Night 145 - Innovations In Hepatitis C Treatment Definitely One Of The Major Medical And Financial Breakthroughs Of 011

Several other Protease Inhibitors are being developed as well, including the nightmare experience I had with the Protease Inhibitor by BI. Still, I believe I will be cured so it does work, and my side effects were more extreme than anyone else in the clinical trials. Lucky boy!

Drug Research Is Big Business: 4-6 Million HCV Infected Adults In The US

Overall, the innovation in the Hepatitis C treatment arena and thus the overall marketplace are nothing less than stunning. Within a few years, it looks like Interferon and Ribavirin will be removed from the treatment regimen, replaced by a Protease Inhibitor that covers all the bases. How great is that!

But let me be clear about my response to these incredible innovations. Despite the severity of my side effects, I am not bitter about my decision to enter the clinical trial and get treatment now. It was the right decision to make at the time, and my bad luck in regards to the side effects was just that - simple bad luck with no dark magic or evil curses. Hey, sometimes we roll the bones and we come up aces and sometimes we just crap out.

Such is life, and I choose to free myself from the burden of bitterness and regret. What's the point?! It's not like I was playing with loaded dice and got screwed. Sometimes the universe works for you and sometimes you work hard for the universe.
             I wish we had more control, but, as the French say, C'est La Vie!

If you choose to hold tight and carry the bitter weight of your regrets, do not ask why their no fluidity or rhythm to your life. What the hell do you expect when you are so overwhelmed by the horrors of the past that you sacrifice the freedom to live in the present.

Here is the article below about some of the new Hep C innovations:

2011 has brought patients with hepatitis C not one but two new groundbreaking medicines to treat the condition. Merck’s Victrelis (boceprevir) and Johnson & Johnson/Vertex’s Incivek (telaprevir) were both launched in the US in May. 

The drugs are both oral protease inhibitors, and promise to significantly improve treatment when added to the current standard treatments for the disease. An estimated 270-300 million people throughout the world have the disease.

Analysts predict Incivek will prevail because it has shown a higher cure rate, and a simpler and faster simpler dosing regimen. But Vertex, which has never launched a drug before, will have to overcome the might of Merck and its new US marketing partner Roche. 

Vertex’s belief in the superiority of its product is reflected in its price, which is $49,200 for a 12-week course. This cost is much higher than Victrelis, and is equivalent to the price of a whole 48-week treatment with Merck’s drug. 

Incivek has had the best start, earning $420 million between May to October, while the same period saw Victrelis earn a more modest $31 million.

Day 75 Night - Beyond Complaints And Under Siege: The Questionable Consolation Of "The Worst Side Effects We Have Seen So Far"

When I saw the Clinical Trials Doctor today in what became a marathon of doctor and pharmacy visits, he checked out the rash on my knees, lower legs and elbows, and told me that the side effects I am experiencing are the worst that they have seen so far. The provides a form of questionable consolation because it means that I have gone beyond the realm of complaining and whining. Is it complaining when you spend an entire night doing nothing but trying not to itch and no prescription cream or over-the-counter product even dents the effects?  Combined with the constant heartburn and the multitude of toilet visits every day, it all implies that I actually am dealing with this storm of shit pretty well. I am trapped in a blizzard of side effects from these drugs, and it truly does suck!

A Blizzard Of Side Effects Caused By The Protease Inhibitors

What is intriguing, as I type these words and ignore the quiet cries of my right shin, is that the blizzard of side effects does not seem to be caused by all the drugs. In truth, I seem to be handling the Ribavirin and Interferon pretty well. What I am not handling well is the new experimental Protease Inhibitor, and I fall into the vast minority of bad luck suckers who get both the bad rash and the stomach problems. Yes, I am unlucky compared to the other patients in the clinical trials, and that is life. C'est La Vie...


I mean, honestly, what else can I do? Stop and roll the dice with my liver, hoping that one day I won't wake up with liver cancer or Cirrhosis so bad that I need a liver transplant to even survive. Cirrhosis is scarring of the liver and poor liver function. It is the final phase of chronic liver disease. It is not easy to hear a doctor describe what you are experiencing as your body being under siege by a blizzard of side effects. I doubt it will help me as I lie in bed tonight and try not to itch. 


There is one thing I promised myself when I started this entry: I will not post a picture from that Steven Seagal movie where he kicks a lot of ass on the boat. I will not use that image to express how my body feels. In fact, I won't use any image. There is no point in showing what can only be experienced. No, for a smile and a laugh and the knowledge that we all have a crazy range of emotional reactions to challenging times, I will leave you with this...

Day 18 Night — Clinical Trials First Step: A Very Cool Nurse And Element Girl

Okay, as with everything in this hyper-intensified process, I perambulated today between deep spirituality and freaked-out crisis like a pinball doing the dance of life and death. My first meeting at the medical office buildings across from Olympia Medical Center for the clinical trials took place, and it was an overall positive with hints of lurking negatives. What is essential is not to fall into the either/or perspective and to understand that I am not dancing between darkness and light, good and evil, or life and death, but lingering in a vast amorphous landscape of grey. The grey offers no easy choices beyond murky fears and no quick solutions, but at least it reflects a certain truth in terms of the nature of reality and human life. There are very few mythic battles and transcendent confrontations. There are mythic hearts and transcendent laughter, and they do battle with the grim truth of everyday reality like the rest of us. Mind you, I have not forgotten that there is beauty and wonder everywhere if you look with clear eyes and open hands.

The Dream of the Mythic Battle Against Monstrous Evil

When I went into the clinical trials, I met Chris Rice, the RN who is the clinical manager of the project. Later, I will go into more details about the clinical trials, but there will be plenty of time for that in the future. Besides being incredibly positive and user-friendly (sounds like a massage with a happy ending) on the phone, Chris presented the details of the trials with precision and understandable specifics. When I went into the office today and Chris took all my medical data and history, we got along incredibly well. Since we are both huge comic book fans, it was wonderful to hear about how he is sharing Neil Gaiman's brilliant Sandman with his 15-year old daughter.

Neil Gaiman's Sandman - Facade (Death of Element Girl)

I have no kids and I have tons of comic books and baseball cards, and I always thought I would pass them down. Maybe I'll have a child in the future - being a man, the ticking clock moves a bit slower - but if I don't, I can always share them with my nephews and my niece. When Chris described watching his daughter read some of my favorite stories from Sandman, I must admit I was deeply moved by vicariously experiencing something I once dreamed of doing myself. In particular, there is one issue called Facade about the despair of the super heroine Element Girl, an eternal metamorpho created by Ra, the ancient Egyptian God of the Sun. Element Girl can change into any element at will and she is incredibly powerful, but she longs for the release of death. Since she naturally changes into any element to adapt to any situation, she does not know how to kill herself and end her overwhelming sense of being an alienated freak. She is surprised when she is unexpectedly visited by Death, one of the Endless.

Death Visits With Element Girl In Her Moment Of Despair

Element Girl is told by Death that all she has to do is ask Ra to release her from life. But how, she asks, do I find him? She is told that Ra is a Sun God so all she has to do is look into the sun and ask nicely. She walks over to the window as the dawn approaches and the sun is rising, asking Ra to free her from the burden of her powers. In a stirring moment, Ra releases her from the eternal battle and she dissipates into dust with her ashy smile blowing away on the breath of the wind. It would be wonderful to watch my child experience such a beautiful story that meant so much to me. But I feel no regret right now; only happiness that I was able to empathize so deeply with a real-life experience and story told. There is more to tell about the doctor and the looming lesion in my kidney and a questionable high five, but that shall come later because there are more days and nights coming for me. I have no desire to have Ra free me from the blessing of this life, and I shall fight to hang on with your help.

Day 17 Night - Major Decision Made, Joining New Clinical Trial in Los Angeles

I must admit that making this decision has left me somewhat drained. After an initial sense of buoyancy and excitement, I already am closing in on the tough reality of starting treatment. Since the treatment still involves Interferon and Ribavirin, the antiviral medications that work to stop the virus in your system while making you quite sick with flu-like symptoms, it is scary to say the least. In addition, I have to do a liver biopsy in the next week and any invasive procedure is frightening. But these are the consequences of my actions and of my disease, and I must face them by walking a path of courage. With a lingering tinge of fear because honesty remains a priority.

Cedars Sinai Medical Center - 8631 My Morning Destination

Let's start at the beginning of the day and move forward. Although it is past 3am in the morning and tomorrow I am getting a cat scan, I already slept for over five hours. When I got home tonight, I collapsed on the couch and fell into a a deep sleep of strange and reflective dreams. But that is another story altogether. This morning, I met with Dr. Graham Woolf, a top hematologist at Cedars Sinai medical center. After looking at all of my lab work (my viral markers — pcr 2.3 million viral lode, genotype 1a, alt 241 elevated liver enzymes showing minor inflammation, normal CVC), he discussed my treatment options.

The two FDA approved medications that have been home runs and changed the Hepatitis C playing field are Encevik and Victrellis. Approved in the last couple of years, they are protease inhibitors that prevent the spread of the virus. Since they are first generation drugs, the dosage regime remains in the evolving stages with serious side effects. Almost 70% of the people taking this drug get a serious skin rash all over their body that has to be treated with Benadryl and Cortisone. Given the nature of my skin and my tendency towards a certain itchiness here and there, I believe it would happen to me. And I simply do not want that to be part of the array of side effects that I experience. The rash is so bad that 6% of the people who do the treatment and get the rash drop out within the first couple of months. That is the first problem with today's treatment regimen.

The second problem is the vast quantity of pills that have to be taken on a daily basis, turning a patient into a walking medical cabinet. I might have my numbers slightly mixed-up so I will say that it is between 18 and 24 pills taken every day (the Encevik and the Victrellis) on different time tables (every two hours and every eight hours). The pill regimen is so intense and confusing that the doctor showed me complex charts given to te patients and told me about a new iPhone application designed to help you keep on track with the exact dosing schedule. The real danger is that if you fail to keep on track because you are exhausted and overwhelmed and sickened by the Interferon, then over a period of time, it is quite possible you will become resistant to the treatment itself. Literally, you can "X" yourself out of the process. Honestly, I am willing to roll the dice. I do not want to be a walking medicine cabinet for six months because I believe it will effect the very essence of who I am. Perhaps a logical fallacy on my part, but a lurking fear nevertheless. A bit like Binkley in Bloom County and his courteous closet of anxieties. God, how I identified with Binkley when I first read that cartoon - his passion and his fears.

Binkley and his Courteous Closet of Anxieties in Berke Breathed's Bloom County

So what is entailed in the new clinical trial as opposed to the old regimen. As opposed to 24 pills a day, it is reduced to 2 pills a day and the chance of getting a rash is reduced from 70% to 6%. Personally, I like those numbers a whole lot better. Mind you, it is a triple armed trial with 1/3 of the patients receiving a placebo, 1/3 receiving 1 placebo and 1 pill and the last 1/3 receiving 2 pills. Since it is a Phase III trial, they are trying to work out the proper optimal dosage. Doctor Woolf believes the new drug - a second generation protease inhibitor - will be approved by the FDA and be in general use by 2015. He asked me if I would rather drive a 2010 Mercedes or a 2015 Mercedes. Since I have always been a futuristic kind of guy with a bit of wishful Willy Wonka Golden Ticket thinking, I choose the 2015 Mercedes.

Okay, that is enough for now. Tomorrow, I go into Kaiser for my Cat Scan to see what the small 1.7cm by 2cm lesion is in my right kidney. But that's a whole different story and most likely, nothing to worry about. Just a bunch of fatty blood cells. Mind you, when you ask your doctor about how the Ultrasound went in regards to your liver and he tells you they found anything anywhere else, particularly in another major organ, it is less than pleasant. C'est la vie... I have faith that everything's gonna be alright. And, unlike that prophet named Bob Marley, I am completely sober today for exactly 3.5 years and off the hard drugs for well over 7 years so I have no ganja to reenforce such a perspective. Instead, all I have is the love and support of my family and friends, and my faith in the path that this universe has laid out before me.