FDA approves 1st long-acting HIV drug combination, which entails monthly shots

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U.S. regulators have approved the first long-acting drug combination for HIV, monthly shots that can replace daily pills.

U.S. regulators have approved the first long-acting drug combination for HIV, monthly shots that can replace the daily pills now used to control infection with the virus that causes AIDS.

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

“That will enhance quality of life” by reducing treatment to just once a month, said Dr. Steven Deeks, an HIV specialist at UC San Francisco, who has no ties to the drug’s makers. “People don’t want those daily reminders that they’re HIV-infected.” Cabenuva combines rilpivirine, sold as Edurant by Johnson & Johnson’s Janssen unit, and a new drug, cabotegravir, from ViiV Healthcare. They’re packaged together and given as separate shots once a month. Dosing every two months also is being tested.The U.S. Food and Drug Administration approved Cabenuva for use in adults who have had their infection well controlled by conventional HIV medicines and who have not shown signs of viral resistance to the two drugs in Cabenuva.

The agency also approved a pill version of cabotegravir to be taken with rilpivirine for a month before switching to the shots to be sure the drugs are well-tolerated.

 

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