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Treatment of hepatitis B infection with thymosin alpha 1 and lamivudine

A technology of famciclovir and lamivudine, applied in the field of hepatitis B treatment, can solve the problems of difficulty in crossing negative enantiomers and limiting toxicity

Inactive Publication Date: 2001-10-31
SCICLONE PHARMACEUTICAL INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Selection of the negative enantiomer of 2'3'-dideoxy-3'-thiacytidine (lamivudine) enhanced antiviral activity but limited toxicity, possibly because the negative enantiomer had difficulty crossing the mitochondrial double membrane
No evidence of drug-related adverse effects on clinical laboratory values, blood pressure, heart rhythm, or electrocardiogram (ECG) measurements

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] Example 1 Treatment of Hepatitis B Infection in Human Patients

[0051] Biochemical (ALT), virological (HBV DNA), serological (HBeAg) assessment of immune tolerance to Tα1 plus lamivudine and optionally famciclovir in adult patients with chronic hepatitis B virus infection As well as histological response, thereby demonstrating the efficacy of hepatitis B treatment. objective criteria of efficacy

[0052] The primary endpoint was the rate of complete virologic response, defined as HBV DNA negative serum (with Chiron Quantiplex TM HBVDNA (bDNA) test to determine the percentage of patients) and HBeAg. Objective Standards of Safety

[0053] The study will evaluate safety data during the 6-month treatment period and a 12-month follow-up period after the final dose of Tα1 plus lamivudine and optional famciclovir, including measures of clinical status, hematology measures, and liver and kidney function. Measurements. Study Population Entry Criteria

[0054] 1. The age ...

Embodiment 2

[0207] This study involved three adult patients (age: 35-65 years) with chronic hepatitis B who were positive for HbeAg, HbeAg, and HBV-DNA (50-250pg / ml) and whose ALT was elevated to at least normal values (80-150μ / l) twice.

[0208]Treatment plan: Tα1 1.6mg, three times a week for 6 months, plus lamivudine 150mg once a day. One year after starting treatment, all patients had normal ALT and were negative for HBV-DNA (hybrid capture). Two patients became HBeAg negative and one remained HBeAg positive. All patients tolerated the treatment well, and no serious side effects were reported. Example 3

Embodiment 3

[0209] The aim of this study was to investigate the efficacy of the combination of Tα1, which increases host immunity, with lamivudine and famciclovir, which inhibit viral replication.

[0210] Eleven patients who had documented chronic hepatitis B, were positive for HBsAg, HBeAg, and HBV DNA, and had elevated ALT to at least twice normal were enrolled in the study. Tα1 1.6mg was subcutaneously administered three times a week for 6 months. Lamivudine 150 mg QD and famciclovir 250 mg TID were administered until the patient became HBeAg negative.

[0211] Within 1 year of total treatment, 64% (7 / 11) of patients became negative for serum HBeAg, and ALT was normal in all patients (11 / 11). HBeAg seroconversion occurs in 4-11 months. HBV DNA became negative in all patients. One patient's ALT increased to 150 U / l and treatment was continued. However, this patient exhibited HBV DNA recurrence. All patients tolerated the treatment, and no serious side effects were reported.

[02...

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PUM

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Abstract

A method of treatment of hepatitis B virus (HBV) infection in a patient by administering to the patient a drug regimen including an antiviral-effective amount of thymosin alpha 1 (Talpha1), an antiviral-effective amount of lamivudine, and optionally an antiviral-effective amount of famciclovir is disclosed.

Description

field of invention [0001] The invention relates to the field of hepatitis B treatment. Background of the invention [0002] Chronic hepatitis B virus (HBV) infection is a serious global health problem affecting approximately 300 million individuals. Of these, around 75 per cent are thought to be Asian. It is also estimated that 25-40% of these HBV carriers will die from cirrhosis or hepatocellular carcinoma. [0003] In contrast to the disease course in Caucasians, the natural history of chronic HBV infection in Asians is characterized by an initial state of active viral replication with minimal liver damage (period of immune tolerance), followed by a period of active immune clearance in chronic active hepatitis, Finally there is the non-replicating phase of inactive HBV, which develops into cirrhosis, possibly complicated by hepatocellular carcinoma (HCC). Additionally, followed by phase IV, characterized by viremia without HBE antigenemia and chronic active hepatitis. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/513A61K31/522A61K38/22A61P31/20
CPCA61K31/513A61K31/00A61K9/00A61K38/2292A61K31/52A61P31/20A61K2300/00
Inventor 梁英杰
Owner SCICLONE PHARMACEUTICAL INC
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