Dataset Information

Nationwide registry of glecaprevir plus pibrentasvir in the treatment of HCV in Taiwan.

ABSTRACT: The study evaluated the real-world treatment outcomes of Glecaprevir/pibrentasvir (GLE/PIB) including effectiveness, safety and healthcare resource utilization based on a nation-wide registry in Taiwan. The Taiwan HCV Registry (TACR) is a nation-wide platform organized and supervised by the Taiwan Association for the Study of the Liver. Data were analyzed for patients treated with GLE/PIB, including 3144 patients who had treatment outcome available. The primary endpoint was sustained virological response (SVR12, undetectable HCV RNA throughout 12 weeks of end-of-treatment). The overall SVR12 rate was 98.9% (3110/3144), with 98.8%, 99.4% and 100% in patients receiving 8 weeks, 12 weeks, and 16 weeks of GLE/PIB respectively. The SVR12 rate in the treatment-naïve cirrhotic patients receiving 8 weeks of GLE/PIB was 98.2% (108/110). The most common AEs were fatigue (7.5%), pruritus (6.7%) and dizziness (1.5%). The mean number of outpatient visits during the GLE/PIB was 5.94 visits for patients treated with 8 weeks, significantly different from the patients treated with 12 weeks of GLE/PIB (6.90 visits). The results support the effectiveness and safety of GLE/PIB treatment in real-world clinical practice, and provide further evidence that the shorter, 8-week GLE/PIB regimen is effective and cost-saving.

SUBMITTER: Huang CF

PROVIDER: S-EPMC8648748 | biostudies-literature | 2021 Dec

REPOSITORIES: biostudies-literature

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Nationwide registry of glecaprevir plus pibrentasvir in the treatment of HCV in Taiwan.

Huang Chung-Feng CF Kuo Hsing-Tao HT Chang Te-Sheng TS Lo Ching-Chu CC Hung Chao-Hung CH Huang Chien-Wei CW Chong Lee-Won LW Cheng Pin-Nan PN Yeh Ming-Lun ML Peng Cheng-Yuan CY Cheng Chien-Yu CY Huang Jee-Fu JF Bair Ming-Jong MJ Lin Chih-Lang CL Yang Chi-Chieh CC Wang Szu-Jen SJ Hsieh Tsai-Yuan TY Lee Tzong-Hsi TH Lee Pei-Lun PL Wu Wen-Chih WC Lin Chih-Lin CL Su Wei-Wen WW Yang Sheng-Shun SS Wang Chia-Chi CC Hu Jui-Ting JT Mo Lein-Ray LR Chen Chun-Ting CT Huang Yi-Hsiang YH Chang Chun-Chao CC Huang Chia-Sheng CS Chen Guei-Ying GY Kao Chien-Neng CN Tai Chi-Ming CM Liu Chun-Jen CJ Lee Mei-Hsuan MH Tsai Pei-Chien PC Dai Chia-Yen CY Kao Jia-Horng JH Lin Han-Chieh HC Chuang Wang-Long WL Chen Chi-Yi CY Tseng Kuo-Chih KC Yu Ming-Lung ML

Scientific reports 20211206 1

The study evaluated the real-world treatment outcomes of Glecaprevir/pibrentasvir (GLE/PIB) including effectiveness, safety and healthcare resource utilization based on a nation-wide registry in Taiwan. The Taiwan HCV Registry (TACR) is a nation-wide platform organized and supervised by the Taiwan Association for the Study of the Liver. Data were analyzed for patients treated with GLE/PIB, including 3144 patients who had treatment outcome available. The primary endpoint was sustained virological ...[more]

PMID: 34873250

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Project description:Background & aimsShort duration treatment may aid HCV elimination among key populations. This study evaluated the efficacy of glecaprevir-pibrentasvir for 4 weeks among people with recent HCV infection.MethodsIn this single-arm multicentre international trial, adults with recent HCV (duration of infection <12 months) received glecaprevir-pibrentasvir 300 mg-120 mg daily for 4 weeks. Primary infection was defined as a first positive anti-HCV antibody and/or HCV RNA measurement within 6 months of enrolment and either acute clinical hepatitis within 12 months (symptomatic illness or alanine aminotransferase >10x the upper limit of normal) or antibody seroconversion within 18 months. Reinfection was defined as new positive HCV RNA within 6 months and prior clearance (spontaneous or treatment). The primary endpoint was sustained virological response at 12 weeks post-treatment (SVR12) in the intention-to-treat (ITT) and per-protocol (PP) populations.ResultsTwenty-three participants (96% men, 70% HIV, 57% ever injected drugs) received treatment, of whom 74% had genotype 1a infection and 35% recent reinfection. At baseline, median duration of infection was 17 weeks (IQR 11-29) and HCV RNA was 5.8 log10IU/ml (IQR 5.2-6.9). SVR12 was achieved by 78% (18/23; 95% CI 56-93%) and 82% (18/22; 95% CI 60-95%) of the ITT and PP populations, respectively, and in 100% (12/12; 95% CI 74-100%) of participants with baseline HCV RNA ≤6 log10. There were four cases of virological failure (relapse); three received retreatment with 12 weeks sofosbuvir-velpatasvir or grazoprevir-elbasvir (SVR, n = 2; loss to follow-up, n = 1). No serious adverse events were reported.ConclusionWhile most achieved SVR, the efficacy of a 4-week regimen of glecaprevir-pibrentasvir was lower than observed with longer treatment durations (≥6 weeks) among people with recent HCV.Trial registrationClinicaltrials.gov Identifier: NCT02634008.Impact and implicationsShort duration treatment may aid HCV elimination among key populations. This investigator-initiated single-arm multicentre international pilot trial demonstrated that efficacy of glecaprevir-pibrentasvir for 4 weeks among people with recent HCV infection was sub-optimal (SVR12 78% ITT, 82% PP). Baseline HCV RNA appeared to impact response, with higher efficacy among participants with lower baseline HCV RNA (≤6 log10; SVR12 100% ITT, 12/12). While most achieved SVR, the efficacy of 4 weeks of glecaprevir-pibrentasvir was below that seen with longer treatment durations (≥6 weeks).

Dataset Information

Nationwide registry of glecaprevir plus pibrentasvir in the treatment of HCV in Taiwan.

Publications

Nationwide registry of glecaprevir plus pibrentasvir in the treatment of HCV in Taiwan.

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