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Heavy Alcohol Use Impairs Biochemical Response to Entecavir for Chronic Hepatitis B

While obese chronic hepatitis B patients and heavy drinkers did not have impaired virological response to entecavir (Baraclude), alcohol use did reduce the likelihood of alanine aminotransferase (ALT) normalization, according to study findings reported in the June 2012 issue of Clinical and Molecular Hepatology.

While obese chronic hepatitis B patients and heavy drinkers did not have impaired virological response to entecavir (Baraclude), alcohol use did reduce the likelihood of alanine aminotransferase (ALT) normalization, according to study findings reported in the June 2012 issue of Clinical and Molecular Hepatology.

Won Gil Chung from Kangbuk Samsung Hospital in Seoul and colleagues looked at the clinical impact of obesity and "hazardous alcohol use" on outcomes of entecavir treatment for chronic hepatitis B.

The investigators retrospectively analyzed medical records from 88 previously untreated hepatitis B patients who received entecavir between March 2007 and September 2009. About 70% were men, the average age was 47 years, and half were hepatitis B "e" antigen (HBeAg) positive. About 22% had liver cirrhosis, but those with decompensated disease were excluded, as were people with HIV or hepatitis C coinfection.

All patients included in the analysis were treated with 0.5 mg once-daily entecavir for more than 12 months. Body mass index (BMI) and scores on the Alcohol Use Disorders Identification Test (AUDIT) were obtained 6 months after the start of treatment. A BMI of 25 kg/m² or more was the threshold for obesity and a total AUDIT score of 8 or more was the cutoff for hazardous alcohol use.

Results

• 24 patients in the cohort (27%) were obese and 17 (19%) were classified as hazardous alcohol users.
• Complete virological response rates (< 300 HBV DNA copies/mL) were 47% at 3 months, 69% and 6 months, and 83% at 12 months after starting entecavir.
• Among the 44 initially HBeAg positive participants, complete virological response rates at these time points were 21%, 48%, and 71%, respectively, compared with 73%, 91%, and 96% for HBeAg negative patients.
• Seroconversion rates for the HBeAg positive group at the same time points were 21%, 25%, and 34%, respectively.
• Rates of complete virological response, HBeAg seroconversion, and ALT normalization did not differ significantly between obese individuals and those with normal BMI.
• Virological response and seroconversion rates were also similar between hazardous alcohol users and those who drank less or not at all.
• But the frequency of ALT normalization at 12 months was significantly lower for hazardous alcohol users, indicating ongoing liver inflammation (92% vs 71%; P=0.03).

"Obesityand hazardous alcohol drinking have no significant impact on the outcome of entecavir treatment," the study authors concluded. "However, the ALT normalization rate at 12 months after initiation of entecavir treatment was significantly lower among the hazardous alcohol users."

"Alcohol and obesity are well known for their noxious effect on the liver and expected to have the negative effect on entecavir efficacy," they added in their discussion. "However, contrary to our expectations, entecavir showed [a] satisfactory antiviral effect in the obese and hazardous alcohol use patients with chronic hepatitis B."

9/28/12

Reference

WG Chung, HJ Kim, YG Choe, et al. Clinical impacts of hazardous alcohol use and obesity on the outcome of entecavir therapy in treatment-naïve patients with chronic hepatitis B infection. Clinical and Molecular Hepatology 18(2):195-202. June 2012.