NLP SNP

The purpose of this study is to assess the safety and efficacy of daclatasvir and simeprevir with and without ribavirin for genotype 1 chronic hepatitis C virus infection in patients who are treatment-naive or null responders to previous pegylated interferon/ribavirin therapy.

NCT01628692 Hepatitis C Virus

MeSH: Hepatitis Hepatitis A Hepatitis C Hepatitis, Chronic Hepatitis C, Chronic

HPO: Chronic active hepatitis Chronic hepatitis Hepatitis

3 Interventions

Name: Daclatasvir

Description: Tablets, oral, 30 mg, once daily

Type: Drug

Cohort 1: (Genotype 1b) Daclatasvir + Simeprevir Cohort 2: (Genotype 1b) Daclatasvir + Simeprevir + Ribavirin Cohort 3: (Genotype 1a) Daclatasvir + Simeprevir + Ribavirin Cohort 4: (Genotype 1a) Daclatasvir + Simeprevir + Ribavirin

Name: Simeprevir

Description: Capsule, oral, 150 mg, once daily

Type: Drug

Name: Ribavirin

Description: Tablets, oral, 500-600 mg, twice daily

Type: Drug

Cohort 3: (Genotype 1a) Daclatasvir + Simeprevir + Ribavirin Cohort 4: (Genotype 1a) Daclatasvir + Simeprevir + Ribavirin

Primary Outcomes

Description: SVR12 rate was defined as hepatitis C virus (HCV) RNA levels to be Measure: Percentage of Participants With Sustained Virologic Response Rate at Post-treatment Week 12 (SVR12)

Time: Post Treatment Week 12 (Follow-up period)

Secondary Outcomes

Description: RVR was defined as hepatitis C virus (HCV) RNA levels to be Measure: Percentage of Participants With Rapid Virologic Response (RVR) at Week 4

Time: Week 4

Description: cEVR was defined as hepatitis C virus (HCV) RNA levels to be Measure: Percentage of Participants With Complete Early Virologic Response (cEVR)

Time: Week 12

Description: eRVR were defined as hepatitis C virus (HCV) RNA levels to be Measure: Percentage of Participants With Extended Rapid Virologic Response (eRVR)

Time: Week 4 and Week 12

Description: EOTR were defined as hepatitis C virus (HCV) RNA levels Measure: Percentage of Participants With End of Treatment Response (EOTR)

Time: End of treatment (Week 24)

Description: Participants were categorized into 3 genotypes based on single nucleotide polymorphisms in the IL28B gene. SVR12 was defined as hepatitis C virus (HCV) RNA levels below lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.

Measure: Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12) by rs12979860 Single Nucleotide Polymorphisms in the IL-28B Gene Categories

Time: Baseline, post-treatment Week 12 (Follow-up period)

Description: AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.

Measure: Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs) and Who Died

Time: From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)

Purpose: Treatment
Allocation: Randomized
Parallel Assignment

There is one SNP

SNPs

1 rs12979860

HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.. Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12) by rs12979860 Single Nucleotide Polymorphisms in the IL-28B Gene Categories.