Gilead Sciences has reported positive data from the Phase Ib clinical trial of lenacapavir, along with broadly neutralising antibodies (bNAbs) teropavimab and zinlirvimab, to treat HIV.
The trial was designed for assessing the efficacy and safety of the investigational combination regimen of lenacapavir with teropavimab and zinlirvimab as a potential twice-yearly approach in selected adult HIV patients, who were virologically suppressed for more than two years while taking antiretroviral therapy (ART).
In the trial, the participants were sensitive to both bNAbs by HIV proviral DNA phenotype and at study entry they had a ≥500 CD4 cell count.
Findings showed that the investigational combination was well tolerated and had high efficacy in select virologically suppressed HIV patients.
In the study, 90% of the participants who were receiving the complete study regimen maintained virologic suppression at week 26.
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No serious adverse events (AEs) or AEs that led to study drug discontinuation were overserved in the trial.
Gilead Sciences HIV Clinical Development vice-president Jared Baeten said: “We’re excited to share these promising results that reinforce lenacapavir’s potential to be a foundational agent for long-acting combination HIV treatment options, and we are especially pleased to see the potential of the combination of lenacapavir plus bNAbs dosed once every six months.
“We are committed to exploring novel therapy approaches that may help deliver care for all people living with HIV, with a focus on developing person-centric options that fit into the diverse lives of people living with the virus, as we continue in our pursuit of ending the HIV epidemic for everyone, everywhere.”
The company stated that the data from the Phase Ib clinical trial will be used in further evaluating the investigational combination in a Phase II trial as a long-acting HIV treatment option.