Abstract
BackgroundSerum hepatitis B virus RNA (HBV RNA) has been reported to be a surrogate marker of intrahepatic cccDNA during nucleos(t)ide analogs therapy. However, in HBeAg-positive patients treated with peg-interferon (peg-IFN), whether HBV RNA is superior to other HBV markers in reflecting cccDNA profile is still unclear.MethodsSerum HBV RNA, HBcrAg, HBV DNA, and HBsAg were longitudinally assessed among 30 HBeAg-positive patients during 48-week peg-IFN treatment. Besides, intrahepatic cccDNA was detected at baseline and week 48 respectively. Then, the individual correlations between HBV RNA, HBcrAg, HBV DNA, HBsAg, and cccDNA were statistically analyzed.ResultsHBV RNA levels decreased more rapidly in patients with HBeAg seroconversion than those without HBeAg seroconversion. Among all patients, cccDNA correlated better with HBV RNA than with HBcrAg, HBV DNA, and HBsAg at baseline. After 48 weeks peg-IFN treatment, cccDNA still correlated more strongly with HBV RNA than other HBV markers. Further analysis indicated that in patients with HBeAg seroconversion cccDNA strongly correlated with HBV RNA and HBcrAg, whereas not correlate with HBV DNA and HBsAg. While in patients without HBeAg seroconversion, cccDNA highly correlated with HBV RNA and HBV DNA, moderately correlated with HBcrAg, and not correlated with HBsAg.ConclusionCompared to HBcrAg, HBV DNA, and HBsAg, serum HBV RNA correlated more strongly with intrahepatic cccDNA levels before and after 48-week peg-IFN treatment. The level of serum HBV RNA may be a superior surrogate marker in reflecting the intrahepatic cccDNA profile in HBeAg-positive patients during peg-IFN treatment.Trial registration ClinicalTrials, NCT03546530. Registered 1 January 2015. https://clinicaltrials.gov/ct2/results?cond=&term=NCT03546530.
Highlights
Serum hepatitis B virus Hepatitis B virus RNA (RNA) (HBV RNA) has been reported to be a surrogate marker of intrahepatic closed circular DNA (cccDNA) during nucleos(t)ide analogs therapy
It could be seen that there were no significant differences in hepatitis B virus RNA (HBV RNA), cccDNA, HBV core-related antigen (HBcrAg), HBV DNA, and Hepatitis B surface antigen (HBsAg) at baseline between the SR and NSR groups
The results showed that there was no difference of serum HBV RNA or HBcrAg in patients with and without Hepatitis B e antigen (HBeAg) seroconversion at baseline, which indicated that HBV RNA and HBcrAg at baseline may be not associated with HBeAg-seroconversion in HBeAgpositive patients treated with peg-IFN
Summary
Serum hepatitis B virus RNA (HBV RNA) has been reported to be a surrogate marker of intrahepatic cccDNA during nucleos(t)ide analogs therapy. In HBeAg-positive patients treated with peg-interferon (pegIFN), whether HBV RNA is superior to other HBV markers in reflecting cccDNA profile is still unclear. (peg-IFN) and nucleotide/nucleoside analogs (NAs) [3] Among these agents, peg-IFN, which has the effects of suppressing HBV replication and immunomodulation, is still widely used in the clinic as the first-line therapeutic option for patients with HBeAg-positive chronic hepatitis B (CHB) [4]. Antiviral agents can effectively reduce the serum HBV DNA level in CHB patients, complete elimination of HBV is difficult due to the existence of intrahepatic covalently closed circular DNA (cccDNA) [5]. Finding non-invasive surrogate markers of intrahepatic cccDNA is clinically meaningful
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