Children’s Hospital Colorado Participates in Global Groundbreaking Study That Could Lead to the Prevention and Potential Elimination of HIV

Children’s Colorado recently participated in a global study HPTN 083 which found that the long-acting injectable drug cabotegravir (CAB LA) protected people at risk of acquiring Human Immunodeficiency Virus (HIV). This could potentially lead to the prevention and elimination of HIV.

Children’s Colorado was one of three U.S. sites chosen specifically to recruit young men who have sex with men (MSM) and transgender women between the ages of 15 and 25 to participate in the study. This is due to our research and expertise in prevention through the Children’s Hospital Immunodeficiency Program (CHIP). CHIP focuses on improving the health and quality of life for children, youth, young adults, and pregnant women living with HIV and offers services to families living with, affected by, or at-risk for HIV.

Global HIV prevention study concludes early due to clear evidence that CAB LA was effective

The study, which began in December 2016, compared the safety and efficacy of CAB LA, given every two months, to Truvada, a daily pill combining two drugs, for pre-exposure prophylaxis, or PrEP. Findings showed that CAB LA was 69% more effective than the current standard of care for HIV prevention and lowered HIV incidence among cisgender, people whose personal identity is the same as their birth sex, men and transgender women. Due to the clear evidence that CAB LA was effective, the trial ended early so the new treatment can be made available as soon as possible. Two-thirds of study participants were under 30 years of age, and 12% were transgender women. Half of the participants in the U.S. study identified as Black or African American.

Study sought to represent populations disproportionately impacted by HIV 

“The study’s results are going to make a huge difference in ending the HIV epidemic on a global scale and reducing the number of people around the world living with HIV. It is especially exciting since we’re approaching the 40th anniversary of the first reports of HIV in medical literature,” said Dan Reirden, MD, medical director for the CHIP Youth Program and lead researcher for the study at Children’s Colorado. “I’m also proud to be part of a study that sought to adequately represent some of the populations most disproportionately impacted by HIV — Black MSM in the U.S., young MSM globally, and transgender women.”

The study, sponsored by the National Institute of Health’s National Institute of Allergy and Infectious Diseases, which recruited more than 4,500 individuals across more than 40 sites in North and South America, Asia and Africa, is one of the first clinical trials to directly compare two active prevention agents.

CAB LA to go through FDA process and CDER review

CAB LA will now go through the FDA approval process within a structured framework to confirm that data on the drug’s effects have been reviewed by the Center for Drug Evaluation and Research (CDER).

“We’re encouraged that regulators found so much benefit that it warranted an early conclusion and the unblinding of this monumental phase 2B/3A study,” said Dr. Reirden. “While we don’t know when this product will be approved by the FDA, it’s important, especially after Pride Month, to give a nod to the important work of HIV activists who fundamentally changed the speed at which life-saving medications went from research to consumers while ensuring safety.”