Observational Prospective Registry of the Efficacy, Safety, and Adherence to Therapy of Infergen® (Interferon Alfacon 1) in Patients Chronically Infected With Hepatitis C Virus (REACH SVR)
This observational prospective registry is designed to evaluate the safety, adherence, and efficacy of prescribed, patient-administered therapy with Infergen® (Interferon alfacon 1) and other prescribed therapies in patients chronically infected with HCV. The primary endpoint for efficacy will be the SVR rate at 24 weeks after therapy ends.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Observational Prospective Registry of the Efficacy, Safety, and Adherence to Therapy of Infergen® (Interferon Alfacon 1) in Patients Chronically Infected With Hepatitis C Virus|
- Determine the incidence of SVR, defined as undetectable HCV RNA measured 24 weeks after therapy ends, associated with prescribed, patient-administered therapy with Infergen® (Interferon alfacon 1) in patients chronically infected with HCV. [ Time Frame: 24 weeks post end of therapy ] [ Designated as safety issue: No ]
- Capture of defined adverse events (AEs),dose changes or cessation, and adherence to the prescribed dose of Infergen and other prescribed therapies over the course of treatment [ Time Frame: Treatment weeks 4, 12, 24, 48, and Follow-Up weeks 4 and 24 ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2009|
|Estimated Study Completion Date:||April 2012|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
|Patients with Chronic Hepatitis C||
Drug: Infergen with or without ribavirin
Infergen at either the 15 mcg or 9 mcg dose given per Providers instructions, with or without weight based ribavirin
This registry plans to enroll 1000 patients at 75 clinical sites across the United States.
Potentially eligible patients will be anti-HCV antibody-positive and have detectable serum or plasma HCV RNA. Patients can have any HCV genotype; they also can be antiviral treatment-naïve or have a history of either nonresponse or relapse to previous antiviral therapy. Patients can roll over directly from current interferon (IFN) therapy into registry Infergen therapy, but the average washout period will be <1 month. Rollovers will occur after 4, 12, or 24 weeks of IFN therapy. Patients coinfected with HBV or HIV can be included in the registry.
Each investigator participating in this registry will employ his or her discretion and standard clinical practice to determine when to see the patient in the clinic, how to manage the patient's drug regimen, and how best to monitor the patient's response and tolerance to therapy.The decision to enroll a patient and start therapy with Infergen and other prescribed therapies may be guided by historic biopsy results, or the patient can undergo liver biopsy at the investigator's discretion. Biopsy is not a prerequisite, however, if the investigator believes it to be unnecessary. When a patient's treatment is expected to require significant dose modification and/or more intensive monitoring because of comorbid conditions, enrolling the patient in the registry is at the investigator's discretion. For purposes of the registry, data will be collected at baseline; at Weeks 4, 12, 24, and 48 from the start of therapy; and at follow-up visits 4 and 24 weeks after treatment ends.
Safety will be assessed by monitoring AEs, reduction/discontinuation of therapy because of AEs, routine laboratory results and by other means determined by the investigator. Adherence over the course of therapy will also be evaluated, taking into account physician-directed dose reduction or cessation, patients' self-reports of compliance, and the return of used and unused medication to each scheduled visit.
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|Principal Investigator:||Andrew Muir, MD||DCRI|