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

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.

The efficacy and safety of elbasvir/grazoprevir treatment in HCV genotype 1 patients in Taiwan

“…The clinical safety evaluation revealed that common side effects such as fatigue or headache were not observed. However, four participants experienced asymptomatic elevation of ALT levels at week 8, but their ALT levels subsequently returned to the normal range at weeks 10 to 12 . In our study, 12 of the recruited participants had comorbid chronic kidney failure, and 8 of them were required to undergo hemodialysis regularly.…”

“…The results of a C‐SURFER clinical trial in HCV patients with comorbid stage 4 or 5 kidney impairment confirmed its therapeutic effects (SVR12, 94%) and is highly safe . In 2018, researchers from the United States and Italy each published research evaluating and discussing the clinical efficacy of EBR/GZR after it was launched in these nations . TRIO is a retrospective study conducted collaboratively by physicians across 34 US states.…”

“…The cases number of GT 1a and medical history of HCC were limited and might result in bias; otherwise, the noncirrhosis plus HCV RNA viral load might be due to the difference of cases number (23 patients <800 000 IU/mL and 47 patients ≧800 000 IU/mL). In 2018, researchers from the United States and Italy each published research evaluating and discussing the clinical efficacy of EBR/GZR after it was launched in these nations 13,14. TRIO is a retrospective study conducted collaboratively by physicians across 34 US states.…”

Real-Life use of Elbasvir/Grazoprevir in Adults and Elderly Patients: A Prospective Evaluation of Comedications used in the PITER Cohort

“…These increases were typically asymptomatic, and they resolved with ongoing therapy or after its completion [16]. The frequency of late ALT increases has been reported to be higher in patients with higher GZR plasma concentrations, which could in part be due to the DDIs with one or more concomitant drugs [28,29]. In our study, no DDIs with ELB/GZR were reported in patients with increased ALT levels during antiviral treatment.…”

Effectiveness and Safety of a New Nutrient Fixed Combination Containing Pollen Extract Plus Teupolioside, in the Management of LUTS in Patients with Benign Prostatic Hypertrophy: A Pilot Study

“…Consistent with our previous article, we used the Naranjo scale and the Drug Interaction Probability Scale to evaluate the development of ADRs or DDIs, respectively [ 19 , 20 , 21 , 22 ].…”