Health Condition 1: null- HCV patients
Conditions
Interventions
None listed
Sponsors
MSD PHARMACEUTICALS PVT LTD
Eligibility
Inclusion criteria
Inclusion criteria: (1)Patients of Asian ethnicity. (2)Patients diagnosed with chronic HCV genotype 1 (only). (3)Patients initiated on PegIFN-α and ribavirin combination therapy with the last dose completed 6 months prior to and treated within the last 5 years from the date of centre initiation. (4)Patients naïve to previous PegIFN-α and ribavirin combination therapy. (5)Patients willing to provide consent and a blood sample for IL-28B analysis. (6)Patients aged 18 years and above.
Exclusion criteria
Exclusion criteria: (1)Co-infected HCV patients (HBV and HIV). (2)Active intravenous drug users at the start of combination therapy. (3)Known chronic alcoholic at the start of combination therapy (in the judgement of the physician). (4)Patients with decompensated liver disease or other causes of liver disease (such as autoimmune hepatitis) at the start of combination therapy. (5)Patients suffering from chronic renal failure. (6)Patients suffering from thalassemia. (7)Patients that have undergone a liver transplantation before or during the PegIFN+ribavirin treatment course. (8)Patients with evidence of hepatocellular carcinoma at the start of combination therapy. ((9)Patients of mixed ethnicity (e.g. White Caucasian and Asian mix, etc.). (10)Patients who are currently pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢To determine the relationship between HCV genotype 1, IL-28B single nucleotide polymorphisms (SNPs) and SVR rates to standard combination therapy in Asia-Pacific patients chronically infected with HCVTimepoint: Jan 2012- Dec 2013 | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢Comparing SNP allele frequencies in relation to other host factors such as age, BMI, gender, viral load prior to treatment, rapid virological response (RVR) & early virological response (EVR) rates (where possible) and liver fibrosis severity. â?¢Investigating reasons for treatment failure. â?¢Understanding physician treatment patterns in each of the countries â?¢Investigating the impact of IL-28B testing on physician and patient treatment decisions. Timepoint: Jan 2012-Dec 2013 | — |
Countries
India, Republic of Korea, Taiwan, Viet Nam
Contacts
Public ContactDr Ajit Sood
Dayanand Medical College
Outcome results
None listed