Treatment of Chronic HCV With Sofosbuvir and Simeprevir in Patients With Cirrhosis and Contraindications to Interferon and/or Ribavirin

Shiffman, Mitchell L.; James, Amy; Long, April; Alexander, Philip C

doi:10.1038/ajg.2015.218

Cited by 39 publications

(33 citation statements)

References 30 publications

(58 reference statements)

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“…The study did not find a significant impact of adding ribavirin in this context 41. Other smaller studies gave similar results 42. The Hepather Cohort study with more than 400 patients, the majority of whom were cirrhotic, with G1 treated with sofosbuvir and daclatasvir reported higher SVR rates when used for 24 weeks or with the addition of ribavirin for 12 weeks 43.…”

Section: Introductionmentioning

confidence: 67%

Hepatitis C virus treatment in the real world: optimising treatment and access to therapies: Table 1

Zoulim

Liang

Gerbes

et al. 2015

Gut

134

132

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Chronic HCV infections represent a major worldwide public health problem and are responsible for a large proportion of liver related deaths, mostly because of HCV-associated hepatocellular carcinoma and cirrhosis. The treatment of HCV has undergone a rapid and spectacular revolution. In the past 5 years, the launch of direct acting antiviral drugs has seen sustained virological response rates reach 90% and above for many patient groups. The new treatments are effective, well tolerated, allow for shorter treatment regimens and offer new opportunities for previously excluded groups. This therapeutic revolution has changed the rules for treatment of HCV, moving the field towards an interferon-free era and raising the prospect of HCV eradication. This manuscript addresses the new challenges regarding treatment optimisation in the real world, improvement of antiviral efficacy in ‘hard-to-treat’ groups, the management of patients whose direct acting antiviral drug treatment was unsuccessful, and access to diagnosis and treatment in different parts of the world.

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Section: Introductionmentioning

confidence: 67%

Hepatitis C virus treatment in the real world: optimising treatment and access to therapies: Table 1

Zoulim

Liang

Gerbes

et al. 2015

Gut

134

132

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show abstract

“…However, patients with undetectable HCV RNA at week 4 had only slightly higher SVR compared to those with detectable HCV RNA at this time point (86% vs. 76%) [67] (Table 3). Other studies support the notion that on-treatment HCV RNA alone may not be a good predictor of SVR with this DAA regimen [40,[97][98][99].…”

Section: Hcv Rna Quantification For the Prediction Of Svr During Simementioning

confidence: 92%

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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“…For a subgroup of patients with decompensated cirrhosis and DAA induced SVR, an improvement in liver function has been reported. Nevertheless, severe adverse events were reported in a substantial percentage of patients, and ascites or hepatic encephalopathy did not resolve completely in all patients[43,44,49,71]. Currently, no biomarkers are available to predict the individual clinical course in patients with decompensated cirrhosis to decide whether treatment should be initiated before or after LT[49,72].…”

Section: Approved Daa-based Treatment In Patients With Decompensated mentioning

confidence: 99%

Concise review: Interferon-free treatment of hepatitis C virus-associated cirrhosis and liver graft infection

Weiler¹,

Zeuzem²,

Welker³

2016

WJG

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Chronic hepatitis C is a major reason for development of cirrhosis and hepatocellular carcinoma and a leading cause for liver transplantation. The development of direct-acting antiviral agents lead to (pegylated) interferon-alfa free antiviral therapy regimens with a remarkable increase in sustained virologic response (SVR) rates and opened therapeutic options for patients with advanced cirrhosis and liver graft recipients. This concise review gives an overview about most current prospective trials and cohort analyses for treatment of patients with liver cirrhosis and liver graft recipients. In patients with compensated cirrhosis Child-Pugh-Turcotte (CTP) class A, all approved agents are safe and SVR rates do not significantly differ from patients without cirrhosis in general. In patients with decompensated cirrhosis CTP class B or C, daclastasvir, ledipasvir, velpatasvir, and sofosbuvir are approved, and SVR rates higher than 90% can be achieved. Especially for patients with a model of end stage liver disease score higher than 15 and therefore eligible for liver transplantation, data is scarce. Reported SVR rates in patients with cirrhosis CTP class C are lower compared to patients with a less severe liver disease. In liver transplant recipients with a maximum of CTP class A, SVR rates are comparable to patients without LT. Patients with decompensated graft cirrhosis should be treated on an individual basis.

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Treatment of Chronic HCV With Sofosbuvir and Simeprevir in Patients With Cirrhosis and Contraindications to Interferon and/or Ribavirin

Abstract: The combination of SMV and SOF achieves high rates of SVR in patients with advanced cirrhosis but is lower with worsening Child class.

Cited by 39 publications

References 30 publications

Hepatitis C virus treatment in the real world: optimising treatment and access to therapies: Table 1

Hepatitis C virus treatment in the real world: optimising treatment and access to therapies: Table 1

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

Concise review: Interferon-free treatment of hepatitis C virus-associated cirrhosis and liver graft infection

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