FDA Approves First Long-acting HIV Drug that Requires One Treatment per Month

Cabenuva was approved by the U.S. Food and Drug Administration (FDA) to replace traditional antiretroviral regimens for the treatment of human immune infections Adult patients with defective virus type 1 (HIV-1).

Cabenuva is developed by Janssen Pharmaceuticals, a subsidiary of the global pharmaceutical giant Johnson & Johnson, and ViiV Healthcare, a well-known AIDS treatment company,

Cabenuva is the first complete injection program approved by the FDA for adult HIV patients. Patients only need to receive treatment once a month to achieve the effect of suppressing the virus. This is also a milestone in the history of HIV treatment, which means the birth of a new and more convenient treatment.

He Dayi, a foreign academician of the Chinese Academy of Engineering and a Chinese AIDS research expert, proposed antiretroviral therapy (cocktail therapy), which brought hope for survival to HIV patients. However, this therapy requires patients to take daily medication to suppress the HIV virus in the body.

The approval of Cabenuva for the market this time means that patients will be treated from 365 days a day to 12 treatments once a month and 12 times a year, greatly improving the compliance of the therapy. In addition to Cabenuva, the FDA also approved cabotegravir’s tablet formulation, Vocabria, to be used in combination with rilpivirine for one month before receiving Cabenuva treatment to ensure that it is well tolerated before the tablet is converted to a sustained-release injection formulation.

Cabenuva is a combination therapy composed of ViiV Healthcare’s cabotegravir (CAB) and Johnson & Johnson’s rilpivirine (RPV). The former is a long-acting HIV-1 integrase chain transfer inhibitor, and the latter is a long-acting non-nucleoside Reverse transcriptase inhibitor.

Cabenuva’s approval is based on two key Phase 3 clinical studies, ATLAS for antiretroviral therapy as a long-acting inhibitor, and FLAR, the first long-acting injection program, covering a total of 1,182 adult HIV patients in 16 countries worldwide.

During the 48-week study period, Cabenuva was as effective in maintaining viral suppression as traditional therapies, i.e. three antiretroviral drugs a day orally, and patients who received the therapy at the end of the study showed sustained virological inhibition, and no clinical changes associated with baseline levels were observed in CD4-plus cell counts.

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