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Ombitasvir/ABT-450/Ritonavir and Dasabuvir Therapy With Low Dose Ribavirin (RBV), Full Dose RBV or RBV Add-On in Treatment Naive Genotype 1a Hepatitis C Virus Infected Adults

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ClinicalTrials.gov Identifier: NCT02493855
Recruitment Status : Completed
First Posted : July 10, 2015
Results First Posted : May 15, 2017
Last Update Posted : October 31, 2017
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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Brief Summary:
To evaluate the effect of ribavirin on second phase plasma hepatitis C virus (HCV) ribonucleic acid (RNA) decline in participants who receive ombitasvir/ABT-450/ritonavir and dasabuvir with full dose ribavirin, low dose ribavirin or without ribavirin for 2 weeks in treatment-naive HCV genotype (GT) 1a-infected adults.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Hepatitis C (HCV) Hepatitis C Genotype 1a Drug: Ombitasvir/ABT-450/Ritonavir Drug: Dasabuvir Drug: Ribavirin (RBV) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Exploratory Study to Evaluate the Kinetics of Viral Load Decline With Ombitasvir/ABT 450/Ritonavir (Ombitasvir/ABT-450/r) and Dasabuvir Therapy With Low Dose Ribavirin (RBV), Full Dose RBV or RBV Add-On in Treatment Naïve Adults With Genotype 1a Chronic Hepatitis C Virus (HCV) Infection
Actual Study Start Date : June 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : December 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A: Ribavirin Full Dose for Last 10 Weeks
Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) for 12 weeks and weight-based ribavirin (1000 mg or 1200 mg split BID) for the last 10 weeks.
 Drug: Ombitasvir/ABT-450/Ritonavir
Ombitasvir/ABT-450/ritonavir combination tablets
Other Name: ABT-267/ABT-450/ritonavir

Drug: Dasabuvir
Dasabuvir tablets
Other Name: ABT-333

Drug: Ribavirin (RBV)
Ribavirin tablets
Experimental: Arm B: Ribavirin Full Dose for 12 Weeks
Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and weight-based ribavirin (1000 mg or 1200 mg split BID) for 12 weeks.
 Drug: Ombitasvir/ABT-450/Ritonavir
Ombitasvir/ABT-450/ritonavir combination tablets
Other Name: ABT-267/ABT-450/ritonavir

Drug: Dasabuvir
Dasabuvir tablets
Other Name: ABT-333

Drug: Ribavirin (RBV)
Ribavirin tablets
Experimental: Arm C: Ribavirin Low-dose for 12 Weeks
Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and 600 mg ribavirin once daily for 12 weeks.
 Drug: Ombitasvir/ABT-450/Ritonavir
Ombitasvir/ABT-450/ritonavir combination tablets
Other Name: ABT-267/ABT-450/ritonavir

Drug: Dasabuvir
Dasabuvir tablets
Other Name: ABT-333

Drug: Ribavirin (RBV)
Ribavirin tablets


Outcome Measures
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Primary Outcome Measures :
  1. Slope of the Second Phase Decline in Plasma HCV Ribonucleic Acid (RNA) Levels During Treatment [ Time Frame: From Week 0 to Week 2 ]
    HCV viral kinetics in plasma during therapy were modeled through non-linear mixed effect models, including a rapid first phase of initial decline and a slower second phase decline. The slope of the second phase decline was estimated for each treatment arm.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Screening laboratory result indicating HCV genotype 1 (GT1) a infection.
  2. Chronic HCV infection.
  3. Subjects must be non-cirrhotic.
  4. Subjects must be able to understand and adhere to the study visit schedule and all protocol requirements as well as voluntarily sign and date an institutional review board (IRB) approved informed consent.

Exclusion Criteria:

  1. Women who are pregnant or breastfeeding.
  2. Positive test result for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab) positive immunoassay.
  3. Clinically significant abnormalities or co-morbidities, other than HCV infection, that make the subject unsuitable for this study or treatment.
  4. Current enrollment in another interventional clinical study. Previous use of any HCV treatments including pegylated interferon (pegIFN), ribavirin, or any direct acting antiviral agent, either investigational or approved, for HCV including protease inhibitors, nucleoside or non-nucleoside polymerase inhibitors, or nonstructural viral protein 5A (NS5A) inhibitors.
  5. History or solid organ transplant.
  6. Screening laboratory analysis that shows abnormal results.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02493855


Sponsors and Collaborators
AbbVie
Investigators
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Study Director: Emily Dumas, PhD AbbVie
More Information
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02493855    
Other Study ID Numbers: M14-242
2014-001478-32 ( EudraCT Number )
First Posted: July 10, 2015    Key Record Dates
Results First Posted: May 15, 2017
Last Update Posted: October 31, 2017
Last Verified: September 2017
Keywords provided by AbbVie:
Treatment naive
HCV
Interferon free
 Hepatitis C Genotype 1a
Chronic Hepatitis C
Hepatitis C
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
 Ritonavir
Ribavirin
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antimetabolites