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Liver Int. 2017 May;37(5):653-661. doi: 10.1111/liv.13288. Epub 2016 Dec 15.

Efficacy and safety of sofosbuvir/simeprevir plus flat dose ribavirin in genotype 1 elderly cirrhotic patients: A real-life study.

Author information

1
Liver Disease Unit, Department of Liver Transplantation, San Camillo Forlanini Hospital, Rome, Italy.
2
Hepatology Department of Medicine, ASL Pescara, Pescara, Italy.
3
Emergency Department, Galliera Hospital, Genoa, Italy.
4
Department of Experimental Medicine and Surgery, University of Tor Vergata, Rome, Italy.
5
Internal Medicine, Catholic University Policlinico Gemelli, Rome, Italy.
6
Gastroenterology, San Filippo Neri Hospital, Rome, Italy.
7
Infectious Disease, ASL Teramo, Teramo, Italy.
8
Infectious Disease, Umberto I Hospital, Siracusa, Italy.
9
Infectious Disease, Sant'Anna and San Sebastiano Hospital Caserta, Rome, Italy.
10
Center for Liver Disease, Fatebenefratelli Hospital, Napoli, Italy.
11
Infectious Disease, Cotugno Hospital, Napoli, Italy.
12
Digestive and Liver Disease Unit, Faculty Medicine and Psychology, S. Andrea Hospital, Sapienza University of Rome, Rome, Italy.
13
Division of General Surgery and Liver Transplantation, S. Camillo Forlanini Hospital, Rome, Italy.
14
Radiology, Camillo Forlanini Hospital, Rome, Italy.
15
Liver Unit, Azienda Universitaria Pisana, Pisa, Italy.
16
Infectious Disease, IRCCS San Matteo, Pavia, Italy.

Abstract

BACKGROUND & AIMS:

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 (SOF) and simeprevir (SMV) plus a flat dose of 800 mg/d ribavirin (RBV) in elderly patients with cirrhosis compared to younger patients.

METHODS:

Retrospective observational multicentre real-life investigation study of SOF/SMV/RBV for a duration of 12 weeks in HCV genotype 1-infected patients with cirrhosis.

RESULTS:

Of the 270 patients enrolled in this study, with compensated cirrhosis, 133 (49.2%) were ≥65 years of age. Sustained virological response at 12 weeks (SVR12) was achieved by 94.2% (129/137) of those aged <65 years and 97.7% (130/133) of those ≥65 years. Diabetes was the most common comorbidity in patients ≥65 years compared to younger patients (26.3% vs 12.4% P<.003). The most common adverse event (AE) in elderly patients was a grade 2 anaemia (35.3% vs 19.9% P<.004).

CONCLUSIONS:

Sofosbuvir/simeprevir plus a daily flat dose of RBV 800 mg for 12 weeks was highly effective and safe in genotype 1 elderly patients with compensated cirrhosis.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT02702739.

KEYWORDS:

cirrhosis; elderly; genotype 1; hepatitis C; simeprevir; sofosbuvir

PMID:
27782373
DOI:
10.1111/liv.13288
[Indexed for MEDLINE]

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