From this April 15, 2016 European Medicines Agency (EMA) News item, “Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 April 2016” we get an overview of a new drug safety issue involving the direct-acting antivirals class of drugs used for treating long-term, or chronic, hepatitis C:
At its previous meeting in March, the Committee had initiated a review following cases of hepatitis B re-activation in patients who have been infected with hepatitis B and C viruses, and who were treated with direct-acting antivirals for hepatitis C.
In April 2016, data from a study became available regarding the risk of liver cancer (hepatocellular carcinoma) coming back in patients who were treated with these medicines. The study suggested that these patients were at risk of their cancer coming back earlier than patients with hepatitis C who were not treated with direct-acting antivirals. The scope of the ongoing review has therefore been extended to also assess the risk of liver cancer with these medicines.
As for what this development means for US patients and physicians, Harvoni, Sovaldi, Daklinza, and Olysio are the implicated direct-acting antivirals currently approved by the FDA.
In addition, Viekira Pak (dasabuvir and ombitasvir and paritaprevir and ritonavir) — which is available for use here — seems to be a “combination-product” of the Exviera and Viekirax drugs which are listed in the EMA press release, above.
We have written in the past about Viekira Pak side effects in this October 2015 article, “Hepatitis C Drugs Viekira Pak And Technivie Require Warnings Label Changes Due To Liver Injury Reports”.
The current EMA Timetable for this PRAC safety review of Harvoni, Sovaldi, and the other new “hep-c” drugs has the current process coming to an end this summer.
Of course, we will be watching for results of safety review and report those out, here, when available.[Read this article in full at original source]
Harvoni / Sovaldi / Viekira Pak
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