Conflicting Findings From Different Medical Studies Leave The Extent Of This Drug Safety Issue Uncertain At Present Time
(Posted by Tom Lamb at DrugInjuryWatch.com)
(1/30/17)
Back in April 2016 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“.
As regards the liver cancer risks that have been mentioned in connection with the hepatitis C drugs Sovaldi and Harvoni, during the nine months since our earlier article, there have mixed messages about whether there is an apparent side-effect situation or not.
We start our update on this still emerging drug safety issue with this April 2016 Medscape news report, “Liver Cancer Found in Hepatitis C Patients on New Antivirals“, from which we get this excerpt:
In a surprising number of patients with hepatitis C and cirrhosis, hepatocellular carcinoma develops within weeks of starting treatment with direct-acting antivirals, new research suggests.
“I do not think that direct-acting antivirals are directly responsible,” said lead investigator Stefano Brillanti, MD, from the University of Bologna, Italy.
“The hypothesis is that immune surveillance may be reduced too rapidly,” he told Medscape Medical News. “You have an immediate drop in viremia, but also attenuation of inflammation. I think inflammation is a bad thing in terms of hepatitis progression, but it may be a good thing in terms of controlling cancer.”
The study by Dr Brillanti’s team, presented here at the International Liver Congress 2016 [Abstract LBP506. Presented April 14, 2016], suggests that patients with hepatitis C should be closely monitored after treatment with direct-acting antivirals. Two days earlier, a study conducted by a team from the University of Barcelona in Spain suggested the same thing (J Hepatol. Published online April 12, 2016).
Both studies indicate that patients with a history of hepatocellular carcinoma have the highest risk of developing a tumor after direct-acting antiviral therapy, but new diagnoses were also reported.
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Then we move forward to this November 2016 article published by PracticeUpdate as part of their Gastroenterology section, “Direct-Acting Antiviral Medications for Hepatitis C Virus Infection Do Not Raise Cancer Risk“, from which we get this more recent information:
Patients with hepatitis C who take direct-acting antiviral medications have been found to be at no higher risk of developing liver cancer than those who do not take the medication. If they do develop liver cancer, however, they might be at an increased risk of more aggressive, infiltrative patterns of cancer.
This finding of a retrospective database study was reported at The Liver Meeting 2016, from November 11 – 15.
Alfredo Alberti, MD, of the University of Padova, Italy, explained, “Data on clinical outcomes in cirrhotic patients with hepatitis C treated with direct-acting antiviral agents are still scanty and controversial. This is the case concerning the development of a liver cancer, one of the most frequent and deadly complications of hepatitis C virus infection.”
Recent studies have suggested the possibility of increased risk of developing hepatocellular carcinoma during and after direct-acting antiviral treatment in patients infected with hepatitis C virus….
Dr. Alberti concluded, “The results, while confirming that direct-acting antiviral treatment doesn’t increase the overall risk of hepatocellular carcinoma, indicate that even successful antiviral therapy does not prevent hepatocellular carcinoma, at least during the first 6 to 12 months after initiation of treatment.”
He continued, “During this interval, microscopic and initially invisible foci of hepatocellular carcinoma might even be boosted in growth as consequence of profound immunological and molecular changes in the liver microenvironment following abrupt cessation of hepatitis C virus replication. It is mandatory, therefore, that patients treated with direct-acting antiviral medications with advanced liver disease continue to be monitored for hepatocellular carcinoma.”
We will continue to monitor the medical literature and watch for any drug regulatory agency action concerning the possible association between direct-acting antiviral hepatitis C drugs like Sovaldi and Harvoni with liver cancer diagnoses, be it the initial incidence or a recurrence of the hepatocellular carcinoma.
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