Truvada in the US will be used to reduce the risk of HIV transmission among adolescents
The biopharmaceutical company Gilead Sciences announced on Wednesday that the Food and Drug Administration (FDA) decided to approve the use of the combination of emtricitabine / tenofovir dizoproxil fumarate (200 mg / 300 mg) (Truvada) in combination with common contraceptive methods for reducing the risk of HIV transmission among adolescents.
As reported by Specialty Pharmacy Times, the safety and efficacy profile of Truvada, used for pre-exposure prophylaxis of HIV (PrEP) in uninfected adults, has already been well studied: the combination entered the US market in 2012.
The FDA's decision on the new appointment of Truvada was also made based on the results of a clinical trial of ATN113, in which 15-17 year olds with HIV-negative status participated.
"The ATN113 trial demonstrated that Truvada, used as a PrEP, is a well-tolerated option for prevention among adolescents who are vulnerable to HIV," said study leader Dr. Sybil Hosek.
Now, in his words, in addition to traditional strategies to reduce the risk of HIV spread, doctors and patients have received another effective tool that reduces the likelihood of transmission of the virus in a group of young people at risk of infection.