Clinical observation of adefovir dipivoxil treatment for chronic hepatitis B. Interferon and nucleoside analogues are the first-line drugs; the latter is easy to use, has strong viral inhibition, but comes with adverse reactions. Due to its low cost and better resistance profile compared to lamivudine, adefovir has become an antiviral drug for low- and middle-income chronic hepatitis B patients. Since October 2006, our department has been using adefovir dipivoxil (produced by JCTT Pharmaceutical Company) to treat chronic hepatitis B patients. This report summarizes the outcomes of at least 12 months' treatment in 42 cases of chronic hepatitis B patients.
### Methods
#### Selection of Patients
From October 2006 to May 2007, 42 inpatients and outpatients were diagnosed with chronic hepatitis B, according to the diagnostic criteria revised at the 10th National Viral Hepatitis Conference held in Xi’an in September 2006. Among them, 40 were initial cases, while two cases had ineffective treatment with lamivudine, i.e., viral rebound. These two cases started taking oral adefovir dipivoxil in February, combined with lamivudine. All 42 cases were HBV-DNA positive, with HBeAg-positive in 32 cases, HBsAg-negative in 8 cases, and anti-HBc alone positive in two cases.
#### General Information
Among the 42 patients, there were 37 males and 5 females, aged between 18 and 53 years, with a mean age of 33.5 years. The duration of hepatitis B virus infection ranged from 2 to 20 years, averaging 8 years. All had abnormal liver function, with ALT fluctuations observed during the course of treatment with adefovir.
### Treatment
Adefovir dipivoxil (produced by JCTT) was administered orally at a dose of 10 mg once daily.
### Observation Items
Subjective and objective symptoms were observed and recorded. Liver function, renal function, and hepatitis B virus indicators were checked before treatment. After initiating treatment, every three months, HBV DNA variables, hepatitis B five markers, liver function, and renal function were reviewed.
### Results
#### 2.1 Adefovir Dipivoxil Therapy: Changes in HBV-DNA (Table 1)
#### 2.2 Relationship Between Pre-treatment ALT Levels and HBV-DNA Negativity (Table 2)
#### 2.3 Changes in Hepatitis B Five Markers Before and After Treatment
Before treatment, HBsAg, HBeAg, and HBcAg were positive in 32 cases. After treatment:
- 19 cases (59.4%) remained 3-positive.
- 2 cases (6.3%) showed positivity for HBsAg and HBcAg.
- 10 cases (31.3%) were positive for anti-HBe and HBcAb.
- Before treatment, HBsAg, anti-HBe, and HBcAb were positive in eight cases. After treatment, 7 cases (87.5%) remained unchanged, while one case (12.5%) turned positive for HBsAg and HBcAb.
- Before treatment, two cases were positive for HBsAg and HBcAb. After treatment, one case turned positive for HBsAg, anti-HBe, and HBcAb, while the other remained unchanged.
#### 2.4 Liver Function Recovery After Treatment
As shown in Table 3, adefovir ester demonstrated efficacy in chronic hepatitis B patients. ALT levels above 100U/L indicated good effectiveness, while ALT levels below 100U/L suggested less effective results.
### Discussion
Observation of adefovir dipivoxil in chronic hepatitis B patients undergoing antiviral treatment for 1 year revealed that the stability of HBV-DNA negativity was achieved early in treatment. Three months after treatment, 11/42 (26.2%) untreated cases became negative, while at six months, more than 2log of HBV-DNA quantitative cases accounted for 38/42 (90.5%). Based on the sensitivity of predicting antiviral therapy, treatment can continue and achieve a certain effect. At 12 months of treatment, the virological response rate was 52.4%, with seroconversion of HBeAg occurring in 10/32 (31.3%) cases. This indicates recent good effects of adefovir ester. Additionally, the level of ALT in HBV-DNA negative cases was closely related to medication; when ALT was 300u/L, all HBV-DNA became negative. Choosing ALT levels of 100u/L or more, especially over 200U/L, makes adefovir dipivoxil more appropriate, which aligns with other standards for antiviral treatment of hepatitis B. The short-term efficacy of adefovir dipivoxil in treating chronic hepatitis B is better. However, due to large-scale use being less than 2 years, its long-term efficacy remains to be seen.
[Received Date: 2008-08-28]
**CHINA FOREIGN MEDICAL TREATMENT AND FOREIGN HEALTH CARE**
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