Taken from the May/June 2013 issue of the Women's Health Activist Newsletter.
Truvada is a combination of two anti-retroviral drugs already used for HIV treatment (tenofovir and emtricitibine); the new approved use is based on research showing that, taken daily before exposure to HIV, the combination offers protection against infection. This is called “pre-exposure prophylaxis,” or (PrEP).
For those of you who aren’t public health nerds, “pre-exposure prophylaxis” describes a medical treatment used before exposure to an infectious agent in order to prevent infection. With the FDA approval, HIV-negative people can take Truvada on a daily basis to reduce the risk that they will become infected.
The National Women’s Health Network (NWHN) is delighted by PrEP’s approval, which is a major milestone in the fight to end AIDS. But, at the same time, we know there are important questions to be answered about the use of PrEP by U.S. women.
Unanswered Questions Remain
The well-conducted clinical trials clearly demonstrated that people who took Truvada every day reduced their risk of contracting HIV by as much as 99 percent. But, the trials also revealed important variations in Truvada’s effectiveness for women that appear to correlate with age and relationship status — older women and those in established relationships were most successful in preventing HIV infection. The rate of effectiveness remained unchanged or was lower among younger women who were less likely to be in stable and/or exclusive relationships.
These results raise questions about Truvada’s effectiveness for women who are not in stable relationships and/or have multiple sex partners; who do not know their partners’ HIV status; do not perceive themselves to be at high risk for HIV infection; or lack the ability to use the drug every day. While the clinical science clearly supports Truvada’s effectiveness, many social, cultural, and behavioral factors may impact a woman’s ability to use it effectively and have yet to be explored and understood. And, because no women from the United States were included in the trials, we also lack information about how best to promote PrEP use in the United States, and how to support use by those who want it.
It is particularly important for African American women, whose risk of HIV infection is disproportionately high, that we get answers to these questions. As Dazon Dixon Diallo, Executive Director of SisterLove and NWHN Board member, notes, “In some communities African American women are at as much risk of HIV as in many African communities, and they need new HIV prevention options that they can control and use to protect themselves.”
A Call for a Coordinated Research Program
After Truvada’s approval, Diallo convened the U.S. Women and PrEP Working Group, a coalition of 38 leading AIDS and women’s health organizations (including the NWHN), to build common understanding of what this new HIV prevention tool could mean for women in the United States. In March 2013, the Working Group released a statement that identified overarching questions and key areas where research is needed about PrEP’s use by women in the United States. (See box for the research questions.)
The overarching questions are:
- How will daily PrEP be used for HIV prevention by women in the United States?
- What data are needed regarding daily PrEP’s acceptability and effectiveness among those women?
- How will daily PrEP be promoted, made accessible, and financed for use by U.S. women?
These questions describe the information women need about PrEP to understand Truvada’s implications for our health. They also highlight the need for social and behavioral research to better understand how PrEP might affect the use of other HIV risk-reduction tools, like male and female condoms. For example, the Working Group statement notes that awareness about PrEP might lead male partners to insist on sex without a condom, which could increase their partner’s risk of HIV/AIDS.
The key questions also address the need to explore possible interactions between Truvada and hormones used by some transgender women, as well as the drugs’ long-term health effects on pregnant women and their children. In addition, two studies showed small but statistically significant reductions in bone mineral density in those taking Truvada, which require further evaluation.
Almost a year after Truvada’s approval, there’s still much we don’t know about how women will use it, the information they are getting about PrEP, and what specific groups will benefit most from its use. Diallo noted, “We now need to develop and fund demonstration projects that will help answer a range of questions about real-world use of PrEP by American women and move toward an integrated plan for PrEP rollout in our communities that includes support for health care providers, social workers, and others who will help women use PrEP effectively.”
To address these issues, the Working Group urged the Office of National AIDS Policy, the Centers for Disease Control and Prevention, and the National Institutes of Health to collaborate and develop a plan to maximize women’s benefits from this important AIDS prevention tool. The Working Group specifically called for the creation of a Federal Coordinating Group that can address questions about PrEP by developing and funding pilot programs, demonstration projects, and qualitative research. The entity should also be tasked with ensuring collaboration between Federal research agencies, city and state health departments, drug companies, health care providers, social service agencies, and the public.
A Proper Introduction for PrEP
In addition, the Working Group recommended that the Federal Coordinating Group create a national education and social marketing plan to introduce PrEP into the United States market and help people make informed decisions about whether PrEP is right for them. This campaign must include information in a variety of languages, literacy levels, formats, and media in order to reach all women at-risk for HIV infection. And, the campaign must include real community involvement so information can be delivered by trusted sources.
The NWHN and our allies in the U.S. Women and PrEP Working Group strongly believe that PrEP has the potential to be a powerful HIV/AIDS prevention tool for some women. For this potential to be realized, however, we must answer key questions about the method; share information and education about PrEP and other forms of HIV prevention; and ensure the full participation and leadership of the individuals and communities most affected by the epidemic.
Read the Working Group’s statement and learn more about Truvada and HIV prevention at:http://www.prepwatch.org/#women.
Allyson Reddy is an intern in the NWHN’s Leadership Development Program.
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