The 2010 edition of the Guidelines for the Prevention and Treatment of Chronic Hepatitis B was released: interpreting the 4 major points of the new version of the guidelines
In the past 5 years, the basic and clinical research on chronic hepatitis B at home and abroad has made great progress. In this regard, the Chinese Medical Association Hepatology Branch and the Infectious Diseases Branch updated and revised the 2005 edition of the Guidelines for the Prevention and Treatment of Chronic Hepatitis B at the end of 2010. The changes in the new guidelines are mainly reflected in the following 4 areas. The new guidelines provide a clearer interpretation of when antiviral therapy should be administered. In addition to the general antiviral criteria, the new guidelines also emphasize that antiviral therapy should be considered for those who are persistently positive for HBV DNA and do not meet the general criteria in one of the following situations: ① ALT (alanine aminotransferase) is greater than the upper limit of normal value and are >40 years old; ② ALT is persistently normal but are older (>40 years old); ③ dynamic observation reveals evidence of disease progression (e.g. enlarged spleen). In the above cases, liver histology is recommended, and antiviral therapy is given if necessary. In the new version of the guidelines, the antiviral indication for patients with compensated hepatitis B cirrhosis has also changed: regardless of whether the ALT is elevated, the antiviral indication for HBeAg (hepatitis B virus e antigen) positive patients is HBV DNA ≥104 copies/mL (HBV DNA ≥105 copies/mL in the 2005 version of the guidelines); the antiviral indication for HBeAg negative patients is HBV DNA ≥103 copies/mL (HBV DNA ≥103 copies/mL in the 2005 version of the guidelines). 103 copies/mL (HBV DNA ≥104 copies/mL in the 2005 edition of the guidelines); for those whose HBV DNA is detectable but does not reach these levels, antiviral therapy may be initiated with informed consent if there is evidence of disease activity or progression and no other reason to explain it. The new guidelines emphasize early antiviral therapy for patients with compensated hepatitis B cirrhosis in order to delay or reduce the occurrence of liver failure and hepatocellular carcinoma. 2. Introduce the concept of “optimal therapy” The new guidelines introduce the concept of “optimal therapy”, i.e. The new guideline introduces the concept of “optimal treatment”, which means to select patients who meet the indications for standardized antiviral treatment, predict the efficacy through evaluation and obtain better efficacy through timely adjustment of treatment regimen. If the HBV DNA is completely negative, continue the original treatment. If the HBV DNA is not negative, the patient is not fully responding, suggesting that there is a risk of drug resistance in the long term and the efficacy may be poor, so the treatment regimen should be adjusted to further optimize the efficacy. If interferon is applied, ALT, HBV DNA level and HBV genotype are important predictors of efficacy before treatment, and HBV DNA level, e antigen and surface antigen titer of hepatitis B virus at 12 or 24 weeks of treatment are also predictors of efficacy. The new guidelines emphasize the importance of early and regular detection of changes in these indicators when patients are on antiviral therapy, which is important for predicting efficacy and adjusting regimens to achieve better treatment outcomes. The new version of the guidelines emphasizes the prevention of drug resistance in order to reduce the double burden of patients’ economy and disease, mainly in the following aspects. ● Strictly control the indications for treatment. Patients with mild liver inflammatory lesions and difficulty in obtaining a sustained response (e.g., ALT normal, HBeAg-positive immune tolerance period), especially when <30 years old, should not start antiviral therapy, especially not with nucleoside (acid) analogues. Otherwise, not only will the treatment be ineffective, but also when antiviral therapy is really needed in the future, you may face the dilemma of having no drugs available because drug resistance has developed. Choose nucleoside (acid) analogues carefully. If conditions permit, it is advisable to start treatment with drugs that have strong antiviral effects and a low incidence of drug resistance to avoid the occurrence of drug resistance as much as possible. The 2005 edition of the guidelines mentions that patients who are resistant to one nucleoside (acid) drug can be treated with another drug or with a more potent drug. However, through actual clinical use, due to the existence of cross-resistance sites between the switched drug and the original therapeutic drug, new drug resistance will also develop as the course of treatment is extended, and disease progression will still not be controlled. The new version of the guidelines therefore provides clearer rules on how to switch drugs in the event of drug resistance, which will help many patients to take the easy way out.4. Clarify the course of antiviral therapyThe course of antiviral therapy, i.e. when to stop, is not only something that doctors should master, but also a question that patients often ask their doctors. The new version of the guidelines clarifies the course of antiviral therapy and points out that extending the course can reduce disease relapse. The course of treatment for HBeAg-positive chronic hepatitis B patients is 1 year with long-acting interferon, and the course of treatment with nucleoside (acid) analogues is 1 year after achieving seroconversion, and the total course of treatment is not less than 2 years. For HBeAg-negative chronic hepatitis B patients, the course of treatment is longer, with at least 1 year of long-acting interferon and at least 2.5 years of nucleoside (acid) drugs. In order to get a better treatment effect, patients must follow the doctor's advice during antiviral treatment and should not stop the medication on their own.