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The aim of the study is to evaluate in clinical practice the efficacy and safety of ombitasvir/paritaprevir/ ritonavir and dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b hepatitis C virus (HCV).
HCV chronic infection affects 200 million people worldwide. HCV antiviral treatment has evolved rapidly since 2011. The introduction of direct-acting antivirals (DAAs) achieve great effectiveness with minimum SAEs and short treatment duration. However, studies evaluating efficacy and safety of ombitasvir/paritaprevir/ ritonavir and dasabuvir during 8 weeks are limited in real clinical practice. The aim of the study is to evaluate in clinical practice the efficacy and safety of ombitasvir/paritaprevir/ ritonavir and dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b hepatitis C virus (HCV).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spanish cohort with HCV treated with DAA | Spanish cohort with HCV treated in real practice with ombitasvir/paritaprevir/ritonavir 8 weeks and dasabuvir 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ombitasvir/paritaprevir/ritonavir 8 weeks | Drug | Spanish cohort with HCV treated in real practice with ombitasvir/paritaprevir/ ritonavir 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sustained virological response 12 weeks post-treatment (SVR12) | Percentage of participants who achieve sustained virological response 12 weeks post-treatment (SVR12) • Measure: Hepatitis C virus ribonucleic acid (HCV-RNA) levels less than the lower limit of quantification. | 12 weeks after the last dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with virologic failure during treatment | Percentage of patients with virologic failure during treatment • Measure: Percentage of patients with confirmed >=1 log10 IU/mL increase from nadir in HCV RNA at any time point during treatment | Up to 12 weeks after last dose of study drug |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with HCV who are treated in real practice with Ombitasvir/Paritaprevir/Ritonavir+Dasabuvir
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carrion, Jose Antonio, PhD | Barcelona | 08003 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30160363 | Derived | Puigvehi M, De Cuenca B, Viu A, Diago M, Turnes J, Gea F, Pascasio JM, Lens S, Cabezas J, Badia E, Olveira A, Morillas RM, Torras X, Montoliu S, Cordero P, Castro JL, Salmeron J, Molina E, Sanchez-Ruano JJ, Moreno J, Anton MD, Moreno JM, De la Vega J, Calleja JL, Carrion JA. Eight weeks of Paritaprevir/r/Ombitasvir + Dasabuvir in HCV genotype 1b with mild-moderate fibrosis: Results from a real-world cohort. Liver Int. 2019 Jan;39(1):90-97. doi: 10.1111/liv.13950. Epub 2018 Nov 12. |
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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 |
|---|---|
| C586094 | ombitasvir |
| C585405 | paritaprevir |
| D019438 | Ritonavir |
| C588260 | dasabuvir |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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|
| dasabuvir 8 weeks | Drug | Spanish cohort with HCV treated in real practice with dasabuvir 8 weeks |
|
|
| Mild fibrosis and sustained virological response 12 weeks post-treatment |
Percentage of patients with mild fibrosis who achieve sustained virological response 12 (SVR12) weeks post-treatment • Measure: percentage of patients with a baseline transient elastography < 6 kPa |
| Up to 12 weeks after last dose of study drug |
| Percentage of participants with low baseline viral load and SVR12 weeks post-treatment | Percentage of participants with low baseline viral load who achieve sustained virological response 12 (SVR12) weeks post-treatment • Measure: HCV RNA levels less than the lower limit of quantification. | Baseline and 12 weeks after the last dose of drug |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |