Daclatasvir combined with sofosbuvir or simeprevir in liver transplant recipients with severe recurrent hepatitis C infection

Fontana, Robert J.; Brown, Robert S.; Moreno-Zamora, Ana; Prieto, M.; Joshi, Shobha; Londoño, María Carlota; Herzer, Kerstin; Chacko, Kristina; Stauber, Rudolf; Knop, Viola; Jafri, Syed Mohammed; Castells, Lluı́s; Ferenci, Péter; Torti, Carlo; Durand, Christine M.; Loiacono, Laura; Lionetti, Raffaella; Bahirwani, Ranjeeta; Weiland, Ola; Mubarak, Abdullah; Elsharkawy, Ahmed M.; Stadler, Bernhard; Montalbano, Marzia; Berg, Christoph P.; Pellicelli, A.; Stenmark, Stephan; Vekeman, Francis; Ionescu‐Ittu, Raluca; Émond, Bruno; Reddy, K. Rajender

doi:10.1002/lt.24416

Cited by 74 publications

(55 citation statements)

References 36 publications

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“…Therefore, the standard immunosuppression does not need any change with the DAAs described in this review. 67 The efficacy and safety data for DCV-based all-oral antiviral therapy in LT has been shown by Fontana et al 79 in 97 cases after LT [(DCV/SOF (n = 77), DCV/ simeprevir (n = 18), and DCV/SOF/simeprevir (n = 2)]. Overall, 35% of the patients received RBV.…”

Section: Management Of Hcv Infection After Liver Transplant (Lt)mentioning

confidence: 94%

Indian National Association for Study of the Liver (INASL) Guidance for Antiviral Therapy Against HCV Infection: Update 2016

Puri

Saraswat

Dhiman

et al. 2016

Journal of Clinical and Experimental Hepatology

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India contributes significantly to the global burden of HCV. While the nucleoside NS5B inhibitor sofosbuvir became available in the Indian market in March 2015, the other directly acting agents (DAAs), Ledipasvir and Daclatasvir, have only recently become available in the India. The introduction of these DAA in India at a relatively affordable price has led to great optimism about prospects of cure for these patients as not only will they provide higher efficacy, but combination DAAs as all-oral regimen will result in lower side effects than were seen with pegylated interferon alfa and ribavirin therapy. Availability of these newer DAAs has necessitated revision of INASL guidelines for the treatment of HCV published in 2015. Current considerations for the treatment of HCV in India include the poorer response of genotype 3, nonavailability of many of the DAAs recommended by other guidelines and the cost of therapy. The availability of combination DAA therapy has simplified therapy of HCV with decreased reliance of evaluation for monitoring viral kinetics or drug related side effects. ( J CLIN EXP HEPATOL 2016;6:119-145) T here have been revolutionary changes in the management of chronic hepatitis C (CH-C) over the last few years. Pegylated interferon alfa (Peg-IFNa) plus ribavirin (RBV) therapy, which till the recent past was the standard of care, has been eclipsed by the arrival of newer directly acting antiviral agents (DAAs). Not only do the DAAs have better efficacy, they are also associated with lower side effects, have better tolerability, a shorter duration of therapy, and have simpler administration.In the recent guidelines issued by the American Association for the study of Liver Diseases (AASLD), in collaboration with the Infectious Diseases Society of America 1 and the European Association for Study of the Liver z (EASL), 2 the role of Peg-IFNa/RBV therapy in the management of HCV has been relegated to second-line, backup status. These newer guidelines, however, cannot be implemented in India as many of the recommended drugs are yet to be marketed in India. Other considerations for the treatment of HCV in India are a predominance of

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Section: Management Of Hcv Infection After Liver Transplant (Lt)mentioning

confidence: 94%

Indian National Association for Study of the Liver (INASL) Guidance for Antiviral Therapy Against HCV Infection: Update 2016

Puri

Saraswat

Dhiman

et al. 2016

Journal of Clinical and Experimental Hepatology

View full text Add to dashboard Cite

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“…Excellent SVR rates are achieved, greater than 95%, even in the FCH group [73,[76][77][78][103][104][105][106]. From a safety point of view, very few severe adverse events have been reported throughout studies.…”

Section: Post Liver Transplantationmentioning

confidence: 83%

“…In terms of clinical benefits, results parallel to the situation as described in the immune competent setting. Most importantly, in FCH, where recurrence is characterized by rapid portal fibrosis and cholestasis leading to fast deterioration of the liver, short series of patients treated with the DAAs have shown that the vast majority of patients survive without the need of re-transplantation, with rapid and profound improvements in clinical status [104,105].…”

Section: Post Liver Transplantationmentioning

confidence: 99%

Reversion of disease manifestations after HCV eradication

Meer

Berenguer

2016

Journal of Hepatology

161

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Chronic infection with the hepatitis C virus (HCV) may lead to hepatic fibrosis and eventually cirrhosis, at which stage, patients have a substantial risk of liver failure, hepatocellular carcinoma (HCC) and liver-related death. Moreover, HCV infection is associated with several extrahepatic manifestations which impact the quality of life and increase the non-liver-related mortality rate. For patients with compensated liver disease, interferon (IFN)-based antiviral therapy has been a treatment option for over two decades. Long-term follow-up studies indicated that among those with sustained virological response (SVR) the extend of hepatic fibrosis can regress and that their risk of cirrhosis-related complications (including HCC) is reduced, also in case of cirrhosis. Recent population-based studies extended these observations for solid extrahepatic outcomes, such as end-stage renal failure and cardiovascular events. Most importantly, SVR has been associated with prolonged overall survival. These results highlight the importance of the development of new direct-acting antivirals (DAAs), by which almost all patients are able to eradicate HCV in a comfortable manner. Based on the excellent first experiences with the DAAs, physicians gained confidence to use these drugs among patients with decompensated cirrhosis on a more regular basis as well. This was not possible with interferon therapy. Also in this high risk population the DAAs show high SVR rates with improvements in biochemical parameters of liver function shortly after therapy, especially in case of SVR. In fact, some patients could actually be removed from the liver transplantation waiting list due to clinical improvement following DAA therapy. How these short-term results translate into a prolonged (long-term) survival has yet to be determined, as well as which patients with decompensated liver disease are likely or not to benefit from viral eradication. Here we review the current data regarding the beneficial clinical outcome with antiviral therapy as well the remaining uncertainties in this field, both for patients with compensated liver disease and patients with decompensated liver disease.

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“…In patients with DCV plus sofosbuvir, the SVR was 88 % without ribavirin and 100 % with ribavirin but with no statistical significance (p = 0.18). Virological breakthrough and relapse occurred in three and two patients, respectively [96]. These studies indicate the role of ribavirin-free regimens in the near future in post transplant rHCV infection…”

Section: Drug Interactionsmentioning

confidence: 96%

Management of post liver transplantation recurrent hepatitis C infection with directly acting antiviral drugs: a review

2016

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Recurrent HCV infection (rHCV) of the liver allograft following transplantation is universal and is associated with poor graft and patient survival in comparison with other indications. Treatment of rHCV infection in the previous era with pegylated interferon and ribavirin was associated with low sustained virological response (SVR) due to poor tolerability, adverse events and graft rejection. Recently, directly acting antiviral drugs (DAA) have been approved for the treatment of hepatitis C infection and a number of clinical trials have been conducted across various centers in the management of rHCV infection of the graft. In this review we discuss about recent studies that have emerged on the use of NS5b polymerase inhibitor, sofosbuvir in combination with second generation protease inhibitor, simeprevir, fixed dose ledipasvir or daclatasvir with or without ribavirin in the treatment of post transplant rHCV infection.

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Daclatasvir combined with sofosbuvir or simeprevir in liver transplant recipients with severe recurrent hepatitis C infection

Cited by 74 publications

References 36 publications

Indian National Association for Study of the Liver (INASL) Guidance for Antiviral Therapy Against HCV Infection: Update 2016

Indian National Association for Study of the Liver (INASL) Guidance for Antiviral Therapy Against HCV Infection: Update 2016

Reversion of disease manifestations after HCV eradication

Management of post liver transplantation recurrent hepatitis C infection with directly acting antiviral drugs: a review

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