Why vulnerable young women at risk of HIV should be prioritized for access to preexposure prophylaxis

In defending their stance that antiretrovirals (ARVs) should be prioritized for treatment over prevention, Cowan and Macklin [1] argue that young women in sub-Saharan Africa (SSA) are ‘neither the most vulnerable, nor do they have the greatest immediate need for ARVs’. The overwhelming and compelling evidence indicates otherwise. Young women in SSA aged 15–24 comprise more than two thirds of the global population of young people living with HIV [2]. Seventy-two percent of young people (aged 15–24 years) living with HIV in SSA are women [3]. Young women are more than twice as likely to be infected with HIV, than young men [4]. In Kenya, young women are four times more likely to be living with HIV than men [5], whereas, in South Africa, which harbors the world's highest burden of HIV, young women are three times more likely to be infected than young men [6]. Fearing violence or rejection, 58% of South African girls (<18 years) avoid discussing condom use with their partners, which increases their vulnerability to HIV [7]. With respect to HIV incidence, young South African women in the age group 20–29 years have an incidence rate of 5.6% compared to 0.9% among men in the same age group [8]. This is despite scaled-up prevention and treatment efforts in these settings. These alarming statistics highlight that we have failed to effectively address the HIV prevention needs of young women, and speak to the urgent need for HIV preexposure prophylaxis (PrEP) if PrEP efficacy is confirmed or if drug regulatory authorities indicate its use based on existing evidence According to UNICEF: ‘the risk of HIV infection for girls and young women is higher when they have sexual partners who are significantly older, have concurrent partners, are involved in transactional sex, or are subject to violence, abuse, and exploitation. These risk factors can be compounded when girls and young women lack access to quality education or are unable to exercise their rights in the economic, social, and domestic spheres’ [6]. Such factors characterize African girls and young women. Additionally, age and gender power imbalances, harmful social gender norms, marginalization, and the consequences of unsafe abortions – all of which also increase vulnerability to HIV – also apply to young African girls and women, more so than other populations at high risk of HIV, such as men who have sex with men, sex workers, and seronegative partners in serodiscordant relationships. Given the above, it is untenable to argue that young women in Africa are not the most vulnerable group at risk of HIV and are not in greatest immediate need of HIV PrEP. Cowan and Macklin [1] also note that ‘at the present time, evidence supporting the use of ARV for prevention in young heterosexual women has not been firmly established.’ To date, PrEP has demonstrated efficacy in women in three studies: the Centre for the AIDS Programme of Research in South Africa (CAPRISA) 004 trial [9]; the Partners Pre-exposure Prophylaxis (PrEP) trial [10]; and the Tenofovir Disoproxil Fumarate (TDF) 2 trial [11]. All three of these trials included, among others, young women aged 18–24 years. Based on these trials, the US Centres for Disease Control has issued guidelines on the use of PreP in certain cohorts. Although PrEP efficacy data in adolescents would be preferable, the lack of PrEP trials in exclusively adolescent cohorts remains a challenge because of ethics and regulatory challenges. The Vaginal and Oral Interventions to Control the Epidemic (VOICE) trial revealed that compared to both older and married participants, young, unmarried women were much less likely to use their study products daily and much more likely to acquire HIV [12]. This highlights the urgent need to develop a safe, effective, and practical PrEP intervention that young, unmarried women will use. Such approaches may include intermittent dosing (as was the case in the CAPRISA 004 trial) and/or interventions offering long-acting protection. A Study to Prevent Infection with a Ring for Extended Use (ASPIRE or MTN-020) [13] and the Ring Study (IPM 027) [14], both of which are evaluating a vaginal ring containing the ARV drug dapivirine that women will use for a month at a time, will hopefully yield a further prevention option for young women in Africa. Should the ASPIRE and Ring trials demonstrate efficacy, and should the Follow-on African Consortium for Tenofovir Studies (FACTS) trial confirm the efficacy of an intermittent dosing strategy of tenofovir gel, it will be incumbent on governments to ensure that women obtain access to such products. The same will apply in regard to other drugs currently under investigation that could demonstrate preventive efficacy, such as maraviroc (currently the subject of the HPTN 069 trial), rilpivirine/TMC278, and GSK744. Cowan and Macklin [1] further argue that ‘it is difficult to see how uninfected individuals, regardless of their vulnerability, can claim a greater need than infected persons who would surely die without treatment.’ Neither group should be denied access to ARVs. Instead, policymakers have an ethical and human rights obligation to ensure incremental and sustainable access to efficacious interventions for both groups, simultaneously. Policymakers who disregard PrEP will ignore the HIV prevention needs of young women. They also risk foregoing an opportunity to achieve UNAIDS’ goal of preventing infection among adolescents and young people. Unless we can reduce incidence dramatically, it will become increasingly challenging to sustain effective treatment programs. We cannot treat our way out of the HIV epidemic. Combating HIV will require employing a suite of modalities: Treatment as Prevention (TasP), optimal HIV testing strategies, behavioral change (including risk reduction and adherence optimization), structural interventions, sexually transmitted infection detection and treatment, and medical male circumcision. Integrated prevention strategies are crucial to realizing the goal of an AIDS-free generation. PreP should be central to such an approach in high-burden settings such as Africa and should complement, and not be discounted in favor of only, treatment. Acknowledgements J.A.S. participated in WHO consultations on ‘The Strategic Use of ARVs’,’ The ethics of PreP and ARVs for prevention: How should countries reach a decision?’ and ‘Programmatic Guidance of the 2013 Consolidated Guidelines on ARV-related Interventions’. Conflicts of interest J.A.S. receives support from the Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa, which forms part of the Comprehensive International Programme on AIDS, funded by the US National Institute of Allergy and Infectious Diseases. He also receives support from the Ethical, Social, and Cultural Program for Global Health at the Sandra Rotman Centre, Toronto, Canada, which receives funding from the Bill and Melinda Gates Foundation. The funders had no role in study design, data collection and analysis, or decision to publish the article. There are no conflicts of interest.

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