Gilead presents proof-of-concept data for GS-6207 in people living with HIV
Gilead Sciences presented the first clinical data in people living with HIV on GS-6207, an investigational, novel, selective, first-in-class inhibitor of HIV capsid function. The Phase 1b data demonstrate the first proof of concept that HIV capsid inhibition can lead to significant declines in viral load in vivo. In addition, Gilead presented preclinical data demonstrating that resistance to GS-6207 in vitro did not lead to resistance to other classes of drugs used in the treatment of HIV. These data were presented at the 10th International AIDS Society Conference on HIV Science in Mexico City. "The data presented at IAS underscore our commitment to scientific discovery, building on Gilead's legacy of transformative advances in HIV therapies," said Diana Brainard, MD, Senior Vice President, HIV and Emerging Viruses, Gilead Sciences. "GS-6207's multi-stage mechanism of action profile is distinguishable from currently approved classes of antiretroviral agents and may provide a new avenue for the development of long-acting treatment regimens for 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 versus placebo. 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. 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, 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 Eric Daar, MD, Chief, Division of HIV Medicine at Harbor-UCLA Medical Center and lead study author. "These early trial results support advancing GS-6207 into the next phase of clinical development to understand its role as part of long-acting HIV therapy."