The purpose of this study is to determine the efficacy of a 12- or 24-week treatment regimen of simeprevir in combination with daclatasvir, as measured by sustain virologic response 12 (SVR12), in treatment-naive, chronic hepatitis C virus (HCV) genotype 1b-infected participants who have advanced fibrosis or compensated cirrhosis (METAVIR F3/F4).
This is an open-label (all people know which treatment the participants receive) study to investigate the efficacy, safety and tolerability of simeprevir and daclatasvir in chronic Hepatitis (inflammation of the liver) C virus (HCV) genotype 1b infected participants who are treatment-naive. The total study duration for each participant will be approximately 40 weeks or approximately 52 weeks. The study will consist of 4 parts: Screening Phase (approximately 4 weeks) and open-label treatment Phase (12 weeks), optional open label treatment phase extension (12 Weeks) and follow-up Phase (up to Week 40 or Week 52). Participants will receive simeprevir (150 milligram \[mg\] capsule) and daclatasvir (60 mg tablet) orally once daily for 12 or 24 weeks. Efficacy will be primarily evaluated by percentage of participants with SVR12. Participants' safety will be monitored throughout the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
106
Simeprevir 150 mg oral capsule will be administered once daily for 12 or 24 weeks.
Daclatasvir 60 mg oral tablet will be administered once daily for 12 or 24 weeks.
Unnamed facility
Antwerp, Belgium
Unnamed facility
Brussels, Belgium
Unnamed facility
Ghent, Belgium
Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Study Drug Treatment (SVR12)
Participants were considered to have reached SVR12, if 12 weeks after the actual end of treatment (EOT), hepatitis C virus (HCV) ribonucleic acid (RNA) was less than lower limit of quantification (\<LLOQ) (detectable or undetectable).
Time frame: At 12 weeks after end of treatment
Percentage of Participants With Sustained Virologic Response 4 Weeks After End of Study Drug Treatment (SVR4)
Participants were considered to have reached SVR4, if 4 weeks after the actual EOT, HCV RNA was \<LLOQ (detectable or undetectable).
Time frame: At 4 weeks after actual EOT
Percentage of Participants With SVR 24 Weeks After End of Study Drug Treatment (SVR 24)
Participants were considered to have reached SVR24, if 24 weeks after the actual EOT, HCV RNA was \<LLOQ (detectable or undetectable).
Time frame: At 24 weeks after actual EOT
Percentage of Participants With On-treatment Failure
Participants were considered on-treatment failures if they did not achieve SVR12 and had (confirmed) detectable HCV RNA, ie, \<LLOQ detectable or greater than equal to (\>=) LLOQ at EOT.
Time frame: Up to Week 24 after actual EOT
Number of Participants With Viral Breakthrough
Participants were considered to have had viral breakthrough if they had a confirmed greater than (\>) 1.0 log10 international units/milliliter (IU/mL) increase in HCV RNA from nadir OR confirmed HCV RNA \>100 IU/mL while previously having achieved HCV RNA \<LLOQ when on study treatment.
Time frame: Up to Week 24
Number of Participants With Viral Relapse
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Unnamed facility
Créteil, France
Unnamed facility
Lyon, France
Unnamed facility
Montpellier, France
Unnamed facility
Nice, France
Unnamed facility
Paris, France
Unnamed facility
Vandœuvre-lès-Nancy, France
Unnamed facility
Frankfurt, Germany
...and 13 more locations
Participants were considered to have had viral relapse if they did not achieve SVR12 and met the following conditions: had HCV RNA \<LLOQ (undetectable) at EOT and had HCV RNA \>=LLOQ during the follow-up period.
Time frame: Up to Week 24 after actual EOT