Study Raises Questions About the Risks of Treating Patients With Late-Stage HCV

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 Congress 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).

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.

"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.

Source: European Association for the Study of the Liver