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.
Study Type
OBSERVATIONAL
Enrollment
60
South-Ural State Med. Academy
Chelyabinsk, Russia
KOGBUZ Kirovsk Infect Hosp
Kirov, Russia
Specialized Clinical Infectiou
Krasnodar, Russia
Orenburg Regional Clinical Hos
Orenburg, Russia
LLC Medical Company
Samara, Russia
GBOU VPO Saratov state Med Uni
Saratov, Russia
Ulyanovsk Regional Clin Hosp
Ulyanovsk, Russia
Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)
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.
Time frame: 12 weeks after the last dose of study drug (week 24)
Percentage of Participants Achieving Virological Response at End of Treatment (EoT)
Virological response is defined as HCV RNA less than 50 IU/mL.
Time frame: End of treatment, maximum of 12 weeks
Percentage of Participants With Relapse
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.
Time frame: End of treatment (week 12) and up to 12 weeks after the end of treatment.
Percentage of Participants With Breakthrough
Breakthrough was defined as at least one documented HCV RNA \< 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment.
Time frame: 12 weeks
Percentage of Participants With Failure to Suppress
Failure to suppress was defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL.
Time frame: 12 weeks
Percentage of Participants With Missing SVR12 Data
Time frame: 12 weeks after the last dose of study drug (week 24)
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