An Observational Study on Predictive Factors of Response in Patients With Chronic Hepatitis C Treated With Pegasys (Peginterferon Alfa-2a) and Ribavirin
- Conditions
- Hepatitis C, Chronic
- Registration Number
- NCT01392742
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 443
- 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
- Coinfection with HIV and/or hepatitis B
- Contraindications according to the SPC for Pegasys/ribavirin
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Were Non-Responders Up to 24 weeks after EOT (up to Week 96) Non-responders were those participants who had not reached аn undetectable HCV RNA during the treatment period.
Percentage of Participants With Sustained Virological Response (SVR) 24 weeks after End of treatment (EOT) (up to Week 96) 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).
Percentage of Participants With Relapse Up to 24 weeks after EOT (up to Week 96) Relapse was define as аn undetectable HCV RNA during the treatment period, but without such during the follow-up.
- Secondary Outcome Measures
Name Time Method Correlation of SVR With Rapid Virological Response (RVR) Up to 24 weeks after EOT (up to Week 96) 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.
Percentage of Participants With Positive Predictive Value on SVR at Week 4 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.
Duration of Treatment in Participants With SVR by HCV Genotype Up to Week 72 SVR was defined as undetectable HCV RNA 24 weeks after end of treatment.
Cumulative PEG-IFN Alfa-2a Dose in Participants With SVR by HCV Genotype Up to Week 72 SVR was defined as undetectable HCV RNA 24 weeks after end of treatment.
Percentage of Participants With Virological Response 4 weeks after EOT (up to Week 76) 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.
Cumulative Ribavirin Dose in Participants With SVR by HCV Genotype Up to Week 72 SVR was defined as undetectable HCV RNA 24 weeks after end of treatment.
Correlation of SVR With Early Virological Response (EVR) Up to 24 weeks after EOT (up to Week 96) 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.
Predictive Power Values of Host-, Virus- and Treatment-related Factors and Virological Response Week 4 and 12 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.
Percentage of Participants With Positive Predictive Value on SVR at Week 12 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.
Trial Locations
- Locations (9)
Mhat - Pleven; Clinic of Gastroenterology
🇧🇬Pleven, Bulgaria
Mhat Queenjoanna; Clinic of Gastroenterology
🇧🇬Sofia, Bulgaria
Umhat St. Georgi; Clinical of Gastroenterology
🇧🇬Plovdiv, Bulgaria
Military Medical Academy; Gastroenterology
🇧🇬Sofia, Bulgaria
Mhat St. Zagora; Clinical of Gastroenterology
🇧🇬Stara Zagora, Bulgaria
UMHAT Alexandrovska EAD; Gastroenterology
🇧🇬Sofia, Bulgaria
Mhat St. Ivan Rilski; Clinic of Gastroenterology
🇧🇬Sofia, Bulgaria
MHAT Tokuda Hospital Sofia; Department of Gastroenterology at Clinic of Internal Deseases
🇧🇬Sofia, Bulgaria
Mhat Sveta Marina; Clinic of Gastroenterology
🇧🇬Varna, Bulgaria