PARIS — Cenicriviroc, an oral C-C chemokine receptor type 2 and type 5 antagonist also known as CVC, was well-tolerated and provided antifibrotic activity in adult patients with nonalcoholic steatohepatitis and fibrosis in a phase 2b clinical study, according to data presented at the International Liver Congress 2018.
“CVC has shown very important efficacy in treatment of liver inflammation injury and fibrosis models,” Vlad Ratziu, MD, PhD, from the Hôpital Pitié Salpêtrière and Université Pierre et Marie Curie, Paris, said in his presentation. “These results further support the first-year analysis.”
Ratziu and colleagues previously reported 1-year results that showed CVC (Takeda and Tobira Therapeutics) had significant antifibrotic benefit over placebo among 289 adults with NASH and fibrosis. During the first year, they randomly assigned patients to receive CVC 150 mg once daily or placebo.
Among the 242 patients from the original study who continued into year 2 of the study, 121 continued with CVC treatment, 60 continued to receive placebo, and 61 switched from placebo to CVC treatment.
Patients who did not achieve a stage 1 or better fibrosis improvement during 1 year of placebo treatment demonstrated fibrosis improvement without worsening of NASH after switching to CVC compared with those who continued with placebo (24% vs. 17%).
Those who continued with CVC also demonstrated a greater improvement in stage 1 or better fibrosis reduction compared with those who received placebo for 2 years (39% vs. 29%).
While a similar proportion of patients treated with CVC for either 1 or 2 years and those who received placebo achieved similar stage 1 or better fibrosis improvements, the researchers observed a higher proportion of stage 2 or better fibrosis improvements without worsening of NASH among patients on CVC.
“There were no new side effects, no unexpected side effects, and no higher proportion of severe side effects in patients who received the drug compared with those who received placebo,” Ratziu said in conclusion.
Ratziu added that a new trial plans to look at CVC in combination with another drug to see if the complementary mechanisms of action are more effective in NASH resolution. – by Talitha Bennett
For more information:
Ratziu V, et al. GS-002. Presented at: International Liver Congress; Apr. 11-15, 2018; Paris, France.
Disclosure: Ratziu reports being on the advisory committees and/or review panels for GalMed, Abbott, Enterome, Genfit and Gilead; and consulting for Boehringer-Ingelheim, Exalenz, Intercept and Tobira