Sunday, August 2, 2015

Harvoni - FDA Side Effects Reported

I started this post a couple of weeks ago but was struggling to upload the FDA report - at any rate, I was able to find a link to the "FDA Adverse Event Reporting System" posted at the bottom.



Awhile back, I read somewhere about a newly released FDA publication that listed Harvoni side effects reported by consumers taking it.    This has recently become available, thanks to being sued by a couple of Patient Advocacy groups.  I have included the link to the FDA file below  - very large - contains over 700 reports of Harvoni Side effects from October 2014 - March 2015.

FDA is Sued by Advocacy Groups That Want Gilead Hepatitis C Trial Data

A pair of public health advocacy organizations has filed a lawsuit against the FDA, claiming the agency failed to release clinical trial data for Gilead Sciences GILD +2.45%’ hepatitis C treatments on a timely basis. And the move is only the latest installment in an ongoing drama in which researchers and patient advocates have tussled with drug makers and regulators over access to such information.

Late last year, Treatment Action Group and the Global Health Justice Partnership asked Gilead for patient-level trial data for the Sovaldi and Harvoni drugs. They sought the data because the drugs are widely prescribed, thanks to very high cure rates, and because the FDA approved the drugs as part of a regulatory process known as a breakthrough designation, which accelerated review.
As far as the health groups are concerned, the accelerated process “may increase the risk that gaps in drug efficacy will go undiscovered, or that side effects or [interactions with other drugs] will go unnoticed,” according to the lawsuit. “Independent analysis of patient-level clinical trial data is essential to identify and bring to light unresolved safety and efficacy issues.”
Specifically, the groups hope to learn about different responses that different patients experienced during clinical trials. Tracy Swan of Treatment Action Group points to relapses in a Harvoni clinical trial that occurred only among African-Americans. The groups also want to perform an independent analysis of poor prognostic factors among people who were not cured in order to identify a patient profile.

The rest of the article is here:

FDA is Sued by Advocacy Groups That Want Gilead Hepatitis C Trial Data


Back in January of this year, when my doctor first approached me about Harvoni, I was definitely in no rush to be on it.  I told the doctor that and he was almost stunned - "You'd turn down over $60,000 in drugs?"    Yes, I would, at this point.  The stuff hasn't been out long enough to know all of the side effects and long term side effects, etc.  I told him.   However, before I knew it, the pharmacy was contacting me, and would be sending me the Harvoni on this date.   So I went ahead and drank the Kool Aid.

I completed the my last Harvoni of an 8 week treatment on June 2nd.  Both 4 and 10 week labs were Undetectable - No Virus found.    I did have some sides, which I've detailed in earlier posts.

Currently, I do feel better than I did for the first 3 weeks after completing Harvoni.  I do worry about relapse as there does seem to be more in the real world than there was reported in the trials.


 I have included the link to the FDA file below -- very large - contains over 700 reports of Harvoni Side effects from October 2014 - March 2015.  Lord knows how many there have been since then:


FDA Adverse Event Reports 10-2014 thru 3-2015

Sunday, June 28, 2015

Harvoni 10 Week Labs



My 10 week labs were also Undetectable!   All other labs were in normal range as well - though they were normal pre-Harvoni.  Feeling better day by day.  Felt like crap from the second month on and for the first few weeks following last pill.

Was really tired... more apathetic than anything else.  Just felt better sitting on the couch than going out and walking. But could never sleep - have never napped during the day - and sleep at night was restless.  Still is - have no problem going to sleep - just wake up at 2-3 and usually toss and turn rest of night.

My doctor was out of town so I had to wait to have labs done at 10 weeks instead of 8.  And just as with getting the 4 week results, I do feel better just having the results in.  Nice to know that the stuff worked and that it didn't destroy my liver and kidneys in the process.  Would love to have my B and D3 levels checked, as well as Magnesium and Thyroid levels.  Some of the Forum folks report that they have doctors that actually test their levels post-treatment - and many are very low, particularly in D and B vitamins.  Which I took throughout the treatment.

Will have the 12 week "End of Treatment" labs done in early September - those are labs done 12 weeks after the last Harvoni pill taken on June 2nd.  If those are clear, then one is declared "cured."

Still a bit bloated and drink more water than I did - though I always did drink a lot to begin with - never sodas.  Some juice,  sometimes wine (on rare occasions) and usually 2-3 cups of coffee daily.

Took supplements throughout - added milk thistle back during second month.  Took Low Dose Naltrexone throughout - around 3-4 times a week.  

The flower in the pic just appeared one day out on the porch - around the time that I got my ten week labs back - kind of a rebirth?


Wednesday, June 10, 2015

After Harvoni

It's been a week now since I took my last Harvoni.  I didn't really feel well for a few days afterwards, then had a couple of good days.  But these last few days, I have been dragging.  I just don't feel well - headaches, virus like feeling, fibro flare, just no energy at all.

Many others on the various forums say the same thing.  I don't know how long it takes to recover from the stuff.  And I was only on it for 8 weeks.  And felt pretty darn good before treatment - at least had energy.

Not really sleeping hasn't helped either.  Still very thirsty and drink a lot of water. 

I was undetectable at 4 weeks - and I am not sure if my doc will do any more lab work until the 12 week End of Treatment labs and viral load.   Hoping of course that I remain undetectable.  We'll see.

Tuesday, May 12, 2015

Harvoni - 4 Week Lab Results - Thoughts on Treatment

 
 
  
 

Saw doctor yesterday and got back HCV PCR test results after 28 days of Harvoni.  Undetectable for HCV!   Normal lab work - CBC - urinalysis.

After spending an interminable weekend worrying about my lab tests, it was kind of a shock to see.  More so, the CBC due to the weird sides I'd been having.  Bloating, having to urinate seemingly constantly, and the recent water retention.  I almost had myself convince that I had ascites!

My blood pressure was 175/87 which freaked me out - last time it was 120/75.   I had seen on the forums that some people's BP does spike with Harvoni.  However, according to my doctor, all of my problems were due to stress.  Ok.  He ruled out ascites, discounted the many side effects that I mentioned "We haven't seen that here."    He did not want to prescribe anything for my blood pressure, and was not worried about anything.  He was very happy for my undetected status.  As am I - now, we just have to get to the finish line.

More later....


May 26, 2015

Sorry for not updating sooner - but I've pretty much been over this stuff - the Harvoni.  Every day is different - don't really feel bad but don't feel good.  But after today, only one week left of the 8 week treatment.  I saw another doctor last week and my blood pressure was still kind of high - 165/85. Also had a low grade temperature.  Having bouts of tinnitus.  I went swimming a couple of weeks ago in the Gulf and got my ear clogged up.  Did not have enough money to pay for deductible so am partially deaf - don't believe that is Harvoni related.  Do have some itching but am getting little bite like marks here and there - they last a few days and go away.

I had mentioned my labs - my ALT and AST in January (pre-Harvoni) had been at 32 and 23.  After 28 days on Harvoni, ALT was 28 and AST at 34.  Albumin was 4.8 - after 4.3.  I had seen on the forums that a lot of folks seem to have lower albumin levels following treatment.

White blood cell count was 5.1 - after - 6.8
Red blood cell count was 3.77 - after - 3.79
Platelet count was 168 - after - 176
Absolute Neutrophils - 2611 - 3828
Absolute Lymphocytes - 1739 - 2040
Absolute Monocytes - 546 - 660
Absolute Eosinophils - 179 - 231
Absolute Basophils - 51.2 - 41

I had seen a few conversations on one of the forums about Harvoni and the immune system - some thought that the Harvoni had an effect on it.   Don't know.  My labs seemed to have improved though I think that the LDN is helping keep it strong.

After I got the undetected test back, I went back to 3-4 times a week dosing of 2-2/12 mls of LDN (compounded made from 50mg Revia)   Based on what I have read, the LDN might enhance the Harvoni, much as it does when used in concurrence with other therapies.

I also went back on milk thistle - just one capsule taken in the morning 12-14 hours away from the Harvoni.

Reading the forums has been informative - and depressing as more folks seem to be relapsing than what Gilead reported from their trials.  Many of them have only done 8 weeks.  They were undetectable at 4 and 8 weeks but end of treatment revealed the relapse.  I don't know how accurate the forum stats are.   I do know that I will not do more than 8 weeks of this stuff!  There are tests now that show if folks have a genetic resistance to the drugs in Harvoni.  Maybe they will start testing folks pre-treatment?

Also, after treatment, many people say that they feel bad - tired and with joint aches, headaches, upset stomach, autoimmune problems, etc.  For months. 

Thoughts - many of these folks also treated using interferon in the past - some multiple times.  Research has shown that interferon will trigger "Celiac Disease" in those who undergo interferon treatment - I have posted this in the past.

Silent celiac disease in chronic hepatitis C: impact of interferon treatment on the disease onset and clinical outcome

Background:

Hepatitis C is associated with autoimmunity, which can be exacerbated by interferon treatment. Cases of celiac disease activation during interferon treatment have been reported.

Conclusions:

In hepatitis C patients, the activation of silent celiac disease during interferon treatment is almost universal and should be suspected, but it uncommonly requires interferon treatment discontinuation.


I would definitely avoid any wheat pre-during-post Harvoni treatment.   A few of celiac/gluten intolerance symptoms:

  • Abdominal Pain
  • Aphthous Ulcers (Canker sores in mouth)
  • Autoimmune Cholangitis - AND ALL AUTOIMMUNE PROBLEMS!
  • Beta Casein Enteropathy (Cow's dairy intolerance similar to celiac disease)
  • Bleeding, Unexplained
  •       Candida Infections
  • Carbohydrate Malabsorption
  • Cheilosis (Red lips, cracking/ oozing at corners of mouth)
  • Colitis, Collagenous
  • Colitis, Lymphocytic
  • Colitis, Ulcerative
  • Colonic Volvulus (Loop of intestine twists causing strangulation of intestine)
  • Constipation
  • Constipation Alternating with Diarrhea
  • Crohn's Disease
  • Defective Tooth Enamel (Yellow, white spots, missing enamel)
  • Delayed Gastric Emptying (Early fullness after eating)
  • Diarrhea, acute (Also called celiac crisis)
  • Diarrhea, chronic
  • Duodenal Erosions in the Second Part of Duodenum (Small ulcers)
  • Dysphagia (Difficulty swallowing)
  • Edema of Small Intestinal Lining
  • Esophageal Small Cell Cancer
  • Esophageal Motor Abnormalities (Poor muscle activity/coordination)
  • Gas
  • Gastric Ulcer (Stomach ulcers)
  • Gastric Ulcerations
  • Gastritis, Collagenous
  • Gastritis, Lymphocytic
  • Gastro-Esophageal Reflux Disease (GERD)
  • Gastro-Intestinal Occult Bleeding (Blood in stool that is not visible to naked eye)
  • Gluten Sensitive Enteritis
  • Gums bleeding/ swollen (Purplish in adults/ red in children)
  • Heartburn
  • H. Pylori Bacter (Infection of the stomach)
  • Impaired Gall Bladder Motility
  • Irritable Bowel Syndrome
  • Jejunitis, chronic
  • Lactose Intolerance (Gas, bloating, loose stools from milk)
  • Laryngospasm
  • Leaky Gut Syndrome
  • Lymphoma
  • Malabsorption of Nutrients
  • Maltose Intolerance (Gas, bloating, loose stools from maltose, a simple carbohydrate)
  • Nausea
  • Oral Mucosal Lesions (Mouth lesions)
  • Plummer-Vinson Syndrome
  • Post-cricoid Cancer
  • Primary Biliary Cirrhosis (Bile backs up in liver)
  • Primary Sclerosing Cholangitis (Scarring of bile ducts in liver)
  • Small Bowel Intussusception (One loop of intestine slips into another)
  • Small Intestinal Bacterial Overgrowth
  • Steatorrhea (Pale, smelly, floating stool hard to flush or sticks to toilet)
  • Sucrose Intolerance (Gas, bloating, mucous in stool from sugar)
  • Tongue (Beefy, red, smooth, burning)
  • Tongue (Fiery red, smooth, swollen, sore)
  • Tongue (Magenta, swollen)
  • Tongue (Pale, smooth, burning)
  • Vomiting

  • Anemia, Folic acid
  • Anemia, Iron
  • Anemia, Vitamin B12
  • Anti-Endomysium Antibodies (EMA)
  • Anti-Gliadin Antibodies (AGA)
  • Anti-Tissue Transglutaminase Antibodies (tTG)
  • Associated Autoimmune Antibodies
  • Bone Alkaline Phosphatase Enzyme, Elevated
  • Calcium, Low
  • Cholesterol, Low (below 156)
  • Coagulation Factors, Low
  • Copper, Low
  • Hemochromatosis
  • Glucose, Low or elevated
  • Homocysteine, Elevated
  • Hyperprolactinemia (elevated prolactin hormone)
  • Hypoprothrombinemia
  • Idiopathic Thrombocytopenic Purpura
  • Liver Enzymes, Elevated
  • Macroamylasemia
  • Macrocytosis
  • Macrolipasemia
  • Magnesium, Low
  • Neutropenia
  • Phosphorus, Low
  • Plasma Proteins, Low
  • Potassium, Low
  • Prolonged Prothrombin Time
  • Transient Erythroblastopenia
  • Zinc, Low


  • The list mentions anemia due to malabsorption of nutrients -  or iron deficiency.  Of course, in Hep C, iron overload or elevated serum ferritin is much more common.   A few forum folks mention elevated serum ferritin - which alone can cause elevated liver enzymes.  Again, I posted about this years ago.   IP6 worked great for me - the capsules not the hard tablets.  My ferritin was not severely elevated though.   Having phlebotomies done regularly will help lower ferritin and reduce the resulting oxidative stress to the liver - the iron in the liver is what does most of the damage!!!!

    I wish that I had more money - I would love to go see Dr. Berkson again.  Or at least be able to see my own integrative doc as she also offers IV ALA.   But of course, insurance won't pay for most of the stuff that actually works - only Big Pharma stuff, which I really don't use.  Except for the Harvoni which thankfully seems to be working for now - hopefully I will remain undetectable after end of treatment and further down the line.  But I will always use Low Dose Naltrexone!

    Saturday, April 25, 2015

    Harvoni Side Effects - Misc Info


    This post from April 20th - updated below this part:

    Will be doing my 13th Harvoni later on today.  So far, not too bad.  Insomnia has mostly been the worst for me - though I have had a history of it over the last couple of years.  I feel pretty good on the days where I have gotten a good nights sleep and draggy on the ones that I don't.   I sometimes have a feeling of being saturated by the Harvoni, a very chemical like feeling, and at times, feeling wired up.
    Taking a regular walk in the evenings seems to help a great deal - I do know that I feel and sleep better if I can get out and do it.  A lot of times I really don't feel like getting up off of the couch, but it seems that once I do start walking, after awhile,  I feel pretty good.  Sometimes I do jog for 50-100 yards at a time.

    Drinking water is great - I have always drank mostly water in the past decade or so, but the Harvoni makes you crave it.  I seem to want really cold water with ice.  Unfortunately, last week my freezer stopped working correctly and I have no ice - and had to throw out some precious food.  My landlord is dragging his heels on getting it fixed.  The Harvoni also has given me an enormous appetite - I have noticed that eating fresh fruits and veggies and keeping away from any kind of heavy meals makes me feel the best.  However, combined with the loss of the food from the freezer and current financial condition, I have had to eat whatever was left in my pantry.   This is why I had wanted to wait to start Harvoni as I did not have to worry about not having food or supplies.  Oh well, will just have to take it one day at a time.

    SIDE EFFECTS of HARVONI  - Lesser Known


    In my previous post, I posted the side effects listed on the Gilead Canada site which were not on the Gilead USA site - still not there as of today.  Does anyone know why the Canadian site would list sides while the USA site does not?    I scan the many forums daily and see that many, many folks are reporting sides other than the nausea, fatigue, headache, and insomnia that are the most common.  And many forums give the advice that these sides are not Harvoni related -  but  most are listed on the Gilead Canada site.  I did mention the Gilead Canada site on one of the Facebook sites - one person looked it up and one of the moderators seemed to know about it but did not post it.  What's the deal?  Wouldn't you want to know that some of the sides that you are feeling are legitimate?  And not in your  head?

    Less Common Clinical Trial Adverse Drug Reactions (less than 2%)
    Adverse reactions (Grades 2 to 4) occurring in less than 2% of patients
    receiving 8, 12 or 24 weeks treatment with HARVONI in clinical trials
    are listed below by body system:

    HARVONI (Ledipasvir/Sofosbuvir) Tablets
    Product Monograph
    Page 8 of 61

    Table 2. Adverse Reactions (Grades 2 – 4) Reported in less than 2% of Patients
    Receiving 8, 12 or 24 Weeks of HARVONIa from the Pooled Phase 3 Studies
    (ION-1, ION-2, ION-3)


    Blood And Lymphatic System Disorders - Factor VIII inhibition

    Cardiac Disorders - Palpitations

    Eye Disorders - Visual impairment

    Gastrointestinal Disorders - Abdominal discomfort, abdominal
    distension, abdominal pain, abdominal pain upper, constipation,
    diarrhoea, dyspepsia, gastrooesophageal reflux disease, mesenteric vein
    thrombosis, nausea, oral discomfort, vomiting

    General Disorders And Administration Site Conditions - Asthenia,
    feeling abnormal, irritability, edema

    Hepatobiliary Disorders - Hepatitis acute

    Infections And Infestations - Conjunctivitis infective, salpingitis,
    sinusitis

    Injury, Poisoning And Procedural Complications - Contusion, ligament
    sprain, meniscus injury, muscle strain

    Metabolism and Nutrition Disorders - Abnormal loss of weight, decreased
    appetite, gout

    Musculoskeletal and Connective Tissue Disorders - Arthralgia, joint
    effusion, muscle spasms, muscular weakness

    Nervous System Disorders - Disturbance in attention, dizziness, memory
    impairment, migraine, migraine with aura, parosmia, somnolence

    Psychiatric Disorders - Affect lability, aggression, anxiety, depressed
    mood, depression, emotional disorder, insomnia, libido decreased, sleep
    disorder

    Renal And Urinary Disorders - Urinary retention

    Reproductive System and Breast Disorders - Erectile dysfunction,
    metrorrhagia

    Respiratory, Thoracic and Mediastinal Disorders - Oropharyngeal pain,
    sinus congestion

    Skin And Subcutaneous Tissue Disorders - Acne, alopecia, hyperhidrosis,
    prurigo, pruritus, rash

    Vascular Disorders - Hemorrhage, hypertension


    Gilead Canada:

    http://www.gilead.ca/pdf/ca/harvoni_pm_english.pdf


    Gilead USA:

    http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/harvoni/harvoni_pi.pdf


    (note, I removed the grid from the first posting and the Sovaldi info too)

    As with any fairly new drug, new side effects will come to light - and it is our guinea pig duty to report them to Gilead and to our doctors.  I know that my doctor did not mention any of these other possible sides. 


    Am posting this now but will add to it later.  Off to scrounge for food for me, cat food and toilet tissue!!!!!!!!!  I envy those with supportive families or the means to just concentrate on treatment not just surviving day to day.

    xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx

    Updated April 25th

    Back and just did # 17.    Was able to get food and freezer seems to be working again.  Disaster averted!  Gee, this stuff makes you extremely hungry!  And also gives you a sweet tooth.  I have succumbed a couple of times and eaten some M and M's and felt pretty cruddy soon after.  I have been trying to avoid as much sugar as possible for years anyway, but it really seems to be a no no with Harvoni.

    I mentioned having to eat what I had in the pantry - one thing that I ran out of was olive oil.  The decent stuff is a bit pricey but what a difference it makes!  I love to make sweet potato fries and baked chicken and using vegetable oil to cook them with really messed with my stomach.  I felt like I had sludge in my system the next day.  The olive oil makes a tremendous difference to me and happily I have some!

    I do get some bloating late at night before bedtime - but it is a different kind of bloating than the intestinal bloat from gluten - it goes away by the next morning.

    Lets see, what else?  I did wake up with an ugly purple blotch on my wrist - don't know if it is an indication that my platelets are a bit low?   But I have had this happen in the past pre-Harvoni.  And a history of slight vasculitis.     And sometimes it feels like my lower legs are made of cement, like now.  Walking helps that feeling and it goes away.  Am about to go walk now - I have a neighborhood route that takes me up next to some railroad tracks - there is a lot of sand mixed in and it feels like my legs get a good workout from walking on it.  

    I do have dryer skin, even with the almost gallon of water a day that I drink - and some itchiness.  Using fragrance free Whole Foods type moisturizers help both the dryness and itch.  By no means use crap like Vaseline Intensive Care lotion!  It is nothing but chemicals which is the last thing your skin and system need.  Just like with food, read all ingredients that are in your body care products and stuff like shampoos, etc. 

    I was troubled at first that my walks happen soon after I take the Harvoni - didn't know if the stuff would give me a heart attack or stroke if I exercised so soon after taking it, lol.  But no problems.

    I did quit the milk thistle after all.  I took it in the first week but 12 hours away from the Harvoni.  But am still doing the LDN twice a week - again 12 hours away from the Harvoni.  The pharmacy told me that it was ok to take but I had to spell Naltrexone for them.  So I have no confidence that they have any idea of how Low Dose Naltrexone works.

    That's all folks - it's Jazz Fest time in NOLA - although a wet one so far - THE WHO and John Legend are playing now.  Not that I have the bucks to go - oh well, maybe next year!

    xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx


    Updated Tuesday April 28th

    Day 21 - Three weeks down - 5 weeks (35 days) to go!  The specialty pharmacy called yesterday and my last bottle of Harvoni is coming on Thursday.  But thank god this is only a two month go round!

    Had cruddy weekend - did not sleep well last 3 nights - was very tired and achy all day Sunday - I think very rainy weather has attributed to overall feeling.

    I had mentioned a very overactive bladder from the first night on.  I do drink a lot of water, as well as Smart Water type drinks (no sugar) so I thought that maybe that was the reason for having to go to the bathroom every 15 minutes.   But this seems to have gotten worse and I feel like there is pressure on my kidneys.

    I have always tested perfect in every kidney type test that I have ever had.   But I decided to call my own doctor to report this - however, over at LSU, it is often difficult to reach him or his nurse.  I needed to call them anyway to see if I am supposed to have 4 week labs done.  Had to leave message and have not heard back from them so far.

    So then, I called the Gilead Support Path - I have heard great things about this as they have helped so many people navigate the Harvoni highway and arranged for folks to receive the Harvoni.  A few people mentioned the 24/7 Nursing Support Line, so I called them a little while ago.

    The first thing that they asked is if I called my own doctor.  Because, excessive urination is not a Harvoni problem.  Oh, funny how the excessive urination began on day one of Harvoni and has continued on to day 21.   Well, this kind of set me off.  I asked the woman if Harvoni only caused headache, fatigue and nausea as described on Gilead's American site and on most other drug description site?  And she pretty much said yes.  I told her that so many people on the forums are reporting so many different sides - seems it must be their imagination - like it is mine.

    Then I mentioned the Gilead Canada site and she said that she was not aware of it.  And that they were not allowed to go to it as a reference point.  OK - so now, I suppose that the Harvoni made at Gilead Canada is different than the Harvoni made by Gilead in the United States?   Why do these assholes list three side affects in the United States and 100 in Canada?  Wouldn't these "health care professionals" want to know all possible sides so that they could actually help people?  Of course not.

    Just venting today - and being pissed.  Yes, I am  happy to have the opportunity to finally get rid of this virus. For many people with liver transplants or cirrhosis - or for those who have gone through several previous brutal treatments and failed them all or had the virus come back, it is a godsend.  But for someone like me who had little symptoms and great numbers (thanks to LDN, diet and supplements)  I feel like I drank the Kool Aid.  And as I said earlier in the year on this blog, I really would have preferred to wait until next year to do this.  

    Well, hopefully I will feel better again -  worrying about impaired kidney function and probably reading too many forum posts from people who have completed treatment, are undetectable but still feel like crap months later.


    xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx


    UPDATE: Friday May 2nd, 2015  -  Day 25

    Called and left several messages for doctor and was told that the clinic would get back to me.  Still waiting.   I did hear that they will run labs after 30 days.  Don't know what kind - probably CBC and hopefully Viral Load.     Guess that if I have any more sides, I will have to go to Urgent Care or the Emergency room.   Not a good feeling to know that your doctor is not there for you.  Feeling pretty alone.  Still have frequent urination and a variety of other minor sides.  Day 25   


    xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx

    UPDATE TUESDAY MAY 5, 2015  - Day 28

    Saturday morning I woke at 6:30 to go to the estate and garage sales as usual (I sell books online).  I felt awful, exhausted, brain fog, headachy and weak.  I had felt fine the night before.  I walked to the bathroom and felt dizzy.  Then, said the hell with it and went back to sleep.  Got up a couple of hours later and felt well enough to function  - not bad but not good.  Just dragged around all day. Sometimes in the morning, I feel cruddy with a slight headache - but once I do get up and have a cup of coffee or two, the headache is gone and I feel much better.   Saturday morning was not like that.

    But, the last two days, I slept really well, and have felt pretty good - You just never know with this stuff!  And the constant need to urinate has gotten a tad better.  I think that my diet might somehow affect it - or whatever is causing my stomach/bladder/whoknowswhat? to swell out.  As mentioned earlier, since I haven't eaten wheat in 7 years, it is different kind of bloat than a "gluten bloat."  I had been eating a lot of cheese and more dairy products than I had been - I cut back on them and the bathroom visits have diminished.  But who knows?

    The good news is that the nurse finally got back to me yesterday - and she finally consulted with the doctor and ordered labs.  I did them earlier today - CBC/HCV-RNA(or whatever test they use for viral load) and had a urinalysis done.  I had wanted to fast before the labs for the CBC but didn't make it - this morning was a "coffee morning."   And wish that I'd known about the urinalysis beforehand - the B vitamins colored the sample.  Oh well.    The hell with the CBC!   I want to know if the Harvoni is working and if I still have a viral load - or??????????????? 

    Guess I'll find out in a couple of days - LSU has a Patient Portal -  but of course, it isn't working right now.  I will post the results soon!  Taking pill @28 in a little while -   Starting second and last bottle tomorrow.


    xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx

    UPDATE SATURDAY MAY, 9TH

    Day 32.   I had hoped to be able to post 30 day labs - however, although the nurse told me on Thursday that they did get in my results, the doctor needed to look at them.  And that he would call me.  Which of course, he did not.  Spoke with nurse again on Friday and was told that doctor wouldn't be back until Monday.  So no big deal - just wondering if the virus that I've had for 40+ years is still around.

    Have had enormous, ridiculous appetite - ate almost a whole jar of peanut butter the other day.  Have gained at least 5 pounds, and now have belly gut.  Looks almost like ascites.  But I guess if anything was really out of whack, it would have shown up in the CBC and the urinalysis.  I hope.  Meanwhile, this is a drag - feel ok but not comfortable in my own skin.

    Will be seeing doctor on Monday afternoon.  He will hear about the side effects which are a hell of a lot more than the usual, "fatigue, headache, insomnia" quoted on Gilead's US site - and repeated ad nauseam by ill informed/arrogant doctors.



    Friday, April 10, 2015

    Harvoni and Low Dose Naltrexone




    Somehow, I was approved for Harvoni last month and things happened quickly afterwards.  The pharmacy called to tell me that my monthly co-pay would be $3.60.  I am to treat for 2 months.

    Initially, I was prepared to wait until next year to do this - but as everything seemed to fall into place, I decided to do it now.

    So I took my first pill two nights ago at around 9:30.  The pharmacy had suggested that I take it before bedtime to offset any side effects.  Unfortunately, for me, insomnia was one of the sides, so I pretty much tossed and turned all night.  I did not feel bad; it was not unlike starting LDN in the early days.   The next morning I felt wired up but ok once I got up and had some coffee.

    Yesterday, I took the Harvoni at around 5:30 in the afternoon.  I felt slightly wired a few hours later but not much else.  It was easier to fall asleep later but I did not sleep well.

    This morning, I decided to go ahead and take the LDN (about 2 1/2 mls)  - and when that kicked in, I really felt pretty wired.  

    Overall, after two doses, I don't feel bad - every now and then, I get a twinge of a headache that quickly goes away.  Same with a rumbling in my stomach and an overall unwell feeling - but these feelings do not last long.  I have been drinking a lot of water!  I have always drank a lot of water  but now I can't seem to get enough - and it does seem to help the brief "unwell" feelings.   Of course, all of this water drinking leads to many, many bathroom visits - particularly on the first night that I took the Harvoni - seemed that I had to get up a dozen times during the night.

    Been taking my usual supplements of Alpha-Lipoic-Acid with a B Complex 100 and a Methyl-Folate capsule.  Lysine and Vitamin D3. IP6.  I did not take the magnesium and initially held off on the Milk Thistle, per the pharmacy instructions.  However, I took the Milk Thistle against all advice.   I think that it is very important to support the methylation system and milk thistle is part of the process.

    And of course, I am completely wheat free as I have been for the past 7 years.  I am wondering if some of the stomach upset and bloating reported by some folks could be caused by the Harvoni triggering an immune response to the gluten in the wheat - as interferon does.

    Hepatitis C is a virus and I am treating a virus.  Seems that most folks say that HCV is a liver disease - sure it resides in and affects the liver, but it is also found in every cell in the body as viruses do.

    Am sure hoping that more of the reported side effects don't show up as time goes on.  I can definitely tell that I am taking a powerful medication -  feels almost like rocket fuel. I do get slightly metallic taste in my mouth at times, but again, the water makes it go away.  The zinc lozenges help as well.

    I wonder why some folks do ok on Harvoni with few sides and others suffer terribly?  Viral load and physical shape and liver condition going into treatment?

    Prior to starting the Harvoni, I read many online forums and pharmaceutical sites to learn more about possible side effects.  Most sites and patients mentioned headache, fatigue and insomnia as being the most common.  However, I had read about a few folks having vision problems and changes after being on Harvoni and even after stopping it.  Interestingly, Gilead Canada had a list of the more "uncommon side effects:"

    Gilead Canada Less Common Side Effects pdf

    Less Common Clinical Trial Adverse Drug Reactions (< 2%)
    Adverse reactions (Grades 2 to 4) occurring in less than 2% of patients
    receiving 8, 12 or 24 weeks treatment with HARVONI in clinical trials
    are listed below by body system:

    HARVONI (Ledipasvir/Sofosbuvir) Tablets
    Product Monograph
    Page 8 of 61

    Table 2. Adverse Reactions (Grades 2 – 4) Reported in < 2% of Patients
    Receiving 8, 12 or 24 Weeks of HARVONIa from the Pooled Phase 3 Studies
    (ION-1, ION-2, ION-3)


    Blood And Lymphatic System Disorders - Factor VIII inhibition

    Cardiac Disorders - Palpitations

    Eye Disorders - Visual impairment

    Gastrointestinal Disorders - Abdominal discomfort, abdominal
    distension, abdominal pain, abdominal pain upper, constipation,
    diarrhoea, dyspepsia, gastrooesophageal reflux disease, mesenteric vein
    thrombosis, nausea, oral discomfort, vomiting

    General Disorders And Administration Site Conditions - Asthenia,
    feeling abnormal, irritability, edema

    Hepatobiliary Disorders - Hepatitis acute

    Infections And Infestations - Conjunctivitis infective, salpingitis,
    sinusitis

    Injury, Poisoning And Procedural Complications - Contusion, ligament
    sprain, meniscus injury, muscle strain

    Metabolism and Nutrition Disorders - Abnormal loss of weight, decreased
    appetite, gout

    Musculoskeletal and Connective Tissue Disorders - Arthralgia, joint
    effusion, muscle spasms, muscular weakness

    Nervous System Disorders - Disturbance in attention, dizziness, memory
    impairment, migraine, migraine with aura, parosmia, somnolence

    Psychiatric Disorders - Affect lability, aggression, anxiety, depressed
    mood, depression, emotional disorder, insomnia, libido decreased, sleep
    disorder

    Renal And Urinary Disorders - Urinary retention

    Reproductive System and Breast Disorders - Erectile dysfunction,
    metrorrhagia

    Respiratory, Thoracic and Mediastinal Disorders - Oropharyngeal pain,
    sinus congestion

    Skin And Subcutaneous Tissue Disorders - Acne, alopecia, hyperhidrosis,
    prurigo, pruritus, rash

    Vascular Disorders - Hemorrhage, hypertension

    Prior to looking at the Gilead Canada site, I did not find most of the above listed in any adverse conditions lists - save for the folks on forums who did mention some of the above.  Granted,  the list was compiled from the Trials and supposedly involved less than 2% of the patients.  But who knows in the real world how many more sides will  come to light.

    I started walking regularly again after becoming extremely lazy over the last couple of years.  I even jogged a bit though my 62 year old bones didn't care for that.  But this rocket fuel makes me feel like going outside and running around the block.  Wonder if I should report that as a side, lol.

    I'll be updating every now and then as this goes on.  Seems that I've been a guinea pig with the Low Dose Naltrexone for over 6 years (lab work in previous post)  and now I am joining thousands of others in being a guinea pig for Harvoni.  And taking it a step further by continuing the Low Dose Naltexone.

    Update after 4 days - doesn't feel so much like rocket fuel.  Don't feel bad - sometimes achy - sleeping better but probably because I am taking it now around 5:45 PM instead of at bedtime.  Do seem to have a somewhat short fuse at times....but as I have been under so much unending financial stress, it is not surprising. I had hoped to be in a better financial shape before doing the Harvoni in case I felt too bad to leave the house.  Neither has happened but it would be nice to just be able to stay home and not deal with the daily chore of finding food for me and the critters, paying bills and caring for the remaining 6 rescue cats....


    Tuesday, March 10, 2015

    6 Years Lab Tests Results and Low Dose Naltrexone

    I am posting some lab test results - going back to 2002, when I was first diagnosed with HCV.  I began taking 3 mg. Low Dose Naltrexone in February 2009.


    HCV PCR:

    12/12/2002 -   >500,000  LOG - 5.7
    01/03/2007 -   853,254
    01/15/2009 - 1,280,000 
    05/01/2009 - 49,400 after being on 3 months
    09/15/2009 - 18,729
    04/29/2010 - 11,300
    02/28/2011 - 16,500
    11/12/2012 - 16,288
    06/19/2013 - 13,973
    02/07/2014 - 34,284
    02/01/2015 - 37,934  -  Retest 02/19/2015 - 81,398? (had taken 2 ml LDN mixture 4 hours before)


    ALT/AST:  (ALT (6-29) - AST(10-35)

    10/18/2002 - 117/63
    12/12/2002 - 76/49
    05/20/2003 - 74/51
    09/23/2003 - 65/49
    03/18/2004 - 58/42
    10/24/2005 - 58/39 - post Katrina
    10/27/2007 - 140/72 
    09/11/2008 - 82/51
    01/15/2009 - 174/99
    05/01/2009 - 23/30  after LDN
    09/15/2009 - 36/37
    12/22-2009 - 34/31
    04/29/2010 - 25/30
    09/16/2010 - 24/31
    02/28/2011 - 33/30
    09/07/2011 - 27/28
    06/19/2013 - 31/30 
    02/08/2014 - 47/39 - after Girls Night Out party the day before (wine)
    02/01/2015 - 32/23


    BILIRUBIN TOTAL:( 0.2-1.2)

    12/12/2002 - 0.8
    05/20/2003 - 1.3
    10/04/2005 - 0.7
    10/27/2007 - 1.1
    09/11/2008 - 0.7
    01/15/2009 - 1.3
    05/01/2009 - .09
    09/15/2009 - 1.1
    12/22-2009 - 0.7
    04/29/2010 - 1.1
    09/16/2010 - 0.8
    02/28/2011 - 0.7
    09/07/2011 - 0.8
    06/19/2013 - 0.6
    02/08/2014 - 0.7
    02/01/2015 - .06

    ALKALINE PHOSPHATASE: (33-130)

    12/12/2002 - 64
    05/20/2003 - 46
    10/27/2007 - 60
    09/11/2008 - 74
    01/15/2009 - 55
    05/01/2009 - 58 after LDN
    09/15/2009 - 57
    12/22/2009 - 66
    04/29/2010 - 54
    09/16/2010 - 59
    02/28/2011 - 67
    09/07/2011 - 64
    11/28/2012 - 65
    06/19/2013 - 54
    02/08/2014 - 62
    02/01/2015 - 56

    ALBUMIN - (3.6-5.1)

    12/12/2002 - 4.3
    05/20/2003 - 4.6
    10/24/2005 - 4.3
    10/27/2007 - 4.9
    09/11/2008 - 4.8
    01/15/2009 - 5.2
    05/11/2009 - 5.0
    09/15/2009 - 4.9
    12/22/2009 - 4.8
    04/29/2010 - 4.9
    09/16/2010 - 4.9
    02/28/2011 - 5.0
    09/07/2011 - 5.1
    06/19/2013 - 4.9
    02/08/2014 - 5.1
    02/01/2015 - 4.8

    GLOBULIN - (2.3-3.5) now (1.9-3.7)

    12/12/2002 - 3.7
    10/27/2007 - 3.3
    09/11/2008 - 2.6
    01/20/2009 - 3.7
    50/11/2009 - 3.0
    02/08/2014 - 2.5
    02/01/2015 - 2.5


    TOTAL PROTEIN (6.1-8.3)

    12/12/2002 - 8.0
    10/27/2007 - 8.2
    09/11/2008 - 7.4
    01/20/2009 - 8.9
    05/11/2009 - 8.0
    02/07/2014 - 7.6
    02/01/2015 - 7.2



    Blood Urea Nitrogen (7-25)

    05/20/2003 - 4
    10/27/2007 - 9
    09/15/2009 - 9
    12/22/2009 - 8
    04/29/2010 -10
    09/16/2010 -10
    02/28/2011 - 11
    09/07/2011  - 8


    02/01/2015 - 12


    Prothrombin Time -(10.0-13.0)

    12/12/2002 - 10.1
    INR: 0.9

    05/20/2003 - 10.3
     INR - 0.9

    02/01/2015 -   10.1
    INR - 1.0


    FERRITIN (10-232)

    12/12/2002 - 95.4 (10.0-150)
    10/22/2007 - 176
    02/04/2008 - 93
    05/06/2008 - 92
    09/11/2008 - 60
    01/20/2009 - 115
    05/11/2009 - 83
    09/15/2009 - 80
    11/12/2012 - 89
    02/01/2015 - 73

    IRON TOTAL: (40-160) (45-160)

    12/12/2002 - 83

    02/01/2015 - 141

    IRON BINDING CAPACITY (250-450)

    12/12/2002 - 346

    02/01/2015 - 377


    ALPHA-FETOPROTEIN - TUMOR MARKER  <6 strong="">

    12/12/2002 - 3.40
    10/27/2007 - 4.0
    09/11/2008 - 4.9
    01/20/2009 - 5.2
    05/11/2009 - 6.1
    09/07/2011 - 5.2
    11/12/2012 - 5.1




    Platelet Count (140-400)

    12/12/2002 - 252
    05/23/2003 - 215
    10/24/2005 - 204
    10/27/2007 - 250
    09/11/2008 - 209
    01/20/2009 - 186
    05/11/2009 - 187
    02/07/2014 - 198
    02/01/2015 - 168


    WHITE BLOOD CELL COUNT (3.8-10.8)

    12/12/2002 - 7.2
    10/24/2005 - 6.0
    10/24/2007 - 5.8
    09/11/2008 - 5.8
    01/20/2009 - 6.0
    05/11/2009- 5.0
    02/07/2014 - 6.7
    02/01/2015 - 5.1


    RED BLOOD CELL COUNT (3.80-5.10)

    12/12/2002 - 3.99
    05/23/2003 - 4.10
    10/24/2005 - 4.25
    10/27/2007 - 4.07
    09/11/2008 - 4.03
    01/20/2009 - 4.21
    05/11/2009 - 3.96
    02/07/2014 - 4.14
    02/01/2015 - 3.77

    Absolute Neutrophils (1500-7800)

    10/27/2007 - 3509
    09/11/2008 - 3300
    01/20/2009 - 3750
    05/11/2009 - 2410

    Absolute Lymphocytes (850-3900)

    10/27/2007 - 1630
    09/11/2008 - 1966
    01/20/2009 - 1686
    05/11/2009 - 1950


    Hemoglobin AIC - <6 strong="">

    10/27/2007 - 5.4 
    10/25/2011 - 5.2 



    Misc. tests - only done once or twice by Integrative doctor:


    Fibrinogen (175-425)

    10/27/2007 - 239


    Insulin  <17 strong="">

    10/27/2007 - 6


     I will be adding more along the way - I have folders filled with lab results going back to 2002 -  some Katrina water logged -  I am still digging through all of them.