Real-world effectiveness and safety of glecaprevir/pibrentasvir for the treatment of patients with chronic HCV infection: A meta-analysis

Lampertico, Pietro; Carrión, J.A.; Curry, Michael P.; Turnés, Juan; Cornberg, Markus; Negro, Francesco; Brown, Ashley; Persico, Marcello; Wick, Nicole; Porcalla, Ariel; Pangerl, Andreas; Crown, Eric D.; Larsen, Lois; Yu, Yao; Wedemeyer, Heiner

doi:10.1016/j.jhep.2020.01.025

Cited by 70 publications

(77 citation statements)

References 38 publications

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“…Our study revealed that GLE/PIB could with the SVR rates reaching values of 96.6% and 98.7%, as observed using ITT and PP analysis, respectively in the real-world setting, and there was no significant difference between patients with and without ESRD. The response rates in the present cohort were comparable with other clinical trials [ 2 , 19 , 20 ] and recent real-world data [ 7 , 21 – 24 ] for patients with and without ESRD. HCV treatment experience from the real world is important because the patient population tends to be clinically more diverse and potentially less adherent to treatment compared with those included in clinical trials.…”

Section: Discussionsupporting

confidence: 90%

“…HCV treatment experience from the real world is important because the patient population tends to be clinically more diverse and potentially less adherent to treatment compared with those included in clinical trials. A recent meta-analysis of the real-world effectiveness of GLE/PIB treatment for HCV in patients with chronic HCV infection included 12,531 adults from 18 cohorts with an overall SVR rate of 96.7% in the ITT group [21]. Available data on patients with renal failure is limited, and only 59 patients were included in that study.…”

Section: Plos Onementioning

confidence: 99%

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Glecaprevir–pibrentasvir for chronic hepatitis C: Comparing treatment effect in patients with and without end-stage renal disease in a real-world setting

Yen

Zeng

et al. 2020

PLoS ONE

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Introduction Chronic hepatitis C virus (HCV) infection is increasingly observed in patients with renal disease. With the introduction of glecaprevir/pibrentasvir (GLE/PIB) as a pan-genotype therapy for HCV, treatment efficacy is expected to rise. Materials and methods This retrospective study evaluated the efficacy and safety of GLE/PIB treatment in adults with HCV infection and end-stage renal disease (ESRD). The primary end point was sustained virological response (SVR) observed 12 weeks after completed treatment. Results We enrolled 235 patients, including 44 patients with ESRD. Median age was 60 years, and 48% were males. Twenty-two percent had cirrhosis. HCV genotypes 1 (43%) and 2 (41%) were the most common. The overall SVR rate was 96.6%. Patients with ESRD were older than those without (67.6 years vs 58.3 years, p < 0.001) and trended toward having a higher prevalence of cirrhosis (32% vs 19%, p = 0.071). A significant proportion of patients with ESRD complained of skin itching during treatment (61% vs 26%, p < 0.001), and the SVR rate were similar between these two groups (95.45% vs 96.86%, p = 0.644). Conclusions Despite a higher rate of pruritus among patients with ESRD, GLE/PIB-based therapy achieved similarly high SVR rates among patients with and without ESRD.

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Section: Discussionsupporting

confidence: 90%

Section: Plos Onementioning

confidence: 99%

Glecaprevir–pibrentasvir for chronic hepatitis C: Comparing treatment effect in patients with and without end-stage renal disease in a real-world setting

Yen

Zeng

et al. 2020

PLoS ONE

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“…17 Consistent with our findings, SVR12 rates were not influenced by the presence or absence of cirrhosis in real world studies. 28,29 Currently, glecaprevir/pibrentasvir is not recommended for patients with decompensated cirrhosis (Child-Pugh B and Child-Pugh C) due to elevated drug exposures. Pharmacokinetic studies of glecaprevir 300 mg/pibrentasvir 120 mg showed a 2.0-fold to 11-fold increase in glecaprevir AUC in HCV-negative subjects with moderate or severe hepatic impairment compared to normal subjects.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Glecaprevir/Pibrentasvir for Chronic Hepatitis C Patients: A Systematic Review and Meta-analysis

Wang

Xiao

et al. 2020

Journal of Clinical and Translational Hepatology

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Background and Aims: Glecaprevir/pibrentasvir is a pangenotypic regimen recently approved for the treatment of chronic hepatitis C virus (HCV) infection. The objective of the present review was to summarize the findings from clinical trials to understand how patient-related factors influence glecaprevir/pibrentasvir efficacy (sustained virologic response rates at 12 weeks' after treatment [referred to as SVR12]) and safety. Methods: Data from 21 phase III clinical trials were analyzed. Results: The integrated efficacy analysis included 4,817 patients. Findings showed 97.5% of all included patients with chronic HCV achieved SVR12 in the intention-to-treat population. SVR12 rate was >95% across subgroups of interest. The integrated safety analysis included 4,015 patients. Findings showed that 64.1% of patients reported an adverse event, and <0.1% of patients reported a serious adverse event related to glecaprevir/pibrentasvir. Conclusions: These results indicate that the 8-or 12-week glecaprevir/pibrentasvir treatment is effective for patients infected with HCV genotypes 1-6 without or with compensated cirrhosis, with good safety profiles, irrespective of treatmentexperience. Glecaprevir/pibrentasvir is a good option for patients with human immunodeficiency virus/HCV coinfection and comorbid HCV and severe renal impairment.

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“…15 Data from a combined analysis of 18 real-world studies showed that the SVR rate for treatment-naïve patients without cirrhosis who received G/P treatment for 8 weeks was 98.2% (n=697) in the ITT population and 99.3% (n=3,657) in the modified ITT population. 49 For patients with treatment experience, the SVR rate was 90.7% (49/54), among which 4 patients were lost to follow-up. 16…”

Section: Treatment-naïve or Patients Experienced In Regimens Containimentioning

confidence: 95%

“…13 Data from real-world studies showed that the SVR12 rate for patients with compensated cirrhosis who received G/P treatment was 97.8% (n=676) in the ITT population and 98.2% (N=822) in the modified ITT population. 49 For treatment-naive patients with compensated cirrhosis treated for 12 weeks, the SVR12 rate was 99.0% (n=362). 49 To our knowledge, currently there is no real-world data to evalu-ate the efficacy of G/P treatment for 8 weeks in treatmentnaïve patients with compensated cirrhosis.…”

Section: Treatment-naïve or Prs-experienced Patients With Compensatedmentioning

confidence: 99%

Efficacy and Safety of Glecaprevir/Pibrentasvir in Patients with Chronic HCV Infection

Liu¹,

Hu²

2021

Journal of Clinical and Translational Hepatology

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Hepatitis C virus (HCV) infection is a major cause of endstage liver disease, including decompensated cirrhosis and hepatocellular carcinoma. Over 95% of patients with HCV infection have achieved sustained virologic response at 12 weeks under the treatment of several pan-genotypic regimens approved for patients with HCV infection. The glecaprevir/pibrentasvir (G/P) regimen has some features that distinguish it from others and is the only 8-week regimen approved for treatment-naive patients and patients experienced in regimens containing (peg)interferon, ribavirin, and/ or sofosbuvir, without an HCV NS3/4A protease inhibitor or NS5A inhibitor (except those with genotype 3). This review aims to summarize the efficacy and safety of G/P in HCVinfected patients from clinic trials and real-world studies, including those who have historically been considered difficult to cure.

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Real-world effectiveness and safety of glecaprevir/pibrentasvir for the treatment of patients with chronic HCV infection: A meta-analysis

Abstract: Highlights Meta-analysis of real-world data from 12,583 patients taking glecaprevir/pibrentasvir. Glecaprevir/pibrentasvir achieved 96.7% virologic cure overall. Virologic cure was > − 95% across subgroups of interest. Serious adverse events were reported in 1.0% of patients.

Cited by 70 publications

References 38 publications

Glecaprevir–pibrentasvir for chronic hepatitis C: Comparing treatment effect in patients with and without end-stage renal disease in a real-world setting

Glecaprevir–pibrentasvir for chronic hepatitis C: Comparing treatment effect in patients with and without end-stage renal disease in a real-world setting

Efficacy and Safety of Glecaprevir/Pibrentasvir for Chronic Hepatitis C Patients: A Systematic Review and Meta-analysis

Efficacy and Safety of Glecaprevir/Pibrentasvir in Patients with Chronic HCV Infection

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