3D8: Effectiveness, Safety and Clinical Outcomes of Paritaprevir/Ombitasvir/r+Dasabuvir 8 Weeks
Study Details
Study Description
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).
Condition or Disease | Intervention/Treatment | Phase |
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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 Design
Arms and Interventions
Arm | Intervention/Treatment |
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Spanish cohort with HCV treated with DAA Spanish cohort with HCV treated in real practice with ombitasvir/paritaprevir/ritonavir 8 weeks and dasabuvir 8 weeks |
Drug: ombitasvir/paritaprevir/ritonavir 8 weeks
Spanish cohort with HCV treated in real practice with ombitasvir/paritaprevir/ ritonavir 8 weeks
Other Names:
Drug: dasabuvir 8 weeks
Spanish cohort with HCV treated in real practice with dasabuvir 8 weeks
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Chronic hepatitis C (anti-HCV antibodies and detectable HCV-RNA).
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Genotype 1b infection
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Treatment-naïve and non-cirrhotic
Exclusion Criteria:
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HCV genotype or subtype other than GT1b.
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Any current or past clinical evidence of cirrhosis.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Carrion, Jose Antonio, PhD | Barcelona | Spain | 08003 |
Sponsors and Collaborators
- Hepa C
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 0002