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).
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).
Study Type
OBSERVATIONAL
Enrollment
200
Spanish cohort with HCV treated in real practice with ombitasvir/paritaprevir/ ritonavir 8 weeks
Spanish cohort with HCV treated in real practice with dasabuvir 8 weeks
Carrion, Jose Antonio, PhD
Barcelona, Spain
Sustained virological response 12 weeks post-treatment (SVR12)
Percentage of participants who achieve sustained virological response 12 weeks post-treatment (SVR12) • Measure: Hepatitis C virus ribonucleic acid (HCV-RNA) levels less than the lower limit of quantification.
Time frame: 12 weeks after the last dose of study drug
Percentage of patients with virologic failure during treatment
Percentage of patients with virologic failure during treatment • Measure: Percentage of patients with confirmed \>=1 log10 IU/mL increase from nadir in HCV RNA at any time point during treatment
Time frame: Up to 12 weeks after last dose of study drug
Mild fibrosis and sustained virological response 12 weeks post-treatment
Percentage of patients with mild fibrosis who achieve sustained virological response 12 (SVR12) weeks post-treatment • Measure: percentage of patients with a baseline transient elastography \< 6 kPa
Time frame: Up to 12 weeks after last dose of study drug
Percentage of participants with low baseline viral load and SVR12 weeks post-treatment
Percentage of participants with low baseline viral load who achieve sustained virological response 12 (SVR12) weeks post-treatment • Measure: HCV RNA levels less than the lower limit of quantification.
Time frame: Baseline and 12 weeks after the last dose of drug
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