Is an 8‐week regimen of glecaprevir/pibrentasvir sufficient for all hepatitis C virus infected patients in the real‐world experience?

Zarębska-Michaluk, Dorota; Jaroszewicz, Jerzy; Pabjan, Paweł; Łapiński, Tadeusz Wojciech; Mazur, Włodzimierz; Krygier, Rafał; Dybowska, Dorota; Halota, Waldemar; Pawłowska, Małgorzata; Janczewska, Ewa; Buczyńska, Iwona; Simon, Krzysztof; Dobracka, Beata; Citko, Jolanta; Laurans, Łukasz; Tudrujek-Zdunek, Magdalena; Tomasiewicz, Krzysztof; Piekarska, Anna; Sitko, Marek; Białkowska-Warzecha, Jolanta; Klapaczyński, Jakub; Sobala-Szczygieł, Barbara; Horban, Andrzéj; Berak, Hanna; Deroń, Zbigniew; Lorenc, Beata; Socha, Łukasz; Tronina, Olga; Flisiak, Robert

doi:10.1111/jgh.15337

Cited by 13 publications

(16 citation statements)

References 28 publications

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“…Our findings on the very high effectiveness of GLE/PIB regardless of the history of previous therapies and liver fibrosis status supported the results of numerous clinical trials [33][34][35][36]. The excellent efficacy of 99-100% in GT1b patients, both noncirrhotic and cirrhotic, as well as treatmentnaïve and experienced, was also documented in published RWE studies [37][38][39][40][41]. Importantly, this option can be administered in renally impaired patients; two patients with kidney failure stage 4 and 5 treated within the current study responded to the therapy, which is consistent with published data [42].…”

Section: Discussionsupporting

confidence: 83%

Genotype-specific versus pangenotypic regimens in patients infected with HCV genotype 1b in real-world settings

Pabjan¹,

Brzdęk²,

Chrapek³

et al. 2021

Polish Archives of Internal Medicine

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The introduction of direct-acting antivirals (DAA) has provided us with hope to eliminate the hepatitis C virus (HCV) infection as a significant public problem in upcoming years. This study compares genotype-specific and pangenotypic regimens in patients with genotype (GT) 1b infection, being the most common GT in Poland. We have confirmed the very high effectiveness and a good safety profile with no significant differences between these two generations of the drug. Male sex and previous treatment with DAA were identified as negative predictors of therapy efficacy. To the best of our knowledge, the presented results of our research have been so far the only study of this type comparing the effectiveness and safety of both generations of drugs within one protocol carried out by the same researchers.

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Section: Discussionsupporting

confidence: 83%

Genotype-specific versus pangenotypic regimens in patients infected with HCV genotype 1b in real-world settings

Pabjan¹,

Brzdęk²,

Chrapek³

et al. 2021

Polish Archives of Internal Medicine

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“…Rates of SVR12 were similar in the PP analysis of GT3‐ vs non‐GT3‐infected patients (97.9% vs 98.8%, respectively); GT3 patients had lower SVR12 in the ITT analysis (82.1% vs 88.8%) with equal patients LTFU. Another real‐world study evaluating 8‐week G/P therapy showed similar results in GT3 cirrhotics with 71.5% of F4 patients achieving SVR12% vs 98.5% of non‐GT3 infected patients; in F0‐F3 patients, 96.3% of GT3‐infected patients achieved SVR12% vs 98.6% of non‐GT3‐infected patients 11 . However, only seven GT3‐infected, F4 patients were included in the modified intention‐to‐treat (mITT) analysis vs 65 non‐GT3 patients.…”

Section: Discussionmentioning

confidence: 75%

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

Klinker

Naumann²,

Rössle

et al. 2021

Liver International

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Glecaprevir/pibrentasvir, a pangenotypic, direct‐acting antiviral combination approved for chronic hepatitis C virus treatment, has limited real‐world evidence supporting 8‐week therapy in compensated cirrhosis. We investigated effectiveness and safety of 187 hepatitis C virus‐infected, treatment‐naïve, patients with compensated cirrhosis receiving 8‐week glecaprevir/pibrentasvir therapy in the German Hepatitis C‐Registry between 2 August 2017 and 1 January 2020. Sustained virologic response was 98.4% (127/129) in the per‐protocol analysis (excluding patients lost to follow‐up or who discontinued treatment due to compliance) and was 85.8% (127/148) in patients with data available in an intention‐to‐treat analysis. Nineteen patients were lost to follow‐up; nine genotype 3 patients, nine nongenotype 3 patients and one mixed genotype patient. One patient relapsed, and one died, unrelated to treatment. Adverse events (>5%) were fatigue and headache. Two serious adverse events occurred; no adverse events resulted in drug discontinuation. An 8‐week glecaprevir/pibrentasvir therapy was effective and well‐tolerated in this real‐world analysis.

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“…The same effectiveness was documented by Lampertico et al following the 8-week GLE/PIB treatment duration in 19 cirrhotic patients with GT3 infection from seven small RWE studies included in the summary analysis [ 34 , 35 ]. A much lower SVR of 72% in PP analysis was demonstrated in nine GT3 infected cirrhotics in our previous study from the EpiTer-2 database, but it was due to a small subset of patients [ 36 ]. In the current study, 16 patients treated for 8 weeks achieved SVR, which gives an unsatisfactory rate of 84% in PP analysis, lower than demonstrated for a 12-week regimen with statistical significance for ITT analysis (80% vs. 95.4%, p = 0.05), however, it should be noted that a number of patients on 8-week regimen was still low.…”

Section: Discussionmentioning

confidence: 98%

Effectiveness and Safety of Pangenotypic Regimens in the Most Difficult to Treat Population of Genotype 3 HCV Infected Cirrhotics

Zarębska-Michaluk

Jaroszewicz

Parfieniuk‐Kowerda

et al. 2021

JCM

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There is still limited data available from real-world experience studies on the pangenotypic regimens in patients with genotype (GT) 3 hepatitis C virus (HCV) infection and liver cirrhosis. The current study aimed to evaluate the efficacy and safety of pangenotypic regimens in this difficult-to-treat population. A total of 236 patients with mean age 52.3 ± 11.3 years and male predominance (72%) selected from EpiTer-2 database were included in the analysis; 72% of them were treatment-naïve. The majority of patients (55%) received the combination of sofosbuvir/velpatasvir (SOF/VEL), 71 without and 58 with ribavirin (RBV), whereas the remaining 107 individuals were assigned to glecaprevir/pibrentasvir (GLE/PIB). The effectiveness of the treatment following GLE/PIB and SOF/VEL regimens (96% and 93%) was higher compared to SOF/VEL + RBV option (79%). The univariate analysis demonstrated the significantly lower sustained virologic response in males, in patients with baseline HCV RNA ≥ 1,000,000 IU/mL, and among those who failed previous DAA-based therapy. The multivariate logistic regression analysis recognized only the male gender and presence of ascites at baseline as the independent factors of non-response to treatment. It should be emphasized that despite the availability of pangenotypic, strong therapeutic options, GT3 infected patients with cirrhosis still remain difficult-to-treat, especially those with hepatic impairment and DAA-experienced.

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Is an 8‐week regimen of glecaprevir/pibrentasvir sufficient for all hepatitis C virus infected patients in the real‐world experience?

Cited by 13 publications

References 28 publications

Genotype-specific versus pangenotypic regimens in patients infected with HCV genotype 1b in real-world settings

Genotype-specific versus pangenotypic regimens in patients infected with HCV genotype 1b in real-world settings

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

Effectiveness and Safety of Pangenotypic Regimens in the Most Difficult to Treat Population of Genotype 3 HCV Infected Cirrhotics

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