Clinical trial NCT03122132: Effectiveness, Safety and Clinical Outcomes of Paritaprevir/Ombitasvir/r+Dasabuvir 8 Weeks
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C Infection
Keywords: Hepatitis C Infection
Ombitasvir/Paritaprevir/Ritonavir+dasabuvir
Lead sponsor: Hepa C
Sponsor class: OTHER
First posted: 2017-04-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with HCV who are treated in real practice with 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Sustained virological response 12 weeks post-treatment (SVR12)
timeFrame: 12 weeks after the last dose of study drug
Secondary outcomes:
measure: Percentage of patients with virologic failure during treatment
timeFrame: Up to 12 weeks after last dose of study drug
measure: Mild fibrosis and sustained virological response 12 weeks post-treatment
timeFrame: Up to 12 weeks after last dose of study drug
measure: Percentage of participants with low baseline viral load and SVR12 weeks post-treatment
timeFrame: Baseline and 12 weeks after the last dose of drug
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Carrion, Jose Antonio, PhD
Study officials:
References:
citation: Puigvehi M, De Cuenca B, Viu A, Diago M, Turnes J, Gea F, Pascasio JM, Lens S, Cabezas J, Badia E, Olveira A, Morillas RM, Torras X, Montoliu S, Cordero P, Castro JL, Salmeron J, Molina E, Sanchez-Ruano JJ, Moreno J, Anton MD, Moreno JM, De la Vega J, Calleja JL, Carrion JA. Eight weeks of Paritaprevir/r/Ombitasvir + Dasabuvir in HCV genotype 1b with mild-moderate fibrosis: Results from a real-world cohort. Liver Int. 2019 Jan;39(1):90-97. doi: 10.1111/liv.13950. Epub 2018 Nov 12.