[Late breaking abstract] LB-2. Sofosbuvir and ribavirin for the treatment of established recurrent hepatitis C infection after liver transplantation: Preliminary results of a prospective, multicenter study (AASLD 2013) - Oct 7, 2013 - Presentation time: Mon, Nov 04, 2013; 3:15 PM - 3:30 PM; Abstract#LB-2; P2, N=40; NCT01687270; Sponsor: Gilead; "Administration of SOF and RBV after liver transplantation in the setting of established HCV recurrence has been well tolerated and achieved an early SVR4 rate to date of 81%. There were no episodes of rejection or drug interaction. SVR12 data will be presented."
P2 data • Hepatitis C Virus
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AASLD 2013 / American Association for the Study of Liver Diseases: The Liver Meeting 2013, Nov 1-5, 2013; Washington, DC
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Background: Recurrence of hepatitis C (HCV) infection is the most common cause of graft loss and mortality in HCV-infected liver-transplant recipients. Interferon-based post-transplantation antiviral regimens, including those utilizing protease inhibitors, are poorly tolerated and achieve sustained virologic response rates (SVR) that are lower than in nontransplant patients. The nucleotide HCV polymerase inhibitor sofosbuvir (SOF) has a high barrier to resistance, lacks interactions with immunosuppressive agents, and has a favorable safety profile.
Methods: In this ongoing single-arm, open-label interferon-free pilot study, naïve and treatment-experienced patients with recurrent HCV infection (any HCV genotype) after liver transplantation received up to 24 weeks of SOF 400 mg and RBV (dose regimen starting at 400 mg/day). Patients were ≥18 years of age and at least 6 months post-transplantation. The primary efficacy endpoint is SVR (HCV RNA
Results:Forty patients (22 GT 1a, 11 GT 1b, 6 GT 3, 1 GT 4) have been enrolled. Mean age 59 years, 78% male, 8% black, 3% Hispanic: 88% previously treated [9 previously treated with protease inhibitors], mean baseline HCV RNA of 6.55 log10 IU/mL [range 4.49- 7.59 log10 IU/mL], and 40% cirrhosis. The mean duration of treatment is 23.2 weeks (15.1-24.4 weeks). Five patients remain on treatment and 2 patients have discontinued treatment due to adverse events (AE) of pneumonia and HCC progression. By week 4 on treatment, 100% of patients had HCV RNA
Conclusions: Administration of SOF and RBV after liver transplantation in the setting of established HCV recurrence has been well tolerated and achieved an early SVR4 rate to date of 81%. There were no episodes of rejection or drug interaction. SVR12 data will be presented.
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