Real World Evidence of the Effectiveness of Paritaprevir/Ritonavir (r) - Ombitasvir, + Dasabuvir Without Ribavirin in Participants With Chronic Hepatitis C and Compensated Liver Cirrhosis in the Russian Federation (CITRIN)

AbbVie

Status: Completed

Conditions: Chronic Hepatitis C

Study type: Observational

Funder types: Industry

Identifiers

NCT03053180

P16-253

Details and patient eligibility

About

This prospective, multi-center, observational study is designed to assess the real world effectiveness of paritaprevir/r - ombitasvir with dasabuvir (3DAA [direct-acting antiviral agent] ABBVIE REGIMEN) without ribavirin (RBV) and to describe baseline characteristics of participants with chronic hepatitis C virus (HCV) genotype 1b (GT1b) infection and compensated liver cirrhosis in Russia.

Enrollment: 60 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 3DAA ABBVIE REGIMEN will be prescribed by physicians according to the routine clinical practice
• Treatment-naïve or interferon (IFN)/ribavirin (RBV)-experienced participants with confirmed CHC Gt1b and compensated liver cirrhosis, receiving therapy with the interferon-free 3DAA ABBVIE REGIMEN initiated not earlier than 2 weeks before the enrollment or the initiation is planned not later than 2 weeks after the day of enrollment in accordance to standard of care and in line with the current local label
• Participants must not be participating or intending to participate in a concurrent interventional therapeutic trial

Exclusion criteria

• Co-administration ribavirin (RBV) with the 3DAA ABBVIE REGIMEN
• Participants with Child Pugh B and C cirrhosis
• Participants with a history of prior direct-acting antiviral agent (DAA) therapy
• Any other contraindications to the administration of 3DAA ABBVIE REGIMEN according to the label

Trial design

60 participants in 1 patient group

Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir

Description:

Participants with chronic hepatitis C (CHC) genotype 1b (GT1b) and compensated liver cirrhosis received paritaprevir/ritonavir (r), ombitasvir and dasabuvir (3DAA ABBVIE REGIMEN) for 12 weeks. The prescription of a treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, was made independently from this observational study and preceded the decision to offer a patient the opportunity to participate in this study.