Natural history, outcome, and sustainability of treatment response in chronic viral hepatitis B: Thai multicenter study

Background: Data regarding the natural history and outcome of treatment of chronic hepatitis B (CHB) patients in Thailand remain inconclusive.

Objective: We aimed to examine the natural history and outcome of therapy in Thai CHB patients treated with nucleoside analogues (NAs) monotherapy or interferon (IFN) monotherapy.

Method: CHB patients without clinical evidence of cirrhosis and alanine aminotransferase (ALT) levels >1.5 times of normal for at least 6 months were enrolled from 6 hospitals (2002 to 2005). Treatment included NAs and IFN. Treatment response was defined as ALT normalization and an HBV DNA level <10,000 copies/ml (or <2,000 IU/ml) and/or HBeAg seroconversion at the end of follow up. The study was approved by the institutional review board of each hospital.

Result: A total of 567 patients with mean age of 46.8 ± 11.9 y were included. The ratio of HBeAg positive to HBeAg negative patients was 1.3:1. Nineteen percent of patients had no HBeAg status. There were 262 HBeAg positive patients (46%) and 197 HBeAg negative patients 35%. Sixty-one percent received NAs while 20% received IFN as a first line treatment and the remaining 19% received no specific medication. For the HBeAg positive patients, HBeAg seroconversion and undetectable HBV-DNA were achieved in 32.8% and 50.5%, respectively in NAs group (on therapy), and HBeAg seroconversion and undetectable HBV-DNA were achieved in 24.3% and 21.4%, respectively in the IFN-treated group (off treatment). For the HBeAg negative patients, undetectable levels of HBV-DNA occurred in 68.8% in the NAs group while undetectable levels of HBV-DNA occurred in 37.5% of patients in the IFN-treated group. HBsAg loss was not found in the NAs group, but 2.8% of patients in IFN group had HBsAg loss. HBV DNA reappeared in the IFN group (off treatment) and NAs groups (on therapy) in 26.6% and 24.3% of patients, respectively. Minor adverse events of therapy were found in 9% of patients. Five percent of patients progressed to Child A cirrhosis and one patient in the NAs group (0.18%) died from causes unrelated to liver disease, during a 3-year follow-up.

Conclusion: The treatment response of Thai CHB patients from multicenter study showed the results similar to previous studies. However, higher durability of treatment with lower rate of reappearance of HBV DNA was observed in Thai CHB patients.