BACKGROUND/AIMS: We undertook a pilot study to investigate the efficacy and safety of peginterferon alfa-2a (40 kDa) plus ribavirin in haemodialysed chronic HCV patients awaiting renal transplant. METHODS: Patients received peginterferon alfa-2a 135 microg/week plus ribavirin 200 mg/day for 24 or 48 weeks (genotype non-1 and 1, respectively). The dose of ribavirin was tailored according to plasma concentrations and to haemoglobin levels. Outcomes in treated patients were compared with those of a matched untreated control group. RESULTS: Thirty-five patients received treatment, while 35 served as untreated controls. Thirty patients completed treatment; patients were withdrawn due to transplantation (n=2), severe anaemia (n=1), dermatitis (n=1) and non-response (n=1) resulting in a drop-out rate of 14%. Overall, 34/35 treated patients were HCV RNA negative at week 4 and had undetectable RNA at the end of treatment, compared with none of the untreated controls (ETR 97% vs 0%; p<0.001). Moreover, all achieved sustained virological response after 24 weeks of treatment-free follow-up versus no control patients (SVR 97% vs 0 %; p<0.001). CONCLUSIONS: In this study, we have shown for the first time in a large cohort of patients that HCV-patients on haemodialysis can be treated successfully with peginterferon alfa-2a (40 kDa) plus ribavirin.
BACKGROUND/AIMS: We undertook a pilot study to investigate the efficacy and safety of peginterferon alfa-2a (40 kDa) plus ribavirin in haemodialysed chronic HCV patients awaiting renal transplant. METHODS:Patients received peginterferon alfa-2a 135 microg/week plus ribavirin 200 mg/day for 24 or 48 weeks (genotype non-1 and 1, respectively). The dose of ribavirin was tailored according to plasma concentrations and to haemoglobin levels. Outcomes in treated patients were compared with those of a matched untreated control group. RESULTS: Thirty-five patients received treatment, while 35 served as untreated controls. Thirty patients completed treatment; patients were withdrawn due to transplantation (n=2), severe anaemia (n=1), dermatitis (n=1) and non-response (n=1) resulting in a drop-out rate of 14%. Overall, 34/35 treated patients were HCV RNA negative at week 4 and had undetectable RNA at the end of treatment, compared with none of the untreated controls (ETR 97% vs 0%; p<0.001). Moreover, all achieved sustained virological response after 24 weeks of treatment-free follow-up versus no control patients (SVR 97% vs 0 %; p<0.001). CONCLUSIONS: In this study, we have shown for the first time in a large cohort of patients that HCV-patients on haemodialysis can be treated successfully with peginterferon alfa-2a (40 kDa) plus ribavirin.