PrEP for Women
August 21, 2018
Table of Contents:
- What Is PrEP?
- How Does PrEP Prevent the Spread of HIV?
- Approval for Daily Oral PrEP
- Has PrEP Been Shown to Be Effective?
- Why Are Some Research Findings Unclear?
- CDC and WHO Guidelines for PrEP Use
- The PrEP Debate
- What Does PrEP Mean for Women?
- Considering Taking Truvada as PrEP?
- New Developments in the PrEP Arena
PrEP stands for Pre-Exposure Prophylaxis. It means taking medicine before being exposed to something to prevent yourself from getting a disease or condition. We use several kinds of medicine this way.
One example is taking anti-malaria medication when we travel to areas where we might be bitten by mosquitoes that carry malaria. When the medicine is in a person's body before getting a mosquito bite, that person is much less likely to get malaria when she or he is bitten.
For women, another example is taking birth control pills (contraceptives). When contraceptives are already in a woman's body when she is exposed to semen during sex, she is mch less likely to get pregnant.
PrEP here means that HIV-negative women take an HIV rdug to reduce their risk of acquiring HIV if they are exposed to the virus. Some people use the term 'topical PrEP' to describe the use of microbicide gels (e.g., vaginal gels containing HIV drugs). However, in this article we are referring only to 'oral PrEP,' or HIV drugs taken by mouth to prevent getting HIV.
Women, PrEP, & Sexual Health (Project Inform & HIVE)
Here is how PrEP works:
- When CD4 cells are infected with HIV, they become little factories that make thousands of new viruses each day
- HIV drugs work by blocking HIV from making copies of itself
- If an HIV-negative woman already has HIV drugs in her bloodstream when she is exposed to HIV, for example during sex without a condom, the medicine can keep the virus from making enough copies of itself to "take hold" and prevent her from getting HIV
In July 2012, the US Food and Drug Administration (FDA) approved the daily use of Truvada (tenofovir disoproxil fumarate plus emtricitabine, or TDF/FTC) as PrEP for sexually active adults at risk of getting HIV. Truvada is often used as part of combination drug treatment for HIV. This is the first time the FDA has approved any medication for the prevention of HIV.
The World Health Organization (WHO) released updated guidelines in June 2016 that expand earlier recommendations. It now recommends that daily oral PrEP be offered as an additional prevention method to all people at substantial risk of getting HIV. The WHO has approved the use of either Viread (tenofovir disoproxil fumarate) or Truvada for this purpose. However, each country must individually approve the use of Truvada or Viread as PrEP and determine how it will provide the drug.
Several recent clinical trials have shown that taking Truvada as oral PrEP (one pill by mouth daily) can help prevent acquisition of HIV. These studies were conducted among men who have sex with men (MSM) and transgender women (women who were assigned male at birth) in the US and Latin America, and among heterosexual women and men in several African countries. In three studies, Truvada provided between 44 and 73 percent additional protection against getting HIV. However, two other studies in southern Africa did not find either oral or topical PrEP to be effective in preventing HIV transmission to women.
Using PrEP as a "bridge" until the partner living with HIV in a serodifferent (serodiscordant) heterosexual couple has an undetectable viral load proved highly effective in another African study. As of February 2015, this strategy had reduced the risk of acquiring HIV by 96%. Recent research has shown that people living with HIV whose viral load is undetectable (cannot be detected by standard tests) do not transmit the virus to their sexual partners.
Current clinical trials of PrEP among women are focusing on topical PrEP in the form of vaginal rings or a gel.
For any drug or other HIV prevention tool to work, it must be used -- and used correctly and consistently. This is true for condoms and is proving true for PrEP as well. In the studies mentioned above, the key to PrEP's success was adherence, which means taking the drug when and how it is prescribed. In all studies, people who took the drug daily as prescribed were significantly less likely to acquire HIV when exposed to the virus during sex or injection drug use.
We do not yet fully understand the reasons why people -- especially women -- do not take oral PrEP consistently as prescribed. This makes more research into issues that might affect women's interest in or ability to take a drug for HIV prevention very important. To answer these questions, women need to take part in future studies about PrEP. For more information about understanding, finding, and participating in research studies, see our fact sheet on clinical trials.
The 2014 guidelines from the US Centers for Disease Control and Prevention (CDC) on the use of PrEP in the US recommend that daily oral Truvada be considered for HIV-negative people who are at substantial risk for HIV. This includes people who:
- are in a sexual relationship with a partner living with HIV
- do not regularly use condoms and who do not know the HIV status of their sexual partner(s)
- have a high number of sexual partners
- are engaged in commercial sex work
- have had a recent bacterial sexually transmitted disease
- use injections drugs and (1) share drug equipment, or (2) were recently in a drug treatment program
There are also some reasons that PrEP is NOT recommended. These include having:
- unknown HIV status; it is important that only people who test negative for HIV take PrEP
- signs or symptoms of acute HIV infection
- decreased kidney function
- unknown hepatitis B status and/or vaccination status
The guidelines also suggest that providers consider PrEP for people who live in areas or have personal networks where HIV is more common (high-prevalence areas). The guidelines provide tools to help providers identify these areas. The CDC also published a clinical providers' supplement, which includes a patient/provider checklist, counseling about using PrEP while trying to become pregnant and during pregnancy, counseling about adherence and HIV risk reduction, and information sheets for patients in English and Spanish.
PrEP needs to be taken daily as prescribed to be as effective as possible. The CDC recommends using it in combination with other HIV prevention strategies, such as condoms or safer injecting practices. PrEP is not intended to be used alone to prevent the transmission of HIV.
It is also important that people have a negative HIV test before starting PrEP. The CDC recommends that people be tested every three months to make sure they remain HIV-negative while taking PrEP.
Lastly, it recommends that HIV-negative women who are pregnant or who are trying to become pregnant talk with their health care providers about the risks and benefits of taking Truvada for PrEP. In 2014, the US Public Health Service released clinical practice guidelines suggesting that health care providers now discuss PrEP as one of several options for protecting HIV-negative partners in serodifferent couples who want to get pregnant. Both drugs for PrEP have been taken by women living with HIV for many years and appear to be safe during early pregnancy.
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