The expanded indication for the HIV regimen provides a treatment option for virologically suppressed young people living with HIV
Cabenuva packaging and product. (Credit: Business Wire)
ViiV Healthcare, a GSK company specialised in HIV treatment, announced that the US Food and Drug Administration (FDA) has expanded the indication for Cabenuva (cabotegravir, rilpivirine), to include adolescents.
The expanded approval indicates the HIV drug for virologically suppressed adolescents, aged 12 years and above, to replace their current antiretroviral regimen.
Also, the treatment requires the patients to weigh at least 35kg, and have no history of treatment failure, and suspected resistance to either cabotegravir or rilpivirine.
Cabenuva is a complete long-acting HIV treatment regimen comprising ViiV Healthcare’s cabotegravir and Janssen’s rilpivirine.
The company has developed the regimen as part of its collaboration with the Johnson & Johnson (J&J)’s pharmaceutical business Janssen.
The regimen was previously approved in the US, as once monthly or every-two-months therapy to treat HIV-1 in virologically suppressed adults.
With the expanded approval, Cabenuva becomes the first and only long-acting HIV treatment approved for the adolescent population.
ViiV Healthcare North America head Lynn Baxter said: “Adolescents living with HIV and their caregivers face notable treatment challenges with daily oral HIV therapy, including the stress and difficulties of taking medication every day.
“With today’s approval for Cabenuva, we are bringing this younger population a first-of-its-kind HIV treatment that is dosed as few as six times a year and removes the need for daily oral therapy altogether.
“At ViiV Healthcare, we are proud to deliver on our mission of leaving no person living with HIV behind and providing an innovative therapy to youth that addresses an unmet need is an important step forward.”
The FDA expanded the indication for Cabenuva based on studies in adults and data from the Week 16 interim analysis of the ongoing Phase 3 MOCHA study.
MOCHA trial is conducted by ViiV Healthcare, in collaboration with the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT).
The Phase 3 trial is designed to evaluate the safety, tolerability, acceptability, and pharmacokinetics of cabotegravir and rilpivirine in adolescents living with HIV.
In the study, oral followed by injectable cabotegravir or oral followed by injectable rilpivirine in adolescents showed a consistent safety profile with that established using cabotegravir plus rilpivirine in adults.