The DELIVER and B-PROTECTED Studies: Preventing HIV in Pregnant and Breastfeeding Women

In a nutshell

  • Globally, more than half of all people living with HIV are women, and in sub-Saharan Africa, women are especially at high risk. While the development of safe and effective prevention methods for women has long been a priority, much less attention has been paid to women’s HIV prevention needs during periods of pregnancy or breastfeeding, when women are at greatest risk.
  • It is estimated that women are 2-3 times more likely acquire HIV during pregnancy and 4 times more likely during periods of breastfeeding. For many women, the amount of time spent pregnant, breastfeeding, or both, represents a significant portion of their reproductive years when they are at heightened risk. Because HIV can infect babies during pregnancy, childbirth or breastfeeding, protecting moms means protecting their babies, too.
  • Daily use of an antiretroviral (ARV) tablet called Truvada®, an approach often referred to as PrEP (short for pre-exposure prophylaxis) is now approved in many countries, but information about its safety in pregnant and breastfeeding women is limited. A monthly vaginal ring containing the ARV dapivirine is a new product under regulatory review – much less is known about its safety in these populations.
  • Knowing whether daily PrEP and the monthly dapivirine ring are safe during pregnancy and breastfeeding is vitally important. The Microbicide Trials Network (MTN) is planning two studies, DELIVER (MTN-042), for pregnant women, and B-PROTECTED (MTN-043), for women who are breastfeeding, so that regulatory authorities and national programs have the kind of information they need to consider making these HIV prevention methods available to pregnant and breastfeeding women.
  • The DELIVER and B-PROTECTED studies are funded by the US National Institutes of Health and will be conducted at trial sites in Malawi, Uganda, South Africa and Zimbabwe. Pending in-country ethics and regulatory approvals both studies could begin by the end of 2019.

 

Two Studies: Protecting Pregnant and Breastfeeding Women Against HIV

DELIVER and B-PROTECTED are called Phase IIIb open-label studies. Phase IIIb studies are conducted after a product has already been shown to be safe and effective in Phase III trials. In Phase III trials, participants are randomly assigned to use either the active product or a placebo, which looks the same but contains no drug. There is no placebo in a Phase IIIb study. This means that all women in the DELIVER and B-PROTECTED studies will use an active product – either oral PrEP or the dapivirine ring.

 

Both studies are designed to learn about the safety of PrEP and the dapivirine vaginal ring in the safest, most efficient way possible.DELIVER Logo

Why oral PrEP and the dapivirine ring?

 

Pregnant and Breastfeeding Women: A History of Being Left Behind in Clinical Research

Pregnant and breastfeeding women are typically excluded from participating in clinical trials, especially from trials of new medicine. Though women of reproductive age may enroll, they often must use contraception throughout participation, and if they become pregnant, must stop using the study product immediately. Such measures are intended to protect the fetus and baby from potential harm, but they also make certain that a drug’s safety cannot be determined in this population. As a result, a drug that receives regulatory approval will be contraindicated (not recommended) in women during pregnancy and lactation. Drugs are often used during pregnancy and breastfeeding anyway – without knowing if the drug will be safe or effective.

 

Pregnancy PictureThe body undergoes many changes during pregnancy that could affect how the drug gets absorbed and distributed; they may work differently or not be as effective as they were in a clinical trial with non-pregnant women or women not breastfeeding. Of great concern is that drug could pass to the placenta and cause harm to the developing fetus – the very reason for excluding pregnant women from participating in research in the first place; or that the drug that passes into breastmilk could affect the health of a baby.

 

As such, most of what has been learned about the safety of a drug during pregnancy and breastfeeding emerges after a drug is approved, through post-marketing surveillance registries that keep track of pregnancy complications and adverse outcomes. Studies of a drug specifically involving pregnant women, if conducted at all, may be years after its approval.

 

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For more information about the dapivirine ring go to www.ipmglobal.org.

For more information about the MTN and the DELIVER and B-PROTECTED studies involving pregnancy and breastfeeding women can be found at www.mtnstopshiv.org.

 

Click here for PDF version of this document.

 

21-March-2019


Source URL: https://mtnstopshiv.org/news/deliver-and-b-protected-studies-preventing-hiv-pregnant-and-breastfeeding-women