FDA approves first long-acting HIV drug combo, monthly shots

US regulators have approved the first long-acting drug combo for HIV that can replace the daily tablets currently used to control the transmission of the AIDS virus.

With the approval of a two-shot combo called Kavenuba on Thursday, people are expected to facilitate the tracking of HIV drugs and protect their privacy. This is a major change from a short time ago when patients had to take multiple tablets several times a day and carefully adjust their meal timing.

“It will improve quality of life,” said Dr. Stephen Dikes, an HIV expert at the University of California, San Francisco, who has nothing to do with pharmaceutical companies. “People don’t want daily reminders of being infected with HIV.”

Cabenuva is a combination of rilpivirine, marketed as Edurant by Johnson & Johnson’s Janssen unit, and cabotegravir, a new drug from ViiV Healthcare. They are packaged together and given as separate shots once a month. Dosing every two months has also been tested.

The US Food and Drug Administration has approved the use of Kavenuba in adults who are well controlled by traditional HIV drugs and who do not show signs of viral resistance to the two Kavenuba drugs.

Authorities also approved a pill version of Cabotegravir to be taken with rilpivarin for a month before switching to shots to ensure that the drug was well tolerated.

According to ViiV, the cost of the shot combo will be $ 5,940 for the first high dose and $ 3,960 per month thereafter. According to the company, this is “within” the cost of the current once-daily pill combo. The amount paid by the patient depends on insurance and income.

Studies have shown that patients are very fond of shots.

“Even those who take the pill once a day have only reported that switching to injections has improved their quality of life,” said Dr. Judith Curia, an HIV expert at the University of California, Los Angeles. I have. She consulted for ViiV and wrote a commentary in the New England Journal of Medicine that accompanies one study of the drug.

Long-acting shots also give hope to reach groups who are struggling to stick to treatment, such as people with mental illness or substance abuse problems, according to Dikes.

“There is a big unmet need,” he said, which shots may meet.

Separately, ViiV will seek approval for Cabotegravir for HIV prevention. Two recent studies have found that bimonthly cabotegravir shots are superior to daily tolbada pills to prevent uninfected individuals from catching the virus from infected sex partners.


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FDA approves first long-acting HIV drug combo, monthly shots

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