Current treatment guidelines indicate that oral antiviral agents for HBeAg-positive chronic hepatitis B virus infection (CHB) can be stopped if the patient has undergone HBeAg seroconversion with HBV-DNA loss measured at two consecutive occasions at least 6 months apart (primary treatment endpoint). Stopping treatment can be considered if undetectable HBV-DNA has been documented on three separate occasions 6 months apart in HBeAg-negative patients. However, oral antiviral drugs currently approved for the treatment of CHB have relatively limited sustained long-term efficacy and a large proportion of patients will suffer from HBV recurrence after stopping treatment.
The purposes of this study are: 1. To evaluate the long-term efficacy of Lamivudine extending therapy in CHB patients who received at least 3-year of oral antiviral agents. 2. To evaluate the long-term outcomes and predictive factors of Lamivudine extending therapy in CHB patients who received at least 3-year of oral antiviral agents. A prospective, open-label, multicenter study will enroll 500 treatment-naïve CHB patients who received at least 3-year of oral antiviral agents. With their voluntary decision after consultation, 250 patients will receive Lamivudine extending therapy for 5 years and the other 250 patients will receive follow-up and serve as controls. The primary outcome measurement is HBV DNA recurrence, whilst the secondary outcome measurement is liver-related outcomes and associated predictive factors
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
500
Lamivudine, 100mg/day, per os
Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospital
Kaohsiung City, NRW, Taiwan
RECRUITINGRate of HBV DNA recurrence
Time frame: up to 12 months
Associated predictive factors of HBV DNA recurrence
Time frame: up to 12 months
Rate of drug resistant mutation
Time frame: up to 12 months
Rate of clinical relapse in Group B (non-intervention)
clinical relapse means HBV DNA\>2000 IU/mL plus ALT \> 2 fold upper limit of normal (ULN) in end of entecavir (ETV) normal alanine aminotransferase (ALT) or 2 fold elevation in end of ETV abnormal ALT patients
Time frame: up to 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.