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Monthly HIV Drug Combo Approved by FDA

HIV released from cell

Illustration of HIV released from the surface of an infected cell (Bette Korber, Los Alamos National Lab)

22 Jan. 2021. The Food and Drug Administration approved a drug regimen given once a month to control HIV infections, to replace daily antiretroviral medications. The monthly injections are a combination of the drugs cabotegravir and rilpivirine, branded as Cabenuva by ViiV Healthcare, in Research Triangle Park, North Carolina, a subsidiary of drug maker GlaxoSmithKline.

Cabotegravir is developed by ViiV as both an oral drug and long-acting injectable treatment for HIV. The drug blocks an enzyme called integrase that inserts DNA from HIV viruses into white blood cells in the immune system. By blocking this integration of viral DNA into immune system cells, HIV cells cannot multiply and the amount of HIV is reduced in the body.

Rilpivirine is already approved by FDA as a daily therapy for HIV, but is prescribed for certain teens and adults with HIV only when taken with other drugs. Rilpivirine, made and branded as Edurant by Janssen Pharmaceutical, a division of Johnson & Johnson, blocks an enzyme called reverse transcriptase that prevents HIV from multiplying, and thus reduces the amount of HIV in the body.

FDA approved Cabenuva for adults with already suppressed and stable HIV viral loads from daily antiretroviral drugs. Cabenuva is designed as a once-a-month injected replacement for the daily drugs, where individuals have no history of treatment failure nor resistance to either cabotegravir or rilpivirine. FDA also approved the companion drug Vocabria, taken daily with rilpivirine for a month to help make Cabenuva more tolerable for recipients. Vocabira is an oral form of cabotegravir.

From 365 to 12 dosing days per year

“Today’s FDA approval of Cabenuva,” says Viiv Healthcare’s North American chief officer Lynn Baxter in a company statement, “represents a shift in the way HIV is treated, offering people living with HIV a completely new approach to care. Cabenuva reduces the treatment dosing days from 365 days to 12 days per year.”

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

Cabenuva faced a rocky review process at FDA. As reported by Science & Enterprise in December 2019, FDA rejected the new drug application for Cabenuva from ViiV and Janssen, raising objections to proposed chemistry, manufacturing, and controls processes for the combination drug. These processes often involve a product’s identity, strength or potency, quality, and purity. However, FDA did not raise any safety issues with the proposed drug combination.

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Disclosure: The author owns shares in Johnson & Johnson.

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