Peginterferon Alfa-2a and Ribavirin for Genotype 2 Chronic Hepatitis C: Duration and Ribavirin Dose Stratified by RVR

Summary

Treatment with peginterferon plus daily low dose (800 mg) or weight-based ribavirin (800-1400 mg) for 24 to 48 weeks has achieved 70-93% sustained virologic response (SVR) rates in patients with genotype 2 or 3 chronic hepatitis C (CHC). Recently, a large randomized study has shown that patients with genotype 2 or 3 CHC have comparable SVR rates for those who received peginterferon for 24 or 48 weeks, and who received daily low dose (800 mg) or standard dose (1000-1200 mg) ribavirin. Therefore, the currently recommended treatment for these patients is 24 weeks of peginterferon plus low dose ribavirin. Because of the high response rates, several studies have shown that when these patients had rapid virologic response (RVR), defined as undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels, at week 4 of peginterferon plus weight-based ribavirin, 12-16 weeks of treatment could have 82-94% SVR rates. However, treatment with peginterferon plus low dose ribavirin for 24 weeks showed significantly higher SVR rates than that for 16 weeks (85% versus 79%) in these patients who achieved RVR. While studies showed concordant results in SVR rates for patients with genotype 3 CHC who received peginterferon plus low dose or weight-based ribavirin for 16 or 24 weeks, the SVR rates stratified by RVR showed great differences in patients with genotype 2 CHC who received such treatment. Currently, there are no studies on the direct comparison of low dose versus weight-based ribavirin, and of 16 to 24 weeks of treatment stratified by RVR for patients with genotype 2 CHC. The investigators aimed to conduct a randomized trial to determine the optimal ribavirin dose and treatment duration of peginterferon plus ribavirin for patients with genotype 2 CHC based on RVR studies.

Conditions

• Chronic Hepatitis C

Interventions

DRUG

Peg-IFN + WB RBV for 16 weeks

1. Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 1000-1200 mg/day (\< 75 kg, 1000 mg/day; \>= 75 kg, 1200 mg/day) from weeks 1-4 2. Rapid virologic response (RVR) at week 4 of therapy: achieved 3. Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 1000-1200 mg/day (\< 75 kg, 1000 mg/day; \>= 75 kg, 1200 mg/day) from weeks 5-16

DRUG

Peg-IFN + LD RBV for 16 weeks

1. Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 1000-1200 mg/day (\< 75 kg, 1000 mg/day; \>= 75 kg, 1200 mg/day) from weeks 1-6 2. Rapid virologic response (RVR) at week 4 of therapy: achieved 3. Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 800 mg/day from weeks 6-16

DRUG

Peg-IFN + WB RBV for 24 weeks

1. Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 1000-1200 mg/day (\< 75 kg, 1000 mg/day; \>= 75 kg, 1200 mg/day) from weeks 1-4 2. Rapid virologic response (RVR) at week 4 of therapy: not achieved 3. Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 1000-1200 mg/day from weeks 5-24

DRUG

Peg-IFN + WB RBV for 48 weeks

1. Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 1000-1200 mg/day (\< 75 kg, 1000 mg/day; \>= 75 kg, 1200 mg/day) from weeks 1-4 2. Rapid virologic response (RVR) at week 4 of therapy: not achieved 3. Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 1000-1200 mg/day from weeks 5-48

DRUG

Peg-IFN + LD RBV for 24 weeks

1. Peginterferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 180 ug/week plus ribavirin (Copegus, Hoffman-LaRoche) 800 mg/day from weeks 1-24 2. Rapid virologic response (RVR) at week 4 of therapy: both achieved and not achieved

Sponsors & Collaborators

• National Science and Technology Council, Taiwan

  collaborator OTHER_GOV

• Department of Health, Executive Yuan, R.O.C. (Taiwan)

  collaborator OTHER_GOV

• National Taiwan University Hospital

  lead OTHER

Principal Investigators

• Jia-Horng Kao, MD, PhD · National Taiwan University Hospital

• Ding-Shinn Chen, MD · National Taiwan University Hospital

• Ming-Yang Lai, MD, PhD · National Taiwan University Hospital

• Pei-Jer Chen, MD, PhD · National Taiwan University Hospital

• Chun-Jen Liu, MD, PhD · National Taiwan University Hospital

• Chen-Hua Liu, MD · National Taiwan University Hospital

• Shih-Jer Hsu, MD · National Taiwan University Hospital, Yun-Lin Branch

• Chih-Lin Lin, MD · Taipei City Hospital, Ren-Ai Branch

• Cheng-Chao Liang, MD · Far Eastern Memorial Hospital

• Ching-Sheng Hsu, MD · Buddhist Xindian Tzu Chi General Hospital

• Sheng-Shun Yang, MD · Taichung Veterans General Hospital

• Chia-Chi Wang, MD · Buddhist Xindian Tzu Chi General Hospital

• Tai-Chung Tseng, MD · Buddhist Xindian Tzu Chi General Hospital

• Ming-Lung Yu, MD, PhD · Kaohsiung Medical University

• Wan-Long Chuang, MD, PhD · Kaohsiung Medical University

• Chia-Yen Dai, MD, Ms · Kaohsiung Municipal Hsiao-Kang Hospital

• Jee-Fu Huang, MD · Kaohsiung Municipal Hsiao-Kang Hospital

• Chang-Fu Chiu, MD · Paochien Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-11-30

Primary Completion

2014-03-31

Completion

2014-03-31

Countries

• Taiwan

Study Locations