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On January 21st, Cabenuva, developed by Janssen Pharmaceuticals, a subsidiary of global pharmaceutical giant Johnson and Johnson, in partnership with ViiV Healthcare, a well-known AIDS treatment company, was approved by the U.S. Food and Drug Administration (FDA) to replace traditional antiretroviral programs for treating adult patients infected with human immunodeficiency virus type 1 (HIV-1).
is known to be the first FDA-approved full injection program for adult HIV patients, who only need to be treated once a month to achieve the effect of suppressing the virus.
is also a milestone in the history of HIV treatment, meaning the birth of a new and more convenient treatment.
16 years after HIV was discovered, He Daying, a foreign academician of the Chinese Academy of Engineering and an expert on Chinese-American AIDS, proposed antiretroviral therapy (cocktail therapy), which offered hope for the survival of HIV patients.
, however, the treatment requires patients to take daily medication to suppress HIV in the body.
the approval of Cabenuva means patients will be treated 365 days a day, a total of 12 times a month, greatly improving the compliance of the treatment.
addition to Cabenuva, the FDA approved Cabotegravir's tablet formulation Vocabria, which was used with rilpivirine orally for one month prior to Cabenuva treatment to ensure good tolerance before the tablet was converted to a slow-release injection formulation.
Cabenuva is a combination of ViiV Healthcare's cabotegravir (CAB) and Johnson and Johnson's Rilpivirine (RPV), a long-acting HIV-1 integrated enzyme chain transfer inhibitor, and Johnson and Johnson's Rilpivirine (RPV), which is a long-acting nonnucleotide reverse transcriptase inhibitor.
Cabenuva was approved as a key Phase 3 clinical study based on antiretroviral therapy as a long-acting inhibitory ATLAS and the first long-acting injection program, FLAR, 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 viral inhibition, and no clinical changes associated with baseline levels were observed in CD4-plus cell counts.
adverse reactions, Cabenuva patients most commonly experience injection site discomfort, fever, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness and rash.
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