First Long-Acting HIV Injectable Cabenuva Receives FDA Approval 

The U.S. Food and Drug Administration (FDA) has approved Cabenuva (cabotegravir and rilpivirine) for the long-acting treatment of HIV. Cabenuva comes as an injectable medicine that is taken once a month. It can be used as a stand-alone treatment option for people with living with HIV who:1,2

  • Have very low or undetectable levels of virus in their blood
  • Are on a stable antiretroviral treatment (ART) regimen
  • Have no history of past treatment failure
  • Have HIV that is not resistant to the ingredients in Cabenuva

The first long-acting injectable for HIV

Cabenuva is officially the first long-acting injectable approved by the FDA for HIV treatment. For the first time, some people with HIV will only need treatment once a month instead of daily.

How will Cabenuva impact treatment adherence?

This may have a large impact on treatment adherence. Treatment adherence is the ability to take every dose of a drug as it is prescribed. This may be especially important for those who have a hard time with daily treatment. Good treatment adherence can help a person achieve and maintain an undetectable viral load and prevent treatment failures.1,2

More on this topic

This approval was so important, the FDA granted it Fast Track and Priority Review. These programs allow life-changing treatment options to make it to the market faster than normal.1,2

How does Cabenuva work?

The 2 active ingredients in Cabenuva are cabotegravir and rilpivirine.1,2

Cabotegravir belongs to a class of drugs called integrase inhibitors. It prevents HIV from getting into human cell DNA. Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI). It directly impacts HIV’s ability to multiply.

Together, the drugs block important steps in the HIV life cycle in order to maintain viral suppression.1,2

A trial of Vocabria and Edurant first

In addition to Cabenuva, the FDA also approved a drug called Vocabria. Vocabria is a tablet that only contains cabotegravir. Vocabria is taken with another previously approved drug called Edurant. These are taken together for 1 month before starting the new, long-acting Cabenuva.

Edurant is the tablet form of rilpivirine. This allows a person to try using both drugs together and monitor for any side effects before committing to the month-long formulation. If a person does not tolerate the short-acting tablets, they may not be able to take the month-long injectable.1,2

Evidence for Cabenuva

Cabenuva was studied in 2 large clinical trials called the ATLAS and FLAIR trials. Together, these included more than 1,100 people with HIV from 16 different countries, including the United States.

In both trials, once-monthly Cabenuva was found to be just as effective as daily, 3-drug oral treatment after 1 year. Cabenuva was found to be safe and tolerable in participants.1,2

Possible side effects of Cabenuva

The most common side effects of Cabenuva include:1,2

  • Injection site reactions, such as pain, redness, or swelling
  • Fever
  • Fatigue
  • Headache
  • Nausea
  • Muscle or joint pain
  • Issues with sleep
  • Dizziness
  • Rash

These are not all the possible side effects of Cabenuva. Talk to your doctor about what to expect or if you experience any changes that concern you during treatment with Cabenuva.

Things to know about Cabenuva

As with any drug, there are several rare but serious side effects to consider. Some people may have a post-injection reaction or a severe allergic reaction called DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms). Tell your doctor as soon as possible if you notice any rashes, fevers, abdominal pain, trouble breathing, or dizziness.1,2

Cabenuva may impact liver function. People taking Cabenuva may need to have blood tests done regularly to monitor their liver. Cabenuva may also cause mood changes, including depression. Tell your doctor immediately if you notice any signs of depression, including thoughts of harming yourself.1,2

Cabenuva cannot be taken with certain other drugs, including carbamazepine, phenytoin, rifampin, and more. Before beginning treatment, tell your doctor about any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs.1,2

For more information, read the full prescribing information of Cabenuva.

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