Chronic Hepatitis B
Conditions
Keywords
HBV, entecavir, peginterferon
Brief summary
Currently, seven medications are approved for the treatment of hepatitis B: two formulations of interferon and five nucleons(t)ide analogues. The current treatment strategy of chronic hepatitis B is now standard: initial selection of entecavir, tenofovir, or peginterferon alfa-2a (peg-IFNα-2a). Interferon is administered for a finite duration while nucleotide analogues are usually administered for many years. But among hepatitis B e antigen （HBeAg） positive patients with high serum hepatitis B virus DNA levels, the rates of virological response are poor. And antiviral drug resistance is a major limiting factor to the success of nucleotide analogue treatment. Therefore, combination therapy using peginterferon with an oral agent with a high genetic barrier to resistance might be superior to standard current monotherapy. However, the addition of lamivudine to peg-IFNα-2a therapy led to a greater decrease in serum HBV DNA levels during treatment but did not increase the rate of HBeAg sero¬conversion. Entecavir is a nucleoside analogue superior to lamivudine and adefovir in achieving higher virological response, histological improvement and normalisation of ALT. Moreover, Entecavir has a high genetic barrier with a very low incidence of drug resistance. This study is aimed to investigate the efficacy of combination or sequential therapy using peg-IFNα-2a and entecavir in HBeAg-positive chronic hepatitis B(CHB) patients.
Interventions
DRUGPeg-IFNα-2a
180ug peg-IFNα-2a, subcutaneous injection per week
DRUGEntecavir
0.5mg,oral administration every day
Sponsors
Beijing 302 Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Age≥16 years 2. HBsAg positive for more than 6 months, and HBeAg detection is positive for two times in 6 months before enrollment 3. Serum HBVDNA \>2×10\^4IU/ml 4. 80U/L \< serum ALT \< 400U/L, and TBIL \< 34 umol/L 5. Serum ALT \< 80U/L, but hepatic inflammation scores ≥ G2 or hepatic fibrosis stage ≥ S3
Exclusion criteria
1. Co-infected with HCV, HDV or HIV, or autoimmune liver diseases combined 2. Hepatic decompensation 3. received antiviral therapy or immunosuppressant drugs before 6 months prior to enrollment 4. Blood routine examination: WBC \<3×10\^9/L，neutrophile granulocyte \< 1.5×10\^9/L，PLT \<80×10\^9/L 5. Renal function: creatinine \>1.5 times of upper normal limit 6. Alcoholism or a history of addiction and abuse 7. Combined with hepatocarcinoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the rates of HBeAg seroconversion | at week 72 |
Secondary
| Measure | Time frame |
|---|---|
| normalisation of ALT | at week 2、4、12、24、36、48、60、72、84、96 |
| liver histological improvement | at baseline and at week 72 |
| The rates of HBsAg negative | at week12、24、36、48、60、72、84、96 |
| the rate of virological response | at week 4、12、24、36、48、60、72、84、96 |
| the rate of HBeAg negative | at week 12、24、36、48、60、72、84、96 |
Countries
China
Contacts
Primary ContactSa Lv, MD
Outcome results
None listed