New Single Tablet Regiment Supported by Clinical Research Team
DALLAS, TX (Feb. 9, 2018) – Wednesday, the Food and Drug Administration announced their approval of Biktarvy®. Biktarvy® is a combination of Descovy® + Bictegravir – a new single tablet regimen for HIV treatment.
Biktarvy® is the first compound that the Prism Health North Texas Clinical Research department worked on from early Phase 1 for safety, to the study for efficacy, and the final closing study.
Prism Health North Texas’ role began in the summer of 2014 when the organization was invited to participate in the first study which determined the safety, efficacy, and dosage of bictegravir, a new HIV integrase inhibitor. PHNTX enrolled 3 of the first 23 humans in the world to receive this medication. Prism Health North Texas patients also participated in the Phase 2 treatment study which opened in the spring of 2015. In 2016, PHNTX began enrollment into the larger Phase 3 studies which included two naïve trials and three switch trials. These studies included the participation of 37 PHNTX patients in the study of bictegravir, which is now FDA-approved: https://biktarvy.com/
In light of the FDA’s approval of Biktarvy®, Prism Health North Texas physician and clinical trial principal investigator, Dr. Gene Voskuhl, shared this, “Prism Health North Texas staff and patients have used their time and energy to continually improve the treatments available to those living with HIV or trying to prevent HIV. We won’t stop until there’s a cure.”
If you have questions about clinical trials at Prism Health North Texas, please contact Lauren Rogers at 972.807.7370.
Naïve trails are when someone living with HIV has not taken any ART (antiviral treatments) medications – i.e. new or naive to any medication.
Switch trials are for individuals who have been stable and virally suppressed on a specific medication regimen and are now switching to a different medication to determine if there is any change in their viral levels, side effects, or health with the new medication.
ABOUT PRISM HEALTH NORTH TEXAS:
Prism Health North Texas is advancing the health of North Texas through education, research, prevention, and personalized integrated HIV care. PHNTX, formerly AIDS Arms, is the largest local nonprofit organization providing care to those living with HIV/AIDS in North Texas. Since 1986 the organization has provided services including: state of the art HIV medical care, case management, prevention services including testing and counseling, research, medication assistance, and substance abuse/mental health counseling. For 27 years, LifeWalk, the Dallas AIDS Walk, has served Prism Health North Texas & the community through fundraising and awareness raising for individuals impacted by HIV/AIDS.
Prism Health North Texas