January 21, 2021

The U.S. FDA has approved Cabenuva® (cabotegravir/rilpivirine), an extended-release, injectable, complete regimen for the treatment of HIV-1 infection in adults. Manufactured by ViiV Healthcare, Cabenuva is indicated to replace a current antiretroviral regimen in patients who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and no known or suspected resistance to either cabotegravir or rilpivirine.

Cabenuva is the first and only long-acting complete regimen for HIV-1 infection to receive FDA approval. This may help reduce the medication burden for patients by allowing them to avoid the need to take oral medication on a daily basis to control their HIV. One goal of treatment for HIV-1 infection is to suppress the virus, limiting the number of copies it makes in the body to prevent disease progression. This also helps to protect CD4 cells, a type of white blood cell needed for proper immune function that can be destroyed by HIV.

In clinical studies, patients who were virologically suppressed (HIV-1 RNA < 50 copies/mL) on their current antiviral regimens and then switched to Cabenuva continued to show virologic suppression. Patients also had no observed clinically relevant changes from baseline in CD4+ cell counts. A count that falls below 200 cells/mm3 is an indicator of acquired immune deficiency syndrome.

The FDA has also approved ViiV Healthcare’s Vocabria® (cabotegravir) tablets, which should be taken in combination with oral rilpivirine for one month prior to starting treatment with Cabenuva. This oral lead- in dosing helps to ensure the combination of cabotegravir and rilpivirine is well-tolerated before switching a patient to the Cabenuva extended-release injection.

For the one-month oral lead in, recommended dosing is 30mg Vocabria and 25mg rilpivirine once daily with a meal. The recommended initial dose of Cabenuva is 600mg of cabotegravir and 900mg of rilpivirine given on the last day of oral lead-in dosing, then 400mg of cabotegravir and 600mg of rilpivirine for subsequent doses. Cabenuva is administered once a month by a healthcare professional via intramuscular injection.

Cabenuva has launched at a wholesale acquisition cost (WAC) of $990 per vial.

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