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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-004128-67 | EudraCT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 16 weeks of treatment | Experimental | Drug : Grazoprevir/Elbasvir + Sofosbuvir + Ribavirin during 16 weeks |
|
| 24 weeks of treatment | Experimental | Drug : Grazoprevir/Elbasvir + Sofosbuvir + Ribavirin during 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Grazoprevir/Elbasvir | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 28 (W28) or Week 36 (W36) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Week 20 (W20) or Week 28 (W28), and W40 or W48 | |
| HCV viral load assessment |
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Inclusion Criteria:
The proportion of patients previously treated with Simeprevir will be limited to a third of all patients included.
Exclusion Criteria:
Non-inclusion biological criteria
Criteria related to study drugs
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| Name | Affiliation | Role |
|---|---|---|
| Victor DE LEDINGHEN | Hôpital de Haut-Lévêque, CHU de Bordeaux | Principal Investigator |
| Eric BELLISSANT | Centre de Méthodologie et de Gestion, CHU de Rennes | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASSELAH Tarik | Clichy | 92110 | France | |||
| Christophe HEZODE |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29077864 | Result | 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. |
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| Sofosbuvir | Drug |
|
|
| Ribavirin | Drug |
|
|
| from Day 0 (D0) to Week 40 (W40) or Week 48 (W48) |
| Assessment of HCV subtypic distribution at baseline | Pre-inclusion |
| 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 | Pre-inclusion |
| Assessment of liver fibrosis by Hepatic impulse elastometry (Fibroscan®), or biological parameters (FibroMeter® or Fibrotest®) | Pre-inclusion, Week 40 or Week 48 |
| For cirrhotic patients, description of the risk of cirrhosis evolution (decompensation, hepatocarcinoma) | Cirrhosis evaluation (Child-Pugh) | Pre-inclusion, Day 0 (D0), Week 16 (W16), W20, W24, W28, W36, W40 or W48 |
| For cirrhotic patients, description of the risk of cirrhosis evolution (decompensation, hepatocarcinoma) | Cirrhosis evaluation (MELD score) | Pre-inclusion, Day 0 (D0), Week 16 (W16), W20, W24, W28, W36, W40 or W48 |
| Clinical and biological adverse events occurring during the treatment and until 24 weeks after the end of the treatment | from Day 0(D0) to Week 40 (W40) or W48 |
| Numbers and proportions of patients who interrupted the treatments of the study | from Day 0 (D0) to Week 40 (W40) or W48 |
| Patient's reported outcomes evaluation with questionnaires | Evaluation of patient's quality of life | Day 0 (D0), Week 4 (W4), W16, W28, W40 or D0, W4, W16, W24, W36, W48 (24 weeks treatment-arm)) |
| Patient's reported outcomes evaluation with questionnaires | Evaluation of perceived symptoms (ANRS questionnaire) | Day 0 (D0), Week 4 (W4), W16, W28, W40 or D0, W4, W16, W24, W36, W48 (24 weeks treatment-arm)) |
| Créteil |
| 94010 |
| France |
| LEROY Vincent | Grenoble | 38043 | France |
| ZOULIM Fabien | Lyon | 69317 | France |
| BOURLIERE Marc | Marseille | 13285 | France |
| LARREY Dominique | Montpellier | 34295 | France |
| TRAN Albert | Nice | 06202 | France |
| SERFATY Lawrence | Paris | 75571 | France |
| POL Stanislas | Paris | 75679 | France |
| JEZEQUEL Caroline | Rennes | 35033 | France |
| ALRIC Laurent | Toulouse | 31059 | France |
| METIVIER Sophie | Toulouse | 31059 | France |
| SAMUEL Didier | Villejuif | 94804 | France |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000611265 | elbasvir-grazoprevir drug combination |
| C578009 | grazoprevir |
| D000069474 | Sofosbuvir |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
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