FDA Approves First Once-a-Month HIV Therapy

The first monthly shots to treat adults with HIV were approved by the U.S. Food and Drug Administration on Thursday.

“Currently, the standard of care for patients with HIV includes patients taking daily pills to adequately manage their condition. This approval will allow some patients the option of receiving once-monthly injections in lieu of a daily oral treatment regimen,” said Dr. John Farley, director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research.

“Having this treatment available for some patients provides an alternative for managing this chronic condition,” he added in an agency news release.

One expert said the shots will likely be welcomed by HIV patients.

The shots “will enhance quality of life” to need treatment just once a month, Dr. Steven Deeks, an HIV specialist at the University of California, San Francisco, told CBS News. “People don’t want those daily reminders that they’re HIV-infected.”

Another expert agreed.

“Even people who are taking one pill once a day … reported improvement in their quality of life to switch to an injection,” Dr. Judith Currier, an HIV specialist at the University of California, Los Angeles, told CBS News. She consults for ViiV Healthcare, the company behind the long-acting treatment, and wrote a commentary accompanying one study of the drug published recently in the New England Journal of Medicine.

Not only that, but Deeks added that “there’s a great unmet need” that the shots may fill, since some patients, including people with mental illness or substance abuse problems, can struggle with daily drug regimens.

Cabenuva (cabotegravir and rilpivirine), which is given as two separate shots, was approved for patients who are HIV-suppressed on a stable antiretroviral regimen, have no history of treatment failure, and don’t have known or suspected resistance to either cabotegravir or rilpivirine, the FDA said.

The FDA also approved Vocabria (cabotegravir, tablet formulation), which should be taken in combination with oral Edurant (rilpivirine) for one month before starting treatment with Cabenuva, to ensure the medications are well-tolerated by patients before they switch to the extended-release monthly injection.

The FDA’s approval of Cabenuva is based on two randomized, open-label, controlled clinical trials that included nearly 1,200 HIV-infected adults who had HIV suppression before they began treatment with Cabenuva.

The patients in both trials continued to show HIV suppression at the end of each study, according to the FDA.

The most common side effects with Cabenuva were injection-site reactions, fever, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness and rash.

Cabenuva should not be given to patients with known previous hypersensitivity reaction to cabotegravir or rilpivirine, or to patients who are not virally suppressed, the FDA said.

ViiV said the shot combo would cost $5,940 for an initial, higher dose and $3,960 per month afterward, CBS News reported. The company said that is “within the range” of what one-a-day pill combos cost. How much a patient pays depends on insurance, income and other things.

More information

The U.S. National Institute of Allergy and Infectious Diseases has more on HIV/AIDS treatment.

SOURCE: U.S. Food and Drug Administration, news release, Jan. 21, 2021