Hepatitis Scotland e-Bulletin 26 October, 2015


FDA warns of serious liver injury risk for those with severe liver disease using Hepatitis C treatments Viekira Pak and Technivie

The U.S. Food and Drug Administration (FDA) has issued a warning that Hepatitis C treatments Viekira Pak and Technivie (marketed in EU as VIEKIRAX (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA (dasabuvir tablets)) can cause serious liver injury mostly in patients with underlying advanced liver disease. As a result, they are requiring the manufacturer, Abbvie, to add new information about this safety risk to the drug labels. Abbvie has changed the labelling to reflect a contraindication rather than "not recommended" in Child Pugh Class B and C stages of liver disease.


Since the FDA approvals of Viekira Pak in December 2014 and Technivie in July 2015, at least 26 cases worldwide submitted to the Adverse Event Reporting System were considered to be possibly or probably related to Viekira Pak or Technivie. In most of the cases, liver injury occurred within 1 to 4 weeks of starting treatment. It is important to note some of the cases occurred in patients for whom these medicines were contraindicated or not recommended and mostly in patients taking Viekira Pak who had evidence of advanced cirrhosis even before starting treatment with it.


In a press release, AbbVie stated, “Viekira Pak, with and without ribavirin (RBV), remains indicated for genotype 1 HCV patients with compensated cirrhosis, including Child-Pugh A. The safety and efficacy of Viekira Pak, with and without RBV, has been studied in Phase III trials in more than 2,300 patients and is one of the recommended regimens in the [American Association for the Study of Liver Disease] guidelines for these patients. Technivie in combination with RBV is indicated for genotype 4 HCV patients without cirrhosis.” They also released a letter for healthcare providers.


The Scottish Medicines Consortium (SMC) had advised that Veikirax and Exviera were acceptable for use in the Scottish NHS in June, 2015, including for patients with compensated cirrhosis. The recent Scottish National Clinical Guidelines for the treatment of HCV in adults however currently advise  that Sofosbuvir is the currently preferred treatment in most scenario's. US Healthcare informatics firm Advera Health Analytics has recently  looked at new side effect reports on Hep C treatments and has compared the new combinations here. (registration required)


The presentation of liver injury in patients with advanced liver disease who receive treatment with Viekira Pak or Technivie may differ from patients with less-advanced disease. The FDA reported transaminase elevations did not appear to be a predominant presentation in the cases with advanced liver disease, in contrast to what has been observed in patients with less-advanced liver disease as described in the current prescriber’s information.


The FDA advised that patients taking these medicines should contact their health care professional immediately if they develop fatigue, weakness, loss of appetite, nausea and vomiting, yellow eyes or skin, or light-colored stools, as these may be signs of liver injury. They also advised that stopping treatment early could result in drug resistance to other hepatitis C medicines and patients should not stop taking these medicines without first talking to their health care professionals. They suggested health care professionals should closely monitor for signs and symptoms of worsening liver disease, such as ascites, hepatic encephalopathy, variceal hemorrhage, and/or increases in direct bilirubin in the blood.


The FDA emphasizes that Viekira Pak and Technivie are contraindicated in moderate and severe hepatic impairment (Child-Pugh Class B & C). Some of the postmarketing cases of hepatic failure occurred in patients for whom Viekira Pak and Technivie are contraindicated or not recommended.


Abbvie was granted a priority review from the FDA for the initial approval of these drugs and was also granted an accelerated review from the European Medicines Agency.



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If you have, or have had, viral hepatitis an easy health win is to come forward and receive a free seasonal flu jab, a simple and effective way to protect against the flu this winter. The flu doesn’t just mean a couple of days in bed – there is potential to cause extremely serious complications if you have an underlying health condition such as Hepatitis C.


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Getting the vaccination could save weeks of misery or worse. Free vaccinations for those living with viral hepatitis and others at risk are accessed through local GPs.


Click for further information on the seasonal flu campaign.


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