Grazoprevir/Elbasvir treatment in liver or kidney transplant recipients with genotype-1b hepatitis C virus infection

Author:

Lai Ping-Chin1,Chen Cheng-Hsu234,Jeng Long-Bin5,Yu Tung-Min2,Tsai Shang-Feng236,Wu Ming-Ju2789,Cheng Shao-Bin710,Yang Sheng-Shun47811,Lee Teng-Yu711ORCID

Affiliation:

1. Division of Nephrology, Department of Medicine, China Medical University Hospital, Taichung, Taiwan

2. Division of Nephrology, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan

3. Department of Life Science, Tunghai University, Taichung, Taiwan

4. Ph.D. Program in Translational Medicine, National Chung Hsing University, Taichung, Taiwan

5. Organ Transplantation Center, China Medical University Hospital, Taichung, Taiwan

6. School of Medicine, National Yang-Ming University, Taipei, Taiwan

7. School of Medicine, Chung Shan Medical University, Taichung, Taiwan

8. Institute of Biomedical Sciences, National Chung Hsing University, Taichung, Taiwan

9. Graduate Institute of Clinical Medical Science, School of Medicine, China Medical University, Taichung, Taiwan

10. Department of Surgery, Taichung Veterans General Hospital, Taichung, Taiwan

11. Division of Gastroenterology & Hepatology, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan

Abstract

More options regarding the choice of direct-acting antivirals (DAAs) are helpful for avoiding individual limitations in treating hepatitis C virus (HCV) infection. We aimed to assess the efficacy and tolerability of grazoprevir (GZR)/elbasvir (EBR) treatment in genotype-1b (GT-1b) HCV-infected liver or kidney transplant recipients. In this phase 4, single-arm, open-label, multicenter trial, patients received GZR 100mg/EBR 50mg daily for 12 weeks. Patients with any HCV infection other than genotype-1b (GT-1b), liver decompensation, human immunodeficiency virus or hepatitis B virus co-infection, a history of NS5A inhibitor exposure, or any severe drug-drug interactions (DDIs) were excluded. The primary endpoint was sustained virologic response at 12 weeks posttreatment (SVR12). Of the 14 patients (10 kidney and 4 liver transplant subjects) enrolled in this study, 9 (64%) were females; the median age was 64.0 (range: 43-73) years. The regularly used immunosuppressants were tacrolimus (93%), everolimus (29%), and sirolimus (7%), with patient blood levels easily managed and generally stable (all p > 0.05 in quantile regression analysis). The rate of SVR12 was 100% in intent-to-treat analysis. Only one patient discontinued GZR/EBR therapy at 6 weeks posttreatment due to a treatment-unrelated adverse event (AE); however, this patient remained achieving SVR12. Most AEs were mild in severity and deemed to be not treatment-related. No organ rejection episodes or deaths occurred during the study period. The single-tablet regimen of GZR/EBR for 12 weeks is highly effective and well tolerated in GT-1b HCV-infected liver or kidney transplant recipients, and its DDIs are generally easy to manage.

Publisher

American Society for Microbiology

Subject

Infectious Diseases,Pharmacology (medical),Pharmacology

Reference118 articles.

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