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Merck
  • HBsAg seroclearance after nucleoside analogue therapy in patients with chronic hepatitis B: clinical outcomes and durability.

HBsAg seroclearance after nucleoside analogue therapy in patients with chronic hepatitis B: clinical outcomes and durability.

Gut (2013-10-29)
Gi-Ae Kim, Young-Suk Lim, Jihyun An, Danbi Lee, Ju Hyun Shim, Kang Mo Kim, Han Chu Lee, Young-Hwa Chung, Yung Sang Lee, Dong Jin Suh
ABSTRACT

Little is known about the long-term clinical outcome and durability of HBsAg seroclearance following nucleos(t)ide analogue (NUC) therapy in patients with chronic hepatitis B (CHB). During a median follow-up period of 6 years (33 567 patient-years) of 5409 CHB patients who were initially treated with lamivudine or entecavir, a total of 110 achieved HBsAg seroclearance (0.33% annual seroclearance rate) and were included in this study. Baseline alanine aminotransferase (ALT) level >5 times of upper limit of normal was associated with higher probability of HBsAg seroclearance (HR 1.80, p<0.01), while HBeAg positivity (HR 0.46, p<0.01), high HBV DNA level (log(10) IU/mL; HR 0.61, p<0.01), and cirrhosis (HR 0.48, p<0.01) were inversely associated with the probability of HBsAg seroclearance by multivariable analysis. During follow-up for 287 patient-years after HBsAg seroclearance, only two patients with baseline cirrhosis developed hepatocellular carcinoma (HCC) or died (0.7% annual risk), which was of a significantly lower rate compared with propensity score-matched patients without HBsAg seroclearance (HR 0.09, p<0.01). HBsAg reversion and/or HBV DNA reversion occurred in 18 patients, most of which were transient with extremely low serum levels of HBsAg (0.05-1.00 IU/mL) and HBV DNA (17-1818 IU/mL). None required retreatment. The cumulative probability of anti-HBs seroconversion (detection of anti-HBs) at 4 years was 67.4% by Kaplan-Meier analysis. Selection for lamivudine-resistance HBV mutants during treatment was not associated with composite reversion (p=0.66). HBsAg seroclearance achieved after NUC treatment was associated with favourable clinical outcomes and was durable in most cases during long-term follow-up.

MATERIALS
Product Number
Brand
Product Description

Supelco
Guanine, Pharmaceutical Secondary Standard; Certified Reference Material
Sigma-Aldrich
Lamivudine, ≥98% (HPLC), powder
USP
Lamivudine, United States Pharmacopeia (USP) Reference Standard
Sigma-Aldrich
Guanine, 98%
Sigma-Aldrich
Guanine, BioUltra
Lamivudine, European Pharmacopoeia (EP) Reference Standard
Lamivudine for system suitability 1, European Pharmacopoeia (EP) Reference Standard
Supelco
Lamivudine, Pharmaceutical Secondary Standard; Certified Reference Material
Lamivudine for system suitability 2, European Pharmacopoeia (EP) Reference Standard