Can a Pill a Day ... Keep HIV Away?
Could a prevention pill prove harmful by giving people a false sense of safety? People might expect to be fully protected by PrEP and stop using more reliable forms of protection like condoms, which are inexpensive and 98% effective when used consistently and correctly. Though data from iPrEx and Partners PrEP are strong, they are not strong enough for advocates to consider PrEP a substitute for condoms. The appeal of a "magic pill" for HIV prevention might lure people looking for an excuse to stop using condoms.
More importantly, the iPrEx results show how difficult it was for people to take their pill every day, and how unrealistic it might be to ask a healthy, HIV-negative person to remember that without consistent support. Poor adherence threatens the long-term effectiveness of all HIV meds, with the virus more likely to build up resistance. Some MSM have reported buying HIV meds on the street and taking them only just before sex, thinking this will provide protection when there is no evidence to support that use. The illegal trade of HIV meds on the black market enables people to take them as PrEP without proper counseling, which can lead to drug-resistant strains. Without close monitoring, PrEP meds could enter the black market more easily and lead to more cases of improper use.
A few AIDS advocacy organizations have waged a campaign against PrEP approval, accusing the FDA of putting profits over safety. They claim that Gilead and the FDA have a close relationship and have worked to speed up the approval process. In early 2011, two Freedom of Information Act (FOIA) requests to obtain documents sent between Gilead and the FDA were filed, and the FDA denied both of them. There is concern that this could set a dangerous standard of pharmaceutical companies affecting public regulations.
Toward a Plan for PrEP
Other AIDS advocacy groups argue that with the epidemic spreading at increasingly high rates among MSM, especially MSM of color, we cannot afford to dismiss PrEP as a potential tool. The CDC estimates that 53% of new HIV infections occur among MSM. Condoms, behavioral counseling, and social marketing have made a difference in some communities, but have not significantly slowed the spread of the epidemic in others. The rejection of any new strategy is a lost opportunity to prevent new infections.
High drug costs are real and devastating, but the dismissal of one request for FDA approval will not fix that problem. AIDS advocacy groups must work to reform drug patent laws so as to ensure the widest possible access to HIV drugs, notwithstanding opposition from drug companies. Cheaper HIV meds could save millions of lives, but wider availability of PrEP could save lives as well. Both approaches are compatible in a comprehensive approach to prevention. Following the FDA's approval of PrEP, AIDS advocates should pressure drug companies and state Medicaid programs to cover PrEP at discounted rates.
Regardless of how we pay for PrEP, we must carefully implement this new tool to preserve scarce resources and ensure that no one thinks of PrEP as a miracle pill for HIV prevention. Advocates and healthcare providers should focus on the groups most vulnerable to HIV, such as MSM and women of color, in particular sex workers, serodiscordant couples, and MSM who have unprotected anal sex with multiple partners. This focus would be the most cost-effective use of PrEP. We must also ensure that health care providers monitor treatment and maintain close communication with people taking PrEP to minimize side effects and fight drug resistance.
We should also not regard PrEP as a replacement for current methods of prevention. Its use must be combined with behavioral interventions to ensure that people practice safer sex and adhere to their drug regimen. Perhaps creative use of technology could increase adherence, like a text messaging reminder service.
In communities where PrEP is introduced, advocates must continue to combat social inequality. Poverty and incarceration, for example, present real obstacles to safer sex and drug adherence. Testing services should reach out to entire communities to ensure that people with HIV become aware of their status and receive counseling on the benefits of HIV treatment -- not only for their own health, but also to lower the risk of transmission. Health care providers need to focus on cultural competency with LGBT communities. This is particularly important for MSM and transgender women of color. Also, community organizations should address the potential stigma that might surround PrEP through counseling and social marketing.
Finally, clinical trials of PrEP should continue even if Truvada gains FDA approval, focusing on those most at risk. Injection drug users should be a priority, since no research is yet available on this group. Alternative forms of PrEP like injections, implants, and patches could address problems of adherence and should be studied.
PrEP could be a powerful tool in national and even global prevention efforts, but we are still far from a solution to the AIDS epidemic. AIDS advocates should support this new innovation, but hold institutions like the FDA and drug companies accountable if profit gets in the way of public health.
Liza Behrendt is a member of AVODAH: The Jewish Service Corps.
This article was provided by ACRIA and GMHC. It is a part of the publication Achieve. Visit ACRIA's website and GMHC's website to find out more about their activities, publications and services.
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