Cabenuva receives FDA-nod as a treatment for HIV infection in adults

The U.S Food and Drug Administration (FDA) has reportedly announced offering an approval to Cabenuva as a potential regime for the treatment of HIV infection in adults to replace one of the current antiretroviral regimens in those who are virologically repressed on a stable antiretroviral treatment with almost no history of treatment failure and with unknown or suspected resistance to rilpivirine or cabotegravir.

This novel accomplishment stands to be the first injectable treatment for HIV-infected adults potentially approved by FDA, that is administered once a month.

It has been reported that the efficacy and safety of Cabenuva were established through open-label, controlled, randomized clinical trials in 1,182 HIV-infected adults who were virologically repressed before the commencement of treatment Cabenuva.

In line with Cabenuva, the organization has announced approving Vocabria, a treatment which is anticipated to be taken in combination with oral Edurant for over 1 month prior to the starting treatment with Cabenuva to make sure that the medications being provided are well-tolerated before making a switch to an extended-release injectable formulation.

Speaking on the novel move, John Farley, M.D, M.P.H, director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research commented that the approval would give patients an option of receiving monthly injections in light of a daily oral treatment regimen. Moreover, this treatment would provide some patients a substitute for managing the chronic condition of HIV.

Speculations have it that some of the most common reaction observed with intake of Cabenuva were injection site reactions, fatigue, fever, musculoskeletal pain, nausea, fever, sleep disorders, and rash. According to official sources, the treatment should not be used is a patient who has a known previous reaction to cabotegravir or rilpivirine.

For the record, the FDA has granted approval of Vocabria and Cabenuva to ViiV Healthcare. These were also granted Priority Review and Fast Track designation by the FDA.

Source Credit: https://www.fda.gov/news-events/press-announcements/fda-approves-first-extended-release-injectable-drug-regimen-adults-living-hiv