Literature DB >> 35090604

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

Dvora L Joseph Davey1, Linda-Gail Bekker2, Elizabeth A Bukusi3, Benjamin H Chi4, Sinead Delany-Moretlwe5, Ameena Goga6, Anne Drapkin Lyerly7, Nyaradzo M Mgodi8, Nelly Mugo9, Landon Myer10, Lisa M Noguchi11, Lynda Stranix-Chibanda12, Catherine Slack13, Jillian Pintye14.   

Abstract

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 non-breastfeeding 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.
Copyright © 2022 Elsevier Ltd. All rights reserved.

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Year:  2022        PMID： 35090604      PMCID： PMC9178651          DOI： 10.1016/S2352-3018(21)00280-0

Source DB:  PubMed          Journal:  Lancet HIV        ISSN： 2352-3018            Impact factor:   16.070


  63 in total

1.  Pharmacokinetics and placental transfer of single-dose tenofovir 1% vaginal gel in term pregnancy.

Authors:  Richard Beigi; Lisa Noguchi; Teresa Parsons; Ingrid Macio; Ratiya P Kunjara Na Ayudhya; Jianmeng Chen; Craig W Hendrix; Benoît Mâsse; Megan Valentine; Jeanna Piper; D Heather Watts
Journal:  J Infect Dis       Date:  2011-09-19       Impact factor: 5.226

2.  Safety, adherence, and HIV-1 seroconversion among women using the dapivirine vaginal ring (DREAM): an open-label, extension study.

Authors:  Annalene Nel; Neliëtte van Niekerk; Ben Van Baelen; Mariëtte Malherbe; Winél Mans; Allison Carter; John Steytler; Elna van der Ryst; Charles Craig; Cheryl Louw; Thando Gwetu; Zonke Mabude; Philip Kotze; Robert Moraba; Hugo Tempelman; Katherine Gill; Sylvia Kusemererwa; Linda-Gail Bekker; Brid Devlin; Zeda Rosenberg
Journal:  Lancet HIV       Date:  2021-02       Impact factor: 12.767

3.  Incident HIV infection in pregnant and lactating women and its effect on mother-to-child transmission in South Africa.

Authors:  Dhayendre Moodley; Tonya Esterhuizen; Logan Reddy; Pravi Moodley; Bipraj Singh; Linda Ngaleka; Devan Govender
Journal:  J Infect Dis       Date:  2011-03-11       Impact factor: 5.226

4.  Pharmacokinetics and safety of single-dose tenofovir disoproxil fumarate and emtricitabine in HIV-1-infected pregnant women and their infants.

Authors:  Patricia M Flynn; Mark Mirochnick; David E Shapiro; Arlene Bardeguez; John Rodman; Brian Robbins; Sharon Huang; Susan A Fiscus; Koen K A Van Rompay; James F Rooney; Brian Kearney; Lynne M Mofenson; D Heather Watts; Patrick Jean-Philippe; Barbara Heckman; Edwin Thorpe; Amanda Cotter; Murli Purswani
Journal:  Antimicrob Agents Chemother       Date:  2011-09-06       Impact factor: 5.191

5.  Neural-Tube Defects and Antiretroviral Treatment Regimens in Botswana.

Authors:  Rebecca Zash; Lewis Holmes; Modiegi Diseko; Denise L Jacobson; Sean Brummel; Gloria Mayondi; Arielle Isaacson; Sonya Davey; Judith Mabuta; Mompati Mmalane; Tendani Gaolathe; M Essex; Shahin Lockman; Joseph Makhema; Roger L Shapiro
Journal:  N Engl J Med       Date:  2019-07-22       Impact factor: 91.245

6.  Pre-exposure prophylaxis uptake and early continuation among pregnant and post-partum women within maternal and child health clinics in Kenya: results from an implementation programme.

Authors:  John Kinuthia; Jillian Pintye; Felix Abuna; Kenneth K Mugwanya; Harison Lagat; Dickens Onyango; Emily Begnel; Julia Dettinger; Jared M Baeten; Grace John-Stewart
Journal:  Lancet HIV       Date:  2019-12-05       Impact factor: 12.767

7.  "I had Made the Decision, and No One was Going to Stop Me" -Facilitators of PrEP Adherence During Pregnancy and Postpartum in Cape Town, South Africa.

Authors:  Dvora L Joseph Davey; Lucia Knight; Jackie Markt-Maloney; Nokwazi Tsawe; Yolanda Gomba; Nyiko Mashele; Kathryn Dovel; Pamina Gorbach; Linda-Gail Bekker; Thomas J Coates; Landon Myer
Journal:  AIDS Behav       Date:  2021-06-03

8.  Use of the dapivirine vaginal ring and effect on cervical cytology abnormalities.

Authors:  Krishnaveni Reddy; Cliff Kelly; Elizabeth R Brown; Nitesha Jeenarain; Logashvari Naidoo; Samantha Siva; Linda-Gail Bekker; Gonasagrie Nair; Bonus Makanani; Lameck Chinula; Nyaradzo Mgodi; Zvavahera Chirenje; Flavia Matovu Kiweewa; Jeanne Marrazzo; Katherine Bunge; Lydia Soto-Torres; Jeanna Piper; Jared M Baeten; Thesla Palanee-Phillips
Journal:  AIDS       Date:  2020-03-15       Impact factor: 4.632

9.  Women's views about contraception requirements for biomedical research participation.

Authors:  Kristen A Sullivan; Margaret Olivia Little; Nora E Rosenberg; Chifundo Zimba; Elana Jaffe; Sappho Gilbert; Jenell S Coleman; Irving Hoffman; Tiwonge Mtande; Jean Anderson; Marielle S Gross; Lisa Rahangdale; Ruth Faden; Anne Drapkin Lyerly
Journal:  PLoS One       Date:  2019-05-08       Impact factor: 3.240

10.  How the CIOMS guidelines contribute to fair inclusion of pregnant women in research.

Authors:  Rieke van der Graaf; Indira S E van der Zande; Johannes J M van Delden
Journal:  Bioethics       Date:  2018-10-20       Impact factor: 1.898
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  1 in total

1.  The importance of assessing and addressing mental health barriers to PrEP use during pregnancy and postpartum in sub-Saharan Africa: state of the science and research priorities.

Authors:  Amelia M Stanton; Conall O'Cleirigh; Lucia Knight; Dvora L Joseph Davey; Landon Myer; John A Joska; Kenneth H Mayer; Linda-Gail Bekker; Christina Psaros
Journal:  J Int AIDS Soc       Date:  2022-10       Impact factor: 6.707
  1 in total

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