TITUSVILLE - The Janssen Pharmaceutical Companies of
The novel regimen was co-developed as part of a collaboration with
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.
CABENUVA, a co-packaged kit with two injectable medicines, offers people living with HIV a new approach for maintaining viral suppression.1
'With the approval of CABENUVA, we're proud to bring a new treatment option to people living with HIV that removes the burden of taking a daily pill,' said
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 patients from 16 countries, including the
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 patients receiving either CABENUVA or their daily current antiretroviral regimen (CAR) having an HIV-1 RNA level 50 c/mL. Two percent of patients receiving the long-acting injectable and 1% of patients receiving CAR had an HIV-1 RNA level 50 c/mL at Week 48 (Treatment Difference 0.7%; 95% CI: -1.2%, 2.5%).
In the FLAIR study, at Week 48, a comparable number of patients receiving either CABENUVA or daily oral dolutegravir/abacavir/lamivudine therapy had an HIV-1 RNA count 50 c/mL, meeting noninferiority criteria. Two percent of patients in both treatment arms had an HIV-1 RNA count 50 c/mL at Week 48 (Treatment Difference -0.4%; 95% CI: -2.8%, 2.1%).
Adverse reactions of at least Grade 2 severity in patients who were receiving CABENUVA or CAR were, respectively: injection site reactions (37%, 0), pyrexia (2%, 0), fatigue (1%,
(C) 2021 Electronic News Publishing, source