FDA approves FDA Approves HIV drug for pre-exposure prophylaxis

By Chuck Longacre
Gayly contributing writer
and columnist

In a recent press release, the US Food and Drug Administration (FDA) approved Truvada as “the first drug approved to reduce the risk of HIV infection in uninfected individuals who are at high risk of HIV infection and who may engage in sexual activity with HIV-infected partners.  Truvada, taken daily, is to be used for pre-exposure prophylaxis (PrEP) in combination with safer sex practices to reduce the risk of sexually-acquired HIV infection in adults at high risk.”

The last time we spoke of this new medical breakthrough was back in December, following the 2011 United States Conference on AIDS held in Chicago, IL.  The headline then read, “No New Infections by 2021,” and here we are just over 6 months later and the journey is looking closer than we think.

While this doesn’t stop ALL new infections - in combination with safer sex practices, risk reduction counseling and regular HIV testing - it is hoped that this will decrease new infections in the United States, significantly.

“Approval marks an important milestone in our fight against HIV," said FDA Commissioner Margaret A. Hamburg, M.D. "Every year, about 50,000 U.S. adults and adolescents are diagnosed with HIV infection, despite the availability of prevention methods and strategies to educate, test, and care for people living with the disease. New treatments as well as prevention methods are needed to fight the HIV epidemic in this country."

Truvada for PrEP is being approved with a Risk Evaluation and Mitigation Strategy (REMS) to minimize the risk to uninfected individuals of acquiring HIV infection and to reduce the risk of development of resistant HIV-1 variants. The central component of these REMS’s is a training and education program to assist prescribers in counseling individuals who are taking or considering Truvada for PrEP.

The training and education program will not restrict distribution of Truvada but will provide information about the importance of adhering to the recommended dosing regimen and understanding the serious risks of becoming infected with HIV while taking Truvada for the PrEP indication.

The PrEP and REMS information and training will take a while to roll out for our community.  However, until then we should do our own part in stopping the spread of HIV/AIDS.  Join us as we take a stride forward in making sure we have “NO NEW INFECTIONS BY 2021” starting right here in our community…starting one relationship at a time…starting today…starting now…starting with YOU.

For more information,  visit www.aidsmeds.com