Multicentre experience using daclatasvir and sofosbuvir to treat hepatitis C recurrence – The ANRS CUPILT study

Coilly, Audrey; Fougerou‐Leurent, Claire; Lédinghen, Victor de; Houssel‐Debry, Pauline; Duvoux, Christophe; Martino, Vincent Di; Radenne, Sylvie; Kamar, Nassim; d’Altéroche, Louis; Leroy, Vincent; Canva, V.; Lebray, Pascal; Moreno, Christophe; Dumortier, Jérôme; Silvain, Christine; Besch, Camille; Perre, Philippe Vande; Botta‐Fridlund, Danielle; Anty, Rodolphe; Francoz, Claire; Abergel, A.; Debette‐Gratien, Maryline; Conti, Filoména; Habersetzer, François; Rohel, Alexandra; Rossignol, Emilie; Danjou, H.; Roque–Afonso, Anne–Marie; Samuel, Didier; Duclos‐Vallée, Jean‐Charles; Pageaux, Georges‐Philippe

doi:10.1016/j.jhep.2016.05.039

Cited by 75 publications

(63 citation statements)

References 25 publications

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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: 90%

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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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Section: Post Liver Transplantationmentioning

confidence: 90%

“…In case of decompensated graft cirrhosis, treatment with DAAs is associated with a reduced likelihood of SVR [76][77][78]103,106,107]. Despite these lower success rates, improvements in MELD score and CTP have been observed.…”

Section: Post Liver Transplantationmentioning

confidence: 99%

Reversion of disease manifestations after HCV eradication

Meer

Berenguer

2016

Journal of Hepatology

161

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“…-Patients with recurrent hepatitis C GT-1, 4, 5 and 6 without cirrhosis (F0-F3), with compensated (Child A) or decompensated (Child B and C) cirrhosis should be treated with: 1) the fixed dose combination Sofosbuvir plus Ledipasvir [30][31][32][33] or 2) the combination of Sofosbuvir plus Daclatasvir [3,9,34] for 12 weeks with daily weight based RBV (1000mg or 1200mg/day in patients <75kg or ≥75 kg, respectively), without the need of adjustments in the immunosuppression regimen (exception for everolimus)[A1]; -Patients with recurrent hepatitis C GT-2 or 3 without cirrhosis (F0-F3), with compensated (Child A) or decompensated (Child B/C) cirrhosis should be treated with the combination of Sofosbuvir plus Daclatasvir for 12/24 weeks with daily weight-based RBV (1000mg or 1200mg/day in patients <75kg or ≥75 kg, respectively) [3,9,34], without the need of adjustments in the immunosuppression regimen (exception for everolimus) [B1]; -All HCV-infected patients, irrespective of HCV GT or stage of the liver disease, could be treated with the fixed-dose combination of Sofosbuvir plus Velpatasvir for 12 weeks or 24 weeks (only in GT-3 and decompensated Child B and C cirrhosis) with daily weight-based RBV (1000mg or 1200mg/ day in patients <75kg or ≥75 kg, respectively) [3] [C2] (results of on-going studies are awaited in order to increase the quality of evidence and the strength of this recommendation, as well as data on DDIs of this regimen with immunosuppressive drugs);…”

Section: Treatment Of Patients With Recurrence Of Hcv Infection Aftermentioning

confidence: 99%

Position Paper on Treatment of Hepatitis C in Romania 2017. Part Two

Gheorghe

Sporea

Iacob

et al. 2017

JGLD

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Background & Aims: Hepatitis C virus (HCV) infection is a common condition with endemic prevalence in some areas of the world. In Romania, the mean prevalence is about 3%. New treatments have become available on the market in recent years and new drugs are in the pipeline. A re-evaluation of HCV therapy was considered mandatory. The Romanian Society of Gastroenterology and Hepatology undertook this task for the practitioners of this country.Methodology: A group of recognized experts was created who screened the available literature and the major available guidelines. A list of items requiring attention was created and these were discussed and rated. Decisions were taken by consensus.Recommendations: We present here the second part of the Society’s recommendations for chronic HCV infection treatment. An agreement between experts was reached regarding the therapy of the special categories of patients infected with HCV, complications and monitoring of the therapy, follow-up of the patients who reached sustained virologic response and re-treatment of the patients with therapy failure.Conclusions: This Position Paper represents a guide for the assessment and the therapy of HCV infection. The recommendations are in concordance with other guidelines but are applied to real-life conditions in Romania. Abbreviations: CKD: Chronic kidney disease; DAAs: Direct-acting antivirals; DDIs: Drug-drug interactions; ESDL: End-stage liver disease; FCH: Fibrosing cholestatic hepatitis; GT: Genotype; HCV: Hepatitis C virus; HCC: Hepatocellular carcinoma; LT: Liver transplantation; MELD score: Mayo-Clinic End-Stage Liver Disease score; PDC: Premature discontinuation; PWID: Persons who inject drugs; RASs: Resistance associated substitutions; RBV: Ribavirin; RCT: Randomized controlled trial; SAE: Serious adverse events; SRGH: Romanian Society of Gastroenterology and Hepatology; SVR: Sustained virologic response.

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“…11,12 Since 2013, the use of second-generation direct-acting antivirals (DAAs) has provided major progress in isolated LT recipients with recurrent HCV (whatever the stage of liver fibrosis) and in previously "difficult-to-treat" patients with fibrosing cholestatic hepatitis. [13][14][15] An SVR 12 weeks after treatment was obtained in more than 90% of cases in all subpopulations, with fewer adverse events than in previous studies. Recent published studies have shown that second-generation oral DAAs also effectively treated HCV infection following isolated KT, with a low rate of treatment-related side effects.…”

Section: -10mentioning

confidence: 55%

“…[13][14][15] To our knowl- Despite their renal metabolism, these inhibitors can be used in patients with CKD without safety concerns. 24 Safety was carefully investigated in our study population.…”

Section: Discussionmentioning

confidence: 99%

Direct-acting antiviral agent–based regimen for HCV recurrence after combined liver-kidney transplantation: Results from the ANRS CO23 CUPILT study

Dharancy

Coilly

Fougerou‐Leurent

et al. 2017

American Journal of Transplantation

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International audienceHepatitis C virus (HCV) infection is associated with reduced patient survival following combined liver-kidney transplantation (LKT). The aim of this study was to assess the efficacy and safety of second-generation direct-acting antivirals (DAAs) in this difficult-to-treat population. The ANRS CO23 "Compassionate use of Protease Inhibitors in Viral C Liver Transplantation" (CUPILT) study is a prospective cohort including transplant recipients with recurrent HCV infection treated with DAAs. The present work focused on recipients with recurrent infection following LKT. The study population included 23 patients. All patients received at least one NS5B inhibitor (sofosbuvir) in their antiviral regimen an average of 90 months after LKT. Ninety-six percent of recipients achieved a sustained virological response (SVR) at week 12 (SVR12). In terms of tolerance, 39% of recipients presented with at least one serious adverse event. None of the patients experienced acute rejection during therapy and there were no deaths during follow-up. The glomerular filtration rate (GFR) decreased significantly from baseline to the end of therapy. However, this study did not show that the decline in GFR persisted over time or that it was directly related to DAAs. The DAA-based regimen is well tolerated with excellent results in terms of efficacy. It will become the gold standard for the treatment of recurrent HCV following LKT

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Multicentre experience using daclatasvir and sofosbuvir to treat hepatitis C recurrence – The ANRS CUPILT study

Cited by 75 publications

References 25 publications

Reversion of disease manifestations after HCV eradication

Reversion of disease manifestations after HCV eradication

Position Paper on Treatment of Hepatitis C in Romania 2017. Part Two

Direct-acting antiviral agent–based regimen for HCV recurrence after combined liver-kidney transplantation: Results from the ANRS CO23 CUPILT study

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