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FDA Approves First Injectable HIV Regimen

 


The Federal Food and Drug Administration has approved Cabenuva, the first complete, long-acting, injectable HIV regimen that does not require daily tablets. Approved for people who want to switch to a long-acting regimen and whose viral load cannot be detected.

Cabenuva consists of a sustained-release version of the new integrase inhibitor cabotegravir and rilpivirine (sold in the form of pills as Edurant). Two injections are given to the buttocks once a month by your healthcare provider. ViiV Healthcare plans to begin shipping Cabenuva in February. Combination therapy costs about $ 4,000 a month.

The FDA’s action took place on 21 January.

“Many of our clients have been taking antiretroviral drugs daily for decades and are interested in long-acting injections,” said San Francisco AIDS Foundation Vice President of Healthcare. One Janesa Blazard told the Bay Area Reporter. “Adherence to daily medication plans can be difficult to maintain for a variety of reasons. In some cases, COVID-19 makes it even more difficult. As a provider, we are pleased to offer Cabenuva to our clients. Alternative proposal.”

In addition to the injection, the FDA has also approved a tablet version of cabotegravir called Vocabria. Those who want to switch should bring Cabotegravir and Rilpivirine tablets for a month and make sure the combination is well tolerated before starting the injection. The pill can also be used as a short-term regimen if someone has to miss a planned Cabenuba injection.

Survey results
Approval is supported by the results of a series of Phase 3 clinical trials. The ATLAS study enrolled more than 600 HIV-positive people whose viral load was completely suppressed by the current oral regimen. They were randomly assigned to either continue their existing regimen or switch to Cabenuba injections. After 48 weeks, both groups were about as likely to maintain undetectable viral load (93% and 96%, respectively).

Follow-up, ATLAS-2M, showed that bi-monthly injections functioned like monthly injections. The FDA has only approved a monthly schedule, but European regulators have recently approved treatment every four or eight weeks. ViiV will request FDA approval for the bimonthly schedule in the United States.

In the FLAIR study, people who started HIV treatment for the first time were given a standard three-drug oral regimen to reduce viral load, followed by randomization to maintain the combination or oral administration for one month. Later I switched to Kavenuba injection. -To. Again, both groups were equally likely to have undetectable viral load after 48 weeks (93% and 94%). Follow-up findings showed that the results were similar without oral introduction.

Injectable Cabotegravir alone is being studied for HIV prevention. Studies show that bimonthly cabotegravir injections for both cisgender men and trans women who have sex with men, and cisgender women, are given daily oral tolvada (tenofovir disoproxil fumarate / emtricitabine). ) Was more effective. Truvada is very effective when used consistently, but in some cases it is easier to stick to a long-acting regimen.

Cabenuva is safe and generally well tolerated. Many study participants experienced injection site reactions such as pain, redness, and swelling, which were mostly mild to moderate, lasting only a few days, and became less common with repeated injections.

Nonetheless, most study participants said they prefer monthly injections to daily tablets. Reasons included increased convenience, having to think about HIV treatment 12 times a year, and no bottles that could reveal the condition of HIV to others.

People who use Cabenuva need to meet with their providers more often than they do today for regular viral load tests. However, a ViiV study found that healthcare professionals could successfully integrate monthly injections into clinical practice.

“In the scientific community, we recognize that the innovation behind Cabenuba really makes sense. It’s just the first complete long-acting regimen that can dramatically reduce dosing frequency. Not even preferred in most clinical trials. Participants when compared to previous daily oral regimens, “said Dr. David Wohl of the University of North Carolina at Chapel Hill in a ViiV news release. “The FDA’s approval of Cabenuva underscores the value of community-centric research and we are pleased to make this new option available to people living with HIV.”

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