Eligibility and safety of the first interferon‐free therapy against hepatitis C in a real‐world setting

Siederdissen, Christoph Höner zu; Maasoumy, Benjamin; Deterding, Katja; Port, Kerstin; Sollik, L.; Mix, Carola; Kirschner, J.; Cornberg, J; Manns, Michael P.; Wedemeyer, Heiner; Cornberg, Markus

doi:10.1111/liv.12774

Cited by 26 publications

(28 citation statements)

References 26 publications

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“…Overall, the treatment was well tolerated, with few severe side effects. Similar results were reported in studies based on real world data such as TRIO and TARGET 2.0 trials [15][16][17][18]. A recent real world data-based study published from Canada on efficacy of SOF-based treatment reported overall SVR rates of 85% in all genotypes [19].…”

Section: Introductionsupporting

confidence: 71%

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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Section: Introductionsupporting

confidence: 71%

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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“…As virological failures during therapy are rare, no stopping criteria have yet been established. Moreover, these regimens are far better tolerated than any of the former IFN-containing treatments [14,33,70,71]. Thus, there seems to be no major interest in shortened treatment durations with respect to drug safety.…”

Section: Cut-off Definitionmentioning

confidence: 90%

Diagnostics in hepatitis C: The end of response-guided therapy?

Maasoumy

Vermehren

2016

Journal of Hepatology

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On-treatment hepatitis C virus (HCV) RNA has been used to predict response to interferon (IFN)-based therapy. The concept of response-guided treatment (RGT) was established to determine optimal treatment duration and to early identify patients not responding to futile therapies. RGT helped to improve sustained virologic response (SVR) rates and lower the rates of adverse effects. RGT was of particular importance for telaprevir- and boceprevir-based triple therapies. RGT strategies are dependent on highly sensitive and reproducible HCV RNA quantification. However, different HCV RNA assays are used in routine clinical practice and these differ significantly in their performance characteristics. The development of IFN-free therapies has fundamentally changed the role of on-treatment HCV RNA for SVR prediction. Given the high efficacy and excellent tolerability of IFN-free regimens, the interest in treatment individualization has decreased. However, shorter treatment durations may still be desirable, particularly with respect to the high costs of current IFN-free direct-acting antiviral agents (DAAs). Moreover, some difficult-to-treat patients remain, e.g., those infected with HCV genotype 3 in whom the current standard of care may not always be sufficient to achieve SVR, especially in treatment-experienced patients with cirrhosis. Here, a RGT extension may be feasible. However, current data on the predictive value of on-treatment HCV RNA are limited and have shown conflicting results. As more potent DAAs become available, the role of response prediction may diminish further. Currently, shorter treatment duration is only based on baseline HCV RNA whereas no RGT strategy is recommended for any of the approved DAA regimens available.

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“…Early mortality due to aggravation of liver function during therapy might occur as was observed during treatment with lamivudine for decompensated HBV-LC [40] . Patients with advanced cirrhosis still have a high risk for hospitalization after the initiation of DAA treatment [36] . In addition, decompensated cirrhosis patients are more prone to develop drug-induced sideeffects when compared to patients with compensated cirrhosis.…”

Section: Expectations and Concerns Of Daa Treatment For Decompensatedmentioning

confidence: 99%

“…Actually, preliminary report showed that DAAs for decompensated LC improved MELD scores in 60% to 79% patients only 4 wk after treatment finalization [31] . For these reasons, DAA treatments would be indicated positively for those with decompensated LC-HCV in real world-settings [36] . Despite of these encouraging situations and that a standardized mortality rate analysis reported a lower liver-related mortality among HCV-cirrhotics with SVR by IFN treatment [37] , to our knowledge there are currently no data on disease progression, delisting from LT, and improvement of life expectancy after the achievement of SVR for decompensated LC-HCV.…”

Section: Expectations and Concerns Of Daa Treatment For Decompensatedmentioning

confidence: 99%

Direct antiviral agent treatment of decompensated hepatitis C virus-induced liver cirrhosis

Ohkoshi

Hirono

Yamagiwa

2015

WJGPT

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Recently, direct antiviral agents (DAAs) have been increasingly used for the treatment of chronic hepatitis C virus (HCV) infections, replacing interferon-based regimens that have severe adverse effects and low tolerability. The constant supply of new DAAs makes shorter treatment periods with enhanced safety possible. The efficacy of DAAs for treatment of compensated liver cirrhosis (LC) is not less than that for treatment of non-cirrhotic conditions. These clinical advantages have been useful in pre-and post-liver transplantation (LT) settings. Moreover, DAAs can be used to treat decompensated HCV-induced LC in elderly patients or those with severe complications otherwise having poor prognosis. Although encouraging clinical data are beginning to appear, the actual efficacy of DAAs for suppressing disease progression, allowing delisting for LT and, most importantly, improving prognosis of patients with decompensated HCV-LC remains unknown. Casecontrol studies to examine the short-or long-term effects of DAAs for treatment of decompensated HCV-LC are urgently need.

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Eligibility and safety of the first interferon‐free therapy against hepatitis C in a real‐world setting

Cited by 26 publications

References 26 publications

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

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

Diagnostics in hepatitis C: The end of response-guided therapy?

Direct antiviral agent treatment of decompensated hepatitis C virus-induced liver cirrhosis

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