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Safety and Efficacy of Grazoprevir and Elbasvir for GT1ang GT6 With and Without HIV

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ClinicalTrials.gov Identifier: NCT03037151
Recruitment Status : Unknown
Verified February 2020 by The HIV Netherlands Australia Thailand Research Collaboration.
Recruitment status was:  Active, not recruiting
First Posted : January 31, 2017
Last Update Posted : February 13, 2020
Sponsor:
Collaborators:
Chulalongkorn University
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
The HIV Netherlands Australia Thailand Research Collaboration

Study Description
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Brief Summary:
This study will evaluate the safety and efficacy of combination treatment with grazoprevir + elbasvir for compensated cirrhotic participants with chronic genotype 1 (GT1) and genotype 6 (GT6) hepatitis C virus (HCV) infection with or without human immunodeficiency virus (HIV) infection.

Condition or disease Intervention/treatment Phase
Compensated Cirrhosis Drug: Grazaoprevir/Elbasavir Drug: Grazaoprevir/Elbasavir/RBV Phase 4

Detailed Description:
Total 100 patients with compensated cirrhosis, chronically infected with HCV GT1 or GT6 with or without HIV infection will be included. Patients with HCV GT1 and GT6 will be enrolled on a 1:1 basis (approximately 50 patients with GT1 and 50 patients with GT6). Treatment-naïve patients will be treated with the combination of grazoprevir plus elbasvir for 12 weeks. Treatment-experienced patients, including null responders, partial responders or post-treatment relapsers, will be assigned to treat with the combination plus weight-based RBV for 16 weeks. The dosages of study drugs are 100 mg of grazoprevir once daily and 50 mg of elbasvir once daily. All patients will follow up to assess SVR (defined by HCV RNA level <12 IU/mL) at week12 and week 24 after treatment (SVR12 and SVR24, respectively). Additionally, participants will be evaluated the longitudinal changes in LS values by TE up to 240 weeks (5 years) after treatment
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Fibrosis Improvement of Grazoprevir and Elbasvir for HCV GT1 and GT6 With or Without HIV
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
Experimental: HCV mono-infection Treatment naives
HCV treatment-naïve patients will be treated with the combination of grazoprevir plus elbasvir for 12 weeks.
 Drug: Grazaoprevir/Elbasavir
treatment naive
Experimental: HCV mono-infection Treatment experienced
HCV treatment-experienced patients, including null responders, partial responders or post-treatment relapsers, will be assigned to treat with the combination plus weight-based RBV for 16 weeks.
 Drug: Grazaoprevir/Elbasavir/RBV
treatment experienced
Experimental: HCV/HIV co-infection Treatment naives
HCV/HIV coinfected, treatment-naïve patients will be treated with the combination of grazoprevir plus elbasvir for 12 weeks.
 Drug: Grazaoprevir/Elbasavir
treatment naive
Experimental: HCV/HIV co-infection Treatment experienced
HCV/HIV co-infected treatment-experienced patients, including null responders, partial responders or post-treatment relapsers, will be assigned to treat with the combination plus weight-based RBV for 16 weeks.
 Drug: Grazaoprevir/Elbasavir/RBV
treatment experienced


Outcome Measures
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Primary Outcome Measures :
  1. Rate of SVR12 [ Time Frame: 12 weeks post-treatment ]
    To evaluate the rate of sustained virological response (SVR) at 12 weeks after the end of treatment (SVR12) in compensated cirrhotic participants with GT1 and GT6 HCV infection with or without HIV infection treated with the combination of grazoprevir and elbasvir


Secondary Outcome Measures :
  1. Rate of SVR24 [ Time Frame: 24 weeks post-treatment ]
    To evaluate the rate of sustained virological response (SVR) at 24 weeks after the end of treatment (SVR24)

  2. Decline of liver stiffness [ Time Frame: 5 years post-treatment ]
    To evaluate the percentage of participants achieving a significant decline in liver stiffness (LS) values (defined as a ≥30% decrease from baseline) up to 240 weeks (5 years) after treatment

  3. changes in liver stiffness [ Time Frame: 5 years ]
    To compare the longitudinal changes in LS values over time between participants and untreated historical controls


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and women aged 18 years or older
  2. Documented chronic HCV GT1 or GT6 (positive for anti-HCV antibody and HCV RNA at least 6 months prior to screening)
  3. HCV RNA of at least 10,000 IU/ml
  4. Cirrhosis defined by: liver biopsy showing cirrhosis METAVIR F4; or TE showing cirrhosis with a result of >13.0 kPa
  5. Treatment-naïve individuals for chronic HCV infection
  6. Treatment-experienced individuals (Previous treatment failure with PEG-IFN plus RBV) for chronic HCV infection

  7. HIV-infected participants enrolled in this study must meet following criteria:

    7.1 Documented HIV infection 7.2 Naïve to treatment with any antiretroviral therapy (ART) or on HIV ART for at least 8 weeks prior to study entry using a dual nucleoside reverse transcriptase inhibitor (NRTI) backbone of tenofovir or abacavir and either emtricitabine or lamivudine plus raltegravir (or dolutegravir or rilpivirine) 7.3 CD4+ T-cell count >200 cells/mm3 if on ART or >500 cell/mm3 if ART treatment naïve 7.4 Undetectable plasma HIV-RNA at least 8 weeks prior to screening if on ART or <50,000 copies/mL if ART treatment naïve

  8. Agree to use two acceptable methods of birth control from at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study drug, or longer if dictated by local regulations (for female subject who is of childbearing potential or male subject with female sexual partner who is of childbearing potential).

Exclusion Criteria:

  1. Evidence of decompensated liver disease (Child-Pugh Class B or C or Child-Pugh score >6, platelets less than 75 × 10³/μL, serum albumin < 3·0 g/dL, presence of or history of ascites, gastric or variceal bleeding, hepatic encephalopathy or other signs or symptoms of advanced liver disease)
  2. Co-infected with hepatitis B virus
  3. Has cirrhosis and liver imaging within 6 months showing evidence of HCC or is under evaluation for HCC
  4. Pregnant or breast-feeding from day 1 or anytime during treatment, and 14 days after the last dose of study medication
  5. Any medical condition requiring or likely to require chronic systemic administration of corticosteroids or other immunosuppressant drugs during the course of the study
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): NCT03037151


Locations
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Thailand
Faculty of Medicine, Chulalongkorn University
Bangkok, Thailand, 10330
HIV-NAT, Thai Red Cross AIDS Research Centre
Bangkok, Thailand, 10330
Sponsors and Collaborators
The HIV Netherlands Australia Thailand Research Collaboration
Chulalongkorn University
Merck Sharp & Dohme LLC
Investigators
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Principal Investigator: Anchalee Avihingsanon, MD, PhD HIV-NAT, Thai Red Cross - AIDS Research Centre
Principal Investigator: Pisit Tangkijvanich, MD Chulalongkorn University
More Information
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Additional Information:

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Responsible Party: The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier: NCT03037151    
Other Study ID Numbers: HIV-NAT 245
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: only when needed as per the auditing/monitoring processes and requirement

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
Safety
Efficacy
grazoprevir
elbasvir
compensated cirrhosis
 genotype 1 (GT1)
genotype 6 (GT6)
hepatitis virus C (HCV)
human immunodeficiency virus (HIV)
Additional relevant MeSH terms:
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Fibrosis
Pathologic Processes