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FDA Eliminates REMS For Truvada

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There were approximately 36.9 million people globally living with HIV/AIDS in 2017, according to the United Nations Programme on HIV/AIDS or UNAIDS. Of these, 1.8 million were children below 15 years.

HIV is a virus that transmits from a person with HIV through certain body fluids like blood, semen, pre-seminal fluids, rectal fluids, vaginal fluids, and breast milk. People, who are born of mothers who have HIV, who have unprotected sex and also those who share injection equipment, face the risk of getting HIV.

Pre-exposure prophylaxis or PrEP is a daily pill that helps lower the risk of contracting HIV for people who have condomless sex or who share needles. According to The Centers for Disease Control and Prevention (CDC), PrEP reduces the risk of contracting HIV from sex by more than 90 percent.

Truvada (tenofovir disoproxil fumarate/emtricitabine), developed by Gilead Sciences, Inc. (GILD) was first approved in 2004 for the treatment of
HIV-infected adults and children aged 12 years or more. In 2012, the drug got thumps up from the FDA to be used for PrEP in combination with safer sex practices to reduce the risk of sexually-acquired HIV infection in adults. In May, 2018, the drug received expanded approval as PrEP against HIV for adoloscents or people who weigh at least 35 kilograms.

In 2012, When Truvada was approved as PrEP against HIV infection, the FDA had established REMS or Risk Evaluation and Mitigation Strategy for the drug. This means that the company has to provide training materials to healthcare providers and educational information to consumers to reduce the risk of development of resistant HIV-1 variants for people who have undiagnosed HIV-1 infection.

On July 1 of this year, the regulator eliminated the REMS for Truvada and its generics. According to FDA, now, after seven years, vast majority of health care professionals and at-risk individuals are aware of the risks and prevention methods of HIV infection, and educational materials and treatment guidelines are readily available at the U.S. Centers for Disease Control and Prevention.

In May, this year, Gilead Sciences had said it would donate up to 2.4 million bottles of Truvada annually to the U.S. Centers for Disease Control and Prevention (CDC).

Now, let's take a look at the new drugs that won FDA approval in June.

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