A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis

NCT02219503 | Completed Phase 3 Results

• 2 other identifiers: M14-4902014-001953-18
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study was to evaluate the safety and efficacy of ombitasvir/ paritaprevir/ ritonavir and dasabuvir in adults with genotype 1b chronic hepatitis C virus (HCV) infection and cirrhosis.

Conditions

Chronic Hepatitis C Infection; Compensated Cirrhosis

Keywords

Hepatitis C; Chronic Hepatitis C; Compensated Cirrhosis; Cirrhotic; Hepatitis C Genotype 1b; Hepatitis C Virus; Interferon-Free; Child Pugh A; Ribavirin-Free

Outcome Measures

Primary Outcomes (1)

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

  Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (\< LLOQ; \< 25 IU/mL) 12 weeks after the last dose of study drug. The primary efficacy endpoints were non-inferiority and superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm compared with the historical threshold for sofosbuvir and peginterferon (pegIFN)/RBV for the treatment of subjects with HCV GT1b infection and cirrhosis.

  Post-treatment Day 1 to Post-treatment Week 12

Secondary Outcomes (2)

• Percentage of Participants With On-Treatment Virologic Failure

  Day 1 through Week 12

• Percentage of Participants With Post-Treatment Relapse

  Post-treatment Day 1 to Post-treatment Week 12

Study Arms (1)

Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir

EXPERIMENTAL

Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks

Drug: Ombitasvir/Paritaprevir/Ritonavir; Drug: Dasabuvir

Interventions

Ombitasvir/Paritaprevir/Ritonavir DRUG

Tablet; paritaprevir co-formulated with ritonavir and ombitasvir

Also known as: ABT-267 also known as ombitasvir, ABT-450 also known as paritaprevir, Ritonavir also known as norvir

Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir

Dasabuvir DRUG

Tablet

Also known as: ABT-333

Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir

Eligibility Criteria

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

You may qualify if:

• Chronic HCV genotype 1-infection prior to study enrollment. Chronic HCV-infection is defined as the following:
• Positive for anti-HCV antibody (Ab) or HCV RNA \> 1,000 IU/mL at least 6 months before Screening, and positive for HCV RNA and anti-HCV Ab at the time of Screening; or
• HCV RNA \> 1,000 IU/mL at the time of Screening with a liver biopsy consistent with chronic HCV-infection (or a liver biopsy performed prior to enrollment with evidence of chronic hepatitis C disease).
• Screening laboratory result indicating HCV genotype 1b-infection.
• Compensated cirrhosis defined as a Child-Pugh Score of 5 or 6 at Screening.

You may not qualify if:

• Women who are pregnant or breastfeeding.
• Positive test result for Hepatitis B surface antigen (HBsAg) or positive human immunodeficiency virus (HIV) antibody (confirmed by Western Blot).
• 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.
• Confirmed presence of hepatocellular carcinoma indicated on imaging techniques such as computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to Screening or on an ultrasound performed at Screening (a positive ultrasound result will be confirmed with CT scan or MRI.)
• Use of contraindicated medications within 2 weeks of dosing
• Screening laboratory analyses showing any of the following abnormal laboratory results:
• Calculated creatinine clearance (using Cockcroft-Gault method) \< 30 mL/min
• Albumin \< 2.8 g/dL
• International normalized ratio (INR) \> 1.8. Participants with a known inherited blood disorder and INR \> 1.8 may be enrolled with permission of the AbbVie Study Designated Physician.
• Hemoglobin \< 10 g/dL
• Platelets \< 25,000 cells per mm3
• Total bilirubin \> 3.0 mg/dL

Sponsors & Collaborators

• AbbVie: lead

Related Publications (1)

• Feld JJ, Moreno C, Trinh R, Tam E, Bourgeois S, Horsmans Y, Elkhashab M, Bernstein DE, Younes Z, Reindollar RW, Larsen L, Fu B, Howieson K, Polepally AR, Pangerl A, Shulman NS, Poordad F. Sustained virologic response of 100% in HCV genotype 1b patients with cirrhosis receiving ombitasvir/paritaprevir/r and dasabuvir for 12weeks. J Hepatol. 2016 Feb;64(2):301-307. doi: 10.1016/j.jhep.2015.10.005. Epub 2015 Oct 22.

  PMID: 26476290 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Hepatitis C; Hepatitis C, Chronic

Interventions

ombitasvir; paritaprevir; Ritonavir; dasabuvir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Hepatitis, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

800-633-9110

Study Officials

• Roger Trinh, 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: August 15, 2014
• First Posted: August 19, 2014
• Study Start: September 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: September 1, 2015
• Last Updated: July 12, 2021
• Results First Posted: June 29, 2016

Record last verified: 2021-07