Gilead Presents Proof-of-Concept Data for GS-6207, a First-in-Class Capsid Inhibitor, in People Living With HIV
– Phase 1b Study Demonstrates Potent Antiviral Efficacy Following a Single Subcutaneous Injection of GS-6207, No Discontinuations Due to Adverse Events –
GS-6207 is an investigational long-acting antiretroviral agent that can be delivered subcutaneously. GS-6207 recently received breakthrough therapy designation from the
“The data presented at IAS underscore our commitment to scientific discovery, building on Gilead’s legacy of transformative advances in HIV therapies,” said
Studies on GS-6207 presented at IAS 2019 include:
Poster LBPEB13: Safety and antiviral activity over 10 days following a single dose of subcutaneous GS-6207, a first-in-class, long-acting HIV capsid inhibitor in people living with HIV
This ongoing Phase 1b trial randomized people living with HIV with no prior capsid inhibitor treatment to receive a single subcutaneous injection of GS-6207 (50 mg, 150 mg and 450 mg doses; n=6 per dose) versus placebo (n=6). The primary endpoint was maximum reduction of HIV-1 RNA through 10 days of treatment. In each dose group, mean maximum reduction in HIV-1 RNA by day 10 ranged from 1.8 to 2.2 log10copies/mL, which were all significantly greater compared with placebo (all p<0.0001). No participant experienced a serious adverse event or discontinued due to adverse events. The most common adverse events were mild to moderate reactions at the injection site (63 percent; 15 of 24), all of which were self-limiting.
“This study provides the first clinical evidence that HIV capsid inhibition can lead to a significant decline in viral load and supports further evaluation of GS-6207 as a component of an effective antiretroviral regimen. In addition, a long-acting regimen can help some people living with HIV by reducing the burden of daily pill taking,” said
Poster TUPEA075: In vitro resistance profile of GS-6207, a first-in-class picomolar HIV capsid inhibitor in clinical development as a novel long-acting antiretroviral agent
This in vitro study evaluated the emergence of resistance to GS-6207 in HIV-infected cells for the first time. At subtherapeutic concentrations, GS-6207 selected for L56I, Q67H, N74D/S or T107N mutations in HIV capsid. Virus containing one or more of these capsid mutations showed reduced susceptibility to GS-6207 but remained fully susceptible to other antiretroviral classes. GS-6207-selected variants occurred at highly conserved capsid residues (94 to 100 percent) and were extremely rare (<1 percent) in viral isolates from treatment-naïve people living with HIV. In vitro resistance to GS-6207 was commonly associated with reduced infectivity and impaired replication capacity, highlighting the importance of capsid in the viral replication cycle.
GS-6207 is an investigational therapy and is not approved by any regulatory authority globally; its safety and efficacy have not been established. There is no cure for HIV or AIDS.
For nearly 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.
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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 studies of GS-6207. 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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