ViiV Healthcare announces first global regulatory approval of CABENUVA; the first complete, long-acting, regimen for the treatment of HIV

发布时间： 2020-03-29 阅读：1434次

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March 20, 2020--ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that Health Canada has approved CABENUVA, the first and only once-monthly, complete long-acting regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral (ARV) regimen in patients who are virologically stable and suppressed (HIV-1 RNA less than 50 copies per milliliter [mL]). VOCABRIA oral tablets, to be used for short time periods in conjunction with CABENUVA, have also been approved by Health Canada. These approvals are the first for CABENUVA and VOCABRIA anywhere in the world.

The approval of CABENUVA is based on the pivotal phase III ATLAS (Antiretroviral Therapy as Long-Acting Suppression) and FLAIR (First Long-Acting Injectable Regimen) studies that included more than 1,100 participants from 16 countries. Prior to initiating treatment with CABENUVA, oral dosing of cabotegravir and rilpivirine lead-in was administered for approximately one month.

 The studies demonstrated that CABENUVA, when injected intramuscularly in the buttocks, once a month, was as effective as continuing their daily, oral, antiretroviral regimens in maintaining viral suppression throughout the 48-week study period.

Chloe Orkin, M.D., Consultant Physician and Clinical Professor at Queen Mary University of London and FLAIR principal investigator, 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.”