Effectiveness, Safety and Clinical Outcomes of Paritaprevir/Ombitasvir/r+Dasabuvir 8 Weeks

Completed

• Conditions: Hepatitis C Infection
• Interventions: Drug: ombitasvir/paritaprevir/ritonavir 8 weeks; Drug: dasabuvir 8 weeks

• Registration Number: NCT03122132
• Lead Sponsor: Hepa C

Brief Summary

The aim of the study is to evaluate in clinical practice the efficacy and safety of ombitasvir/paritaprevir/ ritonavir and dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b hepatitis C virus (HCV).

Detailed Description

HCV chronic infection affects 200 million people worldwide. HCV antiviral treatment has evolved rapidly since 2011. The introduction of direct-acting antivirals (DAAs) achieve great effectiveness with minimum SAEs and short treatment duration. However, studies evaluating efficacy and safety of ombitasvir/paritaprevir/ ritonavir and dasabuvir during 8 weeks are limited in real clinical practice. The aim of the study is to evaluate in clinical practice the efficacy and safety of ombitasvir/paritaprevir/ ritonavir and dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b hepatitis C virus (HCV).

Study Timeline

• Study Start: 2017-02-20
• Study First Submitted: 2017-04-11
• Study First Submitted QC: 2017-04-19
• Study First Posted: 2017-04-20
• Primary Completion: 2018-01-01
• Study Completion: 2018-03-01
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-18
• Last Update Posted: 2018-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Chronic hepatitis C (anti-HCV antibodies and detectable HCV-RNA).
• Genotype 1b infection
• Treatment-naïve and non-cirrhotic

Exclusion Criteria

• HCV genotype or subtype other than GT1b.
• Any current or past clinical evidence of cirrhosis.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Spanish cohort with HCV treated with DAA	ombitasvir/paritaprevir/ritonavir 8 weeks	Spanish cohort with HCV treated in real practice with ombitasvir/paritaprevir/ritonavir 8 weeks and dasabuvir 8 weeks
Spanish cohort with HCV treated with DAA	dasabuvir 8 weeks	Spanish cohort with HCV treated in real practice with ombitasvir/paritaprevir/ritonavir 8 weeks and dasabuvir 8 weeks

Primary Outcome Measures

Name	Time	Method
Sustained virological response 12 weeks post-treatment (SVR12)	12 weeks after the last dose of study drug	Percentage of participants who achieve sustained virological response 12 weeks post-treatment (SVR12); • Measure: Hepatitis C virus ribonucleic acid (HCV-RNA) levels less than the lower limit of quantification.

Secondary Outcome Measures

Name	Time	Method
Percentage of patients with virologic failure during treatment	Up to 12 weeks after last dose of study drug	Percentage of patients with virologic failure during treatment; • Measure: Percentage of patients with confirmed \>=1 log10 IU/mL increase from nadir in HCV RNA at any time point during treatment
Mild fibrosis and sustained virological response 12 weeks post-treatment	Up to 12 weeks after last dose of study drug	Percentage of patients with mild fibrosis who achieve sustained virological response 12 (SVR12) weeks post-treatment; • Measure: percentage of patients with a baseline transient elastography \< 6 kPa
Percentage of participants with low baseline viral load and SVR12 weeks post-treatment	Baseline and 12 weeks after the last dose of drug	Percentage of participants with low baseline viral load who achieve sustained virological response 12 (SVR12) weeks post-treatment; • Measure: HCV RNA levels less than the lower limit of quantification.

Trial Locations

Locations (1)

Carrion, Jose Antonio, PhD; 🇪🇸 Barcelona, Spain