Efficacy and Safety of All-Oral Combination of Narlaprevir/Ritonavir and Sofosbuvir in Treatment-naïve Patients With Chronic Hepatitis C Genotype 1
Condition: Chronic Hepatitis c Genotype 1
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      Multicenter, open-label, phase II safety and efficacy study of all-oral combination of
      narlaprevir/ritonavir and sofosbuvir in Treatment-naïve Patients with Chronic Hepatitis C
      Genotype 1.
    

Detailed description: 
      Two patient cohorts were anticipated in this study:

        1. Cohort A: 60 treatment-naive patients were enrolled into
           narlaprevir/ritonavir/sofosbuvir treatment for 12 weeks.

        2. Cohort B: (exploratory): 25 treatment-naive patients with low viral load (HCV
           RNA<1000000 IU/L) were enrolled into narlaprevir/ritonavir/sofosbuvir treatment for 8
           weeks.

      The enrollment of 25 treatment-naïve patients with low viral load into 8 week cohort started
      after completion of enrollment of 60 treatment-naive patients into 12 week cohort.

      The study included 3 time periods:

        1. Screening period with duration up to 2 weeks during which study eligibility was
           confirmed.

        2. Active treatment period (for 12 or 8 weeks): patients in the Cohort A were receiving
           study therapy with narlaprevir/ritonavir/sofosbuvir for 12 weeks, in the Cohort B -
           during 8 weeks.

           If a patient had virologic breakthrough while receiving therapy, discontinuation of
           antiviral treatment was advised with appropriate clinical follow-up.

        3. Follow-up period during which patients did not receive any study medication. The
           duration of the follow-up period after the end of study treatment was 24 weeks.

      Overall, each patient had been participating in the study for approximately up to 38 weeks
      from the time the patient signed the Informed Consent Form through the final visit.

      If a patient had a screening failure, but was rescreened and subsequently enrolled, the
      reason for the original screening failure must have been documented in the source documents.
      A new subject Identification number (ID) was assigned to the patient.

      The recruitment period in this study was planned to be up to 6 months. The total period of
      the study was anticipated to be approximately 1 year 3 months.

      The patient was considered to be completed the study upon the completion of the last protocol
      specified visit. For those patients who did not complete the study, patient participation was
      considered terminated upon the completion of the last visit or contact (e.g., phone contact
      with the investigator).

      It was estimated that 85 patients meeting inclusion/exclusion criteria would be recruited
      from approximately 6 clinical sites in Russia.
    

Intervention name(s): Narlaprevir; Ritonavir; Sofosbuvir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 100 mg oval shaped, concave, yellow film-coated tablets taken as 200 mg per os once daily. 28 tabs/36 tabs/ 56 tabs in bottle.; 100 mg tablets taken as 100 mg per os once daily. 30 tablets in bottle; 400 mg yellow, capsule-shaped film-coated tablets debossed with "GSI" on one side and "7977" on the other side, taken as 400 mg per os once daily. 28 tablets in bottle.
Intervention MeSH terms: Ritonavir; Sofosbuvir
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hepatitis; HCV; antiviral