Welcome back. In this issue of Ron’s Clinical Corner, I wanted to provide an update on a recently approved medication for the treatment of HIV infection in adults.
On January 21, 2021, the Food and Drug Administration (FDA) approved Cabenuva® (cabotegravir and rilpivirine) as a once-monthly therapy to treat adults infected with HIV. Cabotegravir is classified as an integrase strand transfer inhibitor (INSTI), while rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI). The medications compliment each other by affecting different parts of the pathway used by the HIV virus to replicate, which results in lowering viral loads or levels.
Along with the approval of Cabenuva®, the FDA also approved Vocabria® (cabotegravir) oral tablets. Vocabria® is used in combination with an existing medication, Edurant® (rilpivirine), for the first month as an oral lead-in therapy before the first injection of Cabenuva®. By using the initial oral therapy, any significant side effects or adverse reactions can be identified before a patient begins treatment with the long-acting injections. The oral combination can also be used during treatment in certain circumstances if a patient misses a scheduled injection.
Currently, many single-tablet regimens are available for the treatment of HIV including, but not limited to Biktarvy®, Delstrigo®, Dovato®, Genvoya®, Juluca®, Odefsey®, Symfi®/Symfi Lo®, and Triumeq®. These products have average costs around $30,000 – 40,000 per year. Cabenuva® is estimated to have an annual cost of over $50,000. Due to the high cost, medical and/or prescription carries will most likely require prior authorization or other utilization review before the medication will be considered for coverage. Also, Cabenuva® must be administered by a healthcare professional which would makes it eligible for coverage under the medical benefit. While this could be the case, there may still be opportunity to have the medication sourced through the prescription benefit and brought or delivered to the physician office for administration.
RESEARCH IS ONGOING TO INVESTIGATE FUTURE USES FOR CABENUVA®. THERE IS PRELIMINARY EVIDENCE THAT THE MEDICATION MAY BE EFFECTIVE WHEN GIVEN AT EVERY 8- VERSUS 4-WEEK INTERVALS.
At this time, some experts think that ViiV Healthcare (manufacturer) may submit data to the FDA supporting this in 2021. Also, the medication was evaluated as a potential to be used in pre-exposure prophylaxis (PrEP). At this time, although preliminary information seems to be positive, results from these studies have not been published. Again, some believe there may be more to come on this sometime in early- to mid-2021. If the medication does receive approval for PrEP it would compete with products such as emtricitabine/tenofovir disoproxil fumarate (generic Truvada®) and Descovy®.
Thanks for stopping by and see you next month!