Abstract
We examined the association between serum miRNA (-192-5p, -122-3p, -320a and -6126-5p) levels and the efficacy of pegylated interferon (Peg-IFN) monotherapy for chronic hepatitis B (CHB) patients. We enrolled 61 CHB patients treated with Peg-IFNα-2a weekly for 48 weeks, of whom 12 had a virological response (VR) and 49 did not VR (non-VR). A VR was defined as HBV DNA < 2,000 IU/ml, hepatitis B e antigen (HBeAg)-negative, and nucleos(t)ide analogue free at 48 weeks after the end of treatment. The non-VR group showed a significantly higher HBeAg-positivity rate, ALT, HBV DNA, and serum miR-192-5p levels at baseline (P = 0.024, P = 0.020, P = 0.007, P = 0.021, respectively). Serum miR-192-5p levels at 24-weeks after the start of treatment were also significantly higher in the non-VR than the VR group (P = 0.011). Multivariate logistic regression analysis for predicting VR showed that miR-192-5p level at baseline was an independent factor (Odds 4.5, P = 0.041). Serum miR-192-5p levels were significantly correlated with the levels of HBV DNA, hepatitis B core-related antigen, and hepatitis B surface antigen (r = 0.484, 0.384 and 0.759, respectively). The serum miR-192-5p level was useful as a biomarker for the therapeutic efficacy of Peg-IFN in CHB treatment.
Highlights
Hepatitis B virus (HBV) infection is a global public health problem, with approximately 240 million people, or 6% of the world’s population, chronically infected with HBV [1]
We compared clinical characteristics between the virological response (VR) and non-VR groups among hepatitis B e antigen (HBeAg)-negative patients, which showed that there was no significant difference in ALT and HBV DNA levels, while miR-192-5p levels tended to be higher in the non-VR group (S1 Table)
Several factors have been reported to be associated with VR in the treatment of chronic hepatitis B (CHB), for instance patients with HBeAg-negative CHB who show decreased Hepatitis B core-related antigen (HBcrAg) levels during treatment with pegylated interferon (Peg-IFN) combination therapy with or without nucleos(t) ide analogues (NAs) were more likely to succeed with anti-viral treatment [21, 22]
Summary
Hepatitis B virus (HBV) infection is a global public health problem, with approximately 240 million people, or 6% of the world’s population, chronically infected with HBV [1]. The long-term goal of antiviral therapy for chronic hepatitis B (CHB) has been to eliminate hepatitis B surface antigen (HBsAg). The current standard therapies using nucleos(t) ide analogues (NAs) or pegylated interferon (Peg-IFN) are difficult to achieve the elimination of HBsAg [3]. Peg-IFN has the advantage of maintaining a drug-free therapeutic effect without additional drug administration after treatment in CHB patients who exhibit a therapeutic response [7, 8]. The levels of ALT and HBV DNA, and HBV genotype at baseline, have been reported to significantly affect the response to Peg-IFN therapy after 24-weeks of treatment [8–10]. Along these lines, a reliable marker for the efficacy of Peg-IFN therapy in CHB is needed [11]
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