Huge multi-national pharmaceutical companies, aka Big Pharma, tend to have a bad reputation among many of the people who study health care issues or are in need of exotic drugs to treat diseases. These companies are often portrayed as greedy, rapacious, and insensitive and that’s just how they are described in polite company. While I understand where the opinions of these folks come from, from the point of view of a Hepatitis C sufferer, my opinion is a bit different.
I am somewhat familiar with the issues of drug research. Several folks I know are gene-splicers involved in medical research working at companies as large as Genentech down to small, privately held startup level concerns. My wife has a science background (MS level) and has worked for research companies and I have a lifelong interest in scientific issues and some familiarity with the protocols and problems of medical research. I admit I have tended to be on the side of the folks with low opinions of Big Pharma in the past, due in no small part to the insider stories I have heard over the years. This has changed since I was diagnosed with Hepatitis C and changed even more so since I entered treatment.
There are two reasons for the change. The first is that private sector drug companies are the drivers for research into new ways to treat Hep C. The taxpayer-funded National Institutes of Health (NIH) does not exactly throw money at Hep C. For instance, while there are estimated to be 4,000,000 people in the USA infected with Hepatitis C compared to a bit over 1,000,000 infected with HIV, the NIH spends only about $20 per patient on Hep C research versus roughly $2,750 per patient for HIV. They have also been known to siphon off bits of that pathetically low amount and send it to other research areas. On the other hand, recognizing that 4,000,000 people is a large market for their products, the major drug companies are funding a wide and ever-increasing range of studies to discover new and more effective treatments for Hepatitis C. This is an example of how the profit motive can result in far more benefits for disease sufferers than waiting around for government funded research projects to begin to address the issues.
The other reason is the benefits that I and other people undergoing Hepatitis C treatment have received from the drug companies researching and selling the drugs to treat the disease. When I moved from treatment on the RO5024048 study to out-patient standard of care treatment, there was a gap between the time when I left the study to the time when my treatment and prescription authorizations cleared the insurance company bureaucracy. The people at Roche provided some samples of both Ribavirin and interferon that allowed me to continue treatment without missing any doses as the paperwork cleared. I don’t know whether the samples “fell off the truck” or are routinely provided so that the people at the Hepatology Center can deal with just such issues as mine, but they were a godsend. Likewise when my prescription for procrit fell through the cracks at the specialty pharmacy for a week and it looked like I might have to drastically cut my Ribavirin dose until it arrived, a sample of procrit was also provided by a drug company to give me the chance to address my red blood count issues more quickly and keep me on the maximum dose of Ribavirin.
Big Pharma also has programs to assist uninsured and underinsured patients to receive the treatment they need. There are programs directly from the companies themselves as well as foundation programs funded in part by drug companies that provide treatment almost entirely for free for low-income patients. One of the people in my support group had their entire treatment paid for this way. The only time they had to pay was if a part of the treatment was done outside of the California Pacific Medical Center.
While Big Pharma is far from perfect, they are the folks that those of us infected with Hep C have to look towards for improvements in treatment. Until the public profile of the disease is raised and the government actually begins to dedicate serious money to research, it is the private sector that will drive the research into new treatments. We 4,000,000 potential customers are all saying, you get something that is highly effective and we will push the insurance companies to get it to us and to cover it.
Showing posts with label leaving the research trial. Show all posts
Showing posts with label leaving the research trial. Show all posts
Monday, July 12, 2010
Sunday, June 20, 2010
The Cost of Treatment
Going on the Standard of Care Hepatitis C Treatment of Pegylated Interferon and Ribavirin that is paid for via your insurance plan or out of your own pocket, causes a major restructuring of you financial budgets. The meds to treat Hep C are not cheap. Pegylated interferon is a relatively new drug and thus does not have a generic version available. It is available only via brand name preparations. As anyone dealing with drugs knows, brand name is always more expensive than generic. Ribavirin is a bit of a different story. It is available in generic form as well as brand name and thus is available at a lower cost, but that lower cost is not necessarily cheap.
None of this is news to anyone who approaches the treatment through their hepatologist and insurance company. For those folks, the cost of treatment has been a major component of their decision whether or not to even begin the process. For people who have been involved in research trials where the drugs are provided free of charge by the drug company sponsoring the research plan, it is a rude shock. Complicating the situation is the fact that people entering treatment through their insurance company or via their hepatologist have been thinking long and hard about the cost of the treatment, they have been making plans as to how to pay for it. They may have contacted the drug companies if they are underinsured or uninsured to see whether they qualify for any financial assistance. In short they have been thinking about it seriously for a considerable time.
When you suddenly make the decision to continue treatment through you insurance or out of your own pocket in order to try to continue the gains you have made during the research trial, the cost issue is thrust upon you without a real chance for reflection and planning. You find out that Pegylated interferon is runs up to $550 per dose; That a months supply of Ribavirin might be $1000; making the monthly bill over $3000 if you are paying for it yourself. Even if your insurance is paying for some of the cost of the drugs, it might not be for the same prescription co-payment you have grown used to with the other drugs you have received over the years.
In my case, I am already on 5 drugs to manage the side effects of the interferon and ribavirin, they are Celexa, Trazadone, Levothyroxin, Ativan and Tramadol. I don’t take all of them every day and the scrips run for various lengths but it is safe to say that the co-payment bill is $60 per month for those 5. As we have hustled to continue the Standard of Care treatment without interruption to the dosing schedule, we have heard several different numbers for the co-payments for Ribavirin and Pegasys (which is the drug that is on my insurance company formulary). It started out being a flat 20% of cost or $450 per month, then was reported to be $165 per month, then a test payment run by the specialty pharmacy supplying the Pegasys reported it at $250 per 4-week supply. The ribavirin will be covered at the standard $15 per prescription copay. So what it looks like is that it will cost from $325 per month for the 7 drugs in question up to $525 per month under the worst-case scenario.
In easy to understand terms, it means from $3900 to $6300 per year for the drugs that will give me at best a 40% chance to clear the virus; about $100 per percentage point of potential success. And this does not include any additional drugs which may be prescribed to counteract the low blood cell counts caused by the interferon and ribavirin. This is yet another reason that some people wait years to undergo treatment. It can be hugely expensive.
More on the personal costs in upcoming posts.
None of this is news to anyone who approaches the treatment through their hepatologist and insurance company. For those folks, the cost of treatment has been a major component of their decision whether or not to even begin the process. For people who have been involved in research trials where the drugs are provided free of charge by the drug company sponsoring the research plan, it is a rude shock. Complicating the situation is the fact that people entering treatment through their insurance company or via their hepatologist have been thinking long and hard about the cost of the treatment, they have been making plans as to how to pay for it. They may have contacted the drug companies if they are underinsured or uninsured to see whether they qualify for any financial assistance. In short they have been thinking about it seriously for a considerable time.
When you suddenly make the decision to continue treatment through you insurance or out of your own pocket in order to try to continue the gains you have made during the research trial, the cost issue is thrust upon you without a real chance for reflection and planning. You find out that Pegylated interferon is runs up to $550 per dose; That a months supply of Ribavirin might be $1000; making the monthly bill over $3000 if you are paying for it yourself. Even if your insurance is paying for some of the cost of the drugs, it might not be for the same prescription co-payment you have grown used to with the other drugs you have received over the years.
In my case, I am already on 5 drugs to manage the side effects of the interferon and ribavirin, they are Celexa, Trazadone, Levothyroxin, Ativan and Tramadol. I don’t take all of them every day and the scrips run for various lengths but it is safe to say that the co-payment bill is $60 per month for those 5. As we have hustled to continue the Standard of Care treatment without interruption to the dosing schedule, we have heard several different numbers for the co-payments for Ribavirin and Pegasys (which is the drug that is on my insurance company formulary). It started out being a flat 20% of cost or $450 per month, then was reported to be $165 per month, then a test payment run by the specialty pharmacy supplying the Pegasys reported it at $250 per 4-week supply. The ribavirin will be covered at the standard $15 per prescription copay. So what it looks like is that it will cost from $325 per month for the 7 drugs in question up to $525 per month under the worst-case scenario.
In easy to understand terms, it means from $3900 to $6300 per year for the drugs that will give me at best a 40% chance to clear the virus; about $100 per percentage point of potential success. And this does not include any additional drugs which may be prescribed to counteract the low blood cell counts caused by the interferon and ribavirin. This is yet another reason that some people wait years to undergo treatment. It can be hugely expensive.
More on the personal costs in upcoming posts.
Thursday, June 17, 2010
The Rest of the Story…
What really happened when I formally left the study was, needless to say, much less histrionic, though it had its own brand of drama.
I got a call from AVB in the morning announcing the lab results were back, I had a confirmed viral breakthrough and I had to stop taking the meds belonging to the research study. She was working on getting some medical samples from the Roche representative that would bridge me over until my insurance authorizations went through and my prescriptions for Pegasys and Ribavirin were filled. She told me that when she had some news she would contact me and then I could bring my old meds in and get the bridge meds from her.
Sure enough the call came through at 3:00 p.m. that same day while I was in an event planning meeting. She had arranged the bridge meds and could I get to the hepatology research center no later than 4:30 to pick them up and drop off the old stuff. I was without transportation, but promised to do my best. I excused myself from the meeting by telling everyone I had to go pick up drugs and started walking quickly the 1 ½ miles to my home.
As anyone in San Francisco who relies on the Municipal Railroad system, or MUNI as it is infamously known, schedules are something that are mostly honored in their breach. I walked the distance home along a MUNI route without seeing a bus during the entire 40 minutes. I grabbed my meds, diary, sharps container and fanny pack jumped in my trusty pickup and headed back toward the research center. I went back over the same route and still did not see a bus by the time I had to turn off on other streets.
When I got to the center, I met AVB and she collected my old meds and other materials. I actually got to keep my Roche Logowear. She explained that she had samples of Ribavirin and Pegasys that should tide me over until the insurance authorizations cleared and that she was on her way to Dr. B’s office (who had stayed late to be available) to get the necessary documents signed. She returned with the meds and with the gentleman who would be the nurse coordination for my treatment with Dr. B. She introduced us; he gave me his contact info and he told me he would be in touch with a day or two to follow up on the authorization status. He gave me some lab test request sheets and a preliminary schedule of when I needed to get lab tests done. The he shook my hand and, wished me good luck and said he would contact me soon.
AVB then went over the kit of materials that is given to outpatient treatment subjects and showed me how to use the preloaded syringes that the Pegasys came in. No more vials to fill syringes from, Yay!
At that point she wished me good luck, said that she was still available as well if I had questions or needed to go over any of my previous history on the study. She choked up a bit. I choked up a bit. I thanked her for all the efforts she had made on my behalf, she said don’t worry about that now, just work on having a successful treatment. We shook hands and she put her arm on my shoulder and walked me down the hall to say good-bye.
And that’s the Rest Of The Story…(apologies to Paul Harvey)
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.
Monday, June 14, 2010
Bad/Good News 3 – Participating in Future Research Trials
The final item that concerned me about moving out of the research trial and getting treatment through standard channels is one that will concern anyone in the same situation. Does making this decision preclude you from participating in future research trials?
I specifically asked AVB, the research coordinator about that issue. I framed the question to her that “since I am dropping out of the trial to pursue treatment outside the protocols and on my own…” She immediately cut me off at that point. Her statement to me was that I was not dropping out of the study. I was consulting with the medical personnel in the study and my own doctors and making a decision about what was in my best interests as a patient. This decision transcends the study and is about what is best for the patient in their attempt to fight their disease as effectively as possible.
She stated that I have followed all the protocols, come to all appointments, kept accurate records and come in for additional testing as the situation required. Patients who have done these things are considered to be good research subjects. That fact that patients who have been reliable subjects make decisions to pursue courses in the best interests of their long-term health does not preclude them from being included in further studies. She stated that given a history of positive participation in previous trials she would be inclined to include them in future studies for which they passed the screening.
She mentioned that their have been people who have dropped out of this and other studies she has been involved in either due to viral breakthroughs, inability to tolerate side effects or inability to follow the study protocols. Some of these patients have cut off all communication with the study, not returning phone calls, emails and letters and not returning the unused study medications. In some cases they cannot be found and their ongoing health cannot be determined. These are the sorts of patients she would not include in any future trial. They are not reliable subjects.
This was a load off my mind as my percentages are low to clear the virus on continued treatment. While Telaprevir will no doubt be approved soon, there is not guarantee that I would succeed with it either and having the possibility to participate in trials of future promising treatments is another arrow in the quiver, so to speak.
The only real downside is that I am no longer treatment-naive…
I specifically asked AVB, the research coordinator about that issue. I framed the question to her that “since I am dropping out of the trial to pursue treatment outside the protocols and on my own…” She immediately cut me off at that point. Her statement to me was that I was not dropping out of the study. I was consulting with the medical personnel in the study and my own doctors and making a decision about what was in my best interests as a patient. This decision transcends the study and is about what is best for the patient in their attempt to fight their disease as effectively as possible.
She stated that I have followed all the protocols, come to all appointments, kept accurate records and come in for additional testing as the situation required. Patients who have done these things are considered to be good research subjects. That fact that patients who have been reliable subjects make decisions to pursue courses in the best interests of their long-term health does not preclude them from being included in further studies. She stated that given a history of positive participation in previous trials she would be inclined to include them in future studies for which they passed the screening.
She mentioned that their have been people who have dropped out of this and other studies she has been involved in either due to viral breakthroughs, inability to tolerate side effects or inability to follow the study protocols. Some of these patients have cut off all communication with the study, not returning phone calls, emails and letters and not returning the unused study medications. In some cases they cannot be found and their ongoing health cannot be determined. These are the sorts of patients she would not include in any future trial. They are not reliable subjects.
This was a load off my mind as my percentages are low to clear the virus on continued treatment. While Telaprevir will no doubt be approved soon, there is not guarantee that I would succeed with it either and having the possibility to participate in trials of future promising treatments is another arrow in the quiver, so to speak.
The only real downside is that I am no longer treatment-naive…
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, June 9, 2010
Bad News Is Not So Bad News 1
The situation of having a viral breakthrough and the decisions made about treatment in light of that breakthrough is a good illustration of the differences between undergoing treatment under the protocols of a drug trial and undergoing treatment under the Standard Of Care supervised by a hepatologist. There is a bit about that is this post.
I met with Doctor B, the doctor in charge of the Roche RO5024048 study today. I was getting the blood tests to confirm that I indeed had a viral breakthrough and met with her as part of that process. Given that it would be highly unusual for the tests to show that I was again undetectable, I am going to be dropped from treatment under the protocols of the study (the protocol is that if you show any viral activity at week 24, treatment is suspended). That being the case, I asked Dr. B what her opinion was of the value of my continuing outside the study using the standard interferon and ribavirin treatment.
She was initially noncommittal and wanted to see my viral load history and my dosing history for the Pegasys and ribavirin. She saw that my viral load had been undetectable for 18 weeks. She also saw that I had spent 5 weeks on a ¾ dose of interferon, had skipped 2 doses completely due to low neutrophil counts and had just resumed injecting at a ½ dose level. I had also been on a reduced dose of ribavirin for the past 7 weeks. When she saw that the breakthrough had occurred after the two skipped doses of interferon, she warmed to the idea. She asked me how I have been tolerating the treatment. I told her I had a lot of the usual side effects but that the addition of an antidepressant had really made a huge difference in my mental outlook and my mental energy. Then she pointed out the reasons she thought it might be worthwhile to pursue.
If you undergo treatment under normal circumstances, you can be prescribed drugs to reduce the loss of neutrophils (neutropenia). You can also be prescribed meds to help with the hemoglobin loss as well. They don’t do this in drug trials because they are trying to control the number of variables as well as to determine the effect the study meds are having with the interference of other drugs. Being able to take these additional medications means that the full doses of interferon and ribavirin can be maintained for the longest possible time during the course of treatment. It goes without saying that this increases the chances for a successful outcome.
In my case for about 40 % of the time I have been in the study, I have been taking reduced doses of just those standard medicines that have proven so successful against Hep C. Moving forward with treatment under full doses means I have a chance to reach a successful outcome. Given the 6 months I have spent on this so far, I don’t see why I shouldn’t grab that chance.
I met with Doctor B, the doctor in charge of the Roche RO5024048 study today. I was getting the blood tests to confirm that I indeed had a viral breakthrough and met with her as part of that process. Given that it would be highly unusual for the tests to show that I was again undetectable, I am going to be dropped from treatment under the protocols of the study (the protocol is that if you show any viral activity at week 24, treatment is suspended). That being the case, I asked Dr. B what her opinion was of the value of my continuing outside the study using the standard interferon and ribavirin treatment.
She was initially noncommittal and wanted to see my viral load history and my dosing history for the Pegasys and ribavirin. She saw that my viral load had been undetectable for 18 weeks. She also saw that I had spent 5 weeks on a ¾ dose of interferon, had skipped 2 doses completely due to low neutrophil counts and had just resumed injecting at a ½ dose level. I had also been on a reduced dose of ribavirin for the past 7 weeks. When she saw that the breakthrough had occurred after the two skipped doses of interferon, she warmed to the idea. She asked me how I have been tolerating the treatment. I told her I had a lot of the usual side effects but that the addition of an antidepressant had really made a huge difference in my mental outlook and my mental energy. Then she pointed out the reasons she thought it might be worthwhile to pursue.
If you undergo treatment under normal circumstances, you can be prescribed drugs to reduce the loss of neutrophils (neutropenia). You can also be prescribed meds to help with the hemoglobin loss as well. They don’t do this in drug trials because they are trying to control the number of variables as well as to determine the effect the study meds are having with the interference of other drugs. Being able to take these additional medications means that the full doses of interferon and ribavirin can be maintained for the longest possible time during the course of treatment. It goes without saying that this increases the chances for a successful outcome.
In my case for about 40 % of the time I have been in the study, I have been taking reduced doses of just those standard medicines that have proven so successful against Hep C. Moving forward with treatment under full doses means I have a chance to reach a successful outcome. Given the 6 months I have spent on this so far, I don’t see why I shouldn’t grab that chance.
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