Discontinuation of lamivudine treatment in HBeAg-negative chronic hepatitis B: a pilot study with long-term follow-up.

Abstract

BACKGROUND:

Finite treatment of hepatitis B e antigen (HBeAg)-negative chronic hepatitis B (CHB) with nucleoside/nucleotide analogues (NAs) is important in resource-limited countries. Outcome of treatment discontinuation in patients on long-term lamivudine (LVD) was assessed in a single centre observational pilot study in the current study.

METHODS:

Non-cirrhotic patients on LVD for at least 5 years with undetectable HBV DNA on at least two consecutive assessments were offered to stop treatment. Biochemical, serological and virological measures were determined at 3-6 month intervals after treatment discontinuation. Serum quantitative hepatitis B surface antigen (HBsAg) was determined at treatment discontinuation and 5-6 years thereafter. NA treatment was re-instituted in patients with confirmed viral rebound defined as HBV DNA >20,000 IU/ml. Relapser patients were no longer followed but were re-assessed 6 years after treatment cessation.

RESULTS:

LVD was discontinued in 23 patients. 8 patients relapsed within 1 year and NA treatment was restarted; 15 patients (65%) were non-relapsers. Thirteen of them were followed for at least 5 years. Two patients had undetectable HBV DNA throughout the follow-up period. In the rest, HBV DNA fluctuated at low levels. Two patients cleared HBsAg 24 and 36 months after stopping treatment. Quantitative HBsAg levels 5-7 years after treatment discontinuation were lower in non-relapser compared to relapser patients (1.21 IU/ml ±0.98 versus 2.71 ±0.76; P=0.002). Of 8 relapser patients 1 patient had HBsAg levels less than 100 IU/ml compared to 11 out of 13 non-relapser patients (P=0.0022).

CONCLUSIONS:

These data suggest that cessation of NA treatment is a viable option after a reasonable treatment duration in patients with HBeAg-negative CHB and that HBsAg clearance may become an achievable target in these patients.

• Authors: Fatih Karakaya, Sevil Özer, Çağdaş Kalkan, E Ali Tüzün, Aysun Çalışkan, Onur Keskin, Gökhan Kabaçam, Senem Karatayli, Ersin Karatayli, A Mithat Bozdayi, Ramazan Idilman, Cihan Yurdaydin
• Journal: Antiviral therapy (Antivir Ther) Vol. 22 Issue 7 Pg. 559-570 ( 2017) ISSN: 2040-2058 [Electronic] England
• PMID: 28240596 (Publication Type: Journal Article)

Chemical References

• Antiviral Agents
• Biomarkers
• DNA, Viral
• Hepatitis B Surface Antigens
• Hepatitis B e Antigens
• Lamivudine

Topics

• Adult
• Aged
• Antiviral Agents (adverse effects, therapeutic use)
• Biomarkers
• DNA, Viral
• Drug Therapy, Combination
• Female
• Follow-Up Studies
• Hepatitis B Surface Antigens (blood)
• Hepatitis B e Antigens (blood)
• Hepatitis B virus (immunology)
• Hepatitis B, Chronic (blood, diagnosis, drug therapy, mortality)
• Humans
• Kaplan-Meier Estimate
• Lamivudine (adverse effects, therapeutic use)
• Male
• Middle Aged
• Pilot Projects
• Time Factors
• Treatment Outcome
• Viral Load