Experts address ethical issues raised by FDA's approval of Truvada for HIV prevention

The Food and Drug Administration's approval last year of the drug Truvada for prevention of HIV infection was a milestone in the fight against HIV/AIDS, but experts are cautioning that it is only the beginning of new ethical concerns for health care professionals, policy makers, researchers and those taking Truvada to prevent HIV infection.

"For the first time, we will have a large number of individuals who are not infected with HIV taking medication for HIV, which introduces ethical concerns of well-being and justice," says Jeremy Sugarman, Deputy Director for Medicine at the Johns Hopkins Berman Institute of Bioethics. He and Kenneth Mayer, the director of HIV prevention research at Beth Israel Deaconess Medical Center, advocate for ethical issues to be considered along with medical data in the Journal of Acquired Immune Deficiency Syndromes.

Sugarman and Mayer argue it is ethically critical to ensure that use of an antiretroviral drug like Truvada for "pre-exposure prophylaxis"(PrEP) does not have the ironic consequence of making individuals and communities less safe and healthy. Inconsistent, rather than daily, use of PrEP could result in HIV transmission and the evolution of drug-resistant strain of HIV, the authors warn. Likewise, misunderstanding of PrEP's prevention capacity could lead to the spread of other sexually transmitted infections.

"Communication and careful monitoring by health care professionals is essential for PrEP to be successful," says Sugarman. "Reinforcing the importance of daily dosing, incorporating safer sex counseling and frequent HIV testing will help meet the moral imperative that HIV be prevented and not exacerbated by PrEP," he says. He and Mayer recommend training programs for health care professionals that include explicit consideration of PrEP's ethical issues and their management.

Additionally, Sugarman and Mayer highlight what they say are 'critical, unanswered questions' of access and allocation. When limited antiretroviral drugs are available, should prevention be prioritized over treatment for those already infected with HIV, or vice-versa? Is a clinic environment the best setting to provide necessary counseling as part of PrEP? These questions, as well as how much PrEP should cost and who should pay for it, need to be answered as PrEP continues to be used and evaluated, the authors say.

"The fundamental moral claim for using PrEP, or any other HIV prevention strategy, is decreasing the burden of new HIV infections," Sugarman says. "For PrEP's full promise and medicine's moral obligations to be fulfilled, these complex ethical issues must be monitored along with the performance of PrEP."