Ombitasvir /Paritaprevir/Ritonavir Plus Ribavirin on HCV GT4

Beni-Suef University100 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Hepatitis C Virus Infection

Interventions

OBV/PTV/r) ± ribavirin (RBV)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 12 weeks after last dose

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.

Time frame: Screening up to 30 days after last dose

Secondary Outcomes

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.

Time frame: Up to 12 weeks after last dose

Data from ClinicalTrials.gov

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