U.S. regulators have approved the first long-acting drug combination for HIV, monthly shots that could replace the daily pills people use to control the AIDS virus infection.
The approval of the two-shot combo called Cabenuva, on Thursday, is expected to make it easier for people to stay on track with their HIV medicine and to do so with more privacy. This is a huge change from not long ago, when patients had to take several pills a day, which were carefully adjusted according to meals.
“It will increase the quality of life” to need treatment only once a month, says dr. Steven Deeks, an HIV specialist at the University of California, San Francisco, who has no ties to the drug’s manufacturers. “People do not want the daily reminders that they are infected with HIV.”
Cabenuva combines rilpivirine, sold as Edurant by the Janssen unit of Johnson & Johnson, and a new drug – cabotegravir, from ViiV Healthcare. They are packed together and given once a month as separate shots. Doses are also tested every two months.
The U.S. Food and Drug Administration has approved Cabenuva for use in adults who have controlled their disease well through conventional HIV medicine and who have shown no signs of viral resistance to the two drugs in Cabenuva.
The agency also approved a pill version of cabotegravir that should be taken with rilpivarine for a month before switching to make sure the drugs are well tolerated.
ViiV said the combination would cost $ 5,940 for an initial higher dose and $ 3,960 per month thereafter. The company said it is within the range of what the combination of one-day pill now costs. How much a patient pays depends on insurance, income and other things.
Studies have found that patients prefer the shots a lot.
“Even people who take one pill once a day have only reported an improvement in their quality of life to switch to an injection,” said Dr. Judith Currier, an HIV specialist at the University of California, Los Angeles, said. She consults for ViiV and writes a commentary on one study of the drug in the New England Journal of Medicine.
According to Deeks, long-acting shots also give hope to reach groups that are struggling with treatment, including people with mental illness or drug abuse problems.
“There is a great unfulfilled need” that could fill the shots, he said.
Separately, ViiV plans to seek cabotegravir approval for HIV prevention. Two recent studies found that kabotegravir shots every two months were better than daily Truvada pills to deter uninfected people from catching the virus from an infected sex partner.