HCV treatment allows one in four people to come off the transplant waiting list

Around one in four people with hepatitis C and decompensated cirrhosis came off the transplant waiting list in Europe after direct-acting antiviral treatment, and very few had any subsequent liver-related problems during 15 months of follow-up, Dr Luca Belli reported on behalf of ELITA study investigators at the International Liver Congress in Amsterdam on Friday.

Decompensated cirrhosis leads almost invariably to end-stage liver disease without careful management of portal hypertension, varices and ascites. The severity of cirrhosis is graded by the MELD score; patients with a MELD score of 10 or above should be considered for a liver transplant.

Direct-acting antiviral treatment is a double-edged sword for people with decompensated cirrhosis who are already on the transplant waiting list. For some, it might improve liver function sufficiently that they no longer need a transplant and experience improvement of symptoms. But for others, the improvement in symptoms might take them off the transplant list when, in time, a liver transplant would turn out to be the best solution to their liver disease. Treatment would, therefore, have the effect of re-setting the clock on a liver transplant, sending patients back to join the queue once more.

European liver centres have been investigating this question for several years through a multicentre cohort study, ELITA, which looks at people with hepatitis C and decompensated cirrhosis on the transplant waiting list in Italy, Germany, Austria, France and Spain.

Early findings from the study were presented at last year’s International Liver Congress, showing that about one in five patients had been taken off the transplant waiting list. Details of outcomes in an expanded cohort, with longer follow-up after treatment, were presented this week at the International Liver Congress.

The cohort study recruited 142 consecutive patients with decompensated cirrhosis and hepatitis C who were candidates for liver transplantation, who underwent direct-acting antiviral treatment between February 2014 and June 2015. Of these, 46% received treatment with sofosbuvir (Sovaldi) and ribavirin, the remainder with either sofosbuvir/daclatasvir or sofosbuvir/ledipasvir (Harvoni).

Participants were followed for a median of 28 months, including their time on treatment, during which time half underwent a liver transplant.

Twenty-four per cent (34 patients) were delisted; of these, one died due to hepatocellular carcinoma that had probably been diagnosed late due to a missed ultrasound scan six months previously. Two patients who had experienced improvement subsequently experienced decompensation again; one underwent a liver transplant, the other was successfully treated for ascites.

Delisting was strongly associated with a baseline MELD score below 16, although a small number of patients with higher MELD scores were delisted, in most cases after at least 18 months of follow-up. Clinical improvement was also predicted by the degree of change in MELD score 12 weeks after starting DAA treatment.

Delisted patients experienced significant improvement in liver-related outcomes over time. Median follow-up after delisting was 58 weeks. Median MELD score declined from 14 at baseline to 9 at the last follow-up visit (p<0.001) and the proportion of patients with any ascites fell from 81.6% at baseline to 23.7% at the last follow-up visit (p<0.001). Hepatic encephalopathy almost disappeared among these patients too: at baseline 29% experienced mild hepatic encephalopathy, but by the last follow-up visit only 2.9% were experiencing hepatic encephalopathy.

Dr Belli emphasised that delisting was good news not only for those who come off the transplant list; delisting also frees up a liver for another transplant candidate, enabling them to receive a transplant more quickly.