Abstract
“If I’m not for myself, who will be for me? If I’m only for myself, what am I? If not now, when?”
Go home, enjoy your life! Those are wonderful words for any patient to hear, but in my case, I had just failed to achieve the required sustained viral response (SVR) after 12 weeks of treatment.
The futility algorithm was dreadfully clear, discontinuation of therapy was recommended for any patient with a hepatitis C virus RNA level ≥100 IU/mL at treatment week 12. Which as it turned out, was me. As I was told, further treatment would not likely be successful, and my side effects would only grow worse. I was stunned; how blindly optimistic I had been. Although I was able to complete another 4 weeks of medication, my insurance company pulled the plug on my treatment.
My experience over the 16 weeks of treatment was as expected. I had the typical side effects, fatigue, flu-like symptoms, hemolytic anemia, a platelet count that bottomed out, and a combination rash that covered my arms and torso; it was my summer of long sleeves. As I was told that even though I had failed to achieve SVR, there would be long-term positive effects from the treatment and that there were new treatments on the horizon. Although it was a relief to escape the side effects, I knew I had to start over.
Emotional Roller Coaster Ride
The year leading up to this point had been an emotional roller coaster ride, mostly downward. Like most patients, I remembered the numbing day I was told I had hepatitis C, the day the Board of Health sent me the letter telling me the same, the dark day I found out I had cirrhosis, the supercharged day I administered my first injection of interferon, and now the darker day treatment ended. These were all emotional end points, each one overlapping the other. I had prepared myself for 48 weeks of treatment and now it was over. With no other approved treatment options, where do I go from here?
So yes, I did go home and enjoy my life, but like anyone that has been diagnosed with hepatitis C and cirrhosis, I had a sense of urgency. My cirrhosis was considered “compensating,” but since stopping treatment the prior year my platelet count had hardly risen and bilirubin was elevated, but I didn’t have varices, a dreaded complication. All other laboratory tests were well within range, but I still did not feel that I could wait for new treatments to hit the market or worse, to start decompensating.
My physician understood my concern. I was the highly activated patient who came to appointments with reams of paper detailing the ongoing research, clinical trials, and which ones I thought I could pass screening for. I believed the more I understood about my disease and potential treatments, the more positive my outlook. I wasn’t just infected with the virus, I was captured by it. My physician did not seem as optimistic about the research as I was. His practice did not participate in clinical trials, and he encouraged me to contact the Indiana University Medical Center and to participate in the hepatitis C registry.
Clinical Trials
I was pounding ClinicalTrials.gov looking for potential trials and sending out e-mails to site sponsors but without any luck. After several months, I was not being contacted regarding possible clinical trials. What was I doing wrong? Finally, my physician referred me to a physician at the Indiana University (IU) Medical Center that did participate in clinical trials. He also specialized in liver transplants. The next step began.
Although my referred physician did not have a clinical trial for me at that time, something new had just developed. As my referred physician explained, two new compounds had been approved for treating hepatitis C genotype 1a. Both of these new compounds had been approved to be used with interferon and ribavirin. For me, these combinations would only provide approximately a 70% chance at SVR. Not much of an improvement over my first attempt and I wasn’t sure if I could afford another failure.
He also explained that when some of the medications were combined, the chances for SVR improved to the 90% range. At that time, the combination had been approved for compassionate use in the European Union (EU) but not in the United States by the Food and Drug Administration. When my physician asked if I would be willing to give this treatment a try, I couldn’t say yes fast enough. I needed no convincing; I had been following these drugs in clinical trials and knew the results. My physician wrote the off label script for the combination which costed approximately US$1900/day for 84 days. When my insurance company rejected the first request, I thought it was a mistake. The second time, I had to ask, it couldn’t be the cost of the treatment, could it? Maybe I’m not sick enough, or both?
Finally, after an online session between my physician and my insurance company, it was approved. Here we go again.
As I progressed through the 12 weeks of treatment, I was fatigued and had the expected side effects that were minor compared to my first treatment, but more importantly, at the conclusion of treatment week 2, my hepatitis C RNA was undetectable. It was the same at 4 weeks, 8 weeks, and finally the same at 12 weeks post last dose. I had achieved SVR and I was cured; there is no higher emotional end point than this. At the same time, I was so spaced out from the medications, I kept forgetting if it was really over or not.
My Journey
My journey from diagnosis to SVR was 3.5 years, a brief period of time compared to patients who have gone through treatment multiple times since the 1990’s and never achieved SVR. The combination of medicines I took made me vacillate between disengaged from my life to very aggressively engaged and likely to pick an argument with my friends. During my first treatment attempt, I would administer my weekly interferon injection on a Friday afternoon and then attempt not to interact with anyone for 2 to 3 days. After all, who knows what might come out of my mouth. It wasn’t odd for me to ask my spouse, “Am I acting normal?” Her response could be something humorous, it helped.
Over the course of my treatment, I was lucky to have a very stable environment. I had a job that I enjoyed and the best coworkers. I was able to get exercise almost every day, although my run became a walk and my swim a float, it made no difference. The important thing was that I had a routine to look forward to and for me that was a vital part of my treatment.
Hepatitis C is not a popular disease. Outside of a few family members, I shared the details that I was sick and on treatment with only my supervisor and a coworker. For some patients, a support group may be their only source of sharing, but to expose something that seems so deep, so dark, and so secret with someone you know and care about can be so therapeutic. Being informed by the local Board of Health that I had the virus was as impersonal as it gets. Government has no bedside manner. I believe this only added to my own negative view of the disease. This stigma can be so self-imposed. Patients should never have to spend energy hiding from ignorant perceptions, especially their own. I’ve never seen anyone wear a ribbon as a hepatitis C survivor; maybe we should. Not only clinicians, but patients like myself, now have the opportunity to tell the positive story that there is a cure and just as important to reinforce that the virus does not define anyone.
My physician was quick to explain the high incidence of liver cancer among patients with HCV and cirrhosis. What I would have liked to have heard was what I could hope for, rather than a worst case scenario.
One of the worst days I experienced was the day I received the results of my liver biopsy. As my physician explained the results he finally stopped, put down his pen, looked directly at me and said, “You are a METAVIR 4, you have cirrhosis, and you need treatment.” He then proceeded to explain what the treatment would be; I never heard a single word. All I heard was the word cirrhosis, and I seemed to freeze on that frame, because I thought I knew what it meant.
Since diagnosis, I was told numerous times that cirrhosis is not reversible. I no longer believe it because I’ve followed some of the most current research that says otherwise. This is probably the most exciting information I have encountered over the last 4 years. It’s both the looking for and finding of positive information that can be so comforting and motivating. There is no guarantee that the cirrhosis will regress in every patient, but the mere fact it has been observed is “good news.” Patients need to hear this. Clinicians now have the opportunity to explain and frame this information. I know it could make the difference between a patient going on treatment or possibly giving up.
The statement, that I am cured, is not completely correct and is a subject for debate. Even though I have achieved SVR, I still have cirrhosis and need to be vigilant for the complications it brings, including cancer. Nonetheless, I have an opportunity to ENJOY the life I have been fighting so hard for. I’m still the activated patient, but more so, I’ve become the activated person and I believe that has forever changed my life.