POTENTE Study: A Study of Early Virological Response in Naive Patients With Chronic Hepatitis C, Genotype 2 or 3, Treated With PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Copegus (Ribavirin).

A Prospective, Observational Study to Assess the Virological Response at Week 4 to the Therapy With PEGASYS® (Peginterferon Alfa 2a) Plus COPEGUS® (Ribavirin) in a Population of Treatment Naïve Patients With Chronic Hepatitis C, Genotype 2 or 3.

This single arm study will investigate the predictive value of a week 4 virological response on sustained virological response in patients with chronic hepatitis C, genotype 2 or 3, treated with PEGASYS + Copegus. Eligible patients will be treated with PEGASYS 180 micrograms/week sc + Copegus 800mg/day po; those who have a virological response at week 4 will continue to be treated for 24 weeks, followed by a 24 week treatment-free follow-up. Non-responders at week 4 will be entered into a separate protocol (MV21371) to receive PEGASYS + Copegus for 24 or 48 weeks. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.

Study Overview

• Status: Completed
• Conditions: Hepatitis C, Chronic
• Intervention / Treatment: Drug: peginterferon alfa-2a [Pegasys]; Drug: ribavirin [Copegus]

• Study Type: Observational
• Enrollment (Actual): 262

Contacts and Locations

Study Locations

• Brazil
  • DF
    • Brasilia, DF, Brazil, 70335900
  • ES
    • Vitoria, ES, Brazil, 29043-260
  • MA
    • Sao Luis, MA, Brazil, 65020560
  • RJ
    • Rio de Janeiro, RJ, Brazil, 20020-022
  • RS
    • Porto Alegre, RS, Brazil, 90035-003
    • Porto Alegre, RS, Brazil, 90020-090
  • SP
    • Campinas, SP, Brazil, 13083-888
    • Campinas, SP, Brazil, 13060-803
    • Ribeirao Preto, SP, Brazil, 14049-900
    • Santo Andre, SP, Brazil, 09060-650
    • Sao Paulo, SP, Brazil, 04040-003
    • Sorocaba, SP, Brazil, 18047-600

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants with serologically proven chronic hepatitis C and genotype 2 or 3, with or without cirrhosis and compensated liver disease (Child-Pugh A cirrhosis.)

Description

Inclusion Criteria:

• adult patients, >=18 years of age;
• positive serum HCV RNA.

Exclusion Criteria:

• co-infection with HIV or HBV (patients with a positive HBsAg);
• previous treatment with interferon, or peginterferon and/or ribavirin;
• severe hepatic dysfunction or decompensated cirrhosis of liver.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Peginterferon Alfa-2a + Ribavirin	Drug: peginterferon alfa-2a [Pegasys]; 180 micrograms/week sc for 24 weeks; Drug: ribavirin [Copegus]; 800mg po daily for 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Sustained Virological Response at Week 48	Sustained Virological Response (SVR) is defined as participants with undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at 24 weeks after the last dose of study drug. The detection limit of HCV RNA was 15 international units (IU) per milliliter (mL) by qualitative polymerase chain reaction (PCR).	At Week 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Rapid Virological Response at Week 4	Rapid Virological Response (RVR) is defined as participants with) undetectable HCV RNA at 4 weeks after initiation of the treatment period. The detection limit of HCV RNA was 15 IU/mL by qualitative PCR.	At Week 4
Percentage of Participants With Virological Response at Week 24	Virological response is defined as participants with undetectable HCV RNA after the last dose of study drug (Week 24).	At Week 24
Percentage of Participants With Virological Relapse	Virological relapse is defined as participants with virological response (undetectable HCV RNA) but did not achieve SVR.	At week 48
Percentage of Participants With Positive Predictive Value	Positive predictive value is defined as participants with RVR who did not achieve SVR.	At Week 48
Number of Participants With Any Adverse Events and Any Serious Adverse Events	An any adverse events (AEs) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An serious adverse events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.	Up to 48 weeks
Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48	Hematology parameters included hemoglobin, hematocrit, leukocytes, neutrophils and platelets.	At Baseline (Day 0), Week 2, Week 4, Week 12, Week 24 and Week 48
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48	Biochemistry parameters included alanine transaminase (ALT), aspartate transaminase (AST), gamma-glutamyl transpeptidase (Gamma-GT),fasting cholesterol, blood glucose, insulin, total bilirubin, creatinine, triglycerides, homeostatic model assessment score, prothrombin time (PT) and international normalized ratio (INR). The homeostatic model assessment (HOMA) score is a method used to quantify insulin resistance. HOMA score = (fasting glucose in mg/dL × fasting insulin in μIU/mL) / 405. A normal participant can have a HOMA score up to 3. A patient with a score of >3 is definitely insulin resistance. Low HOMA score indicate high insulin resistance, whereas high HOMA score indicate low insulin resistance.	Baseline, Week 4, Week 12, Week 24 and Week 48

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: June 17, 2008
• First Submitted That Met QC Criteria: June 17, 2008
• First Posted (Estimate): June 18, 2008

Study Record Updates

• Last Update Posted (Estimate): June 21, 2016
• Last Update Submitted That Met QC Criteria: May 12, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Hepatitis; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Ribavirin; Peginterferon alfa-2a
• Other Study ID Numbers: ML21543