Clinical Studies Of Lamivudine Anti-virus Treatment In Patients With Chronic Hepatitis B

Hepatitis B is a worldwide infectious disease, and its epidemicspeaks in China. It is estimated that there are 30,000,000 chronic HBVinfections in China, and 15-25 percents of these chronic infections willeventually progress into cirrhosis and/or hepatic cellular carcinoma(HCC), which definitely raises serous health issues. Lowering orclearing virus load is important to minimize liver damage and recovernormal liver function, and further slow down or prevent fromprogressing to cirrhosis, liver failure or HCC. In Chronic Hepatitis B,severe liver damage mainly happens in immune clearance stage. If nofast HBeAg clearance occurs in this stage, anti-virus medication isindicated to stop virus duplication, and further induces HBeAgclearance and recovery of liver damage. A useful anti-virus treatmentshould be able to continuously suppress the duplication of virus DNA,maintain a normal lever of serum transaminases, and achieve a stableHBeAg clearance and a sustained anti-HBe a in blood circulation.Lamivudine is the first medicine developed to treat HBV infection viaanti-nucleosideanalogues mechanism, and it directly suppresses virusduplication. We investigate the biochemistry, virology, andimmunology of patients with HBeAg positive, HBV DNA positive,and abnormal ALT before and after Lamivudine treatment. We try tounderstand suitability of Lamivudine anti-virus and terminationcriteria, and evaluate the tolerance, long-term application, andfeasibility of treatment, in order to find suitable time and appropriatetreatment . We chose 48 patients with chronic hepatitis B, who hadHBeAg positive, HBV DNA positive, and abnormal ALT whentreatment started. Treatment lasted from 12-24mouths. We evaluatedpatients at 12th mouth,24th mouth after treatment began, we stoppedtreating patients who non-responsed and occurred drug-resistant, andwe performed a 12-mouths follow-up to patients after Lamivudinetreatment. Results: ①Patients with the treatment of Lamivudine canresponse fastly, they has a rate of 81.8% of ALT back to normal, therate of HBV DNA turning negative is 73.3%, the rate of HBeAgturning negative is 25% after 12 mouths of therapy. ② Partialresponsing patients with continuing treatment lasting for 24 mouthsproves to have further 18.5% HBeAg/HBeAb sero-conversion rates.③ 33.3% (5/15) patients who obtained HBeAg/HBeAbsero-conversion and 37.5%(6/16) patients who did not obtainHBeAg/HBeAb sero-conversion relapsed , there is no differencefound between them. But time of relapsing is 9.2±2.8 months,5.3±2.5 months respectively, there is a significant difference between them.④ Three of the 11 replapsing patients were found ALT>10ULN, andtheir conditions were worser. But there is no difference found betweenthe pretreatmental and aftertreatmental ALT and HBV DNA levels;P<0.05. ⑤ Different therapies were given patients according todifferent conditions. Patients still obtain response in retreatment withLamivudine. Conclusion: our results suggest that Lamivudine helps inHBeAg/HBeAb sero-conversion, suppressing serum HBV DNA andnormalizing ALT in patients with chronic hepatitis who demonstrateHBeAg positive,HBV DNA positive and abnormal ALT. A 12-mouthLamivudine medication is proved to be effective and tolerable. Afterceasing Lamivudine treatment, those patients obtainingHBeAg/HBeAb sero-conversion and those non-obtainingHBeAg/HBeAb sero-conversion had similar rate of relapsing, butthose patients obtaining HBeAg/HBeAb sero-conversion relapsedlatterly. Minority patients were in worser conditions, but there is nodifference found between the pretreatmental and aftertreatmental inmost patients. In addition, Lamivudine has other benefits: decreasingthe level of ALT and HBV DNA, even obtaining HBeAg/HBeAbsero-conversion, convenient to administrate, low complications, wideapplyment. Lamivudine is an effective anti-virus option. ButLamivudine has other shortcoming: drug-resistant of Lamivudine afterlong-term therapy, low sustained response after short-term therapy,easy relapsing after ceasing therapy. These led to nonclear period oftreatment. Therefore, patients must not cease therapy withoutauthotization. No mater what causes of ceasing therapy are, mustpatients with long-term therapy be investigated continually in order totreat relapsing patients as soon as possible.