This study aims to evaluate the efficacy and safety of DCV plus sofosbuvir (SOF) with or without ribavirin (RBV) for treatment of Egyptian participants infected with HCV GT4.
Egyptian participants infected with HCV GT4 were classified into two groups: group 1 (easy to treat) was treated with a dual therapy of SOF/DCV daily for 12 weeks and group 2 (difficult to treat) was treated with a triple therapy of SOF/DCV/RBV daily for 12 weeks. SOF dose was 400 mg/day given orally DCV was given in a dose of 60 mg/day, orally. RBV was given as oral tablets in the morning and in the evening based on patient's weight and tolerability (starting dose 600 mg/day to reach 1200 mg/day.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
946
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm SVR12
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level \< 15 IU/m 12 weeks after the last dose of drugs.
Time frame: 12 weeks after last dose
Number of Participants With Adverse Events in Each Treatment Arm
An adverse event (AE) is defined as any untoward medical occurrence in a participant clinical investigation after administering a pharmaceutical drugs Serious adverse event (SAE) is an event that results in death, life-threatening, requires hospitalization, or significant disability/incapacity
Time frame: up for 12 weeks after planned End of Treatment (EOT).
Percentage of Participants With Viral relapse
Viral relapse was HCV RNA level ≤ 15 IU/ml at EOT, but detectable HCV RNA level \> 15 IU/ml 12 weeks after planned EOT.
Time frame: 12 weeks after last dose
Percentage of Participants With On-treatment Virologic Failure
On-treatment virologic failure was defined as quantifiable HCV RNA throughout the entire treatment period with HCV RNA greater than 15 IU/ml
Time frame: up tp 24 weeks
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