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Emricasan improves liver function in patients with cirrhosis, high MELD
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Compared with placebo, treatment with emricasan for 3 months reduced MELD scores, international normalized ratio and total bilirubin in patients with cirrhosis and MELD score 15 or higher, according to a recently published study.
“This study is a proof of concept study for this medication which may potentially reverse and stabilize decompensated cirrhosis in patients with MELD scores between 15 and 20,” Catherine T. Frenette, MD, from the Scripps Clinic in California, told Healio Gastroenterology and Liver Disease. “If this is proven to be of benefit in larger studies, then it may be an option for patients to delay the need for liver transplant, or to help those patients who cannot get a liver transplant.”
Frenette and colleagues enrolled patients with Child-Pugh class A or B cirrhosis and MELD scores between 11 and 18 to participate in the study. The researchers randomly assigned 42 patients to receive emricasan (Conatus Pharmaceuticals) and 44 patients to receive placebo.
Most of the patients were decompensated (90.7%), including variceal hemorrhage (12.8%), ascites (52.3%) and hepatic encephalopathy (68.6%).
While the researchers observed no significant difference in total bilirubin, INR or serum albumin between the groups’ overall populations at 3 months, patients with MELD scores of 15 or higher showed improvement in total bilirubin (–0.79 mg/dL; P < .05) and INR (–0.19; P < .05) compared with placebo. Patients with nonalcoholic steatohepatitis showed a nonsignificant trend toward similar improvements.
Both patients with MELD scores of 15 or higher (P = .003) and patients with NASH (P = .029) had significant improvements in MELD scores at 3 months compared with placebo.
At 6 months, the researchers compared patients in the emricasan group with their baseline results and found that those in the high-MELD subgroup either stabilized or continued to show improvements for MELD score (–1.6 to –2.8) and INR (–0.14 to –0.21). The NASH subgroup also showed stabilized or relative improvements over a total of 6 months.
The rates of moderate adverse events (38.6% vs. 28.6%), severe adverse events (11.4% vs. 9.5%) and discontinuations due to adverse events (6.8% vs. 4.8%) were similar between the treatment and placebo groups, with no reported deaths.
“The results need to be proven in a larger phase 3 study, but with these results I am hopeful that we will soon have a treatment for these patients.,” Frenette said. – by Talitha Bennett
Disclosure: Frenette reports she is consultant to Bayer, BTG, Conatus, Gilead, Intercept and Wako; an advisory board member of Eisai; a member of the speakers bureau for AbbVie, Bayer, Bristol-Myers Squibb, Gilead, Intercept, Merck and Salix; and receives research support from Bayer, Conatus and Genfit. Please see the full study for the other authors' relevant financial disclosures.