Results of the long-term etiotropic HBeAg-negative chronic hepatitis B therapy

• Sukhoruk Anastasiya A.
• Zakharov Konstantin А.
• Shimanskaya Aleksandra S.
• Stasishkis Tatyana A.
• Esaulenko Elena V.
• Alexey Yu. Kovelenov

Abstract

Rapidly progressing and hard to treat HBeAg-negative chronic hepatitis B (CHB) is for the prevalent type of the disease in the world, including Russia. Antiviral therapy (AT) by nucleotide (nucleoside) analogues (NA) is aimed at the permanent suppression of hepatitis B virus (HBV) replication in this category of patients. Lifetime NA prescription has its own significant disadvantages. Undefined duration of the NA treatment in HBeAg-negative patients is a serious problem taking into account absence of adequate predictors of the disease course after treatment discontinuation.

Aim of the study is to analyze the results of the long-term antiviral therapy of HBeAg-negative CHB patients.

Material and methods. AТ efficacy analysis was performed in 79 HBeAg-negative patients with confirmed CHB diagnosis who had not previously received NA or interferon-alpha. The administration of AT [telbivudine in a daily dose of 600 mg (n=49) or entecavir in a daily dose of 0.5 mg (n=30)] was started in accordance with the recommendations of the European Association for the Study of the Liver at the viral load (VL) of 2.0x10⁴ IU/ml and higher. The therapy course, which lasted from 5 months to 7 years, also included patients with a viral load less than 2.0x10⁴ IU/ml in presence of severe hepatic fibrosis (F3 or F4 stages by METAVIR). Efficacy of the treatment was evaluated based on the activity of alanine aminotransferase (ALT) and the level of HBV DNA, monitoring also included the biochemical and serological parameter measurements.

Results and discussion. The study had shown that VL reached undetectable levels in 92.3% of cases after 52 weeks of AT (p<0.05). Five patients out of six non-responders, who did not respond to AT, received telbivudin. A significant decrease in the proportion of patients with ALT levels above ULN (16.8 vs 44.3% at the beginning of the treatment), as well as severity of cytolytic activity (ALT levels 109.8±102.4 vs 68.8±39.2 IU/l at the beginning of the treatment) (p<0.05) were noted. The remarkable fact was the decrease in the proportion of patients responding to treatment at 104-156 weeks of AT. In most cases, failure of the therapy was associated with the telbivudine administration, and telbivudine replacement with entecavir was associated with increase of the virological response rates.

Conclusion. Thus, it can be concluded that treatment with telbivudine is currently impractical due to the high level of virological breakthroughs. Entecavirhas demonstrated higher efficacy during the treatment, lasting for up five or more years. However, there is a number of issues related to the prediction of the relapse risks after discontinuation of the NA therapy, which remains unsolved and requires further studying.

Keywords:chronic hepatitis B, antiviral therapy, entecavir, telbivudine

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