US regulators have approved the first combination of long-acting HIV drugs, 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 is expected to make it easier for people to keep their HIV drugs and more privacy. It is a big change from not long ago, when patients had to take several pills several times a day, carefully timed between meals.
“This will improve the quality of life,” because it only needs treatment once a month, said Dr. Steven Deeks, an HIV specialist at the University of California, San Francisco, who has no ties to the drug’s manufacturers. “People don’t want these daily reminders that they are infected with HIV.”
Cabenuva combines rilpivirine, sold as Edurant by Johnson & Johnson’s Janssen unit, and a new drug – cabotegravir, from ViiV Healthcare. They are packaged together and given as separate injections once a month. The dosage every two months is also being tested.
The US Food and Drug Administration has approved Cabenuva for use in adults who have had their disease well controlled by conventional HIV drugs and who have not shown signs of viral resistance to the two drugs in Cabenuva.
The agency also approved a tablet version of cabotegravir to be taken with rilpivarine for a month before switching to injections to make sure the drugs are well tolerated.
ViiV said the injection combination would cost $ 5,940 for a higher starting dose and $ 3,960 per month later. The company said it is “within the range” of how much a day’s tablet combos currently cost. How much a patient pays depends on insurance, income and other things.
Studies have found that patients very much preferred injections.
“Even people who are taking a pill once a day only reported an improvement in their quality of life by switching to an injection,” said Dr. Judith Currier, an HIV specialist at the University of California, Los Angeles. She consults ViiV and wrote a commentary accompanying a study of the drug in the New England Journal of Medicine.
Deeks said long-term taking also gives hope for reaching groups that find it difficult to stay on treatment, including people with mental illness or substance abuse problems.
“There is a huge unmet need” that doses can fill, he said.
Separately, ViiV plans to seek approval for cabotegravir for HIV prevention. Two recent studies found that cabotegravir vaccines every two months were better than daily Truvada pills to prevent uninfected people from contracting the virus from an infected sexual partner.
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