Observational Prospective Registry of the Efficacy, Safety, and Adherence to Infergen® in Patients Infected With Hep C
Observational Prospective Registry of the Efficacy, Safety, and Adherence to Infergen® in Patients Infected With Hep C
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.
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.
Inclusion Criteria:

 1. Willing to consent to data being collected and provided to the Duke Clinical Research
 Institute (DCRI) and Three Rivers Pharmaceuticals

 2. Able and willing to give written informed consent and Health Insurance Portability and
 Accountability Act (HIPAA) authorization, and to comply with the requirements of the
 registry protocol

 3. Anti-HCV antibody-positive

 4. HCV RNA concentration >100,000 IU/mL on reverse transcriptase-polymerase chain
 reaction (RT-PCR) assay at baseline or >90 days before the baseline visit

 5. Deemed by the investigator to be an appropriate patient for treatment with Infergen
 and other prescribed medications

 6. Baseline CD4 count >200 cells/mm3 (human immunodeficiency virus [HIV]-HCV coinfected
 patients)

 7. Women: must be documented to be surgically sterile, be postmenopausal (defined as >2
 years without menses), or agree to use 2 forms of effective contraception during the
 registry and for 6 months after receiving the final dose of study drug. Men: must
 agree to use 2 forms of effective contraception during the registry and for 6 months
 after receiving the final dose of study drug, and their partners of childbearing
 potential must not be pregnant at screening.

 8. Women: must not be lactating and, if of childbearing potential, must have a negative
 serum pregnancy test result at the baseline visit

 9. Age >18 years

 Exclusion Criteria:

 1. Unable to complete all clinic visits and comply with registry procedures, including
 self-injection of Infergen

 2. Known hypersensitivity to alpha-interferons or any component of the product

 3. Decompensated hepatic disease

 4. Autoimmune hepatitis

 5. Hemoglobinopathies (i.e., thalassemia or sickle cell anemia)

 6. Any other condition that, in the opinion of the investigator, would make the patient
 unsuitable for enrollment or could interfere with the patient participating in and
 completing the registry