More Medical Studies Reach Different Conclusions About Whether New Hepatitis C Virus Medications Might Cause The Return Of Liver Cancer
(Posted by Tom Lamb at DrugInjuryWatch.com)
We continue to hear reports of patients who used Harvoni or Sovaldi for to cure their hepatitis C only to afterwards have the return of their earlier liver cancer, which had been in remission before their "Hep-C" was treated by one of these so-called "direct-acting antiviral" (DAA) drugs.
As background, we first wrote about this still-emerging drug safety issue about a year ago, in April 2016, when we posted this article, "European Drug Regulators Consider Whether Harvoni, Sovaldi, And Other New "Hep-C" Drugs May Cause Liver Cancer Return, Hepatitis B Reactivation".
More recently, in January 2017, we posted this article, "Is Liver Cancer Associated With Harvoni, Sovaldi, And Other Direct-Acting Antiviral Medications For Hepatitis C?"
Earlier today we found an April 25, 2017 news report, "The Link Between Direct-Acting Antiviral Therapy for Hepatitis C Virus and Liver Cancer Risk Continues To Be Debated", which was published on the PracticeUpdate website (free registration required).
This recent report draws upon eight new medical studies which were presented at the International Liver Congress 2017, from April 19 to 23, 2017, in Amsterdam.
By means of the following excerpt from this report we get an update on the possible association between Sovaldi and Harvoni with liver cancer recurrence or return:
While remarkable progress has been made in the development of successful antiviral therapies for hepatitis C virus infection, recent studies suggest that curing patients of their hepatitis C virus does not eliminate their risk of developing liver cancer. An unexpectedly high rate of hepatocellular carcinoma recurrence is becoming apparent in patients whose tumor was treated successfully and had received direct-acting antiviral drugs.
The claim was further supported by a study led by Maria Reig, MD, of the Hospital Clinic Barcelona. Patients with hepatitis C virus and hepatocellular carcinoma who had been cured of hepatocellular carcinoma and received direct-acting antiviral therapy experienced a hepatocellular cancer recurrence rate of 31.2% (24/77). Of those who received treatment for hepatocellular carcinoma at recurrence, 30% (6 of 20) of patients presented progression in the immediate 6-month follow-up.
Dr. Reig said, “Our study results offer further support to previous findings of an unexpectedly high recurrence rate of hepatocellular carcinoma associated with direct-acting antiviral drugs. This association may result in a more aggressive pattern of recurrence and faster tumor progression. The data indicate that further research is needed to clarify the mechanism for the association between liver cancer recurrence and direct-acting antiviral therapy.”
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But several other medical studies suggested there is no link between Sovaldi or Harvoni use and liver cancer returning, as pointed out by this April 2017 news report:
- Gregory Dore, MD, and Reem Waziry, MD, of the Kirby Institute, University of New South Wales, Sydney, Australia, found no evidence of higher risk of hepatocellular carcinoma or its recurrence following direct-acting antiviral treatment vs interferon-based therapy for hepatitis C virus infection in a systematic review, meta-analysis, and meta-regression study of 41 studies, including 26 of hepatocellular carcinoma and 15 on its recurrence (total, n = 13,875).
- Hamish Innes, MD, of Glasgow Caledonian University, UK, found that the risk of liver cancer following sustained virological response was not associated with the use of direct-acting antiviral drugs, but rather baseline risk factors.
- George Lau, MD, of the Beijing 302-Hong Kong Humanity and Health Hepatitis C Diagnosis and Treatment Centre, China, also found no increase in the incidence of liver cancer in patients who achieved sustained virological response 12 with direct-acting antiviral drugs compared to peginterferon plus ribavirin.
Accordingly, to date (as seen above), the issue of whether liver cancer recurrence is associated with Harvoni, Sovaldi, or other direct-acting antiviral" (DAA) hepatitis C drugs has not been definitively determined but, rather, remains under debate in the medical realm.
We will continue to monitor the medical literature for reports relevant to the safety profile of Harvoni and Sovaldi, as well as other "Hep-C" drugs in the DAA class, such as Viekira Pak, Technivie, Olysio, Daklinza, Epclusa, and Zepatier.
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