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Hepatitis C virus (HCV) chronic infection affects 200 million people worldwide. HCV antiviral treatment has evolved rapidly since 2011. The use of pegylated interferon (PEG-INF) with ribavirin (RBV) has supposed high serious adverse events (SAEs) and low efficacy, especially in patients with cirrhosis. The introduction of 1st generation protease inhibitors (PIs) in genotype-1 (GT1) HCV, such as boceprevir (BOC) and telaprevir (TVR), improved the efficacy but increased the SAEs. Currently, interferon-free direct-acting antivirals (IF-DAAs) achieve great effectiveness with minimum SAEs. However, studies evaluating efficacy and safety of DAAs in cirrhotic patients are limited in real clinical practice. The aim of our study is to evaluate in HCV-cirrhotic patients the efficacy and safety of 3 treatment strategies (PEG-IFN/RBV, PEG-IFN/RBV/PIs, and IF-DAAs) in routine practice according to European guidelines from 2010 to 2015. The secondary aim is to evaluate the impact of sustained virological response on gastroesophageal varices (GOV).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG/RBV | Pegylated interferon alfa-2a 180 microg/week plus ribavirin 800-1200 mg during 48 weeks according to routine practice and European Guidelines (EASL recommendations 2011) |
| |
| PEG/RBV+BOC or TVR | Boceprevir 800 mg/8h or Telaprevir 750 mg/8h plus Pegylated interferon alfa-2a 180 microg/week plus ribavirin 800-1200 mg during 48 weeks according to routine practice and European Guidelines (EASL recommendations 2014) |
| |
| IF-DAAs | Interferon-free direct-acting antiviral combinations according to routine practice and European Guidelines (EASL recommendations 2015)
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegylated interferon alfa-2a + Ribavirin | Drug |
| ||
| Pegylated interferon alfa-2a + Ribavirin + Boceprevir |
| Measure | Description | Time Frame |
|---|---|---|
| sustained virological response (SVR) | undetectable HCV viral load 12 weeks after the end of antiviral treatment in each cohort of antiviral treatment | 12 weeks after treatment completion |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with gastroesophageal varices | Number of patients with GOV before and 12-24 weeks after treatment completion in patients with or without SVR | gastroesophageal varices (GOV) before antiviral treatment and 12-24 weeks after treatment completion |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with chronic hepatitis C by genotype 1 and liver cirrhosis
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31493238 | Derived | Puigvehi M, Londono MC, Torras X, Lorente S, Vergara M, Morillas RM, Masnou H, Serrano T, Miquel M, Gallego A, Lens S, Carrion JA. Impact of sustained virological response with DAAs on gastroesophageal varices and Baveno criteria in HCV-cirrhotic patients. J Gastroenterol. 2020 Feb;55(2):205-216. doi: 10.1007/s00535-019-01619-0. Epub 2019 Sep 6. |
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| Drug |
|
| Pegylated interferon alfa-2a + Ribavirin +Telaprevir | Drug |
|
| Ledipasvir/Sofosbuvir | Drug |
|
| Ombitasvir/paritaprevir/ritonavir+Dasabuvir | Drug |
|
| Daclatasvir+Sofosbuvir | Drug |
|
| Simeprevir+Sofosbuvir | Drug |
|
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| C512204 | N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide |
| C000595958 | ledipasvir, sofosbuvir drug combination |
| C000607373 | Viekira Pak |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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