Antiviral therapy prolongs survival in immune tolerant hepatitis B patients

A new study, presented today at The International Liver Congress 2016 in Barcelona Spain, demonstrates that the use of antiviral therapy for patients in the immune tolerant phase of Hepatitis B (HBV) prolongs overall survival and reduces the risk of the most common form of liver cancer (Hepatocellular Carcinoma, HCC) and scarring of the liver (cirrhosis).

The study showed that the risks of developing HCC and liver cirrhosis were significantly lowered among those who received nucleos(t)ide analogue treatment.

Hepatitis B is the most common serious liver infection in the world. It is caused as the virus, transmitted through blood and infected bodily fluids, attacks the liver.1 In the immune tolerant stage, HBV actively replicates in the liver, but remains unrecognised by the immune system. Patients can remain in this stage for decades with high viral load but no apparent damage to the liver.2 There are two treatment options for HBV immune tolerant patients: pegylated interferon strategy, or nucleos(t)ide analogues.3

"Our study demonstrates that nucleos(t)ide analogue treatment offers promising results in reducing the risk of liver cancer and damage among those patients who have limited treatment options," said Professor Jeong-Hoon Lee of the Liver Research Institute at Seoul National University, Korea and corresponding author of the study. "Furthermore, in contrast to the control group who received no treatment during immune tolerant phase, overall survival was significantly prolonged for those who received nucleos(t)ide analogue treatment."

The single-center retrospective study was conducted in 644 patients diagnosed as HBeAg-positive chronic HBV (an indicator of active viral replication) with alanine aminotransferase levels within two times of upper normal limit, without evidence of liver cirrhosis. Patients were divided into two groups, the group who received antiviral therapy and the control group who received no therapy until the immune-active phase. The primary endpoint of the study was overall survival and secondary endpoints were the development of HCC and liver cirrhosis.

After balancing for baseline characteristics between the two groups, the risk of developing HCC (Hazard Ratio [HR]= 0.084; 95% Confidence Interval [CI]=0.030-0,234; p<0.001) and liver cirrhosis (HR=0.250, 95% CI=0.089-0.707; p=0.009) were significantly lower in the antiviral group. Furthermore, antiviral treatment significantly prolonged overall survival compared to the control group (HR=0.059, 95% CI=0.008-0.415; p=0.005).

"This study results are significant in helping to advance medical alternatives for patients with immune tolerant Hepatitis B, a sub-group of patients who thus far, doctors have been hesitant to treat," said Professor Tom Hemming Karlsen, EASL Vice-Secretary.