Volume 58, Issue 10 p. 1248-1253
Therapeutics

Efficacy and Safety of Elbasvir-Grazoprevir Fixed Dose in the Management of Polytreated HCV Patients: Evidence From Real-Life Clinical Practice

Benedetto Caroleo MD

Benedetto Caroleo MD

Department of Medical Science, and Elderly Operative Unit, Mater Domini Hospital, University of Catanzaro, Catanzaro, Italy

Search for more papers by this author
Lidia Colangelo MD

Lidia Colangelo MD

Department of Medical Science, and Elderly Operative Unit, Mater Domini Hospital, University of Catanzaro, Catanzaro, Italy

Search for more papers by this author
Maria Perticone MD

Maria Perticone MD

Department of Medical Science, and Elderly Operative Unit, Mater Domini Hospital, University of Catanzaro, Catanzaro, Italy

Search for more papers by this author
Giovambattista De Sarro MD

Giovambattista De Sarro MD

Department of Health Sciences, and Clinical Pharmacology and Pharmacovigilance Unit, MaterDomini Hospital, University of Catanzaro, Catanzaro, Italy

Search for more papers by this author
Luca Gallelli MD, PhD

Corresponding Author

Luca Gallelli MD, PhD

Department of Health Sciences, and Clinical Pharmacology and Pharmacovigilance Unit, MaterDomini Hospital, University of Catanzaro, Catanzaro, Italy

Corresponding Author:

Luca Gallelli, MD, PhD, Department of Health Science, University of Catanzaro and Clinical Pharmacology and Pharmacovigilance Operative Unit, MaterDomini Hospital, Via T Campanella 115-88100, Catanzaro, Italy.

Email: [email protected]

Search for more papers by this author
First published: 10 May 2018
Citations: 3

Abstract

Chronic hepatitis C virus (HCV) infection represents a global public health challenge, and new drugs have been authorized for its treatment. In this study, we evaluated both the clinical efficacy and safety of elbasvir-grazoprevir fixed-dose combination in HCV patients. We performed a prospective single-blind study on patients admitted to the Regional Center for HCV Treatment of the University of Catanzaro from March 1, 2017, to December 31, 2017, in patients >30 years old with a history of chronic HCV infection. During the study period, we enrolled 29 HCV patients (18 women and 11 men; age, 62.5 ± 14 years, range 36-82; HCV-RNA: 2 384 859 ± 2 487 747 IU/mL, range, 60 400 − 8 930 000 IU/mL genotype 1b). In 28 of 29 patients (96.5%) we documented a rapid and complete remission of HCV infection 4 weeks after the beginning of the treatment, while in 1 patient it was reached in 8 weeks. During the study, we did not record any serious adverse drug reaction or drug interaction and no patients discontinued the treatment. However, 4 patients (13.8%) developed an asymptomatic plasma transaminase increase that appeared at 8 weeks after the beginning of the treatment and disappeared 4 weeks later in 3 patients and 8 weeks later in 1 patient. In conclusion, we documented that in real life the development of plasma transaminase increase in 4 elderly women >70 years old, suggesting that more attention must be focused on this age population.