Imagine what it would mean to have a medication that would make it harder for HIV to enter a person's body. Tomorrow, May 10, may lead to just such a turning point in the fight against HIV/AIDS. On this date the U.S. Food and Drug Administration will review a supplemental new drug application for emtricitabine/tenofovir disoproxil fumarate (FTC-TDF) to reduce the risk of acquiring HIV in men and women by pre-exposure prophylaxis (PrEP), offered as part of a comprehensive HIV-prevention package including risk reduction counseling.
Before Westerners go to some African countries, they take malarial drugs as a preventive strategy. PrEP works much the same way: HIV treatment medications are taken to make it harder for HIV to enter the body.
PrEP has shown efficacy with men who have sex with men (MSM) and heterosexual women and men. Biomedical prevention interventions such as PrEP have great potential, especially if coupled with traditional prevention approaches such as condom use, expanded testing, and linkage to treatment and care. Modeling demonstrates the most effective deployment of PrEP will be in combination with scaled-up HIV treatment of people who are known to be HIV-positive, as this was shown to reduce infections.
The FDA's Antiviral Drugs Advisory Committee will consider and vote on whether to recommend approving FTC-TDF for PrEP with MSM, serodiscordant couples, and others at risk of HIV through sexual activity. The FDA is expected to issue a final decision in mid-June.
We are hopeful that the full dossier of submitted PrEP research, based on multiple clinical trials with a number of different populations vulnerable to HIV, can lead to a responsible regulatory and marketing plan that allows for safe use in the populations that may benefit most from this innovative development. If the FDA approves the additional indication of the use of tenofovir-emtricitabine for PrEP, health programs and individuals will have improved choices to address one of the administration's domestic health priorities, and save lives.
Some have raised concerns about PrEP related to potential side effects, risk compensation (the idea that people will stop using condoms if PrEP becomes available), and drug resistance. However, reviews of five major clinical trials involving about 6,000 participants by the Forum for Collaborative HIV Research found no greater risk of side effects, no risk compensation, and no clinically significant development of drug resistance in participants.
Recent press coverage has emphasized the cost of FTC-TDF. Last year the Centers for Disease Control and Prevention estimated the medications would cost $8,030 per person per year. While the cost of PrEP in the U.S. would be substantial, private insurers and state Medicaid departments are open to providing coverage. Low-cost generic medications could enable access in low-income countries. The prioritization of highly vulnerable populations could increase the cost-effectiveness of PrEP. Providing PrEP is also much less expensive than treating someone for HIV over the course of a lifetime. Recent modeling of PrEP implementation coupled with scaled-up treatment (focusing on MSM in San Francisco, the general adult population in Botswana, and serodiscordant couples in South Africa) predicts that PrEP could significantly reduce HIV incidence and prevalence, saving health care costs and lost economic productivity.
We therefore urge the FDA to approve the application of Gilead Sciences Inc.'s supplemental new drug application for emtricitabine/tenofovir disoproxil fumarate for reducing the risk of acquiring HIV by means of pre-exposure prophylaxis (PrEP) offered as part of a comprehensive prevention package including risk reduction counseling.
We believe that if the FDA looks closely at the science, it will see the merit of allowing PrEP to be added to our toolkit to prevent HIV infections. We must deploy new tools to prevent new infections, which are affecting 50,000 Americans each year and more than 2 million people worldwide, most in Africa. PrEP combined with sustained behavioral interventions and medical care to maintain adherence could help us finally begin to turn the tide with this virus.
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