Label Changes for Cabenuva, the Long-acting, Injectable HIV Treatment

The oral run-in period for the injectable is now optional. The FDA also approved a label change that opens the door for adolescents to be treated with long-acting HIV treatment.

The FDA has approved a label update for Cabenuva, making the oral lead-in with cabotegravir and rilpivirine tablets optional.

Until the label change, oral cabotegravir and rilpivirine were to be taken for a month to assess tolerability to the medicines prior to starting, an injectable formulation of the two drugs.

Lynn Baxter, a senior vice president at ViiV Healthcare, the maker of Cabenuva, said in a press release that making the oral run-in period optional “provides a streamlined initiation process for the regimen by allowing people to start directly on long-acting injections and underscores ViiV Healthcare’s ongoing commitment to providing innovative treatment options.”

In addition, the FDA expanded Cabenuva’s label in March to include virologically suppressed adolescents 12 years of age or older and weighing at least 35 kg, marking the first time a long-acting HIV treatment is available for young people living with HIV.

Kimberly Smith, M.D., M.P.H., senior vice president, head of research and development for ViiV, says that Cabenuva is a meaningful option for the HIV community because it is the first complete treatment for HIV that does not include a daily pill.

With Cabenuva, people can go to their healthcare provider once a month, or every two months, to receive the injections and then can go on with their everyday lives without thinking about their HIV status, Smith noted./Some people worry about their pill bottle being found and their status being disclosed accidentally, so a long-acting treatment may ease those concerns.

“Many people face challenges with daily oral therapy and to offer a first-of-its-kind regimen for virologically suppressed adults that reduces dosing to as few as six times a year is a true innovation,” she says.

Even so, Fierce Pharma reported in March that uptake of Cabenuva has been hindered by the COVID-19 pandemic and a centralized distribution system. Citing a report aboot a physician survey, the Fierce publication said that only 1% to 2% of patients are receiving the monthly injectable.

Cabenuva is comprised of two injectable medicines—ViiV Healthcare’s cabotegravir extended-release injectable suspension in a single-dose vial (200mg/mL) and rilpivirine extended-release injectable suspension in a single-dose vial (300mg/mL), a product of Janssen Sciences Ireland Unlimited Company, one of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Cabotegravir is an integrase strand transfer inhibitor (INSTI), and rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI); both medicines work by blocking enzymes that allow HIV to multiply in the body.

“INSTIs, like cabotegravir, block an HIV enzyme called integrase which can reduce the amount of HIV in the body,” Smith says. “Rilpivirine interferes with an enzyme called reverse transcriptase. By blocking reverse transcriptase and stopping reverse transcription, rilpivirine can stop the HIV virus from multiplying. The long-acting injectable formulations allow the medicines to stay in the body for longer, so people living with HIV can take it less frequently.”

“Based on our Cabenuva clinical trial data, we know some people living with HIV have been waiting for long-acting injectables,” Smith says. “Cabenuva dosed every two months was preferred by approximately nine out of every 10 participants, compared to daily oral cabotegravir and rilpivirine taken as the oral lead-in.”

As a leader in long-acting HIV regimens, ViiV Healthcare will continue to push the boundaries in its research and development efforts to make a difference in the lives of people living with HIV, she adds.

“Providing a broad range of treatment options is critical to improving health outcomes; no one therapy is going to work for everyone, so it’s important that people feel in control and that they have a choice when it comes to a treatment that fits within their lifestyle,” Smith says.