Label Update for Cabotegravir and Rilpivirine Long-Acting HIV Treatment

With FDA Approval, the oral lead-in for the cabotegravir and rilpivirine long-acting HIV treatment (Cabenuva) is now optional. Clinical trial data showed similar safety and efficacy profiles for initiating the therapy with or without the oral lead-in.

This morning, ViiV Healthcare announced the US Food and Drug Administration (FDA) approved a label update for Cabenuva, their cabotegravir and rilpivirine long-acting HIV treatment.

The FDA acquiesced to make the therapy’s oral lead-in with cabotegravir and rilpivirine tablets optional. Now, cabotegravir and rilpivirine may or may not be taken orally for a month to assess tolerability, before initiating cabotegravir and rilpivirine injections.

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.

“Since launching Cabenuva, we have been keenly focused on optimizing the user experience for both people living with HIV and healthcare providers,” said Lynn Baxter, the North American head of ViiV Healthcare. “Today’s label update for the optional oral lead-in 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 that address the evolving needs of the HIV community.”

Cabenuva is the first and only complete long-acting HIV treatment regimen. On January 21, 2021, Cabenuva was first approved as an injectable, once-monthly HIV therapy. The FDA granted a label expansion on February 1, 2022, for Cabenuva to be administered once every 2 months.

The Cabenuva cabotegravir and rilpivirine regimen was co-developed by ViiV Healthcare and Janssen Pharmaceutical Companies of Johnson & Johnson. Cabenuva is intended as a replacement antiretroviral therapy (ART) for virologically suppressed adults (HIV-1 RNA <50 c/ml) with HIV-1 infection.

Previous antiretroviral therapies required dosing every day, a strict regimen that is not necessarily accessible for some populations at high risk of HIV, like homeless people or people who inject drugs.

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.

The most common side effects of Cabenuva, reported in ≥2% of participants, were injection site reactions, rash, pyrexia, fatigue, headache, musculoskeletal pain, nausea, dizziness, and sleep disorders.

ViiV Healthcare is a global HIV specialist company, majority owned by GlaxoSmithKline (GSK), with majority shareholders Pfizer Inc. and Shionogi Limited. The company was established in November 2009 to advance care and treatment for people living with HIV or people at high risk of contracting HIV.