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PrEP for women – Position paper
What is PrEP?
HIV pre-exposure prophylaxis, or PrEP, is the newest prevention strategy to reduce HIV transmission
in people who are at high risk of acquiring HIV. PrEP in its current form, is the daily use of Truvada
Truvada contains two antiviral drugs that are often used to treat people living with HIV. When
taken daily, PrEP has proven to be highly effective for preventing HIV.1
The evidence
There have been six trials that have evaluated the efficacy of PrEP in women. In a WHO metaanalysis of these six trials, PrEP reduced HIV transmission in women by 43%. This meta-analysis
included two trials, the Fem-PrEP study2 and the VOICE (Vaginal and Oral Interventions to Control
the Epidemic) trial3, where adherence among women may have been too low to detect any
protective effect of Truvada. In the Partner’s PrEP study, PrEP reduced HIV transmission in women
by up to 75%4. However for those women in Partner’s PrEP who had detectable Truvada levels in
their plasma, their risk of acquiring HIV infection was reduced by 90%4
Recent findings suggest women need to take daily doses of Truvada to prevent HIV infection from
vaginal exposure while men need a minimum of four doses per week to achieve the same level of
protection5. For women practising anal sex, it is assumed that they too will need a minimal of four
doses weekly to protect against HIV. It’s possible that daily adherence may prove challenging for a
variety of behavioural, psychosocial, cultural and structural factors, and women face specific
challenges inherent to their gender. Structural inequities that disempower women, such as family
violence and certain cultural norms and practices, must be evaluated with the clinical evidence,
especially for women who may intend to rely on PrEP as the sole approach to reducing the risk of
HIV transmission. However there is good evidence that women are able to have high adherence
rates to PrEP.
1.
2.
3.
4.
5.
6.
Center for Disease Control and Prevention. (2014). Preexposure prophylaxis for the prevention of HIV infection in the United
States – 2014.
Van Damme, L., et al. (2012). Preexposure prophylaxis for HIV infection among African women. N Engl J Med, 367:411-422.
Marrazzo, J.M., et al. (2015). Tenofovir-based preexposure prophylaxis for HIV infection among African women. N Engl J Med,
372(6):509-18.
J.M. Baeten, D. D. (2012). Antiretroviral Prophylaxis for HIV Prevention in Heterosexual. The New England Journal of Medicine,
399-410.
Cottrell, M. L., et al. (2016). A translational pharmacology approach to predicting outcomes of preexposure prophylaxis against
HIV in men and women using tenofovir disoproxil fumarate with or without emtricitabine. The Journal of Infectious Diseases.
Virginia A. FONNER, S. L. (2016). Effectiveness and safety of oral HIV pre-exposure prophylaxis (PrEP) for all populations: A
systematic review and meta-analysis. AIDS, 1973-83.
Who should take PrEP?
PrEP is not for everyone. The risk factors for HIV are the same for men and women; however HIV
transmission occurs mostly between men who have sex with men in Australia. Based on individual
characteristics and risk environment, there are circumstances where the use of PrEP should be
considered for women.
International and national PrEP practice guidelines recommend that PrEP be considered for people
who are HIV-negative and at a high risk of acquiring HIV 7,8, 9. PrEP is indicated for women who do
not regularly use condoms during sex with partners of unknown HIV status who are at substantial
risk of HIV infection (e.g. people who inject drugs or male partners who have sex with other men).
PrEP is also indicated for women who are likely to have multiple events of sharing needles or other
injecting equipment with an HIV-positive individual, or a man who has sex with men and has
inadequate access to safe injecting equipment.
High adherence to antiretroviral treatment lowers and supress HIV viral load to undetectable levels,
virtually eliminating the risk of onwards HIV transmission in heterosexuals10. In the setting where an
HIV-negative woman has an HIV positive male partner whose HIV viral load test results have been
consistently undetectable, PrEP is unlikely to offer any considerable decrease in the risk of HIV
transmission. However PrEP may greatly reduce anxiety about HIV acquisition in this situation and
women and PrEP is a reasonable consideration in this setting. PrEP may be considered as an
additional strategy when an HIV-negative woman is trying to conceive with an HIV-positive partner
and women may choose to stay on PrEP during pregnancy if their risk of HIV acquisition remains
high.
There are other instances when PrEP can offer security that is physically, mentally and emotionally
beneficial for both partners, such as: when an undetectable viral load is unable to be achieved by the
HIV-positive partner; during the short period of time between commencing HIV treatment and
achieving an undetectable viral load; when the HIV-positive partner cannot access HIV treatment
due to reasons such as Medicare ineligibility; and when the HIV-positive partner cannot tolerate HIV
treatment due to the side effects.
7.
World Health Organization. (2015). GUIDLINE ON WHEN TO START ANTIRETROVIRAL THERAPY AND ON PRE-EXPOUSRE
PROPHYLAXIS FOR HIV. Geneva: World Health Organization.
8. Center for Disease Control and Prevention (2014). PREEXPOSURE PROPHYLAXIS FOR THE PREVENTION OF HIV INFECTION IN THE
UNITED STATES - 2014 Clinical Practice Guideline. Atlanta: Centre for Disease Control and Prevention.
9. ASHM. (2015). Australian National PrEP Guidelines. Surry Hills: ASHM.
10. Cohen M et al. Final results of the HPTN 052 randomized controlled trial: antiretroviral therapy prevents HIV transmission. 8th
International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention, Vancouver, abstract MOAC0101LB,
2015.
In situations where the HIV-positive partner chooses not to commence HIV treatment and the
woman is unable to negotiate condom use, Positive Women recommends a holistic approach to
assessing her suitability for PrEP, considering how her diminished decision-making power and the
burden of maintaining the sexual health of herself and her partner will impact on her ability to
adhere to the drug.
It is important to remember that PrEP does not prevent the transmission of other STIs, such as
hepatitis C, syphilis, gonorrhoea, chlamydia and herpes. Condoms remain the best method for
preventing STIs. Along with condoms, PrEP can also be used in conjunction with TasP to provide the
best prevention of HIV and STIs.
Positive Women’s position on PrEP
Positive Women recognises the potential of PrEP to help end the HIV epidemic in Australia and
welcomes the addition of another HIV preventative tool. Positive Women supports the use of preexposure prophylaxis (PrEP) for high risk HIV-negative women attempting to mitigate the risk of
contracting HIV, while recognising the complexity of influences on women’s health-seeking
behaviours. Although PrEP has been found to be highly effective in drug trials when used as
prescribed by at-risk men who have sex with men and heterosexual men and women, the internal
validity of PrEP studies solely among women has been jeopardised by adherence issues in some
studies. Barriers to adherence should be carefully considered when assessing individual applicability
and appropriateness of PrEP for women.
Although the primary benefit of PrEP use is biological, Positive Women also acknowledges the
emotional and psychological benefits that may be experienced by both HIV-negative women and
women living with HIV in serodiscordant relationships. For HIV-negative women, the collateral
benefits of PrEP can include increased autonomy and control over their health. PrEP use by partners
of women living with HIV can promote the feeling of safety during sexual encounters and reduce
feelings of guilt and anxiety for HIV-positive women.
Positive Women endorses the use of PrEP by any woman who is at a high risk of contracting HIV and
has made an informed decision to commence preventative treatment under the care of a clinician.
Positive Women also supports women living with HIV who contribute to the decision to incorporate
PrEP into a serodiscordant relationship.
Taking PrEP is a personal decision and must be delivered as part of a program that includes regular
HIV testing, regular STI screens (and treatment if necessary), medical monitoring and adherence
support. Further research on the use of PrEP among women should continue to examine not only
the clinical efficacy of the drug but the social and structural contexts that impact adherence among
women.