NCT04378608

Ombitasvir /Paritaprevir/Ritonavir Plus Ribavirin on HCV GT4

Efficacy of Ombitasvir With Paritaprevir/Ritonavir Plus Ribavirin on the Treatment naïve Patients With Chronic Hepatitis C Virus Genotype 4

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Beni-Suef University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Detailed 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).

Conditions

• Hepatitis C Virus Infection

Interventions

Type	Name	Description
DRUG	OBV/PTV/r) ± ribavirin (RBV)

Timeline

• Start date: 2017-01-05
• Primary completion: 2017-09-08
• Completion: 2017-09-08
• First posted: 2020-05-07
• Last updated: 2020-05-12