Paul Y. Kwo, MD - 7/29/2015
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Will we finally have options to prevent posttransplantation HCV recurrence across the spectrum of genotypes?
Although current options for posttransplantation recurrence of genotype 1 and 4 HCV can achieve high SVRs, options with equivalent efficacy for posttransplantation recurrence of genotype 3 HCV are limited. At the 2015 European Association for the Study of the Liver (EASL) meeting, data from the phase III ALLY-1 study gave us a clear glimpse at an upcoming option for managing patients with genotype 3 HCV recurrence following orthotopic liver transplantation. The multicenter, open-label trial evaluated the investigational NS5A inhibitor daclatasvir in combination with sofosbuvir and ribavirin for 12 weeks in patients with advanced cirrhosis or posttransplantation HCV recurrence.
Eligible patients were ≥ 3 months posttransplantation with no evidence of rejection at enrollment. Of importance, any immunosuppressive regimen was allowed. The overall SVR12 rate in this posttransplantation population of 53 patients was 94%; when broken down by patient factors, 97% of patients with genotype 1a, 90% of those with genotype 1b, and 91% of those with genotype 3 HCV infection achieved SVR12. There was even 1 patient with genotype 6 HCV infection enrolled, who also achieved SVR12.
The regimen was well tolerated, with the few serious adverse events considered unrelated to treatment.
Will we finally have options to prevent posttransplantation HCV recurrence across the spectrum of genotypes?
Although current options for posttransplantation recurrence of genotype 1 and 4 HCV can achieve high SVRs, options with equivalent efficacy for posttransplantation recurrence of genotype 3 HCV are limited. At the 2015 European Association for the Study of the Liver (EASL) meeting, data from the phase III ALLY-1 study gave us a clear glimpse at an upcoming option for managing patients with genotype 3 HCV recurrence following orthotopic liver transplantation. The multicenter, open-label trial evaluated the investigational NS5A inhibitor daclatasvir in combination with sofosbuvir and ribavirin for 12 weeks in patients with advanced cirrhosis or posttransplantation HCV recurrence.
Eligible patients were ≥ 3 months posttransplantation with no evidence of rejection at enrollment. Of importance, any immunosuppressive regimen was allowed. The overall SVR12 rate in this posttransplantation population of 53 patients was 94%; when broken down by patient factors, 97% of patients with genotype 1a, 90% of those with genotype 1b, and 91% of those with genotype 3 HCV infection achieved SVR12. There was even 1 patient with genotype 6 HCV infection enrolled, who also achieved SVR12.
The regimen was well tolerated, with the few serious adverse events considered unrelated to treatment.
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