Gilead presented data on the safety of its long-acting ARV drug
On March 7, the final day of the International Conference on Retroviruses and Opportunistic Infections (CROI2019), the first data on the safety and tolerability of a fundamentally new ARV-medication of prolonged action GS-6207 were presented. The development of the pharmaceutical company Gilead Sciences is a selective multistage HIV capsid inhibitor molecule.
According to Jennifer E. Zager, who presented a report on the preliminary results of phase 1 clinical trials, GS-6207 is characterized by powerful antiviral activity, low water solubility and good tolerability, which makes it suitable for a prolonged-release ARV formulation.
The main purpose of the studies conducted by Gilead Sciences was to evaluate the safety, tolerability and pharmacokinetics of GS-6207 subcutaneous suspension in healthy volunteers.
A randomized, blind, placebo-controlled study covered 40 people. All selected participants were randomly divided into several groups to receive a single dose of GS-6207 (N = 8 / cohort) or placebo (N = 2 / cohort) in doses of 30, 100, 300, or 450 mg.
Pharmacokinetics parameters were evaluated and summarized for each dosage separately. Final conclusions about the safety and tolerability of the drug will be made on the basis of 24 weeks of observation.
According to preliminary results, after 20 weeks after the injection for group 1 (30 mg), 16 weeks for group 2 (100 mg), 8 weeks for group 3 (300 mg) and 4 weeks for group 4 (450 mg), the specialists were able to analyze the profiles safety and tolerability for cohorts 1 and 2. The pharmacokinetics of GS-6207 correspond to prolonged action. To date, no deaths, serious side effects, or adverse events of grade 3 or 4 have been recorded.
Thus, judging by the interim data from clinical studies of phase 1, GS-6207 demonstrated safety and good tolerance in healthy people after a single injection of up to 450 mg. A stable dosage of the drug in the body is maintained for at least 3 months.
According to experts, this indicates a good potential of the drug as a prolonged-action therapy among people living with HIV.