HIV Combination Therapy Candidate May Deliver Care

Gilead Sciences, Inc. today announced data evaluating lenacapavir in combination with broadly neutralizing antibodies (bNAbs) teropavimab and zinlirvimab as a potential long-acting HIV treatment regimen with twice-yearly dosing.

Results from the Phase 1b clinical trial demonstrated the investigational combination was generally well tolerated with high efficacy in select virologically suppressed participants living with HIV.

At Week 26, 90% of participants receiving the complete study regimen (n=18/20) maintained virologic suppression (HIV-1 RNA ≤50 copies/mL). 

“Novel long-acting HIV treatment options will drive the next chapter in care and may help meet the therapy needs and preferences of people living with HIV. In this study, we found that lenacapavir and bNAbs in a combination approach may have a significant role to play in the future treatment of HIV,” said Dr. Joseph Eron, MD, lead study investigator and the Chief of the Division of Infectious Diseases at the University of North Carolina School of Medicine, in a press release on February 21, 2023.

“As a clinician who strives to support the people living with the virus under my care, it will be exciting to continue evaluating the combination regimen as a potential twice-yearly long-acting HIV treatment option.”

The combination of lenacapavir with teropavimab and zinlirvimab will advance to a Phase 2 study later in 2023 in virologically suppressed people living with HIV.

Lenacapavir is being developed as a foundation for future HIV therapies to offer long-acting oral and injectable options with several dosing frequencies, combined with other antiretroviral agents for treatment or as monotherapy for prevention, that help address individual patient needs and preferences.

Sunlenca® (lenacapavir), alone or in combination, is not approved by any regulatory authority outside the United States, United Kingdom, Canada, or the European Union for any use.

Note: bNAbs are not preventive vaccines. Furthermore, the U.S. FDA has not approved any HIV vaccine candidate.