The purpose of this study is to show superiority of simeprevir (SMV) in combination with sofosbuvir for 12 weeks versus a historical control. Historical control will be a composite of the observed historical sustained virological response at Week 12 (SVR12) rates of SMV in combination with (pegylated) interferon (PegIFN)/ribavirin (RBV) of the subpopulations in study HPC3011 (NCT01567735) and will depend on the percentage of treatment-naive, prior relapser, prior non-responder, interferon (IFN)-intolerant and other subjects enrolled in this study.
This is a Phase 3, open-label (all people know the identity of the intervention), single-arm, multicenter study (conducted at multiple sites). The study consists of 3 periods: a Screening period (up to 4 weeks), Treatment period (12 Weeks) and Post treatment follow-up period (until 24 weeks after end of treatment). The duration of the subjects' participation will be approximately 40 weeks. In the treatment period subjects will receive oral capsule simeprevir along with oral tablet sofosbuvir once daily for 12 weeks. Primarily efficacy will be evaluated as percentage of subjects with sustained virologic response at Week 12 after the end of treatment. Subjects' safety will be monitored throughout the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Subjects will receive oral capsule of Simeprevir 150 mg, once a day from Day 1 up to Week 12.
Subjects will receive oral tablet of sofosbuvir 400 mg, once a day from Day 1 up to Week 12.
Unnamed facility
Badalona, Spain
Unnamed facility
Barcelona, Spain
Unnamed facility
Madrid, Spain
Unnamed facility
Santander, Spain
Unnamed facility
Seville, Spain
Unnamed facility
Valencia, Spain
Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Treatment (EOT) (SVR12)
SVR12 is defined as the percentage of participants with hepatitis C virus ribonucleic acid (HCV RNA) less than (\<) lower limit of quantification (LLOQ; 15 international unit per milliliter \[IU/mL\]) detectable or undetectable 12 weeks after actual EOT.
Time frame: 12 weeks after EOT
Percentage of Participants With Sustained Virologic Response 4 Weeks After End of Therapy (SVR4)
SVR4 is defined as the percentage of participants with hepatitis C virus ribonucleic acid (HCV RNA) less than (\<) lower limit of quantification (LLOQ; 15 international unit per milliliter \[IU/mL\]) detectable or undetectable 4 weeks after actual EOT.
Time frame: 4 weeks after EOT
Percentage of Participants With Sustained Virologic Response 24 Weeks After End of Therapy (SVR24)
Participants were considered to have reached SVR24, if at the time point of SVR24 (that is \[i.e.\], 24 weeks after the end of treatment \[EOT\]) the following condition has been met: HCV RNA \< lower limit of quantification (LLOQ), i.e., 15 IU/mL, detectable or undetectable.
Time frame: At 24 weeks after EOT
Percentage of Participants With On-treatment Virologic Response of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)
Percentage of participants with HCV RNA less than (\<) 15 IU/mL undetectable or detectable or detectable /undetectable at specific time points were observed.
Time frame: Week 2, 3, 4, 12 and EOT
Percentage of Participants With On-Treatment Failure
Participants were considered on-treatment failures if they have at EOT (confirmed) detectable HCV RNA, i.e., \<LLOQ detectable or \>=LLOQ.
Time frame: through 12 weeks (EOT)
Percentage of Participants With Viral Breakthrough
Participants with confirmed \>1.0 log10 increase in HCV RNA from nadir or confirmed HCV RNA \>100 IU/mL in participants who had previously achieved HCV RNA \<LLOQ.
Time frame: Up to follow-up Week 24
Percentage of Participants With Viral Relapse
Participants were considered to have viral relapse if they did not achieve SVR12 and meet the following conditions: 1) at EOT, HCV RNA less than (\<)LLOQ, undetectable, and 2) during the follow-up period, HCV RNA greater than or equal to (\>=)LLOQ.
Time frame: Up to follow-up week 24
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