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Hepatitis CPhase 2NCT02647632

Study to Assess Efficacy and Safety of Grazoprevir/Elbasvir Associated With Sofosbuvir and Ribavirin in HCV Genotype 1 or 4-infected Patients Who Failed Direct Acting Antivirals (DAA) Bitherapy With Sofosbuvir

A Phase 2 study testing Grazoprevir/Elbasvir, Sofosbuvir and Ribavirin in people with Hepatitis C, run by ANRS, Emerging Infectious Diseases at 13 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of this study is to estimate, in HCV genotype 1 or 4-infected patients who failed a prior DAA bitherapy with Sofosbuvir, the efficacy of a treatment with Grazoprevir/Elbasvir, Sofosbuvir and Ribavirin in the two treatment groups and compare the rate of sustained virological response (SVR) 12… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C
What is being tested?
Grazoprevir/Elbasvir, Sofosbuvir and Ribavirin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
13 sitesFrance
Study dates
Jan 2016to Apr 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult ≥18 years
  • Infection with HCV genotype 1 or 4, confirmed by detectable HCV RNA at pre-inclusion
  • Failure to a prior therapy with Sofosbuvir +/- Ribavirin associated with Simeprevir or Daclatasvir or Ledipasvir, with documented presence of NS5A or NS3/4A RAVs (Resistance Associated Variants) at the time of failure (presence of RAVs on at least one sample since the time of failure).
  • The proportion of patients previously treated with Simeprevir will be limited to a third of all patients included.
  • Fibrosis at any stage
  • Men and women of child-bearing age and their heterosexual partners must use adequate contraceptions from 15 days before their inclusion in the study up to 7 months after the end of treatment for men and up to 4 months after the end of treatment for women
  • Written informed consent signed by the patient and the investigator (on the day of the pre-inclusion at the latest and before any examination required by the study) (article L1122-1-1 Public Health Code)
  • Patients with Health insurance (Sécurité Sociale or Couverture Médicale Universelle)

Who cannot join

  • Child B or C cirrhosis (or Child A patients with history of Child B)
  • Patients with documented presence of RAVs conferring resistance to sofosbuvir
  • Positive HBs Antigen
  • Confirmed HIV-1 or HIV-2 infection
  • Pregnant or breast-feeding women or men whose female partners are pregnant
  • Transplant recipients
Show all 24Show fewer
  • Any evolutive ongoing malignant disease, including hepatocellular carcinoma, which will be specifically screened for before inclusion
  • History of severe rhythm disorders or cardiac disease (coronary artery disease, heart failure, arteriopathy,…): the opinion of a cardiologist is compulsory (< 6 months)
  • Consumption of alcohol which, in the investigator's opinion, will be an obstacle to the patient's participation and to his/her remaining in the study
  • Drug addiction which, in the investigator's opinion, will be an obstacle to the patient's participation and to his/her remaining in the study. Patients included in a programme of substitution with methadone or buprenorphine could be included. The opinion of an addictology consultant is recommended for patients presenting with current drug use or drug use in the past year
  • Patients taking part in another clinical trial within 30 days prior to inclusion
  • Patient under guardianship, trusteeship or judicial protection
  • Non-inclusion biological criteria
  • Hemoglobin < 11 g/dL
  • Platelets < 50 000/mm3
  • INR > 1.5 unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR
  • ALT or AST > 10xULN
  • Creatinine clearance < 50 mL/mn (MDRD formula)
  • Albumin < 30 g/L
  • HbA1c > 10% (only in diabetic patients)
  • Criteria related to study drugs
  • Contra-indication to treatment with Grazoprevir/Elbasvir, Sofosbuvir or Ribavirin including a history of hypersensitivity to one of their excipients
  • Patients with a non-compliance history, who will be at risk of not complying with the study follow-up timetable
  • Treatment with contra-indicated associated drugs

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

France13 sites

  • ASSELAH Tarik

    Clichy, 92110

  • Christophe HEZODE

    Créteil, 94010

  • LEROY Vincent

    Grenoble, 38043

  • ZOULIM Fabien

    Lyon, 69317

  • BOURLIERE Marc

    Marseille, 13285

  • LARREY Dominique

    Montpellier, 34295

  • TRAN Albert

    Nice, 06202

  • SERFATY Lawrence

    Paris, 75571

  • POL Stanislas

    Paris, 75679

  • JEZEQUEL Caroline

    Rennes, 35033

  • ALRIC Laurent

    Toulouse, 31059

  • METIVIER Sophie

    Toulouse, 31059

  • SAMUEL Didier

    Villejuif, 94804

Other trials in France

About this study

The primary objective of this study is to estimate, in HCV genotype 1 or 4-infected patients who failed a prior DAA bitherapy with Sofosbuvir, the efficacy of a treatment with Grazoprevir/Elbasvir, Sofosbuvir and Ribavirin in the two treatment groups and compare the rate of sustained virological response (SVR) 12 weeks after 16 or 24 weeks of this treatment. SVR12 is defined as HCV RNA < LLOQ (either TD[u] or TND).

Conditions
Hepatitis C
Being tested
Grazoprevir/Elbasvir, Sofosbuvir, Ribavirin
Keywords
HCV genotype 1 or 4, failure to DAA
Medical subject headings
Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Grazoprevir/ElbasvirDrug

    Also called Grazoprevir/Elbasvir is also known as MK-5172A or Zepatier

  • SofosbuvirDrug

    Also called Sofosbuvir is also known as Sovaldi

  • RibavirinDrug

    Also called Ribavirin is also known as Rebetol

Study groups in NCT02647632
Study groupRoleWhat they receive
16 weeks of treatmentExperimentalDrug : Grazoprevir/Elbasvir + Sofosbuvir + Ribavirin during 16 weeks
Receives: Drug: Grazoprevir/Elbasvir; Drug: Sofosbuvir; Drug: Ribavirin
24 weeks of treatmentExperimentalDrug : Grazoprevir/Elbasvir + Sofosbuvir + Ribavirin during 24 weeks
Receives: Drug: Grazoprevir/Elbasvir; Drug: Sofosbuvir; Drug: Ribavirin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. rate of the Sustained Virological Response 12 weeks after the end of the therapy (SVR12), i.e. at W28 or W36 for treatment duration of 16 weeks and 24 weeks respectively.

    The primary endpoint is the rate of the Sustained Virological Response defined as HCV RNA < LLOQ (either TD[u] or TND) 12 weeks after the end of the therapy associating Grazoprevir/Elbasvir, Sofosbuvir and Ribavirin (SVR12), i.e. at W28 or W36 for treatment duration of 16 weeks and 24 weeks respectively.

    Measured: Week 28 (W28) or Week 36 (W36)

Secondary outcomes (11)

  1. SVR rate 4 weeks after the end of treatment (i.e. at week 20 or week 28 for treatment duration of 16 weeks and 24 weeks respectively) and 24 weeks after the end of treatment (i.e. at week 40 or week 48).

    Measured: Week 20 (W20) or Week 28 (W28), and W40 or W48

  2. HCV viral load assessment

    Measured: from Day 0 (D0) to Week 40 (W40) or Week 48 (W48)

  3. Assessment of HCV subtypic distribution at baseline

    Measured: Pre-inclusion

  4. Numbers and proportions of patients presenting variants of resistance (RAV) at baseline

    The numbers and proportions of patients presenting variants of resistance (RAV) and their characteristics will be studied

    Measured: Pre-inclusion

  5. Assessment of liver fibrosis by Hepatic impulse elastometry (Fibroscan®), or biological parameters (FibroMeter® or Fibrotest®)

    Measured: Pre-inclusion, Week 40 or Week 48

  6. For cirrhotic patients, description of the risk of cirrhosis evolution (decompensation, hepatocarcinoma)

    Cirrhosis evaluation (Child-Pugh)

    Measured: Pre-inclusion, Day 0 (D0), Week 16 (W16), W20, W24, W28, W36, W40 or W48

  7. For cirrhotic patients, description of the risk of cirrhosis evolution (decompensation, hepatocarcinoma)

    Cirrhosis evaluation (MELD score)

    Measured: Pre-inclusion, Day 0 (D0), Week 16 (W16), W20, W24, W28, W36, W40 or W48

  8. Clinical and biological adverse events occurring during the treatment and until 24 weeks after the end of the treatment

    Measured: from Day 0(D0) to Week 40 (W40) or W48

  9. Numbers and proportions of patients who interrupted the treatments of the study

    Measured: from Day 0 (D0) to Week 40 (W40) or W48

  10. Patient's reported outcomes evaluation with questionnaires

    Evaluation of patient's quality of life

    Measured: Day 0 (D0), Week 4 (W4), W16, W28, W40 or D0, W4, W16, W24, W36, W48 (24 weeks treatment-arm))

  11. Patient's reported outcomes evaluation with questionnaires

    Evaluation of perceived symptoms (ANRS questionnaire)

    Measured: Day 0 (D0), Week 4 (W4), W16, W28, W40 or D0, W4, W16, W24, W36, W48 (24 weeks treatment-arm))

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionJan 2017
  4. Study completionApr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02647632
Sponsor's protocol ID
ANRS HC34 REVENGE
Other IDs
2015-004128-67, 2015
Status last verified
Jun 2026
First submitted
16 Dec 2015
Last updated
12 Jun 2026
Results posted
No

Publications

  • de Ledinghen V, Laforest C, Hezode C, Pol S, Renault A, Alric L, Larrey D, Metivier S, Tran A, Jezequel C, Samuel D, Zoulim F, Tual C, Pailhe A, Gibowski S, Bourliere M, Bellissant E, Pawlotsky JM. Retreatment With Sofosbuvir Plus Grazoprevir/Elbasvir Plus Ribavirin of Patients With Hepatitis C Virus Genotype 1 or 4 Who Previously Failed an NS5A- or NS3-Containing Regimen: The ANRS HC34 REVENGE Study. Clin Infect Dis. 2018 Mar 19;66(7):1013-1018. doi: 10.1093/cid/cix916.

    PubMed 29077864

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Grazoprevir/Elbasvir, Sofosbuvir and Ribavirin in people with Hepatitis C, run by ANRS, Emerging Infectious Diseases at 13 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

rate of the Sustained Virological Response 12 weeks after the end of the therapy (SVR12), i.e. at W28 or W36 for treatment duration of 16 weeks and 24 weeks respectively. (time frame: Week 28 (W28) or Week 36 (W36)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02647632, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.

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