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Experts say the approval of Truvada for HIV prevention raises new ethical issues that must be addressed

The Food and Drug Administration’s approval last year of the drug Truvada for prevention of was a milestone in the fight against HIV/AIDS, but experts are cautioning that it is only the beginning of new ethical concerns for , 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 , Deputy Director for Medicine at the Johns Hopkins Berman Institute of Bioethics. He and , the director of research at Beth Israel Deaconess Medical Center, advocate for 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.”

Source

Sugarman, Jeremy MD, MPH, MA; Mayer, Kenneth H. MDEthics and Pre-exposure Prophylaxis for HIV Infection, JAIDS Journal of Acquired Immune Deficiency Syndromes, 1 July 2013 – Volume 63, Issue p S135-S139, doi: 10.1097/QAI.0b013e3182987787