Ombitasvir /Paritaprevir/Ritonavir Plus Ribavirin on HCV GT4

Hepatitis C Virus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04378608
• Other study ID #: Qu2018
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 5, 2017
• Est. completion date: September 8, 2017

Study information

• Verified date: May 2020
• Source: Beni-Suef University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 8, 2017
• Est. primary completion date: September 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• Hepatitis C Virus Infection
• Virus Diseases

Intervention

Drug:
• OBV/PTV/r) ± ribavirin (RBV)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

References & Publications (1)

Abdel-Moneim A, Aboud A, Abdel-Gabbar M, Zanaty M, Ramadan M. Retreatment Efficacy of Sofosbuvir/Ombitasvir/Paritaprevir/Ritonavir + Ribavirin for Hepatitis C Virus Genotype 4 Patients. Dig Dis Sci. 2018 May;63(5):1341-1347. doi: 10.1007/s10620-018-5005-8. Epub 2018 Mar 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)	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.	12 weeks after last dose
Primary	adverse event (AE)	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.	Screening up to 30 days after last dose
Secondary	Percentage of Participants With Post-treatment Relapse Within 12 Weeks Following End of Treatment	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.	Up to 12 weeks after last dose

External Links

•   This link clarify the retreatment efficacy and safety of SOF with OBV/PTV/r + RBV, for chronic HCV GT4-experienced patients who failed treatment with DAA-based regimens