Therapy Areas: AIDS & HIV
US FDA Approves Cabenuva as Long-Acting Regimen for the Treatment of HIV
22 January 2021 - - The US Food and Drug Administration has approved Cabenuva (consisting of Janssen's rilpivirine and ViiV Healthcare's cabotegravir), the first and only once-monthly, long-acting regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults, US-based healthcare company Johnson and Johnson's (NYSE: JNJ) Janssen Pharmaceutical business said.

The novel regimen was co-developed as part of a collaboration with ViiV Healthcare and builds on Janssen's 25-year commitment to make HIV history. In the US, ViiV Healthcare is the marketing authorization holder for Cabenuva.

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.

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 US.

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 patients receiving either Cabenuva or their daily current antiretroviral regimen having an HIV-1 RNA level ≥50 c/mL. 2% 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 % 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%,
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