The Predictive Value of On-treatment Virological Response for Sustained Virological Response in Chronic Hepatitis C

September 24, 2016 updated by: Yao Xie, Beijing Ditan Hospital

The Predictive Values of Rapid Virus Response and Complete Early Virus Response for Sustained Virus Response in Chronic Hepatitis C Treated With Individual Therapeutic Programme

The efficacy of combination antiviral therapy for chronic hepatitis C is influenced by many factors. Important patient-specific factors include, age, gender, race, body weight. Important virus-specific factors include HCV genotype and serum HCV RNA level. Finally, important treatment-related factors include the type of interferon, dose of ribavirin and the duration and adherence to treatment.

Despite the importance of patient- and virus-specific factors, the most important indicator of treatment success is a rapid, profound and sustained decrease in serum HCV RNA levels after the start of treatment.

The on-treatment virological response can thus be used to predict the probability that a given patient will achieve an SVR if they remain on therapy. It can also be used to individualize the duration of treatment.

In this study, treatment for patients with chronic hepatitis C was individualized on the basis of clinical characteristics and the on-treatment virological response. The aim was to investigate the usefulness of undetectable HCV RNA levels at week 4 (RVR) and 12 in tailoring the duration of treatment and predicting SVR in Chinese patients with chronic hepatitis C.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

297 consecutive patients with chronic hepatitis C who were admitted to hospital or treated as outpatients at Beijing Ditan Hospital were eligible for the study. The diagnosis of chronic hepatitis C was based on the detection of anti-HCV antibodies (anti-HCV) by a third generation microparticle chemoluminescence assay and HCV RNA by a reverse transcription polymerase chain reaction (RT-PCR) assay. Patients were required to have evidence of HCV infection for at least 6 months.

patients received peginterferon alfa-2a (40KD) (Pegasys®; Roche, Basel, Switzerland) 135 or 180 µg by subcutaneous injection once weekly.

Among treatment-naive patients, the duration of therapy was determined by HCV genotype and the on-treatment virological response at week 4, 12 or 24. Genotype 1 infected patients were assigned to complete a 48~72 weeks of treatment, and those who had not responded to a previous course of therapy were assigned to complete a total of 72 weeks of treatment.

Dose adjustment: In the event that a patient did not achieve an RVR at week 4, and provided they were not experiencing adverse events, the daily dosage of ribavirin was increased by 200 mg or 300 mg, and in the case of those who started treatment on the lower dosage of peginterferon alfa-2a (40KD) or conventional interferon alfa, the dosage of peginterferon alfa-2a (40KD) was increased from 135 µg/week to 180 µg/week. In the event of adverse events that could not be ameliorated with symptomatic treatment, the dose of peginterferon alfa-2a (40KD) was reduced from 180 µg/week to 135 µg/week and of ribavirin by 200 mg/day or 300 mg/day.

Quantitative HCV RNA testing was performed before starting treatment (week 0), at week 4, 12, and 24, and at the end of treatment, and 24 weeks after completion of treatment using a commercially available real-time fluorescence quantitative PCR kit. The primary efficacy end-point was achievement of SVR defined as undetectable HCV RNA at the end of a 24-week untreated follow-up period. The percentage of patients with undetectable HCV RNA (<500 copies/mL) at week 4 (RVR), and 12 were secondary efficacy endpoints.

Study Type

Observational

Enrollment (Actual)

297

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100015
        • Beijing Ditan Hospital,Capital Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients with chronic hepatitis C who were admitted to hospital or treated as outpatients at Beijing Ditan Hospital were eligible for the study.

Description

Inclusion Criteria:

  • Patients with anti-HCV and HCV RNA positive for at least 6 months

Exclusion Criteria:

  • Had a haemoglobin level <100 g/L
  • Neutrophil count <1.5 x 109/L
  • Platelet count <50 x 109/L
  • Decompensated liver cirrhosis or liver disease other than that attributable to chronic hepatitis C
  • Co-infected with hepatitis B virus or human immunodeficiency virus
  • Had an autoimmune disease, liver tumour, or severe cardiac disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
chronic hepatitis C
Drug: Pegylated interferon alfa-2a and ribavirin
all patients were given peginterferon alfa-2a (40KD) (Pegasys®; Roche, Basel, Switzerland) 135 or 180 µg by subcutaneous injection once weekly, and received twice daily oral ribavirin at a target total daily dose of 13 mg/kg/day. .
Other Names:
  • Pegasys®; Roche, Basel, Switzerland

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustained virus response
Time Frame: serum HCV RNA was undetectabale at the end of treatment and 24 weeks follow
after treatment, the HCV RNA levels were tested before treatment, at week 4, 12, and 24, and at the end of treatment, and 24 weeks after completion of treatment. The sustained virus response was defined as HCV RNA undetectabale at 24 week after completion of treatment.
serum HCV RNA was undetectabale at the end of treatment and 24 weeks follow

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Ditan Hospital

Investigators

  • Study Director: Yao Xie, phD/MD, Beijing Ditan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

October 28, 2011

First Submitted That Met QC Criteria

November 1, 2011

First Posted (Estimate)

November 2, 2011

Study Record Updates

Last Update Posted (Estimate)

September 27, 2016

Last Update Submitted That Met QC Criteria

September 24, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DTH-XY001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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