An Observational Study on Predictive Factors of Response in Patients With Chronic Hepatitis C Treated With Pegasys (Peginterferon Alfa-2a) and Ribavirin

Hoffmann-La Roche443 enrolled

Overview

This observational study will evaluate predictors of early on-treatment response and sustained virological response in patients with chronic hepatitis C receiving Pegasys (peginterferon alfa-2a) and ribavirin. Data will be collected from patients on treatment (24 or 48 weeks) and 24 weeks after the end of treatment.

Study Type

OBSERVATIONAL

Enrollment

443

Conditions

Hepatitis C, Chronic

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients, \>/= 18 years of age * Serologically confirmed chronic hepatitis C (all genotypes) * Treatment with Pegasys and ribavirin according to the current standard of care and in line with current summaries of product characteristics (SPCs)/local labelling Exclusion Criteria: * Coinfection with HIV and/or hepatitis B * Contraindications according to the SPC for Pegasys/ribavirin

Locations (9)

Mhat - Pleven; Clinic of Gastroenterology

Pleven, Bulgaria

Umhat St. Georgi; Clinical of Gastroenterology

Plovdiv, Bulgaria

MHAT Tokuda Hospital Sofia; Department of Gastroenterology at Clinic of Internal Deseases

Sofia, Bulgaria

Outcomes

Primary Outcomes

Percentage of Participants With Sustained Virological Response (SVR)

SVR was defined as undetectable Hepatitis C Virus Ribonucleic Acid (HCV RNA) 24 weeks after completion of the actual treatment period (a single last undetectable HCV RNA Polymerase Chain Reaction \[PCR\] measured greater than or equal to \>=140 days post-treatment).

Time frame: 24 weeks after End of treatment (EOT) (up to Week 96)

Percentage of Participants With Relapse

Relapse was define as аn undetectable HCV RNA during the treatment period, but without such during the follow-up.

Time frame: Up to 24 weeks after EOT (up to Week 96)

Percentage of Participants Who Were Non-Responders

Non-responders were those participants who had not reached аn undetectable HCV RNA during the treatment period.

Time frame: Up to 24 weeks after EOT (up to Week 96)

Secondary Outcomes

Percentage of Participants With Positive Predictive Value on SVR at Week 4

Predictive value determined the relationship of the virological response at specified time to the total response. Positive predicted value= number of true positives/(number of true positives+ number of false positives). SVR was defined as undetectable HCV RNA 24 weeks after end of treatment. Percentage of participants who showed positive predictive value in treatment naive and those who failed previous treatment with interferon were reported.

Time frame: Week 4

Percentage of Participants With Positive Predictive Value on SVR at Week 12

Predictive value determined the relationship of the virological response at specified time to the total response. Positive predicted value= number of true positives/( number of true positives+ number of false positives). SVR was defined as undetectable HCV RNA 24 weeks after end of treatment. Percentage of participants who showed positive predictive value in treatment naive and those who failed previous treatment with interferon were reported.

Data from ClinicalTrials.gov

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UMHAT Alexandrovska EAD; Gastroenterology

Mhat Queenjoanna; Clinic of Gastroenterology

Sofia, Bulgaria

Military Medical Academy; Gastroenterology

Sofia, Bulgaria

Mhat St. Ivan Rilski; Clinic of Gastroenterology

Sofia, Bulgaria

Mhat St. Zagora; Clinical of Gastroenterology

Stara Zagora, Bulgaria

Mhat Sveta Marina; Clinic of Gastroenterology

Varna, Bulgaria

Correlation of SVR With Rapid Virological Response (RVR)

Correlation of SVR with RVR was based on 3 symmetric measures; Kendall's tau-b, Kendall's tau-c and Gamma. SVR was defined as undetectable HCV RNA 24 weeks after end of treatment. RVR was defined as having undetectable HCV RNA 4 weeks after start of treatment.

Time frame: Up to 24 weeks after EOT (up to Week 96)

Correlation of SVR With Early Virological Response (EVR)

Correlation of SVR with EVR was based on 3 symmetric measures; Kendall's tau-b, Kendall's tau-c and Gamma. SVR was defined as undetectable HCV RNA 24 weeks after end of treatment. EVR was defined as having undetectable HCV RNA 12 weeks after start of treatment.

Time frame: Up to 24 weeks after EOT (up to Week 96)

Predictive Power Values of Host-, Virus- and Treatment-related Factors and Virological Response

Predictive value determined the relationship of host factors to virological response. Host factors included; RVR (EVR for Week 12), gender, liver fibrosis, HCV genotype, height and treatment duration for Week 4 after EOT excluding HCV genotype at Week 12 EOT. RVR was defined as having undetectable HCV RNA 4 weeks after start of treatment and EVR was defined as having undetectable HCV RNA 12 weeks after start of treatment.

Time frame: Week 4 and 12

Duration of Treatment in Participants With SVR by HCV Genotype

SVR was defined as undetectable HCV RNA 24 weeks after end of treatment.

Time frame: Up to Week 72

Cumulative PEG-IFN Alfa-2a Dose in Participants With SVR by HCV Genotype

SVR was defined as undetectable HCV RNA 24 weeks after end of treatment.

Time frame: Up to Week 72

Cumulative Ribavirin Dose in Participants With SVR by HCV Genotype

SVR was defined as undetectable HCV RNA 24 weeks after end of treatment.

Time frame: Up to Week 72

Percentage of Participants With Virological Response

The Virological response at the end of treatment was defined as the percentage of participants with undetectable HCV RNA, HCV test (based on a single last undetectable HCV RNA PCR falling in the 4 weeks' time window at end of treatment), is basically the sum of participants with SVR and with relapse.

Time frame: 4 weeks after EOT (up to Week 76)