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Clinical Trial Summary

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


Clinical Trial Description

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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04378608
Study type Interventional
Source Beni-Suef University
Contact
Status Completed
Phase Phase 1/Phase 2
Start date January 5, 2017
Completion date September 8, 2017

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