entecavir combined short-term intravenous hepatitis b immune globulin (hbig) to prevent hepatitis b recurrence after liver transplantation

Conditions: Hepatitis B; Liver Transplantation

Summary: the purpose of this study is to observe a new scheme can achieve is the same as the traditional scheme of the effect of preventing hepatitis b recurrence.

at present, the prevention of hepatitis b recurrence after liver transplantation is the most commonly used scheme for nucleoside analogue combined hepatitis b immune globulin (hbig). hbig is a condensed to prevent the efficient price of invasion of hepatitis b immunoglobulin, its function is a direct and virus.also it is to block the virus into liver cells. lamivudine with hbig therapy has hepatitis b recurrence rate reduced to below 10%, entecavir combined hbig hepatitis b recurrence rate is low below 1%. in european and american countries, hbig the most commonly used method for long-term high-dose intravenous drip, but our country is long-term low-dose intramuscular injection, but all need lifelong medication, for how long after surgery or which patients can disable or not hbig no consensus. whether long-term intravenous drip or intramuscular hbig, are some disadvantages such as high cost, drug side effects, also brought inconvenience to patients. the advent of potent against hepatitis b virus drugs continuously under the background of, in recent years, scholars have already begun to no application or short-term application hbig discontinuation to prevent hepatitis b recurrence after research, low before transplantation of hepatitis b virus(hbv) dna replication, such as effective antiviral therapy of hepatitis b recurrence after after transplantation were created the conditions of no hbig solution. most studies suggest that transplantation of nucleoside analogues alone for a long time without application or short-term application of hbig scheme to prevent hepatitis b recurrence is safe, but there are only several transplant center in study abroad, and the chinese mainland for all application or short-term application of hbig clinical studies. entecavir with potent antiviral capacity and high genetic barrier to resistance, low incidence of drug resistance, is currently the prevention and treatment of hepatitis b recurrence after liver transplantation of first-line drugs, entecavir combined long-term muscle injection low-dose hbig is at present our country is the most commonly used drug for liver transplantation in our center. this study for entecavir combined after liver transplantation for short-term application type static note hbig to prevent hepatitis b recurrence of prospective, multicenter, randomized, controlled experimental study, the equivalence. the purpose of this study is to observe a new scheme can achieve is the same as the traditional scheme of the effect of preventing hepatitis b recurrence.

Eligibility criteria:
inclusion criteria: 1. correlation disease hepatitis b viral hepatitis liver transplantation recipients for the first time; 2. older than 18 years old, men and women not limited; 3. preoperative hbsag positive, regardless of whether preoperative hbv dna level, regardless of whether preoperative antiviral treatment, regardless of whether associated with primary liver cancer; 4. donor hbsag negative, other virology negative in liver conditions; 5. to integrate research, good adherence. exclusion criteria: 1. overlap other types of viral hepatitis; 2. the correlation of end-stage liver disease hepatitis b; 3. again to liver transplantation, or joint organ transplantation; 4. allergic to hepatitis b immune globulin; 5. of primary hepatocellular carcinoma with vena cava, portal vein around the trunk or branch, hepatic vein and other large vascular invasion; 6. abo blood group incompatibility in liver transplantation; 7. moderately severe renal insufficiency, serum creatinine 180 umol/l or higher; 8. there has been a drug resistance of entecavir before liver transplantation.

Keywords: hepatitis b immune globulin (hbig) liver transplantation hepatitis b entecavir