FDA Authorizes First Long-Acting Injectable for HIV Treatment

January 27, 2021 - FDA recently approved ViiV Healthcare’s Cabenuva, the first and only complete long-acting injectable HIV treatment for positive adults. 

The drug will be administered to HIV-positive adults once a month and will replace the current treatment regimen in those who are virologically suppressed with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. 

FDA warned that Cabenuva should not be used in patients that have had a hypersensitivity reaction to cabotegravir or rilpivirine. The new HIV drug is also not appropriate for patients who are not virally suppressed. 

“Currently, the standard of care for patients with HIV includes patients taking daily pills to adequately manage their condition. This approval will allow some patients the option of receiving once-monthly injections in lieu of a daily oral treatment regimen,” John Farley, MD, MPH, Director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, said in the announcement. 

“Having this treatment available for some patients provides an alternative for managing this chronic condition,” Farley continued. 

Cabotegravir is an investigational drug currently being studied to treat and prevent HIV infection, while rilpivirine reduces the activity of the enzyme used by HIV-infected cells to produce less HIV. 

At the beginning of October, ViiV Healthcare initiated a study to evaluate the best approaches to implementing cabotegravir and rilpivirine, which both need to be injected into patients twice a month.

The Cabotegravir and Rilpivirine Implementation Study (CARISEL) will recruit 450 individuals living with HIV and 54 clinical staff members from France, Spain, Belgium, Germany, and the Netherlands, in two parts of the one-year study. 

The goal of the study is also to uncover how to boost the frequency of clinic visits to administer the treatment. Results for the CARISEL trial are expected by the end of this year.  

In addition to the approval of Cabenuva, FDA also approved Vocabria (Cabotegravir in tablet formulation). 

Vocabria must be taken in combination with rilpivirine for one month prior to starting treatment with Cabenuva, which will ensure the medications are well-tolerated before switching to the injectable formulation, the agency stated. 

FDA based its approval of Cabenuva on available data from two randomized-open-label clinical trials which showed that 1,182 HIV-positive adults who were virologically suppressed before Cabenuva treatment continued to show virologic suppression at the conclusion of each study.

Nine out of ten patients also preferred Cabenuva over their previous daily oral therapy in the clinical trials.

In a pooled exploratory analysis, 532 patients completed a single-item question at Week 48 and 88 percent of these patients preferred Cabenuva, compared to just two percent who preferred the previous antiretroviral therapy treatment.

Additionally, researchers did not observe any clinically relevant change from baseline in CD4+ cell counts. 

“Today’s FDA approval of Cabenuva 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,” Lynn Baxter, head of North America at ViiV Healthcare, said in a press release. 

Back in 2012, Gilead earned FDA approval for a daily oral medication for HIV prevention called Pre-Exposure Prophylaxis (PrEP), making it a leader in the HIV drugs market.

Studies have shown that PrEP, under the brand name Truvada, reduces the risk of getting HIV from sex by about 99 percent when taken daily and 74 percent among people who inject drugs. 
But at the end of May, a global HIV prevention study found that the cabotegravir was 69 percent more effective than among key patient populations compared to the current standard of care, including Truvada.