Ombitasvir /Paritaprevir/Ritonavir Plus Ribavirin on HCV GT4

Sponsor

Beni-Suef University (Other)

Overall Status

Completed

CT.gov ID

NCT04378608

Collaborator

(none)

100

Enrollment

Arm

8.1

Actual Duration (Months)

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C Virus Infection	Drug: OBV/PTV/r) ± ribavirin (RBV)	Phase 1/Phase 2

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

100 Egyptian naive patients infected with HCV GT4 was allocated and administered orally OBV/PTV/r with RBV which given as oral tablets based on patient tolerability100 Egyptian naive patients infected with HCV GT4 was allocated and administered orally OBV/PTV/r with RBV which given as oral tablets based on patient tolerability

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 5, 2017

Actual Primary Completion Date :

Sep 8, 2017

Actual Study Completion Date :

Sep 8, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: 2 DAA (OBV/PTV/r) ± ribavirin (RBV) Administering Ombitasvir/Paritaprevir/Ritonavir/ tablets plus RBV tablets to HCV GT4 in the treatment of Egyptian naïve patients	Drug: OBV/PTV/r) ± ribavirin (RBV) Other Names: Paritaprevir (ABT-450) is inhibitor of the NS3-4A serine protease Ombitasvir (ABT 267) is an NS5A inhibitor

Arm

Intervention/Treatment

Other: 2 DAA (OBV/PTV/r) ± ribavirin (RBV)

Administering Ombitasvir/Paritaprevir/Ritonavir/ tablets plus RBV tablets to HCV GT4 in the treatment of Egyptian naïve patients

Drug: OBV/PTV/r) ± ribavirin (RBV)

Other Names:

Paritaprevir (ABT-450) is inhibitor of the NS3-4A serine protease Ombitasvir (ABT 267) is an NS5A inhibitor

Outcome Measures

Primary Outcome Measures

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) [12 weeks after last dose]
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 12 IU/mL 12 weeks after the last dose of study drug.
adverse event (AE) [Screening up to 30 days after last dose]
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation observed after administering a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is an event that results in, death, participant hospitalization, life-threatening, significant disability/incapacity, or a congenital anomaly.

Secondary Outcome Measures

Percentage of Participants With Post-treatment Relapse Within 12 Weeks Following End of Treatment [Up to 12 weeks after last dose]
Post-treatment relapse was defined as defined as confirmed HCV RNA > 12 IU/ml between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < 12 IU/ml at the end of treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Treatment-naïve patients with HCV GT4 with plasma HCV RNA level >10,000 IU/ml

Exclusion Criteria:

Hepatitis of non-HCV cause
Coinfection with other than HCV GT4
Poorly controlled diabetics (HbA1C >8) patients
a history of extra-hepatocellular malignancy in the last 5 years
Major severe illness such as congestive heart failure, respiratory failure, evidence of hepatic decompensation.
Laboratory and blood picture abnormalities such as anemia (hemoglobin concentration of 10 <g/dl) and thrombocytopenia (platelets <50,000 cells/mm3) and (serum albumin <2.8 g/dL, international normalized ratio (INR) of > 2.3, serum total bilirubin concentration of >3.0 mg/dL.