ViiV Healthcare to Present First Head-to-head Data for New HIV Treatment Regimen Cabenuva Against Biktarvy

On February 14, UK-based ViiV Healthcare announced its plan to present key abstracts at the Conference on Retroviruses and Opportunistic Infections (CROI) 2023 highlighting the company’s diverse portfolio of industry-leading innovative HIV treatment and prevention options alongside next-generation pipeline advancements.

CROI is an annual scientific meeting devoted to the understanding, prevention, and treatment of HIV/AIDS and the opportunistic infections associated with AIDS. The global specialist HIV company majority owned by GSK will present its first head-to-head study for Cabenuva, a long-acting HIV treatment regimen, compared against once-daily Biktarvy at the 2023 edition of the conference held in Seattle, Washington, from February 19-22.

Related article: Game-Changing Antiretroviral Regimen from ViiV Receives FDA Approval 

Innovative Long-acting 2-drug Treatment Regimen

Biktarvy is a combination of three antiretroviral drugs (bictegravir, emtricitabine and tenofovir alafenamide) in one pill, taken orally once a day. It is currently a prescription drug approved by the U.S. Food and Drug Administration (FDA) for treating HIV infection. Bictegravir is an HIV integrase inhibitor that stops the virus from producing integrase, an essential enzyme for viral replication. The other two drugs belong to a category known as NNRTIs (nucleoside/nucleotide reverse transcriptase inhibitors), which bind to and block HIV reverse transcriptase, thereby preventing HIV from replicating.

Cabenuva is the first FDA-approved injectable, complete regimen for HIV-1 infected adults which secured approval from the US FDA in January 2021. Similar to Biktarvy, this injectable 2-drug treatment regimen is a combination of HIV integrase inhibitor (cabotegravir) and NNRTI (rilpivirine). Yet unlike conventional daily pills, it works continuously and allows patients to take the medication every other month (6 times a year). 

The data to be presented by ViiV at CROI 2023 come from the Phase 3b SOLAR study, which is the first clinical trial for a head-to-head comparison between Cabenuva and Biktarvy in terms of antiviral activity and safety. The multicenter, non-inferiority study began in November 2020 and assessed virologically suppressed adults who had been taking oral Biktarvy and were randomly selected to switch to Cabenuva or continue their current treatment. During the CROI 2023, researchers will share 12-month findings on treatment satisfaction, patient preference for the two regimens, and head-to-head efficacy and safety results. In addition, the results of an analysis of observed weight and metabolic changes when switching to Cabenuva or continuing on Biktarvy will be included in the presentation. 

Dr. Kimberly Smith, M.D., MPH, Head of Research and Development at ViiV Healthcare, believes that long-acting regimens will prevail in HIV treatment and they will provide an alternative to daily pills and this is the main reason for the company to conduct a head-to-head study with a commonly prescribed, daily, oral medicine. “The exciting findings in HIV treatment and prevention to be presented at CROI 2023 underscore ViiV Healthcare’s position as the industry leader in 2-drug and long-acting regimens,” said Dr. Smith.

Multiple Key Abstracts to be Presented at CROI 2023

Apart from the clinical data of Cabenuva, ViiV and its study partners will also present several other key abstracts regarding the latest findings of their HIV medications. These include new findings from the Phase 3 HPTN 084 study on cabotegravir long-acting for HIV prevention; data from a Phase 2a proof-of-concept study of N6LS (VH3810109), a novel, investigational, broadly neutralising antibody (bNAb) that is being investigated in adults living with HIV; as well as the 48-week metabolic health results from RUMBA, an open-label, randomised clinical trial comparing the effects of switching from Biktarvy to Dovato, a 2-drug regimen consisting of dolutegravir and lamivudine.

Author

Richard Chau