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

Efficacy and Safety in Clinical Practice of Ombitasvir/Paritaprevir/ Ritonavir and Dasabuvir Administered for 8 Weeks (3D8) in Treatment-naïve Genotype 1b Hepatitis C Virus Infected Patients: Analysis of Data From Hepa-C Registry.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03122132

Acronym

3D8

Enrollment

200

Registered

2017-04-20

Start date

2017-02-20

Completion date

2018-03-01

Last updated

2018-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C Infection

Keywords

Hepatitis C Infection, Ombitasvir/Paritaprevir/Ritonavir+dasabuvir

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).

Interventions

DRUGombitasvir/paritaprevir/ritonavir 8 weeks

Spanish cohort with HCV treated in real practice with ombitasvir/paritaprevir/ ritonavir 8 weeks

DRUGdasabuvir 8 weeks

Spanish cohort with HCV treated in real practice with dasabuvir 8 weeks

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026