69983
document
Randomized trial of interferon- and ribavirin-free ombitasvir/paritaprevir/ritonavir in treatment-experienced hepatitis C virus-infected patients . UNLABELLED Approximately 2 million Japanese individuals are infected with hepatitis C virus and are at risk for cirrhosis , end-stage liver disease , and hepatocellular carcinoma . Patients in whom interferon ( IFN ) /ribavirin ( RBV ) therapy has failed remain at risk as effective therapeutic options are limited . This phase 2 , randomized , open-label study evaluated an IFN- and RBV-free regimen of once-daily ombitasvir ( ABT-267 ) , an NS5A inhibitor , plus paritaprevir ( ABT-450 ) , an NS3/4A protease inhibitor dosed with ritonavir ( paritaprevir/ritonavir ) , in pegylated IFN/RBV treatment-experienced Japanese patients with hepatitis C virus subtype 1b or genotype 2 infection . Patients without cirrhosis ( aged 18-75 years ) with subtype 1b infection received ombitasvir 25 mg plus paritaprevir/ritonavir 100/100 mg or 150/100 mg for 12 or 24 weeks ; patients with genotype 2 infection received ombitasvir 25 mg plus paritaprevir/ritonavir 100/100 mg or 150/100 mg for 12 weeks . Sustained virologic response ( SVR ) at posttreatment week 24 ( SVR24 ) was the primary endpoint . Adverse events were collected throughout the study . One hundred ten patients received ≥1 dose of study medication . In the subtype 1b cohort , SVR24 rates were high ( 88.9 % -100 % ) regardless of paritaprevir dose or treatment duration . In the genotype 2 cohort , SVR24 rates were 57.9 % and 72.2 % with 100 mg and 150 mg of paritaprevir , respectively . The SVR24 rate was higher in patients with subtype 2a ( 90 % ) than 2b ( 27 % ) . Concordance between SVR12 and SVR24 was 100 % . The most common adverse events overall were nasopharyngitis ( 29 % ) and headache ( 14 % ) . CONCLUSION In this difficult-to-treat population of patients in whom prior pegylated IFN/RBV had failed , ombitasvir/paritaprevir/ritonavir demonstrated potent antiviral activity with a favorable safety profile among Japanese patients with hepatitis C virus genotype 1b or 2a infection .
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Intervention_Pharmacological
interferon-
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Intervention_Pharmacological
ribavirin-free ombitasvir/paritaprevir/ritonavir
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Intervention_Pharmacological
interferon ( IFN
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Intervention_Pharmacological
/ribavirin ( RBV )
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Intervention_Pharmacological
IFN- and RBV-free
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Intervention_Pharmacological
ombitasvir ( ABT-267 )
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Intervention_Pharmacological
NS5A inhibitor
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Intervention_Pharmacological
paritaprevir ( ABT-450 )
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Intervention_Pharmacological
NS3/4A protease inhibitor
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Intervention_Pharmacological
ritonavir ( paritaprevir/ritonavir )
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Intervention_Pharmacological
IFN/RBV
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Intervention_Pharmacological
ombitasvir 25 mg plus paritaprevir/ritonavir
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Intervention_Pharmacological
ombitasvir 25 mg plus paritaprevir/ritonavir 100/100 mg or 150/100 mg
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Outcome_Physical
Sustained virologic response ( SVR )
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Outcome_Physical
cohort , SVR24 rates
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Outcome_Physical
cohort , SVR24 rates
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Outcome_Physical
SVR24
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Outcome_Physical
between SVR12 and SVR24
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Outcome_Physical
were nasopharyngitis
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Outcome_Physical
and headache
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Participant_Condition
treatment-experienced hepatitis C virus-infected patients .
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Participant_Condition
hepatitis C virus subtype 1b or genotype 2 infection
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Participant_Age
Patients without cirrhosis ( aged 18-75 years )
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Participant_Condition
patients with genotype 2 infection
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Participant_Sample-size
One hundred ten patients
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Participant_Condition
this difficult-to-treat population of patients in whom prior pegylated IFN/RBV had failed
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Participant_Condition
among Japanese patients with hepatitis C virus genotype 1b or 2a infection