FDA approves first combination of long-acting anti-HIV drugs

US regulators have approved the first long-acting HIV drug combo, monthly injections that can replace the daily pills now used to control infection with the AIDS virus.

Thursday’s approval of the two-dose combo called Cabenuva should make it easier for people to stay on track with their HIV medications and to do so with more privacy. This is a huge change from not too long ago when patients had to take multiple pills several times a day, carefully timed around meals.

“It will improve the quality of life” to only need treatment once a month, said Dr Steven Deeks, an HIV specialist at the University of California at San Francisco, who has no connection. with the manufacturers of the drug. “People don’t want these daily reminders that they are infected with HIV.

Cabenuva combines rilpivirine, sold as Edurant by Johnson & Johnson’s JNJ,
+ 0.46%
Janssen, and a new drug, cabotegravir, from ViiV Healthcare, majority owned by GlaxoSmithKline GSK,
-0.38%.
They are packaged together and administered separately once a month. A dosage every two months is also tested.

The United States Food and Drug Administration has approved Cabenuva for use in adults whose disease has been well controlled by conventional HIV drugs and who have not shown signs of viral resistance to both Cabenuva drugs.

The agency has also approved a pill version of cabotegravir to be taken with rilpivarin for a month before switching to injections to make sure the drugs are well tolerated.

ViiV said the shot combo would cost $ 5,940 for a higher initial dose and $ 3,960 per month thereafter. The company said it was “in the range” of what day-pill combos currently cost. The amount a patient pays depends on their insurance, income, and other factors.

Studies have shown that patients much prefer injections.

“Even people who take a pill once a day have reported an improvement in their quality of life switching to an injection,” said Dr. Judith Currier, HIV specialist at the University of California, Los Angeles. She consults for ViiV and wrote a comment accompanying a study of the drug in the New England Journal of Medicine.

Deeks said the long-lasting gunfire also gives hope to reach groups who struggle to stick to treatment, including people with mental illness or addiction issues.

“There is a great unmet need” that the shots could fill, he said.

In addition, ViiV plans to seek approval of cabotegravir for the prevention of HIV. Two recent studies found that cabotegravir injections every two months were better than daily Truvada pills at preventing uninfected people from catching the virus from an infected sexual partner.


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