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Study raises questions about the risks of treating patients with late stage hep C virus

April 14, 2016

April 14, 2016, Barcelona, Spain: New data presented today raise the question of whether patients with severe Hepatitis C virus (HCV) should be treated with direct-acting antivirals (DAAs), given their high risk of short-term death at this late-disease stage.

The study, presented at The International Liver CongressTM in Barcelona, Spain, demonstrated that those with advanced liver disease are more likely to die during or within 12 weeks after treatment with DAAs (medicines which have been used to treat and cure almost all patients with HCV).1,2,3,4

Patients with advanced liver disease who have cirrhosis (scarring of the liver) have differing prognoses. Patients with the most advanced cases of liver disease have a life expectancy of one to three years according to the Child-Pugh-Turcotte (CPT) classification system, which is used to estimate prognosis in cirrhosis.5

"Direct-acting antivirals have transformed the lives of people living with HCV, however there has been much debate around the pros and cons of their use in patients with advanced liver disease," said Dr Carlos Fernández Carrillo, Liver Unit of Puerta de Hierro-Majadahonda University Hospital, Spain and lead study author. "The results of our study clearly show that those patients suffering from very advanced liver disease may not obtain benefit from these treatments. We believe that in these severe cases, a discussion must take place between the healthcare professional and the patient, to make an individual decision. Sometimes it could be better to let the condition run its natural course rather than intervene and risk severe adverse events or death before curing the Hepatitis", added Dr José Luis Calleja, the senior study author.

The Hepa-C registry, governed by the Spanish Association for the Study of the Liver and the Networked Biomedical Research Centre for the Study of the Liver and Digestive Diseases, Spain, was used to register 843 study members who demonstrated clinical symptoms of advanced liver disease, had liver cirrhosis and had not received a liver transplant during or within 12 weeks after treatment.

The results showed that patients with baseline CPT B/C (or advanced cirrhosis) had lower sustained virologic response (SVR), more relapses and more severe adverse events than CPT A (mild cirrhosis) patients who were treated with DAAs (77% vs 94% ITT, p<0.001; 15% vs 5%, p<0.001; 50% vs 12%, p<0.001, respectively). There were also more deaths in the advanced cirrhosis group (B/C vs A: 11 vs 4, p<0.001). 25% of patients with the most severe disease, measured using the Model for End-Stage Liver Disease (MELD) score (a commonly used scale which assesses disease severity and urgency for a liver transplant), died compared to 1.6% of the rest of the patients (p<0.001).

"This study highlights the risks of using direct-acting antivirals in patients with severe liver disease. It is important that hepatologists weigh up the risks and the benefits of treating patients with late-stage disease, and have open and honest discussions with their patients as to the best course of treatment for them," said Professor Laurent Castera, EASL Secretary General.
-end-
Scoring systems

The MELD score is a reliable, numerical measure of mortality risk in patients with end-stage liver disease and helps to prioritise allocation of livers for transplant. The score ranges from six, for those with less severe disease, to 40, for those who are critically ill. The score determines the risk of death within 12 weeks and takes into consideration results from three routine lab tests, which include bilirubin (a measure of the ability of the liver to excrete bile), the International Normalised Ratio (INR) of Prothrombin Time (a measure of the liver's ability to make blood clotting factors), and creatinine (a measure of kidney function).6

About The International Liver Congress™

This annual congress is the biggest event in the EASL calendar, attracting scientific and medical experts from around the world to learn about the latest in liver research. Attending specialists present, share, debate and conclude on the latest science and research in hepatology, working to enhance the treatment and management of liver disease in clinical practice. This year, the congress is expected to attract approximately 10,000 delegates from all corners of the globe. The International Liver Congress™ takes place from April 13 - 17, 2016, at the Fira Barcelona Gran Via, Barcelona, Spain.

About EASL

Since EASL's foundation in 1966, this not-for-profit organisation has grown to over 4,000 members from all over the world, including many of the leading hepatologists in Europe and beyond. EASL is the leading liver association in Europe, having evolved into a major European Association with international influence, with an impressive track record in promoting research in liver disease, supporting wider education and promoting changes in European liver policy.

Contact

For more information, please contact the ILC Press Office at:Onsite location reference

General session 1 and opening, Hall 6.0
Thursday 14 April, 13:30 - 15:30
Presenter: Carlos Fernández Carrillo, Spain
Abstract: GS01, Treatment of Hepatitis C virus in patients with advanced cirrhosis: Always justified? Analysis of the Hepa-C registry

Author disclosures of interest

None

References

1 Afdhal N, et al. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med. 2014 May 15;370(20):1889-98.
2 Afdhal N, et al. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. N Engl J Med. 2014 Apr 17;370(16):1483-93.
3 Kowdley KV, et al. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. N Engl J Med. 2014 May 15;370(20):1879-88.
4 Sulkowski MS, et al. Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection. N Engl J Med. 2014 Jan 16;370(3):211-21.
5 Weerakkody Y, et al. Child-Pugh score. Available from: http://radiopaedia.org/articles/child-pugh-score. Last accessed: March 2016.
6 United Network for Organ Sharing. Talking about transplantation: Questions & answers for transplant candidates about MELD and PELD. Available from: https://www.unos.org/wp-content/uploads/unos/MELD_PELD.pdf. Last accessed: March 2016.

European Association for the Study of the Liver

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