The U.S. Food and Drug Administration (FDA) approved CABENUVA (rilpivirine and cabotegravir), the first long-acting regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. CABENUVA offers adults living with HIV a new once-monthly injectable option for maintaining viral suppression. CABENUVA consists of Janssen’s rilpivirine and ViiV Healthcare’s cabotegravir. In the U.S., ViiV Healthcare is the marketing authorization holder for CABENUVA.
CABENUVA comes as a co-packaged kit with two injectable medicines. CABENUVA is indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine. Prior to initiating treatment with CABENUVA, oral cabotegravir (VOCABRIA) and oral rilpivirine (EDURANT®) should be administered for approximately one month to assess the tolerability of each therapy.
The approval of CABENUVA is based on the pivotal Phase 3 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, including the U.S. The studies demonstrated that CABENUVA was as effective as continuing a daily, oral, three-drug regimen in maintaining viral suppression throughout the 48-week study period. In the ATLAS study, CABENUVA met the primary endpoint for noninferiority (the proportion of participants with plasma HIV-1 RNA ≥50 copies per milliliter [c/mL] at Week 48), with a comparable number of people receiving either CABENUVA or their daily current antiretroviral regimen (CAR) having an HIV-1 RNA level ≥50 c/mL. Two percent of people receiving the long-acting injectable and 1% of people receiving CAR had an HIV-1 RNA level ≥50 c/mL at week 48.
The once-monthly rilpivirine and cabotegravir injectable treatment was approved by Health Canada on March 20, 2020, and the European Commission approved a once-monthly and once every two-month version of the injectable treatment on December 21, 2020. Regulatory reviews continue in Australia and Switzerland, and several additional submissions are planned throughout 2021.
Janssen Pharmaceutical Companies of Johnson & Johnson focuses on cardiovascular and metabolism, immunology, infectious diseases and vaccines, neuroscience, oncology, and pulmonary hypertension. ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline and Pfizer dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV.
This was reported by Janssen and ViiV Healthcare on January 21, 2021.
Contact information: Janssen Pharmaceutical Companies of Johnson & Johnson, 1000 U.S. Route 202 South, Raritan, New Jersey 08869; 732-258-1540; Website: www.janssen.com
Contact information: ViiV Healthcare US, Five Moore Drive, Research Triangle Park, North Carolina, 27709-3398; Website: https://viivhealthcare.com/en-us/