The injectable formulation of cabotegravir and rilpivirine — sold under the brand name Cabenuva — is meant for patients with human immunodeficiency virus type 1 (HIV) who are already virally suppressed, having reached a plasma HIV viral load at less than 50 copies per milliliter, a measure that indicates the virus is under control. RELATED: What Is HIV/AIDS? This injectable therapy from ViiV Healthcare, which is to be administered once a month by a healthcare provider, offers an alternative to maintaining viral suppression with pill-a-day therapies now available. Currently, several daily oral HIV treatments are on the market, including Atripla, Biktarvy, Complera, Odefsey, Stribild, Genvoya, Triumeq, Symtuza, Dovato, and Delstrigo. RELATED: How Is HIV Treated? “Despite there being many great choices of once-daily pill combinations to treat HIV now, there are many patients who will prefer this option of a once-monthly injection,” says David Hirschwerk, MD, a physician who specializes in infectious disease at Northwell Health in Manhasset, New York. ViiV Healthcare says it will begin shipping Cabenuva to wholesalers and specialty distributors in the United States this month.
Injectable Seen as an Important Advance in HIV Treatment
William Schaffner, MD, an infectious-disease specialist and a professor of preventive medicine and health policy at the Vanderbilt University School of Medicine in Nashville, praises the injectable as another advance in the treatment of HIV infection. “Everybody who takes medication every day knows that sometimes they miss doses and sometimes they run out of medicine — this will help a lot of people who have difficulty being adherent,” says Dr. Schaffner. “It will make it much easier to maintain a low viral load.” To ensure the extended-release injectable formulation is well tolerated, patients will need to take a combination of Vocabria (a tablet formulation of cabotegravir) and oral rilpivirine (Edurant) for one month prior to starting treatment with Cabenuva.
Approval Was Based on Two Clinical Trials
FDA approval was based on efficacy and safety established in two clinical studies of 1,182 HIV-infected adults who were virologically suppressed before beginning therapy with Cabenuva. RELATED: FDA Watch Dr. Hirschwerk says that the injectable regimen “compared favorably” with standard therapy in these clinical trials, and participants maintained virologic suppression at the conclusion of each investigation. The most common adverse reactions among those taking Cabenuva were injection site reactions, fever (pyrexia), fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash. The FDA warned that the injectable formulation should not be used if a patient has a known previous hypersensitivity reaction to cabotegravir or rilpivirine, or in patients who are not virally suppressed.
