Pre-exposure prophylaxis (PrEP) is the provision of antiretrovirals (ARVs) to HIV-negative people in order to prevent HIV infection. In light of recently released data, a heated debate is raging in the HIV community on how and if PrEP should be implemented. A vast array of ethical, financial, and medical concerns have been expressed, in fact too many to address in one article. However, most agree that PrEP (with more research), although not a single solution to preventing the continued spread of HIV, should be added to the arsenal of HIV prevention strategies where it is needed most.
Many contend that PrEP cannot be justified at the present time in all populations while millions already living with HIV are in desperate need of treatment. At the same time, the need for additional effective prevention methods, particularly among serodiscordant couples, men who have sex with men who practice unsafe sex, and disenfranchised women is immense, leading most to agree that PrEP should be explored for these groups.
Despite the concerns regarding PrEP, many in the HIV community view the recent PrEP data as a dramatic step and a valuable tool in reducing HIV transmission. “We’re excited about PrEP,” states Frank Oldham, president and CEO, National Association of People with AIDS. “Not because it will end HIV in America. It won’t and can’t. The epidemic is caused as much by poverty, homophobia, and an unfair healthcare system as it is by a virus, and no prevention tool, however promising, is going to end it until we do something about those problems. But PrEP has real promise for people for whom other prevention tools aren’t working—like sex workers, homeless youths, and women who aren’t in a position to negotiate safer sex with their partners. PrEP isn’t for everyone. We need to know more about its safety for women and adolescents. We need safeguards to make sure it isn’t given to people who already have HIV. But used wisely PrEP will save lives.”
Michael Ruppal, executive director of The AIDS Institute, echoes NAPWA’s concerns for caution and more data as well as their enthusiasm for PrEP’s potential. “The study data about PrEP offers some of the most exciting hope for stopping the transmission of HIV. With that comes a responsibility to be diligent to do more to answer long-term questions such as drug safety, efficacy, cost, access and ensuring additional studies. We all have a responsibility to educate ourselves and others about the truths surrounding PrEP and not let myths and fear drive our actions.”
Perhaps the greatest concern voiced by those both supportive and critical of PrEP is the high cost of this prevention modality. Close monitoring is essential for those on PrEP, adding to the cost of its use. Frequent HIV testing is necessary to prevent drug resistance from occurring from the use of suboptimal therapy if a person unknowingly seroconverts. Routine monitoring for ARV-related toxicities and adverse events, particularly kidney damage, loss of bone density, and changes in fat metabolism, which have been observed in clinical trials, must be conducted, as well as additional research to measure the long-term effects of ARVs on HIV-negative individuals.
In the iPREX study condom use was reported at ninety percent. Although self-reported adherence is not always accurate, the question if this high rate could be sustained under real world circumstances where counseling and safe sex education is not provided frequently as it was in the iPREX study has arisen. Could PrEP actually increase the risk of infection for some who, under the guise of being protected from infection by PrEP, discontinue using condoms?
These and other concerns have some advocates asserting the need to weigh all the facts. “I understand people’s concerns with the challenges associated with PrEP, and the worries about the unknowns. I understand, because I have concerns as well, like every prevention advocate I know. What I don’t understand is a ‘head in the sand’ approach that reflexively dismisses PrEP because of these fears of the unknown,” states Jim Pickett, director of Prevention Advocacy and Gay Men’s Health, AIDS Foundation of Chicago. “That to me is completely unacceptable. We have irrefutable evidence that PrEP can work. Now it is our duty, our responsibility, our charge to figure out how to use PrEP in the best, most strategic way possible—how to get it to the people most in need at the right time, in the right place. We can’t do that with our eyes closed and our hands over our ears. We also can’t pit PrEP against treatment, and it is upsetting to me that we have a number of advocates and researchers doing just that. We need to think about how to expand ARV access for all that need ARVs—positive people and negative people.”
Although PrEP is not yet approved by the FDA or regulatory authorities outside the U.S., it is already being used by some outside of clinical trials. A few clinics in the U.K. are offering PrEP to couples wishing to conceive a child. In addition, some insurance carriers are covering PrEP for those wishing to use it, possibly concluding it is cheaper to pay for Truvada than to treat HIV. One such individual is Nick Literski, who portrays his experience with PrEP in a poignant blog entry (http://lifelube.blogspot.com/search/label/My%20PrEP%20Experience).
Cornelius Baker, senior communications advisor and project director, NIAID HIV Vaccine Research Education Initiative, Center on AIDS & Community Health, whose advocacy spans over two decades, comments on our expanded knowledge of the benefits of ARVs that PrEP research has allowed us. “Since the early 1990s, antiretroviral drugs have helped change the course of the HIV epidemic. First through prevention of mother-to-child transmission. Later, the development of combination therapy has kept millions of people living with HIV alive. Until we have a vaccine, the power of these drugs in preventing new infections among the sexually active must be considered as a tool in our arsenal against this dangerous foe.”
The lessons learned from the treatment-as-prevention study provides us with many new opportunities including the incentive to work even harder towards lowering the community viral load. We now know that a sustained undetectable viral load dramatically reduces infectiousness in people with HIV. The study and advancement of therapies already in development that appear to substantially decrease viral load, such as some gene and cell therapies in development, may accomplish both the goals of decreasing the risk of new HIV infections while at the same time providing treatment to those who need it. More funding and research needs to be directed towards studying these potential therapies to determine their full potential.
It is clear that a great deal of time and energy will need to be spent hashing out the benefits and disadvantages as well as the medical, financial and ethical concerns regarding the use of PrEP. At the same time other modalities and new prevention and treatment strategies must be investigated and utilized, including microbicides, treatment as prevention, novel drugs in development and, most importantly, the search for a cure for HIV.
Author: Jeannie Wraight