa, Durban, South Africa

[16] Univ KwaZulu Natal, Sch Clin Med, Durban, South Africa

[17] Family Hlth Int 36o, Durham, NC USA

[18] Anova Hlth Inst, Johannesburg, South Africa

[19] Univ Cape Town, Sch Publ Hlth & Family Med, Cape Town, South Africa

[20] NIAID, Div Aids, NIH, Bethesda, MD 20892 USA

[21] Eunice Kennedy Shriver Natl Inst Child Hlth & Hum, NIH, Bethesda, MD USA

[22] Johns Hopkins Univ, Sch Med, Dept Pathol, Baltimore, MD 21205 USA

[23] Kilimanjaro Christian Med Ctr, Moshi, Tanzania

[24] Wits RHI Shandukani Res Ctr CRS, Johannesburg, South Africa

[25] Soweto IMPAACT CRS, Johannesburg, South Africa

[26] FAM CRU CRS, Tygerberg, Western Cape, South Africa

[27] Malawi CRS, Lilongwe, Malawi

[28] Durban Paediat HIV CRS, Durban, South Africa

[29] George CRS, Clin Med, Cape Town, Western Cape Pr, South Africa

[30] George CRS, Cape Town, Western Cape Pr, South Africa

[31] MU JHU Res Collaborat MUJHU CARE LTD, Kampala, Uganda

[32] Umlazi CRS, Durban, Kwazulu Natal, South Africa

[33] Blantyre CRS, Blantyre, Malawi

[34] St Marys CRS, Johannesburg, South Africa

[35] Seke North CRS, Chitungwiza, Zimbabwe

[36] Byramjee Jeejeebhoy Med Coll BJMC CRS, Pune, Maharashtra, India

[37] Harare Family Care CRS, Harare, Zimbabwe

来源：

HIV CLINICAL TRIALS | 2018年 / 19卷 / 06期

基金：

美国国家卫生研究院;

关键词：

HIV/AIDS; antiretroviral therapy (ART); postpartum maternal health; HIV and breastfeeding; ISONIAZID PREVENTIVE THERAPY; DISEASE PROGRESSION; ANTIRETROVIRAL THERAPY; POSTPARTUM WOMEN; MORTALITY; TUBERCULOSIS; MANAGEMENT; PREGNANCY;

D O I：

10.1080/15284336.2018.1537327

中图分类号：

R51 [传染病];

学科分类号：

100401 ;

摘要：

Background: IMPAACT PROMISE 1077BF/FF was a randomized study of antiretroviral therapy (ART) strategies for pregnant and postpartum women with high CD4+ T-cell counts. We describe postpartum outcomes for women in the study who were randomized to continue or discontinue ART after delivery. Methods: Women with pre-ART CD4+ cell counts >= 350 cells/mm(3) who started ART during pregnancy were randomized postpartum to continue or discontinue treatment. Women were enrolled from India, Malawi, South Africa, Tanzania, Uganda, Zambia, and Zimbabwe. The primary outcome was a composite of progression to AIDS-defining illness or death. Log-rank tests and Cox regression models assessed treatment effects. Incidence rates were calculated per 100 person-years. A post hoc analysis evaluated WHO Stage 2/3 events. All analyses were intent-to-treat. Findings: 1611 women were enrolled (June 2011-October 2014) and 95% were breastfeeding. Median age at entry was 27 years, CD4+ count 728 cells/mm(3) and the majority of women were Black African (97%). After a median follow-up of 1.6 years, progression to AIDS-defining illness or death was rare and there was no significant difference between arms (HR: 0 center dot 55; 95%CI 0 center dot 14, 2 center dot 08, p = 0.37). WHO Stage 2/3 events were reduced with continued ART (HR: 0 center dot 60; 95%CI 0 center dot 39, 0 center dot 90, p = 0.01). The arms did not differ with respect to the rate of grade 2, 3, or 4 safety events (p = 0.61). Interpretation: Serious clinical events were rare among predominately breastfeeding women with high CD4+ cell counts over 18 months after delivery. ART had significant benefit in reducing WHO 2/3 events in this population.

引用

页码：209 / 224

页数：16

共 28 条

[1] The contribution of HIV to pregnancy-related mortality: a systematic review and meta-analysis [J].

Calvert, Clara ;

Ronsmans, Carine .

AIDS, 2013, 27 (10) :1631-1639

[2] Consideration of Postpartum Management in HIV-Positive Haitian Women: An Analysis of CD4 Decline, Mortality, and Follow-Up After Delivery [J].

Coria, Alexandra ;

Noel, Francine ;

Bonhomme, Jerry ;

Rouzier, Vanessa ;

Perodin, Christian ;

Marcelin, Adias ;

Li, Zhongze ;

Tosteson, Tor D. ;

Deschamps, Marie-Marcelle ;

Wright, Peter F. ;

Pape, Jean W. .

JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES, 2012, 61 (05) :636-643

[3] Randomized trial of stopping or continuing ART among postpartum women with pre-ART CD4 ≥ 400 cells/mm3 [J].

Currier, Judith S. ;

Britto, Paula ;

Hoffman, Risa M. ;

Brummel, Sean ;

Masheto, Gaerolwe ;

Joao, Esau ;

Santos, Breno ;

Aurpibul, Linda ;

Losso, Marcelo ;

Pierre, Marie F. ;

Weinberg, Adriana ;

Gnanashanmugam, Devasena ;

Chakhtoura, Nahida ;

Klingman, Karin ;

Browning, Renee ;

Coletti, Anne ;

Mofenson, Lynne ;

Shapiro, David ;

Pilotto, Jose .

PLOS ONE, 2017, 12 (05)

[4] Mortality among HIV-1-infected women according to children's feeding modality -: An individual patient data meta-analysis [J].

Dabis, F ;

Leroy, V ;

Newell, ML ;

Read, JS ;

Coutsoudis, A ;

Dabis, F ;

Fawzi, W ;

Gaillard, P ;

Haverkamp, G ;

Harris, RD ;

Jackson, JB ;

Meda, N ;

Msellati, P ;

Nduati, R ;

Wiktor, S ;

Keast, S ;

Li, S ;

Mitchell, R ;

Muenz, L ;

Owen, D ;

Rukblya, A ;

Coutsoudis, A ;

Pillay, K ;

Spooner, E ;

Kuhn, L ;

Coovadia, H ;

Sinclair, G ;

Mburu, A ;

Mngqundaniso, N ;

Uebel, K ;

Coetzee, I ;

Annamalai, K ;

Doorasamy, T ;

Govender, U ;

Willumsen, J ;

Rollins, N ;

Moodley, J ;

Moodley, D ;

Gaillard, P ;

Mwanyumba, F ;

Verhofstede, C ;

Temmerman, M ;

Guay, L ;

Musoke, P ;

Fleming, T ;

Bagenda, D ;

Allen, M ;

Nakabiito, C ;

Sherman, J ;

Bakaki, P .

JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES, 2005, 39 (04) :430-438

[5] A Trial of Early Antiretrovirals and Isoniazid Preventive Therapy in Africa [J].

Danel, Christine ;

Moh, Raoul ;

Gabillard, Delphine ;

Badje, Anani ;

Le Carrou, Jerome ;

Ouassa, Timothee ;

Ouattara, Eric ;

Anzian, Amani ;

Ntakpe, Jean-Baptiste ;

Minga, Albert ;

Kouame, Gerard M. ;

Bouhoussou, Franck ;

Emieme, Arlette ;

Kouame, Antoine ;

Inwoley, Andre ;

Toni, Thomas-d'Aquin ;

Ahiboh, Hugues ;

Kabran, Mathieu ;

Rabe, Cyprien ;

Sidibe, Baba ;

Nzunetu, Gustave ;

Konan, Romuald ;

Gnokoro, Joachim ;

Gouesse, Patrice ;

Messou, Eugene ;

Dohoun, Lambert ;

Kamagate, Synali ;

Yao, Abo ;

Amon, Solange ;

Kouame, Amadou-Barenson ;

Koua, Aboli ;

Kouame, Emmanuel ;

Ndri, Yao ;

Ba-Gomis, Olivier ;

Daligou, Marcelle ;

Ackoundze, Simplice ;

Hawerlander, Denise ;

Ani, Alex ;

Dembele, Fassery ;

Guehi, Calixte ;

Kanga, Constance ;

Seri, Jonas ;

Oyebi, Mykayila ;

Mbakop, Nathalie ;

Makaila, Olewole ;

Babatunde, Carole ;

Babatounde, Nathanael ;

Bleoue, Gisele ;

Tchoutedjem, Mireille ;

Kouadio, Alain-Claude .

NEW ENGLAND JOURNAL OF MEDICINE, 2015, 373 (09) :808-822

[6] Maternal HIV-1 Disease Progression 18-24 Months Postdelivery According to Antiretroviral Prophylaxis Regimen (Triple-Antiretroviral Prophylaxis During Pregnancy and Breastfeeding vs Zidovudine/Single-Dose Nevirapine Prophylaxis): The Kesho Bora Randomized Controlled Trial [J].

Fao, Paulin ;

Ky-Zerbo, Odette ;

Gouem, Clarisse ;

Somda, Paulin ;

Hien, Herve ;

Ouedraogo, Patrice Elysee ;

Kania, Dramane ;

Sanou, Armande ;

Kossiwavi, Ida Ayassou ;

Sanogo, Bintou ;

Ouedraogo, Moussa ;

Siribie, Issa ;

Valea, Diane ;

Ouedraogo, Sayouba ;

Some, Roseline ;

Rouet, Francois ;

Rollins, Nigel ;

McFetridge, Lynne ;

Naidu, Kevi ;

Luchters, Stanley ;

Reyners, Marcel ;

Irungu, Eunice ;

Katingima, Christine ;

Mwaura, Mary ;

Ouattara, Gina ;

Mandaliya, Kishor ;

Wambua, Sammy ;

Thiongo, Mary ;

Nduati, Ruth ;

Kose, Judith ;

Njagi, Ephantus ;

Mwaura, Peter ;

Newell, Marie-Louise ;

Mepham, Stephen ;

Viljoen, Johannes ;

Bland, Ruth ;

Mthethwa, Londiwe ;

Bazin, Brigitte ;

Rekacewicz, Claire ;

Taylor, Allan ;

Flowers, Nicole ;

Thigpen, Michael ;

Fowler, Mary Glenn ;

Jamieson, Denise ;

Mofenson, Lynne M. ;

Read, Jennifer S. ;

Bork, Kirsten ;

Cames, Cecile ;

Cournil, Amandine .

CLINICAL INFECTIOUS DISEASES, 2012, 55 (03) :449-460

[7] Benefits and Risks of Antiretroviral Therapy for Perinatal HIV Prevention [J].

Fowler, M. G. ;

Qin, M. ;

Fiscus, S. A. ;

Currier, J. S. ;

Flynn, P. M. ;

Chipato, T. ;

McIntyre, J. ;

Gnanashanmugam, D. ;

Siberry, G. K. ;

Coletti, A. S. ;

Taha, T. E. ;

Klingman, K. L. ;

Martinson, F. E. ;

Owor, M. ;

Violari, A. ;

Moodley, D. ;

Theron, G. B. ;

Bhosale, R. ;

Bobat, R. ;

Chi, B. H. ;

Strehlau, R. ;

Mlay, P. ;

Loftis, A. J. ;

Browning, R. ;

Fenton, T. ;

Purdue, L. ;

Basar, M. ;

Shapiro, D. E. ;

Mofenson, L. M. .

NEW ENGLAND JOURNAL OF MEDICINE, 2016, 375 (18) :1726-1737

[8]

Gupta A, C RETR OPP INF MARCH

[9] Tuberculosis Incidence Rates during 8 Years of Follow-Up of an Antiretroviral Treatment Cohort in South Africa: Comparison with Rates in the Community [J].

Gupta, Ankur ;

Wood, Robin ;

Kaplan, Richard ;

Bekker, Linda-Gail ;

Lawn, Stephen D. .

PLOS ONE, 2012, 7 (03)

[10]

Holtz Sara A, 2015, Int J MCH AIDS, V4, P11

← 1 2 3 →