FDA Approves Cabenuva to Treat HIV in Adolescents 12 Years of Age or Older

FDA approves expanded indication for the treatment of HIV-1 in virologically suppressed adolescents 12 years of age or older, who weigh at least 35 kg, and who are on a stable antiretroviral regimen, with no history of treatment failure or known or suspected resistance to either cabotegravir or rilpivirine.

The FDA has approved an expanded indication for the HIV therapy cabotegravir and rilpivirine (Cabenuva) in adolescents.

The expanded indication is for the treatment of HIV-1 in virologically suppressed adolescents (HIV-1 RNA less than 50 copies per milliliter [c/mL]), 12 years of age or older, who weigh at least 35 kg (~77 lbs), and who are on a stable antiretroviral regimen, with no history of treatment failure or known or suspected resistance to either cabotegravir or rilpivirine.

“HIV remains one of the most significant challenges in global health, and as part of our decades-long commitment to fighting HIV, Janssen is working tirelessly to advance innovative new treatment options for young people living with HIV,” James Merson, PhD, global therapeutic area head, Infectious Diseases, Janssen Research & Development, LLC, said in a press release. “With this milestone, we’re continuing to redefine how HIV can be managed so that even more people, including adolescents, can benefit from long-acting injectable therapies.”

Cabenuva is co-developed as part of a collaboration with Janssen Pharmaceutical Companies of Johnson & Johnson and ViiV Healthcare. It is now the first and only complete long-acting HIV-1 treatment regimen, as well as the first to be made available for eligible adolescents.

“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,” said Lynn Baxter, the head of ViiV Healthcare North America, in a press release. “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 6 times a year and removes the need for daily oral therapy altogether.”

The expanded indication was based on studies in adults and by data from the week 16 interim analysis of the More Options for Children and Adolescents (MOCHA) study conducted via ViiV Healthcare’s collaboration with the International Maternal Pediatric Adolescent AIDS Clinical Trials Network. Cabenuva’s efficacy in adolescents was extrapolated from adults with support from pharmacokinetic analyses that indicated similar drug exposure.

The safety profile of Cabenuva in adolescents was found to be comparable to adult participants. In adolescents, 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, according to the study.

The Cabenuva regimen combines the integrase strand transfer inhibitor (INSTI) of ViiV Healthcare’s cabotegravir with Janssen’s non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine. INSTIs prevent the replication of HIV cells by inhibiting the viral DNA from entering the genetic material of human T-cells. NNRTIs stop the HIV virus from multiplying by impairing the reverse transcriptase enzyme.

Last week, the FDA approved a label update for Cabenuva that makes the therapy’s oral lead-in with cabotegravir and rilpivirine tablets optional. As a result, Cabenuva may or may not be taken orally for a month to evaluate tolerability prior to initiating injections of the medication.

The decision resulted from clinical data that demonstrated similar safety and efficacy among trial participants who did or did not initiate treatment with the oral lead-in. Cabenuva is intended as a replacement antiretroviral therapy for virologically suppressed adults (HIV-1 RNA <50 c/ml) with HIV-1 infection.