Abstract
BackgroundPegylated interferon (PEG-IFN) alfa-2b is recommended for chronic hepatitis B (CHB). We aimed to investigate the sustainability of off-treatment responses among Chinese HBeAg-positive CHB patients treated with PEG-IFN alfa-2b from a randomized trial.MethodsEligible Chinese patients (n = 322) were followed up by one visit after a median of 6 years (LTFU) following their participation in a randomized trial evaluating the efficacy of three PEG-IFN alfa-2b dosing regimens (1.0 or 1.5 μg/kg/wk. 24 weeks or 1.5 μg/kg/wk. 48 weeks). Primary endpoints at the LTFU were sustained SR and CR (SR/CR at the end of original study [EOS] and at the LTFU). SR was defined as HBeAg loss and seroconversion to anti-HBe and CR as HBeAg loss and seroconversion to anti-HBe and HBV-DNA < 2000 IU/mL.ResultsThe proportions of patients achieving sustained SR among patients who had SR at EOS were high in three treatment groups (61.9, 65.5, 76.5%, respectively, p = 0.46); treatment with PEG-IFN alfa-2b 1.5 μg/kg/wk. 48 weeks had the highest proportion of a sustained CR among patients who had CR at EOS (75.0%, p = 0.05). A considerable number of patients achieved sustained SR (18.2–29.9%) and sustained CR (14.8–18.3%) after EOS despite no further NA treatment. At the LTFU, rates of SR and CR were less than 70.0 and 50.0%, respectively, among all enrolled patients regardless of additional nucleos(t)ide analogs before the LTFU.ConclusionsPEG IFN alfa-2b therapy had considerable off-treatment sustainability in Chinese HBeAg positive chronic hepatitis B patients with serological and complete responses.
Highlights
Pegylated interferon (PEG-IFN) alfa-2b is recommended for chronic hepatitis B (CHB)
Because CHB is a significant risk factor for cirrhosis and hepatocellular carcinoma (HCC), intensive efforts have focused on the development of effective therapeutic strategies that aim for the clearance of hepatitis B virus (HBV) as measured by hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), viral DNA, normalization of hepatic function indicated by alanine transaminase (ALT), and slowing the progression of cirrhosis and inflammation in the liver [4]
Study population A total of 615 subjects from P05170 who resided in mainland China were qualified for telephone or physical recall to participate in the long-term follow-up (LTFU) by 1 onsite visit
Summary
Pegylated interferon (PEG-IFN) alfa-2b is recommended for chronic hepatitis B (CHB). We aimed to investigate the sustainability of off-treatment responses among Chinese HBeAg-positive CHB patients treated with PEG-IFN alfa-2b from a randomized trial. 240 million people worldwide are affected by chronic hepatitis B (CHB) [1]. Complications occur in approximately 20 to 30% of CHB patients, resulting in a CHB-related mortality rate of 650,000/year globally. In China, 90 million people are affected, accounting for almost 7% of the total population. The annual hepatitis B virus (HBV)-related cancer mortality rate in China is 330,000/year [2, 3]. Current therapeutic guidelines recommend the use of oral nucleosides/nucleotide analogues (NAs) and interferon-based therapy with interferon-alpha or pegylated interferon-alpha for patients with HBeAg-positive CHB [5, 6]
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