Drug Regulatory Agency Has Requested Additional Safety Information From Some Manufacturers Of Direct-Acting Antivirals (DAAs)
The May 2017 edition of Health Product InfoWatch included this report, "Summary Safety Review - Direct-Acting Antivirals - Assessing the Potential Risk of Liver Cancer Recurrence", which was issued on April 27, 2017 by Health Canada.
From the Key Messages part of this drug safety report concerning Sovaldi, Harvoni, and other Direct-Acting Antivirals (DAAs), we get these three main points:
- Direct-acting antivirals (DAAs) are prescription drugs authorized for sale in Canada to treat chronic hepatitis C virus (HCV) infection in adult patients, which is a serious condition that can result in decreased liver function, serious scarring of the liver (cirrhosis) or liver cancer.
- Health Canada reviewed the potential risk of liver cancer coming back (recurrence) with the use of DAAs, following the publication of a study suggesting this potential risk.
- Health Canada’s review concluded that there was not enough information to establish a link between DAAs and liver cancer recurrence. Health Canada has requested additional safety information from some manufacturers of DAAs.
In more detail, from the Safety Review Findings part of same report we get this additional information:
At the time of the review, Health Canada had received 3 unique Canadian reports of liver cancer recurrence related to DAAs use (2 with Sovaldi and 1 with Holkira Pak [(known as Viekira Pak in the US)]). All 3 reports were considered to be related to the use of DAAs. However, other factors present in the cases may have played a role in the liver cancer recurrence, such as serious scarring of the liver (cirrhosis), previous history of liver cancer and other treatments known to be associated with a higher risk of liver cancer recurrence, including surgery and a cancer treatment using radio waves (radiofrequency ablation).
This safety review also looked at information from 14 international reports of liver cancer recurrence related to DAAs use: 9 reports involved Sovaldi, 4 reports involved Harvoni and 1 report involved Holkira Pak [(known as Viekira Pak in the US)]. All 14 reports were considered to be related to DAAs use. However, factors known to be associated with a higher risk of liver cancer recurrence may have played a role.
A search of the scientific literature identified 7 relevant studies describing the recurrence of liver cancer related to DAA use. The safety review could not conclude whether the use of DAAs played a role because the lengths of time the patients were monitored were different between the studies. The patients also had a variety of risk factors for liver cancer, including HCV infection, cirrhosis, previous history of liver cancer and advanced age.
Some studies have found that liver cancer recurrence was more likely to happen in patients who underwent surgery or radiofrequency ablation compared to those patients that received a liver transplant.
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This recent report from Health Canada serves to update our April 2017 article, "Harvoni / Sovaldi: Spring 2017 Update On Issue Of Liver Cancer Recurrence After Using Direct-Acting Antiviral 'Hep-C' Drugs".
We will continue to monitor the safety profile of Harvoni, Sovaldi, and Viekira Pak. These newer hepatitis C medicines and several others which are part of the Direct-Acting Antivirals (DAAs) class of drugs have been associated with acute liver injury, liver failure, and reactivation of hepatitis B, besides the possibility of liver cancer recurrence.
To learn more, you can go to the Harvoni / Sovaldi / Viekira Pak / Technivie / Olysio / Daklinza / Epclusa / Zepatier page on our Drug Injury Law website.
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