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

Completed

• Conditions: Chronic Hepatitis C

• Registration Number: NCT03053180
• Lead Sponsor: AbbVie

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-02-08
• Study First Submitted QC: 2017-02-10
• Study First Posted: 2017-02-15
• Study Start: 2017-03-20
• Primary Completion: 2017-12-18
• Study Completion: 2017-12-18
• Status Verified: 2018-11
• Results First Submitted: 2018-11-20
• Results First Submitted QC: 2018-11-20
• Last Update Submitted: 2018-11-20
• Results First Posted: 2019-03-14
• Last Update Posted: 2019-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)	12 weeks after the last dose of study drug (week 24)	SVR12 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Virological Response at End of Treatment (EoT)	End of treatment, maximum of 12 weeks	Virological response is defined as HCV RNA less than 50 IU/mL.
Percentage of Participants With Relapse	End of treatment (week 12) and up to 12 weeks after the end of treatment.	Relapse was defined as participants with a virologic response (VR; HCV RNA \< 50 IU/mL) at end of treatment (EOT) followed by HCV RNA ≥ 50 IU/mL at any time after the end of treatment.
Percentage of Participants With Failure to Suppress	12 weeks	Failure to suppress was defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL.
Percentage of Participants With Breakthrough	12 weeks	Breakthrough was defined as at least one documented HCV RNA \< 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment.
Percentage of Participants With Missing SVR12 Data	12 weeks after the last dose of study drug (week 24)

Trial Locations

Locations (7)

KOGBUZ Kirovsk Infect Hosp; 🇷🇺 Kirov, Russian Federation

South-Ural State Med. Academy; 🇷🇺 Chelyabinsk, Russian Federation

Specialized Clinical Infectiou; 🇷🇺 Krasnodar, Russian Federation

Orenburg Regional Clinical Hos; 🇷🇺 Orenburg, Russian Federation

LLC Medical Company; 🇷🇺 Samara, Russian Federation

GBOU VPO Saratov state Med Uni; 🇷🇺 Saratov, Russian Federation

Ulyanovsk Regional Clin Hosp; 🇷🇺 Ulyanovsk, Russian Federation