Sofosbuvir/Simeprevir Plus a Flat Dose of Ribavirin in Genotype 1 Elderly HCV Cirrhotic Patients

NCT02702739 | Completed Phase 4

• 1 other identifier: FDAAA 801
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Adverse events and severe adverse events during the treatment period

  up 12 weeks

Study Arms (2)

Group I (<65 years)

ACTIVE COMPARATOR

Group I treated with Sofosbuvir 400mg/day/Simeprevir 150mg/day /Ribavirin 800mg/day for 12 weeks

Drug: 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

Drug: Sofosbuvir 400mg/day/Simeprevir 150mg/day /Ribavirin 800mg/day for 12 weeks

Interventions

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

Also known as: Sovaldi Olysio Copegus

Group I (<65 years); Group II (>65 years)

Eligibility Criteria

• Age: 18 Years - 82 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Naive or experienced patients with genotype 1 compensated cirrhosis

You may not qualify if:

• HIV and hepatitis B infection, active hepatocellular carcinoma (HCC), decompensated cirrhosis, history of organ transplant, severe psychiatric disorders or treatment with drugs that showed an interaction with antiviral treatment.

Sponsors & Collaborators

• Azienda Ospedaliera San Camillo Forlanini: lead

Study Sites (1)

AO San Camillo Forlanini

Rome, Italy, 00142, Italy

Location

Related Publications (4)

• 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.

  PMID: 22510262 BACKGROUND

• 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.

  PMID: 26890629 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.

  PMID: 24997638 RESULT

• 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.

  PMID: 27782373 DERIVED

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Sofosbuvir; Simeprevir; Ribavirin

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Ribonucleosides; Nucleosides

Study Officials

• Adriano M Pellicelli, MD

  AO San Camillo Forlanini ROme ITALY

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Liver Unit

Study Record Dates

• First Submitted: February 23, 2016
• First Posted: March 9, 2016
• Study Start: January 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: February 1, 2016
• Last Updated: March 9, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)