Effectiveness, Safety and Clinical Outcomes of Paritaprevir/Ombitasvir/r+Dasabuvir 8 Weeks (3D8)

Hepa C

Status: Completed

Conditions: Hepatitis C Infection

Treatments: Drug: ombitasvir/paritaprevir/ritonavir 8 weeks; Drug: dasabuvir 8 weeks

Study type: Observational

Funder types: Other

Identifiers

NCT03122132

0002

Details and patient eligibility

About

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).

Full 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).

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

200 participants in 1 patient group

Spanish cohort with HCV treated with DAA

Description:

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

Treatment:

Drug: dasabuvir 8 weeks

Drug: ombitasvir/paritaprevir/ritonavir 8 weeks