Hepatitis C: Does “No Detectable Virus” Equal Cure Or Is It Smoke?

Am I cured or is it just smoke?

Hepatitis C cure?

 If my hepatitis C virus test shows non-detectable virus 6 months after the end of treatment, am I negative?  Will I  stay negative?  Am I cured?  In the recent past only “non-detectable virus” was declared. Now doctors are adding “cure” to the jargon.  This is with the addition of Incivek and Victrelis, and depending on the discussion.  No two clinical trials are alike and so Hepatitis C researchers use (they say utilize) sustained viralogical response (SVR) to compare outcomes.  Most trial design is by the company developing the drug.  One goal is to ask the study questions just right to get scientific and marketable answers.  “GodZillapravir had a non-detectable  SVR at weeks 12 and 24 in 85% of patients including those with mild to moderate cirrhosis”. “KingKongViracide cleared Hepatitis C virus in 94% of patients at 24 weeks including children 12 to 18 years of age”.  Which is the better drug?  You can’t tell by the claims because two different patient populations and time lines .  But they have  SVR in common.  That is why researchers use SVR.  BTW I made up the examples.  Now don’t get down on industry just yet.  Academics are accountable to department heads and medical journals.  That can be as powerful as a stockholder.

Industry is different: Stock holders in towers

When it comes to patients , the word “Cure” has emerged because research shows that if you have no detectable virus after six months, the chances of Hep C returning is about 1-2%.  And the argument is that it was never cleared, just so low that it was undetectable.

So with Hepatitis what does this mean?

Successful treatment for Hepatitis C hasn’t been available for long, so doctors are just starting to understand the long-term outcomes.  Do cancer survivors say cured?  I think they say  cancer-free for 2 years, 5 years, etc.  Am I a Hepatitis C survivor or am I cured?  Is it still a pre-existing condition?   A research site, not insurance, paid for my treatments.  But my medical records say Hepatitis C.

So at 24 weeks can I tell the insurance company that I no longer have Hepatitis C?  I can’t find the answer to that question without talking to them directly. I will wait until 2014 (I think that is the year) when they cannot cancel me for pre-existing conditions.  Insurance politics are so confusing, I am not clear if that stipulation is on the potential chopping block.  In speaking with my mental  Dr, I realize that I do not have confidence in my treatment and I am waiting for it to come back.  I am at 4 1/2 months post treatment.   I have been Hep C positive for so long, I don’t know how to have a future in which chronic debilitating illness isn’t a key player.  What is the world like with only mild hypertension and chronic but manageable depression?

Below is a good article for defining end-of-treatment terms, although it is a bit dated.  Newer drugs are not addressed but the terms are the same.

 Hepatitis C: What Is a Sustained Virologic Response or “SVR”? (From Charles  Daniel, former About.com GuideSVR) 

SVR is the closest you’ll get to “a cure” for hepatitis C.
 Sustained virologic response, or SVR, is the goal of hepatitis C treatment.  Conventional treatment (a combination of interferon and ribavirin) doesn’t  necessarily eliminate the hepatitis C virus from your liver. It can, however,  suppress the virus to undetectable levels for an extended period of time. In clinical language, this is called a “sustained virologic response,” or sustained  response. It means that during the six months after you complete treatment,  there is no detectable hepatitis C virus in your blood.                                         SVR is a good thing.
Studies have shown that with a six-month SVR (which means no detectable virus in your blood for six months after finishing treatment), relapse occurred in only 1-2% of patients. So, for every 100 people who finished treatment and attained SVR, the virus will return in only 2 of them. However, for these people, the
virus never really left. The medicine was able to eliminate most of the virus (so much that medical tests couldn’t detect it), but after treatment ended, for whatever reason the virus was able to continue replicating itself.

Early SVR is beneficial
Since the liver has incredible regenerative ability, achieving SVR
 as quickly as possible is important. This is important because some liver damage can be reversed if the cause of the damage is removed. After SVR is reached and depending on the degree of damage from the virus, the risk of hepatocellular cancer is reduced and about 25% of people see an improvement in fibrosis.

SVR compares one treatment to another. For those in treatment, SVR is the goal. However, for physicians and scientists researching new hepatitis treatments, SVR is also used to evaluate new medicines and compare them with proven therapies.
 For example, depending on the genotype, treatment with interferon alone usually achieves SVR in 15% of the patients. When interferon is combined with ribavirin in the same genotype, SVR is increased to 70% in some people.

Jana L. Lee, R.N., CCRC Clinical Research Nurse St. Luke’s Episcopal Hospital Advanced Liver Therapies, my practical answer source and demon fighter.

http://www.hepcadvocacy.org/factsheets/HepatitisC.pdf

http://hepatitis.about.com/bio/Charles-Daniel-37713.htm

Advertisements

Ungrateful Bastard that I am…Hepatitis C

You Bastard, you killed Kenny

Hepatitis C treatment ended five weeks ago.  All is going well (~ nothing is wrong).  Went to Costa Rica with grand kids, hiked (slowly) up mountain sides.  Thank you Symbicort and red blood cells.  Now home.  I want to lay in guest bedroom (my sick room), watch recorded TV shows and eat sugar.  What’s up with that?  Fighting some mental and physical depression.  Back up.  Not necessarily so…anytime things are caddy wampass I frighten myself with the depression (DEBression) stick.  Kinda like a boogie man under the bed.

Ungrateful bastard that I am, I want to just “be okay”.  WTF does that mean?  Everyone who is “okay” raise your something.  Last time I re-uped for life post-treatment, I slowly weeded the front garden to demonstrate focus and progress to myself.  It took a week.  Currently it is 108 F heat index…so the hell with that.  I go to bed and get up the same time everyday.  Learning how to fall asleep naturally.  Not true…trying to learn how to fall asleep.  I’ve always had some distressing insomnia.  Maybe that contributed to my drinking a quarter century ago.  Maybe not. Currently I’m on two non sedating antidepressants and one sedating, slowly weaning off.  I can hear AA people judging.  Ta hell with ’em. Note to self:   What other people think of me is of no consequence.

You’d think I’d be more sensitive to the term bastard.  I’m not.  One thing I’m clear about, being born out-of-wedlock is not my burden.  Not sure I knew that 30-40 years ago.  And views change.

“Now more than half of all births to American women under 30 are born out of wedlock, and the trend in marriage-less birth is becoming an accepted reality of American life.” Don’t you love marriage-less over out of wedlock?  I wonder which group with an axe to grind is funding this.

“According to an analysis of government data, conducted by the research group Child Trends and reported by The New York Times, the last 20 years have seen illegitimacy among white women in their 20s with some college — but not a full four-year degree — rise more quickly than in other groups.”  …gotta love the internet.

Ah, yet another chapter in “Me-Me-Me”  My favorite subject, I am afraid.  Better keep dancing with the psychiatrist a bit longer. 

http://www.mysymbicort.com/

“You bastard, you killed Kenny”http://www.youtube.com/watch?feature=player_detailpage&v=1A6f3jHTC-Y

http://articles.businessinsider.com/2012-02-21/home/31081751_1_illegitimacy-black-children-unmarried-women

Snoop Dog, Come On Down!

Don't forget to spay and neuter your petsBeing in bed 24/7 without the ability to lift your head will cause your brain to accept the unacceptable…Reality TV Shows.  I began to watch them as though watching a poorly rehearsed train wreck.  In horror, I couldn’t look away.  At first it was a Project Runway  seven-hour marathon which I slobbered and dozed through.  Then Yard Crashers/Bath Crashers/House Crashers/Income Property/Dear Genevieve/Run My Renovation (RMR).  I even submitted to RMR on line…But they don’t really send out cute Joni.  In fact they don’t do anything and that is good.  I can’t imagine a reality show at my house with me on hepatitis c treatment. ” Hello, pretend the camera’s not in your face and tell us how happy you are with your new environment friendly parrot poop kitchen.  The newspaper floor’s recyclable”.

Going through hepatitis c treatment is sort of like going through labor.  There would be zero population growth if women could remember the first one.  I have one child.  She was born full breech.  I remember.  So why go through a second round of hep c treatment?  Fear of the pain of a cirrhotic death.  Again pain avoidance.  I can’t believe I used the old “going through labor”  analogy.  I hate it when women do that.  I won’t even have lunch with those women.  Shut the Fuck Up!

I had lofty dreams for this down time: learn Spanish, keep a diary, write a book, plan a big trip, read a couple of classics, walk every day, meditate.  What was I thinking?  That I was just gonna have a fractured spine?  I’ve had that and got back on the horse, no shit.

DIY: I couldn’t do shit but got it in my head that my bedroom needed french doors, the living room color was too dark (Osso Buco) and the dining area needed a skylight.  I hated the bed sconces, was sick of the plaster patch on the ceiling and the thumping ceiling fan.  All must be fixed right now (I know, redundant).  Even in the best of health, I cannot do anything myself. My dad told me years ago, when I was trying to help him remodel my house “Good thing you went to school”  Truer words were never spoken.   Poor Spanky tried to explain the error of my crazy thinking process without me going straight to sobbing.  I have no  explanation for the sobbing.  Except to say that my every emotion could and would leap tall logic in a single bound.

Cooking shows:  I watched them and it looked so easy.  Giada, Ina, Nadia G’s Bitchin’ Kitchen (my favorite because it is a comedy too), Top Chef, Chef Roble, Chopped, Chopped Champions.  I couldn’t watch Iron Chef, too many moving parts.  Why would I watch cooking shows when I couldn’t stand the taste or smell of food? I don’t know.  I dropped 20 pounds and never moved.  Basal metabolic rate.

I couldn’t watch my favorite game show,  Jeopardy.  I felt like I stroked and couldn’t find my answers.   Couldn’t watch  The Daily Show with Jon Stewart.  It required knowledge of current events to get the jokes.    Couldn’t watch movies with a story line.  The Marx brothers were good but again too many moving parts.  I found myself watching Ice Loves Coco with Ice T (my personal bottom)  and The Price Is Right with Drew Carey. I shit you not.   Drew Effing Carey!  Snoop Dog was on for his charity.  That man knew the price of everything from Zesta saltines to a Harley.  He won $75K for an old lady.  I think she shit herself on stage.

How did I get from “I don’t watch TV” to “The Price is Right”?

Yep, Snoop Dog on Price is Right. I thought it was the drugs

How did Drew Carey get from here to The Price Is Right???

 

 

 

 

 

I couldn’t read, the books were too heavy and my concentration too light.  During the second treatment I listened to books on tape.  The important issue was the sound of the reader’s voice.

At the kids section of the library I got books  on how to draw.  I sat in bed and drew dinosaurs, flying squirrels and bunny rabbits.  I drew the two trees in the pasture through our three seasons.  Then with the drought last year, I drew them dead.   My art work was terrible,  but that wasn’t the point. Since my analytical brain was pithed, I went to my dormant-since-five-year-old creative brain. I now have a closet full of art stuff/supplies and I like it. I never show my stuff to anyone but Spanky.  He never judges.  He calls me an artist. It makes me squirm. I hung one painting on the wall (on a push-pin) but not where folks would notice.  I still listen to books on tape a lot.  Still can’t sleep.

Don’t forget to spay and neuter your pets Bob Barker.  BTW, turns out Drew Carey has a blog.  Don’t we all?

en.wikipedia.org/wiki/Ice_Loves_Coco

http://bitchinlifestyle.tv/

http://www.drewfromtv.blogspot.com/

I Pooped Today, Things to Track with Hepatitis C Treatment

“I Pooped Today”  Important information to track while on Hepatitis C treatment

If you choose to participate in a drug study while being treated for Hepatitis C, be prepared to keep a diary.  Most of these examples are from round one.  You know what they say about experience:  There are those that got it and those that are going to get it.  I’ve been both.  During round two, I knew a lot of holes were out there and walked around them.  Or paved them in advanced.  I did find new ones.

Dear Diary:

How many bowel movements have you had since your last visit? What color is it? I think this is a test to see if I am fixated on poop.  BTW Your family doesn’t want to know about your poop even if they pretend to.  Most people on treatment have frequent stools but not me.  See, don’t you wish you didn’t know?

Get comfortable discussing your bodily functions with everyone in a white coat. You haven’t had dignity for a while. How dark is your urine? I don’t know, it’s diluted when it hits the toilet bowl. Does it smell? I really want to make a nose joke here.

How’s your eating? Food smells and tastes like pennies and my stomach burns. Have you tried not eating spicy foods? I am only eating buttered noodles and Little Debbie Oatmeal Cakes.  Oh.

Brain fog “Loss of ability to concentrate. Memory loss”   How has your memory been?Huh?    Non-participative.  Try to write everything down in one place.  I can’t seem to find my notebook, so I start another. Kinda makes it worse.Try to hold a job let alone a career with that side effect.

Did I take my medicine? When did I take my medicine? Did I take it in lemon duck? Did I take it with a eunuch?  Did I take it on my death-bed?  Did it make me see a dragon’s head?  Write it all down, you won’t remember.  (ref Brain Fog)

Try to get as much sleep as you can. Brilliant. Now I lay me down to sleep, to lie awake with Lil Bo Peep.  Okay, a bit too much rhyming.  But today my brain wants to rhyme. 

Avoid undue excitement. You mean like my brain running The Fifth Element  Flossing Paradise 24/7? We can prescribe sleep medications. Why didn’t you tell me that 6 months ago?

We recommend aerobic exercise 15-20 minutes/day. Are you shitting me? Do I keep track if you are shitting me?

How many times did you have a blinding H/A this week? How many not so blinding?  Let me see, I cry a couple of times a day.  Crying results in a blinding headache.  So I hold in the crying.  The result, “not blinding” headache.  I’m not sure if I am crying on the inside or outside.

Rashes and skin changes. Is that because of medications or just old spots?  What about the ones that are 3-D?

My skin itches. Take an antihistamine. I did. Take Benadryl 50 mg. Spit will fall out of my mouth if I have any secretions Can I see a dermatologist about this?  Sure but it will be weeks before we can get you in.  WTF is a dermatologist so busy doing?

How has your mental health been since your last visit? Can you draw a line on this form to show the change? I can’t give you any more instructions, even if you don’t understand this (silly) form.  The -Y axis is not long enough to document  the rate of my decline.

Do you think we should put you on antidepressants? I don’t know who I am much less what I need. Have you had suicidal or homicidal thoughts? I can’t remember. With or without headaches?

It is Tuesday, time for my weekly injection. Just when I was feeling up line dancing in a circle (props go Dos XX commercial). Where was your injection site last week? In my forehead with a silver bullet.

Because my Hemoglobin (HgB) is so low, I can’t walk  from the parking structure to my work appointments. Can I get a Handicap Placard? No one has ever asked for one before. So can I get one? Bring us the form. The Dr. will have to sign it.

License branch information booth: Do I have to stand in the long line with the masses? If I could stand that long I wouldn’t need a Handicap placard. Then bring someone to stand in line for you. Next

Null Responders in a horse race

Null Responders:   Poor Bastards and Horse Racing

Being a null responders is kinda like paying for your horse to run in the Kentucky Derby, going to the first turn, watching all the other horses go by and realizing that your horse never left the gate.  You put all your money and resources on that horse and ….he is a fizzle.  This is one opportunity I missed!  When you enter a treatment or a study, that is the horse you pick.  Put some research into picking your horse. At the end of the day, everyone else tears up their ticket.  You gotta load up that horse and take it home.

Note on the graph below by Vertex is an example of full, partial, breakthrough and null responder

http://www.vrtx.com/assets/pdfs/VRTXHCVTreatmentResponse.pdf

Partial Responders with Hepatitis C

All Hepatitis C studies are not created equal. Duh

I used to see myself as smarter than the average bear.  Not so much now.

Being me, I was not passive when searching for a Hep C study.  But I was mistaken.   I assumed. Don’t make an assumption.  I knew better.   My mom taught me this.  Every time some of us kids got in trouble, she pulled me aside and said, “You know better”.  It was years before it dawned on me that other kids knew better too.  My mom was once a kid.  In fact she was still a kid when she had me.  In 1951 it was not cool to have a baby out-of-wedlock.  My biological father passed on marriage and she had to go back home to Harlan County, Ky.   This is where I was born.  Papaw told me to say I was from “Bloody Harlan” because of the bloody mine strikes.   So that is what I told my teacher.  Papaw and all Moms’ brothers were coal miners.  We didn’t make moonshine (the other career path)

I learned that the TV show Justified   is about Harlan County.  I don’t watch it myself.  Makes me jumpy.

fig 1.Me, Mom in the white car coat, dad that raised me, Mamaw, Papaw, and aunts. Harlan County, KY. My mom has the big nose like Papaw.  She waited to get a nose job after Papaw died

Coal tipple loads rail road cars 1

When I was a curly headed baby
My daddy sat me down upon his knee
He said, “Boy, you go to school and learn your letters
Don’t you be a dirty miner like me”

I used to think my daddy was a black man
With script enough to buy the company store
Now he goes downtown with empty pockets
And his face is white as a February snow

I was born and raised in the mouth of the Hazard Hollow
Coal cars rambled past my door
Now they’re standin’ in a rusty row all empty
And the L & N
Don’t stop here anymore

http://www.sing365.com/music/lyric.nsf/The-L-amp-N-Don’t-Stop-Here-Anymore-lyrics-Johnny-Cash/6B378501111ECA5D48256DEA000A5308

I love this song but never heard it until I moved to Texas

Where was I?    Okay brain get back on track.  Let me recommend that you do not have your driver’s license photo taken while on treatment. Very scary.

I chose to participate in a Multi Centered, Randomized, Placebo Controlled, Double Blinded study, evaluating Standard of Care (SOC) Interferon and Ribavirin (which had been my only choice all these years) vs. SOC and telaprevir for round one.  In fact I sought out this study. There were three arms, two with study drug.  I had a 66.7% chance of receiving study drug.  As I learned later, I was not randomized to study drug (telaprevir).  I assumed SOC included addressing anemia and other life threatening events.  In this case, SOC did not include blood transfusions or red blood cell (RBC) stimulant injections such as Procrit.  Standards of care have not caught up to current practices. Step one was to reduce the Ribavirin dose.  .  My hemoglobin (HgB) was 8.9 and the guideline minimum for taking Ribavirin is 10.0. Normal HgB range for females is 11.5-15.8 mg/dL.   My Ribavirin dose was decreased. Hemoglobin got slightly better but I paid for it later by not clearing the virus. In order to treat the anemia I would have to walk away from the study.  Dang it!   I quickly lost the ability to walk down a hallway, climb stairs or lift baggage without major shortness of breath (SOB) and the ability to complete a thought, all necessary for my job (oops, career). More about that later.

After treatment completion, an individual is assessed for response to measure viral load. If there is virus remaining but a reduction of disease by 30% or more  – it is called a partial response.   Partial response (PR) implies further treatment  required.  www.about.com   I moved from treatment naïve to partial responder.  Here I had saved myself for newer treatments but still got the same treatment that was available years ago.  Plus no treatment for the anemia.  How did a smart girl like me get in a dumb box like this?  I hung in there and finished the (long) 48 week trial.  Not only did I not have red blood cells (RBCs) or white blood cells (WBCs), but then the virus that was left was a stronger warrior.   Not good.  Here is the part where my education went out the window.  I was so depressed that I couldn’t function.  Every little thing was monumental.  I should have quit the study when my blood chemistry went to hell.  But I couldn’t think clearly enough to look at the situation logically.  All my decisions were made by a scared little girl.  See fig 1

You know I wanted to blame insurance companies.  It is so easy to blame insurance companies.  I wanted to blame pharmaceutical companies and the FDA.  They are easy targets too.  In reality, I, more than most, understand the study requirements and commitments. Sort of. I have been a research pharmacist for a couple of decades.  The data must be unsullied from outside forces like blood transfusions that will make it impossible to evaluate the toxicity.  That is the point of the study, not patient care.  Don’t misunderstand me.  Patients are well cared for. A patient can get treated without a study but a study cannot evaluate a treatment without patients

FYI, HgB is the molecule in the blood that carries oxygen, (O2) from your lungs to your blood and carbon dioxide (CO2) to your lungs so you can exhale this gas.  Speaking of HgB, it is a bucket brigade that carries water to a fire.  Even if you have plenty of water, if you don’t have enough buckets, the barn burns down.  Wait, that wasn’t a great example.  It wasn’t completely accurate either.  Never mind.  It’s just that I spent all these years learning this stuff; I want to get my money’s worth.  Kurt Vonnegut said only hermaphrodites use a semi colon; .Sort of.  While metaphorically I don’t relate to that, he did say it.   I didn’t pay Kurt Vonnegut, God rest your soul Mr. Rosewater.  Anyway my WORD grammar check said uses it.  I think I paid for that.  Yes of course I did.

Telaprevir (Incivek) and boceprevir (Victrelis) are now available to add to Standard of Care (SOC).  In fact by now they may be a part of SOC.  Glad I contributed to the body of knowledge that is clinical research.  Really I am.  But I wouldn’t repeat round one for nothing, not no way, not no how. It was two years before I was well enough to go for round two of treatment.  My career never recovered.