Long-Acting Cabenuva Injections Now Approved for Teens

The Food and Drug Administration (FDA) has extended the indication for Cabenuva (capotegravir injection plus rilpivirine) to include adolescents 12 years of age and older. This will allow eligible young people living with HIV to take antiretroviral therapy only six or 12 times a year.

Daily antiretroviral pills are very effective, but some people find long-acting injections more convenient, which could lead to better adherence. This could be especially important for teenagers, as some studies have shown that this group has trouble joining.

Cabenuva consists of an extended-release formulation of cabotegravir, an integrase inhibitor from ViiV Healthcare, plus an injectable version of rilpivirine, a non-nucleoside reverse transcriptase inhibitor from Janssen. It is indicated as maintenance therapy for adults and adolescents weighing at least 77 pounds (35 kilograms) who have achieved viral suppression (a viral load below 50 copies) on daily oral antiretroviral therapy and who have no history of treatment failure and no known or suspected disease. resistance to either drug.

The FDA originally approved Cabenuva as a once-a-month regimen for adults in January 2021. A bimonthly schedule was added in February 2022. Last week, the federal agency cleared a new dosing schedule that allows people to start injections directly without taking cabotegravir and rilpivirine pills for a month; the oral introduction period is now optional. (Injectable cabotegravir alone for pre-exposure prophylaxis, sold as Apretude, was originally approved in December 2021 for adults and adolescents.)

The ATLAS study showed that people who switched from a standard oral regimen to monthly Cabenuva injections were about as likely to maintain viral suppression as those who continued to take daily pills (93% and 96%, respectively). The ATLAS-2M study showed that those who received the injections every eight weeks were as likely to maintain an undetectable viral load as those who received it every four weeks. The FLAIR trial found that Cabenuva is also effective for people starting HIV treatment for the first time. Interim data from an ongoing study called MOCHA (More Options for Children and Adolescents) showed that drug levels and safety profiles in adolescents were similar to those in adults.

Cabenuva is safe and generally well tolerated. The most common side effect is a reaction at the injection site, such as pain, redness or swelling. These are usually mild to moderate and last an average of three days. Other adverse events including fever, fatigue, headache, muscle aches, nausea, trouble sleeping, dizziness, and rash are uncommon. Few people taking Cabenuva in clinical trials experienced serious adverse events or discontinued treatment due to side effects.

Studies in adults found that participants were more satisfied with Cabenuva than with daily oral treatment. Reasons for preferring injections include not having to think about HIV treatment every day and not having pill bottles that could reveal HIV status – benefits that will also benefit teenagers. The downside is that the regimen requires a health care provider to visit for butt injections every month or two; Cabenuva cannot be self-administered.

“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,” ViiV’s Lynn Baxter said in A press release. “With today’s approval for Cabenuva, we are offering this younger population a first-of-its-kind HIV treatment that is administered as little as six times per year and completely eliminates the need for daily oral therapy. .”

Click here for updated prescribing information on Cabenuva.
Click here for more information on long-acting HIV treatment.


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