CABENUVA is now the first once-monthly, complete long-acting regimen for the treatment of HIV-1 in adults, which has been indicated to replace the current antiretroviral (ARV) regimen in patients who are stable virologically and suppressed.
According to ViiV Healthcare, its drug regimen allows virologically suppressed adults with HIV to maintain viral suppression while lowering their dosing schedule from 365 days to 12 days per year.
The company has simultaneously bagged the approval for VOCABRIA (cabotegravir oral tablets) by Health Canada for short time periods in conjunction with CABENUVA.
As per the company, both the drug regimens should not be used in patients having known or suspected resistance to either cabotegravir or rilpivirine.
ViiV Healthcare CEO Deborah Waterhouse said: “Today’s approval marks a monumental step in the treatment of HIV and is a true testament to ViiV Healthcare’s R&D innovation. With CABENUVA, people living with HIV who are virologically suppressed now have an option to maintain that suppression with 12 treatments a year thereby positively impacting their lives.”
The Canadian approval of the drug regimen has been driven by the findings of the phase 3 ATLAS (Antiretroviral Therapy as Long-Acting Suppression) and FLAIR (First Long-Acting Injectable Regimen) trials that included over 1,100 participants from 16 countries.
Before initiating treatment with CABENUVA, oral dosing of cabotegravir and rilpivirine lead-in was injected for nearly a month to evaluate the tolerability of cabotegravir and rilpivirine. ViiV Healthcare said that the trials showed that CABENUVA, when intramuscularly injected in the buttocks, monthly once, was as effective as continuing their daily, oral, antiretroviral regimens in sustaining viral suppression throughout the study period which lasted 48 weeks.
FLAIR principal investigator Chloe Orkin said: “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. Most participants in the clinical trials preferred it over their prior oral daily regimens.”