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.
Keywords: HCV infection; efficacy; elbasvir-grazoprevir fixed-dose combination; real life; safety.
© 2018, The American College of Clinical Pharmacology.