FDA Approves First Once-a-Month HIV Therapy

FRIDAY, Jan. 22, 2021 (HealthDay News) – The first monthly injections to treat HIV-positive adults were approved by the U.S. Food and Drug Administration on Thursday.

“Currently, the standard of care for HIV-infected patients includes patients taking daily pills to adequately manage their condition. This approval will allow some patients to receive injections once a month instead of daily oral therapy, ”said Dr. John Farley, director of the Office of Infectious Diseases at the Center for Drug Evaluation and Research at the FDA.

“The availability of this treatment for certain patients constitutes an alternative to manage this chronic disease”, he added in a press release from the agency.

One expert said the vaccines would likely be well received by HIV-positive patients.

The injections “will improve the quality of life” so that they only require treatment once a month, said Dr Steven Deeks, an HIV specialist at the University of California, San Francisco. CBS News. “People don’t want these daily reminders that they are infected with HIV.”

Another expert agrees.

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

Not only that, but Deeks added that “there is a great unmet need” that injections can fill, as some patients, including those with mental illness or addiction issues, may have difficulty with the drugs. daily treatment regimens.

Cabenuva (cabotegravir and rilpivirine), given as two separate injections, has been approved for patients whose HIV is suppressed on stable antiretroviral therapy, who have no history of treatment failure and who do not have resistance known or suspected to cabotegravir or rilpivirine, the FDA said.

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

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