Switch or Sequential Combination Therapy of Peginterferon in Hepatitis B Patients With Longterm Entecavir Therapy
- Conditions
- Chronic Hepatitis B
- Interventions
- Registration Number
- NCT02589652
- Lead Sponsor
- Huashan Hospital
- Brief Summary
This is a multicenter, prospective cohort study to evaluate the efficacy and safety of sequential combination or switch therapy of pegylated interferon alfa-2a in chronic hepatitis B patients with low HBsAg and HBeAg titers after long-term entecavir therapy, and compared to those who continued on ETV therapy.
- Detailed Description
Chronic hepatitis B (CHB) infection remains a global health treat. The ideal end point of therapy is HBsAg loss or HBsAg seroconversion, indicating a complete remission of CHB. In patients with HBeAg-positive CHB, sustained HBeAg seroconversion is also a desirable end point. Current therapies include pegylated interferon (PegIFN) finite and nucleos(t)ide analogues (NUCs) longterm therapy. However, only 30-40% of patients may achieve HBeAg seroconversion on PegIFN monotherapy, whereas 15-20% of patients on entecavir (ETV). Recently, accumulating evidence had shown that optimization of switching or combining PegIFN in patients on long-term ETV therapy may increase rate of HBeAg seroconversion and even lead to the complete eradication of HBV. However, these two regimens has not been tested adequately in patients with low HBsAg/HBeAg titers on long-term ETV therapy.
This is a multicenter, prospective cohort study to evaluate the efficacy and safety of sequential combination or switch therapy of pegylated interferon alfa-2a in chronic hepatitis B patients with low HBsAg and HBeAg titers after long-term entecavir therapy, and compared to those who continued on ETV therapy.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 294
- Male and female patients > 18 and ≤ 60 years of age;
- Positive HBsAg for more than 6 months;
- Patients receiving previous ETV therapy ≥2 years;
- Patients who have achieved undetectable HBV DNA, HBsAg <1500IU/mL and HBeAg <200S/CO prior to switch or S-C therapy;
- ALT<=10*ULN and TB<2*ULN;
- Patients who have been assigned to treatment with PegIFN (S-C or switch) or continuous ETV after previous ETV therapy
- Evidence of decompensated cirrhosis or hepatocellular carcinoma;
- Serological evidence of co-infection with HCV, HDV or HIV;
- Pregnant or breast-feeding women;
- Patients with diseases that might contraindicate to PegIFN therapy including severe psychiatric diseases, immunological diseases, severe retinopathy, thyroid dysfunction, leukocytopenia, thrombopenia, etc
- Patients receiving concomitant therapy with telbivudine;
- A history of drug or alcohol abuse;
- Other conditions that investigates consider not suitable for participate
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Switch group Pegylated interferon alfa-2a Patients who have been assigned to pegylated interferon alfa-2a. ETV group Entecavir Patients who have been assigned to entecavir monotherapy. Sequential combination group (S-C group) Pegylated interferon alfa-2a plus Entecavir Patients who have been assigned to pegylated interferon alfa-2a plus entecavir.
- Primary Outcome Measures
Name Time Method Rate of HBeAg seroconversion week 72 (24 weeks after 48 weeks of treatment) Loss of HBeAg and detection of anti-HBe antibodies
- Secondary Outcome Measures
Name Time Method Rate of HBV DNA <20IU/mL week 72 (24 weeks after 48 weeks of treatment) Rate of HBsAg loss week 72 (24 weeks after 48 weeks of treatment) HBsAg loss with or without detection of anti-HBs antibodies
Rate of HBsAg seroconversion week 72 (24 weeks after 48 weeks of treatment) Percentage of patients reaching a ≥ 1log10 decline of quantitative HBsAg week 72 (24 weeks after 48 weeks of treatment) Decline of quantitative HBsAg from baseline week 72 (24 weeks after 48 weeks of treatment
Trial Locations
- Locations (17)
The First Affiliated Hospital, Anhui Medical University
🇨🇳Hefei, Anhui, China
Fuzhou Municipal Infectious Disease Hospital
🇨🇳Fuzhou, Fujian, China
The Third Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Zhongshan No.2 People's Hospital, Zhongshan, Guangdong
🇨🇳Guangzhou, Guangdong, China
The Second Affiliated Hospital, Anhui Medical University
🇨🇳Hefei, Anhui, China
Shandong Provincial Hospital of Shandong University
🇨🇳Jinan, Shandong, China
Sichuan Provincial People's Hospital
🇨🇳Sichuan, Sichuan, China
The First Affiliated Hospital, College of Medicine, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
Rui'an People's Hospital
🇨🇳Rui'an, Zhejiang, China
Beijing Ditan Hospital
🇨🇳Beijing, Beijing, China
Fifth People's Hospital of Suzhou
🇨🇳Suzhou, Jiangsu, China
The third People's Hospital of Shenzhen
🇨🇳Shenzhen, Guangdong, China
The Affiliated Hospital of Xuzhou Medical College
🇨🇳Xuzhou, Jiangsu, China
Shenyang Municipal Infectious Disease Hospital
🇨🇳Shenyang, Liaoning, China
The First Affiliated Hospital Medical School of Xi'an Jiaotong University
🇨🇳Xi'an, Shanxi, China
The Affiliated Hospital of Luzhou Medical College
🇨🇳Luzhou, Sichuan, China
The Second Hospital of Yinzhou of Ningbo
🇨🇳Ningbo, Zhejiang, China