I am a 57-year-old white American male infected with Hepatitis C. I am involved in a controlled medical research study by Roche Pharmaceuticals of an experimental Polymerase Inhibitor (RO5024048 also known as RG7128) drug therapy for the virus. This document is the story of my illness and the experience of treatment. My lovely and pretty damn wonderful wife will be contributing her take on the experience as well.
Sunday, May 30, 2010
I have long hair. I have had long hair since my twenties. In fact, it has been about 35 years since I have done more that trim the length of my ponytail every several months and keep my beard trimmed. In years past (as little as 10 years ago), much of my hair was dark brown. It was also present in a reasonable quantity. Sure, there were areas where it was clear that my scalp was encroaching into areas previous covered with hair, but overall, I was doing better than any of the men in my family had ever done before. Over those ten years it has gradually gone increasingly gray; to the point that before treatment started I was more gray than brown.
Then interferon began to exert is magic. First my hair began to turn increasingly white. It is not completely white yet (that would be James Coburn cool), but the strands of gray and brown seem to getting mighty few and far between. Then it began to slowly up and leave my head. It does not fall out in huge clumps as is the case with other forms of Chemotherapy. It just gradually gives up the ghost, hair by hair, and slips away. I track its disappearance by my elastic ponytail band. When I started treatment, I needed three loops of the band to hold my hair securely. Now, when I brush my hair in the morning, I have to loop the band 5 (Five!) times around the few remaining hairs in my ponytail to hold them firmly in its grasp. In fact it’s not really accurate to call it a ponytail anymore, it’s more of a pony strand.
Where does all this hair go? That is where the catlike nature of the situation lies. Any chair that I use regularly – those at work for example - becomes gradually covered with a layer of long gray hairs. The sofa at home, the chair on the back porch, even my pillow, all slowly receive a coating of long gray hair. It is not long enough to be my wife’s and besides, she is clearly not losing any hair. It is mine, or more accurately was mine. My jackets and coats as well all testify to the fact that I am shedding, more rapidly as time goes on, what is left of my hair. To be genteel about the situation, I find it most distressing. To be more straightforward, it sucks.
Everyone involved with the treatment and with our support group tells me it will grow back, but that is cold comfort. Cold being an operative term as the lack of hair definitely points up that it had been keeping my head warm all those years. There are far more serious issues involved with hepatitis C and its treatment, but this one just strikes a nerve. While I like cats, I don’t want to shed my coat until I become a large pink hairless version.
The only thing that saves me now is that my hair is light, my scalp is white and it seems there is more hair than really exists. How much more time I can buy with that before it’s time for the shaved head well, I’ll keep you informed.
Friday, May 28, 2010
Once they move beyond the Phase 1 trials to determine basic efficacy and safety, research trials increase in size and length. The reason is that to determine the effectiveness and side effects of the drugs under study, they need a large enough sample to give them statistical significance. Therefore they recruit hundreds of subjects for the trials. There is another reason for recruiting larger numbers of subjects. The researchers know that a certain number of the patients entering their trial will not finish it. Some will fail to abide by the parameters of the study. Others will consistently miss taking doses of their drugs and be dropped from the study. Still others will have such severe reactions to the drugs that they will not be allowed to continue. There are those who will leave the area and not be moving to a location that has the necessary facilities to allow them to continue and some will just not be able to stay the course for the necessary time to complete the study. So they need to recruit enough people to collect enough data even after the inevitable attrition of subjects.
This is where your leverage comes in. The researchers want your data, they need your data and they need you to complete the trial for that data to become a useful part of their records, reports and papers. Therefore they will go to some lengths to keep you in the study. If you move, they will try to find a lab or medical facility near you that can continue the testing they need for the trial. They will work hard to educate you about what you have to do as far as dosing and record keeping and keep at you to do it correctly. They will also prescribe remedies for some of the side effects to make it possible for you to stay in the trial.
That is why it is important to report side effects to the researchers as they happen. It is also important to tell them how severe they are. If they are interfering with your ability to function effectively tell the researchers that as well. For some of the side effects, they will adjust you research drug dose to attempt to mitigate the situation, for others they will prescribe medications to ease the side effects. It is not necessary to exaggerate any of the information you are giving them. Be factual, but above all be timely. If you report accurately and quickly when you have side effects and when those side effects are becoming a real detriment to your life, they will do what they can to help because they want your data. To get your data, they need you in the study. That is your leverage and if you don’t use it, you lose the advantages it can bring.
To use my case as an example, if I had reported the muscle pain in my sides that the interferon causes as soon as it happened, they would have prescribed Tramadol sooner. I would have been more comfortable and probably better rested earlier in the study than I was simply by reporting the severity of the situation as soon as it was happening. Likewise with the insomnia that is a common side effect. I was sleeping badly for a few weeks before the truly enormous bags and dark circles under my eyes made it plain that I was not getting enough sleep. When it became obvious they moved quickly to prescribe the Trazadone to help me sleep. The same was true with the depression caused by the interferon. If I had been reporting my mental state more accurately, it would have been apparently several weeks earlier that I need help for my mental state. As soon as it was plain that I did, they started on the search for the correct antidepressant.
So even though, they want to watch the progression and severity of the effects and side effects of the drugs and they want to control the variables of drug interactions by keeping what you are taking to a minimum, they also want you to complete the study and get your data. Use that leverage to help make your own treatment as bearable as possible.
Wednesday, May 26, 2010
What this means in practical terms is that the subjects of a research study will experience all the side effects of the anti-Hep C medications without the benefits of many of the established remedies that patients who undergo the Standard of Care of Pegylated Interferon and Ribavirin can take advantage of from the very beginning of the study.
Pegylated Interferon is well known to cause depression, fatigue, brain fog, nausea, insomnia and depressed white blood cell counts. Patients undergoing SOC through their doctors are often prescribed antidepressants before the start of the study in order to combat the depression. They are routinely prescribed anti-nausea medications and sleep aids from very early in their treatment to deal with those particular side effects as well. Ribavirin is well known to cause anemia (often severe), itchy rash, nausea and muscle pain. SOC patients are prescribed drugs to combat the anemia, given anti-itch creams (often with steroids), anti-nausea meds and painkillers for muscle and joint pain. These are usually given as the symptoms are reported and continue for the length of the treatment. This is not exactly the case with the subjects of a research study and there are very good reasons for that.
As I discussed in this post, the effectiveness of the Hep C drugs and the results of drug interactions are complex things to parse. Combine that with trying to track the side effects caused by the study drugs and you need to control as many of the variables as you can for an effective study. To that end during the screening process for the study, the study doctors want to know every drug and supplement you are taking. If any of them would interfere with their ability to determine the effects of the study medications, they will ask you to stop taking them or, if you cannot stop taking them for medical or other reasons, they may disqualify you from participating.
The same need for a controlled medical environment applies once the study begins. The researchers need to track the efficacy of the treatment drugs and the number and severity of the side effects. To do this, you need to experience the effect of the drugs and the side effects of the drugs without the interfering effects of other treatments and if there are other compounds you are taking, they need to be able to track their use.
So you are going to experience the side effects in full force. It is when the side effects are either dangerous or interfere with your ability to continue with the study that you may be prescribed something to help you deal with them. To use my case as an example, I have not and will not be prescribed anything to deal with the anemia caused by the Ribavirin. This is because they want to track as clearly as possible whether this new combination of drugs changes the instances and severity of the anemia. Many other individuals I have talked with about their treatment experience were given drugs to stimulate red blood cell production. Rather than do that the researchers have adjusted my Ribavirin dose to try to keep my hemoglobin count above the minimum they require to continue the trial. I have not been given anything to help with my white blood cell counts but have had my interferon dose adjusted and even skipped to attempt to keep my neutrophil and lymphocyte counts above the minimum to continue the trial. When I began to report muscle pain associated with treatment, I was told to take over the counter medications. It was only when I reported that the pain acute enough to interfere with my sleep, that I was prescribed a painkiller.
Interruption of your normal sleep patterns is one area that they respond to fairly rapidly. The researchers believe that getting enough sleep is vital to your ability to be able to complete the study. They want to hear if you are having difficulty sleeping and they want to be the ones to determine what remedy, be it over the counter or prescription you are going to take to combat the problem. It is a matter of controlling the variables again. In my case, about 6 weeks after the had prescribed the pain med Tramadol to deal with the pain that was keeping me awake I reported that I was having difficulty getting any more than 4-5 hours of sleep per night. They immediately prescribed Trazadone to help me sleep.
Depression is another major side effect that gets handled differently in a study. Unless a patient was already taking an antidepressant previous to screening for the study, they generally do not prescribe them until the researchers believe they are necessary to your ability to complete the study. Those of us undergoing the study in San Francisco were all given information on strategies to handle the stresses of the treatment and programs to give support to Hep C sufferers, but we were not prescribed anything for the condition until they were convinced we needed it. In my case it was about 18 weeks into the study before AVB began to believe I needed to be given something. By that time, it took me three weeks to gather my thoughts and energy enough to realize I was beginning to tip over into serious depression. At that point, they moved fast and started me on SSRI antidepressant drugs.
All these discussions and examples are provided to make sure you think about this aspect of a research study. I did not consider it at all. It was not until I had been in treatment for a few months that I went to a support group and talked to people who had undergone the standard treatment, that I found out that they were routinely prescribed things to deal with side effects. It was then that it hit me that as lab rats for Roche, we were going “naked” in the study. I have a bit of background in science and my wife has “A Masters Degree In Science,” as Doctor Science used to say. We both realize that controlling study variables is essential to getting good data and ending up with a useful study. I just didn’t think clearly at the beginning of the study, that I was the one whose variables were being controlled and that might mean the course of treatment might be a bit rougher than the SOC.
Knowing what I know now, I would not choose differently. In my mind, the chance to take a drug that increases my chances of clearing Hepatitis C genotype 1a by 50% is worth the potential of having a harder time in treatment. I wish I had thought it through and prepared myself mentally for the realities of what that would mean, but I would not change my decision.
Your decision is up to you. Think it through; be aware of what entering a research study means and then with the most forethought you can, make up your mind.
Monday, May 24, 2010
It is very clear to me now both why doctors prescribe antidepressants and why patients endure the early symptoms until their brain chemistry stabilizes and the drug begins to work. I feel…better. It is a curious state to attempt to describe. As my friend BS says, “You generally don’t notice feeling okay or good, but you do notice when you feel bad.” There is also the fact that as you experience a particular state for an extended period of time, be it either feeling good or feeling blah, you come to take it as your normal state and forget that you used to feel differently.
In my case, I realize now that the treatment regimen had gradually been grinding down my mental energy and state of mind. I had not noticed it as it happened though the folks running the study, and AVB in particular, claimed that they could see it happening to me. They actually had the advantage of seeing me intermittently as opposed to every day. This allowed them to notice the changes more clearly because they showed up as significant differences. It’s like the first time you spend some serious time away from home. When you return you notice real changes in your parents and siblings that would not have been nearly so obvious had you been with them on a daily basis. Likewise with me, my wife and I were immersed every day in the grind of treatment and thus the incremental changes became what were normal as opposed to something we should be paying attention to. If nothing else, the declining number of posts per month to this blog should have been a tip-off that the depression and why-bother attitude induced by the interferon were taking a very real toll.
Now that I have been taking antidressants for about 3 weeks and Celexa in particular for about 10 days, I feel a bit better; a touch more mentally alert; less likely to have the why-bother attitude. I still get tired and lose the ability to concentrate by early afternoon, but now when I get home, I don’t just drop onto the sofa and watch a couple hours of awful television in a kind of passive stupor. I still turn on the TV, but I now get bored after a while and find something else to do. The ability to be bored by stupid, mindless crap is a great gift of mental achievement that has been returned to me by modern bio-medical research and I am grateful.
This is yet another reason to keep notes about yourself while you are in treatment. If I had done nothing more than record the number of hours I was watching television, it might have tipped me off that my mental outlook was going downhill. So take notes, date them and look them over from time to time as treatment goes on. You have to review them regularly because the interferon is going to fog your brain and ruin your memory during treatment. If you do these things, you can stay ahead of the side effects and do your doctors a great service by having good information to give them. Both of these things will help you come through you treatment more successfully.
PS: A purely personal note about Celexa because it means a lot, SEX IS BACK!
Saturday, May 22, 2010
It is amazing how much you can forget in 20 days. While I had a lot going on the past few weeks what with the acclimatization side effects of the antidepressants and the new drugs I was taking because of it, nonetheless the number of interferon related physical symptoms that disappeared without my noting their passing surprises me.
I injected Thursday evening and that night I had night sweats and had to change my t-shirt twice. By Friday late morning/early afternoon I had the mild headache and general crappy feeling in the head that you feel when you are coming down with something. By 5:00 p.m. my muscles started to ache, especially in the butt area (How can you mindlessly watch TV while feeling crappy and sore if you butt is aching?). That night I had a generally stuffy head and by Saturday morning the middle of my back was stiff and cramping. I had my first wave of nausea around noon and I also had a sore spot in my breast but with my general clumsiness of late, it could easily be the result of my running into a door, or wall, or chair, you get the idea.
All of these symptoms had disappeared over the past 20 days. Their disappearance was accompanied by completely forgetting about them. I didn’t really even register the fact that I hadn’t felt nauseous in almost three weeks. That would seem to be the sort of thing that you might take note of.
I think this points up the importance of keeping notes about your general health, side effects and mental state throughout your treatment. It doesn’t have to be elaborate. Just a small notebook wherein you note how you are feeling generally and any unusual or unique effects you are feeling. It really helps to be able to flip through you notes and realize that a particular symptom or side effect or your general state of health and feeling is something that you have experienced before. The interferon really affects your concentration and memory and it is very easy to completely forget about something earlier in the treatment cycle that seemed it would be unforgettable at the time. So make notes and keep records. A little notebook of the history of your treatment can be a great friend to you when something seems to be coming out of nowhere, but actually happened to you in the past.
Thursday, May 20, 2010
To use my case as an example, initially I was taking 3 drugs to attack the Hepatitis C virus. The interferon (Pegasys) and Ribavirin (Copegus) were well known drugs; indeed they are the Standard of Care or SOC, with well-documented effects and side effects. Those effects, however, all vary with the individual receiving treatment. For some, they have little effect on the Hep C virus, for others they are tremendously effective. Some individuals are devastated by the side effects, even to the point of being unable to complete the treatment, others individuals have a relatively straightforward time of it with a few difficult side effects but none that are debilitating. To this well-known set of circumstances they added a new drug, the polymerase inhibitor RO5024048 aka RG7128. Phase 1 testing had already been done using the new drug alone and its side effects noted, but aside from a worrying potential effect on the kidneys, many of the side effects mimicked those of the SOC. So as the study progresses and the effects and side effects are tracked and cataloged, it becomes vastly more complex to attempt to determine which drug might be doing what; what synergistic effects might be occurring between drugs; and what other effects might be the just the degree of effect of each drug on the specific individual undergoing treatment.
As the treatment progresses the Ribavirin wipes out your hemoglobin and gives you anemia and potentially itchy rashes. The interferon wipes out your white blood cells, saps your energy, fogs your brain, tends to give you depression and robs you of the ability to sleep well if at all. So to counteract these effects, additional drugs are prescribed. To continue the example of my case, I am currently taking 4 additional drugs. Firstly, I was given Tramadol (Ultram) to counteract the fact that as part of my interferon cycle, the muscles along the sides of my body can be achy and painful enough to leave me unable to lie down. As you might imagine this makes it difficult to sleep. Next, as the general insomnia caused by the interferon kicked in, I was given Trazadone to use as a sedative. Then, as the interferon gradually eroded my natural good cheer (okay my occasional good cheer) they prescribed an antidepressant, Paxil. In order to bridge the time it took for the Paxil to reach full effect, they added Ativan to the witches’ brew of drugs. The side effects of the Paxil necessitated a switch to another antidepressant, Celexa, but the total result is still the same. I am taking 4 additional drugs to counteract the effects of the drugs I am taking for the Hep C.
A final complication during the trial is changing dosing of drugs. In this trial, we only took the experimental polymerase inhibitor for either 8 or 12 weeks and potentially (depending on which arm of the trial you were in) at three different strengths. So after the first 12 weeks of the trial we were all down to 2 anti-Hep C drugs. There is also dose-adjusting going on for those two drugs as well. I have administered full, half and ¾ doses of interferon and even been told to skip a dose at various times during the study depending on my various white blood cell counts. I have been reduced to a lower level of Ribavirin to attempt to counteract my anemia. These sorts of adjustments are the norm for various patients throughout the course of the study.
To all this you can add the complicating effects of human foolishness, forgetfulness and folly (I should have written sports headlines). Again, we have the convenient example of my own case as an illustration. The context for this particular case of foolish forgetfulness comes from two previous posts. In one, I detailed all the benefits of The Everything Tastes Like Crap Diet, in the other I mentioned that chocolate had some very powerful effects on me after I started treatment. Well, the third day after I started the Paxil, while still in the speed rush phase of the acclimation period, I began to actually fell hungry again. I don’t know if it was the psychological effects of the Paxil or just because my body was using so many calories it was crying for food, but I went to the store with a real desire to buy food. I also noticed that foods I had not though appealing in weeks or months began to seem like they would be really good. The though of eating ice cream occurred to me for the first time in months, particularly chocolate ice cream. So I bought a pint of chocolate ice cream and went home and ate it in one sitting. The next day I did it again, and the next. All this time I was noticing that I was jittery and had a great deal of nervous energy. The jitteriness was moderating as the days went by (as I acclimated to the Paxil I thought), but did it occur to me that the effects of the massive doses of chocolate might be contributing to this? Heck no, never crossed my mind. By the way, despite the massive influx of delicious fat into my body, I still continued to lose weight.
Due to side effects that I believe are completely unrelated to any chocolate consumption (chocolate is supposed to increase libido, I believe), they switched me to Celexa. About 4 days in to the Celexa regimen, I once again noticed that I was a bit jittery and nervous. Finally it occurred to me that I had been eating a lot of chocolate. That same day, as I bought my pint of ice cream on the way home from work, I bought vanilla and have ever since. I haven’t noticed a huge difference, though I continue to be less jittery and nervous every day, but there is one more piece of evidence that I just can’t ignore.
I was at work today and I got a bit hungry around 11:00 a.m. I went down to the lunchroom and among the volunteer snax there was a bowl what I thought was trail mix but turned out to be pure M&Ms. I took a small cup of them went back up to my lair and proceeded to nibble on them as I prepped eBay auctions. About 15 minutes later I noticed I was a lot more wired than I had been before. It was not just a sugar rush, it was the jitters, case closed.
So, not only do the researchers have to deal with the seemingly endless complications of drug to disease interactions, drug to drug interactions and drug to human interactions, they also have the wild card of patients who can’t even keep track of their own food reactions. And these reactions are the ones the researchers are never even aware exist. Good luck to all of them, because we patients aren’t always reliable reporters.
I blame it all on the brain fog…
Monday, May 17, 2010
My weight has stabilized, but the sexual dysfunction persists. I don’t really have the interest to even attempt it anymore. That fact that it doesn’t bother me creeps me out.
I went in today for yet another redraw to check neutrophil and lymphocyte counts. They were low enough last week that I was told to skip my interferon dose. They hope that the interruption of the interferon dose with allow a bounce back of my white cell counts and allow me to resume the interferon with the next dose.
After the blood work, AVB quizzed me at length again about my reactions to the Paxil, whether the Ativan had helped with the symptoms and how I generally felt about being on the Paxil. I told her about the powerful initial side effects and the time it took for them to call down. I mentioned that I was now in a state of steady unconcern with a side order of being spaced out and out of focus. I also told her that I thought that Doctor NB could do a great favor for future patients by spending some time to go over the more likely side effects and the periods of time that they might expect them to last. AVB asked whether the pharmacist went over the side effects and I informed her that at my inner city pharmacy, their was never much in the way of consultation.
I also went over the sexual side effects. She was quite concerned and put in a call to Doctor NB for a consult. As she said, the treatment is hard enough to deal with without removing your enjoyment of a basic component of living. She also mentioned that sex is one of the ways for couples to feel close to each other and offer support and during treatment, you need that more than ever.
It took about 25 minutes for Doctor B to arrive and the fact that I sat calmly and stared out the window without a care in the world for most of that time speaks to the spaceyness I was feeling.
When she arrived, Doctor B apologized to me for not spending the necessary time on side effects the last time we talked. She stated that they often left that to the pharmacists but that was not really acceptable. It was gracious and heartfelt of her and I appreciated it. After hearing about the sexual issues, she decided to switch me to another antidepressant. This one is also an SSRI, but is a different drug. It has a much smaller incidence of negative impact on sexual functioning. She went over the expected side effects (hooray!) and sent me out the door with a prescription for Celexa. She told me to hold on to the Paxil because you never know.
After Doctor B left, AVG talked about the many and varied forms of antidepressants. She said that someone like myself who is a virgin to those types of drugs is much harder to prescribe. Many people come into treatment with a history of antidrepressant use due to the side effects of Hep C and thus already know that Welbutrin works, but Zoloft, Prozac and Celexa do not for example. It may take even another drug before we settle on the best fit for me.
So once again, I am armed and dangerous with celexa in my holster and heading for a showdown with my other drugs, or something.
Friday, May 14, 2010
It is difficult to describe the state I find myself in. It feels as though both of my eyes are not focusing together. While I can see clearly when I concentrate on something, those things at the edge of my visual field seemed to be focused at different distances. When I turn my head and move my visual field it has to come to a resting point before everything seems focused. It is as if there is a piece of slightly distorted glass between my eyes and what I am looking at.
This feeling is not disconcerting because my mental state is definitely toward the unconcerned side of the spectrum. I find both the visual and mental effects to be interesting, but ultimately of little matter. I am concerned enough to limit my driving to the minimal I need to do to handle my treatment and occasionally my job. I don’t intend to return to driving as much as I did a few months ago until this all settles down.
There is an additional side effect which is of concern. The fact that it is important to me and yet still does not make me upset or anxious certainly speaks to the power and effect of the antidepressants. Antidepressants in general and Paxil in particular can cause side effects in your sexual functioning. I have noticed a definite and extreme drop in my libido. I don’t much care about sex and indeed have not had an erection in about 5 days. The few times I have achieved an erection and engaged in sexual activity, I have found that it is impossible to have an orgasm. This is most frustrating and that frustration can cause a real impediment to the intimacy that sex brings about between two people. You are much less inclined to want to do it if there is no payoff at the end of the process. The wife of an old friend of mine had the same problem when she was on Prozac. She still liked sex but the complete inability to have an orgasm eventually drove her to swear off all antidepressants.
I am not going to go that far, but I am going to talk to my doctors. I am going in for yet another blood redraw (the 10th time) and will sit down with them and go over the side effects I am experiencing. There are a wide range of antidepressants with a number of mechanisms for achieving their effects, so it is certainly possible to switch from one to another until you find one that works best for you.
It is most important to keep in close touch with you doctors about the effects whatever antidepressant you are taking is having upon you. If they are debilitating or just very difficult to endure, talk about changing drugs. There are a wide range of them. All individuals react differently to the individual drugs. So moving from one to another to find the one that works best for you is standard procedure for these drugs. Do not let your doctors tell you that you have to endure difficult or debilitating or scary side effects. You do not and in fact have the right to get the best treatment for your situation.
So use the calm resolution that you are striving for to stand up to the man if you have to. Insist on your right to the correct drugs. Make sure that you keep communications open so that you and your doctors can finally settle on the treatment modality that is best for you.
Believe me, it’s better than being spacey, impotent, anxiety-ridden or suicidal, really.
Wednesday, May 12, 2010
I took my first dose of Paxil before going to sleep on Saturday. I woke up by 6:30 a.m. on Sunday (very early for me to awaken on weekend) and could not get back to sleep. I felt a bit restless so I did some yard work in the morning. In the afternoon my wife and I went for a walk and I noticed that I was becoming increasingly spacey and tired. Back at home, I napped for about an hour and woke up to a splitting headache. Ibuprofen handled that and being a bit tired, I went to bed just past 9:00 p.m.
I woke up at about 6:00 a.m. Monday and I was wired. I felt jittery and full of nervous energy. I would sit down for a bit, then get up and pace around the house. I could sit and read the paper, but as soon as I was done with a story, I would get up and pace. I realized my inability to concentrate for any period of time would make going to work useless, so I called in sick for the day. I called my various health professionals to ask if this was a normal reaction or extreme. Their reply was that it was at the upper edge of normal and if it continued for very long to let them know. The rest of the day was about the same and I took some of the Ativan at night to try to calm down the jitters.
Over the next few days the jittery nervous energy gradually moderated. I was able to go to work for a few hours a day until I got so physically restless and mentally scattered that I had to go home. I found myself compulsively doing little things around the house because I could only read for so long before I had to get up and move around and do something. I took small doses of Ativan during the day to steady myself out and returned to taking trazadone to sleep, which helped a great deal.
On the bright side, since starting on the Paxil, I have not felt nauseous at all. In fact all the muscular tension and nervous energy have actually made me hungry for the first time in weeks. Despite this, I have lost 5 pounds in 4 days since starting the drug.
This is definitely Mr. Toad’s Wild Ride going on in my body. Once again, I feel lucky I did a fair amount of reality hacking in my youth because I have clearly recognized that all the side effects I am going through are definitely drug-induced. I’m not going crazy or having anxiety attacks, I am just experiencing a drug reaction. But for the folks out there who haven’t had much experience with drugs that have a direct effect on their mind, this could be a scary experience.
Which leads me to a last comment. Doctor NB did not spend any time going over the commonly occurring side effects of Paxil or explain how much time they continue on average. This would have been a great help and, again, anyone without drug experience who was not prepped about the side effects could have real problems dealing with them.
So now we get to see how the rest of the ride goes. Stay jittery, steady out, maybe even achieve some chemical balance and generally calm down, stay tuned folks, it may stay bumpy…
Monday, May 10, 2010
It came about because I had been noticing that I was feeling an increase in impatience and tension during conversations with people. They were the sorts of conversations you have all the time with co-workers, your partner and your friends. It seems that when I would talk to my wife in the evening about how her day had gone, I could feel myself get tense if she talked for very long at all. The same thing happened with co-workers. I found myself thinking, “all right, I get it, you don’t have to keep going on about it, just leave me alone.” This did not happen all the time, but it was increasing in frequency. Just a note, I was not saying any of this stuff aloud, but I was thinking it, sometimes forcefully.
The study coordinator AVB called me to tell me that they needed to redraw blood because my neutrophil count was so low. They wanted to determine whether to adjust my next interferon dose to a smaller amount. I mentioned that I had been noticing a subtle change in my mental state the past few weeks and told her the nature of it. I told her that when I came in two days to do the blood draw, I would like to talk to someone about whether something needed to be done. She said that I should come in immediately. It took awhile, but I managed to convince her that it wasn’t so serious that I was going to start running people down in my truck or screaming at my wife and coworkers. She finally agreed that it could wait till Friday and we left it at that. Her main concern from years of experience was that these sorts of small changes could quickly escalate. Her example was a patient who suddenly started ramming people with her shopping cart at Costco because they weren’t moving fast enough. I promised I wouldn’t do any shopping before Friday.
When I came in for my appointment, they did the quick blood draws and then AVB quizzed me at length about my mental state. I repeated what I told her on Wednesday and then answered her questions about all my various side effects. She told me that even though I had been telling her that I was getting along okay over the past several weeks, she had been noticing some deterioration in my mood. She said that even though I was a tough guy who was intent on soldiering through the treatment, she had “seen it in my eyes” that I was having an increasingly difficult time. I had to tell her that she was about the only person I could remember who ever used the words tough guy to refer to me. Sure I have a generous helping of Slavic fatalism, midwestern quiet desperation, and general stubbornness, but actual toughness, not so much. Nonetheless, she paged the study doctor NB to come in and go over the situation.
When Doctor NB arrived, we went over the same material and discussion of mental state and symptoms. She concurred with AVB that I might be approaching a tipping point in my mental state. Her solution to the problem was to prescribe the antidepressant Paxil. She also prescribed Ativan as something to take when needed if I felt anxious. She said that Paxil can take 2 weeks or more to take effect and that the Ativan would be something to use as a bridge until the Paxil kicked in.
So now I will be starting antidepressants as soon as I fill the various prescriptions. I am not sure what to think about that or what to expect mentally when I start taking them. I have no real feelings about antidepressants, though they do defeat the concept of Slavic fatalism. My wife took Paxil about 15 years ago and it helped her a great deal. I have also found, through talking with other individuals who have gone through treatment, that I am one of the few people who started treatment without being given antidepressants right at the start of treatment.
When I told my wife that I was going to start taking Paxil, she reminded me that for the first few days she had taken it she felt “rubbery.” While we have no idea what my reaction will be to starting the drug, I am definitely expecting some sort of side effects at the beginning. I guess it’s time to hit the internet and start my research…
Wednesday, May 5, 2010
I have restless feet, and legs and hands. I have had this all my life. I am sure that if I were growing up today, I would be diagnosed as hyperactive or ADD or whatever the current fashionable term is. When I was about 14 my younger brother was diagnosed with ADD by the family doctor. When he asked my mother if she hadn’t noticed that he was a bit over-energetic and hard to control, she said, “Oh no, I have another one just like him at home.” Whenever I sit down, my feet are tapping, or my knees are jiggling and it goes on 24 hours a day.
I did not know that I did it at night until I was 18. Three high school buddies and I drove to Mexico City from Minneapolis to visit one of the guy’s uncles. That is an innocuous sounding statement until you realize that it is about 2500 miles, 4 guys in one car, driving straight through until we got there. We were young…
The first night we were in Mexico City, we were all bunked in one large room. The next morning, my three friends looked bleary-eyed and haggard. They had been awakened all night long by the sound of my feet rubbing together under the sheets. They thought it might be mice or bugs and it was not for several hours that they traced the noise to my feet. They could not believe that I could sleep through the noise I was making. I was exiled to a small room next door for the duration of our visit.
Trazadone makes my legs jumpy. It doesn’t happen till about 30 minutes after I take it, then it sets in. There is a strange feeling of tension build up in my leg and then it twitches sharply. This goes on until I fall asleep. When I took 50 mg, the jumpy leg defeated the sedative, but when I went to 100 mg. the sedative effect put me to sleep despite the twitching. Luckily for me, and more notably my wife, the twitching subsides shortly after I fall asleep and reverts back to my normal foot rubbing. I can usually get a reasonable night’s sleep after taking it without feeling logy in the morning.
One small, twitchy, step against side effects, one great leap for enduring treatment…
Saturday, May 1, 2010
Doctor C is a great listener and takes as much time as needed to deal with his patients’ questions and problems. He went over my file and the latest test results I brought with me. He had a number of questions about the physical side effects of treatment. He asked about the nature and severity of them as well as any measures that were being taken to either counteract or mitigate their effects. I also asked him for his opinion of the drugs they had given me for the muscle pain (tramadol) and for insomnia (trazadone). He immediately pulled up his drug reference app on his smartphone and gave me the details. He told me that the tramadol was fairly standard for the pain. He went into more detail about the trazadone. He told me it was an antidepressant that had been around for over 20 years and that it was a very safe drug. He said that it had also demonstrated good results as a sedative. He told me that as an antidepressant the dose went up to 300 mg. and that as a sedative the dose was either 50 or 100 mg. I was prescribed one 50 mg tablet as needed. He told me that if it was not working at that dose to take two. It was perfectly okay and would probably be very effective.
He also questioned me quite extensively about my state of mind. He is very concerned about the side effects of interferon. He has had extensive experience in prescribing it for various conditions and has seen that it can be devastating to some patient’s mental state. He mentioned that his father had taken it for a lung condition and had become extremely depressed. He was a bit surprised that I was not on any antidepressants. He mentioned that when he prescribed the standard therapy for Hep C for his own patients he usually started a prophylactic regime of antidepressants right at the start. He suggested that I pay close attention to my mental state and that I should keep both the study doctors and him informed of any changes.
It was a good meeting and I think it shows the importance of having someone you trust on your team going into treatment, whether it be a research trial or the standard of care.
The books and advice sites all say that you should have a hepatologist as well as your primary care or personal physician in your medical team. I am not sure it is absolutely essential that you have a hepatologist. Doctor C is a gastroenterologist who has extensive experience with Hep C. As a hepatologist is a sub-specialty of gastroenterology, an experienced gastro person should be familiar with Hep C. If not, look around until you find one if you can.
You need to have a doctor who listens to you. That is the most important characteristic you need to find. You need to find the best mix of attention and knowledge in your doctor. This is especially true for a research trial. The research trial doctors are very good and want their patients to succeed, but I have never talked to a trial doctor for more than four or five minutes. The conversations are about specific reactions and not about the general state of my health, my state of mind or my progression of symptoms. Thus, you need to have a doctor outside the trial to backstop the questions, the decisions and the information you are getting in the trial. You need someone who is on your side.
Unless you don’t have a choice, and unfortunately there are lots of people in that situation, don’t go into a research trial unless you have a personal or primary care doctor who knows exactly what you are planning to do and what to watch for because of it. If you can, get a referral to a gastro person with Hep C experience or a hepatologist before the trial. You can give them the details of the trial, they can get your history and you can forward your results to them as you receive them. This way you can get the support you need when you have questions and concerns that may not be met by the study doctors.
Never be afraid to ask for a second opinion. It is your right as a patient. Get all the information you need to feel comfortable proceeding with your treatment be it drug trial or standard of care. You are the only person who has only your best interests at heart, so do whatever you need to defend those interests.