The Individualized Management With Pegylated-interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) Offering Viral Eradication: A Study of Pegylated-interferon Alfa-2a Plus Ribavirin in Participants With Chronic Hepatitis C (CHC) Non-genotype 2/3 (IMPROVE)

Roche

Status and phase: Completed; Phase 3

Conditions: Hepatitis C, Chronic

Treatments: Drug: Pegylated-interferon Alfa-2a; Drug: Ribavirin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00483938

ML21035

Details and patient eligibility

About

This study will compare the efficacy and safety of treatment with pegylated-interferon alfa-2a plus ribavirin in participants with non-genotype 2/3 CHC who, after 12 weeks of study treatment, have undetectable hepatitis C virus (HCV)-ribonucleic acid (RNA) or a greater than or equal to (>=) 2 log10 drop in HCV-RNA. Participants will be randomized to receive pegylated-interferon alfa-2a 180 micrograms subcutaneously weekly plus ribavirin (1000-1400 milligram [mg]) orally daily for the specified duration, followed by 24 weeks of treatment-free follow-up. Participants with detectable HCV-RNA and less than (<) 2 log10 drop in HCV-RNA at week 12 will discontinue therapy.

Enrollment: 236 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• evidence of CHC;
• evidence of hepatitis C non-genotype 2 or 3;
• compensated liver disease.

Exclusion criteria

• infection with HCV genotype 2 or 3;
• history of having received systemic antiviral therapy with activity against CHC <=3 months prior to start of study;
• hepatitis A, hepatitis B or human immunodeficiency virus (HIV) infection;
• history or evidence of a medical condition associated with chronic liver disease other than CHC.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

236 participants in 7 patient groups

Pegylated-interferon Alfa-2a + Ribavirin (Group A)

Experimental group

Description:

Participants with HCV RNA levels greater than (\>) 15 international units per milliliter (IU/mL) at Week 4, HCV RNA greater than or equal to (\>=) 15 IU/mL at Week 8, and either HCV RNA less than (\<) 15 IU/mL or \>=2 times logarithmic (2 log10) drop at Week 12, will receive pegylated-interferon alfa-2a (Pegasys) 180 micrograms (mcg) subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 milligrams (mg) orally daily for 48 weeks.

Treatment:

Drug: Ribavirin

Drug: Pegylated-interferon Alfa-2a

Pegylated-interferon Alfa-2a + Ribavirin (Group B)

Experimental group

Description:

Participants with HCV RNA levels \>15 IU/mL at Week 4, HCV RNA \>=15 IU/mL at Week 8, and either HCV RNA \<15 IU/mL or \>=2 log10 drop at Week 12, will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 72 weeks, and ribavirin 1000 to 1400 mg orally daily for 72 weeks.

Treatment:

Drug: Ribavirin

Drug: Pegylated-interferon Alfa-2a

Pegylated-interferon Alfa-2a + Ribavirin (Group C)

Experimental group

Description:

Participants with HCV-RNA levels \>15 IU/mL at Week 4, and HCV-RNA \<15 IU/mL at Week 8, will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 36 weeks, and ribavirin 1000 to 1400 mg orally daily for 36 weeks.

Treatment:

Drug: Ribavirin

Drug: Pegylated-interferon Alfa-2a

Pegylated-interferon Alfa-2a + Ribavirin (Group D)

Experimental group

Description:

Participants with HCV-RNA levels \>15 IU/mL at Week 4, and HCV-RNA \<15 IU/mL at Week 8, will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.

Treatment:

Drug: Ribavirin

Drug: Pegylated-interferon Alfa-2a

Pegylated-interferon Alfa-2a + Ribavirin (Group E)

Experimental group

Description:

Participants with HCV-RNA levels \<15 IU/mL at Week 4, will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks.

Treatment:

Drug: Ribavirin

Drug: Pegylated-interferon Alfa-2a

Pegylated-interferon Alfa-2a + Ribavirin (Group F)

Experimental group

Description:

Participants with HCV-RNA levels \<15 IU/mL at Week 4, will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.

Treatment:

Drug: Ribavirin

Drug: Pegylated-interferon Alfa-2a

Pegylated-interferon Alfa-2a + Ribavirin (Group NR)

Experimental group

Description:

Participants who do not have any change in HCV-RNA levels at Weeks 4, 8, and 12 will not be randomized (NR) to any of the other groups. Participants will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.

Treatment:

Drug: Ribavirin

Drug: Pegylated-interferon Alfa-2a