EMA Expands Review of New HCV Drugs

The European Medicines Agency (EMA) has extended the scope of its review of the six direct-acting antivirals approved for use in the European Union for treating chronic hepatitis C virus (HCV) infection to include the risk for early liver cancer recurrence, the agency said today.

They are daclatasvir (Daklinza, Bristol-Myers Squibb), dasabuvir (Exviera, AbbVie), sofosbuvir/ledipasvir (Harvoni, Gilead Sciences), simeprevir (Olysio, Janssen), sofosbuvir (Sovaldi, Gilead Sciences), and ombitasvir/paritaprevir/ritonavir (Viekirax, AbbVie).

Last month, as reported by Medscape Medical News, the EMA Pharmacovigilance Risk Assessment Committee initiated a review to assess the extent of hepatitis B reactivation in patients treated with direct-acting antivirals for HCV. The review was prompted by cases of hepatitis B reactivation in patients who were infected with hepatitis B virus and HCV and who were treated with direct-acting antivirals for HCV, the EMA said in a statement March 18.

Today, the EMA said data from a just-published study suggest that hepatocellular carcinoma recurrence may happen earlier in patients treated with direct-acting antiviral drugs for HCV compared with those not treated with these agents.

"The scope of the ongoing review has therefore been extended to also assess the risk of liver cancer with these medicines," the agency said.

The study was published online April 13 in the Journal of Hepatology to coincide with its presentation at The International Liver Congress in Barcelona, Spain.

It included 58 patients with HCV infection and prior history of treated hepatocellular carcinoma who achieved complete response and lacked "non-characterized nodules" at the time they underwent anti-HCV treatment with all-oral direct-acting antivirals in four hospitals. None of the patients received interferon as part of the antiviral regimen.

After a median follow-up of 5.7 months, three patients died and 16 developed radiologic tumor recurrence (27.6%). The pattern of recurrence was: intrahepatic growth (three patients), new intrahepatic lesion (one nodule in five patients, up to three nodules less or equal to 3 cm in four cases and multifocal in one patient), and infiltrative ill-defined hepatocellular carcinoma and/or extrahepatic lesions in three patients. The median time between antiviral treatment and detection of recurrence was 3.5 months.

"Our data show an unexpected high rate and pattern of tumor recurrence coinciding with HCV clearance and, though based in a very small cohort of patients, should be taken as a note of caution and prime a large scale assessment," María Reig, MD, from the Barcelona Clinic Liver Cancer Group, Hospital Clinic Barcelona, Spain, and colleagues conclude in their article.

In a conference statement, Massimo Colombo, MD, professor of gastroenterology at the University of Milan, Italy, and former editor-in-chief of the Journal of Hepatology, said, "It is important that hepatologists continue to weigh up the risks and the benefits of [direct-acting antiviral] treatment for each individual patient, as these drugs are still relatively new. Meanwhile we look forward to further data examining the mechanisms of metastatic awakening and the immune system so that we can accordingly tailor treatment for our patients."

J Hepatol. Published online April 13, 2016. Abstract

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EMA Expands Review of New HCV Drugs for Liver Cancer Recurrence

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Megan Brooks

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