Lactic Acidosis During Entecavir(ETV)Treatment (ETV)
Lactic Acidosis
About this trial
This is an interventional diagnostic trial for Lactic Acidosis focused on measuring lactic acidosis, entecavir, lamivudine
Eligibility Criteria
for ETV or LAM group
Inclusion criteria:
- 18 and more than 18 years, and less than 65 years
- HBV-related liver cirrhosis or acute-on-chronic liver failure
- Prior documentation of chronic HBV infection at least 6 months before randomization
- MELD score 18 and more than 18
- Venous blood lactate level 2 and less than 2 mmol/L
Exclusion criteria:
- Age of 65 or older, or younger than 18
- Patients with acute hepatitis B including acute liver failure
- Acute-on-chronic liver failure precipitated by acute hepatitis A or acetaminophen intoxication
- MELD score less than 18
- entecavir, lamivudine, telbivudine, clevudine, adefovir or tenofovir treatment continued longer than 3 months before entry.
- Evidence of genotypic or virological resistance to lamivudine, clevudine, telbivudine, or adefovir
- Patients with elevated venous blood lactate levels more than 2 mmol/L
- Recent episodes of active infection, hypotension (systolic blood pressure less than 90 mmHg), gastrointestinal or other active bleeding within 2 weeks before entry
- Any alcohol intake within 2 weeks before entry
- Recent use of acetaminophen, epinephrine, metformin, iron, isoniazid, propofol, salicylate, sulfasalazine, or valproic acid within 2 weeks before entry. Use of lactulose is permitted.
- Presence of hepatocellular carcinoma. Patients with hepatocellular carcinoma meeting the Milan criteria can be permitted.
- Any cancer other than hepatocellular carcinoma except cervical carcinoma in situ, treated basal cell carcinoma, and superficial bladder tumors (Ta, Tis & T1). Any cancer curatively treated at least 3 years prior to entry is permitted.
- Patients with HIV infection
- Female patients in pregnancy
- for no NRTI group
Inclusion criteria:
- Age of 65 or older, or younger than 18
- Liver cirrhosis or acute-on-chronic liver failure not related with HBV
- MELD score 18 and more than 18
- Venous blood lactate level 2 and less than 2 mmol/L
Exclusion criteria:
- Age of 65 or older, or younger than 18
- Patients with positive HBsAg or IgM anti-HBc
- Acute-on-chronic liver failure precipitated by acute hepatitis A or acetaminophen intoxication
- MELD score less than 18
- Patients with elevated venous blood lactate levels more than 2 mmol/L
- Recent episodes of active infection, hypotension (systolic blood pressure less than 90 mmHg), gastrointestinal or other active bleeding within 2 weeks before entry
- Any alcohol intake within 2 weeks before entry
- Recent use of acetaminophen, epinephrine, metformin, iron, isoniazid, propofol, salicylate, sulfasalazine, or valproic acid within 2 weeks before entry. Use of lactulose is permitted.
- Presence of hepatocellular carcinoma. Patients with hepatocellular carcinoma within Milan criteria can be permitted.
- Any cancer other than hepatocellular carcinoma except cervical carcinoma in situ, treated basal cell carcinoma, and superficial bladder tumors (Ta, Tis & T1). Any cancer curatively treated at least 3 years prior to entry is permitted.
- Patients with HIV infection
- Female patients in pregnancy
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
No Intervention
entecavir
lamivudine
no NRTI group
Oral 0.5mg/day until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18. Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.
Oral 100mg/day lamivudine until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18. Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.
hepatitis C virus associated LC patients for the calculation of lactic acidosis incidence