HIV Treatment Cabenuva Now Available for Adolescents 12 and Older

Today, the FDA approved the long-acting HIV treatment Cabenuva (cabotegravir and rilpivirine dually administered) for virologically suppressed adolescents 12 years and older.

Today, ViiV Healthcare announced that the US Food and Drug Administration (FDA) expanded the HIV treatment Cabenuva (cabotegravir and rilpivirine administered together). The first and only long-acting HIV therapy will now be available for adolescents 12 and older.

“This approval marks the first time a long-acting HIV treatment is available for the adolescent population,” ViiV said in a statement. Previous HIV treatment regimens required dosing every day.

Cabenuva is now authorized to treat HIV-1 disease in virologically suppressed adolescents (HIV-1 RNA less than 50 copies per milliliter [c/mL]) who are at least 12 years old and 35 kg (~77 lbs.). People living with HIV who meet these requirements, and are on a stable antiretroviral regimen with no history of treatment failure and no resistance to cabotegravir or rilpivirine, have the option of dosing as few as 6 times a year with Cabenuva.

Cabenuva is FDA approved as a once-monthly or every-2-months complete HIV regimen. Cabenuva is comprised of ViiV Healthcare’s extended-release injectable cabotegravir and Janssen’s extended-release injectable rilpivirine. These 2 injections are administered in succession.

“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. “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.”

The FDA expanded Cabenuva for use in adolescents based upon positive results from the ongoing More Options for Children and Adolescents (MOCHA) clinical trial. The study, a collaborative effort from ViiV Healthcare and the Internal Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT), found the safety profile of Cabenuva in adolescents to be comparable to the adult participants’ safety profile.

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.

ViiV Healthcare is a global HIV specialist company majority owned by GlaxoSmithKline (GSK), with Pfizer Incorporated and Shionogi Limited as shareholders. ViiV Healthcare was established in November 2009 by GSK and Pfizer, with Shionogi coming onboard in October 2012.