A Randomized Trial of 24-Week Versus 48-Week Courses of Peginterferon Plus Ribavirin for HCV Genotype-6 Patients

Sun Yat-sen University

Status and phase: Completed; Phase 3

Conditions: Chronic Hepatitis C

Treatments: Drug: Ribavirin; Drug: Peginterferon alfa2a

Study type: Interventional

Funder types: Other

Identifiers

NCT01263860

TAH115G6HCV

Details and patient eligibility

About

Patients with HCV genotype 6 infection who have a rapid virological response to treatment are randomised to either 24 or 48 weeks HCV treatment. Our hypothesis is that there is no important difference in effect between the two treatment effect.

Full description

High rate of infection of Hepatitis C Virus(HCV) Genotype 6 was recently confirmed in Southern China. Recent study implied chronic hepatitis C genotype 6 responds better to the 48-week treatment with pegylated interferon and ribavirin than genotype 1. Approximately 75.7% obtain sustained virological response (HCV RNA undetectable 24 weeks after treatment) to this approach. However, the treatment is associated with many and sometimes serious side effects. In addition, the treatment is costly also in economical terms. Shorter treatment for chronic hepatitis C genotype 6 is necessary to be assessed.

In this randomised,open label,multicenter phase 3 trial with active controls patients are treated with pegylated interferon alfa 2a (180ug/week)and ribavirin(800-1200mg based on weight)for 4 weeks. Those who are HCV RNA negative at week 4 (<50 IU; Cobas Amplicor Monitor Test, Roche Diagnostic) are defined as rapid virological responders and randomised to either an additional 20 or 44 weeks combination treatment. Patients who are HCV RNA positive are all treated for 44 more weeks. The endpoint is sustained virological response defined as undetectable HCV RNA 24 weeks after end of treatment.

Our hypothesis is that there is no important difference in the effect in the two groups.

This is a non-inferiority trial. The smallest difference considered to be clinically important is 15%. Thus to state "non-inferiority" the 95% confidence interval of the observed difference between the groups shall not overlap 10%. Both intention to treat and and per protocol analyses will be published. Conclusion will be conservative and based on the analysis who detect the biggest difference.

Enrollment: 242 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HCV RNA is positive
• Genotype 6
• Treatment naive
• Raised ALT

Exclusion criteria

• Active substance abuse
• Poorly controlled psychiatric disease
• HBsAg positive
• Anti-HIV positive
• Suffering from other significant concurrent medical conditions including chronic liver diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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242 participants in 2 patient groups

24-Week treatment group

Experimental group

Description:

Genotype 6 chronic hepatitis C patients with rapid virological response(undetectable HCV RNA at weeks 4) in this group will be treated with Peginterferon alfa-2a plus ribavirin for an additional 20 weeks

Treatment:

Drug: Peginterferon alfa2a

Drug: Ribavirin

Drug: Ribavirin

Drug: Peginterferon alfa2a

48-Week treatment group

Active Comparator group

Description:

Genotype 6 chronic hepatitis C patients with rapid virological response(undetectable HCV RNA at weeks 4) in this group will be treated with Peginterferon alfa-2a plus ribavirin for an additional 44 weeks

Treatment:

Drug: Peginterferon alfa2a

Drug: Ribavirin

Drug: Ribavirin

Drug: Peginterferon alfa2a