US regulators have approved the first long-acting drug combination for HIV, monthly injections that can replace the daily pills that people take to control AIDS virus infection.
Thursday’s approval of the two-shot combo called Cabenuva is expected to make it easier for people to stay on track with their HIV drugs and 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 improve the quality of life” to need treatment just once a month, said Dr. Steven Deeks, an HIV specialist at the University of California, San Francisco, who has no affiliation with the drug’s makers. “People don’t want those 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 packed together and given as separate shots once a month. The dosage every two months is also tested.
The US Food and Drug Administration approved Cabenuva for use in adults whose disease was well controlled with conventional HIV drugs and who showed no signs of viral resistance to the two drugs in Cabenuva.
The agency also approved a pill version of cabotegravir to be taken with rilpivarin for a month before switching to the shots to make sure the drugs are well tolerated.
ViiV said the shot combo would cost $ 5,940 for an initial, higher dose and $ 3,960 per month after that. The company said this is “within reach” of what a daily pill combination now costs. How much a patient pays depends on insurance, income and other matters.
Studies have shown that patients greatly preferred the shots.
“Even people who take one pill once a day just reported an improvement in their quality of life switching to an injection,” says Dr. Judith Currier, an HIV specialist at the University of California, Los Angeles. She consults ViiV and wrote a commentary on a study of the drug in the New England Journal of Medicine.
Deeks said long-acting shots also give hope of reaching groups who are struggling to adhere to treatment, including those with mental illness or substance abuse problems.
“There is a great unmet need” that the shots can fill, he said.
Separately, ViiV plans to seek approval for cabotegravir for HIV prevention. Two recent studies found that cabotegravir injections every two months were better than daily Truvada pills at preventing uninfected people from contracting the virus from an infected sex partner.