Real-world effectiveness and safety of glecaprevir/pibrentasvir in 723 patients with chronic hepatitis C

D’Ambrosio, Roberta; Pasulo, L.; Puoti, Massimo; Vinci, M.; Schiavini, Monica; Lazzaroni, Sergio; Soria, Alessandro; Gatti, Fábio; Menzaghi, Barbara; Aghemo, Alessio; Capelli, F; Rumi, Maria Grazia; Morini, Lorenzo; Giorgini, Alessia; Pigozzi, Marie Graciella; Rossini, Angelo; Maggiolo, Franco; Pan, Angelo; Memoli, Massimo; Spinelli, Ombretta; Poggio, P. Del; Saladino, Valeria; Spinetti, Angiola; Bona, Anna De; Capretti, A.; Uberti-Foppa, Caterina; Bonfanti, Paolo; Terreni, N.; Menozzi, Fernanda; Colombo, Alberto; Giglio, Omar; Centenaro, Riccardo; Borghi, Marta; Baiguera, Chiara; Picciotto, Viviana; Landonio, Simona; Gori, Andrea; Magnani, Carlo; Noventa, Franco; Paolucci, Stefania; Lampertico, Pietro; Fagiuoli, Stefano

doi:10.1016/j.jhep.2018.11.011

Cited by 114 publications

(93 citation statements)

References 16 publications

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“…Therefore, the result of our study is of importance, demonstrating for the first time very high effectiveness of G/P in the real‐world setting in the US in treatment‐naïve, noncirrhotic patients with chronic, HCV infection. Similar high real‐world effectiveness of the G/P regimen has been demonstrated in other countries …”

Section: Discussionsupporting

confidence: 79%

Real‐world effectiveness of 8‐week glecaprevir/pibrentasvir (G/P) for treatment naive, noncirrhotic patients with HCV infection in the TRIO network

et al. 2020

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Summary Background and Aims Glecaprevir/Pibrentasvir (G/P) is the only regimen approved by the United States Food and Drug Administriation with 8‐week treatment duration for chronic HCV genotype (GT) 1‐6 infection in treatment naïve (TN), noncirrhotic (NC) patients. Real world effectiveness data from the US are lacking in these populations and the aim of this study was to address this gap. Methods Data from 560 treatment naïve, noncirrhotic patients who initiated 8 weeks of G/P treatment between August 2017 and April 2018 were collected electronically from providers and specialty pharmacies of the Trio Health network. The primary outcome assessed was Per Protocol (PP) sustained virologic response at 12 weeks post‐treatment (SVR12). Results Seventy one percent (397/560) of patients had HCV genotype 1 infection, and 89% (496/560) had a fibrosis score of F0‐2. The majority of patients (85%) received care in community practices. The per protocol (PP) SVR12 rate was 99% (537/540) and intent‐to‐treat (ITT) SVR12 rate was 96% (537/560). Reasons for not achieving SVR12 were virological failure (0.5%, 3/560), lost‐to‐follow‐up (2%, 13/560) and discontinuation (1%, 7/560). Bivariate analyses including gender, practice type, HCV genotype, eGFR, FIB‐4, baseline HCV viral load and insurance type did not reveal significant association with SVR12. Reasons for discontinuations were medical care unrelated to treatment, patient choice, physician choice, insurance denial, positive drug/alcohol screening and side effects. Conclusion 8‐week G/P treatment is highly effective in 560 treatment naïve, noncirrhotic patients from the TRIO network with SVR12 rates similar to those as in registration trials.

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Section: Discussionsupporting

confidence: 79%

Real‐world effectiveness of 8‐week glecaprevir/pibrentasvir (G/P) for treatment naive, noncirrhotic patients with HCV infection in the TRIO network

et al. 2020

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“…Several well‐designed, robust clinical trials have demonstrated the safety and high curative efficacy of glecaprevir/pibrentasvir and sofosbuvir/velpatasvir among treatment‐naive persons without cirrhosis regardless of HCV genotype. These findings have been confirmed in real‐world cohort studies for both glecaprevir/pibrentasvir and sofosbuvir/velpatasvir . Based on these data, 8 weeks of glecaprevir/pibrentasvir or 12 weeks of sofosbuvir/velpatasvir is recommended for adults eligible for the simplified treatment algorithm.…”

Section: Universal Treatment Of Adults With Chronic Hepatitis C and Smentioning

confidence: 54%

“…Eight weeks of the daily fixed‐dose combination of glecaprevir (300 mg)/pibrentasvir (120 mg) gained FDA approval for use in treatment‐naive or interferon‐experienced adolescents aged ≥ 12 years or weighing ≥ 45 kg with any HCV genotype infection, without cirrhosis or with compensated cirrhosis (Child‐Pugh A). Although the registration trial included only adolescents with genotype 1‐4, glecaprevir/pibrentasvir garnered FDA approval for all genotypes based on the safety and efficacy of the regimen demonstrated in adults . The recommendations for use of glecaprevir/pibrentasvir in treatment‐experienced adolescents are also based on clinical trial data from adults .…”

Section: Hcv In the Pediatric Populationmentioning

confidence: 99%

Hepatitis C Guidance 2019 Update: American Association for the Study of Liver Diseases–Infectious Diseases Society of America Recommendations for Testing, Managing, and Treating Hepatitis C Virus Infection

2020

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“…Following the clinical trials which demonstrated the excellent safety and efficacy by GLE/PIB, the real‐world data from Western countries and Japan revealed that the SVR 12 rates according to label recommendation were also excellent and were comparable to the reports from clinical trials . In 2018, GLE/PIB was reimbursed by Taiwan National Health Insurance (NHI) for patients with chronic HCV infection who had a hepatic fibrosis stage of ≥F3.…”

Section: Introductionmentioning

confidence: 88%

Glecaprevir/pibrentasvir for patients with chronic hepatitis C virus infection: Real‐world effectiveness and safety in Taiwan

Liu

Hung

et al. 2019

Liver International

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Background & Aims Large‐scale data regarding the real‐world effectiveness and safety of glecaprevir/pibrentasvir (GLE/PIB) for patients with chronic hepatitis C virus (HCV) infection were limited in East Asia. We aimed to evaluate the clinical performance of GLE/PIB in different HCV populations in Taiwan. Methods A total of 658 chronic HCV patients with compensated liver diseases receiving GLE/PIB for 8 (n = 549), 12 (n = 103) or 16 (n = 6) weeks were retrospectively enrolled. The effectiveness was determined by sustained virologic response at off‐therapy 12 weeks (SVR12). Patient characteristics potentially related to SVR12 and the safety profiles were also assessed. Results By evaluable population (EP) and per‐protocol (PP) analyses, the overall SVR12 rate was 98.2% (95% confidence interval (CI): 96.8%‐99.0%) and 99.4% (95% CI: 98.4%‐99.8%). The SVR12 rates were 98.9% (95% CI: 97.6%‐99.5%), 94.2% (95% CI: 87.9%‐97.3%) and 100% (95% CI: 60.1%‐100%) in patients receiving 8, 12 and 16 weeks of treatment respectively. A total of 656 (99.7%) patients completed the scheduled treatment. The SVR12 rates were comparable regardless of baseline characteristics or week 4 viral decline. Twenty (3.0%) patients had serious adverse events (AEs), but none were not related to GLE/PIB. The two most common AEs were pruritus (7.8%) and fatigue (5.5%). Two (0.3%) and no patients had ≥3‐fold upper limit of normal (ULN) for total bilirubin and alanine aminotransferase (ALT) levels. Conclusions GLE/PIB for 8‐16 weeks is effective and well‐tolerated for patients with chronic HCV infection in Taiwan.

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Real-world effectiveness and safety of glecaprevir/pibrentasvir in 723 patients with chronic hepatitis C

Cited by 114 publications

References 16 publications

Real‐world effectiveness of 8‐week glecaprevir/pibrentasvir (G/P) for treatment naive, noncirrhotic patients with HCV infection in the TRIO network

Real‐world effectiveness of 8‐week glecaprevir/pibrentasvir (G/P) for treatment naive, noncirrhotic patients with HCV infection in the TRIO network

Hepatitis C Guidance 2019 Update: American Association for the Study of Liver Diseases–Infectious Diseases Society of America Recommendations for Testing, Managing, and Treating Hepatitis C Virus Infection

Glecaprevir/pibrentasvir for patients with chronic hepatitis C virus infection: Real‐world effectiveness and safety in Taiwan

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