THU-124-Efficacy and safety of glecaprevir/pibrentasvir for the pangenotypic treatment of chronic hepatitis C in former intravenous drug users: Subanalysis from a Spanish real-world cohort (Hepa-C)

Puigvehí, Marc; Albillos, Agustı́n; Viu, Ana; Hernández‐Guerra, Manuel; Vázquez, Inmaculada Fernández; Prieto, M.; Torras, Xavier; Zábal, José Miguel Rosales; Santamaría, Lourdes Grande; Morillas, Rosa; Diago, M.; Morón, Beatriz de Cuenca; Delgado, Manuel; Bonet, Lucía; Turnés, Juan; Crespo, Javier; Baliellas, Carme; Panero, José Luis Calleja; Badia-Aranda, Esther; Pascasio, J.M.; Moreno, José María Ruiz; Monterde, Vanesa Bernal; Carmona, Isabel; Fernandez–Bermejo, Miguel; Quiles, R.; Garcia, Pablo Bellot; González-Santiago, Jesús M.; Gutiérrez, María Luisa; Moreno, José Juan Rodríguez; Conejero, María Dolores Antón; Vega, Juan de la; Escudero-García, Desamparados; Arenas, Juan; Carrión, J.A.

doi:10.1016/s0618-8278(19)30399-8

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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%

“…Similar high real-world effectiveness of the G/P regimen has been demonstrated in other countries. [22][23][24][25] Importantly, GT1a infection is predominant in the US and more difficult to treat when compared to GT1b. 26,27 In our study, Limitations of this retrospective observational study include the lack of capture of adverse events and absence of granular data that led to treatment discontinuation that would have been collected in a clinical trial.…”

Section: Discussionmentioning

confidence: 99%

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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%