Ombitasvir /Paritaprevir/Ritonavir Plus Ribavirin on HCV GT4

Beni-Suef University

Status and phase

Completed

Phase 2

Phase 1

Conditions

Hepatitis C Virus Infection

Treatments

Drug: OBV/PTV/r) ± ribavirin (RBV)

Study type

Interventional

Funder types

Other

Identifiers

NCT04378608

Qu2018

Details and patient eligibility

About

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

Full 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).

Enrollment

100 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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.