A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Genotype 1 and Human Immunodeficiency Virus-1 (HIV-1) Co-infection

Study Description

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Brief Summary:

This 2-arm study will compare the efficacy and safety of treatment with Pegasys (180 µg weekly) plus Copegus (800 mg daily) and Pegasys (180 µg weekly) plus Copegus (1000-1200 mg daily) in interferon-naive patients with CHC genotype 1 co-infected with HIV-1. Treatment will be administered for 48 weeks, and this will be followed by 24 treatment-free weeks. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Condition or disease	Intervention/treatment	Phase
Hepatitis C, Chronic	Drug: Peginterferon alfa-2a; Drug: Ribavirin	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	415 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	A Randomized, Multicenter, Double Blinded Study Comparing the Safety and Efficacy of Pegasys® 180 ug Plus Copegus® 1000 or 1200 mg to the Currently Approved Combination of Pegasys® 180 ug Plus Copegus® 800 mg in Interferon-naïve Patients With Chronic Hepatitis C Genotype 1 Virus Infection and HIV-1
Study Start Date :	June 2006
Actual Primary Completion Date :	April 2009
Actual Study Completion Date :	April 2009

Arms and Interventions

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Arm	Intervention/treatment
Experimental: PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg	Drug: Peginterferon alfa-2a; 180 µg subcutaneously weekly for 48 weeks; Other Name: Pegasys Drug: Ribavirin; 800 mg orally daily for 48 weeks; Other Name: Copegus
Active Comparator: PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg	Drug: Peginterferon alfa-2a; 180 µg subcutaneously weekly for 48 weeks; Other Name: Pegasys Drug: Ribavirin; 1000 mg or 1200 mg (based on patient weight of < 75 kg or ≥ 75 kg, respectively) orally daily for 48 weeks; Other Name: Copegus

Outcome Measures

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Primary Outcome Measures :

1. Sustained Virological Response (SVR) [ Time Frame: Week 72 ]
   SVR was defined by the percentage of patients with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks after completion of the 48-week treatment period (i.e., a single last HCV RNA < 20 IU/mL measured ≥ Day 477 [≥ Week 68]). Patients without an HCV measurement at the end of the 24-week untreated follow-up period were considered nonresponders.
2. Incidence of Adverse Events, Dose Reductions and Withdrawals Due to Anemia [ Time Frame: Up to Week 72 ]
   Adverse events of anemia included hemolytic anemia, aplasia pure red cell, and pancytopenia.

Secondary Outcome Measures :

1. Virological Response at End of Treatment Period [ Time Frame: Week 48 ]
   Virological response at the end of the treatment period was defined as a single last HCV RNA measurement <20 IU/mL at the completion of the treatment period (Days 324 to 351). Patients without an HCV measurement at Week 48 were considered nonresponders.
2. Virological Response at Weeks 4, 12 and 24 [ Time Frame: Weeks 4, 12 and 24 ]
   Virological response at Weeks 4, 12 and 24 was also defined as a single last undetectable HCV RNA (< 20 IU/mL) falling within the visit windows of Days 16 to 43, 72 to 99, and 156 to 183, respectively. Patients without an HCV measurement at a study week were considered nonresponders at that study week.
3. Relapse of Virological Response [ Time Frame: Weeks 48 and 72 ]
   Relapse of virological response was calculated by dividing the number of patients who achieved a virological response at the end of treatment but had detectable HCV RNA at the last assessment posttreatment by the number of patients with a virological response at the end of treatment who had at least one HCV RNA assessment posttreatment.
4. Rapid Virological Response (RVR) by Week 4 [ Time Frame: Week 4 ]
   RVR was defined as an undetectable HCV RNA < 20 IU/mL (a single last HCV RNA < 20 IU/mL falling in the time window of Days 2 to 43). Patients without an HCV measurement by Week 4 were considered nonresponders.
5. Early Virological Response (EVR), Partial EVR and Complete EVR by Week 12 [ Time Frame: Week 12 ]
   EVR: Undetectable HCV RNA <20 IU/mL or ≥2 log10 drop from pretreatment level, by Week 12 (a single last HCV RNA <20 IU/mL or ≥2 log10 drop from pretreatment level in the time window of Days 2 to 99). Partial EVR: Detectable HCV RNA but ≥2 log10 drop from pretreatment, by Week 12 (a single last HCV RNA detectable but ≥2 log10 drop from pretreatment in the time window of Days 2 to 99). Complete EVR: Undetectable HCV RNA <20 IU/mL, by Week 12 (a single last HCV RNA <20 IU/mL in the time window of Days 2 to 99). Patients without an HCV measurement by Week 12 were considered nonresponders.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Adult patients, ≥18 years of age
• CHC genotype 1
• Stable HIV-1 infection

Exclusion Criteria:

• Previous treatment with an alpha interferon, ribavirin, viramidine, levovirin, amantadine or investigational HCV protease or polymerase inhibitors
• Medical condition associated with liver disease other than CHC infection

Contacts and Locations

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Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:	Clinical Trials	Hoffmann-La Roche

More Information

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Additional Information:

Clinical Study Report Synopsis 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Rodriguez-Torres M, Slim J, Bhatti L, Sterling R, Sulkowski M, Hassanein T, Serrão R, Sola R, Bertasso A, Passe And S, Stancic S. Peginterferon alfa-2a plus ribavirin for HIV-HCV genotype 1 coinfected patients: a randomized international trial. HIV Clin Trials. 2012 May-Jun;13(3):142-52. doi: 10.1310/hct1303-142.

Responsible Party:	Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00353418 History of Changes
Other Study ID Numbers:	NV18209
First Posted:	July 18, 2006
Results First Posted:	June 15, 2010
Last Update Posted:	August 3, 2010
Last Verified:	July 2010

Additional relevant MeSH terms:

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