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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yao Xie, Beijing Ditan Hospital
ClinicalTrials.gov Identifier:
NCT01464008
First received: October 28, 2011
Last updated: November 1, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention
Chronic Hepatitis C
Drug: Pegylated interferon alfa-2a and ribavirin

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Beijing Ditan Hospital:

Primary Outcome Measures:
  • Sustained virus response [ Time Frame: serum HCV RNA was undetectabale at the end of treatment and 24 weeks follow ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 297
Study Start Date: January 2004
Study Completion Date: September 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Pegasys®; Roche, Basel, Switzerland

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.

  Eligibility

Ages Eligible for Study:   11 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01464008

Locations
China, Beijing
Beijing Ditan hospital,Capital Medical University
Beijing, Beijing, China, 100015
Sponsors and Collaborators
Beijing Ditan Hospital
Investigators
Study Director: Yao Xie, phD/MD Beijing Ditan Hospital Capital Medical University
  More Information

No publications provided

Responsible Party: Yao Xie, liver diseases center, Beijing Ditan Hospital
ClinicalTrials.gov Identifier: NCT01464008     History of Changes
Other Study ID Numbers: DTH-XY001
Study First Received: October 28, 2011
Last Updated: November 1, 2011
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Interferon-alpha
Peginterferon alfa-2a
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 02, 2014