Sofosbuvir compassionate use program for patients with severe recurrent hepatitis C after liver transplantation

Forns, Xavier; Charlton, Michael; Denning, Jill; McHutchison, John G.; Symonds, William T.; Brainard, Diana M.; Brandt-Sarif, T.; Chang, P; Kivett, Valerie; Castells, Lluı́s; Prieto, M.; Fontana, Robert J.; Baumert, Thomas F.; Coilly, Audrey; Londoño, María Carlota; Habersetzer, François

doi:10.1002/hep.27681

Cited by 226 publications

(204 citation statements)

References 27 publications

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“…The beneficial effect of SOF and RBV therapy in postliver transplant scenario has also been demonstrated in other studies. 42,78 In the SOLAR-1 study, SOF/LDV/RBV for 12 or 24 weeks was evaluated in 223 LTRs. 64 These predominantly GT-1 patients included 50% (n = 111) with METAVIR score of F0-3, 23% (n = 51) with CPT-A cirrhosis, 23% (n = 52) with CPT-B cirrhosis, and 4% (n = 9) with CPT-C cirrhosis.…”

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

confidence: 99%

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: 99%

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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“…79 These concerns may be diminished by recent data from liver recipients showing successful treatment of fibrosing cholestatic hepatitis using current DAAs. [80][81][82][83] These results are encouraging; however, we await confirmation of these outcomes in kidney recipients.…”

Section: Grazoprevir and Elbasvirmentioning

confidence: 96%

Hepatitis C Virus Infection in Chronic Kidney Disease

Ladino

Pedraza

Roth

2016

JASN

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Soon after the hepatitis C virus (HCV) was identified in 1989, it was recognized that the prevalence of infection in patients with ESRD far exceeded that in the general population. Infection with HCV predisposes to the hepatic complications of cirrhosis and hepatocellular carcinoma. However, important extrahepatic manifestations include immune complex glomerular disease, accelerated progression of CKD, increases in cardiovascular event risk, and lymphoproliferative disorders. Advances in understanding the molecular biology of HCV have ushered in a new era in the treatment of this infection. Second generation direct-acting antiviral agents have revolutionized therapy, with sustained virologic response rates (undetectable viral load 12 weeks after completing therapy) of .90% in most patients. Studies using direct-acting antivirals in patients with CKD and those on dialysis are showing excellent safety and efficacy as well. In this context, it is imperative that nephrologists become familiar with this literature, reviewed here, so that the important decisions, including which patients should be treated and the optimal timing to initiate therapy, are vetted in association with the compounding issues of CKD, ESRD, and kidney transplantation.

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“…With the advent of the directly acting drugs, such as sofosbuvir and simeprevir, a dramatic increase of sustained virologic responses and thus cure in patients with severe recurrent HCV and cirrhosis before and after transplant can be expected (152,(160)(161)(162).…”

Section: Impact Of Antiviral Therapy On Allograft Dysfunctionmentioning

confidence: 99%

The Impact of Infection on Chronic Allograft Dysfunction and Allograft Survival After Solid Organ Transplantation

Martín-Gandul

Mueller

Pascual

et al. 2015

American Journal of Transplantation

129

100

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Infectious diseases after solid organ transplantation (SOT) are a significant cause of morbidity and reduced allograft and patient survival; however, the influence of infection on the development of chronic allograft dysfunction has not been completely delineated. Some viral infections appear to affect allograft function by both inducing direct tissue damage and immunologically related injury, including acute rejection. In particular, this has been observed for cytomegalovirus (CMV) infection in all SOT recipients and for BK virus infection in kidney transplant recipients, for community-acquired respiratory viruses in lung transplant recipients, and for hepatitis C virus in liver transplant recipients. The impact of bacterial and fungal infections is less clear, but bacterial urinary tract infections and respiratory tract colonization by Pseudomonas aeruginosa and Aspergillus spp appear to be correlated with higher rates of chronic allograft dysfunction in kidney and lung transplant recipients, respectively. Evidence supports the beneficial effects of the use of antiviral prophylaxis for CMV in improving allograft function and survival in SOT recipients. Nevertheless, there is still a need for prospective interventional trials assessing the potential effects of preventive and therapeutic strategies against bacterial and fungal infection for reducing or delaying the development of chronic allograft dysfunction.

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Sofosbuvir compassionate use program for patients with severe recurrent hepatitis C after liver transplantation

Cited by 226 publications

References 27 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

Hepatitis C Virus Infection in Chronic Kidney Disease

The Impact of Infection on Chronic Allograft Dysfunction and Allograft Survival After Solid Organ Transplantation

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