FDA Expands Label of Cabotegravir and Rilpivirine Dual Injectable for Adults With HIV

This morning, ViiV Healthcare announced that the US Food and Drug Administration (FDA) expanded its approval of cabotegravir and rilpivirine (Cabenuva), the first and only long-acting regimen to treat HIV infection in adults.

Previously approved for monthly use, the label expansion allows ViiV Healthcare’s cabotegravir and Janssen’s rilpivirine to be dually administered once every 2 months.

The cabotegravir and rilpivirine formulation allows virologically suppressed adults living with HIV to maintain viral suppression with 6 injection days a year. The expanded approval still only applies to adults living with HIV with HIV-1 RNA less than 50 copies per milliliter on a stable regimen, with no prior treatment failure or resistance to cabotegravir or rilpivirine.

The dual injectable consists of extended-release suspension single-dose vials of both cabotegravir and rilpivirine.

The label expansion was based upon positive results from the global ATLAS-2M phase 3b trial, demonstrating that dosing every 2 months was comparable to once-a-month dosing. At week 48, the every-2-month arm (9/522, 1.7%) and every month arm (5/523, 1.0%) had similar efficacies. The ATLAS-2M trial also showed comparable rates of virologic suppression between every-2-month dosing (492/533, 94.3%) and once-a-month dosing (489/523, 93.5%).

The most commonly reported (≥2%) adverse events of cabotegravir and rilpivirine were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash. The type and frequency of adverse events were similar for participants receiving monthly and bimonthly injections. Rates of serious adverse events and withdrawal due to adverse events were comparable for the once-every-2-month arm and once-a-month arm.

ATLAS-2M (NCT03299049) is an ongoing, randomized, open-label, active-controlled, multicenter, parallel-group phase 3b clinical trial. ATLAS-2M assesses the antiviral activity and safety of long-acting cabotegravir and rilpivirine administered every 8 weeks (3 ml dose), in comparison to dosing every 4 weeks (2 ml dose). The trial includes 1045 adults living with HIV-1, monitored over a 48-week study period.

The primary outcome of the ATLAS-2M trial was the number pf participants with HIV-1 RNA ≥ 50 c/ml at week 48, in accordance with the US FDA Snapshot algorithm (intent-to-treat-exposed population). ATLAS-2M is underway at research centers in Australia, Argentina, Canada, France, Germany, Italy, Mexico, Russia, South Africa, South Korea, Spain, Sweden and the United States.

ViiV Healthcare is a global HIV specialist company majority owned by GlaxoSmithKline (GSK), with Pfizer Incorporated and Shionogi Limited as shareholders. ViiV Healthcare was established in November 2009 by GSK and Pfizer, with Shionogi coming onboard in October 2012.