Ombitasvir /Paritaprevir/Ritonavir Plus Ribavirin on HCV GT4

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-05

Study Completion Date

2017-09-08

Brief Summary

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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

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Detailed Description

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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).

Conditions

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Hepatitis C Virus Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

OBV/PTV/r) ± ribavirin (RBV)

Intervention Type DRUG

Interventions

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OBV/PTV/r) ± ribavirin (RBV)

Intervention Type DRUG

Other Intervention Names

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

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No