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Evaluate the efficacy of 12 or 8 weeks treatment with Grazoprevir/Elbasvir in Early Chronic Hepatitis C GT1,4 in HIV co-infected patients and evaluate the safety and tolerability of Grazoprevir + Elbasvir in HIV-HCV co-infected patients.
Genotype 1b: 8 weeks treatment with Grazoprevir/Elbasvir
Genotype 1a and 4: 12 weeks treatment with Grazoprevir/Elbasvir
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genotype 1b | Experimental | Grazoprevir 100 mg/d during 8 weeks. Elbasvir 50 mg/d during 8 weeks. |
|
| Genotype 1a and 4 | Experimental | Grazoprevir 100 mg/d during 12 weeks. Elbasvir 50 mg/d during 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Grazoprevir 100 mg/d 8 weeks | Drug | Patients with 1b HCV genotype will be received treatment with Grazoprevir (100 mg) during 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sustained virological response. | Sustained virological response 12 (SVR12) defined as HCV-RNA undetectable at post-treatment. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Reinfection rate | Evaluate the reinfection rate during 1 year of follow-up Sustained virological response defined as HCV-RNA undetectable at post-treatment. | 1 year |
| Evaluate the safety and tolerability by means of number of participants with treatment-related adverse events. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnico y provincial de Barcelona | Barcelona | 08036 | Spain |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C578009 | grazoprevir |
| C000589335 | elbasvir |
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| Elbasvir 50 mg/d 8 weeks | Drug | Patients with 1b HCV genotype will be received treatment with Elbasvir (50mg) during 8 weeks. |
|
|
| Grazoprevir 100 mg/d 12 weeks | Drug | Patients with 1a or 4 HCV genotype will be received treatment with Grazoprevir (100 mg) during 12 weeks. |
|
|
| Elbasvir 50 mg/d 12 weeks | Drug | Patients with 1a or 4 HCV genotype will be received treatment with Elbasvir (50mg) during 12 weeks. |
|
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number of adverse events treatment-related assess in 62 patients. |
| 2 years |
| Evaluate the emergence of of viral resistance-associated variants (RAV) resistant to MK-5172 and MK-8742. during the follow up. | In case of viral failure confirmation during the follow up, viral resistence-associated variants will be assess by samples genotyping HCV protease and NS5A gene at baseline and after the viral failure. | 2 years |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |