Health Canada approves long-acting HIV treatment Cabenuva

Health Canada has approved a long-acting injectable HIV treatment that the FDA recently declined to approve.

Cabenuva is a once-monthly regimen that includes cabotegravir (ViiV Healthcare) and rilpivirine (Janssen). It is intended to take the place of a patient’s current antiretroviral regimen for those who are virologically stable and suppressed (defined as less than 50 copies/mL of HIV-1 RNA).

Health Canada has also approved Vocabria (cabotegravir oral tablets, ViiV) used for short time periods in combination with Cabenuva. According to a press release from the company, these approvals are the first for Cabenuva and Vocabria anywhere in the world.

“Today’s approval marks a monumental step in the treatment of HIV and is a true testament to ViiV Healthcare’s [research and development] innovation,” Deborah Waterhouse, CEO of ViiV Healthcare, said in the release. “With Cabenuva, people living with HIV who are virologically suppressed now have an option to maintain that suppression with 12 treatments a year.”

The approval of Cabenuva comes after the phase III ATLAS and FLAIR trials, which examined efficacy and safety among more than 1,100 participants from 16 countries. According to the release, both studies found that Cabenuva, when given intramuscularly once a month, was as effective for maintaining viral suppression as daily oral antiretroviral regimens over the 48-week study period.

“Cabenuva, an injectable treatment, has the potential to transform HIV care by offering monthly instead of daily treatment to suitable patients. It reduces the frequency of dosing and is as effective as daily, oral, three-drug regimens in maintaining viral suppression among adults living with HIV,” Chloe Orkin, MD, consultant physician and clinical professor at Queen Mary University of London and FLAIR principal investigator, said in the release. “Most participants in the clinical trials preferred it over their prior oral daily regimens.”

Previous investigations of Cabenuva in the United States led to the FDA denying approval of the treatment, citing “chemistry, manufacturing and controls (CMC)” as reasons. Janssen Pharmaceuticals and ViiV Healthcare said at the time that there had been no reported CMC-related safety issues and that the FDA’s response did not relate to the regimen’s clinical safety data that was submitted to the agency. – by Caitlyn Stulpin

Health Canada has approved a long-acting injectable HIV treatment that the FDA recently declined to approve.

Cabenuva is a once-monthly regimen that includes cabotegravir (ViiV Healthcare) and rilpivirine (Janssen). It is intended to take the place of a patient’s current antiretroviral regimen for those who are virologically stable and suppressed (defined as less than 50 copies/mL of HIV-1 RNA).

Health Canada has also approved Vocabria (cabotegravir oral tablets, ViiV) used for short time periods in combination with Cabenuva. According to a press release from the company, these approvals are the first for Cabenuva and Vocabria anywhere in the world.

“Today’s approval marks a monumental step in the treatment of HIV and is a true testament to ViiV Healthcare’s [research and development] innovation,” Deborah Waterhouse, CEO of ViiV Healthcare, said in the release. “With Cabenuva, people living with HIV who are virologically suppressed now have an option to maintain that suppression with 12 treatments a year.”

The approval of Cabenuva comes after the phase III ATLAS and FLAIR trials, which examined efficacy and safety among more than 1,100 participants from 16 countries. According to the release, both studies found that Cabenuva, when given intramuscularly once a month, was as effective for maintaining viral suppression as daily oral antiretroviral regimens over the 48-week study period.

“Cabenuva, an injectable treatment, has the potential to transform HIV care by offering monthly instead of daily treatment to suitable patients. It reduces the frequency of dosing and is as effective as daily, oral, three-drug regimens in maintaining viral suppression among adults living with HIV,” Chloe Orkin, MD, consultant physician and clinical professor at Queen Mary University of London and FLAIR principal investigator, said in the release. “Most participants in the clinical trials preferred it over their prior oral daily regimens.”

Previous investigations of Cabenuva in the United States led to the FDA denying approval of the treatment, citing “chemistry, manufacturing and controls (CMC)” as reasons. Janssen Pharmaceuticals and ViiV Healthcare said at the time that there had been no reported CMC-related safety issues and that the FDA’s response did not relate to the regimen’s clinical safety data that was submitted to the agency. – by Caitlyn Stulpin