FDA Approves First Long-Acting Injectable Drug for HIV

The US Food and Drug Administration (FDA) has approved cabotegravir and rilpivirine injection formulation (Cabenuva) for the treatment of HIV-1 infection in adults, replacing antiretroviral therapy (ART) regimen in those who are virologically suppressed on a stable ART regimen with no history of treatment failure nor any observed resistance to cabotegravir or rilpivirine.

With the indication, Cabenuva becomes the first injectable, once-monthly complete regimen approved for adults with HIV.

Additionally, the FDA approved cabotegravir tablet formulation (Vocabria), which the agency note should be taken in combination with oral rilpivirine (Edurant) for one month prior to starting injectable combination therapy, to assure tolerance of the latter.

The ViiV Healthcare products were previously granted Fast Track and Priority Review designations by the FDA.

Cabenuva’s efficacy and safety were evidenced in a pair of randomized, open-label, controlled trials involving 1182 adults with HIV who were virologically suppressed before initiation of treatment. Viral suppression was defined as RNA <50 copies/mL.

Investigators observes that both trials’ treated patients showed continued virologic suppression at the study’s endpoints, with no clinically relevant change from baseline CD4+ cell counts.

Adverse events common among patients treated with the injectable combination drug included injection site reactions, fever, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash.

Experts advise against using Cabenuva in patients with known previous hypersensitivity reaction to cabotegravir or rilpivirine, or among patients who are not virologically suppressed.

John Farley, MD, MPH, director of the Office of Infectious Diseases in the FDA's Center for Drug Evaluation and Research, praised the introduction of a new “alternative for managing” the chronic burdens of HIV-1 infection.

"Currently, the standard of care for patients with HIV includes patients taking daily pills to adequately manage their condition,” Farley said in a statement. “This approval will allow some patients the option of receiving once-monthly injections in lieu of a daily oral treatment regimen.”

In February 2020, ViiV received a complete response letter (CRL) from the FDA for its new drug application for the long-acting injectable, with reasons relating to chemistry manufacturing and controls.

However, ViiV stated there were no reported safety issues related to chemistry manufacturing and controls at the time.

In an interview with sister publication HCPLive last month, Alex Rinehart, PhD, senior director, Global HIV Prevention Strategy at ViiV Healthcare, highlighted the long-term efficiency and patient preference which surrounds a long-acting injectable for HIV suppression.

“They are discreet…we are talking about taking 6 injections a year as opposed to having to take a pill every day,” Rinehart said. “This is a really big issue for women because they are able to protect themselves and not have to negotiate HIV prevention with their partners.”