Efficacy and Safety of All-Oral Combination of Narlaprevir/Ritonavir and Daclatasvir in Treatment-Naїve Patients With Chronic Hepatitis C Genotype 1b

Phase 2

Completed

Brief Summary: The purpose of this study is to confirm that combination of Narlaprevir, Ritonavir and Daclatasvir is safe and highly effective regimen in treatment-naїve patients with chronic hepatitis C (HCV) genotype 1b infection.

Detailed Description: To evaluate effectiveness and safety of treatment with Narlaprevir, Ritonavir and Daclatasvir combination will be selected 105 treatment-naїve patients with chronic HCV genotype 1b without genetic variants coding for the NS5A-Y93 С/H/N/S and/or L31 F/M/V/I amino acid substitutions, eligible as per protocol criteria.

Each patient will participate in the trial approximately up to 38 weeks:

* 2 weeks are expected for screening

* up to 12 weeks for treatment period

* 24 weeks for follow-up period

During treatment period all patient will receive equal drug combination.

Efficacy and safety parameters will be assessed as per primary and secondary endpoints. Also Ctrough for Narlaprevir and Daclatasvir on day 14 will be evaluated as pharmacokinetic objective.

The results of this study will provide new information about treatment of patients with chronic hepatitis C genotype 1 with Narlaprevir/Ritonavir in combination with Daclatasvir during 12 weeks.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Narlaprevir + Ritonavir + Daclatasvir	Ritonavir	All of enrolled patients receive equal study therapy with Narlaprevir/Ritonavir/Daclatasvir daily for 12 weeks
Narlaprevir + Ritonavir + Daclatasvir	Daclatasvir	All of enrolled patients receive equal study therapy with Narlaprevir/Ritonavir/Daclatasvir daily for 12 weeks
Narlaprevir + Ritonavir + Daclatasvir	Narlaprevir	All of enrolled patients receive equal study therapy with Narlaprevir/Ritonavir/Daclatasvir daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
The proportion of patients achieved Sustained Virologic Response (SVR12)	Week 12 of follow-up period	SVR12 - Undetectable HCV RNA by lower limit of detection (LOD) 12 weeks following the end of treatment

Secondary Outcome Measures

Name	Time	Method
The proportion of patients achieved End of Treatment Response (ETR)	Week 12 of treatment	ETR - HCV RNA \< LOD at the treatment end
The proportion of patients Relapsed	Week 12 of follow-up period	Relapse - HCV RNA undetectable by LOD at the end of treatment with subsequent detectable HCV RNA at the end of the follow-up period (week 12)
The proportion of patients achieved Sustained Virologic Response (SVR24)	Week 24 of follow-up period	SVR24 - Undetectable HCV RNA by (LOD) 24 weeks following the end of treatment
The proportion of patients achieved Sustained Virologic Response (SVR4)	Week 4 of follow-up period	SVR4 - HCV RNA \< LOD 4 weeks after the end of treatment
The proportion of patients developed Viral Breakthrough	Week 12 of treatment	Viral Breakthrough - Greater than or equal to 1 log10 increase in HCV-RNA above nadir, or detectable HCV-RNA, while on treatment after an initial drop below detection

Locations (4): FBIS CSRI of Epidemiology of Federal Service on Customers
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Moscow, Russian Federation
St. Petersburg SBHI Center of Prevention and Fight against AIDS and Infection Diseases
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Saint Petersburg, Russian Federation
SBEI HPE Moscow State Medical and Dental University n.a. A.I. Evdokimov of Ministry of Health of Russia
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Moscow, Russian Federation
SBHI of Moscow "City Clinical Hospital #24"
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Moscow, Russian Federation