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Efficacy of Ombitasvir With Paritaprevir/Ritonavir Plus Ribavirin on the Treatment naïve Patients With Chronic Hepatitis C Virus Genotype 4
The objective of the investigators was to delineate the efficacy and safety of Ombitasvir, paritaprevir with ritonavir (OBV/PTV/r) plus ribavirin (RBV) on chronic HCV GT4 Egyptian naïve patients
Direct-acting antivirals (DAAs) combination therapies from various mechanisms of action and families have been revolutionized the management landscape of chronic hepatitis C virus (HCV). Ombitasvir, paritaprevir with ritonavir (OBV/PTV/r) ± ribavirin (RBV) are approved to treat HCV genotype 4 (GT4) infection. Here, investigators' objective was to delineate the efficacy and safety of OBV/PTV/r plus RBV of HCV GT4 in the treatment of Egyptian naïve patients. Between 5 January and 8 September 2017, a cohort of 100 Egyptian patients infected with HCV GT4 was allocated and administered orally OBV/PTV/r with RBV, for 12 weeks, which given as oral tablets based on patient tolerability. The primary endpoint of investigators' study was a sustained virological response (HCV RNA \< 12 IU/mL) 12 weeks from the cessation of the treatment (SVR12).
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
No
Start Date
January 5, 2017
Primary Completion Date
September 8, 2017
Completion Date
September 8, 2017
Last Updated
May 12, 2020
100
ACTUAL participants
OBV/PTV/r) ± ribavirin (RBV)
DRUG
Lead Sponsor
Beni-Suef University
NCT05361603
NCT05975216
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT05071261