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Sustained virologic response was reached by 98% of the study at 12 weeks following the conclusion of treatment and remained consistent among genotype, HCV RNA values, fibrosis stage, and the subgroup of interest.
Elbasvir-grazoprevir treatment results in high rates of sustained virologic response (SVR), as well as drops in alcohol use and increases in quality of life for patients with chronic hepatitis C virus (HCV) infections.
A team, led by Jean-Pierra Bronowicki, Hépato-gastroentérologie, CHRU Nancy, INSERM 1256, Université de Lorraine, Nancy, CHRU Vandoeuvre les Nancy, assessed the real-life effectiveness of elbasvir-grazoprevir therapy in the general population and among subgroups with a high hepatitis C virus prevalence in France.
There is a well-established efficacy and safety profile of elbasvir-grazoprevir, with data from more than 10 clinical trials available.However, the characteristics of patients treated in routine clinical practice could differ.
In the multicenter, prospective, observational Zephyr study, the investigators analyzed the use and effectiveness of elbasvir-grazoprevir in current practice for 467 patients with chronic HCV. The results are based on data for adult patients who received at least 1 dose of the treatment between December 2017 and June 2019 in 67 hospitals and clinics in France. The mean age of patients was 55.7 years.
The investigators balanced gender among the patient population and designed a treatment plan to monitor patients for 48 weeks after the end of treatment.
Data was collected from medical records that were closest to the treatment initiation and prespecified follow-up time points, as well as from the routine interviews during the consultations.
The majority of patients (89.5%) were treatment-naïve and infected with genotype 1b (70.4%).
Of the 75 patients with HCV Gt1a genotype, 56% had HCV RNA ≥ 800,000 IU/ml, while 24.2% of the entire patient population had stage F3-F4 fibrosis.
The investigators also conducted a subgroup analysis among 110 migrants (23.6%) and found `5.3% (n = 58) were using opioid agonist treatment, including individuals who inject drugs, 6.8% (n = 30) with chronic kidney disease stages 3–5, 1.9% (n = 9) with an inherited blood disorder, and 0.9% (n = 4) coinfected with HIV.
The remaining 58.7% (n = 269) of the study were included in the general population subgroup analysis.
Sustained virologic response was reached by 98% of the study at 12 weeks following the conclusion of treatment. This remained consistent among genotype, HCV RNA values, fibrosis stage, and the subgroup of interest.
However, the rate of Alcohol Use Disorders Identification Test-Consumption and Life Habit questionnaire completion was high at each visit. The data suggested alcohol consumption was decreasing with an improvement in the quality of life.
“Using real-world evidence data on a French population representative of HCV patients, we confirmed the results obtained during EBR/GZR development program,” the authors wrote.
The study, “An observational, prospective, multicenter study on the utilization and effectiveness of elbasvir–grazoprevir treatment association for chronic hepatitis C in France (ZEPHYR study),” was published online in Health Science Reports.