VV116 Pharmacokinetics & Safety in Mild/Moderate Hepatic Impairment – COVID-19 Study

A Phase 1 clinical trial has demonstrated that VV116, an oral antiviral medication for COVID-19, does not require dose adjustments for patients with mild or moderate hepatic impairment. The study, involving adults with varying degrees of liver function, found that overall exposure to the drug remained comparable to that of healthy individuals.

Researchers assessed the pharmacokinetics and safety of a single 0.3-gram oral dose of VV116 in participants with mild and moderate hepatic impairment, as defined by the Child-Pugh method, comparing them to a control group of healthy adults. Analysis of plasma samples collected over 72 hours revealed that the area under the curve (AUC) – a measure of overall drug exposure – was similar across all groups, with geometric mean ratios of 94.10% (90% confidence interval 71.59%-123.68%) for mild impairment and 97.72% (74.34%-128.44%) for moderate impairment, relative to the control group.

While maximum drug concentration (Cmax) was lower in both impairment cohorts, median time to maximum concentration (Tmax) and half-life (t1/2) remained consistent across all groups. Treatment-emergent adverse events were reported in 12.5% of the mild impairment group, 37.5% of the moderate impairment group, and 12.5% of the control group. These events were generally mild or moderate in severity, transient, and resolved without intervention. The increased incidence in the moderate impairment group was not deemed clinically significant, as the events were isolated and not linked to VV116 exposure levels.

No serious adverse events, deaths, or study discontinuations were recorded during the trial. VV116 is a deuterated remdesivir hydrobromide, and has received accelerated approval in China for the treatment of adult patients with mild-to-moderate COVID-19, according to reports from January 2023. The drug functions as a viral RNA-dependent RNA polymerase inhibitor, demonstrating broad activity against human coronaviruses, and has shown synergistic potential when combined with the 3CLpro inhibitor nirmatrelvir, as indicated in research published in September 2023.

A separate clinical trial is currently evaluating COVID-19 rebound rates following a five-day course of VV116 compared to nirmatrelvir-ritonavir. Remdesivir derivative VV116 has been reported to have promising antiviral effects against SARS-CoV-2 and positive therapeutic outcomes in clinical trials.