Lancet (new article): Efficacy and safety of lenacapavir, teropavimab, and zinlirvimab: week-26 primary outcome results from a multicentre, open-label, randomised, active-controlled, phase 2 study

This phase 2, open-label study evaluated whether switching to twice-yearly injections of lenacapavir combined with the broadly neutralizing antibodies (bNAbs) teropavimab and zinlirvimab could maintain HIV-1 viral suppression as effectively as continuing daily oral antiretroviral therapy (ART).

Eighty participants with HIV-1 already suppressed on oral ART and whose virus was highly susceptible to both bNAbs were enrolled. At week 26, virological suppression was comparable between groups: only 1 of 53 participants in the injectable treatment group and none of the 27 in the oral ART group had viral load ≥50 copies/mL.

The injectable regimen was generally well tolerated. Apart from mild injection site reactions associated with subcutaneous lenacapavir, no serious adverse events, infusion-related reactions, or treatment discontinuations occurred.

Conclusion:
A single twice-yearly administration of lenacapavir plus teropavimab and zinlirvimab maintained viral suppression similarly to daily ART at week 26, showing promise as the first complete long‑acting HIV‑1 injectable regimen.

Additional informaiton to the following link: Efficacy and safety of lenacapavir, teropavimab, and zinlirvimab: week-26 primary outcome results from a multicentre, open-label, randomised, active-controlled, phase 2 study - The Lancet Microbe