The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of therapy with Sofosbuvir/Velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX ) FDC in participants with chronic HCV infection.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
87
400/100 mg FDC tablet orally once daily.
400/100/100 mg FDC tablet orally once daily.
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-D, South Korea
Percentage of Participants With Sustained Virologic Response (SVR) < Lower Limit of Quantification (LLOQ) 12 Weeks After Discontinuation of Study Treatment
SVR12 was defined as HCV RNA \< LLOQ (i.e., 15 IU/mL) at 12 weeks after stopping study treatment.
Time frame: Posttreatment Week 12
Percentage of Participants Who Permanently Discontinued the Study Drug Due to an Adverse Event
Time frame: First dose date up to 12 weeks plus 30 days
Percentage of Participants With SVR < LLOQ 4 Weeks After Discontinuation of Study Treatment
SVR4 was defined as HCV RNA \< LLOQ (i.e.15 IU/mL) 4 weeks after stopping study treatment.
Time frame: Posttreatment Week 4
Percentage of Participants With Virologic Failure
Virologic failure was defined as: On-treatment virologic failure: * Breakthrough (HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ, while on treatment, confirmed with 2 consecutive values), or * Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment ) Virologic relapse: • Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit
Time frame: Baseline up to Posttreatment Week 12
Percentage of Participants With HCV RNA < LLOQ on Treatment
LLOQ was 15 IU/mL.
Time frame: Week 2, Week 4, Week 8, Week 12
Change From Baseline in HCV RNA
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12
Number of Participants With Alanine Aminotransferase (ALT) Normalization
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Inje University Busan Paik Hospital
Busan, South Korea
Dong-A University Hospital
Busan, South Korea
Pusan National University Hospital
Busan, South Korea
Kyungpook National University Hospital
Daegu, South Korea
Keimyung University Dongsan Hospital
Daegu, South Korea
Chungnam National University Hospital
Daejeon, South Korea
Chosun University Hospital
Gwangju, South Korea
The Catholic University of Korea, Incheon St. Mary's Hospital
Incheon, South Korea
Gachon University Gil Medical Center
Incheon, South Korea
...and 12 more locations
Number of participants with ALT normalization, defined as ALT \> upper limit of normal (ULN) (ULN = 43 U/L) at baseline and ALT ≤ ULN, at each visit was presented.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12