Abstract
Serum hepatitis B virus (HBV) pregenomic RNA (pgRNA) is correlated with covalently closed circular DNA. We aimed to investigate the utility of serum HBV pgRNA in chronic hepatitis B patients receiving nucleos(t)ide analogue treatment and those achieving HBsAg loss. One hundred and eighty-five patients were enrolled for studying long-term HBV pgRNA kinetics during treatment. Twenty patients achieving HBsAg loss after treatment were enrolled for examining HBV pgRNA kinetics around HBsAg loss. HBV pgRNA significantly decreased in the high baseline HBV pgRNA (≥6 log copies/mL) group but significantly increased in the low baseline HBV pgRNA (<4 log copies/mL) group after 3-month entecavir treatment. Among the 20 patients achieving HBsAg loss, 13 (65%) patients had serum HBV pgRNA higher than the limit of detection (LOD, 1466 copies/mL) when they achieved HBsAg loss. Finally, all 20 patients had HBV pgRNA going below the LOD within 3 years after achieving HBsAg loss. In conclusion, baseline serum HBV pgRNA alone is insufficient for predicting the trajectory of HBV pgRNA. Most patients still had HBV pgRNA higher than the LOD when they achieved HBsAg loss. Further studies on HBV pgRNA kinetics around HBsAg loss would provide an enhanced basis for further applications of HBV pgRNA.
Highlights
Chronic hepatitis B virus (HBV) infection is an important health problem worldwide.The WHO estimated that 257 million people were living with chronic HBV infection in2015 [1]
185 chronic hepatitis B (CHB) patients were enrolled for studying the long-term kinetics of serum HBV pregenomic RNA (pgRNA) during entecavir therapy (Part I) and 47 CHB patients for analyzing the factors associated with virological relapse after cessation of entecavir therapy (Part II), 55 CHB patients who had achieved HBsAg loss, 20 healthy subjects with negative HBsAg but positive antibody to hepatitis B core antigen, and 17 healthy controls with negative HBsAg and negative anti-HBc for determining the expression of serum HBV pgRNA after HBsAg loss (Part III). 20 CHB
No significant differences were observed in HBV pgRNA levels at 6 months, 12 months, and 60 months between the medium and low HBV pgRNA groups
Summary
Chronic hepatitis B virus (HBV) infection is an important health problem worldwide.The WHO estimated that 257 million people were living with chronic HBV infection in2015 [1]. Chronic hepatitis B virus (HBV) infection is an important health problem worldwide. The 5-year cumulative incidence of cirrhosis is 8–20% in untreated patients, and the 5-year cumulative risk of hepatic decompensation is 20% among those with cirrhosis [2]. Current treatment guidelines recommend pegylated interferon, entecavir (a nucleoside analog), and tenofovir (a nucleotide analogue) as preferred treatments for chronic HBV infection [2,4,5]. Pegylated interferon treatment achieves hepatitis B e antigen (HBeAg) seroconversion in approximately one-third of patients with HBeAg-positive chronic hepatitis B (CHB), but this treatment is associated with a number of side effects that limit its use [6]. Entecavir and tenofovir are broadly used because of their efficacy, safety, and convenience. Long-term treatment is necessary to maintain efficacy due to the persistence of covalently closed circular DNA (cccDNA) [7]
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