The purpose of this study is to evaluate the safety and antiviral effect of ABT-450/r and ABT-530 coadministered with and without Ribavirin in adults with genotype 3 HCV infection.
Once the efficacy and safety data were obtained from participants administered ABT-450/r + ABT-530 + RBV weight-based (Arm 1) in Study M14-213, the decision was made to end this study before subjects were enrolled into Arm 2.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
The Percentage of Subjects Who Achieve 12-week Sustained Virologic Response (SVR12)
SVR12 defined as hepatitis C (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
Time frame: 12 weeks after last dose of study drug
The Percentage of Subjects Who Achieve 24-week Sustained Virologic Response (SVR24)
SVR24 defined as HCV RNA LLOQ 24 weeks after last dose of study drug.
Time frame: 24 weeks after last dose of study drug
The Percentage of Subjects With Virologic Failure During Treatment
Percentage of subjects with quantifiable HCV RNA throughout the entire treatment period, confirmed quantifiable HCV RNA after previously having unquantifiable HCV RNA, or a confirmed increase of at least one log10 in HCV RNA during treatment.
Time frame: Up to Treatment Week 12
The Percentage of Subjects With Post-Treatment Relapse
Percentage of subjects with confirmed quantifiable HCV RNA within 12 weeks of last dose among subjects with unquantifiable hepatitis C virus ribonucleic acid at the end of treatment.
Time frame: Within 12 weeks after the last dose of study drug
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