Conditions: Chronic Hepatitis C Hepatitis C (HCV) Hepatitis C Genotype 1a
Keywords: Treatment naive Interferon free HCV Chronic Hepatitis C Hepatitis C Genotype 1a Hepatitis C pegylated-interferon (pegIFN)/ribavirin (RBV) experienced
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 25
Healthy volunteers: no

Brief summary:
A study to evaluate immune restoration following removal of viral antigen in non-cirrhotic hepatitis C virus (HCV) genotype (GT) 1a treatment-naïve and pegylated-interferon (pegIFN)/ribavirin (RBV) treatment-experienced adults receiving treatment with ombitasvir/paritaprevir/ritonavir and dasabuvir coadministered with ribavirin (RBV) for 12 weeks.

Detailed description:
A study to evaluate the role of ombitasvir/paritaprevir/ritonavir and dasabuvir coadministered with RBV treatment leading to sustained virologic response 12 weeks post-dosing (SVR12) on the changes from baseline in IFN-stimulated gene (ISG) expression in peripheral blood mononucleated cells (PBMCs) in HCV GT 1a-infected adult participants.

Arms:
arm 1: Ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily \[QD\]) + dasabuvir (250 mg twice daily \[BID\]) + weight based Ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided BID)

Interventions: intervention 1: ombitasvir/paritaprevir/ritonavir intervention 2: dasabuvir intervention 3: ribavirin
Intervention descriptions: intervention 1: ombitasvir/ABT-450/ritonavir tablets intervention 2: dasabuvir tablets intervention 3: ribavirin tablets

Protocol document: