The Very Silly Myth That Harvoni Causes Cancer

A couple of times a week I get an email from someone who has Hepatitis C but is concerned about using DAAs to treat the Hep C because they have heard a rumour that Harvoni (or DAAs generally) causes liver cancer. Here is an example that I received today:
Hi Greg
My health is severely compromised from raging Hepatitis C but we cannot afford to enter into mainstream medical treatment. Your compassion interested me in regard to generic HARVONI. However, I am very worried about rumours I have heard about treatment with Harvoni causing liver cancer… is there any credibility to the recent leaks that in quite a few individuals, Harvoni is causing hepatocellular carcinoma 6-12 months after completing treatment and clearing HEP C? I have heard that these people either get a transplant or die. I read that it is a great cover-up by the manufacturer and because it was RUSHED through the FDA was not revealed as a side effect.
Thanks for your advice
#####
So this is typical of the emails I get every week and before I get into the details of why this “myth” is such utter nonsense and what its origins are I will share my reply to the above email.

Hi ####
Thanks for your email and I am sorry to read that you are suffering with Hep C… I do understand how that feels having been in the same situation myself a few years back.
Now I must tell you that the stories about Harvoni causing liver cancer are total nonsense.
These stories have their roots in the fact that some people already have undetected liver cancer when they start treatment. Then when they finish treatment the cancer is detected in the follow-up medical tests. Then the person blames the medication.
The facts are that Hepatitis C causes liver cancer. If a person already has cancer when they start treatment then the treatment will not get rid of the cancer… only the Hep C.
The cover up thing is just the usual “conspiracy” nonsense and has no basis in Science.
The facts are simple Hep C causes cancer and DAAs cure Hep C.
I am attaching information about getting generic Harvoni.
Please write if I can be of further assistance
Best wishes Greg
Now my readers will know that I am no defender of Big Pharma and even more-so I dislike GILEAD however facts are facts and lies are lies and I am a BIG defender of the truth and the truth is that treating Hepatitis C with DAAs does not cause liver cancer, in fact quite the opposite. Treating Hep C with Harvoni or any other DAA significantly REDUCES the chance of a person developing liver cancer. That is a fact that is proven and I will discuss it later.

The chances of developing Liver Cancer increase with the level of liver fibrosis. Once the Hep C virus is removed the liver can heal and fibrosis levels can improve dramatically

Liver Cancer and Hepatitis C

First some background about Liver Cancer (HCC). The risk of developing HCC for a patient with HCV-related cirrhosis is approximately 4% per year. In real terms this means that in any one year 4 out of every hundred people with Hep C will develop liver cancer. A person infected with Hepatitis C is almost 20 times more likely to develop liver cancer than a person not infected with Hepatitis C. In general, HCC (liver cancer) develops only after two or more decades of HCV infection and the increased risk applies strongly to patients with cirrhosis or advanced fibrosis; that is to say F2 or F3 or F4.
So we see having Hep C very significantly increases the chance of getting liver cancer.
But where did these rumours about DAAs causing liver cancer begin? How and why were they spread?
I am in the fortunate position of have been present when the main source of these rumours began.
This was at the EASL conference in Barcelona in April 2016.
Here is the story.

EASL 2016

The ” DAAs Cause Liver Cancer”  myth began in April 2016 when, coincidentally, I attended the annual EASL Conference in Barcelona with Dr James Freeman. James was presenting our paper showing that treating Hepatitis C with low cost generic DAAs was just as effective as treating Hep C with the vastly more expensive branded DAAs such as Harvoni and Sovaldi.
As well as being a co-author of this paper I was at the conference as a journalist, in my capacity as a blogger for HepMag and my own website.

Dr James Freeman and myself at the 2016 EASL Conference

Immediately before Dr Freeman’s presentation was a presentation by Dr Federica Buonfiglioli from the University of Bologna in Italy; it was titled something like: People treated for hepatitis C have unexpectedly high rate of liver cancer.
Having recently completed treatment of my own Hep C using DAAs I, naturally, listened with great interest and some concern.
He displayed various graphs and figures and spoke nicely in English. However, by the end of his presentation I had seen nothing to alarm me or to support his conclusion that people treated with DAAs were at a higher risk of developing liver cancer (HCC).
To cut a long story short his research showed that out of a total of 344 people treated with DAAs 26 tested positive for HCC after reaching SVR 24. Of these 26 patients who tested positive for HCC 17 were known to have had liver cancer prior to starting treatment and of these only five people had multiple nodules. In other words 65% of the people who tested positive for HCC after DAA already had HCC before DAA treatment.
Out of the 344 people in this study just nine patients, or 3.2%, with no previous known HCC actually went on to develop liver cancer, which is about the expected rate of HCC in the Hep C population anyway.
So there was nothing in the Buonfiglioli study that showed DAA treatment increased the risk of liver cancer. What I found interesting was that after giving his talk Dr Buonfiglioli was immediately surrounded a large contingent of Italian news media. His presentation was a sensational claim designed to attract media attention. It was a staged event that attracted media attention and started these rumours about DAA treatment and HCC.

AASLD 2017

A year after Buonfiglioli’s 2016 presentation, and with the liver cancer rumours spreading, a number of larger studies of Hep C patients treated with DAAs were completed by early 2017. Those findings directly contradicted the conclusions of the Buonfiglioli study, in fact they showed the opposite; that curing Hepatitis C with DAAs could be linked to a more than 70% reduction in liver cancer rates amongst people with Hepatitis C; for people who achieved a sustained viral response to Hepatitis C treatment with DAAs.

Successful treatment with DAAs such as Harvoni was actually proven to significantly lower the risk of developing liver cancer. One of these studies looked at the results of more than 62,000 people with Hepatitis C, in the USA,  who were treated with various DAAs including Harvoni, Sovaldi and Epclusa. This was a study population 200 times larger than what Buonfiglioli used. These results were presented by George Ioannou at the 2017 AASLD Liver Meeting in Washington, DC where Ioannou stated:
“Eradicating hepatitis C will have a tremendous benefit in reducing liver cancer in individual patients and in the entire population. Physicians and patients should not be withholding antiviral treatment for fear of inducing liver cancer. On the contrary, physicians should be treating hepatitis C specifically to reduce the risk of liver cancer.”

George Ioannou at the 2017 AASLD Liver Meeting in Washington, D.C.

Hepatitis C  and HCC

So the real story, the truth, about DAAs, whether Harvoni or Epclusa or the VPak, whether generic or branded, is that Hepatitis C causes liver cancer and when we cure our Hep C then we reduce our chance of getting liver cancer. The longer you have the Hep C virus living in your liver the more damage it does and the higher your chance of getting HCC. So do not delay getting treatment. Do not tolerate being told that you have to wait until you get to a fibrosis level of F2 or F3 or F anything!!! Get rid of the virus now, get cured, get well!!!!

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