enrolled participants were treated orally with SOF plus a fixed dose combination of OBV/PTV/r plus RBV.
Enrolled participants were treated orally with SOF plus a fixed dose combination of Sofosbuvir/Ombitasvir/Paritaprevir/ Ritonavir plus Ribavirin (OBV/PTV/r plus RBV), which was administered orally based on the participants' tolerability. The primary end point was a sustained virological response (HCV RNA level \< 15 IU/ mL), observed 12 weeks after the end of the treatment (SVR12).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
113
They were given SOF in a dose of 400 mg/day, and a fixed dose combination of OBV (25 mg), PTV (150 mg), and r (100 mg) taken with food once daily. RBV was supplied in 200 mg capsules, and the recommended dose was 600 mg/ day to reach 1200 mg/day based on patient's body weight and tolerability.
Beni-Suef University
Banī Suwayf, Egypt
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm
SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) level \< 15 IU/ml 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: Screening up to 12 weeks after last dose]
Percentage of Participants With Viral relapse
Viral relapse was HCV RNA level undetectable at End of Treatment (EOT) (≤ 15 IU/ml), but detectable HCV RNA ( \> 15 IU/ml) levels 12 weeks after planned EOT.
Time frame: Up to 12 weeks after last dose
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