Early View of the Effectiveness of New Direct-Acting Antiviral (DAA) Regimens in Patients with Hepatitis C Virus (HCV)

Abstract

IntroductionClinical trials have demonstrated the efficacy of all-oral direct-acting antiviral (DAA) regimens in the treatment of patients infected with hepatitis C virus (HCV). This study assessed real-world effectiveness of two recently approved regimens; paritaprevir/ritonavir/ombitasvir; dasabuvir (3D), and sofosbuvir/ledipasvir (SOF/LDV) in patients with HCV genotype 1.MethodsA retrospective analysis of administrative claims data (IMS Health Patient-Centric Data Warehouse/Medivo database) from October 1, 2013 to August 14, 2015 was conducted. Patients ≥19 years of age with a HCV genotype 1 infection, a prescription fill for 3D or SOF/LDV, and ≥1 HCV viral load (VL) assessment from weeks 4–30 post-treatment were selected for analysis. Percentages of patients achieving sustained virologic response (SVR; defined as HCV RNA ≤43 IU/mL) were determined. Unadjusted SVR rates were compared between treatment groups using Fisher’s exact tests. SVR rates were also assessed using multivariate regression with adjustment for age group, sex, and treatment history. Analyses were repeated for a subset of patients with VL assessment from 12 to 30 weeks post-treatment.ResultsA total of 1707 (44 3D and 1663 SOF/LDV) patients were included. The majority (60%) were male, 49% were aged 55–64 years, and 97% were treatment-naïve 1 year prior to index. The unadjusted relative risk (RR) for achieving SVR in patients treated with SOF/LDV compared with 3D was 0.98%, 95% confidence interval (CI): 0.93–1.02. After adjusting for the baseline covariates, the RR was 0.98%, 95% CI: 0.94–1.03.ConclusionsIn this early view of real-world data, effectiveness of all-oral DAA regimens in HCV genotype 1 patients was concordant with results from registration trials. SVR rates were similar for the two regimens. Further studies are needed to confirm these results.FundingAbbVie, Inc.Electronic supplementary materialThe online version of this article (doi:10.1007/s12325-015-0258-5) contains supplementary material, which is available to authorized users.

Real-Life Use of 3 Direct-Acting Antiviral Regimen in a Large Cohort of Patients with Genotype-1b HCV Compensated Cirrhosis

“…This is best reflected by very high SVR rates in both compensated and decompensated HCV GT-1 liver cirrhosis patients. Our study is in accordance with previous real-life studies investigating the efficacy of OBV/PTV/r+DSV±RBV in chronic hepatitis C patients [9][10][11][12][17][18][19] with SVR rates between 86% and 100%. In real-life cohorts, patients who failed to achieve SVR were mainly cirrhotics [9][10][17][18].…”

“…This is similar to a controlled clinical trial where cirrhotic 1b-infected patients taking RBV during 12 weeks, achieved a SVR12 rate of 98.5% [5]. The single real-life study [19] showing 100% SVR rates for 3DAA regimen included only 15 patients and no information about the stage of fibrosis, thus comparison to our study is not reliable. It is true that HCV GT-1b is the easiest-to-treat genotype in DAA era and the addition of RBV to 3DAA regimen in the national protocol probably contributed to the high SVR rate in this F4 GT-1 population.…”

Screening and diagnosis of chronic HCV infection in Bulgaria: A review of the current practice

“…The therapeutic success increased significantly to 95%-97% Sustained Viral Response (SVR) depending on the fibrosis stage and cirrhosis [5][6][7][8][9]. Therefore a necessity of earlier diagnosis became indubitable to prevent the future complications and deaths.…”

Effectiveness of dasabuvir/ombitasvir/paritaprevir/ritonavir for hepatitis C virus in clinical practice: A population-based observational study

“…Without such treatments, chronic infection with HCV has a major impact on quality of life and healthcare utilization [9, 10], including long-term complications such as liver failure, the need for liver transplant, the development of hepatic cancer, and an elevated risk for mortality [11]. …”