Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Low-Dose Ribavirin QD in Subjects With Genotype 1a Chronic Hepatitis C Virus Infection (GEODE II)

AbbVie

Status and phase: Completed; Phase 3

Conditions: Hepatitis C Virus (HCV)

Treatments: Drug: ribavirin; Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir

Study type: Interventional

Funder types: Industry

Identifiers

NCT02609659

M15-582

Details and patient eligibility

About

This study seeks to assess the safety and efficacy of treatment with ombitasvir/paritaprevir/ritonavir and dasabuvir with low-dose ribavirin in non-cirrhotic, genotype 1a (GT1a) hepatitis C virus infected participants who are treatment-naïve or treatment-experienced with Interferon (IFN) or Pegylated Interferon (pegIFN) with or without Ribavirin (RBV).

Enrollment: 105 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic hepatitis C virus (HCV) infection
• Non-cirrhotic subjects
• Screening laboratory results showing HCV Genotype 1a (HCV GT1a) infection
• HCV treatment-naïve or if treated previously, only with interferon (IFN) or pegylated interferon (pegINF) with or without ribavirin (RBV)

Exclusion criteria

• Pregnant or breastfeeding women
• Positive for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab)
• HCV genotype of any subtype other than GT1a or unable to subtype
• Prior or current use of any investigational or commercially available anti-HCV agents other than IFN, pegIFN or RBV. Subjects with previous participation in trials of investigational direct-acting antiviral agents (DAAs) may be enrolled if they can produce documentation that they received only placebo.
• Current enrollment in another interventional clinical study or receipt of any investigational product within 6 weeks prior to study drug administration.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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105 participants in 1 patient group

3-DAA + RBV 600 mg

Experimental group

Description:

3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) plus RBV (ribavirin \[600 mg once daily\]) for 12 weeks.

Treatment:

Drug: ribavirin

Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir