Eight-week glecaprevir/pibrentasvir in Canadian hepatitis C virus-infected, treatment-naïve, compensated cirrhotic people: CREST study

Aim: Evaluation of the real-world effectiveness and safety of 8-week glecaprevir/pibrentasvir (G/P) in treatment-naive Canadian individuals with hepatitis C and compensated cirrhosis. Patients & methods: Analysis of Canadian people enrolled in the CREST study. Primary end point was sustained virologic response at posttreatment Week 12 (SVR12) rates; safety end points were also assessed. Results: Fifty-three individuals received ≥1 dose of G/P. In the modified analysis set (MAS; which excluded those who discontinued G/P [n = 1] or with missing SVR12 data [n = 12]), 98% (39/40) achieved SVR12; 1 person experienced virologic failure. No individuals experienced or discontinued treatment due to a serious adverse event. Conclusion: In this real-world Canadian cohort, 8-week G/P was well tolerated, with SVR12 rates similar to those in clinical trials. Clinical research studies have shown that a high proportion of individuals infected with hepatitis C virus (HCV) and with advanced liver disease who had not been treated before, were cured after treatment for 8–12 weeks with the oral medication glecaprevir/pibrentasvir (G/P). However, data in real-life are limited. To support these studies, we present the effectiveness and safety of G/P given for 8 weeks, in a real-life setting, in Canadian people with HCV infection and advanced liver disease who have not previously received HCV treatment. Our population included people who use drugs, those with excessive alcohol use and those with mental health conditions. These individuals represent a population at high risk for HCV infection and transmission. Our findings show that treatment with G/P for 8 weeks was effective and well tolerated in the general population as well as in vulnerable individuals. The results in this real-world setting were similar to those seen in clinical research studies, and more importantly in populations that are often underrepresented. This supports the use of G/P for treating HCV infection in underserved populations, which will be key to achieving global HCV elimination. Hepatitis C remains a global health concern. In Canada it is estimated that approximately 194,500 people are still living with hepatitis C virus (HCV) infection despite widespread availability of highly effective and well tolerated therapies. The World Health Organization has set a goal for the elimination of HCV as a public health concern by 2030. There are limited real-world data in patients with HCV infection and compensated cirrhosis (CC). This study examined the real-world effectiveness and safety of 8-week glecaprevir/pibrentasvir (G/P) in 53 Canadian, treatment-naive people with CC, including those with drug use disorder, excessive alcohol use and mental health conditions. In the overall population, 98% of patients achieved sustained virologic response at posttreatment Week 12 (SVR12). SVR12 rates remained high in patients including those with substance use disorder, excessive alcohol use, depression, FibroScan® ≥12.5 kPa and FibroScan >20 kPa or platelet count <150 × 109/l. Most common adverse events (AEs) were fatigue (26%, n = 14) and headache (11%, n = 6), with no serious or drug-related AEs reported and no AEs leading to treatment discontinuation. Our findings confirm the effectiveness and safety of G/P therapy in treatment-naive people with HCV genotype 1–6 and CC, including those who may be underserved in clinical trials. If strategies to optimize screening for HCV infection and linkage to care are implemented, we can be confident that an 8-week course of treatment with G/P can be offered to patients with CC, irrespective of co-morbidities and concomitant medications.

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