FDA approves Cabenuva for some adolescents living with HIV

US Food and Drug Administration (FDA) has approved ViiV Healthcare’s Cabenuva (cabotegravir, rilpivirine) for the treatment of HIV-1 in virologically suppressed adolescents (HIV-1 RNA less than 50 copies per milliliter [c/mL]) who are 12 years of age or older and weigh at least 35kg on a stable antiretroviral regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine.

The regimen was co-developed as part of a collaboration with the Janssen Pharmaceutical Companies of Johnson & Johnson. This approval marks the first time a long-acting HIV treatment is available for the adolescent population, underscoring ViiV Healthcare’s commitment to delivering options for young people living with HIV, the company said.

Cabenuva is the first and only complete long-acting HIV treatment regimen and is approved as a once monthly or every-two-months treatment for HIV-1 in virologically suppressed adults and adolescents. Cabenuva contains ViiV Healthcare’s cabotegravir extended-release injectable suspension in a single-dose vial and rilpivirine extended-release injectable suspension in a single-dose vial, a product of Janssen Sciences Ireland Unlimited Company, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, zhe company said.

Lynn Baxter, Head of North America at ViiV Healthcare, 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 expanded indication for Cabenuva is supported by studies in adults and by data from the Week 16 interim analysis of the ongoing MOCHA (More Options for Children and Adolescents) study from ViiV Healthcare’s collaboration with the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT). The efficacy of Cabenuva in adolescents is extrapolated from adults with support from pharmacokinetic analyses showing similar drug exposure. The safety profile in adolescents with the addition of either oral cabotegravir followed by injectable cabotegravir (n = 8) or oral rilpivirine (n = 15) followed by injectable rilpivirine (n = 13) was consistent with the safety profile established with cabotegravir plus rilpivirine in adults, the company said.

Also, based on data from the Week 16 analysis of the MOCHA study in 23 adolescents, adverse reactions were reported in 61% of subjects receiving either cabotegravir or rilpivirine in addition to their current antiretroviral treatment. The majority of these subjects (86%) had a Grade 1 or Grade 2 adverse reaction. The adverse reactions reported by more than one subject (regardless of severity) were injection site pain (n = 13) and insomnia (n = 2). Two subjects had Grade 3 adverse reactions of hypersensitivity (n = 1) and insomnia (n = 1). The Grade 3 adverse reaction of drug hypersensitivity led to discontinuation of rilpivirine during oral lead-in. Sixty-two percent of subjects who received at least one injection of cabotegravir or rilpivirine reported at least one injection site reaction. All injection site reactions were Grade 1 or Grade 2.