G02 : Ledipasvir/sofosbuvir with ribavirin is safe and efficacious in decompensated and post liver transplantation patients with HCV infection: Preliminary results of the prospective solar 2 trial

Manns, M.; Forns, Xavier; Samuel, Didier; Denning, Jill; Arterburn, Sarah; Brandt-Sarif, T.; Dvory‐Sobol, Hadas; Pang, Phillip S.; McHutchison, John G.; Gane, Ed; Mutimer, David

doi:10.1016/s0168-8278(15)30003-9

Cited by 62 publications

(64 citation statements)

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“…Consistently in all studies, the SVR was lower in patients scored as Child-Pugh class C than in those scored as Child-Pugh class A or B before or after liver transplant. 27,42,43 However, the predictors of failure differ between regimens. For instance, a thrombocytopenia predicted that treatment would fail in patients treated with sofosbuvirledipasvir-ribavirin, whereas hypoalbuminemia predicted that treatment would fail in patients who were given sofosbuvir and daclastasvair.…”

Section: Discussionmentioning

confidence: 99%

Untitled

Suraweera

Saab²,

Tong³

et al. 2016

Exp Clin Transplant

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Chronic hepatitis C virus infection is a substantial health care burden worldwide and is the leading cause of liver transplant in adults. In patients with detectable hepatitis C virus RNA at the time of transplant, interferon-based therapies for hepatitis C virus were poorly tolerated with low virologic response rates. Although reinfection after transplant is inevitable, the recent advent of direct-acting antiviral agents has revolutionized treatment of hepatitis C virus in the pre-and posttransplant settings. These antiviral agents have been shown to have high-sustained virologic response rates, shorter courses of treatment, and decreased frequencies of adverse effects. Here, we review the current literature on the use of direct-acting agents for treatment of patients with hepatitis C virus before and after liver transplant. Key words: HCV, Liver transplantation IntroductionHepatitis C virus (HCV) is the most common indication for liver transplant in the United States and Europe. 1 However, patient survival for HCV has been historically the lowest of all indications for liver transplant. 2,3 The main reason for the poor outcome is related to viral recurrence that occurs uniformly and to recurrent liver disease that occurs in up to 30% of patients within 5 years after liver transplant. [4][5][6][7] The need for liver transplant has increased not only for decompensated liver disease but also for hepatocellular carcinoma and for the aging cohort of HCVinfected patients seeking medical care. 8 Achieving a sustained virologic response (SVR) with antiviral therapy is associated with improved clinical outcomes in liver transplant recipients, 7,9 and at present, the availability of direct-acting agents has dramatically transformed the treatment of HCV. Whereas antiviral therapy with interferon was associated with significant adverse effects, interferonfree therapy has been found to be safe, tolerable, and effective. 10 These direct-acting agents are classified according to their mode of action and differ in potency, barrier to resistance, dosing, and drug-drug interactions. 11 The treatment of HCV in liver transplant recipients can occur at different time points along the continuum of liver disease. Treatment may be initiated before liver transplant in patients with compensated or decompensated cirrhosis, immediately after transplant, or after when disease reoccurs after transplant. Here, we review the use of antiviral therapies both in patients who are candidates for liver transplant and in recipients after liver transplant. PretransplantAchieving an SVR has clearly been associated with improved clinical outcomes in patients with advanced liver disease. 12 Liver-related mortality, need for liver transplant, hepatocellular carcinoma, and hepatic decompensation are all decreased with an SVR. [13][14][15][16] Moreover, achieving an SVR before liver transplant reduces risk of graft reinfection after transplant. 17 Although the likelihood of achieving an SVR is greatly enhanced with the use of interferonfree regime...

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Section: Discussionmentioning

confidence: 99%

Untitled

Suraweera

Saab²,

Tong³

et al. 2016

Exp Clin Transplant

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“…These DAAs have already been shown to change the landscape of AVT for HCV infection in non-transplant and post LT settings. Recently published randomized controlled studies on the use of sofosbuvir based AVT reported SVR rates ranging between 70% to 85% in post LT patients with child-pugh-turcotte (CTP) A, B and C patients [4,13,14]. Overall, the treatment was well tolerated, with few severe side effects.…”

Section: Introductionmentioning

confidence: 89%

Multidisciplinary Approach to treat Liver Transplant Recipients with Hepatitis C using Sofosbuvir based Therapy

Pastrana-Camacho

Bradley

Winters

et al. 2017

GHOA

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Introduction: The safety and efficacy of the direct acting antivirals in liver transplant recipients is unknown. Materials and Methods:Retrospective cohort study on 44 liver transplant recipients, ≥18 years old who received Sofosbuvir (SOF) based antiviral therapy (AVT) at our hospital from January 2012 through May 2016. Multidisciplinary (MDT) approach involving hepatologists, transplant pharmacists and a patient access coordinator was adapted. SVR at 12 and 24 weeks, safety and compliance of SOF based AVT were reported. We also reported on improvement in APRI and CPT score at SVR.Results: 35 patients (79.5%) were treated with Ledipasvir (LDV) /SOF, 7 (16 %) with SOF/RBV and 2 (4.5%) with SOF/Simeprevir (SIM). Most patients were HCV genotype 1 (n=37; 84.1%) and treatment experienced (n= 24; 55%). Median time between liver transplant (LT) and AVT was 2.7 years with majority (66%) treated ≥ 12 months after LT. Median pre-treatment HCV viremia was 3,800,000 (71,000-66,000,000) with a high viral load ≥ 800,000 copies/ml in 36 (82%) patients. SVR 12 and 24 were achieved in 43/44 (98%), despite a low (77.3%) rapid virological response. Statistically significant improvement was observed in pre-treatment and post-SVR median albumin levels, APRI and CPT scores. Fatigue (27%) was the most commonly reported adverse effect. Compliance rate was 100%. Conclusion:With a MDT approach, using SOF based AVT, a very high SVR was achieved in liver transplant recipients with recurrent HCV infection. A MDT approach positively impacts medication acquisition, enhances patient education and compliance in post LT HCV management.

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“…Occurrence of HCC is not a rare event during and after antiviral treatment in older HCV patients [211] or HCV patients with advanced fibrosis [210]. Further studies will be needed regarding this point after interferon-free treatment [212][213][214][215][216].…”

Section: Laboratory Testing After Hcv Curementioning

confidence: 99%

APASL consensus statements and recommendations for hepatitis C prevention, epidemiology, and laboratory testing

et al. 2016

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The Asian Pacific Association for the Study of the Liver (APASL) convened an international working party on ''APASL consensus statements and recommendations for management of hepatitis C'' in March 2015 to revise the ''APASL consensus statements and management algorithms for hepatitis C virus infection'' (Hepatol Int 6:409-435, 2012). The working party consisted of expert hepatologists from the Asian-Pacific region gathered at the Istanbul Congress Center, Istanbul, Turkey on 13 March 2015. New data were presented, discussed, and debated during the course of drafting a revision. Participants of the consensus meeting assessed the quality of the cited studies. The finalized recommendations for hepatitis C prevention, epidemiology, and laboratory testing are presented in this review.

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G02 : Ledipasvir/sofosbuvir with ribavirin is safe and efficacious in decompensated and post liver transplantation patients with HCV infection: Preliminary results of the prospective solar 2 trial

Cited by 62 publications

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Multidisciplinary Approach to treat Liver Transplant Recipients with Hepatitis C using Sofosbuvir based Therapy

APASL consensus statements and recommendations for hepatitis C prevention, epidemiology, and laboratory testing

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