I am a 57-year-old white American male infected with Hepatitis C. I am involved in a controlled medical research study by Roche Pharmaceuticals of an experimental Polymerase Inhibitor (RO5024048 also known as RG7128) drug therapy for the virus. This document is the story of my illness and the experience of treatment. My lovely and pretty damn wonderful wife will be contributing her take on the experience as well.

Sunday, July 25, 2010

Standard of Care Pace vs. Research Pace

I just got my latest viral load numbers back from the lab today. The viral load has declined to just a bit over 1500 I.U./ml. I have now achieved a log level reduction in viral load since the peak of the viral breakthrough. This is great news but also points up one of the biggest differences between being on the Standard of Care treatment of interferon and Ribavirin and the research trial treatment of interferon, Ribavirin and Polymerase Inhibitor RO5024048. The Hep C virus is definitely harder to kill on only two drugs instead of three.

My viral load progression on Standard of Care has been:

Week 1: 40,000 IU/ml. (peak number of viral breakthrough)
Week 2: 10,000 IU/ml
Week 5: 5,000 IU/ml
Week 7: 1,500 IU/ml (log 1.6 reduction)

My viral load progression on the Research Trial drug was:

Week 0: 12,900,000 IU/ml.
Week 1: 4,260 IU/ml (log 3.48 reduction)
Week 2: 1,110 IU/ml
Week 4: 195 IU/ml
Week 6: undetectable (log 5.83 reduction)

As you can see, the pace at which the virus is destroyed is much slower (though steady) on the interferon and Ribavirin combination. It has taken 6 weeks to get a log 1.6 reduction from the peak breakthrough number when it only took one week to get a log 3.5 reduction from my pre-trial viral load on the polymerase inhibitor. This has taken some getting used to. You get spoiled on the three drug therapy, especially in the case of the polymerase inhibitor because it does not seem to carry major additional side effects along with it. While I steadily heading towards the log 2 reduction in my viral load needed by week twelve after the breakthrough in order to continue treatment, it seems to be happening in slow motion after the knockout blow the RO5024048 dealt the virus while I was on the three drug combination.

While this may pose a few psychological issues for me to deal with, the overall outlook for the polymerase inhibitor plus interferon and Ribavirin mode of treatment is very good. It definitely deals a hammer blow to the virus and so far, most of the individuals I have talked to who are in the trial (admittedly a very small sample) have not reported serious side effects associated with the RO5024048. Also the addition of a new group to the trial which will receive the drug for 24 weeks instead of the 8-12 weeks we got it indicates that the safety issues are not a major concern and that the drug is promising enough to expand the range of patients eligible. This is all very good news for people both awaiting treatment and considering their treatment options. Another effective tool appears to be on the way in the battle against the Hep C virus.

Saturday, July 24, 2010

The Little Things…

Slogging ones way through the cycle of treatment, you really do start to appreciate little things. You have to let go of the level of activity and accomplishment you had before the relentless round of powerful drugs began. It’s either that or drive yourself crazy with frustration and depression. On the other hand, you can begin to appreciate as accomplishments things you either took for granted or viewed as things to get out of the way in the past; for instance: housecleaning.

My wife is the beneficiary of this newfound appreciation of accomplishing small tasks. The house has been a bit cleaner, in some rooms anyway, than it was before I started treatment. Weekends usually find me in the headache, backache, nausea, fatigue, and muscle weakness phase of my injection cycle. This generally means that I don’t get out and do much outside the house on at least one of the weekend days. But I can clean the bathrooms, or degrease the stove, clean the grout, you know, all the delightful tasks that you generally find any excuse to avoid. When you spend the day really getting some part of your environment clean, it makes you feel better. You’ve done something good for yourself and your family. It may not be much, but it does have the feel of accomplishment. And there is always the benefit of having your wife say, “Honey, did you clean the cooktop? It looks like new.” As any married guy knows, a happy wife makes for a happy husband.

Reorganizing is another manageable task that can give you a sense of progress. Over the past several weeks, I have opened cupboards, ventured into closets and examined boxes that have not been opened, ventured into or examined in months (okay years, but that might be revealing too much…). It is amazing how much room you can create just buy arranging things in a logical way instead of the “throw it in and close the door before it can escape” method. The archaeological finds you can make in the back of your closets are quite amazing as well. When did you wear those shoes, where did that shirt come from and I don’t remember that photo at all are the sorts of reactions you can expect. There is nothing like the joy your wife expresses when she discovers that there is now additional room in the closet for more stuff!

After a day of cleaning, reorganizing, weeding, or some other task, there is also the joy of flopping down in front of the TV and discovering that the movie “Juno” just started and you can recover while enjoying a great flick. Small movie, but huge enjoyment.

Another thing I have had to learn to accept and let slide is the effect brain fog has on my ability to write. It’s not hard to sit at the computer and write; I have the energy to do that. It is the frustration of sitting in front of the screen while trying to remember where I was going with a particular story or experience. Combine that with not be able to remember the words for certain thoughts, actions, feelings and even places and things and it really drove me crazy. Now I just sit here and let it slide. It’s still annoying, but the flip side is that I can genuinely say to people, “I have no idea,” or “I don’t remember that at all” in all sorts of situations. Gets you off the hook when your blank look of incomprehension is clearly real.

I would the mindset resembles the one touted in the AA serenity prayer. Unfortunately there is no chance that I will have the wisdom to know the difference…

Monday, July 19, 2010

Co-Pay & Prescription Assistance Programs

As I am beginning to see the co-payments for my medications mount up, I know that many other people undergoing treatment are facing the same issue. Many of the folks I have met who have Hepatitis C, are putting off the decision to undergo treatment because of the cost of the medications. Others are waiting for the chance to screen for research trials of new drugs because the drug companies running the trials cover the cost of the medications and the monitoring care.

There are resources available to help with the cost of medications. I mentioned a few that are run by the drug companies themselves in this post. There are also a wide range of other programs run by both pharmaceutical companies and private foundations. A list of some of these programs follows. I hope it is useful.


Patient Access Nework Foundation

https://www.panfoundation.org/
1-866-316-7263
Assists patients who cannot access the treatments they need due to out-of-pocket health care costs including deductibles, copayments and coinsurance. Up to 4K yearly in drug/co-pay assistance. Patients can apply on line or call the phone number listed above.

Healthwell Foundation
www.healthwellfoundation.org
1-800-675-8416
Addresses the needs of individuals who cannot afford their insurance copayments, premiums, coinsurance or other out-of-pocket health care costs.

National Organization For Rare Disorders (NORD)
www.rarediseases.org
1-800-634-7207
Assists uninsured or under-insured individuals in securing life-saving or life-sustaining medications.

Partnership For Prescription Assistance (PPA)
www.pparx.org
1-888-477-2669
Offers a single point of access to more than 475 public and private patient assistance programs, including more than 150 programs offered by pharmaceutical companies. Includes assistance for the uninsured.

Patient Advocate Foundation’s Co-Pay Relief Program
www.copays.org
1-866-512-3861
Provides direct co-payment assistance for pharmaceutical products to insuraed patients (including Medicare Part D beneficiaries) who financially and medically qualify.

Chronic Disease Fund
www.cdfund.org
1-877-968-7233
Patient will have to call monthly to see if they have funds. Funds are based off individual donations.


Families USA
www.familiesusa.org
1-202-628-3030
Families USA is a national nonprofit, non-partisan organization dedicated to the achievement of high-quality, affordable health care for all Americans.

Modest Needs Foundation
www.modestneeds.org
(415) 956-9395
Modest Needs is an award-winning public charity with a simple but critical mission: we work to stop the cycle of poverty BEFORE it starts for the low-income workers whom conventional philanthropy has forgotten.

Needy Meds
www.needymeds.org
1-978-281-6666
NeedyMeds is a non-profit with the mission of helping people who cannot afford medicine or healthcare costs. The information at NeedyMeds is available anonymously and free of charge.

Patient Services Inc. (PSI)
www.uneedpsi.org
1-800-366-7741
Assists patients in locating health insurance policies. Provides health insurance premium assistance (including COBRA) and co-payment assistance (including helping satisfy Medicare Part D true-out-of-pocket.

Advocacy Attorney through Crohn’s Foundation
Email: patient_advocate@sbcglobal.net
1-860-674-1370

Patient Advocate Foundation
www.patientadvocate.org
1-800-532-5274
Patient Advocate Foundation is a national non-profit organization that seeks to safeguard patients through effective mediation assuring access to care, maintenance of employment and preservation of their financial stability relative to their diagnosis of life threatening or debilitating diseases.


OTHER FINANCIAL ASSISTANCE PROGRAMS



Chrohn’s & Colitis Foundation of America – www.ccfa.org - 1-800-932-2423

American Cancer Society – www.cancer.org – 1-800-227-2345

Brain Tumor Society – BTS Cares – www.tbts.org – 1-800-770-8287

Cancer Care – www.cancercare.org – 1-800-813-4673

Leukemia and Lymphoma Society – www.LLS.org – 1-800-955-4572

Lymphoma Research Foundation – www.lymphoma.org – 1-800-500-9976

National Brain Tumor Foundation – www.braintumor.org – 1-800-934-2873

National Marrow Donor Program – www.marrow.org – 1-888-999-6743

Sunday, July 18, 2010

Since We Were Talking About Side Effects…

The past four or five days have seen another shift in the nature of the side effects associated with treatment. Generally, I have noticed that the side effects I am experiencing are consistent for an extended period of time. The cycle of flu-like symptoms, fatigue and nausea has consistently started about 14-18 hours after the interferon injection and lasts about 36 hours. The fatigue also continues to moderate through the week after the interferon injection and my best days are usually Wednesday and Thursday, just before my next injection. The headaches and dyspepsia (which they define as an overly full feeling and general stomach discomfort) are intermittent but they happen for a few days each weekly cycle. This experience of side effects has been the same for about 10 weeks. This week saw changes in some of the effects and the resurfacing of one that had disappeared 10 weeks ago.

The last 5 days I have been mildly nauseous for most of my waking hours. This has also been accompanied by a bloated feeling in my stomach. I also had a return of dysgeusia (a change in the taste of food) as well. The nausea didn’t seem like much of an issue to me, although it did keep me from doing some of the things I was planning. I wasn’t running to the bathroom to vomit, I only had to lie down a couple of times and mostly I could ignore it or wait it out. Then I woke up this morning without it and realized how good it felt to just feel normal. There is nothing like suddenly not feeling a side effect to make you realize just how crappy it had been making you feel. I may have been tired all day today but damn, I felt good!

I have also had yet another change in the taste of food. The last one came about the time I started taking antidepressants and resulted in ice cream suddenly tasting good again. This time I have become extremely sensitive to things that taste sweet. I tried to eat a piece of chocolate on Thursday (yes, I shouldn’t be eating chocolate, see here, but I am weak) and it was so sweet I couldn’t finish it. Ice cream has once again become something I just can’t face eating as well as things like fruit preserves. I realized how extreme it had become just this evening. I had bought some sweet corn (25 cents an ear) and after boiling it up to have with sausage and potato salad, I could barely finish eating it as it seemed to be sickeningly sweet. Sweet corn, along with tomatoes, one of the iconic tastes of summer, what is Hep C treatment turning my body into?

I am now injecting 3 drugs per week, interferon, Procrit and Neupogen, so that might have something to do with the change in side effects. It might just be long-term sensitization to the drugs. It could be the changes in white and red blood levels or the interaction of the 7 daily and weekly drugs I am now taking, who knows. It seems my body is reaching a new rapprochement with the drugs I am taking and that it might mean a new cycle of side effects to get used to. It could be worse, the next time it might be grilled sausage that starts to taste like cardboard, anything but that…

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.

Monday, July 12, 2010

A Good Word For Big Pharma

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.

Saturday, July 10, 2010

Treatment Update - 5 weeks along in Standard Therapy

My latest viral load test results came back and I have a viral load of just a hair over 5,000 I.U./ml. That is a 3.76 log reduction from the 12,900,00 I registered at the beginning of treatment 29 weeks ago. It also shows a trend in the right direction following the viral breakthrough. My numbers from week 24 going forward are 17,000; 40,000; 10,000 and now 5,000. While the 5,000 number is not yet a truly significant reduction from the peak of my breakthrough viral load, it is getting awfully close.

Two other numbers are showing some change as well. My hemoglobin has dropped to 8.2 from the 11.4 it had climbed to after they reduced my Ribavirin dose to 1000 mg. during the final 6 weeks I was in the research study. My neutrophil count has dropped to 500 in the five weeks since they reinstituted a full dose of interferon. The response to these test results by my hepatologist illustrates clearly the difference in being treated outside of a research study. As I discussed in this post, the researchers running the study need to control, as thoroughly as they possibly can, the drugs that are utilized in the study. One of the primary goals of studies like this, after they determine the drug is effective against the virus, is to determine the side effects and potential dangers of the drug. They know the side effects of the standard of care and by adding only the new drug to the treatment, they can see if it amplifies or minimizes or introduces completely new side effects to the standard treatment. So when presented with test results that show that the research subject has anemia or low neutrophil counts they adjust the doses of the standard of care drugs or the research drugs to determine whether this is what is causing the problems. Unfortunately this can result, as in my case, in reducing the effectiveness of the treatment.

Now that I am being treated outside the research study in the standard of care therapy, they have a panoply of treatments they can use to address the problems and keep me on the full doses of the anti-viral drugs. In my case, the hemoglobin count went down fairly quickly and they put me on folic acid to attempt to build up my red blood cells. When that did not have much effect after about 10 days of taking it and my hemoglobin continued to fall, they prescribed procrit, a drug that directly stimulates red blood cell production. It is a drug that has to be injected once a week under the skin, like the interferon. In doing this for the first time, I tried to inject it into a pinched-up roll of fat on the right side of my belly area and discovered that the skin in that part of my body is like rubber. After trying three times to push the needle through this highly resilient and puncture-resistant patch of skin, I gave up and tried my left side. On that side it went right in and the injection was no problem. I’m thinking of offering the skin on the right side of my spare tire as a new material for bicycle tires. Spare tire tires; alligator skin tires; super skin tires; there has to be some money in selling skin outside the skin industry.

They are also attacking the low neutrophil count by prescribing neupogen another injectable drug that stimulates white blood cell production. I am currently in the process of urgent insurance authorization for that drug and should start using it next week. My wife thinks all this is turning me into a pincushion, as I will now be injecting three different drugs every week. I am also taking levothyroxine to stabilize my thyroid function. The change in thyroid function is also a side effect of the interferon. Luckily, this drug is in pill form and I take it once a day. The three drugs mentioned here are all being taken to enable me to continue taking full doses of interferon and Ribavirin to combat the Hepatitis C virus.

So the drug roster being taken either weekly or daily to fight the Hep C or the side effects of the drugs is:
Pegylated Interferon
Ribavirin
Procrit
Neupogen
Levothyroxine
Celexa
Trazadone
Tramadol
Ativan
The final numbers are not in yet as my nurse AR is working to find the cheapest drugs with the lowest copays but so far it works out to be a bit over $375 per month in copayments. This may go up or down some but if it holds at that number it is about $4500 for the duration of the treatment, assuming no additional drugs are needed.

Considering the only drugs I ever really took up until this time were the occasional course of antibiotics; painkillers after surgery or some muscle relaxants after throwing my back out, this level of involvement with the pharmaceutical industry is a whole new world…

Wednesday, July 7, 2010

Support Group Redux

In a previous post, I described going to my first support group meeting. It was a good experience and my intermittent appearances at other meetings of the group have been useful both for the emotional support of others who have undergone the same experience and for the information they can pass on about their coping mechanisms for getting through treatment. There are times when the group can be a bit trying and the other day was one of those experiences.

Before mentioning the circumstances that made it an infinitely long 90 minutes, there was one piece of anecdotal evidence we discovered as a group that we have not seen described in the literature as an effect of becoming symptomatic Hepatitis C sufferers. Several of the individuals at the meeting had been diagnosed with Hep C relatively recently. As they related the stories of how they had ended up being tested for Hep C and the symptoms that led them to their doctors, one of the repeated statements was that they had experienced shortness of breath. After the third individual mentioned this, the moderator of the group mentioned that she had that same symptom at the time she was diagnosed and asked the group in general whether that was the case for them as well. Of the eleven people there, eight, including myself, related that previous to and continuing after the diagnosis, they had experienced shortness of breath and some difficulty feeling that they could draw a complete lungful of air. As I said, anecdotal evidence to be sure, but we all wonder whether that is a common experience of Hep C sufferers. You learn something new at every group.

You also occasionally have to suffer through a meeting with a plethora of difficult personalities and this was one of them. The first individual to speak related the experience of undergoing treatment twice and failing both times to clear the virus. It was entirely the fault of incompetent doctors, unresponsive nurses, delayed treatments, bad communication, shoddy lab work, you name it and this individual named it as a reason treatment had failed. After listening to the ranting for about 10 minutes, and knowing the doctors named were among the leaders in the field, we realized that we were experiencing directly some of the reasons this person had not experienced a successful outcome.

Three other individuals at the meeting clearly do not get out much and used the meeting to ramble on about their personal lives before, during and after treatment without offering much information about their experience with the disease. Having worked in retail at various times, I have experienced this before. Individuals often came into the store and, perceiving the clerk as a captive audience, proceed to spend no little time describing their personal problems at length until you find a way to cut them off. In the case of the support group, these individuals are usually not hard to deal with, but the number of folks doing it at this particular meeting just ended up being a bit more than I was prepared for.

Finally we had the new age proselytizer. Every person who related symptoms of the disease or issues of treatment was given an herbal nostrum to try, a meditation regimen to use or a dietary modification to make to help with the preservation of the liver or the mitigation of side effects. I have an open mind about strategies for treating disease. I have investigated a number of alternative therapies for a wide range of conditions and found some of them to be efficacious, but when someone insists that I must drink filtered water in order to lighten the toxic load on my liver but does not seem to understand that vastly more toxins are inhaled by a typical individual every day in any major city than they will ever get through treated tap water, it certainly raises my level of tension. Likewise the insistence on a vegetarian diet, organic foods and particular methods of preparation sounds great until you run into the situation I described as The Everything Tastes Like Crap Diet. Then I think it is far more important to just find things you feel like eating and eat them, than worry overmuch about the specific balancing of your diet.

I could go on, but then I would turn in to individual number one at our meeting. I will continue to go to the support group as it is indeed helpful and there is always new information to discover. Just remember that the occasional meeting can find you clock watching and hoping for the end as opposed to suddenly being surprised by the custodians and realizing it’s time to give them a chance to do their job and wait to continue the discussion till the next time.

Friday, July 2, 2010

Viral Load and Log Numbers

Viral Load is one of the numbers that folks with Hepatitis C take very seriously. We take it more seriously than we probably should given that the viral load numbers do not directly correlate with whether you are symptomatic, the amount of damage to your liver or the seriousness of the side effects that you may be experiencing. It is, however, the number that is measured to determine the ongoing success of your treatment regimen and to determine in the long run whether you have cleared your body of the virus. Given that, it is followed with a great deal of attention.

The viral load is expressed in the number of copies of the Hep C Virus RNA that are contained in a milliliter (ml) of blood. This is expressed as the number international units (IU) of Hep C RNA per ml. In my case, my viral load number ranged from 3,000,000 IU per ml when I was diagnosed to just slightly below 13,000,000 IU/ml at the onset of treatment.

The changes in viral load that we track during treatment are expressed as logarithmic or log numbers. Log number differences in the amount of virus are differences in amount that are expressed as factors of 10. These log number differences are the numbers that are considered significant in Hepatitis C treatment. Using my case as an example, if 13,000,000 IU/ml is my viral load at the start of treatment, then a drop in viral load to 1,300,000 is a log 1 change. A drop to 130,000 is a log 2 change, to 13,000 is a log 3 change, 1,300 is log 4, 130 is log 5 and going to undetectable, or under 15, is right about a log 6 change in viral load. In treatment, the doctors want to see a log 2 drop in viral load by week 12 or the patient is considered to be non-responsive.

Once we understand that, the changes in viral load that we see at various times during our disease and during treatment and the significance of those changes become easier to understand. For example, the changes in my viral load as I progressed from 3,000,000 to 13,000,000 before starting treatment are actually not significant changes despite the fact that they look like large changes. In order to have a log 1 increase in my viral load, I would have had to see it increase to 30,000,000 and a log 2 increase would mean that I would have had to see a viral load number of 300,000,000 IU/ml. Now that would be a high viral load indeed. Likewise if you had a viral load of 250,000 and saw it jump to 500,000 it would be considered a not significant change in amount even though your viral load doubled.

The same thing applies to watching viral load as it drops. If you have that same 250,000 IU/ml at the beginning of treatment, a log 1 drop would require a change to 25,000 and to achieve the log 2 reduction your doctors will want to see by week 12 you need a drop to 2,500 IU/ml. In order to reach the undetectable level, you would need a drop of somewhat over log 4. In my case, when I went from 13,000,000 to 4,000 after one week of treatment, that was over a log 3.5 drop in viral load. Likewise when I had my viral breakthrough and went from under 15 to 17,000 it was about a log 3.1 increase in my viral load.

Both of these numbers were significant because of the size of the logarithmic change in the amount. When my confirmation breakthrough test came back with a number of 40,000 that was not a significant change from the 17,000 number that signaled my viral breakthrough despite the fact that it doubled. When the first test results I got after going on treatment outside the study came back at 10,000 that was also not a significant change. I was happy to see my number going down, but just to get to a simple log 1 change I would have to drop to 4,000 and the magic log 2 change means I have to drop to 400 IU/ml.

So don’t panic over fluctuations in your viral load numbers that might appear to be quite large if they don’t reach the level of a ten-fold (log 1) change or greater. Even then, it may not be signaling a major change in your illness, but if it doesn’t even reach that level, it probably means little or nothing at all…