P1232 Sofosbuvir and Ribavirin for the Treatment of Recurrent Hepatitis C Infection After Liver Transplantation: Results of a Prospective, Multicenter Study

Samuel, Didier; Charlton, Michael; Gane, Ed; Brown, Robert S.; Curry, Michael P.; Kwo, P.; Fontana, R.; Gilroy, Richard; Teperman, Lewis; Muir, Andrew J.; McHutchison, John G.; Symonds, William T.; Denning, Jill; McNair, Lindsay; Arterburn, Sarah; Terrault, Norah A.; Forns, Xavier; Manns, M.

doi:10.1016/s0168-8278(14)61392-1

Cited by 28 publications

(23 citation statements)

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“…Side effects of these regimens result in frequent use of erythropoietin (in 77 to 100% of patients), modifications in the ribavirin dose (in 70 to 100%), and blood transfusions (in 33 to 64%) to manage anemia. [21][22][23][24] Grade 3 and grade 4 laboratory abnormalities were each observed in 28% of patients receiving treatment with sofosbuvir and ribavirin, including hemoglobin levels of less than 8.0 mg per deciliter in 20% of patients, 35 although this study population included patients with cirrhosis, and such abnormalities may be observed more frequently in patients with cirrhosis than in those without cirrhosis.…”

Section: Dosing Of Calcineurin Inhibitorsmentioning

confidence: 87%

“…the nucleotide polymerase inhibitor sofosbuvir and ribavirin for 24 weeks resulted in a sustained virologic response at post-treatment week 12 in 28 of 40 liver-transplant recipients (70%). 35 The patients included in these studies generally had advanced fibrosis, which may be associated with a decreased response rate. Treatment of liver-transplant recipients with telaprevir or boceprevir plus peginterferon and ribavirin is associated with high rates of treatment discontinuation owing to adverse events.…”

Section: Dosing Of Calcineurin Inhibitorsmentioning

confidence: 99%

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An Interferon-free Antiviral Regimen for HCV after Liver Transplantation

Mantry²,

et al. 2014

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Section: Dosing Of Calcineurin Inhibitorsmentioning

confidence: 87%

Section: Dosing Of Calcineurin Inhibitorsmentioning

confidence: 99%

An Interferon-free Antiviral Regimen for HCV after Liver Transplantation

Mantry²,

et al. 2014

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“…Results of a noncomparative, multicentre study also suggest that sofosbuvir plus ribavirin is effective in the treatment of patients with recurrent HCV infection following liver transplantation [67]. Although sofosbuvir is not currently approved for use post-transplantation in the US [12], a compassionate-use protocol is available permitting the administration of sofosbuvir-based treatment to patients with severe recurrent HCV infection following liver transplantation [68].…”

Section: Place Of Sofosbuvir In the Management Of Chronicmentioning

confidence: 99%

Sofosbuvir: A Review of its Use in Patients with Chronic Hepatitis C

Keating¹

2014

Drugs

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Sofosbuvir (Sovaldi(®)) is a nucleotide hepatitis C virus (HCV) NS5B polymerase inhibitor that has pangenotypic antiviral activity and a high genetic barrier to resistance. This article reviews the clinical efficacy and tolerability of sofosbuvir in patients with chronic hepatitis C and summarizes its pharmacological properties. Interferon-free treatment with sofosbuvir plus ribavirin achieved high sustained virological response (SVR) rates in treatment-naïve and treatment-experienced patients with HCV genotype 2 or 3 infection, and also had efficacy in patients with HCV genotype 1 infection. Sofosbuvir plus ribavirin was also effective in patients co-infected with HCV and HIV, and sofosbuvir plus ribavirin administered prior to liver transplantation prevented recurrent HCV infection in the majority of patients who had HCV RNA levels below the limit of quantification at the time of transplantation. Sofosbuvir plus peginterferon-α-2a and ribavirin achieved high SVR rates in patients with HCV genotype 1 infection, and also appeared effective in patients with HCV genotype 4, 5 or 6 infection. Oral sofosbuvir was generally well tolerated in patients with chronic hepatitis C. The most commonly reported adverse events and laboratory abnormalities were consistent with those expected with ribavirin and peginterferon-α. In conclusion, sofosbuvir represents an important advance in the treatment of chronic hepatitis C.

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“…In a phase II study, 40 LT recipients with compensated recurrent hepatitis C (fibrosis stage [3: 63 %, genotype 1: 83 %, previously treated: 88 %, previous first generation PI failure: 23 %) were treated with SOF ? low ascendingdose RBV for 24 weeks [18]. All patients achieved RVR and end of treatment viral response and 70 % achieved SVR 12.…”

Section: Interferon-free Regimensmentioning

confidence: 92%

“…Indeed SVR rates over 90 % have been observed using a combination of DAAs without interferon in non-cirrhotic patients and in patients with early cirrhosis [12][13][14][15][16]. The first studies in transplant recipients reported a higher rate of SVR, a much better tolerance and less drug-drug interactions [17][18][19]. We will review here the new antiviral strategies after liver transplantation and their impact on the outcome.…”

Section: Introductionmentioning

confidence: 99%

Management of post transplant hepatitis C in the direct antiviral agents era

et al. 2015

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Hepatitis C virus (HCV) infection is one of the main indications for liver transplantation. Viral recurrence occurs in all patients with detectable serum HCV RNA at the time of transplantation leading to cirrhosis in 20-30% of patients within 5 years. Viral eradication using antiviral therapy has been shown to improve patient and graft survival. Pegylated interferon (PEG-IFN) and ribavirin (RBV) antiviral therapy achieved SVR in around 30% of transplant recipients. In the non-transplant setting, first generation NS3/4 protease inhibitors, boceprevir or telaprevir associated with PEG-IFN and RBV, has improved the SVR rates to 75% in genotype 1 infected patients. However, tolerability and drug-drug interactions with calcineurin inhibitors are both limiting factors of their use in transplant recipients. In the non-transplant patients, using new direct-acting antiviral therapy has dramatically improved the efficacy of antiviral C therapy over recent years leading to SVR rates over 90% in phase II and III clinical trials, without PEG-IFN and/or RBV. Preliminary results in transplant patients showed better efficacy, better tolerability and less drug-drug interactions.

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P1232 Sofosbuvir and Ribavirin for the Treatment of Recurrent Hepatitis C Infection After Liver Transplantation: Results of a Prospective, Multicenter Study

Cited by 28 publications

References 0 publications

An Interferon-free Antiviral Regimen for HCV after Liver Transplantation

An Interferon-free Antiviral Regimen for HCV after Liver Transplantation

Sofosbuvir: A Review of its Use in Patients with Chronic Hepatitis C

Management of post transplant hepatitis C in the direct antiviral agents era

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