FDA OKs Truvada to Reduce HIV Risk in Adolescents

Gilead Sciences, Inc. announced that the FDA approved once-daily oral emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (Truvada) in combination with safe 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 is well established. Truvada for pre-exposure prophylaxis (PrEP) was first approved for use in adults in 2012.

The addition of the adolescent indication is backed by a single-arm, open-label clinical trial, ATN113, conducted in HIV-negative individuals 15–17 years old by the Adolescent Medicine Trials Network for HIV/Aids.

“Study ATN113 has demonstrated that Truvada for PrEP is a well-tolerated prevention option for adolescents who are vulnerable to HIV,” lead study investigator, Sybil Hosek, PhD, clinical psychologist, Cook County Health and Hospital System’s Stroger Hospital, said in a statement. “In addition to traditional risk-reduction strategies, health care providers and community advocates are now equipped with another tool to help address the incidence of HIV in younger at-risk populations.”

Click to continue reading on MD Magazine. 


Stay up to date on the latest news in specialty pharmacy by getting Specialty Pharmacy Times in your mailbox or inbox for free!

Click here to sign up for free for the bi-monthly Specialty Pharmacy Times print journal delivered to your address.

Click here to sign up for our email newsletters delivered every Monday, Wednesday, and Friday, in addition to breaking news alerts.

Click here to follow us on Facebook. 

Click here to follow us on Twitter. 

Click here to join our LinkedIn group. 


Most Popular

Related Articles

Findings suggest daily use of Truvada is safe and effective among males aged 15 to 17 years.
Four doses of PrEP around the time of sexual activity reduced HIV-infection risk by 97%.
Scientists say ring containing pre-exposure prophylaxis and Truvada is safe in US teens, now need data in African adolescent girls.
Company Profile >
Contributors >
Industry Guide >
Market News >
Peer Exchange >
Conferences >
Subscribe >
Specialty Times Resources
About Us
Advertise
Careers
Contact Us
Terms & Conditions
Privacy
MJH Associates >
Pharmacy Times
OTCGuide
American Journal of Managed Care
Cure
MD Magazine
ONCLive
Targeted Oncology
Physicians' Education Resource
Pharmacy & Healthcare Communications, LLC
2 Clarke Drive
Suite 100
Cranbury, NJ 08512
P: 609-716-7777
F: 609-716-4747

Copyright Specialty Pharmacy Times 2006-2018
Pharmacy & Healthcare Communications, LLC. All Rights Reserved.
 

$vacMongoViewPlus$