Clinical trial NCT04378608: Ombitasvir /Paritaprevir/Ritonavir Plus Ribavirin on HCV GT4
Official title: Efficacy of Ombitasvir With Paritaprevir/Ritonavir Plus Ribavirin on the Treatment naïve Patients With Chronic Hepatitis C Virus Genotype 4
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hepatitis C Virus Infection
Keywords: Ombitasvir
Paritaprevir
Ritonavir
Ribavirin
HCV
Genotype 4
Naïve
Egyptians
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2020-05-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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 tolerability
Primary purpose: TREATMENT

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

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
timeFrame: 12 weeks after last dose
measure: adverse event (AE)
timeFrame: Screening up to 30 days after last dose
Secondary outcomes:
measure: Percentage of Participants With Post-treatment Relapse Within 12 Weeks Following End of Treatment
timeFrame: Up to 12 weeks after last dose
Other outcomes:
Locations:
Study officials:
affiliation: Biochemistry Dep., Faculty of Science, Beni-Suef University, P.O. Box 52621
name: Mohammed Abdel-Gabbar, Ass. Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.