Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease

NCT02207088 | Completed Phase 3 Results

• 2 other identifiers: M14-2262014-001527-77
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

Brief Summary

This open-label study will evaluate safety, pharmacokinetics and efficacy of a 12 or 24-week regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in HCV-genotype 1-infected subjects with an Estimated Glomerular Filtration Rate (eGFR) \<30, including those on hemodialysis or peritoneal dialysis.

Conditions

Chronic Hepatitis C; Hepatitis C Virus; Compensated Cirrhosis; Severe Renal Impairment; End-stage Renal Disease

Keywords

Chronic Hepatitis C; Hepatitis C; End-stage renal disease; Hepatitis C Genotype 1; Severe Renal Impairment; renal disease; Compensated Cirrhosis; Renal impairment; dialysis; Hepatitis C Virus; cirrhosis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Sustained Virologic Response 12 (SVR12) Weeks Post-treatment

  SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (\<LLOQ) 12 weeks after the last dose of study drug.

  12 weeks after the last actual dose of study drug

Secondary Outcomes (2)

• Percentage of Participants With On-treatment Virologic Failure

  Up to 24 weeks

• Percentage of Participants With Post-Treatment Relapse

  Within 12 weeks after the last dose of study drug

Study Arms (1)

3-DAA (Direct Acting Antivirals) with or without RBV

EXPERIMENTAL

3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily \[QD\] and dasabuvir 250 mg twice daily \[BID\]) with or without ribavirin (RBV; dosed divided twice a day) for 12 or 24 weeks

Drug: ombitasvir/paritaprevir/ritonavir; Drug: dasabuvir; Drug: Ribavirin

Interventions

ombitasvir/paritaprevir/ritonavir DRUG

tablet

Also known as: ABT-450/r/ABT-267, Viekira Pak, paritaprevir also known as ABT-450, ombitasvir also known as ABT-267, dasabuvir also known as ABT-333

3-DAA (Direct Acting Antivirals) with or without RBV

dasabuvir DRUG

tablet

Also known as: ABT-333

3-DAA (Direct Acting Antivirals) with or without RBV

Ribavirin DRUG

tablet

Also known as: RBV

3-DAA (Direct Acting Antivirals) with or without RBV

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Positive for anti-HCV Ab (Antibody) and HCV RNA \>1,000 IU/mL at Screening.
• Screening laboratory result indicating HCV genotype 1 infection.
• Subject has never received antiviral treatment for hepatitis C infection (treatment-naive subject) or subject has received previous treatment with peginterferon with or without RBV with non-response (HCV RNA quantifiable at end of treatment or relapsed after end of treatment).
• Estimated Glomerular Filtration Rate (eGFR) \< 30 mL/min/1.73 m\^2 as estimated by the Modification of Diet in Renal Disease (MDRD) method.

You may not qualify if:

• Women who are pregnant or breastfeeding.
• Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency Virus (HIV Ab).
• Any current or past clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation such as ascites (noted on physical exam), variceal bleeding, or hepatic encephalopathy.

Sponsors & Collaborators

• AbbVie: lead

Related Publications (2)

• Shuster DL, Menon RM, Ding B, Khatri A, Li H, Cohen E, Jewett M, Cohen DE, Zha J. Effects of chronic kidney disease stage 4, end-stage renal disease, or dialysis on the plasma concentrations of ombitasvir, paritaprevir, ritonavir, and dasabuvir in patients with chronic HCV infection: pharmacokinetic analysis of the phase 3 RUBY-I and RUBY-II trials. Eur J Clin Pharmacol. 2019 Feb;75(2):207-216. doi: 10.1007/s00228-018-2566-6. Epub 2018 Oct 5.

  PMID: 30291369 DERIVED

• Pockros PJ, Reddy KR, Mantry PS, Cohen E, Bennett M, Sulkowski MS, Bernstein DE, Cohen DE, Shulman NS, Wang D, Khatri A, Abunimeh M, Podsadecki T, Lawitz E. Efficacy of Direct-Acting Antiviral Combination for Patients With Hepatitis C Virus Genotype 1 Infection and Severe Renal Impairment or End-Stage Renal Disease. Gastroenterology. 2016 Jun;150(7):1590-1598. doi: 10.1053/j.gastro.2016.02.078. Epub 2016 Mar 11.

  PMID: 26976799 DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C; Renal Insufficiency; Kidney Failure, Chronic; Kidney Diseases; Fibrosis

Interventions

ombitasvir; Viekira Pak; paritaprevir; dasabuvir; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

800-633-9110

Study Officials

• Eric Cohen, MD

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2014
• First Posted: August 1, 2014
• Study Start: September 23, 2014
• Primary Completion: December 6, 2016
• Study Completion: December 6, 2016
• Last Updated: November 9, 2017
• Results First Posted: November 9, 2017

Record last verified: 2017-10