Investigators Define Criteria for Liver Improvement in Chronic Hepatitis B Patients

There is now a defined criteria to liver functioning test improvements in patients with chronic hepatitis B virus (HBV) infections.

A team, led by Qi Wang, Center of Liver Diseases, Beijing Ditan Hospital, Capital Medical University, validated the Baveno VII definition of recompensation and explored the criteria for stable improvement of liver function tests in patients with chronic HBV-related decompensated cirrhosis treated with entecavir.

Predicting HBV

Antiviral therapy is an effective tool in improving clinical outcomes of patients with chronic HBV, including individuals with cirrhosis.

In recent years, investigators have proposed the idea of recompensation for patients who experience an improvement in liver function if the underlying cause of their disease is addressed.

One treatment option is nucleos(t)ide analogues (NAs), which can lead to viral suppression and the amelioration of necroinflammation and regression of fibrosis in most patients with chronic hepatitis B virus infections.

“Many studies have also demonstrated that NAs can improve the long-term prognosis of patients with cirrhosis, even those in the decompensated stage,” the authors wrote. Therefore, the concept of recompensation has been proposed, which means no further occurrence of decompensating events (including ascites, gastroesophageal variceal bleeding [VB], and hepatic encephalopathy [HE]) for an extended period (at least 1 year) as a result of the removal or effective control of the underlying aetiology.”

Testing

In the multicenter, prospective study, the investigators examined 320 patients with decompensated chronic HBV-related cirrhosis that were treated with entecavir over 120 weeks. Patients were followed up with every 6 months for clinical events, viral and biochemical tests, and ultrasonography.

The investigators also calculated the recompensation rate using the Baveno VII criteria and identified predictors of recompensation using multivariate regression models. Finally, they explored the criteria for stable improvement of liver function tests.

Of the 320 patients, 283 completed the study and 92.2% (n = 261) achieved HBV DNA levels of less than 20 IU/ml. In addition, 60.4% (n = 171) achieved resolution of ascites, encephalopathy, and absence of recurrent variceal bleeding for at least 12 months.

The team identified model for end-stage liver disease less than 10 and/or liver function tests within Child-Pugh Class A (albumin >35 g/L, international normalized ratio <1.50 and total bilirubin <34 μmol/L) as the criteria for stable improvement of liver function tests.

The results show 56.2% (n = 159) of participants fulfilled the Baveno VII definition of recompensation with a stable improvement of liver function tests defined by the study parameters.

“Our study defined the criteria for a stable improvement of liver function tests required by the Baveno VII definition of recompensation in patients with CHB-related decompensated cirrhosis on antiviral therapy,” the authors wrote. “The criteria derived from this multicenter prospective study warrant further validation in patients with cirrhosis of other etiologies.”

The study, “Validation of Baveno VII criteria for recompensation in entecavir-treated individuals with hepatitis B-related decompensated cirrhosis,” was published online in the Journal of Hepatology.