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Chronic Hepatitis B | Combination or Sequential Therapy of Peginterferon Alfa-2a and Entecavir for Patients With Chronic Hepatitis B

Chronic Hepatitis B research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Chronic Hepatitis B

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Peg-IFNα-2a180ug peg-IFNα-2a, subcutaneous injection per week

Drug:Entecavir0.5mg,oral administration every day

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Peg-IFNα-2a monotherapyParticipants will receive 180ug peg-IFNα-2a therapy for 72 weeks, and then followed to 96 weeks.

Sequential therapyParticipants will receive entecavir monotherapy for 12 weeks, and 180ug peg-IFNα-2a therapy is added for the following 12 weeks. After that, entecavir will be stopped and 180ug peg-IFNα-2a monotherapy for the following 48 weeks. All participants will followed to 96 weeks.

Combination therapyParticipants will receive 180ug peg-IFNα-2a combined with entecavir therapy for 72 weeks, and then followed to 96 weeks.

Study Status

Unknown status

Start Date: July 2011

Completed Date: July 2016

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: the rates of HBeAg seroconversion

Secondary Outcome: normalisation of ALT

Study sponsors, principal investigator, and references

Principal Investigator: Fu-Sheng Wang, Professor

Lead Sponsor: Beijing 302 Hospital

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01906580

Kwon H, Lok AS. Hepatitis B therapy. Nat Rev Gastroenterol Hepatol. 2011 May;8(5):275-84. doi: 10.1038/nrgastro.2011.33. Epub 2011 Mar 22. Review.

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