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

Liver Cirrhosis Clinical Trial

— HCV  

Official title:

Efficacy and Safety of Sofosbuvir/Simeprevir Plus a Flat Dose of Ribavirin in Genotype 1 Elderly Cirrhotic Patients: a Real Life Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02702739
• Other study ID #: FDAAA 801
• Status: Completed
• Phase: Phase 4
• First received: February 23, 2016
• Last updated: March 8, 2016
• Start date: January 2015
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: Azienda Ospedaliera San Camillo Forlanini
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: February 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 82 Years

Eligibility

Inclusion Criteria:

• Naive or experienced patients with genotype 1 compensated cirrhosis

Exclusion Criteria:

• 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Cirrhosis

Intervention

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

Locations

Country	Name	City	State
Italy	AO San Camillo Forlanini	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera San Camillo Forlanini

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Fontana RJ, Brown RS, Moreno-Zamora A, Prieto M, Joshi S, Londoño 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, Montal — View Citation

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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes