Treatment and Prognosis of Patients With Chronic HBV Infection

Condition(s) studied

Investigational drug(s) / intervention(s)

Standard antiviral therapy: pegylated interferon or/and nucleos(t)ide analogues

Study summary

Hepatitis B virus (HBV) infection is a major global health issue with 257 million chronically infected individuals. Of note, China has the largest population accounting for one third of the world's infected population. Approximately, about 300 000 people die each year due to the consequences of HBV. In 2016, the World Health Organization (WHO) proposed the goal for elimination of hepatitis B as public health threat by 2030 and China will be a major contributor towards this global goal. Currently, two approved therapeutic strategies are available including pegylated interferon (IFN) or nucleos (t) ide analogues (NA), which could suppress HBV replication and slow disease progression. Here, investigators hope to launch a cohort study to reveal the clinical features relating to therapeutic efficacy of antiviral therapy and the prognosis of patients with differential therapeutic strategies.

Eligibility

Primary outcome measure(s)

• virological response — 3 years
  serum HBV DNA level below the detection limit
• HBeAg seroconversion — 3 years
  Loss of HBeAg and presence of anti-hepatitis B e antibody (anti-HBe) in a person who was previously HBeAg-positive and anti-HBe-negative
• Clinical cure — 3 years
  Sustained virological response and HBsAg clearance or with anti-HBs seroconversion, alanine aminotransferase (ALT) within the normal range, and mild or no lesions in the liver

Trial sites (1)

More Xiangya Hospital of Central South University trials in China

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