Efficacy and Safety Evaluation of a Regimen Consisting of Peginterferon Lambda-1a + Ribavirin + Daclatasvir (Lambda + RBV + DCV) in HCV Genotype 1b Treatment naïve Patients or Prior Relapsers to Peginterferon Alfa + Ribavirin (Alfa + RBV) Therapy (STRUCTURE)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Hepatitis C

Treatments: Biological: Peginterferon Alfa-2a; Biological: Peginterferon Lambda-1a; Drug: Telaprevir; Drug: Daclatasvir; Drug: Ribavirin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01718158

AI452-021

2011-005409-65 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to determine if treatment with Pegylated Interferon Lambda-1a, given in combination with Ribavirin and Daclatasvir for 24 weeks, is as safe and effective as the standard treatment with Pegylated Interferon Alfa-2a + Ribavirin + Telaprevir in subjects who are infected with Chronic Hepatitis C virus genotype 1b and have never received any prior anti-HCV treatment, or who have relapsed after an initial, successful treatment with Pegylated Interferon Alfa + Ribavirin

Enrollment: 444 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients chronically infected with HCV Genotype-1b
• Naïve to prior treatment or documented evidence of relapse after completion of the prescribed duration of treatment (duration may be 24 or 48 weeks, to be determined based upon local guidelines)
• HCV RNA viral load ≥100,000 IU/mL at screening
• Patients with compensated cirrhosis are permitted

Exclusion criteria

• Infection with Hepatitis C virus (HCV) other than Genotype-1b

• Positive Hepatitis B surface antigen (HBsAg) or Human immunodeficiency virus (HIV)-1/HIV-2 antibody test at screening

• Evidence of chronic liver disease caused by diseases other than chronic HCV infection

• Current evidence of or history of variceal bleeding, hepatic encephalopathy, or ascites requiring diuretics or paracentesis or evidence of any of these findings on physical examination performed at screening

• Current or known history of cancer (except adequately treated in situ carcinoma of the cervix, or basal or squamous cell carcinoma of the skin) within 5 years prior to screening

• Current evidence or known history of decompensated cirrhosis based on radiologic criteria or biopsy results and clinical criteria

• Laboratory values:

  1. Hemoglobin <12.0 g/dL (males) or <11.0 g/dL (females)
  2. Platelets <90,000/mm3
  3. Total serum bilirubin ≥2 mg/dL (unless due to Gilbert's disease)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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444 participants in 2 patient groups

Peginterferon Lambda-1a + Ribavirin + Daclatasvir

Experimental group

Description:

Peginterferon Lambda-1a 180 µg solution for subcutaneous injection, once a week for 24 Weeks Ribavirin 200 mg tablets \[1000-1200 mg total daily dose: subjects should take either 400 mg (2 tablets for subjects \< 75 kg) or 600 mg (3 tablets for subjects ≥ 75 kg) in the morning with food and 600 mg (3 tablets) in the evening with food\] by mouth, twice daily, for 24 weeks Daclatasvir 60 mg tablets by mouth, once a day for 12 weeks

Treatment:

Drug: Ribavirin

Drug: Daclatasvir

Biological: Peginterferon Lambda-1a

Peginterferon Alfa-2a + Ribavirin + Telaprevir

Experimental group

Description:

Peginterferon Alfa-2a 180 µg solution for subcutaneous injection, once a week for 24 to 48 weeks depending on response Ribavirin 200 mg tablets \[1000-1200 mg total daily dose: subjects should take either 400 mg (2 tablets for subjects \< 75 kg) or 600 mg (3 tablets for subjects ≥ 75 kg) in the morning with food and 600 mg (3 tablets) in the evening with food\] by mouth, twice daily, for 24 to 48 weeks depending on response Telaprevir 375 mg tablets \[2250 mg total daily dose: subjects should take 750 mg (two 375 mg tablets) orally three times a day, approximately 7-9 hours apart) for 12 weeks

Treatment:

Drug: Ribavirin

Drug: Telaprevir

Biological: Peginterferon Alfa-2a