Where are the pregnant and breastfeeding women in new pre-exposure prophylaxis trials? The imperative to overcome the evidence gap

被引：20

作者：

Davey, Dvora L. Joseph ^{[1
,2
,3
]}

Bekker, Linda-Gail ^{[3
]}

Bukusi, Elizabeth A. ^{[5
,6
]}

Chi, Benjamin H. ^{[8
]}

Delany-Moretlwe, Sinead ^{[11
]}

Goga, Ameena ^{[12
,13
]}

Lyerly, Anne Drapkin ^{[9
,10
]}

Mgodi, Nyaradzo M. ^{[14
]}

Mugo, Nelly ^{[4
,7
]}

Myer, Landon ^{[2
]}

Noguchi, Lisa M. ^{[17
]}

Stranix-Chibanda, Lynda ^{[14
,15
]}

Slack, Catherine ^{[16
]}

Pintye, Jillian ^{[7
]}

机构：

[1] Univ Calif Los Angeles, Fielding Sch Publ Hlth, Dept Epidemiol, Los Angeles, CA 90095 USA

[2] Univ Cape Town, Sch Publ Hlth & Family Med, Div Epidemiol & Biostat, Cape Town, South Africa

[3] Univ Cape Town, Desmond Tutu HIV Ctr, Cape Town, South Africa

[4] Kenya Govt Med Res Ctr, Ctr Clin Res, Nairobi, Kenya

[5] Kenya Govt Med Res Ctr, Ctr Microbiol Reseacrh, Nairobi, Kenya

[6] Univ Washington, Dept Obstet & Gynecol, Seattle, WA 98195 USA

[7] Univ Washington, Dept Global Hlth, Seattle, WA 98195 USA

[8] Univ N Carolina, Dept Obstet & Gynecol, Chapel Hill, NC 27515 USA

[9] Univ N Carolina, Dept Social Med, Chapel Hill, NC 27515 USA

[10] Univ N Carolina, Ctr Bioeth, Chapel Hill, NC 27515 USA

[11] Univ Witwatersrand, Wits RHI, Johannesburg, South Africa

[12] South African Medial Res Council, Cape Town, South Africa

[13] Univ Pretoria, Dept Paediat & Child Hlth, Pretoria, South Africa

[14] Univ Zimbabwe, Clin Trials Res Ctr, Harare, Zimbabwe

[15] Univ Zimbabwe, Fac Med & Hlth Sci, Child & Adolescent Hlth Unit, Harare, Zimbabwe

[16] Univ KwaZulu Natal, Sch Appl Human Sci, Pietermaritzburg, South Africa

[17] Ohns Hopkins Univ, Jhpiego, Baltimore, MO USA

来源：

LANCET HIV | 2022年 / 9卷 / 03期

关键词：

TENOFOVIR DISOPROXIL FUMARATE; DAPIVIRINE VAGINAL RING; HIV PREVENTION; OPEN-LABEL; ANTIRETROVIRAL THERAPY; POSTPARTUM WOMEN; UNDUE INDUCEMENT; YOUNG-WOMEN; SAFETY; PREP;

D O I：

10.1016/S2352-3018(21)00280-0

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

Pregnant and breastfeeding populations are at substantial risk of acquiring HIV in some settings, yet are underrepresented in clinical trials of new pre-exposure prophylaxis (PrEP) agents. Several PrEP formulations are in development (eg, vaginal rings, long-acting injectables, and other modalities). Pregnant and breastfeeding populations are typically excluded from initial clinical trials. We identified 14 PrEP trials of novel agents in non-pregnant or nonbreastfeeding populations, and six phase 1-3 trials and open label extensions among pregnant and breastfeeding populations, that are currently ongoing or complete. A framework shift is needed to consider the ethical costs of excluding pregnant and breastfeeding populations at risk for HIV in PrEP clinical trials and promote inclusion to maximise the benefits from PrEP tools in the pipeline. Research on new PrEP agents should include pregnant and breastfeeding populations to avoid delays in reaching those who could benefit from PrEP after efficacy is established.

引用

页码：E214 / E222

页数：9

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