Deciding About Treatment - did I avoid a disaster?

I few posts ago I wrote a bit about Questions you need to think about in regards to treatment.

Let me tell you about the first time I made a decision

It was my second visit to the Gastroenterologist, the fabulous Doctor C. The first visit was relatively brief in that we went over a bit about the disease and he order a full set of labs to determine the genotype of the virus, the viral load and a bunch of liver function tests as well as some general blood work. The primary result of the visit was to realize that I had a great doctor on my side. Doctor C is a warm, supportive personality and also a doctor who Listens. He is not one of those folks who are merely waiting for a chance to talk when he is silent. He listens carefully, gives considered answers and is well versed in the details of the disease. He is not a certified Hepatologist, but he does a great deal of work with coinfected HIV patients and is up on the research and the treatments for Hep C.

The second visit was more detailed as we went over the results of the labs. The bad news was that I had genotype 1 which is the hardest to cure. It is also the one infecting the vast majority of North Americans. My viral load was over 4,000,000 IU per ml. which put me in the category considered to be medium-high viral load. My liver seemed to be in good shape with the various enzyme and function tests not indicating there was much damage. By this time my wife and I had read a great deal about Hep C (interestingly enough for those of you following the progression of side effects, I have forgotten a great deal of that information and have to keep looking stuff up to refresh my memory). We had lots of questions and Doctor C took a great deal of time answering them. Then he asked the fateful question. Do you want to be aggressive in your approach to the disease?

Yes, I replied. He told me that he knew of one of his colleagues currently enrolling a study for a Vertex compound VX-950 (now Telaprevir) and reached for the phone. He caught the doctor in, set up an appointment for two days hence and I was in the process of potentially beginning treatment for the disease. I spent the next 2 days doing research on VX-950. It is a protease inhibitor in phase 3 testing and has a Sustained Viral Response result of 62-64% in trials when it is combined with the Standard of Care (Interferon and Ribavirin). The study in question was an open label phase 3 study wherein every participant got the experimental drug; they were just testing for dosage effects. I admit I had a romantic fantasy about the possibility of being in the study: Man is diagnosed with Hep C on Halloween, goes into treatment in January, finishes treatment in December and is declared clear of the virus under 18 months after being diagnosed. We all have our fantasies, mine are usually not about drugs, but this time they were.

I went to the meeting, learned about the study, was told about the drug and the SOC side effects, signed the papers and went in for the lab tests the next day. It turned out that I showed a thyroid abnormality in my blood tests and there was not enough time to get me retested by the official lab in time to get me into the trial. So close and then the chance for the experimental drug was snatched away. It was particularly painful at the time because there are so few phase 3 tests of promising drugs and so very few tests as well wherein everyone gets the experimental drug and there is no placebo group.

As it turned out, it was probably for the best that I did not make the trial.

The next 3 months were spent in an extremely high-stress situation. My organization was moving an entire portion of its operation into a new space. I had been managing a great deal of the operation for my boss, who was in the middle of number of large projects. In January as the facilities move hit is most vital period, his wife became dangerously ill and they suffered a financial reverse which threatened to wipe out their life savings. I had to step forward and assume control of the entire project and manage it through the actual move and start-up of the new facility. I managed to do it, but the cost to my health was extreme. I was exhausted all the time. I went home from work every day and was capable of merely sitting for a few hours before going to bed. My wife is convinced to this day that the stress load spiked my viral load from the 4,000,000 range to the 6,500,000 number it hit in my next test in June.

If I had been going through treatment, I would never have been able to handle the job that was thrust upon me. I would most likely have collapsed either physically or mentally due to the strain. So, even though I lost the chance to get a late-stage experimental drug which raises SVR rates 40% above the standard of care treatment, my health may be better in the long run for missing the opportunity.

I did not examine all the ramifications of my decision before I made it. That is why it is so important to examine all sides of the issue before you reach a decision. It is hard to go through treatment. Even at its best, it is tiring and depressing and long. So think clearly and try to plan for as many eventualities as you can. It can make the difference between a successful outcome and something potentially very ugly.

Deciding About Treatment – Lot’s to Think About

I have had several people ask me why I decided to enter treatment. Specifically, they wanted to know why now?
My situation was this: 56 years old, high viral load at 13,000,000 per ml of blood, stage 1 liver disease, my Hep C had been symptomatic for 18-24 months.
Mine was not a desperate situation, no advanced liver disease, symptoms were present and annoying but not yet debilitating, and I was not in poor health generally. It came down to a long and serious consideration of a number of variables from health to work to family considerations. Here are some of the considerations:

What is the stage of your liver disease? Clearly, if you have advanced liver disease, treatment becomes something much more important and possibly mandatory than if your liver is not so deteriorated. If it early stage, you have the gift of time to consider all your options and potentially await additional treatment developments. If it is late stage, you have to decide much more quickly as the consequences of putting off treatment become exponentially more serious.

What is the state of your general health? Is the Hep C directly attacking your health through its symptoms and side effects and/or is the state of your liver creating additional health issues that are threatening or debilitating? To a certain extent the poorer your health, the more difficult the side effects of the treatment may be, but the more important it may well be to begin treatment in order to battle the effects of the disease. Again, the better your general health, the less immediate the decision becomes.

How are the general Hep C symptoms affecting you? Are you able to use available therapies to mitigate the effects of the symptoms of Hep C? Fatigue, Depression and Brain Fog are 3 of the more widely reported symptoms of Hep C. There are also joint pain, Ascites or fluid build-up in the abdomen, weight loss and the really serious symptoms of late-stage liver disease. There are a number of therapies for the general symptoms and if you are using them successfully and your life seems to be stable and at an acceptable level of health, this affects your decision. If the symptoms are beginning to overwhelm you, or become more than is tolerable for you, this also will have a large influence on your choice.

What is your health insurance situation? Hugely important of course. In countries with government financed health care systems this is a bit less of a concern, though the time before you can get authorization and enter treatment has to be considered carefully. If you have private health insurance, does it cover Hep C at all and if so, which of the therapies does it cover and for how long? If you eventually have to change insurers, will your Hep C be considered a per-existing condition and therefore the treatment would not be covered by insurance? Does this mean you should go for it while it is still covered? These are really tough questions and can definitely make the difference in treatment decisions. Something as basic as timing your treatment to begin the year right after your insurance renews can make all the difference in being covered through the entire length of treatment.

What is your employment or general work situation? This is a multifaceted question. If you are self-employed or run your own business, can you keep it going while not being able to put in the 40-60 hours per week that self-employment and business ownership generally require. Do you have people who can pick up the slack and help you during the 48 or more weeks that you will be, most likely, not at your best? Can your company survive if you have to take some time off without being able to work much at all?

If you are employed, what is your employer’s attitude going to be? Can you let anyone know you have Hep C? Is it clear to you that the attitudes at work would not be in your favor if they knew you had the disease? While it is illegal to discriminate against someone with a chronic disease like Hep C, remember that the burden of proof is on you. Should it come down to contesting a lay-off or firing, you have to bring the case and prove the action was because of Hep C.

If you believe that there is support from your employer what form will it take? Can you work a shortened workday or 4 day week? Can you take time off during the day to rest if necessary? Will they be supportive of the time you need to visit doctors and have tests? Do you have a sick leave policy or accumulated sick time that can be used to make up the time that you cannot be at the job? All these questions are vitally important and must be considered carefully before you make choices about treatment.


Which Genotype of the Virus am I and what are the chances for success? The common genotypes in North America are genotypes 1, 2 and 3. Genotype 1 is the most common and conversely, the most difficult to treat successfully. Genotypes 2 &3 are much less common in North America (and much more common in the rest of the world) and have a much higher success rate with treatment. The Standard of Care (SOC) is pegylated interferon (Pegasys, Peg-Intron) and Ribavirin (Copagus) taken for 48 weeks. The percentage of patients with a Sustained Virologic Response (SVR) is about 46% for genotype 1 and 80+% for genotypes 2 &3. So you have a bit less than a 50-50 shot to be cleared of the virus after treatment if you have the most common genotype present in the USA. The question boils down to: do you want to endure the effects of treatment for a year (and then some recovery time as well) for a 50-50 shot at a cure?

This is where the question of experimental drug studies comes into consideration. The study I am in uses a polymerase inhibitor (RO5024048) in addition to the SOC. The early studies indicated that it could result in a SVR rate of upwards of 70% in genotype 1 patients. There are very advanced compounds in the protease inhibitor family (Telaprevir is one example) that have shown in phase 3 studies that they have SVR rates of about 64%. When you see these sorts of results, the question changes quite a bit. Can I deal with treatment for a year if it means I have a 2-1 shot at clearing the virus or even a 3-1 shot?

What is your family situation? How stable is your relationship? How do you think your partner and/or children will react to the situation? Will they support you through the difficult parts of treatment? Does your family have the necessary financial means to deal with the potential loss of income and increased costs brought on by undergoing treatment? These are all highly personal questions whose answers are different for every individual considering treatment. They can also be questions whose answers change over time. Sometimes folks can start out very supportive and be worn down over time. Other times people step up to offer support and assistance in ways that can be astonishing in their generosity.

These are just some of the questions that arise when considering treatment. More to come…