Glecaprevir/pibrentasvir for 8 weeks in patients with compensated cirrhosis: Safety and effectiveness data from the German Hepatitis C‐Registry

Klinker, Hartwig; Naumann, Uwe; Rössle, Martin; Berg, Thomas; Bondin, Mark; Lohmann, K; Koenig, Bettina; Zeuzem, Stefan; Cornberg, Markus

doi:10.1111/liv.14937

Cited by 11 publications

(9 citation statements)

References 16 publications

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“…Patients in subgroups of interest such as those with low platelets or with high FibroScan, FIB-4 index, or APRI scores had similar rates of SVR12, supporting the use of 8-week therapy in patients with CC. The favorable safety profile of G/P in this real-world cohort was consistent with that reported in previous clinical trials and real-world studies of G/P for patients with CC [ 8 , 12 ], including EXPEDITION-8, where no serious drug-related AEs or discontinuations due to AEs were reported [ 9 ]. Furthermore, the high SVR12 rates observed in patients traditionally considered as being underserved are in line with the findings from studies which have demonstrated that G/P treatment was highly effective in patients with substance abuse and psychiatric comorbidities [ 13 , 14 , 17 ].…”

Section: Discussionsupporting

confidence: 87%

“…A few real-world studies have evaluated G/P in patients with CC, with a special interest in harder-to-treat groups such as those with comorbidities, those with HCV GT3 infection, people who use drugs (PWUD), those with a psychiatric disorder, and those with other barriers to treatment [ 11 – 14 ]. These studies have shown that SVR12 rates with G/P remain high and ≥ 98% in the PP population of GT1–6 patients [ 11 , 12 , 15 ]. Although these data showed G/P was well tolerated and led to high SVR12 rates, potential barriers to successful treatment, such as the presence of comorbidities and patients with other risk factors, may not always be well represented in registrational trials.…”

Section: Introductionmentioning

confidence: 99%

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Safety and Effectiveness Using 8 Weeks of Glecaprevir/Pibrentasvir in HCV-Infected Treatment-Naïve Patients with Compensated Cirrhosis: The CREST Study

et al. 2022

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Introduction In clinical trials with hepatitis C virus-infected treatment-naïve (TN) patients with compensated cirrhosis (CC), glecaprevir/pibrentasvir (G/P), a fixed-dose, once-daily, pangenotypic regimen, has demonstrated sustained virologic response at posttreatment Week 12 (SVR12) > 95%. We evaluated the real-world safety and effectiveness of 8-week G/P therapy in TN patients with CC, including certain subgroups of interest. Methods The CREST study is a real-world, noninterventional, multicenter study retrospectively assessing data from Canada, Germany, Israel, Italy, and Spain. The full analysis set (FAS) designated all patients in the study; the modified analysis set (MAS) excluded patients who discontinued G/P for nonvirologic failure or who had missing SVR12 data. The primary endpoint was SVR12; safety endpoints were also assessed. Results A total of 386 patients were included in the FAS, 375 patients completed the study, and 325 patients were included in the MAS; 51 patients had missing SVR12 data. Overall, in the MAS and FAS, SVR12 was achieved in 99.1% and 84.2% of patients, respectively. In subgroups of interest, the percentage of patients achieving SVR12 in the MAS (and FAS) was: genotype (GT)3: 97.5% (80.6%); FibroScan ® ≥ 12.5 kPa: 98.9% (89.3%); platelet count < 100 × 10 9 /l: 100% (88.2%); both platelets < 150 × 10 9 /l and FibroScan ® > 20 kPa: 100% (88.9%); aspartate aminotransferase-to-platelet ratio index > 1.09: 98.7% (83.1%); fibrosis-4 index > 3.25: 98.6% (84.0%); albumin < 3 g/dl: 100% (91.7%); people who use drugs: 97.7% (84.3%); psychiatric disorders: 96.6% (84.8%); and human immunodeficiency virus coinfection: 100% (95.0%). Overall, 26.9% (104/386) of patients experienced an adverse event, none of which were classed as serious. Conclusion In this real-world cohort, 8 weeks of G/P therapy was well tolerated in TN patients with CC. SVR12 rates were similar to clinical trials, supporting 8-week treatment in TN patients with CC, including those with signs of advanced liver disease and GT3 infection.

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Section: Discussionsupporting

confidence: 87%

Section: Introductionmentioning

confidence: 99%

Safety and Effectiveness Using 8 Weeks of Glecaprevir/Pibrentasvir in HCV-Infected Treatment-Naïve Patients with Compensated Cirrhosis: The CREST Study

et al. 2022

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“…In one meta-analysis, involving 12,531 adults treated with G/P from 18 real-world reports [15], only 362 were cirrhotic. The recent German Hepatitis C-Registry report [24] was the largest to date, reporting the effectiveness and safety of 187 patients with compensated cirrhosis, who received the 8-week GLE/PIB therapy. The SVR was 98.4% (127/129) in the PP analysis and 85.8% (127/148) in the ITT analysis.…”

Section: Discussionmentioning

confidence: 99%

Real-World Experience of Chronic Hepatitis C-Related Compensated Liver Cirrhosis Treated with Glecaprevir/Pibrentasvir: A Multicenter Retrospective Study

Chen

Lai

et al. 2021

JCM

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Background: Glecaprevir/pibrentasvir is a protease inhibitor-containing pangenotypic direct-acting antiviral regimen that has been approved for the treatment of chronic hepatitis C. The present study aimed to evaluate the safety and efficacy of glecaprevir/pibrentasvir in patients with compensated cirrhosis in a real-world setting. Methods: We evaluated the real-world safety and efficacy of glecaprevir/pibrentasvir in patients with compensated cirrhosis from five hospitals in the Changhua Christian Care System, who underwent treatment between August 2018 and October 2020. The primary endpoint was a sustained virological response observed 12 weeks after completion of the treatment. Results: Ninety patients, including 70 patients who received the 12-week therapy and 20 patients who received the 8-week therapy, were enrolled. The mean age of the patients was 65 years, and 57.8% of the patients were males. Sixteen (17.8%) patients had end-stage renal disease, and 15 (16.7%) had co-existing hepatoma. The hepatitis C virus genotypes 1 (40%) and 2 (35.6%) were most common. The common side effects included anorexia (12.2%), pruritus (7.8%), abdominal discomfort (7.8%), and malaise (7.8%). Laboratory adverse grade ≥3 events included anemia (6.3%), thrombocytopenia (5.1%), and jaundice (2.2%). The overall sustained virological response rates were 94.4% and 97.7% in the intention-to-treat and per-protocol analyses, respectively. Conclusions: the glecaprevir/pibrentasvir treatment regimen was highly effective and well tolerated among patients with compensated cirrhosis in the real-world setting.

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“…In this multiple-center cohort study of mixed-genotype or genotype-undetermined HCV-infected patients receiving pan-genotypic DAA therapy, we found an overall SVR rate of 96.5% via PP analysis in a real-world setting. Despite the well-known treatment efficacy of these pan-genotypic DAAs in their landmark clinical trial setting [ 24 , 25 , 26 , 27 ], data on the effect of DAA treatment for these less frequently encountered HCV genotype populations are scarce [ 17 , 28 , 29 ]. In this study, we attempted to fill this knowledge gap on the DAA treatment of infection and demonstrated that the pan-genotypic DAA with either SOF/VEL or GLE/PIB are effective and safe for these patients in the real-world setting.…”

Section: Discussionmentioning

confidence: 99%

Pan-Genotypic Direct-Acting Antiviral Agents for Undetermined or Mixed-Genotype Hepatitis C Infection: A Real-World Multi-Center Effectiveness Analysis

Yen

Chen

Lai

et al. 2022

JCM

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Although the pan-genotypic direct-acting antiviral regimen was approved for treating chronic hepatitis C infection regardless of the hepatitis C virus (HCV) genotype, real-world data on its effectiveness against mixed-genotype or genotype-undetermined HCV infection are scarce. We evaluated the real-world safety and efficacy of two pan-genotypic regimens (Glecaprevir/Pibrentasvir and Sofosbuvir/Velpatasvir) for HCV-infected patients with mixed or undetermined HCV genotypes from the five hospitals in the Changhua Christian Care System that commenced treatment between August 2018 and December 2020. This retrospective study evaluated the efficacy and safety of pan-genotypic direct-acting antiviral (DAA) treatment in adults with HCV infection. The primary endpoint was the sustained virological response (SVR) observed 12 weeks after completing the treatment. Altogether, 2446 HCV-infected patients received the pan-genotypic DAA regimen, 37 (1.5%) patients had mixed-genotype HCV infections and 110 (4.5%) patients had undetermined HCV genotypes. The mean age was 63 years and 55.8% of our participants were males. Nine (6.1%) patients had end-stage renal disease and three (2%) had co-existing hepatomas. We lost one patient to follow-up during treatment and one more patient after treatment. A total of four patients died. However, none of these losses were due to treatment-related side effects. The rates of SVR12 for mixed-genotype and genotype-undetermined infections were 97.1% and 96.2%, respectively, by per-protocol analyses, and 91.9% and 92.7% respectively, by intention-to-treat population analyses. Laboratory adverse events with grades ≥3 included anemia (2.5%), thrombocytopenia (2.5%), and jaundice (0.7%). Pan-genotypic DAAs are effective and well-tolerated for mixed-genotype or genotype-undetermined HCV infection real-world settings.

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Glecaprevir/pibrentasvir for 8 weeks in patients with compensated cirrhosis: Safety and effectiveness data from the German Hepatitis C‐Registry

Cited by 11 publications

References 16 publications

Safety and Effectiveness Using 8 Weeks of Glecaprevir/Pibrentasvir in HCV-Infected Treatment-Naïve Patients with Compensated Cirrhosis: The CREST Study

Safety and Effectiveness Using 8 Weeks of Glecaprevir/Pibrentasvir in HCV-Infected Treatment-Naïve Patients with Compensated Cirrhosis: The CREST Study

Real-World Experience of Chronic Hepatitis C-Related Compensated Liver Cirrhosis Treated with Glecaprevir/Pibrentasvir: A Multicenter Retrospective Study

Pan-Genotypic Direct-Acting Antiviral Agents for Undetermined or Mixed-Genotype Hepatitis C Infection: A Real-World Multi-Center Effectiveness Analysis

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