Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Hepatitis C Antiviral Long-term Treatment Against Cirrhosis Trial (HALT-C)
Brief Summary: The HALT-C Trial is a National Institute of Diabetes and Digestive and Kidney Diseases sponsored, randomized clinical trial of long-term use of Peginterferon alfa-2a (pegylated interferon) in patients who failed to respond to prior interferon treatment. All patients who enter the trial will be treated for 6 months with Peginterferon alfa-2a and Ribavirin. Patients who respond to this 6 month treatment will continue to be treated for an additional 6 months.

Patients who do not respond to this treatment will be eligible for the long-term maintenance phase of this study where patients will be randomly selected to be treated with Peginterferon alfa-2a or to discontinue treatment for 3.5 years. Patients in both arms of this study will be followed closely with quarterly study visits.

The combination of peginterferon plus ribavirin has recently been approved by the FDA for treatment of chronic hepatitis C. Patients who remain HCV-RNA positive after being treated for at least 6 months with peginterferon and ribavirin outside of this study may be eligible to directly enter the randomized portion of the HALT-C Trial.

The HALT-C study is designed to determine if continuing interferon long-term over several years will suppress Hepatitis C virus, prevent progression to cirrhosis, prevent liver cancer and reduce the need for liver transplantation.


Options:
A: Arm Label: Cohort A, Group 1 (12 wk): CPT Class B (7-9); Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV | Arm Label: Cohort A, Group 1 (24 wk): CPT Class B (7-9); Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV | Arm Label: Cohort A, Group 2 (12 wk): CPT Class C (10-12); Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV | Arm Label: Cohort A, Group 2 (24 wk): CPT Class C (10-12); Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV | Arm Label: Cohort B, Group 3 (12 wk): F0-F3 Fibrosis; Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV | Arm Label: Cohort B, Group 3 (24 wk): F0-F3 Fibrosis; Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV | Arm Label: Cohort B, Group 4 (12 wk): CPT Class A (5-6); Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV | Arm Label: Cohort B, Group 4 (24 wk): CPT Class A (5-6); Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV | Arm Label: Cohort B, Group 5 (12 wk): CPT Class B (7-9); Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV | Arm Label: Cohort B, Group 5 (24 wk): CPT Class B (7-9); Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV | Arm Label: Cohort B, Group 6 (12 wk): CPT Class C (10-12); Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV | Arm Label: Cohort B, Group 6 (24 wk): CPT Class C (10-12); Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV | Arm Label: Cohort B, Group 7 (12 wk): FCH; Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV | Arm Label: Cohort B, Group 7 (24 wk): FCH; Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV | Intervention Type: DRUG; Name: LDV/SOF; Assigned to Arm(s): Cohort A, Group 1 (12 wk): CPT Class B (7-9), Cohort A, Group 1 (24 wk): CPT Class B (7-9), Cohort A, Group 2 (12 wk): CPT Class C (10-12), Cohort A, Group 2 (24 wk): CPT Class C (10-12), Cohort B, Group 3 (12 wk): F0-F3 Fibrosis, Cohort B, Group 3 (24 wk): F0-F3 Fibrosis, Cohort B, Group 4 (12 wk): CPT Class A (5-6), Cohort B, Group 4 (24 wk): CPT Class A (5-6), Cohort B, Group 5 (12 wk): CPT Class B (7-9), Cohort B, Group 5 (24 wk): CPT Class B (7-9), Cohort B, Group 6 (12 wk): CPT Class C (10-12), Cohort B, Group 6 (24 wk): CPT Class C (10-12), Cohort B, Group 7 (12 wk): FCH, Cohort B, Group 7 (24 wk): FCH | Intervention Type: DRUG; Name: RBV; Assigned to Arm(s): Cohort A, Group 1 (12 wk): CPT Class B (7-9), Cohort A, Group 1 (24 wk): CPT Class B (7-9), Cohort A, Group 2 (12 wk): CPT Class C (10-12), Cohort A, Group 2 (24 wk): CPT Class C (10-12), Cohort B, Group 3 (12 wk): F0-F3 Fibrosis, Cohort B, Group 3 (24 wk): F0-F3 Fibrosis, Cohort B, Group 4 (12 wk): CPT Class A (5-6), Cohort B, Group 4 (24 wk): CPT Class A (5-6), Cohort B, Group 5 (12 wk): CPT Class B (7-9), Cohort B, Group 5 (24 wk): CPT Class B (7-9), Cohort B, Group 6 (12 wk): CPT Class C (10-12), Cohort B, Group 6 (24 wk): CPT Class C (10-12), Cohort B, Group 7 (12 wk): FCH, Cohort B, Group 7 (24 wk): FCH
B: Arm Label: LDV/SOF; Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: Placebo to match RBV | Arm Label: LDV/SOF + RBV; Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV, Drug: Placebo to match LDV/SOF, Drug: Placebo to match RBV | Intervention Type: DRUG; Name: LDV/SOF; Assigned to Arm(s): LDV/SOF, LDV/SOF + RBV | Intervention Type: DRUG; Name: RBV; Assigned to Arm(s): LDV/SOF + RBV | Intervention Type: DRUG; Name: Placebo to match LDV/SOF; Assigned to Arm(s): LDV/SOF + RBV | Intervention Type: DRUG; Name: Placebo to match RBV; Assigned to Arm(s): LDV/SOF, LDV/SOF + RBV
C: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Peginterferon alfa-2a + Ribavirin, Drug: Peginterferon alfa-2a | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Peginterferon alfa-2a + Ribavirin | Intervention Type: DRUG; Name: Peginterferon alfa-2a + Ribavirin; Assigned to Arm(s): 1, 2 | Intervention Type: DRUG; Name: Peginterferon alfa-2a; Assigned to Arm(s): 1
D: Arm Label: Healthy control; Type: N/A; Interventions: Diagnostic Test: PIVKA-II | Arm Label: Metastatic liver cancer patients; Type: N/A; Interventions: Diagnostic Test: PIVKA-II | Arm Label: Hepatocellular carcinoma patients; Type: N/A; Interventions: Diagnostic Test: PIVKA-II | Arm Label: Chronic liver disease patients; Type: N/A; Interventions: Diagnostic Test: PIVKA-II | Intervention Type: DIAGNOSTIC_TEST; Name: PIVKA-II; Assigned to Arm(s): Chronic liver disease patients, Healthy control, Hepatocellular carcinoma patients, Metastatic liver cancer patients

Answer: C