My first article for the HCV Advocate appeared 20 years ago. Hepatitis C virus infection (HCV) wasn't curable yet. HCV is now easily curable and one would think the problem is solved, but it isn't. Numerous obstacles stand in the way of eliminating this disease. A large percentage of the population is still undiagnosed because of inadequate HCV screening. Access to health care is uneven, particularly for those who need it the most.
Never would I have imagined that one of the obstacles to care would come from a vocal few in the HCV community. They believe that the cure for HCV is dangerous, even deadly. This small faction is certain in their beliefs and vocal in their opinions. I believe their intentions are good in that they don't want others to be harmed by HCV treatment.
Do they have a case? Rather than dismiss their concerns, I went on a fact-finding mission. Could HCV medications be riskier than reported and advertised?
I began by reviewing the data. Most of the research shows that HCV treatment using direct-acting antivirals (DAAs) are: 1) safe, and 2) improve quality and quantityof life. However, what if you don't trust the Food and Drug Administration (FDA), pharmaceutical companies, or the mainstream medical establishment? What if you or someone you know became sick or died during or after using HCV DAAs? What if your experience doesn't match what you are being told?
This is the crux of the problem. Experience can look like fact. If a loved one got liver cancer and died a year after finishing HCV treatment, it's natural to wonder if treatment caused this.
Related: Hepatitis C: How Is It Transmitted and Who Should Be Tested?
Recent Data
As I mentioned, the data support the safety and benefits of HCV treatment. In one large study, there was a 71 percent drop in risk of hepatocellular carcinoma (liver cancer or HCC) after a successful treatment outcome (sustained virologic response or SVR). Many other studies had similar outcomes. For brevity's sake, I'll just mention a recent one.
In a recent paper by Lisa Backus and colleagues, data were collected from 103,346 HCV patients with genotypes 1, 2 and 3. Those with cirrhosis, liver cancer, HIV or history of liver transplantation were excluded. The data were from the Department of Veterans Affairs, collected 2013-2017. Of the 40,664 patients treated with interferon-free DAA regimens, 39,374 (96.8%) had SVRs. There were 62,682 untreated patients.
Findings
First, the mortality rate for patients who did not have an SVR was more than two and a half times that of patients who did. Second, the mortality rate for untreated patients was nearly three and a half times that of SVR patients. (Direct-Acting Antiviral Sustained Virologic Response: Impact on Mortality in Patients without Advanced Liver Disease; accepted January 29, 2018 Hepatology)
Suppose though that you already have cirrhosis. This is where the benefits of HCV treatment begin to narrow. Most studies show that cirrhotic patients who have an SVR have a reduced incidence of HCC. What we do know is:
Advanced liver disease is the biggest risk for HCCdevelopment.
HCC risk decreases if you have an SVR even if youhave cirrhosis.
This risk exists whether you were treated withpeginterferon, DAAs, or not at all.
HCC risk increases with age and levels of a livercancer marker, alpha-fetoprotein (AFP).
It's important to note that liver cancer deaths have nearly doubled since the 1990s. HCV isn't the only factor for this rise in HCC. Hepatitis B, fatty liver, obesity, inactivity, alcohol and other lifestyle factors contribute to cancer risk.
What If You Don't Trust the Data?
I examined global data. Information from regulatory agencies outside of the U.S. looks similar to the FDA's info. However, if you don't trust regulatory agencies, there is a source that is above reproach. Meet James Freeman, MD, the Australian physician who defied authority by prescribing generic hepatitis C medicines to patients who could not otherwise get treatment. With over 3000 patients and no links to big pharma or government regulatory agencies, I asked Freeman if he had concerns about the safety of DAAs.
Freeman responded, "To me, the remarkable thing about these medications is actually how safe they are, not how dangerous they are." He acknowledges that there have been both significant side effects and deaths but the rates are very low. Freeman points out that initially, the United States rationed treatment. This means that the sickest patients were the first to be treated; older patients who were already at risk for serious complications and death. In fact, they did better than one might expect.
Freeman does caution that no drug is 100 percent safe. However, DAAs are safer than hepatitis C infection. "Hepatitis C is a very unpleasant disease that amputates 10 years of life from the average patient. Most of that death rate is not liver failure or HCC; it's cardiovascular, diabetes, lymphoma, and renal cell carcinoma, and more, all of which occur at higher rates in hep C patients."
Freeman stated emphatically that if he had concerns about the safety of hepatitis C medicines, he would sound the alarm.
So Why Do Some Patients Think That DAAs are Dangerous?
The answer to this is complicated. Here are a few explanations:
Most of us aren't skilled at understanding data. Some of the most vocal opponents who question the safety of DAAs have pointed to information they obtained from the FDA Adverse Event Reporting System (FAERS). If you don't know how to interpret that information, it can be overwhelming. There are tens of thousands of adverse events. Honestly, it looks like DAAs are dangerous. However, they aren't.
Dr. Freeman helped me out on this one by organizing the data so I could see it more clearly. Looking at reports collected from 2014 to 2017, there were 782 deaths (with an estimate of a million people treated). This sounds huge, but given the seriousness of the patients' medical conditions, you'd expect it to be ten times that. In other words, 782 deaths sounds horrible (and is, especially if people you know are among the counted), but the fact that the number is so low affirms the safety of DAAs.
Note: The FAERS reports are raw, and without supporting information, some of the reports are useless or misleading. For instance, hepatitis C was reported as a side effect of DAAs. Clearly, the reporter made a mistake.
Our brains are wired to connect dots, even when they shouldn't be connected. A friend with cancer told me that there is a lot of cancer in our county. She wondered if this was due to a factor unique to our community. In fact, the cancer rate where I live is no different from anywhere else. A more likely explanation is that because my friend talks openly about her cancer, others talk to her about their cancer. She sees cancer all around her.
So, if you post to Facebook that your loved one died from liver cancer after having undergone HCV treatment, you may be hearing from people with similar experiences. You may draw false conclusions about this.
Here is another way that hepatitis C treatment may be incorrectly implicated: adverse events that happen long after the medicines have been eliminated from the body are not a reason for a recent symptom. Also, if more than one person experiences the same adverse event, we may draw false conclusions. This is why science designs studies to minimize bias. Our experiences are subjective, and not useful indicators of truth.
We latch on to studies that support our claims. Initially, a couple of studies reported an increase of HCC following DAA treatment. These studies were small and had flaws. Larger studies show us otherwise. However, if you feel strongly in your belief, it can be hard to let go of research that supports your claim. We see what we want to see.
We care about each other. It's painful when loved ones are hurt or die. We want to know why; we may blame others for these injuries. We feel helpless and want to protect others from suffering the same misery. We turn to social media, warning others about the dangers of DAAs. There we get affirmation for our beliefs because we meet people who had similar experiences. This affirmation feels like proof, but it isn't. That's because ...
We confuse experience with evidence. Personal experience creates our beliefs. If we are convinced that DAAs caused a medication side effect or cancer, there is little reason to believe otherwise. We think we have evidence, when in fact we have anecdotes. Anaïs Nin summed it up when she wrote, "We don't see things as they are; we see things as we are."
The Danger
People may be frightened away from hepatitis C treatment if they think it is dangerous. However, untreated hepatitis C increases the risk for heart disease, stroke, liver and kidney cancer, lymphoma, Parkinson's, and diabetes. False allegations about DAAs could lead to huge consequences.
This has already happened. People died because they didn't want to undergo interferon-based hepatitis C treatment. I understand that choice, knowing how difficult interferon-base treatment was. However, we are in a new era. DAAs are effective, with minimal side effects. The benefits far exceed the risks.
What We Can Do
I am guessing that this article won't change any minds. I have been publicly attacked for my views and will likely incur a few more barbs. Advocates I hold in high regard have also been targeted. We are accused of being in "pharma's pocket." This is particularly amusing since anyone who knows me knows that I am a thorn in the side of pharma.
However, there are ways we can act. I think the lesson here is that we aren't educating people sufficiently. Health care providers and advocates need to increase awareness about the risks associated with advanced liver disease. We need to spread the following:
"Get treated for hepatitis C, and the earlier the better. However, if you have or nearly have cirrhosis, you are still at risk for liver cancer, even if your hep C is cured. DAAs may help but are not a guarantee against HCC. Liver cancer kills quickly. If you already have cirrhosis, be sure you are being followed by a specialist. Get the prescribed diagnostic tests, go to your appointments faithfully, and do everything you can to live a healthy lifestyle. If you don't have cirrhosis but your liver disease is advanced, you too need to be closely monitored for HCC."
If you are brave, try to correct misinformation with good data. However, know that you may be attacked. Never, ever attack anyone else. After you have said your piece, don't engage any longer. If you are on the side of science, you have a powerful ally.
Lucinda Porter, R.N., is a long-time contributor to the HCV Advocate and author of "Free from Hepatitis C" and "Hepatitis C One Step at a Time." She blogs at www.LucindaPorterRN.com and HepMag.com.
[Note from TheBodyPRO: This article was originally published by HCV Advocate in March 2018. We have cross-posted it with their permission.]