Real World Study: Genotype 1 Chronic Hepatitis C Virus Treatment and Evaluation of Real World SVR and PRO
Completed
AbbVie
Phase 4
2015-06-01
This is a Phase IV, open-label, multi-center study to evaluate the real world sustained
virological response rate, subject adherence, and subject reported outcomes during and after
treatment of non-cirrhotic genotype 1 chronic hepatitis C subjects aged 18 years and older,
with VIEKIRA PAK (ombitasvir, paritaprevir/r, dasabuvir), with or without RBV (ribavirin).
Real World Study: Genotype 1 Chronic Hepatitis C Virus Treatment and Evaluation of Real World SVR and PRO
Completed
Kaiser Permanente
Phase 4
2015-06-01
This is a Phase IV, open-label, multi-center study to evaluate the real world sustained
virological response rate, subject adherence, and subject reported outcomes during and after
treatment of non-cirrhotic genotype 1 chronic hepatitis C subjects aged 18 years and older,
with VIEKIRA PAK (ombitasvir, paritaprevir/r, dasabuvir), with or without RBV (ribavirin).
Phase 1 of this study compared the effectiveness of 3 approved DAA (direct-acting antiviral)
HCV treatment regimens to learn whether they worked equally well under real-world conditions.
Phase 2 of this study began early 2017 with removal of 1 DAA regimen, limiting randomization
to just 2 FDA approved DAA regimens. Patients receiving HCV therapy in community and academic
clinics were offered the opportunity to consent to be randomly assigned to one of three
(phase 1) or one of two (phase 2) regimens and observed for outcomes. Once randomized, all
medical care, laboratory testing, and any disease or side effect management were assumed by
usual care conditions, and patient-reported outcomes were collected outside clinic in keeping
with pragmatic design principles.
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