ViiV Official Answers MHE Questions About Cabenuva

Kimberly Smith, M.D., M.P.H, head of research & development at ViiV Healthcare, recently answered several emailed questions from Managed Healthcare Executive® about Cabenuva, the company’s long-acting injectable HIV medication that may improve adherence to antiretroviral therapy.
GlaxoSmithKline is the majority owner of ViiV, which specializes in developing and marketing HIV medications.

On FDA approvals

Cabenuva (cabotegravir, rilpivirine) is the first and only complete long-acting HIV treatment regimen. It was first approved by the FDA in January 2021 as a once-monthly treatment for HIV-1 in virologically suppressed adults. On Jan. 31, 2022, the FDA expanded the label to include every-two-month dosing, allowing people living with HIV to maintain viral suppression while reducing their dosing days to as few as six times a year.

How Cabenuva is delivered exactly?

Cabenuva is comprised of two injectable medicines – ViiV Healthcare’s cabotegravir extended-release injectable suspension in a single-dose vial and Janssen’s rilpivirine extended-release injectable suspension in a single-dose vial. These are administered intramuscularly as two individual injections in the buttocks (gluteus muscle) by a healthcare provider, either once monthly or every two months. Before starting the injections, oral cabotegravir and rilpivirine tablets should be used for one month to assess tolerability.

Can you explain the data concerning adherence from the clinical trials of Cabenuva?

Until Cabenuva, all HIV regimens required taking a pill every day and that’s a challenge for some people. Now, individuals just need to adhere to their clinic visits every month or every two months. In our phase III clinical trials, more than 97% of participants were able to attend their clinic visits within the (plus or minus) seven-day dosing window.

What is the price of Cabenuva?

The price of Cabenuva is similar to that of other key single tablet regimens in the market. The list price of Cabenuva (cabotegravir 600mg/3ml; rilpivirine 900mg/3ml) is $6,088.50 and the list price of Cabenuva (cabotegravir 400mg/2mLlrilpivirine 600mg/2ml) is $4,059. There’s no cost for the cabotegravir or rilpivirine oral-in tablets.

Are insurers covering Cabenuva?

We have strong coverage of Cabenuva today, with most payers providing access to the once-monthly dosing, and we expect similar coverage for the every-two-month dosing.

In many cases, the existing coverage does not specify dosing limits so the every-two-month dosing may be immediately available to patients now that it is FDA approved.

For those payers that specify dosing limits in their coverage criteria, we expect coverage policies to be updated in the coming weeks to reflect the newly FDA-approved every-two-month dosing.

Smith said more information about Cabenuva is available at www.viivconnect.com.