Vision changes are a big part of the side effects of both standard treatment and several of the additional drugs either approved (boceprevir, telaprevir) or under study for treating Hepatitis C (RO5024048 RG7128). They can include blurry vision, changes in the strength of your vision, sparkles or light shows within or at the edge of your visual field and worst of all macular degeneration. The effects can vary in intensity during the course of treatment. Most of the visual side effects reverse after treatment is ended save for macular degeneration, which is permanent. In my case, the effects seem to be slowly reversing themselves.
In this post (about 6 paragraphs down) there is a description of the onset of the visual side effects when treatment began. At the time the primary effect seemed to be a reduction in my ability to focus on things that were close-up in my visual field. I lost most of my natural monocular vision in which the left eye focused up close the right eye focused at a distance. It eventually progressed to the point that, at the end of treatment, there was little difference between the two eyes. The left still focused a touch better close up and the right a touch better at a distance, but there was no longer a significant difference.
There was also some variation in the strength of vision. It seemed that from month to month there were variations in the amount of short sightedness I was victim to. Sometimes, it seemed my glasses were not nearly strong enough and other times they were far too strong. I took to not wearing them most of the time and carrying around reading glasses for when there was a need to focus closely (for those of you in the San Francisco Bay Area, Ichiban Kan the Japanese discount store has reading glasses for $1.50 per pair; and stylin ones at that). I decided not to get new glasses or even try to determine my prescription until the treatment was over.
Several months after I had been dropped from the experimental study and was on the standard treatment, I began to notice that there were sparkles in my visual field. They were not large nor were they particularly intrusive, but they were apparent when I wasn’t focusing on a specific area. They were also apparent at the edges of the visual field, particularly in low light. I kept thinking that I saw something out of the corner of my eye and when I tried to turn and focus on it, there was never anything there. It took a while to realize that it was due to the sparklies and not to flies, birds, mice, rain, ghosts or any of the other things that appear in the corners of your vision.
Now that 9 weeks have passed since finishing the interferon and Ribavirin treatment, there has been some reversal of the visual side effects. The sparklies in the visual field and at the corners of my eyes are mostly gone. They still appear when I am very tired, but they may have always done that and I wouldn’t know it given the state of my memory. The variations in my strength of vision have stabilized as well. There are no longer times when I cannot wear glasses because they make my eyes hurt. Perhaps it is time to visit the eye doctor and get a new prescription and even new glasses (Costco here we come). There has been no change in the loss of monocular vision. My two eyes remain slightly different, but the old ability to read with the left eye and focus long-distance with the right seems to be gone permanently.
The side effect of the eyes getting tired rapidly during reading and watching a movie, TV or computer screen has also begun to reverse. So much so that this past weekend my lovely wife and I were able to take in two movies in two days. These were not “films” either with long static takes of characters talking or meditative pans across beautiful scenery. These were eye-taxing action films with rapid changes in focus, explosions, chase scenes and all the things you watch movies on the big screen for. Yes, we saw “Cowboys and Aliens” and “Rise of the Planet of the Apes” - two brilliant examples of all that is right in Hollywood filmmaking. At least with Hep C, the treatment doesn’t make apes smarter and people dead. We got that going for us…
Showing posts with label Hepatitis C combination Treatment. Show all posts
Showing posts with label Hepatitis C combination Treatment. Show all posts
Tuesday, September 6, 2011
Monday, August 1, 2011
Coming Back To Life
I finished my course of treatment for Hepatitis C on June 30, 2011. The last 6 weeks were particularly tough with bouts of nausea, some dizziness, decreasing red blood cell counts, consistent exhaustion and increasing mental fog. Eighteen months of interferon and Ribavirin apparently do a number on us humans. The good side is that at the end of the treatment cycle, the viral load was undetectable with negative viral activity. Now we wait for 6 months until January of 2012 for the follow-up test to determine if I have stayed negative and thus qualify for having a true Sustained Viral Response or SVR. It brings to mind the song from the Mel Brooks movie “The Twelve Chairs” with the chorus:
“Hope for the best, expect the worst
Some drink champagne, some die of thirst,
No way of knowing which way you’re going,
Hope for the best, expect the worst.”
By the way, did you know that Mel Brooks wrote the music and lyrics for the songs in his movies.
So we are hoping for the best over the next six months (though the thought that the next test occurs in 2012, the year of the end of the world certainly tempers the enthusiasm).
We return to the subject of the post after that small digression. On about the 8th or 9th of July, I was lying on the sofa catching up on the episodes of “Mob Wives” I had missed, when I thought about unloading the dishwasher and tidying up the kitchen counters. For months, this sort of urge was met with the thought that it could be put off until later that night or tomorrow or to some indefinite time in the future. But on this occasion, I arose from the sofa, walked to the kitchen and actually unloaded the dishwasher and wiped down the counters. It was the first sign that some mental and physical energy was returning. Over the next few days, I began to do a bit more. It was a great feeling to experience energy as opposed to lethargy. It genuinely felt like I was rising from the depths back to life. It’s going to be a long, slow struggle back to normalcy by all accounts, but as the old saying goes, “every journey begins with a single loading of the dishwasher.”
“Hope for the best, expect the worst
Some drink champagne, some die of thirst,
No way of knowing which way you’re going,
Hope for the best, expect the worst.”
By the way, did you know that Mel Brooks wrote the music and lyrics for the songs in his movies.
So we are hoping for the best over the next six months (though the thought that the next test occurs in 2012, the year of the end of the world certainly tempers the enthusiasm).
We return to the subject of the post after that small digression. On about the 8th or 9th of July, I was lying on the sofa catching up on the episodes of “Mob Wives” I had missed, when I thought about unloading the dishwasher and tidying up the kitchen counters. For months, this sort of urge was met with the thought that it could be put off until later that night or tomorrow or to some indefinite time in the future. But on this occasion, I arose from the sofa, walked to the kitchen and actually unloaded the dishwasher and wiped down the counters. It was the first sign that some mental and physical energy was returning. Over the next few days, I began to do a bit more. It was a great feeling to experience energy as opposed to lethargy. It genuinely felt like I was rising from the depths back to life. It’s going to be a long, slow struggle back to normalcy by all accounts, but as the old saying goes, “every journey begins with a single loading of the dishwasher.”
Wednesday, December 15, 2010
Ode to California Pacific Medical Center Hepatology Center
Today was my bi-weekly blood test. It was a quick and dirty one-tube wonder that measured the standard blood chemistry, hemogloblin, neutrophils, white and red cell counts, etc. It was a screening day for folks who were applying to be in one of the upcoming drug trials, so there was a bit of a wait at the Hepatology Center lab. They have a TV in the waiting room playing nature DVDs on a continuous loop with the sound turned way down. Anyone who has read much of this blog knows how much I like watching concentration free video, so it was not a burden to sit in a comfortable chair and wait my turn.
While waiting my managing nurse from the Roche drug trial (RO5024048 or RG7128 depending on which company you favor) AVB saw me and stopped by to chat me up. Actually she just sat down to ask how I was doing but we older guys can always dream. We talked for a bit and she asked if I was still on treatment, how much longer it was to last, if I was negative, whether I was still working and how I was coping in general. (I asked about her mother and she told me that she was fine, but probably needed to have somebody to talk to outside her family).
I gave her the lowdown on how I was doing – still on treatment, 54 weeks in 24 to go, I have been negative for 12 weeks now, I am still working 4 days a week and aside from feeling very tired all the time and stupid some of the time I felt I was doing okay. Like many people with experience in either undergoing or administering Hepatitis C treatment, she was surprised I am still working. She urged me to make sure that working was not taking too much out of me. She emphasized that if work wore me out too much, it could inhibit my ability to succeed at treatment and that I have to remember to think of my own health first. She reiterated something that she told me several times when I was in the experimental trial, that they would write the papers for a disability claim for me whenever I felt it was necessary. We talked briefly about our holiday plans; she patted my knee (see what I meant about chatting me up…) and went about her business.
I mention that meeting because it is characteristic of the vast majority of interactions I have had with the staff of the CPMC Hepatology Center. From the folks at the front desk to the people who draw blood, to the nurses, technicians and the doctors themselves, they all exhibit genuine concern and care for their patients. I am a relatively relaxed patient in most circumstances, but I have seen them show tremendous patience with difficult, disturbed, confused and unresponsive patients. They are gentle with the physically challenged, explain in great detail the nature of diseases and care, are helpful with the people for whom English is not a first language and generally kind and concerned with those under their treatment.
When they are dealing with me personally, I never feel that they are rushing me through our appointments. They answer my questions (and in fact are more than willing to grill me about how I am reacting and whether previously reported symptoms are still present) and explain medications and procedures until they are sure I understand what is going on. My nurse Alex (who, sadly, is leaving for a better paying job with another health organization) goes so far as to leave messages on all my various phones and then insists I call him back to make sure that his information has gotten to me. Dr. Bzowej has first-rate knowledge of the field and has a warm manner that is a great comfort during a trying time.
There are folks I know (a few in the local Hep C support group) who have not had experiences as positive as mine at CPMC. My wife claims that some of my experience is because I am a good person and that difficult people tend to have difficult experiences but she is not exactly unbiased in her analysis. Nonetheless, I have to say that the CPMC Hepatology Center and the people who staff it have been great to me and a huge reservoir of support for the past year. Let’s hope they only have to play that role for me until next May and that they never have to treat me again after that.
While waiting my managing nurse from the Roche drug trial (RO5024048 or RG7128 depending on which company you favor) AVB saw me and stopped by to chat me up. Actually she just sat down to ask how I was doing but we older guys can always dream. We talked for a bit and she asked if I was still on treatment, how much longer it was to last, if I was negative, whether I was still working and how I was coping in general. (I asked about her mother and she told me that she was fine, but probably needed to have somebody to talk to outside her family).
I gave her the lowdown on how I was doing – still on treatment, 54 weeks in 24 to go, I have been negative for 12 weeks now, I am still working 4 days a week and aside from feeling very tired all the time and stupid some of the time I felt I was doing okay. Like many people with experience in either undergoing or administering Hepatitis C treatment, she was surprised I am still working. She urged me to make sure that working was not taking too much out of me. She emphasized that if work wore me out too much, it could inhibit my ability to succeed at treatment and that I have to remember to think of my own health first. She reiterated something that she told me several times when I was in the experimental trial, that they would write the papers for a disability claim for me whenever I felt it was necessary. We talked briefly about our holiday plans; she patted my knee (see what I meant about chatting me up…) and went about her business.
I mention that meeting because it is characteristic of the vast majority of interactions I have had with the staff of the CPMC Hepatology Center. From the folks at the front desk to the people who draw blood, to the nurses, technicians and the doctors themselves, they all exhibit genuine concern and care for their patients. I am a relatively relaxed patient in most circumstances, but I have seen them show tremendous patience with difficult, disturbed, confused and unresponsive patients. They are gentle with the physically challenged, explain in great detail the nature of diseases and care, are helpful with the people for whom English is not a first language and generally kind and concerned with those under their treatment.
When they are dealing with me personally, I never feel that they are rushing me through our appointments. They answer my questions (and in fact are more than willing to grill me about how I am reacting and whether previously reported symptoms are still present) and explain medications and procedures until they are sure I understand what is going on. My nurse Alex (who, sadly, is leaving for a better paying job with another health organization) goes so far as to leave messages on all my various phones and then insists I call him back to make sure that his information has gotten to me. Dr. Bzowej has first-rate knowledge of the field and has a warm manner that is a great comfort during a trying time.
There are folks I know (a few in the local Hep C support group) who have not had experiences as positive as mine at CPMC. My wife claims that some of my experience is because I am a good person and that difficult people tend to have difficult experiences but she is not exactly unbiased in her analysis. Nonetheless, I have to say that the CPMC Hepatology Center and the people who staff it have been great to me and a huge reservoir of support for the past year. Let’s hope they only have to play that role for me until next May and that they never have to treat me again after that.
Saturday, August 21, 2010
Heading Towards Undetectable
As I walked in the door from doing some grocery shopping today I picked up the mail which included my latest set of lab results (10 days old actually, but still the most recent I have). My viral load number is down to 310 IU/ml. Yes! Woohoo, etc.!
Since my viral breakthrough my numbers have run 40,000; 10,000; 5,000; 1500; 990 and now 310. In ten weeks I have achieved a log 2.2 reduction in my viral load. With any luck, my test this Wednesday will put me very close to undetectable.
Yes, it’s getting ahead of myself to think about hitting undetectable (under 47IU/ml by this test method) but optimism is what fuels successful treatment and I remain resolutely optimistic.
So there, the graph is going down, the interferon is hunting out and killing the remnants of the Hepatitis C viral horde that was infesting my body and now I am going to go take some drugs and watch a terrible Sci-Fi channel movie with my wife.
I hope your evening is as exciting as mine…
Since my viral breakthrough my numbers have run 40,000; 10,000; 5,000; 1500; 990 and now 310. In ten weeks I have achieved a log 2.2 reduction in my viral load. With any luck, my test this Wednesday will put me very close to undetectable.
Yes, it’s getting ahead of myself to think about hitting undetectable (under 47IU/ml by this test method) but optimism is what fuels successful treatment and I remain resolutely optimistic.
So there, the graph is going down, the interferon is hunting out and killing the remnants of the Hepatitis C viral horde that was infesting my body and now I am going to go take some drugs and watch a terrible Sci-Fi channel movie with my wife.
I hope your evening is as exciting as mine…
Wednesday, June 16, 2010
Drummed Out of the Study
The confirmatory test results came in and I got the phone call from AVB formally telling me that I had a viral breakthrough and as per the protocols of the research trial must be taken off research treatment. I was asked to come in with my unused meds and my records.
I gathered together my bottles of Ribavirin both empty and full, my sharps container with all my used syringes, my unused vials of interferon in my insulated Roche fanny pack, my diary with records of the timing and amount of my daily doses of meds, loaded them into a bag and drove to the CPMC hepatology research center.
I trudged, gasping, up the hill to the hospital, rode alone in the clanking elevator to the third floor and was escorted into one of the closet-sized examining rooms. I stood in front of the desk of research coordinator AVB and unloaded my bag. The vials were counted, the pills were counted, the sharps container set aside for the later counting of the used syringes and my never-to-be completed dosing diary was confiscated from me. The Roche logo was ceremoniously cut off my insulated fanny-pack and it was tossed back to me. I was slapped on each cheek with the partially completed diary and as the theme song to Branded played in the background I was marched out of the room. As I walked down the hallway towards the elevator the nurses averted their eyes, the lab tech closed his door and the other patients behaved as though I did not exist. The walk back to my truck became another endless, gasping, uphill climb. What shreds of my dignity I had managed to preserve until that time broke down when I got into my vehicle and I sobbed uncontrollably over the steering wheel until I could gather what composure I could and drive back across the pitiless city to my cold, echoing home.
Tomorrow…The Rest of The Story.
I gathered together my bottles of Ribavirin both empty and full, my sharps container with all my used syringes, my unused vials of interferon in my insulated Roche fanny pack, my diary with records of the timing and amount of my daily doses of meds, loaded them into a bag and drove to the CPMC hepatology research center.
I trudged, gasping, up the hill to the hospital, rode alone in the clanking elevator to the third floor and was escorted into one of the closet-sized examining rooms. I stood in front of the desk of research coordinator AVB and unloaded my bag. The vials were counted, the pills were counted, the sharps container set aside for the later counting of the used syringes and my never-to-be completed dosing diary was confiscated from me. The Roche logo was ceremoniously cut off my insulated fanny-pack and it was tossed back to me. I was slapped on each cheek with the partially completed diary and as the theme song to Branded played in the background I was marched out of the room. As I walked down the hallway towards the elevator the nurses averted their eyes, the lab tech closed his door and the other patients behaved as though I did not exist. The walk back to my truck became another endless, gasping, uphill climb. What shreds of my dignity I had managed to preserve until that time broke down when I got into my vehicle and I sobbed uncontrollably over the steering wheel until I could gather what composure I could and drive back across the pitiless city to my cold, echoing home.
Tomorrow…The Rest of The Story.
Saturday, June 12, 2010
Bad News is Not So Bad 2
The Kindness of Doctors.
All of us who have being living in the American health care system have stories of the system letting people down. Doctors who sleepwalk through their job; insurance companies that find any way possible to deny care; nurses who are surly and hostile; hospitals that warehouse and ignore patients. After a lifetime of these kinds of events, you can become fairly cynical about the motives of healthcare professionals and about their dedication to their jobs and those under their care. The response that has been shown by the folks in the Roche RO5024048 study is the kind of event that can restore your faith in doctors.
In the first phone call to me informing me that I had had a viral breakthrough, AVB the study coordinator told me that I should ask Doctor B, the hepatologist, what she thought about my continuing treatment outside the study protocol. She said there were no guarantees, but I should certainly ask the question. I did not have a lot of confidence in Doctor B’s response. She is the lead doctor on the study. She gets her name on the research paper written about the study and in the interests of gaining research data for the study putting me off-protocol does not help her do that.
When we had our meeting just after the retest blood draws, she went over the viral breakthrough test results and mentioned that, subject to the results of these tests, I would be off the research treatments. AVB mentioned that I had a question for her and I asked about continuing treatment outside the study. Doctor B wanted to look at me test results and most particularly my dosing record. We she examined them in detail and saw that the breakthrough had occurred after 2 skipped doses of interferon due to low neutrophil counts and that I had been on a reduced interferon dose for several weeks before that, her whole personal affect changed. It was a subtle shift from researcher to doctor. She looked closely at my viral load numbers and saw that I had been undetectable for between 12 and 18 weeks even on the reduced dosing and that the dose reductions had all been due to low neutrophil counts (neutropenia). She asked me how I had been handling treatment and the treatment side effects. She told me that outside the research study protocol, she could administer drugs to combat both the neutropenia and the lowered hemoglobin counts. This would allow me to have a good chance to continue treatment on the full doses of interferon and ribavirin, thus giving me the best chance to clear the virus. She mentioned that other drugs were in the pipeline and nearing approval, particularly telaprevir, and did I think I wanted to wait or to continue with treatment now.
I told her I was leaning toward continuing treatment now, but wanted to talk to doctor C, my gastroenterologist before I made my final decision. She immediately told me that she would call him and let him know the latest situation and that I should talk to him and my primary care person as soon as possible so as to be able to get the treatment drug approval process under way with the insurance company as soon as possible. She also volunteered to oversee my treatment if I got a referral to her from my primary care doctor. She also volunteered to call him as well and let him know the situation.
To see the change in view from research scientist to medical doctor determining the best course of care for her patient caught me completely off-guard. It seemed to occur in a matter of an eye-blink. She became completely focused on letting me know the options and the possibilities. It gives me a great deal of confidence in having her as my hepatologist going forward.
My conversation with Doctor C was similar. He wanted to know if I felt I could handle treatment going forward. He also wanted me to know that the percentages of clearing after an event like this are not high. He also emphasized the availability of the drugs to treat the low blood cell counts and the fact that this would allow the higher doses of the Hep C Standard of Care drugs. But the decision is always in my hands.
I am going forward with treatment. It may take a few weeks to get everything set up, but the test results don’t come back until after my usual dosing schedule, so I will have one last dose in my from the Roche study before I forge ahead on my own.
Just as a final note and reality check, I had a meeting with my primary Doctor K. I have some thyroid function issues due to treatment and he needed to prescribe something for that and issue the referral to Doctor B for insurance company purposes. Ah, the reality of being back in the arms of my overworked primary care doctor. Listen, no chance, talk over me, of course, give me confusing instructions, par for the course. It’s good to know something things don’t change…
All of us who have being living in the American health care system have stories of the system letting people down. Doctors who sleepwalk through their job; insurance companies that find any way possible to deny care; nurses who are surly and hostile; hospitals that warehouse and ignore patients. After a lifetime of these kinds of events, you can become fairly cynical about the motives of healthcare professionals and about their dedication to their jobs and those under their care. The response that has been shown by the folks in the Roche RO5024048 study is the kind of event that can restore your faith in doctors.
In the first phone call to me informing me that I had had a viral breakthrough, AVB the study coordinator told me that I should ask Doctor B, the hepatologist, what she thought about my continuing treatment outside the study protocol. She said there were no guarantees, but I should certainly ask the question. I did not have a lot of confidence in Doctor B’s response. She is the lead doctor on the study. She gets her name on the research paper written about the study and in the interests of gaining research data for the study putting me off-protocol does not help her do that.
When we had our meeting just after the retest blood draws, she went over the viral breakthrough test results and mentioned that, subject to the results of these tests, I would be off the research treatments. AVB mentioned that I had a question for her and I asked about continuing treatment outside the study. Doctor B wanted to look at me test results and most particularly my dosing record. We she examined them in detail and saw that the breakthrough had occurred after 2 skipped doses of interferon due to low neutrophil counts and that I had been on a reduced interferon dose for several weeks before that, her whole personal affect changed. It was a subtle shift from researcher to doctor. She looked closely at my viral load numbers and saw that I had been undetectable for between 12 and 18 weeks even on the reduced dosing and that the dose reductions had all been due to low neutrophil counts (neutropenia). She asked me how I had been handling treatment and the treatment side effects. She told me that outside the research study protocol, she could administer drugs to combat both the neutropenia and the lowered hemoglobin counts. This would allow me to have a good chance to continue treatment on the full doses of interferon and ribavirin, thus giving me the best chance to clear the virus. She mentioned that other drugs were in the pipeline and nearing approval, particularly telaprevir, and did I think I wanted to wait or to continue with treatment now.
I told her I was leaning toward continuing treatment now, but wanted to talk to doctor C, my gastroenterologist before I made my final decision. She immediately told me that she would call him and let him know the latest situation and that I should talk to him and my primary care person as soon as possible so as to be able to get the treatment drug approval process under way with the insurance company as soon as possible. She also volunteered to oversee my treatment if I got a referral to her from my primary care doctor. She also volunteered to call him as well and let him know the situation.
To see the change in view from research scientist to medical doctor determining the best course of care for her patient caught me completely off-guard. It seemed to occur in a matter of an eye-blink. She became completely focused on letting me know the options and the possibilities. It gives me a great deal of confidence in having her as my hepatologist going forward.
My conversation with Doctor C was similar. He wanted to know if I felt I could handle treatment going forward. He also wanted me to know that the percentages of clearing after an event like this are not high. He also emphasized the availability of the drugs to treat the low blood cell counts and the fact that this would allow the higher doses of the Hep C Standard of Care drugs. But the decision is always in my hands.
I am going forward with treatment. It may take a few weeks to get everything set up, but the test results don’t come back until after my usual dosing schedule, so I will have one last dose in my from the Roche study before I forge ahead on my own.
Just as a final note and reality check, I had a meeting with my primary Doctor K. I have some thyroid function issues due to treatment and he needed to prescribe something for that and issue the referral to Doctor B for insurance company purposes. Ah, the reality of being back in the arms of my overworked primary care doctor. Listen, no chance, talk over me, of course, give me confusing instructions, par for the course. It’s good to know something things don’t change…
Wednesday, May 26, 2010
Why Research Trials put the P in Pain, the F in Fatigue and the M in Mental Breakdown.
The pitfall of participating in a research drug trial for Hepatitis C is that it will tax your mind and body more harshly than if you underwent the standard treatment or Standard of Care. The upside of participating in the trial is that you get a chance to take a drug that improves (sometimes drastically) you chance of clearing the virus. In order to do the research necessary and gather the data needed for the study, the subjects of the research are required to enter the study “naked” or without the support of drugs and supplements that can help mitigate the side effects of the anti-Hep C medications, at least until the study doctors decide to administer any such mitigating therapies. (The word “naked” refers to a baseball term reported by Hall of Famer Tony Gwynn of the San Diego Padres. He stated that during his time in the Major Leagues players who took the field without using amphetamines were said to be “playing naked”).
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.
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.
Saturday, March 13, 2010
Getting’ Sweaty
Hep C can certainly play havoc with your laundry schedule. This next piece of information may be revealing a bit more about our home life than my wife is comfortable with, but we generally change our sheets and such on a weekly basis. I know there are some of you out there who change linens on a daily basis. I also know there are some of you out there who change sheets somewhat less than on a weekly basis, some of you (you all know who you are) way less than that. Weekly has always seemed to be a reasonable interval to me.
No doubt that has something to do with my upbringing. My mother did our sheets on a weekly basis. The bed-changing day was a big day. We got to tear everything on our beds apart and drag the sheets down the hall to the bathroom where the laundry chute was. For those of you who never lived in a house with more than one floor or without a basement, a laundry chute is narrow chute running from the top floor down through the house, with doors on all intervening floors, that ends up in basement. Usually there is a box placed beneath it wherein all the laundry thrown down the chute collects and from there is dragged to the laundry room, sorted and washed. You threw your sheets down the chute, stuck your head in after and watched them slide down and end up in the box. When you are six or so, it is a great deal of fun. Sometimes, not that I ever did this of course, a large pile of clothes was left in the chute and an individual climbed into the chute and slid down into the pile of clothes – with a much harder landing than the individual supposed there would be.
Having this weekly event indelibly etched in my mind, my adult life was similarly patterned, except of course when I single and living in a warehouse and had not the motivation to launder bed linens so frequently. That being in the past, my wife and I have comfortably lived with a weekly pattern for some considerable time.
Interferon sure puts the kibosh on all that. Last night was a prime example. I injected in the early evening and we went to bed at our usual time of around 10:30. By midnight I was up and had sweated enough to soak the undershirt I was sleeping in. I changed, hanging the other to dry. By 3:00 I was awake and soaked through again so I changed again, hung again and went back to sleep. Waking at 4:30 to serious dampness again, I changed, hung and went back to bed; a three shirt night. Needless to say the sheets were a bit damp as well, at least on my side of the bed.
This used to happen each and every week a few months ago during the early weeks of treatment. I would change the sheets on Saturday, sweat like a pig that night, change the sheets on Sunday, and lather, rinse, repeat. You get the picture. Every week was a marathon of linen washing, not to mention the sheer number of t-shirts I went through. I haven’t been that intimate with a washing machine since my mother made me “help” her with the laundry when I was a lad.
Luckily all that had calmed down a bit and we were down to only having to change the linens maybe twice weekly. Until this dose. I wish my damn body would just adjust to these meds and give me some sense of consistency. Maybe it has to do with being off the experimental drug? But if I am going to go back to multiple washings and changings per week, we may need to invest in a dryer. Hanging all those sheets to dry every week makes us look like we are operating something more than just a single family home over here.
Really folks, its just me, getting sweaty with my meds, the old-fashioned way. And only 35 more weeks to go – maybe a new washer too…
No doubt that has something to do with my upbringing. My mother did our sheets on a weekly basis. The bed-changing day was a big day. We got to tear everything on our beds apart and drag the sheets down the hall to the bathroom where the laundry chute was. For those of you who never lived in a house with more than one floor or without a basement, a laundry chute is narrow chute running from the top floor down through the house, with doors on all intervening floors, that ends up in basement. Usually there is a box placed beneath it wherein all the laundry thrown down the chute collects and from there is dragged to the laundry room, sorted and washed. You threw your sheets down the chute, stuck your head in after and watched them slide down and end up in the box. When you are six or so, it is a great deal of fun. Sometimes, not that I ever did this of course, a large pile of clothes was left in the chute and an individual climbed into the chute and slid down into the pile of clothes – with a much harder landing than the individual supposed there would be.
Having this weekly event indelibly etched in my mind, my adult life was similarly patterned, except of course when I single and living in a warehouse and had not the motivation to launder bed linens so frequently. That being in the past, my wife and I have comfortably lived with a weekly pattern for some considerable time.
Interferon sure puts the kibosh on all that. Last night was a prime example. I injected in the early evening and we went to bed at our usual time of around 10:30. By midnight I was up and had sweated enough to soak the undershirt I was sleeping in. I changed, hanging the other to dry. By 3:00 I was awake and soaked through again so I changed again, hung again and went back to sleep. Waking at 4:30 to serious dampness again, I changed, hung and went back to bed; a three shirt night. Needless to say the sheets were a bit damp as well, at least on my side of the bed.
This used to happen each and every week a few months ago during the early weeks of treatment. I would change the sheets on Saturday, sweat like a pig that night, change the sheets on Sunday, and lather, rinse, repeat. You get the picture. Every week was a marathon of linen washing, not to mention the sheer number of t-shirts I went through. I haven’t been that intimate with a washing machine since my mother made me “help” her with the laundry when I was a lad.
Luckily all that had calmed down a bit and we were down to only having to change the linens maybe twice weekly. Until this dose. I wish my damn body would just adjust to these meds and give me some sense of consistency. Maybe it has to do with being off the experimental drug? But if I am going to go back to multiple washings and changings per week, we may need to invest in a dryer. Hanging all those sheets to dry every week makes us look like we are operating something more than just a single family home over here.
Really folks, its just me, getting sweaty with my meds, the old-fashioned way. And only 35 more weeks to go – maybe a new washer too…
Sunday, January 17, 2010
Week 2 Results: Giving It The Lowdown
I went in for the week 4 testing and got the week two results. Not that it was all beer and skittles for the testing. This particular blood draw and assorted other tests was to occur before my daily med dosing. To explain this, they gave me a sheet indicating what would occur during this type of test. What was not emphasized was that the sheet they gave me was an example of what could take place during a typical pre-dose test, not what would occur at the actual pre-dose test that I was to undergo.
So there I was at 8:00 a.m. instead of the usual 9:00 a.m., dazed and confused, with all my drugs, needles, vials, sharps container and studly fanny pack. Why, because I remembered seeing the 8:00 a.m. start time on the sheet, that’s why. The fact that I had misplaced the sheet – okay, I lost it – didn’t help matters. About 35 minutes later AVB came in to work and saw me sitting in the waiting room and asked why I was there so early. When I explained about the time on the sheet and the fact that it was pre-dose, she had the wonderful good grace to look embarrassed. She went on to explain that the sheet was a sample and that I was scheduled for my normal 9:00 a.m. appointment.
At any rate, after the sorting out and the trek back to the appointment room, they did the test sequence: 16 vials of blood (a new record), the 2 EKGs, the 2 blood pressure readings and the usual pulse and weight.
Two things stood out. My blood pressure was down to 133/85 from 155/102. AVB was very happy about this as she told me that after the last few blood pressure readings, the research scientists were going to require weekly appointments for the duration of my participation in the study unless my BP went down immediately. Well it did. I personally think that my BP started to go down the moment I got the viral load data from the first week of treatment. My BP had been going up steadily at every testing appointment and I think the data I got for the first week of treatment that showed the treatment was working reduced my stress level immediately.
The other is that my weight is not going down much at all. It has only dropped a few pounds since the start of the study. As one of the side effects of the meds is often some serious weight loss, this is somewhat of a good thing – to the researchers. After the usual holiday larding-on of poundage, I was thinking that with all the other unpleasant side effects, at least I was going to get some weight loss out of it, but nothing significant so far.
I also wonder about the amount of blood they take. I know they need the data on a wide ranged of blood contents but 16 vials of blood at even ½ oz. per vial adds up to 8 ounces of blood every two weeks – perhaps more if I am underestimating the size of the vials. Given that the Pegasys suppresses white blood cell production and the Ribavirin suppresses red blood cell production, does taking that much blood contribute to the potential anemia and low white blood cell counts? Does the test protocol itself contribute to the reported side effects of the drugs?
But now the news that matters: Viral Load.
My viral load was down to 1110 IU per ml. That is a log 4.06 reduction in viral load from the start of the study. Since the week-two blood draw was done early, that means that in 11 days the viral load went from 12,900,000 IU per ml. to 1110 IU per ml. The Mongol Horde is continuing to slaughter the viral peasants. Or perhaps Patton has blown through the defensive line and is wreaking havoc in the enemy rear areas. It doesn’t matter what the metaphor you use to visualize the effects, that fact is the treatment is working and I’m getting a serious viral response. AVB said again, that she would bet money I am on the Polymerase Inhibitor; that you just don’t see that kind of response on standard therapy.
I hope it holds up and I hope it transforms into a sustained viral response. I was a bad candidate for treatment with the viral load I started out with. If this stuff adds that much viral response to the standard therapy, it means a lot of folks with high viral loads and genotype 1 Hep C, have a lot better shot at clearing than they did before.
It is all far too early to talk like this, but I am excited as hell that this is happening and that, so far, I have been able to tolerate the therapy.
Let us hope that in the immediate future, that RG7128 or RO5024048 or the Polymerase Inhibitor or whatever you want to call it, keeps kicking viral ass.
So there I was at 8:00 a.m. instead of the usual 9:00 a.m., dazed and confused, with all my drugs, needles, vials, sharps container and studly fanny pack. Why, because I remembered seeing the 8:00 a.m. start time on the sheet, that’s why. The fact that I had misplaced the sheet – okay, I lost it – didn’t help matters. About 35 minutes later AVB came in to work and saw me sitting in the waiting room and asked why I was there so early. When I explained about the time on the sheet and the fact that it was pre-dose, she had the wonderful good grace to look embarrassed. She went on to explain that the sheet was a sample and that I was scheduled for my normal 9:00 a.m. appointment.
At any rate, after the sorting out and the trek back to the appointment room, they did the test sequence: 16 vials of blood (a new record), the 2 EKGs, the 2 blood pressure readings and the usual pulse and weight.
Two things stood out. My blood pressure was down to 133/85 from 155/102. AVB was very happy about this as she told me that after the last few blood pressure readings, the research scientists were going to require weekly appointments for the duration of my participation in the study unless my BP went down immediately. Well it did. I personally think that my BP started to go down the moment I got the viral load data from the first week of treatment. My BP had been going up steadily at every testing appointment and I think the data I got for the first week of treatment that showed the treatment was working reduced my stress level immediately.
The other is that my weight is not going down much at all. It has only dropped a few pounds since the start of the study. As one of the side effects of the meds is often some serious weight loss, this is somewhat of a good thing – to the researchers. After the usual holiday larding-on of poundage, I was thinking that with all the other unpleasant side effects, at least I was going to get some weight loss out of it, but nothing significant so far.
I also wonder about the amount of blood they take. I know they need the data on a wide ranged of blood contents but 16 vials of blood at even ½ oz. per vial adds up to 8 ounces of blood every two weeks – perhaps more if I am underestimating the size of the vials. Given that the Pegasys suppresses white blood cell production and the Ribavirin suppresses red blood cell production, does taking that much blood contribute to the potential anemia and low white blood cell counts? Does the test protocol itself contribute to the reported side effects of the drugs?
But now the news that matters: Viral Load.
My viral load was down to 1110 IU per ml. That is a log 4.06 reduction in viral load from the start of the study. Since the week-two blood draw was done early, that means that in 11 days the viral load went from 12,900,000 IU per ml. to 1110 IU per ml. The Mongol Horde is continuing to slaughter the viral peasants. Or perhaps Patton has blown through the defensive line and is wreaking havoc in the enemy rear areas. It doesn’t matter what the metaphor you use to visualize the effects, that fact is the treatment is working and I’m getting a serious viral response. AVB said again, that she would bet money I am on the Polymerase Inhibitor; that you just don’t see that kind of response on standard therapy.
I hope it holds up and I hope it transforms into a sustained viral response. I was a bad candidate for treatment with the viral load I started out with. If this stuff adds that much viral response to the standard therapy, it means a lot of folks with high viral loads and genotype 1 Hep C, have a lot better shot at clearing than they did before.
It is all far too early to talk like this, but I am excited as hell that this is happening and that, so far, I have been able to tolerate the therapy.
Let us hope that in the immediate future, that RG7128 or RO5024048 or the Polymerase Inhibitor or whatever you want to call it, keeps kicking viral ass.
Sunday, January 10, 2010
Week 1 Test Results: Get On The Good Foot
Well, I went in for the week two tests. The tests involved taking 12 vials of blood, 2 EKGs, 2 Blood pressure tests, I chilled urine from home, I warm sample while I was there. But this is just details, the real meat came when I got the viral load numbers from the first week of treatment: 4,260 IUs per milliliter. YES!!!
In only 7 Days of being on the treatment program my viral load went from 12,900,000 IUs per ml to 4,260! Now THAT is an effective Viral Response.
AVB said that – though the test is blind and we won’t know for sure for over a year – in her educated opinion those kind of results mean that I must be getting the RG7128 Polymerase inhibitor. She said that less than 5% of people getting the standard treatment have that kind of viral response and even those don’t usually show it so quickly.
She also stated that being able to share the results like this is unusual for a research study. Most of the studies have the results blinded as well as who is taking which meds, so that no individual in the test finds out specifically what their personal viral response is. In this one, the viral load data are not blinded so we can all find out how the virus in our bodies is responding to the drugs. My viruses are going down like foot soldiers in the face of the Mongol Horde.
I know that everyone has different responses to good news, some are overwhelmed, some are stoic, some respond quickly, others have a delayed reaction, in my case I could feel a sort of vibration running up and down my arms and legs and a stupid grin breaking out on my face. You spend a great deal of time and mental and emotional energy gearing up for any kind of serious treatment. In a case like this, you combine the normal buildup with a sort of brainwashing behavior to convince yourself that YOU are one of the 80% who are going to be getting the good stuff, the new stuff, the stuff that really works. Then you screen and are accepted and wait for the study to begin and then wait after it starts for the results to come in. The whole time you are keeping up this suspension of reality in your mind. Yes, I am getting the new drug and it will work as well in me as it did in the original phase 1 test subjects and it will be worth the risk of the side effects because, damn it, it is going to work.
The feeling that the results brought – Yes It Is Working! – is a combination of elation and relief. A log 3 drop in viral load in 7 days, when a log 2 drop by week 12 is the requirement to continue treatment, is overwhelming. I couldn’t wait to get home and call my wife - Which I did as soon as I got in the door. I didn’t trust myself to try to tell her the news while I was driving.
It’s a good thing I waited because as soon as I called her and told her and she got all excited, I started crying. She was so excited, so happy for me, so relieved to hear that it was working and that we were vastly probably on the test meds, it just thrilled me to be able to tell her something that would make her that happy.
It was such a relief to think that it seems to be working and that I am getting the test drug, which is the reason we all signed up for the study in the first place. We all wanted a better shot at clearing the virus than was offered by the standard therapy and now I know I have that chance. In the midst of the fatigue and heartburn and nausea and itching and all the rest, I know it’s because I have a great shot clearing.
That’s another thing that AVB said, “keep this result with you so that when you hit your walls in treatment, you can take it out and look at it and see why you are going through this.” I feel like framing it, but I know there are lots more results to follow and anything can happen. The one fly in the ointment so far is that my blood pressure remains naggingly high: 155 over 102 this time around. They want me to see my primary care physician about the blood pressure, because if it stays high it might affect drug dosage and other treatment parameters. So it’s off to Doctor K for another round of arguments about which drugs he may want to give me for blood pressure. Oh well, it’s all for a good cause.
But nothing can dampen these feelings. I’ve got a real shot at clearing. It’s never a guarantee for the long term, but it’s great start and I will clutch these results to my bosom as tight as I can until the next news comes. It is definitely time for dancing.
In only 7 Days of being on the treatment program my viral load went from 12,900,000 IUs per ml to 4,260! Now THAT is an effective Viral Response.
AVB said that – though the test is blind and we won’t know for sure for over a year – in her educated opinion those kind of results mean that I must be getting the RG7128 Polymerase inhibitor. She said that less than 5% of people getting the standard treatment have that kind of viral response and even those don’t usually show it so quickly.
She also stated that being able to share the results like this is unusual for a research study. Most of the studies have the results blinded as well as who is taking which meds, so that no individual in the test finds out specifically what their personal viral response is. In this one, the viral load data are not blinded so we can all find out how the virus in our bodies is responding to the drugs. My viruses are going down like foot soldiers in the face of the Mongol Horde.
I know that everyone has different responses to good news, some are overwhelmed, some are stoic, some respond quickly, others have a delayed reaction, in my case I could feel a sort of vibration running up and down my arms and legs and a stupid grin breaking out on my face. You spend a great deal of time and mental and emotional energy gearing up for any kind of serious treatment. In a case like this, you combine the normal buildup with a sort of brainwashing behavior to convince yourself that YOU are one of the 80% who are going to be getting the good stuff, the new stuff, the stuff that really works. Then you screen and are accepted and wait for the study to begin and then wait after it starts for the results to come in. The whole time you are keeping up this suspension of reality in your mind. Yes, I am getting the new drug and it will work as well in me as it did in the original phase 1 test subjects and it will be worth the risk of the side effects because, damn it, it is going to work.
The feeling that the results brought – Yes It Is Working! – is a combination of elation and relief. A log 3 drop in viral load in 7 days, when a log 2 drop by week 12 is the requirement to continue treatment, is overwhelming. I couldn’t wait to get home and call my wife - Which I did as soon as I got in the door. I didn’t trust myself to try to tell her the news while I was driving.
It’s a good thing I waited because as soon as I called her and told her and she got all excited, I started crying. She was so excited, so happy for me, so relieved to hear that it was working and that we were vastly probably on the test meds, it just thrilled me to be able to tell her something that would make her that happy.
It was such a relief to think that it seems to be working and that I am getting the test drug, which is the reason we all signed up for the study in the first place. We all wanted a better shot at clearing the virus than was offered by the standard therapy and now I know I have that chance. In the midst of the fatigue and heartburn and nausea and itching and all the rest, I know it’s because I have a great shot clearing.
That’s another thing that AVB said, “keep this result with you so that when you hit your walls in treatment, you can take it out and look at it and see why you are going through this.” I feel like framing it, but I know there are lots more results to follow and anything can happen. The one fly in the ointment so far is that my blood pressure remains naggingly high: 155 over 102 this time around. They want me to see my primary care physician about the blood pressure, because if it stays high it might affect drug dosage and other treatment parameters. So it’s off to Doctor K for another round of arguments about which drugs he may want to give me for blood pressure. Oh well, it’s all for a good cause.
But nothing can dampen these feelings. I’ve got a real shot at clearing. It’s never a guarantee for the long term, but it’s great start and I will clutch these results to my bosom as tight as I can until the next news comes. It is definitely time for dancing.
Thursday, January 7, 2010
One Week Later – The First Lost Weekend
The 1-week follow-up appointment was the first chance to get a benchmark on what I was experiencing. They allowed me to change my interferon injection to Thursday evening. This gives me an extra 12 hours or so for the side effects to quiet down before returning to work on Monday. They wanted me to take the pills in their presence again, so bringing food was still a must.
This time they only took 11 vials of blood, the 2 EKGs, blood pressure twice and a warm urine sample in addition to the chilled one I brought along from home (in the flashy Roche fanny pack, of course).
I gave a full report on the side effects I have been experiencing up to this point in the study. Low, but persistent, levels of nausea, fatigue, some irritability (I reported this, but others who know me are not so sure that the irritability is any worse than normal…), headaches, muscle aches, low energy, bouts of sadness and crying, some minor chills and most importantly to me - insomnia. AVB, the truly wonderful coordinator of the study, was quite thorough in questioning me about the side effects. She was also emphatic in letting me know that they would do whatever fit within the protocols to manage the side effects. One of the things she told me was that once the study started, the researchers at Roche would do a great deal to keep me in the study. They want the data and having people drop out of the study definitely reduces the statistical validity of the results. So a bit of the power shifts from the drug company to the study subject once the study is underway and this can be exploited to the benefit of the study subjects.
It was good to hear this and to realize as well that the people at California Pacific Medical Center (CPMC) who run these studies, are trying very hard to make the experience of treatment as non-debilitating as possible. They want to know if you are having problems and want to help you solve these problems as much as they can.
The high point of the visit was going over the test results from the previous visit. The tests in the first week were all done with blood that had been taken just prior to treatment beginning. So they served as a baseline for the various blood cell and enzyme levels moving forward through the treatment. The most important one to me was the viral load.
When I was first diagnosed with Hep C, I had a viral load of just over 4,000,000 International Units (IU) per milliliter (ml) of blood. This, I was told was considered a moderately high viral load. When I screened for this study 2 months ago, I reported a viral load of 6,270,000 IU per ml of blood, clearly an even higher viral load. The results from the week one test were 12,900,000 IU per ml of blood. This put me just below the high viral load segment of the Hep C population. Now AVB spent some time telling me that the viral load fluctuates all the time and can jump up and down by millions of IU from one day to the next. I realize that, and my own research both in books and on the internet, confirms what she told me. Nonetheless, I can’t say I was happy to see the progression from 4 million to 6 million to 12 million. I am very anxious to see the results at the next appointment as they will show the results from the first week of treatment and I really need to see a drop in the viral load to believe in this study.
The rest of the tests were fine. I have a decent amount of red and white blood cells which I will need to withstand the white blood cell suppression of the Interferon and the red blood cell suppression of the Ribavirin. The enzymes were fine and my heart is working okay as well. Perhaps too well as my blood pressure has been a bit high over the two appointments and they are a bit concerned about that.
All in all an okay visit. The next one is only a few days away (trust the Swiss to start a portion of a major drug study during the holidays – the worst time to try to you’re your subjects to have consistently timed dosing and for the researchers to get consistently spaced testing) and I will be getting the first week of treatment test results. I am both excited and terrified to get them.
This time they only took 11 vials of blood, the 2 EKGs, blood pressure twice and a warm urine sample in addition to the chilled one I brought along from home (in the flashy Roche fanny pack, of course).
I gave a full report on the side effects I have been experiencing up to this point in the study. Low, but persistent, levels of nausea, fatigue, some irritability (I reported this, but others who know me are not so sure that the irritability is any worse than normal…), headaches, muscle aches, low energy, bouts of sadness and crying, some minor chills and most importantly to me - insomnia. AVB, the truly wonderful coordinator of the study, was quite thorough in questioning me about the side effects. She was also emphatic in letting me know that they would do whatever fit within the protocols to manage the side effects. One of the things she told me was that once the study started, the researchers at Roche would do a great deal to keep me in the study. They want the data and having people drop out of the study definitely reduces the statistical validity of the results. So a bit of the power shifts from the drug company to the study subject once the study is underway and this can be exploited to the benefit of the study subjects.
It was good to hear this and to realize as well that the people at California Pacific Medical Center (CPMC) who run these studies, are trying very hard to make the experience of treatment as non-debilitating as possible. They want to know if you are having problems and want to help you solve these problems as much as they can.
The high point of the visit was going over the test results from the previous visit. The tests in the first week were all done with blood that had been taken just prior to treatment beginning. So they served as a baseline for the various blood cell and enzyme levels moving forward through the treatment. The most important one to me was the viral load.
When I was first diagnosed with Hep C, I had a viral load of just over 4,000,000 International Units (IU) per milliliter (ml) of blood. This, I was told was considered a moderately high viral load. When I screened for this study 2 months ago, I reported a viral load of 6,270,000 IU per ml of blood, clearly an even higher viral load. The results from the week one test were 12,900,000 IU per ml of blood. This put me just below the high viral load segment of the Hep C population. Now AVB spent some time telling me that the viral load fluctuates all the time and can jump up and down by millions of IU from one day to the next. I realize that, and my own research both in books and on the internet, confirms what she told me. Nonetheless, I can’t say I was happy to see the progression from 4 million to 6 million to 12 million. I am very anxious to see the results at the next appointment as they will show the results from the first week of treatment and I really need to see a drop in the viral load to believe in this study.
The rest of the tests were fine. I have a decent amount of red and white blood cells which I will need to withstand the white blood cell suppression of the Interferon and the red blood cell suppression of the Ribavirin. The enzymes were fine and my heart is working okay as well. Perhaps too well as my blood pressure has been a bit high over the two appointments and they are a bit concerned about that.
All in all an okay visit. The next one is only a few days away (trust the Swiss to start a portion of a major drug study during the holidays – the worst time to try to you’re your subjects to have consistently timed dosing and for the researchers to get consistently spaced testing) and I will be getting the first week of treatment test results. I am both excited and terrified to get them.
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