In the study, lenacapavir was generally well-tolerated, and no serious adverse events were reported. These data were presented at the 23rd
'Long-acting antiretroviral therapy may help address challenges with treatment adherence and treatment fatigue, providing additional options to people living with HIV,' said
Lenacapavir is an investigational agent that is being developed as a component of a long-acting regimen in combination with other antiretroviral agents. Lenacapavir disrupts HIV capsid, a multimeric shell that is essential to viral replication, at multiple stages throughout the viral life cycle. In
'There is a compelling unmet need for interventions that can potentially improve treatment adherence to chronic HIV therapy, including the development of long-acting formulations, which can be administered less frequently,' said
The safety, efficacy and dosing of lenacapavir are being evaluated in multiple ongoing clinical studies, and have not yet been established. Initial data from Phase 1 studies that assessed the antiviral activity of lenacapavir were presented at the 17th
Data presented on lenacapavir at AIDS 2020: Virtual:
Virtual Poster PEB0265: GS-6207 Sustained Delivery Formulation Supports 6-Month Dosing Interval
In this ongoing, randomized, blinded, placebo-controlled, single-ascending dose (SAD) Phase 1 study, 30 participants were randomized (4:1) to receive 300 mg/mL of subcutaneous lenacapavir (n=eight per cohort) or placebo (n=two per cohort), at 300 mg (1 x 1.0 mL) or 900 mg (3 x 1.0 mL or 2 x 1.5 mL). All study participants completed dosing, and pharmacokinetic and safety data were collected through approximately 64 weeks post-dose.
A slow initial release of lenacapavir was observed, and therapeutic plasma concentrations were sustained for at least six months following a single 900 mg dose, administered as 3 x 1.0 mL injections. Similar results were observed following a 900 mg dose administered as 2 x 1.5 mL injections. Lenacapavir exposures increased in a generally dose-proportional manner from 300 mg to 900 mg, with maximum concentrations achieved 11 to 14 weeks post-dose and an apparent half-life of roughly 15 weeks.
Lenacapavir was generally well-tolerated; no serious or grade 3 or 4 adverse events (AEs) related to study drug or leading to study discontinuation occurred. The most common AEs were injection site induration (87 percent), pain (63 percent) and erythema (70 percent), all of which were mild. There were no clinically relevant laboratory abnormalities of grade 3 or higher.
Lenacapavir is an investigational compound and is not approved by the
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For more than 30 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention, testing and linkage to care, and cure research. Today, it's estimated that more than 12 million people living with HIV globally receive antiretroviral therapy provided by Gilead or one of the company's manufacturing partners.
Gilead is committed to supporting the global health community to quickly and effectively respond to serious and life-threatening viral outbreaks worldwide. To that end, we are contributing our antiviral expertise and resources to help investigate potential treatments for patients with COVID-19.
Forward-Looking Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility of unfavorable results from ongoing and additional clinical trials involving lenacapavir, and the possibility that we are unable to complete one or more of such trials on the currently anticipated timelines or at all.
In addition, it is possible that Gilead may make a strategic decision to discontinue development of lenacapavir, and as a result, lenacapavir may never be successfully commercialized. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended
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