Hepatitis B virus (HBV) RNA in serum declines profoundly during treatment with pegylated interferon (PEG-IFN); therefore, early on-treatment HBV RNA levels may be used to predict nonresponse, according to a study published in the Journal of Viral Hepatitis.

HBV RNA in serum is a novel biomarker that reflects the main HBV replication template,  covalently closed circular DNA (cccDNA) activity. One of the major limitations of current chronic HBV treatment options is that they do not silence or eliminate cccDNA, thereby limiting the achievement of functional cure. Studying these biomarkers in PEG-IFN treatment is needed because it is increasingly being used in clinical studies of new therapeutic compounds.

Therefore, researchers studied HBV RNA levels and dynamics before and during PEG-IFN treatment in a multiethnic population of 266 patients with HBeAg-positive chronic HBV who were previously treated in a global randomized controlled trial. Results found that at baseline, the mean serum level of HBV RNA was 6.8 log copies/mL, which declined to 4.7 log copies/mL after 1 year of PEG-IFN therapy alone and to 3.3 log copies/mL after combination therapy with PEG-IFN and lamivudine.

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From week 12 onward, HBV RNA levels were significantly lower in patients who demostrated HBeAg loss at the end of follow-up compared with those who did not, regardless of treatment allocation (week 12: 4.4 vs 5.1 log copies/mL; P =.01; week 24: 3.7 vs 4.9 log copies/mL; P <.001). 

“To summarize, we showed that HBV RNA in serum declines significantly during PEG-IFN based treatment,” stated the study authors. They added that, “Studies involving multiple HBV biomarkers, especially within the context of novel treatment approaches which target the HBV life cycle or cccDNA, are warranted to define more applications for this novel biomarker.”

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Disclosure: This clinical trial was supported by F. Hoffmann-La Roche Ltd. (Basel, Switzerland) and Bristol Myers Squibb (New York, USA). Please see the original reference for a full list of authors’ disclosures.


van Campenhout MJH, van Bömmel F, Pfefferkorn M, et al. Serum hepatitis B virus RNA predicts response to peginterferon treatment in HBeAg-positive chronic hepatitis B [published online February 12, 2020]. J Viral Hepat. doi:10.1111/jvh.13272