The purpose of this study is to evaluate the percentage of participants with sustained virologic response 12 weeks after the actual end of study treatment (SVR12)
This is a Phase 2, open-label (identity of study drug will be known to volunteer and study staff), single-arm, multicenter (when more than one hospital work on a medical research study) study to evaluate the efficacy, safety, tolerability and pharmacokinetics of 12 weeks treatment with Simeprevir (SMV) and Daclatasvir (DCV) in participants with chronic Hepatitis C Virus (HCV) genotype 1b or 4 infection and either severe renal impairment or End-stage Renal Disease on hemodialysis. The study consists of a Screening Phase of 4 weeks, an Open-label Treatment Phase of 12 weeks, and a post-Treatment Follow-up Phase of 24 weeks. The total study duration for each participant will be approximately 40 weeks. All participants will receive a treatment regimen consisting of SMV 150 mg and DCV 60 mg co-administered once daily for a total treatment duration of 12 weeks. Participants who experience inadequate virologic response at Week 8 (defined as confirmed HCV RNA greater than or equal to \[\>=\] lower limit of quantification \[LLOQ\]) or viral breakthrough at any on-treatment visit (defined as confirmed increase in HCV RNA of \>1 log base 10 from nadir, or confirmed HCV RNA \>100 International unit per milliliter \[IU/mL\] in participants whose HCV RNA had previously been \<LLOQ while on treatment) should discontinue all study drugs. Participants will be primarily evaluated for sustained virologic response 12 weeks after the actual end of study treatment (SVR12). Participants' safety will be evaluated throughout the study duration.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Simeprevir (SMV) 150 milligram (mg) capsule orally, once daily for a duration of 12 weeks.
Daclatasvir (DCV) 60 mg tablet, orally, once daily for a duration of 12 weeks.
Unnamed facility
Paris, France
Unnamed facility
Toulouse, France
Unnamed facility
Villejuif, France
Unnamed facility
Barcelona, Spain
Unnamed facility
Madrid, Spain
Percentage of Participants With Sustained Virologic Response at Week 12 After End of Treatment (SVR12)
SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than (\<) lower limit of quantification (LLOQ) , detectable or undetectable at 12 weeks after EOT.
Time frame: 12 weeks after end of treatment (EOT) (Week 12 of follow-up phase)
Percentage of Participants With On-treatment Response
HCV RNA results satisfying a specified threshold. The following thresholds will be considered at any time point: \<LLOQ undetectable, \<LLOQ detectable, \<LLOQ undetectable/detectable.
Time frame: Baseline up to EOT (Week 12)
Percentage of Participants With Sustained Virologic Response at Week 4 After End of Treatment (SVR4)
SVR4 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than (\<) lower limit of quantification (LLOQ) , detectable or undetectable at 4 weeks after EOT.
Time frame: 4 weeks after EOT (Week 4 of follow-up phase)
Percentage of Participants With Sustained Virologic Response at Week 24 After End of Treatment (SVR24)
SVR24 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than (\<) lower limit of quantification (LLOQ) , detectable or undetectable at 24 weeks after EOT.
Time frame: 24 weeks after EOT (Week 24 of follow-up phase)
Percentage of Participants With on-treatment Failure
Participants who did not achieve SVR12 and with confirmed detectable HCV RNA at the actual end of study treatment.
Time frame: Baseline up to EOT (Week 12), 12 weeks after EOT (Week 12 of follow-up phase)
Percentage of Participants With Viral Relapse
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Unnamed facility
Santander, Spain
Participants who did not achieve SVR12, with undetectable HCV RNA at the actual end of study treatment and confirmed HCV RNA \>=LLOQ during 24-week follow-up.
Time frame: EOT (Week 12) until end of follow-up phase (Week 24 of follow-up phase)
Change From Baseline in Hepatitis C Virus (HCV) Nonstructural Protein 3/4A (NS3/4A) and Nonstructural Protein 5A (NS5A) Sequence in Participants not Achieving SVR
Time frame: Baseline until end of follow-up phase (Week 24 of follow-up phase)
Change From Baseline in HCV Symptom and Impact Questionnaire version 4 (HCV-SIQv4) Overall Body Symptom score
The HCV-SIQv4 is a self-administered questionnaire containing 33 items (ranging from 0=Not at All to 4=Extremely): 29 questions developed to assess the severity or frequency of symptoms associated with HCV or its treatment, 3 questions regarding the impact of symptoms on work/school attendance, and 1 question regarding the impact of symptoms on daily activities. Higher HCV-SIQv4 scores indicate worse symptom severity, more time missed from work or school, and more impairment in daily activities, respectively.
Time frame: Baseline until end of follow-up phase (Week 24 of follow-up phase)