Background: Predictors of failure of combined therapy with sofosbuvir (SOF) and ribavirin (RIBA) in liver transplant (LT) recipients affected with recurrent hepatitis C virus (HCV) are largely unknown. Materials and methods: This was a retrospective analysis of adult, maintenance LT recipients enrolled in the SOF compassionate program at a single center. Patients were included into current analysis if: adult (³18 years), F3-F4 at baseline, and receiving at least one dose of SOF+RIBA. Primary endpoint was treatment effcacy as end of treatment (EOT), and sustained viral responses at 4 (SVR4) and 12 weeks (SVR12). The secondary endpoint was identifcation of predictors of SVR12 among all clinical variables retrieved with medical record review. Results: Among 176 LT recipients enrolled in the compassionate program, 163 (male 83.5%; median age [range] 58 [30-75] years) were treated with a 24-week course of SOF+RIBA and included into current analysis. Treatment was initiated at a median of 38 months [30-75] after transplantation. At baseline, mean (SD) fbrosis was 15.7 (7.8) KPa; mean (SD) HCV RNA was 1,145,288.7 (2,073,664.1) IU/mL, and genotype (GT) 1-4 was present in 123 (75.5%) cases. Child-Pugh (C-P) status was B/C in 30 (18.4%) and A in 133 (81.6%), and mean (SD) MELD score was 16.2 (3.6). Six (3.0%) patients were affected with post-transplant fbrosing cholestatic hepatitis. One-hundred-sixty-two (99.4%) patients completed the 24-week treatment course, and EOT, SVR4 and SVR12 were 100% (163/163), 85.2% (138/162), and 83.3% (135/162), respectively. The only variable associated with SVR12 was baseline serum albumin (r = 0.41; p=0.0001), while total bilirubin (r=-0.04; p=0.78), INR (r =-0.13; p=0.25), serum creatinine (r=0.17; p=0.12), C-P status (chi-square=1.41; p =0.23), MELD (r=-0.12; p=0.24), and severity of fbrosis (r=-0.19; p=0.11) were not signifcantly associated. Conclusions: Our experience suggests that failure to respond to a combined regimen with SOF+RIBA is associated with lower serum albumin levels in LT recipients with recurrent HCV graft disease.
Failure to respond to sofosbuvir and ribavirin after liver transplantation
De Simone, Paolo;Filipponi, Franco
2016-01-01
Abstract
Background: Predictors of failure of combined therapy with sofosbuvir (SOF) and ribavirin (RIBA) in liver transplant (LT) recipients affected with recurrent hepatitis C virus (HCV) are largely unknown. Materials and methods: This was a retrospective analysis of adult, maintenance LT recipients enrolled in the SOF compassionate program at a single center. Patients were included into current analysis if: adult (³18 years), F3-F4 at baseline, and receiving at least one dose of SOF+RIBA. Primary endpoint was treatment effcacy as end of treatment (EOT), and sustained viral responses at 4 (SVR4) and 12 weeks (SVR12). The secondary endpoint was identifcation of predictors of SVR12 among all clinical variables retrieved with medical record review. Results: Among 176 LT recipients enrolled in the compassionate program, 163 (male 83.5%; median age [range] 58 [30-75] years) were treated with a 24-week course of SOF+RIBA and included into current analysis. Treatment was initiated at a median of 38 months [30-75] after transplantation. At baseline, mean (SD) fbrosis was 15.7 (7.8) KPa; mean (SD) HCV RNA was 1,145,288.7 (2,073,664.1) IU/mL, and genotype (GT) 1-4 was present in 123 (75.5%) cases. Child-Pugh (C-P) status was B/C in 30 (18.4%) and A in 133 (81.6%), and mean (SD) MELD score was 16.2 (3.6). Six (3.0%) patients were affected with post-transplant fbrosing cholestatic hepatitis. One-hundred-sixty-two (99.4%) patients completed the 24-week treatment course, and EOT, SVR4 and SVR12 were 100% (163/163), 85.2% (138/162), and 83.3% (135/162), respectively. The only variable associated with SVR12 was baseline serum albumin (r = 0.41; p=0.0001), while total bilirubin (r=-0.04; p=0.78), INR (r =-0.13; p=0.25), serum creatinine (r=0.17; p=0.12), C-P status (chi-square=1.41; p =0.23), MELD (r=-0.12; p=0.24), and severity of fbrosis (r=-0.19; p=0.11) were not signifcantly associated. Conclusions: Our experience suggests that failure to respond to a combined regimen with SOF+RIBA is associated with lower serum albumin levels in LT recipients with recurrent HCV graft disease.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
