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

Szu‐Jen Wang ,Chien‐Neng Kao ,Chi‐Chieh Yang ,Ming‐Jong Bair ,Sheng‐Shun Yang ,Kuo‐Chih Tseng ,Chun–Jen Liu ,Pei‐Lun Lee ,Chun‐Ting Chen ,Yi-Hsiang Huang,Wen‐Chih Wu ,Chao‐Hung Hung ,Te‐Sheng Chang ,Ming‐Lun Yeh ,Wei‐Wen Su ,Tsai‐Yuan Hsieh ,Hsuan-Shu Lee ,Chia-Sheng Huang,Chih–Lin Lin ,Hsing‐Tao Kuo ,Jee‐Fu Huang ,Chi-Jen Chang ,Lee‐Won Chong ,Jia‐Horng Kao ,Chien-Yu Cheng,Wen-Li Chuang ,Lein‐Ray Mo ,Chia‐Yen Dai ,Chi-Yi Chen,Jianhe Hu ,Pin-Nan Cheng,Ching‐Chu Lo ,Han–Chieh Lin ,Cheng‐Yuan Peng ,Guei-Ying Chen,Tzong‐Hsi Lee ,Chia-Chi Wang,Chi‐Ming Tai ,Pei‐Chien Tsai ,Cheng‐Jui Lin ,Chung‐Feng Huang ,Ming–Lung Yu ,Chien‐Wei Huang

doi:10.1038/s41598-021-03006-3

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.

Highlights

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
One of the five core interventions identified by the World Health Organization (WHO) toward eliminating viral hepatitis is to enhance and expand the response of the oral, well-tolerated direct-acting antivirals (DAAs) for people with chronic hepatitis C virus (CHC) infection, which can achieve cure rates of over 90% and thereafter avoid further transmission and reduce Hepatitis C virus (HCV)-related complications, including decompnesated cirrhosis, liver transplantations and d eath[1,4]
Among the 3209 patients treated with GLE/PIB, 21 patients were excluded because of documented decompensated cirrhosis at baseline (12 patients) or previous exposure to NS3/4A protease inhibitor and/or NS5A inhibitor-containing DAAs (9 patients), in accordance with the Taiwan Food and Drug Administration (TFDA)-approved label

Summary

Introduction

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. As nation-wide data of GLE/PIB, especially from special populations, are scarce, the aim of the present study was to evaluate the real-world efficacy and safety of GLE/PIB in adult patient with CHC infection enrolled in the Taiwan Association for the Study of the Liver HCV Registry (TACR)

Objectives

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Results

Conclusion