FDA Approves PrEP, the drug that helps reduce the risk of getting HIV from sex by more than 90% and among people who inject drugs, reducing the risk by more than 70%. The Food and Drug Administration (FDA) today gave PrEP a green light for Gay and Bisexual teens who engage in unprotected (high risk) sexual conduct.
Conservatives have already begun their opposition campaign on AM Talk radio with their headline of ‘FDA Approves PrEP. The FDA approved the use of PrEP for adults in 2012, and now with their new research confirmed, made the decision following new research into PrEP’s effectiveness in YMSM.
The study which as funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, known as ATN113, provided FDA regulators daily PrEP treatment information on 67 HIV-negative males ages 15 to 17 who had sex with males.
GLAAD released the following press release on FDA Approves PrEP for Gay and Bisexual teens:
Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved once-daily oral Truvada® (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg)—in combination with safer sex practices—to reduce the risk of sexually acquired HIV-1 in at-risk adolescents. The safety and efficacy profile of Truvada for HIV prevention in uninfected adults, a strategy called pre-exposure prophylaxis (PrEP), is well established, and Truvada for PrEP was first approved for use in adults in 2012.
The addition of the adolescent indication is based on a study in HIV-negative individuals 15 to 17 years of age. In the United States, adolescents and young adults 13 to 24 years of age comprised 21 percent of all new infections in 2016, according to the U.S. Centers for Disease Control and Prevention, and 81 percent of those infections were among young men who have sex with men (YMSM).
Truvada for PrEP is now indicated in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 in at-risk adults and adolescents weighing at least 35 kg. Individuals must have a negative HIV test immediately prior to initiating Truvada for PrEP. Truvada has a boxed warning in its product label regarding the risks of post treatment acute exacerbation of hepatitis B and the risk of drug resistance with the use of Truvada for PrEP in undiagnosed early HIV infection. Further important safety information, adverse drug reactions and prescribing considerations are included below.
“Study ATN113 has demonstrated that Truvada for PrEP is a well-tolerated prevention option for adolescents who are vulnerable to HIV,” said Sybil Hosek, PhD, Clinical Psychologist at the Cook County Health and Hospital System’s Stroger Hospital, Chicago, and lead investigator of the study. “In addition to traditional risk-reduction strategies, healthcare providers and community advocates are now equipped with another tool to help address the incidence of HIV in younger at-risk populations.”
Clinical psychologist at the Stroger Hospital in Chicago Sybil Hosek, along with the study’s lead investigator praised the results today in a joint statement they released to the press today:
“Study ATN113 has demonstrated that Truvada for PrEP is a well-tolerated prevention option for adolescents who are vulnerable to HIV,” Hosek said in a statement. “In addition to traditional risk-reduction strategies, healthcare providers and community advocates are now equipped with another tool to help address the incidence of HIV in younger at-risk populations.
In fact after numerous studies on adults have shown that when taken daily, PrEP can be an effect protection tool with results of up to 99 percent effective in preventing HIV. But please remember that PrEP is not a protection against STDs so please remember to use protection when ever you can. You only have one life and the last thing you want to be is hit with a STD over 30 minutes or more of sexual pleasure.
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