Vemlidy tackles hep B in late-stage trials

by | 14th Nov 2019 | News

The impact of chronic hepatitis B treatment on hepatocellular carcinoma incidence was evaluated in a long-term analysis of the Gilead drug.

New data from Gilead has shown that Vemlidy (tenofovir alafenamide) continues to trump tenofovir disoproxil fumarate (TDF) for hepatocellular carcinoma in chronic hepatitis B (HBV).

The results, which show an improved safety profile compared to the latter drug, were presented at The Liver Meeting 2019 in Boston along with new data from Gilead’s HBV cure and hepatitis C (HCV) research programmes.

The impact of HBV treatment on HCC incidence was evaluated in a long-term analysis of two Phase III studies of Vemlidy, and through three or five years of follow-up, dependent on cohort, HCC was observed in 21 patients with a median time to onset of 104 weeks.

Specifically, of the 1,632 HBV patients who were randomised to receive either TAF or TDF once daily in two cohorts, 1.0% in the TAF group and 1.9% in the TDF group experienced HCC. The company says that additional follow-up is needed to further characterise the impact of longer-term treatment on HCC risk reduction.

The drug is already authorised in Europe for the treatment of chronic HBV infection in adults and adolescents, but “Chronic infection with hepatitis B virus can lead to an increased risk of developing serious and life-threatening liver damage,” said Young-Suk Lim, lead study author and professor, University of Ulsan College of Medicine.

He continued, “This analysis suggests that sustained viral suppression from treatment with TAF may reduce the risk of hepatocellular carcinoma in chronic hepatitis B patients, which is the most common type of liver cancer in adults.”

Chronic HBV infection is a leading risk factor for the development of hepatocellular carcinoma (HCC) globally.

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