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Gilead has published preliminary data on a first-class HIV-1 capsid function inhibitor that may play a role in long-acting combination therapies. The data confirmed the progress of the asset, GS-6207, in a phase 1b trial in adults infected with HIV-1.
Teams from Gilead, Pfizer and other research groups have spent years looking at the capsid that covers the genetic material of HIV. As the capsid is vital for the virus and the RNA that codes for it is relatively stable, a rupture of the shell could strike a critical blow to HIV without running the risk of rapid resistance.
Gilead is now ready to test this idea at the clinic. The advancement of GS-6207 in patients has been corroborated by data from healthy Gilead volunteers presented this week at the Conference on Retroviruses and Opportunistic Infections (CROI) of 2019.
The study involving 40 subjects gave single and subcutaneous doses of GS-6207 ranging up to 450 mg. After collecting 20 weeks of data on the 30 mg and 4-week cohorts on the 450 mg group, Gilead has not yet observed any grade 3 or higher adverse events. Most side effects were mild and resolved.
Gilead also has sufficient data from both low-dose cohorts to estimate the pharmacokinetic parameters of GS-6207. This confirms Gilead's belief that factors such as low human clearance will make GS-6207 suitable for use in sustained-release formulations. Current data suggest that a dosing interval of three months or more is possible.
With a favorable dosage regimen and features reducing the risk of resistance, the GS-6207 could be part of an effective long-acting combination therapy. But Gilead still has some way to go to generate the data to validate this hypothesis.
Gilead has shared more in vitro data on the GS-6207 at CROI, but the biggest tests of efficiency are just beginning. Gilead began registering the first of 32 HIV patients scheduled in a Phase 1b in December and revealed the activation of several sites this week. The study examines the maximum reduction in HIV-1 plasma RNA during the 10 days following administration of GS-6207.
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