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Background Treatment with SOF/VEL for 12 weeks results in high sustained virologic response rates 12 weeks after treatment (SVR12) in genotype 1–6 HCV infected patients in clinical trials and real-world settings. The current study evaluated the safety and efficacy of SOF/VEL in adult patients with recurrent chronic genotype (GT) 1–6 HCV infection post-liver transplant. Methods This Phase 2, single-arm, open-label study evaluated 12 weeks of SOF/VEL 400/100 mg daily for 12 weeks in HCV-infected liver transplant recipients. Patients could be treatment experienced or treatment naive with no cirrhosis or compensated cirrhosis and had to be ≥3 months post-transplant with no signs of rejection at screening and history of pre-transplant chronic HCV. The primary endpoint was SVR12. Results A total of 79 patients were enrolled and treated. Of these, 81% were male, 82% were white, 9% had compensated cirrhosis, 59% were treatment-experienced, 47% had GT1, 4% GT2, 44% GT3, and 5% GT4 HCV infections. For immunosuppression, 71% of patients used tacrolimus, 24% mycophenolic acid, 14% cyclosporine, 11% azathioprine, 10% sirolimus, 6% everolimus, and 1% prednisolone. Median (range) time from liver transplantation was 7.5 (0.3–23.9) years. Rates of SVR4 for available patients are presented in the Table (IDDF2018-ABS-0109 Table 1). There was one virologic failure (relapse; GT1a, non-cirrhotic, treatment naive) and one non-virologic failure (GT1b, cirrhotic, treatment naive). All 34 GT3 HCV-infected patients including 2 with cirrhosis achieved SVR4. Complete SVR12 and viral sequencing data will be presented. There were 61 (77%) patients with adverse events (AEs). Common (>10%) AEs were headache (24%), fatigue (20%), and cough (10%). One patient discontinued SOF/VEL on Day 7 due to an AE of grade 1 hyperglycemia. No serious or severe AEs were assessed by the investigator as related to SOF/VEL, there were no episodes of liver transplant rejection, and there were no deaths. Conclusions Treatment with the single tablet regimen of SOF/VEL for 12 weeks was highly effective and well tolerated in genotype 1–4 HCV-infected liver transplant recipients with and without cirrhosis. |
