Chronic hepatitis B seriously endangers the health of our people, especially the occurrence of HCC, which brings huge economic burden and life threat to our people. 84% - 92% of HCC in China is related to chronic HBV infection. How to further reduce the risk of liver cancer is an urgent problem to be solved in clinical research and an important direction. Although NAs treatment can make patients achieve the negative transformation of virus, it can not effectively reduce the level of virus antigen, and it also lacks the ability to improve the immune clearance of virus. As a result, the incidence of liver cancer in patients with long-term NA treatment is still 4.5% - 10.5%, and the incidence of HCC in patients with hypoviremia in Na treatment is higher. In current clinical practice, nearly 1 / 3 of patients treated with NAs can not reach the detection line of highly sensitive reagent. It is an important measure to make the patients with hypoviremia and inactive low virus replication treated by NAs below the detection line of highly sensitive reagent and further reduce the risk of HCC. However, it is still not enough to minimize the risk of HCC to achieve a complete viral response only through NA treatment. The long-term follow-up showed that the incidence of HBsAg disappeared by only 2.0% - 0.0% regardless of the long-term treatment of HBsAg. Therefore, the most important measure to minimize the occurrence of HCC is to optimize the treatment of NA treated patients with low virus replication and inactive patients with low virus replication to achieve complete virus response and clinical cure. The purpose of this study is to explore the optimal treatment scheme for chronic hepatitis B NA treated patients with hypoviremia and natural low virus replication patients to significantly reduce the risk of HCC.
Chronic hepatitis B seriously endangers the health of our people, especially the occurrence of liver cancer, which brings huge economic burden and life threat to our people. 84% - 92% of hepatocellular carcinoma (HCC) in China is related to chronic HBV infection. How to further reduce the risk of liver cancer is an urgent problem to be solved in clinical research and an important direction. Although NAs treatment can make patients achieve the negative transformation of virus, it can not effectively reduce the level of virus antigen, and it also lacks the ability to improve the immune clearance of virus. As a result, the incidence of liver cancer in patients with long-term NA treatment is still 4.5% - 10.5%, and the incidence of HCC in patients with hypoviremia in Na treatment is higher. In current clinical practice, nearly 1 / 3 of patients treated with NAs can not reach the detection line of highly sensitive reagent. It is an important measure to make the patients with hypoviremia and inactive low virus replication treated by NAs below the detection line of highly sensitive reagent and further reduce the risk of HCC. However, it is still not enough to minimize the risk of HCC to achieve a complete viral response only through NA treatment. The long-term follow-up showed that the incidence of HBsAg disappeared by only 2.0% - 0.0% regardless of the long-term treatment of HBsAg. Therefore, the most important measure to minimize the occurrence of HCC is to optimize the treatment of NA treated patients with low virus replication and inactive patients with low virus replication to achieve complete virus response and clinical cure. The purpose of this study is to explore the optimal treatment scheme for chronic hepatitis B Na treated patients with hypoviremia and natural low virus replication patients to significantly reduce the risk of liver cancer.
Study Type
OBSERVATIONAL
Enrollment
1,200
PEG-IFN 180 or 135 micrograms, subcutaneously injected once a week, with a personalized treatment course of 24 weeks
Department of Hepatology Division 2, Beijing Ditan Hospital
Beijing, Beijing Municipality, China
RECRUITINGIncidence of HCC during the project study
In the intervention treatment of the above Na treated patients with hypoviremia, the NAS treatment patients who did not have the disappearance of HBsAg have been maintained for a long time, and long-term treatment and follow-up observation are still carried out after the end of the project. For patients treated with NAS combined with PEG-IFN, if HBsAg disappears, continue the treatment after HBsAg disappears, and stop all drug treatment after 12-24 weeks. For the patients who have not lost HBsAg after PEG-IFN combined with NAS treatment, the researcher shall decide whether to stop all drug treatment or stop PEG-IFN treatment and continue NAS maintenance treatment according to the treatment response.
Time frame: 48 weeks
The negative conversion rate of HBV DNA after 48 weeks of treatment was optimized (below the detection line of highly sensitive detection reagent)
In the intervention treatment of the above Na treated patients with hypoviremia, the NAS treatment patients who did not have the disappearance of HBsAg have been maintained for a long time, and long-term treatment and follow-up observation are still carried out after the end of the project. For patients treated with NAS combined with PEG-IFN, if HBsAg disappears, continue the treatment after HBsAg disappears, and stop all drug treatment after 12-24 weeks. For the patients who have not lost HBsAg after PEG-IFN combined with NAS treatment, the researcher shall decide whether to stop all drug treatment or stop PEG-IFN treatment and continue NAS maintenance treatment according to the treatment response.
Time frame: 48 weeks
The incidence of HBsAg disappearance during the study period;
In the intervention treatment of the above Na treated patients with hypoviremia, the NAS treatment patients who did not have the disappearance of HBsAg have been maintained for a long time, and long-term treatment and follow-up observation are still carried out after the end of the project. For patients treated with NAS combined with PEG-IFN, if HBsAg disappears, continue the treatment after HBsAg disappears, and stop all drug treatment after 12-24 weeks. For the patients who have not lost HBsAg after PEG-IFN combined with NAS treatment, the researcher shall decide whether to stop all drug treatment or stop PEG-IFN treatment and continue NAS maintenance treatment according to the treatment response.
Time frame: 48 weeks
HBeAg seroconversion rate in HBeAg positive patients;
In the intervention treatment of the above Na treated patients with hypoviremia, the NAS treatment patients who did not have the disappearance of HBsAg have been maintained for a long time, and long-term treatment and follow-up observation are still carried out after the end of the project. For patients treated with NAS combined with PEG-IFN, if HBsAg disappears, continue the treatment after HBsAg disappears, and stop all drug treatment after 12-24 weeks. For the patients who have not lost HBsAg after PEG-IFN combined with NAS treatment, the researcher shall decide whether to stop all drug treatment or stop PEG-IFN treatment and continue NAS maintenance treatment according to the treatment response.
Time frame: 48 weeks
Incidence of chronic hepatitis B during the study period
In the intervention treatment of the above Na treated patients with hypoviremia, the NAS treatment patients who did not have the disappearance of HBsAg have been maintained for a long time, and long-term treatment and follow-up observation are still carried out after the end of the project. For patients treated with NAS combined with PEG-IFN, if HBsAg disappears, continue the treatment after HBsAg disappears, and stop all drug treatment after 12-24 weeks. For the patients who have not lost HBsAg after PEG-IFN combined with NAS treatment, the researcher shall decide whether to stop all drug treatment or stop PEG-IFN treatment and continue NAS maintenance treatment according to the treatment response.
Time frame: 48 weeks
To study the incidence of complications such as cirrhotic ascites and upper gastrointestinal bleeding during long-term follow-up.
In the intervention treatment of the above Na treated patients with hypoviremia, the NAS treatment patients who did not have the disappearance of HBsAg have been maintained for a long time, and long-term treatment and follow-up observation are still carried out after the end of the project. For patients treated with NAS combined with PEG-IFN, if HBsAg disappears, continue the treatment after HBsAg disappears, and stop all drug treatment after 12-24 weeks. For the patients who have not lost HBsAg after PEG-IFN combined with NAS treatment, the researcher shall decide whether to stop all drug treatment or stop PEG-IFN treatment and continue NAS maintenance treatment according to the treatment response.
Time frame: 48 weeks
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