Glecaprevir/pibrentasvir is safe and effective in hepatitis C patients with cirrhosis: Real‐world data from the German Hepatitis C‐Registry

Abstract

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Real-World Outcomes in Historically Underserved Patients with Chronic Hepatitis C Infection Treated with Glecaprevir/Pibrentasvir

“…Although real-world studies of glecaprevir/pibrentasvir use in routine clinical practice are currently limited, our results are consistent with findings from recently published or presented real-world studies of glecaprevir/pibrentasvir in Germany [ 19 , 37 ], Italy [ 20 , 25 ], USA [ 23 , 26 ], and Scotland [ 24 ]. Similarities include the high percentages of treatment-naïve non-cirrhotic patients (> 77%), a majority of patients with HCV GT1, and median age greater than 45 years in this PMOS and in the other cohorts.…”

“…Thirteen treatment-naïve patients with CC received 8-week glecaprevir/pibrentasvir, of which nine achieved SVR12 with no virologic failures (SVR12 for the remaining patients are pending). Previous real-world data have also demonstrated high SVR12 rates among patients receiving 8-week glecaprevir/pibrentasvir [ 19 , 23 – 26 , 37 , 43 ]. These data suggest that glecaprevir/pibrentasvir may be an appropriate and effective treatment option for all patients with CHC, including PWUD and other underserved populations.…”

“…1 Patients who consumed more than two drinks/day. ARV antiretroviral, CC compensated cirrhosis, CPSFU core population with sufficient follow-up, G/P glecaprevir/pibrentasvir, PI protease inhibitor, OST opioid substitution treatment, PWUD persons who use drugs, SVR12 sustained virologic response at post-treatment week 12, TN treatment-naïve, VF virologic failure, wk week findings from recently published or presented real-world studies of glecaprevir/pibrentasvir in Germany [19,37], Italy [20,25], USA [23,26], and Scotland [24]. Similarities include the high percentages of treatment-naïve non-cirrhotic patients ([ 77%), a majority of patients with HCV GT1, and median age greater than 45 years in this PMOS and in the other cohorts.…”

“…One-third (35%, n / N = 697/2008) of the patients in our study were PWUD. Several of the previous studies did not specifically evaluate SVR12 rate among PWUD or had only small percentages of patients reporting active drug use [ 19 , 20 , 23 , 25 , 26 , 37 ]. It may be that active drug use was underreported in those studies or that active drug use remains a barrier to DAA treatment in real-world clinical settings across many countries.…”

Validation of Algorithms Using ICD-10 Clinical Modification (CM) Codes in Claims Data to Identify People With Viral Hepatitis

“…An increasing number of studies using real world data to assess the effectiveness and safety of anti-viral medication among people with viral hepatitis. [1][2][3][4][5] One critical step in using real world data is the use of the International Classi cation of Diseases (ICD) codes to identify people with a given disease, either as the main health outcome or as a covariate. 6,7 The checklist item 6.2 in REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) states that "any validation studies of the codes or algorithms used to select the population should be referenced."…”