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The proportion of HCV infected patients over age 65 years in Western countries is increasing. This growth and the advent of new antiviral therapy bring into the question the real world efficacy and safety of the combination of Sofosbuvir and Simeprevir (SOF/SMV) plus a flat dose of ribavirin (RBV) in elderly patients compared to younger patients.
The proportion of HCV infected patients over age 65 years in Western countries is increasing. This growth and the advent of new antiviral therapy bring into the question the real world efficacy and safety of the combination of Sofosbuvir and Simeprevir (SOF/SMV) plus a flat dose of ribavirin (RBV) in elderly patients (Group II) compared to younger patients (Group I) Multicenter, real world investigation study of once daily treatment with SOF 400 mg + SMV 150 mg with a flat dose of RBV 800 mg/day for a duration of 12 weeks in treatment naïve or experienced HCV genotype 1-infected patients with compensated cirrhosis.To evaluate efficacy, tollerability and safety of SOF/SMV/RBV in two different Group of patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (<65 years) | Active Comparator | Group I treated with Sofosbuvir 400mg/day/Simeprevir 150mg/day /Ribavirin 800mg/day for 12 weeks |
|
| Group II (>65 years) | Active Comparator | Group II treated with Sofosbuvir 400mg/day/Simeprevir 150mg/day /Ribavirin 800mg/day for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sofosbuvir 400mg/day/Simeprevir 150mg/day /Ribavirin 800mg/day for 12 weeks | Drug | Sofosbuvir 400 mg/day/Simeprevir 150 mg/day /Ribavirin 800/day for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sustained virological response week 12 after the end of treatment | to evaluate the efficacy in term of sustained virological response after 12 weeks from the end of treatment in the two Groups of patients | up 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events and severe adverse events during the treatment period | To report Adverse events and severe adverse events during the treatment period in the two Groups of patients | up 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adriano M Pellicelli, MD | AO San Camillo Forlanini ROme ITALY | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AO San Camillo Forlanini | Rome | Italy | 00142 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22510262 | Background | Pellicelli AM, Romano M, Guarascio P, Vignally P. Which is the real efficacy of pegylated interferon alpha 2a or 2b plus ribavirin in HCV infected patients with advanced fibrosis? J Hepatol. 2012 Sep;57(3):704-5. doi: 10.1016/j.jhep.2012.03.008. Epub 2012 Apr 14. No abstract available. | |
| 26890629 | Result | Fontana RJ, Brown RS Jr, Moreno-Zamora A, Prieto M, Joshi S, Londono MC, Herzer K, Chacko KR, Stauber RE, Knop V, Jafri SM, Castells L, Ferenci P, Torti C, Durand CM, Loiacono L, Lionetti R, Bahirwani R, Weiland O, Mubarak A, ElSharkawy AM, Stadler B, Montalbano M, Berg C, Pellicelli AM, Stenmark S, Vekeman F, Ionescu-Ittu R, Emond B, Reddy KR. Daclatasvir combined with sofosbuvir or simeprevir in liver transplant recipients with severe recurrent hepatitis C infection. Liver Transpl. 2016 Apr;22(4):446-58. doi: 10.1002/lt.24416. |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000069474 | Sofosbuvir |
| D000069616 | Simeprevir |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
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|
| 24997638 | Result | Pellicelli AM, Montalbano M, Lionetti R, Durand C, Ferenci P, D'Offizi G, Knop V, Telese A, Lenci I, Andreoli A, Zeuzem S, Angelico M. Sofosbuvir plus daclatasvir for post-transplant recurrent hepatitis C: potent antiviral activity but no clinical benefit if treatment is given late. Dig Liver Dis. 2014 Oct;46(10):923-7. doi: 10.1016/j.dld.2014.06.004. Epub 2014 Jul 3. |
| 27782373 | Derived | Pellicelli AM, Pace Palitti V, Vignally P, Ceccherini-Silberstein F, Siciliano M, Giannelli V, Moretti A, Tarquini P, Scifo G, Messina V, Ascione A, Izzi A, Marignani M, D'Ambrosio C, Fondacaro L, Ettorre GM, Ialongo P, Sacco R, Perno CF, Barbarini G; CLEO Group. Efficacy and safety of sofosbuvir/simeprevir plus flat dose ribavirin in genotype 1 elderly cirrhotic patients: A real-life study. Liver Int. 2017 May;37(5):653-661. doi: 10.1111/liv.13288. Epub 2016 Dec 15. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |