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In a phase 2b trial, Cenicriviroc (CVC), a new oral medication acting as an antagonist for chemokine receptor types 2/5, has shown promising results in relieving fibrosis in non-alcoholic steatohepatitis (NASH)-affected people. This open-label, phase 2, rollover study aimed to assess the safety and tolerance of long-term CVC use in NASH patients suffering from liver fibrosis (stage 0-4).
A daily dose of 150 mg of Cenicriviroc is safe and well-tolerated among patients with liver fibrosis ranging from stage 0 to stage 4, which is associated with NASH.
In a phase 2b trial, Cenicriviroc (CVC), a new oral medication acting as an antagonist for chemokine receptor types 2/5, has shown promising results in relieving fibrosis in non-alcoholic steatohepatitis (NASH)-affected people. This open-label, phase 2, rollover study aimed to assess the safety and tolerance of long-term CVC use in NASH patients suffering from liver fibrosis (stage 0-4).
Subjects who completed the CENTAUR phase 2 trial or reached specified endpoints in the AURORA phase 3 trial were eligible for enrollment in this open-label, phase 2 extension study. Participants received 150 mg CVC once daily and underwent safety evaluations at study initiation and every three months until CVC development was terminated by the sponsor. Safety measures encompassed monitoring for treatment-emergent adverse events (TEAEs), their severity, and lab assessments.
Overall, 167 volunteers participated, with a median therapy duration of 33.6 months. About 21.6% (36 patients) prematurely discontinued the study, and 16.8% (28 patients) reported treatment-related TEAEs. Common events encompassed diarrhea (2.4%), abdominal pain, nausea, elevated liver enzymes, rash, itching, muscle pain, and hypertriglyceridemia (each 1.2%). These events were mostly mild, with none being life-threatening. Hepatic function, chemistry, and liver parameters remained stable throughout the study.
Once daily administration of 150 mg CVC was well-tolerated in NASH (also known as metabolic dysfunction–associated steatohepatitis) patients with varying degrees of liver fibrosis. No new safety concerns emerged, reinforcing the favorable safety profile of CVC.
Hepatology Communications
Phase 2, open-label, rollover study of cenicriviroc for liver fibrosis associated with metabolic dysfunction-associated steatohepatitis
Sven M Francque et al.
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