(4) Mild anemia is more common with BOC and severe anemia with TVP. (5) Of the patients who achieved SVR, 72.7% in the TVP group were hepatitis C PCR negative at week 4 and 86.5% were negative
at week 8 in the BOC group. SI STRASSER,1 X FORNS,2 M PRIETO,3 M CHARLTON,4 JG MCHUTCHISON,5 WT SYMONDS,5 J DENNING,5 T BRANDT-SARIF,5 P CHANG,5 V KIVETT,5 TF BAUMERT,6 A COILLY,7 L CASTELLS,8 F HABERSETZER6 1Royal Prince Alfred Hospital, Sydney, NSW, 2Liver Unit, IDIBAPS, CIBEREHD, Hospital Clinic, Barcelona, Spain, 3Hepatology Unit, CIBEREHD, Hospital Universitari i Politècnic La Fe, Valencia, Spain, 4Mayo Clinic, Rochester, MN, USA, 5Gilead Sciences, Foster City, CA, USA, 6Hôpitaux Universitaires de Strasbourg, Inserm U 1110, Strasbourg, France, 7Centre Hépato-Bilaire, Hôpital Paul Brousse, Villejuif, France,
8Liver Unit-Internal Medicine Department, CIBEREHD, Hospital Universitari Vall Ivacaftor Hebron, Barcelona, Spain Background: There are no effective treatment options for patients with severe recurrent hepatitis C after liver transplantation (LT). Sofosbuvir (SOF) has demonstrated high efficacy across a broad range of HCV genotypes and patient populations, a high barrier to resistance, no interactions with immunosuppressive agents, and favourable safety profile. Methods: Patients who had exhausted all treatment options and had poor clinical prognoses received compassionate use SOF for severe recurrent hepatitis C following BAY 80-6946 concentration LT. The regimen included SOF 400 mg/day and RBV for up to 48 weeks, with PEG-IFN at the physician’s discretion. Results: 104 patients received a SOF-containing regimen; baseline characteristics are shown in the table. 72 patients completed 24–48 weeks treatment at time of analysis, 7 patients discontinued treatment, 12 patients underwent liver transplantation and 13 patients died. SVR12 was achieved in 53/85
(62%) patients (excluding the LT recipients and patients with missing 上海皓元 data). Of the 104 patients, the clinical outcome of 60 (62%) improved on treatment, 22 (21%) stabilized and 22 (21%) worsened/died, with all deaths attributed to progression of liver disease or associated complications. Fifty (48%) subjects reported SAEs. Baseline Characteristics Overall (n = 104) Male, n (%) 76 (73) Median age, y (range) 55 (16–76) Median HCV RNA, log10 IU/mL (range) 8.4 (1.3–8.9) GT, n 1/1a/1b 8/29/51 2/3/4 1/7/8 Median bilirubin, mg/dL (range) 3.1 (0.4–45) Median albumin, g/dL (range) 3.1 (1.3–12.2) Median INR (range) 1.3 (0.8–4.5) Median ALT, IU/L (range) 71 (8–1162) Median platelets, ×103/μL (range) 78 (19–340) Median MELD (range) 15 (6–43) Median months from LT to treatment, (range) 17 (1–262) Conclusions: In patients with severe HCV recurrence, a compassionate-use regimen containing SOF + RBV (with or without PEG-IFN) was well-tolerated and demonstrated potent antiviral activity, with many patients achieving SVR and clinical improvement.