Hepatitis C, Chronic
Conditions
Brief summary
Primary objective: • Develop and validate a tool towards patients with chronic hepatitis C genotype 1 and 4 to allow optimize treatment.
Detailed description
This Tool: 1. Predicting the overall impact of prognostic factors (including the new factor of genetic polymorphism of the IL28B) on Sustained Viral Response (SVR). 2. Identify those patients most likely to respond. 3. Therapy and therefore optimize resources The validation tool will check into clinical practice its predictive power (it will consider its ability to calibrate and discriminate) and make correct inferences and interpretations of the scores obtained when applying.
Interventions
DRUGPeginterferon alfa-2a
Treatment as usual clinical practice
DRUGRibavirin
Treatment as usual clinical practice
Sponsors
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients with \> 18 years old. * Patients diagnosed with chronic hepatitis C in the presence of HCV RNA in plasma that meet criteria for initiating antiviral therapy in routine clinical practice conditions. * Patients Genotype 1 and 4. * Patients with the results of all the factors evaluable at the time of inclusion. * Patients who have accepted their participation in the study through informed consent.
Exclusion criteria
* Patients previously treated with interferon (IFN) and ribavirin (RBV). * Patients with genotype 2, 3, 5 and 6. * Patients with co-infection with hepatitis B. * Patients with other liver diseases. * Patients with any contraindications to the drugs used in the treatment of hepatitis C.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sustained Viral Response (RVS) | 1 ½ years (72 weeks) | Measurement of HCV RNA negativization 24 weeks after treatment |
Countries
Spain
Outcome results
None listed