San Francisco has a thriving science and nerd community. A symptom of that is the wide array of science events that occur throughout the Bay Area every month. One of them is a monthly series titled “Science Café” in which a scientist or two is inveigled to come to a local café and talk for a few hours about their area of expertise. The most recent event was about Hepatitis C.
The Atlas Café was the scene and the scientists were Dr. Melanie Ott of the Gladstone Institute who researches the reproduction cycle of the Hep C virus and Dr. Todd Frederick a Hepatologist at the California Pacific Medical Center who treats Hep C patients. As a disclaimer I must mention that Dr. Frederick has examined, palpated and prescribed for me as part of the Polymerase Inhibitor study I was in.
Dr. Frederick gave an overview of the scope of the Hep C epidemic and the nature of current treatments available to combat it. He talked about the new protease inhibitors Telaprevir and Boceprevir that are awaiting FDA approval to be used in combination with interferon and ribavirin. He also gave a hint at possible future therapies using polymerase inhibitors with interferon and ribavirin and the possible combination of polymerase and protease inhibitors with ribavirin to create a treatment regimen that does not use interferon.
Dr. Ott gave us a basic yet thorough crash course in the reproductive cycle of the Hep C virus. She revealed its dependence on fat molecules in human cells and the promising area of research involved in using fat disabling compounds to interfere with the ability of the Hep C virus to reproduce itself. She also had a very cool animation that illustrated the reproductive cycle of the virus. She was quick to state that this was still basic, in the petri dish research and many years away from demonstrating efficacy in living organisms. It was fascinating stuff and the crowd of 30 was intent throughout both presentations.
A few of the questions asked in the Q & A were about the new compounds being developed and particularly about the issue of deciding whether to treat now or wait for new developments. Dr. Frederick clearly attempted to be balanced in his answers, but as a doctor involved in clinical trials of promising new compounds he is really exited about the possibilities of the new treatment combinations and he showed a bit of a bias towards waiting for new developments.
I respect Dr. Frederick’s viewpoint a great deal, but I think if you are seriously considering entering treatment, you need to consider a wide range of factors beyond the simple consideration of treatment outcome percentages. The condition of your general health, the condition of your liver, the amount of impact the disease is having on your quality of life, your family situation, your housing situation, your work situation, your insurance situation, your financial situation, the quality of support you can expect, all of these are important factors to consider in your decision. We still don’t know when the new drugs will be approved, how quickly they may be included in insurance company covered drug rosters, and how much they will cost (though we do know they will be expensive). So think it all through thoroughly and carefully before making a decision. While the future may be so bright we gotta wear shades, the shades might be very expensive and the future a bit further off than we would wish.
Showing posts with label Polymerase Inhibitor. Show all posts
Showing posts with label Polymerase Inhibitor. Show all posts
Tuesday, November 23, 2010
Wednesday, July 14, 2010
RO5024048 Side Effects Reconsidered
Now that I am out of the study and on the Standard of Care of Interferon and Ribavirin, I have been looking back at the first 8 to 12 weeks of treatment to try to determine whether the RO5024048 polymerase inhibitor had side effects of its own, whether it intensified the side effects of the interferon and Ribavirin or did both.
As I have mentioned before in this post, I believe I received the study drug at the beginning of treatment. My viral load dropped log 3.6 or so during the first week of the drug trial, which is almost unheard of on the standard of care. I have yet to drop a full log number from the peak viral load after my viral breakthrough 5 weeks ago now that I am on Standard of Care treatment. This just reinforces my belief that I was given RO5024048. That said, I do not know either how long I received the study drug, nor the size of the dose I received. I could have received 500 mg for 12 weeks, 1000 mg for 12 weeks, or 1000 mg for 8 weeks. In any case, I believe I received the polymerase inhibitor for either the first 8 weeks or the first 12 weeks of the study.
Looking at the list of side effects from the drugs involved I can draw some conclusions about the variation in them as the study went on.
Nausea: seems about the same throughout the study, mild but occasionally intrusive
Vomiting: only happened once
Diarrhea: definitely more serious at the beginning of the study and gradually disappeared as the study went on
Abdominal Pain: is more noticeable in the past 8 weeks
Anorexia: I don’t believe I had it
Dysgeusia: Didn’t notice it until about 8 weeks into treatment
Dry Mouth & Dyspepsia: consistently present throughout treatment
Anemia: seems worse now that I am on standard of care
Neutropenia: set in about 8 weeks into the study and has been consistently present since
Fatigue: seems a bit better since I have been on only interferon and Ribavirin
Chills: present the first several weeks of the trial has disappeared since
Fever: cyclic with the interferon injection schedule throughout the trial
Muscle Pain: intermittently present throughout treatment up to the present, also a general feeling of muscle weakness and fatigue after exertion
Joint Pain: present during the first few months of the trial not present now
Headache: present throughout the trial, more intense early in the trial and during the past 5 weeks
Rash: Never a big problem, but more noticeable during the first few months
Dizziness: only when taking some of the ancillary drugs
Anxiety: peaked during weeks 12-18
Depression: peaked during weeks 10-18
Insomnia: consistently present throughout treatment
Irritability: very irritable early in the trial, became a problem again in weeks 12-18, not a problem since introduction of antidepressants
Throat Pain: have not had any
Injection Site Redness: has not appeared at any time
Sinus Congestion: tends to occur during the first 4 or 5 days after each interferon injection
Alopecia: Hair loss consistent through first 20 weeks of treatment, has moderated since
Blurred Vision: not specifically noticed, but my close focusing ability deteriorated immediately at the start of the trial and the deterioration has remained
Eye Pain: have consistently had eye pain. It tends to happen when attempting to focus on something relatively close to my eyes. Generally moderates when I relax my eyes and my focus
Blood Sugar Problems: none
Back Pain: tightness occurs within a few days of every interferon injection
Laryngitis: none
Sore Throat: has occurred intermittently since the start treatment
Loss of Concentration: As the treatment progressed, my ability to concentrate noticeably declined at about 2:30 every day
Confusion: my short term memory has declined noticeably since the start of treatment
Liver Problems: I developed a hypothyroid condition starting at about week 10
As I look over the list of side effects I notice only a few that seem like they could be directly related to the RO5024048. Diarrhea is something that was only a problem during the time I was on the test drug. Chills have not really happened since the first 8 weeks either. Fatigue seems to have been amplified a bit by the polymerase inhibitor. Joint pain also seemed to disappear after the first 8-10 weeks of the trial. The rash problem was never more than an annoyance and was more extensive during the first 8 weeks. Irritability was definitely high at the beginning of the trial and has moderated since them, particularly since taking the antidepressants. The vision change happened right away, but I also noticed that there was a bit of change to it when I went back on full interferon doses 5 weeks ago.
Most of these are also side effects of the interferon and Ribavirin so the fact that they have moderated over time might just be that my body acclimated to the drugs. If I had to make the call, I would say that diarrhea, joint pain fatigue and rash were all either caused by or intensified by the RO5024048. It seems that the polymerase inhibitor is an easier to tolerate drug that the protease inhibitors such as Telaprevir and Boceprevir. The research coordinators I talked to all said that the Telaprevir study they had run had been much harder on the patients in terms of side effects (especially rash) than the RO5024048.
Given that it seems to hit the virus like the blitzkrieg hit Poland and that it appears to have a more moderate level of side effects than some of the other new drugs, RO5024048 seems to have a bright future fighting Hepatitis C.
As I have mentioned before in this post, I believe I received the study drug at the beginning of treatment. My viral load dropped log 3.6 or so during the first week of the drug trial, which is almost unheard of on the standard of care. I have yet to drop a full log number from the peak viral load after my viral breakthrough 5 weeks ago now that I am on Standard of Care treatment. This just reinforces my belief that I was given RO5024048. That said, I do not know either how long I received the study drug, nor the size of the dose I received. I could have received 500 mg for 12 weeks, 1000 mg for 12 weeks, or 1000 mg for 8 weeks. In any case, I believe I received the polymerase inhibitor for either the first 8 weeks or the first 12 weeks of the study.
Looking at the list of side effects from the drugs involved I can draw some conclusions about the variation in them as the study went on.
Nausea: seems about the same throughout the study, mild but occasionally intrusive
Vomiting: only happened once
Diarrhea: definitely more serious at the beginning of the study and gradually disappeared as the study went on
Abdominal Pain: is more noticeable in the past 8 weeks
Anorexia: I don’t believe I had it
Dysgeusia: Didn’t notice it until about 8 weeks into treatment
Dry Mouth & Dyspepsia: consistently present throughout treatment
Anemia: seems worse now that I am on standard of care
Neutropenia: set in about 8 weeks into the study and has been consistently present since
Fatigue: seems a bit better since I have been on only interferon and Ribavirin
Chills: present the first several weeks of the trial has disappeared since
Fever: cyclic with the interferon injection schedule throughout the trial
Muscle Pain: intermittently present throughout treatment up to the present, also a general feeling of muscle weakness and fatigue after exertion
Joint Pain: present during the first few months of the trial not present now
Headache: present throughout the trial, more intense early in the trial and during the past 5 weeks
Rash: Never a big problem, but more noticeable during the first few months
Dizziness: only when taking some of the ancillary drugs
Anxiety: peaked during weeks 12-18
Depression: peaked during weeks 10-18
Insomnia: consistently present throughout treatment
Irritability: very irritable early in the trial, became a problem again in weeks 12-18, not a problem since introduction of antidepressants
Throat Pain: have not had any
Injection Site Redness: has not appeared at any time
Sinus Congestion: tends to occur during the first 4 or 5 days after each interferon injection
Alopecia: Hair loss consistent through first 20 weeks of treatment, has moderated since
Blurred Vision: not specifically noticed, but my close focusing ability deteriorated immediately at the start of the trial and the deterioration has remained
Eye Pain: have consistently had eye pain. It tends to happen when attempting to focus on something relatively close to my eyes. Generally moderates when I relax my eyes and my focus
Blood Sugar Problems: none
Back Pain: tightness occurs within a few days of every interferon injection
Laryngitis: none
Sore Throat: has occurred intermittently since the start treatment
Loss of Concentration: As the treatment progressed, my ability to concentrate noticeably declined at about 2:30 every day
Confusion: my short term memory has declined noticeably since the start of treatment
Liver Problems: I developed a hypothyroid condition starting at about week 10
As I look over the list of side effects I notice only a few that seem like they could be directly related to the RO5024048. Diarrhea is something that was only a problem during the time I was on the test drug. Chills have not really happened since the first 8 weeks either. Fatigue seems to have been amplified a bit by the polymerase inhibitor. Joint pain also seemed to disappear after the first 8-10 weeks of the trial. The rash problem was never more than an annoyance and was more extensive during the first 8 weeks. Irritability was definitely high at the beginning of the trial and has moderated since them, particularly since taking the antidepressants. The vision change happened right away, but I also noticed that there was a bit of change to it when I went back on full interferon doses 5 weeks ago.
Most of these are also side effects of the interferon and Ribavirin so the fact that they have moderated over time might just be that my body acclimated to the drugs. If I had to make the call, I would say that diarrhea, joint pain fatigue and rash were all either caused by or intensified by the RO5024048. It seems that the polymerase inhibitor is an easier to tolerate drug that the protease inhibitors such as Telaprevir and Boceprevir. The research coordinators I talked to all said that the Telaprevir study they had run had been much harder on the patients in terms of side effects (especially rash) than the RO5024048.
Given that it seems to hit the virus like the blitzkrieg hit Poland and that it appears to have a more moderate level of side effects than some of the other new drugs, RO5024048 seems to have a bright future fighting Hepatitis C.
Monday, April 19, 2010
New Developments in Roche RO5024048 Combination Treatment Drug Trial
I went in last Friday for my week 18 tests. Before we started the usual blood draws, EKG and vital signs routine, there was a new development. There is a change to the study protocols that required signing a new consent form. There had been a previous, minor, change that necessitated my signing a one-sheet addendum to the original consent form, but this change involved major changes and resulted in my having to agree to changes throughout the agreement. The new protocol is very good news for the safety of the drug and offers an additional chance for study under-responders.
What is happening is that Roche is adding another treatment arm to the study. In this arm “The safety and efficacy of open-label HCV polymerase inhibitor Prodrug (RO5024048) in combination with PEG-INF and RBV in the subset of patients who only received currently approved combination of SOC in the main study and who did not demonstrate an early virologic response (Treatment Failures) will be evaluated.” What this means is that the people in the arm of the study that received the SOC (pegylated interferon and ribavirin) and did not receive the experimental drug and who did not have a log 210 reduction in virus after 12 weeks or who had virus still in the blood after 24 weeks and thus had to stop taking all medications will get a shot at receiving the full triple-drug therapy.
The new arm (Group F) will take RO5024048 1000mg twice daily for 24 weeks in combination with the SOC of weekly Pegasys (interferon) and daily Copegus (ribavirin), followed by an additional 24 weeks of the SOC (Pegasys and Copegus). The study will be open-label meaning patients and doctors will know the medications they are receiving.
The best aspect of this new arm being added to the study is that the folks who were in the placebo arm of the original study and did not respond, now have a shot at getting a drug whose initial results against the HCV virus are very positive. One of the problems with experimental studies, particularly early stage studies, is that there is always an arm of the study that does not receive the experimental drug and thus you are potentially both entering a difficult treatment process and giving up your treatment-naïve status and not getting anything but the treatment you would have received outside of the study. Here, even the folks in the placebo arm who did not respond, will get a chance to attack their Hep C with cutting-edge treatment.
The other positive news is that the safety issues they were testing for regarding possible kidney damage have shown themselves to be of lesser importance. One of the reasons they are adding this arm to the study, I was told by my research coordinator, was that the kidney problems were not showing up in the test subjects so far in the study. That is one of the reasons that the length of treatment in the Group F arm will be extended to 24 weeks from the 12 weeks of treatment the rest of the study arms received. The researchers believe they can give the drug for longer periods without undue fear of kidney damage.
There is another potential development in the study as well. There is a petition in front of the study governors to allow test subjects in the low dose arm (Group A) of the study who had rebounds in their HCV Viral Load amounts to join the Group F arm as well. Group A received 500mg of RO5024048 twice a day, the other arms receiving the experimental drug either received higher doses (1000mg twice daily) or a more concentrated dose (1000mg once daily). There is apparently some thought that the dose in Group A might not have been powerful enough to have the desired effect on the virus and that by including those patients in Group F, they would find out if a higher dose had the desired effect even on people who had been already treated with the RO5024048.
The developments in the trial seem all to the positive to me. People who did not respond to the SOC placebo treatment, get a chance to actually receive the experimental triple-drug therapy, the kidney damage issues seem to be less of a concern than originally thought and finally even those who did not respond to a low dose of the drug might get a chance to see if a high dose can smack down their Hep C.
What is happening is that Roche is adding another treatment arm to the study. In this arm “The safety and efficacy of open-label HCV polymerase inhibitor Prodrug (RO5024048) in combination with PEG-INF and RBV in the subset of patients who only received currently approved combination of SOC in the main study and who did not demonstrate an early virologic response (Treatment Failures) will be evaluated.” What this means is that the people in the arm of the study that received the SOC (pegylated interferon and ribavirin) and did not receive the experimental drug and who did not have a log 210 reduction in virus after 12 weeks or who had virus still in the blood after 24 weeks and thus had to stop taking all medications will get a shot at receiving the full triple-drug therapy.
The new arm (Group F) will take RO5024048 1000mg twice daily for 24 weeks in combination with the SOC of weekly Pegasys (interferon) and daily Copegus (ribavirin), followed by an additional 24 weeks of the SOC (Pegasys and Copegus). The study will be open-label meaning patients and doctors will know the medications they are receiving.
The best aspect of this new arm being added to the study is that the folks who were in the placebo arm of the original study and did not respond, now have a shot at getting a drug whose initial results against the HCV virus are very positive. One of the problems with experimental studies, particularly early stage studies, is that there is always an arm of the study that does not receive the experimental drug and thus you are potentially both entering a difficult treatment process and giving up your treatment-naïve status and not getting anything but the treatment you would have received outside of the study. Here, even the folks in the placebo arm who did not respond, will get a chance to attack their Hep C with cutting-edge treatment.
The other positive news is that the safety issues they were testing for regarding possible kidney damage have shown themselves to be of lesser importance. One of the reasons they are adding this arm to the study, I was told by my research coordinator, was that the kidney problems were not showing up in the test subjects so far in the study. That is one of the reasons that the length of treatment in the Group F arm will be extended to 24 weeks from the 12 weeks of treatment the rest of the study arms received. The researchers believe they can give the drug for longer periods without undue fear of kidney damage.
There is another potential development in the study as well. There is a petition in front of the study governors to allow test subjects in the low dose arm (Group A) of the study who had rebounds in their HCV Viral Load amounts to join the Group F arm as well. Group A received 500mg of RO5024048 twice a day, the other arms receiving the experimental drug either received higher doses (1000mg twice daily) or a more concentrated dose (1000mg once daily). There is apparently some thought that the dose in Group A might not have been powerful enough to have the desired effect on the virus and that by including those patients in Group F, they would find out if a higher dose had the desired effect even on people who had been already treated with the RO5024048.
The developments in the trial seem all to the positive to me. People who did not respond to the SOC placebo treatment, get a chance to actually receive the experimental triple-drug therapy, the kidney damage issues seem to be less of a concern than originally thought and finally even those who did not respond to a low dose of the drug might get a chance to see if a high dose can smack down their Hep C.
Sunday, January 24, 2010
Week 4 Results: The Future’s So Bright….
The Polymerase Inhibitor seems like a very promising compound, at least from the viewpoint of someone infected with Hepatitis C.
I do not know officially that I am getting the RO5024048 experimental drug. My assumption is based entirely on the viral load results and the fact that AVB, the study coordinator has told me that her 14 years of experience in managing trials and watching the results of those trials, she has not seen Viral Response at that level unless there is something acting in addition the standard Interferon and Ribavirin.
But given my results and her gut feeling, I think that I am receiving it and that it is working tremendously well at inhibiting the reproduction of the Hep C virus.
My viral load after 28 days in treatment is now at a level of 195 IU per milliliter of blood.
195 viruses per milliliter is a log 4.82 reduction from the baseline level at the beginning of the test. It is also beginning to get near the non-detectable level that indicates the body is clearing the virus from the blood.
This is great news as it might mean number of things moving forward if these results hold up. It could mean a much higher percentage of patients with a sustained viral response (SVR). It could mean that the treatment time could be reduced in length which would mean a major reduction in the level of suffering endured by patients undergoing treatment. It could mean variations in the levels of drugs administered which might again have an effect on the level of side effects that must be endured.
There is even a study in the proposal stage that would involve treatment using a combination of Polymerase and Protease inhibitors and no Interferon or Ribavirin. If that sort of treatment became a reality, then future patients with Hep C might never have to undergo the joys of Interferon and Ribavirin side effects.
All of this is extremely speculative and primarily the result of me being way too happy and perhaps overreacting to my person viral load results. But considering where Hep C treatment was 10 years ago, and the exciting new avenues of research opening up seemingly on a weekly basis, the future is indeed so bright we gotta wear shades.
I do not know officially that I am getting the RO5024048 experimental drug. My assumption is based entirely on the viral load results and the fact that AVB, the study coordinator has told me that her 14 years of experience in managing trials and watching the results of those trials, she has not seen Viral Response at that level unless there is something acting in addition the standard Interferon and Ribavirin.
But given my results and her gut feeling, I think that I am receiving it and that it is working tremendously well at inhibiting the reproduction of the Hep C virus.
My viral load after 28 days in treatment is now at a level of 195 IU per milliliter of blood.
195 viruses per milliliter is a log 4.82 reduction from the baseline level at the beginning of the test. It is also beginning to get near the non-detectable level that indicates the body is clearing the virus from the blood.
This is great news as it might mean number of things moving forward if these results hold up. It could mean a much higher percentage of patients with a sustained viral response (SVR). It could mean that the treatment time could be reduced in length which would mean a major reduction in the level of suffering endured by patients undergoing treatment. It could mean variations in the levels of drugs administered which might again have an effect on the level of side effects that must be endured.
There is even a study in the proposal stage that would involve treatment using a combination of Polymerase and Protease inhibitors and no Interferon or Ribavirin. If that sort of treatment became a reality, then future patients with Hep C might never have to undergo the joys of Interferon and Ribavirin side effects.
All of this is extremely speculative and primarily the result of me being way too happy and perhaps overreacting to my person viral load results. But considering where Hep C treatment was 10 years ago, and the exciting new avenues of research opening up seemingly on a weekly basis, the future is indeed so bright we gotta wear shades.
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.
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