Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir Co-Administered With Sofosbuvir With and Without Ribavirin in Treatment-Naive HCV Genotype 1-Infected Adults

Phase 3

Completed

• Conditions: Chronic Hepatitis C Virus (HCV Infection Genotype 1)
• Interventions: Drug: ombitasvir/paritaprevir/ritonavir, dasabuvir; Drug: sofosbuvir (SOF); Drug: ribavirin (RBV)

• Registration Number: NCT02399345
• Lead Sponsor: AbbVie

Brief Summary

This open-label study will evaluate the safety and efficacy of co-formulated ombitasvir/paritaprevir/ritonavir and dasabuvir co-administered with sofosbuvir with or without ribavirin administered for either 4 or 6 weeks in treatment naive adults with chronic HCV-genotype 1 infection without cirrhosis

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-23
• Study First Submitted QC: 2015-03-23
• Study First Posted: 2015-03-26
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2016-10
• Results First Submitted: 2016-10-19
• Results First Submitted QC: 2016-10-19
• Last Update Submitted: 2016-10-19
• Results First Posted: 2016-12-12
• Last Update Posted: 2016-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Male or female at least 18 years of age at time of screening
2. Chronic Hepatitis C virus (HCV) infection prior to study enrollment
3. Screening laboratory results from the central clinical laboratory indicating HCV genotype 1 infection only
4. Absence of cirrhosis and advanced bridging fibrosis

Exclusion Criteria

1. Positive test result for hepatitis B surface antigen (HbsAg) or human immunodeficiency virus (HIV) positive immunoassay
2. Clinically significant abnormalities or co-morbidities, other than HCV infection, that make the subject an unsuitable candidate for this study or treatment with Ribavirin (RBV) in the opinion of the investigator
3. Any current or past clinical evidence of cirrhosis such as ascites or esophageal varices, or prior biopsy showing cirrhosis or advanced bridging fibrosis, e.g., a Metavir score > 2 or an Ishak score > 3
4. Use of medications contraindicated for ombitasvir/paritaprevir/ritonavir, dasabuvir, sofosbuvir, or ribavirin (RBV; for those that receive RBV), within 2 weeks or 10 half-lives whichever is longer, prior to study drug administration
5. Current enrolment in another clinical study, previous enrolment in this study, or previous use of any investigational or commercially available anti-HCV agents

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF plus RBV	sofosbuvir (SOF)	Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks.
Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF plus RBV	ribavirin (RBV)	Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks.
Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF plus RBV	ombitasvir/paritaprevir/ritonavir, dasabuvir	Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment	12 weeks after the last actual dose of study drug	The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid \[HCV RNA\] level less than the lower limit of quantitation \[\< LLOQ\]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL.

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects With On-treatment Virologic Failure	6 weeks	Virologic failure during treatment was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA \< LLOQ during treatment; confirmed increase from nadir in HCV RNA (defined as 2 consecutive HCV RNA measurements \> 1 log10 IU/mL above nadir) during treatment; or failure to suppress during treatment (defined as all values of HCV RNA ≥ LLOQ during treatment).
Percentage of Subjects With Post-treatment Relapse	Up to 12 weeks after last actual dose of active study drug	Percentage of subjects with HCV RNA less than the lower limit of quantification at the end of treatment with confirmed HCV RNA greater than or equal to the lower limit of quantification through 12 weeks post treatment