I started this post last year after my one year post-Harvoni lab reports - which by the way, were very good! My labs were really outstanding - Viral load still Undetectable - My ALT was 16 - that has never been that low since forever. The LDN helped keep all of my liver enzymes in the normal range pre-harvoni but 24 was the lowest that ALT got with LDN. CBC, etc. all normal range! Ultrasound was pretty much the same pre-treatment. But I never got around to posting it - anyway, 2 years later!
I really haven't had any bad type sides in some time - however, I did seem to be in a state of inertia - just didn't feel like doing too much. Like updating this blog! This was attempt #26 at actually publishing something.
2017 POST HARVONI RESULTS:
HCV RNA - NOT DETECTED
CMP - All in range - ALT 14 (6-29) AST 19 (10-35) ALBUMIN 4.9 (3.6-5.1) ALK PHOS 61 (33-130)
CBC - All in range - RED BLOOD CELL - 4.12 (3.80-5.10) PLATELET - 228 (140-400)
The only kind of troubling result was the Abdominal Ultrasound - this time with Elastography included. Mild hepatomegaly (liver enlargement - actually same as last U/S) All other visible organs, ducts, etc. all normal. However...
IMPRESSION
" Liver demonstrates coarse heterogeneous texture consistent with diffuse hepatocellular disease."
Elastography metrics suggest liver fibro staging/Metavir score of (F2-F3);[ Mild-Moderate]
Geez, why didn't they just say consistent with chronic liver disease? This makes it sound that I am well on my way to HCC! I hate U/S's - this was my 12th one since 2003 and there is always something in them that is disconcerting. And this result was disappointing as I had expected that my liver would have improved with the elimination of the HCV. (As other folks claim have happened or hope to have happened) A friend of mine with cirrhosis just completed a successful treatment with Epclusa (with Riba) He insisted that he have a Fibrosure test done soon after - despite his doctor (and me) telling me that taking the test would not be helpful. And it wasn't of course. But my friend is an example of some folk's expectation of what these DAA's can do. That the elimination of the HCV will immediately reverse any damage done to the liver!
My gastro seemed to think that my results were similar to those of 2 years ago (pre-harvoni) on the Fibrosure test. He wasn't concerned as my liver function tests were perfect. He said that I am no where near cirrhosis and that I had "plenty of liver left!)
I must admit that I did not take any ALA (alpha-lipoic-acid) and greatly reduced my milk thistle over the last year or so. Guess I was another one who thought that maybe I didn't need to take liver supplements anymore as I no longer had a measurable viral load? I also indulged a bit more with wine and gluten free beer than I had in a very long time. So with that info, my U/S was really not that bad. I immediately began the ALA and upped the milk thistle dosage back to where it had been.
As far as drinking - this seems to be a touchy subject - Seems to me that most folks just want to go back to the life that they had prior to being diagnosed with HCV. And if that included wine with dinner or a few beers, then so be it. Others consider it the height of foolishness to drink at all. Comes down to common sense to me - if you are near a transplant or have had one, then don't drink. If not, then do what you want - but again, I live in New Orleans.
Been feeling pretty good - but still struggling with poverty and 5 cats. I am still reeling over the deaths of Smoke and Velvet this year - my 11 year old siblings that were rescued in 2006 post-Katrina New Orleans. The original Katrina Survivor cats still with me are down to three: 16 year old Tortie Miss and Woody Woodlawn. Sky is 13. Voodoo, the City Park rescue cat from 2012 is probably around 7 or so - he is FIV positive. And even though I swore I would never get another cat, Matilda found me over a year ago underneath my car in a Goodwill Parking lot. She initially tested FLV positive as a kitten but was clear on the follow up tests. All of the cats get LDN 2-3 times a week.
I have lost a bit of weight since the HARVONI 2 summers ago. Currently around 100 lbs or so - my weight fluctuates so much - will be 100 one day and 104 the next. My teeth are probably part of the reason that I cannot keep weight on. Back in 2007 or so, (back when I had $$$ to spend on all of this health stuff!) I had all of my mercury amalgams removed. Temporary crowns were placed in that have now, of course, all fallen out. I ran out of money to fix them. So it's very hard to chew and properly digest what food I do eat. Also, I have heard that Harvoni (and other DAAs) can be very hard on one's teeth. Thankfully, I just was able to get a Medicare supplement that includes some dental care - so we shall see.
The other reason for my weight problem is that I usually have no appetite at all. Marijuana (medical or dirt) helps immensely with my food intake! The good (expensive stuff) helps with all of the above - appetite, pain, energy levels, etc. The Fibromyalgia still flares at times - I can feel really stiff, achy and glued to the couch at times. The medical grade gets me up and moving, stretching and even going on walks. I still take Soma as a muscle relaxer - tho for me, it acts more as an anti-anxiety tool.
Oh. As there have been the troubling studies showing possible serious problems with the Direct Acting Antivirals (DAA's) Reactivation of Hep B....cancer recurrence or new cancers found, etc. I insisted that my doctor run a complete HBV panel as well. Same results - have the antibody and am considered immune to it - so the doctors say.
Heb B Virus DNA - <20 -="" detected="" nbsp="" not="" p="">
Hep B Surface Antigen W/REFL CONFIRM - NON-REACTIVE
Hep B Surface Antibody (Quant) - 13miU/ml Normal Range >10 - Comments: Patient has immunity to hepatitis b virus
I am taking around 2 mls of LDN 3-4 times a week in the morning. Still getting the 50mg tablets and mixing my own. But am looking for a primary care doc who would be open to prescribing it, as well as ordering tests like Vitamin D and B levels, etc. Am also still wheat free - since 2008 or so.
So here I am - HCV free after a 15 year journey since my diagnosis in October 2002. Just in time for my 65th birthday in January. Overlong ridiculous strange trip that I hope/thought was over with...?
Anyway, sorry that it has taken so ridiculously long to update this. I continue to receive comments and emails and post them whenever I can. Thanks for reading!
Tuesday, October 10, 2017
Friday, September 18, 2015
Cured! Hep C Virus Undetectable!!
14 weeks after taking my last Harvoni in early June, 2015, I tested Undetectable on my HCV RNA test yesterday. I was previously U/D on the 4 and 10 week labs as well.
So according to my doctor, I am cured. I am hearing about other protocols that recommend further testing at 24 weeks. Guess it depends on who your doctor is. The nurse said to see him again in 6 months. Ended up arguing with her as there was no CBC or CMP tests done. Could she ask the doctor to please run them? She said that as my viral load was now normal, all of my liver enzymes were probably normal so not to worry about it. Sure, guess it's wrong of me to want to know the state of my liver, kidney, thyroid, platelets, etc after undergoing a powerful new medication where no long term side effects studies have been done. But that's just me. Believe me, it was a relief to see that last Not-Detected and I am thrilled to be rid of this crap! See update below:
UPDATE: Weeks later, I did finally get labs done and all of my numbers look great! Granted they were never bad to begin with....at any rate, most are the same or some either better?
In January 2015, my ALT/AST was at 32/23 (range - 6-29/10-35)
In May, after one month of Harvoni, my ALT/AST was 28/34
Sept. 2015 ALT/AST - 14/17
Wasn't much change in red blood cells or platelets - both ok. The Absolute Neutrophils went from 2611 back in January up to 4345 presently. Nothing much else.
I'd love to be able to afford to go back to my integrative doc, who would run a lot more tests! Vitamin D3, Magnesium, all of the B vitamins, and all of the thyroid tests besides the TSH, Iron and Ferritin, etc. Although my labs were pretty much perfect, I'd like to know if and what I am or have become deficient in. I do feel much better - don't know if it's because of no longer having HCV or just that I felt so crappy during and after treatment.
I guess that I am cured - or just have such a low percentage of virus left that it can't be measured. On the other hand, I "feel" cured. I have felt much better these last few weeks.
I had labs done on Monday (were supposed to have been done 2 weeks previously) and was expecting results - I got an email to check my "Patient Portal" - and the big U/D report was there.
I am very happy for sure....however, it will always be in the back of my mind...
So, we shall see - hopefully, 5 years down the line, if I am even still here, I will still remain negative for HCV - and forever. Much more will be learned in the future.
So according to my doctor, I am cured. I am hearing about other protocols that recommend further testing at 24 weeks. Guess it depends on who your doctor is. The nurse said to see him again in 6 months. Ended up arguing with her as there was no CBC or CMP tests done. Could she ask the doctor to please run them? She said that as my viral load was now normal, all of my liver enzymes were probably normal so not to worry about it. Sure, guess it's wrong of me to want to know the state of my liver, kidney, thyroid, platelets, etc after undergoing a powerful new medication where no long term side effects studies have been done. But that's just me. Believe me, it was a relief to see that last Not-Detected and I am thrilled to be rid of this crap! See update below:
UPDATE: Weeks later, I did finally get labs done and all of my numbers look great! Granted they were never bad to begin with....at any rate, most are the same or some either better?
In January 2015, my ALT/AST was at 32/23 (range - 6-29/10-35)
In May, after one month of Harvoni, my ALT/AST was 28/34
Sept. 2015 ALT/AST - 14/17
Wasn't much change in red blood cells or platelets - both ok. The Absolute Neutrophils went from 2611 back in January up to 4345 presently. Nothing much else.
I'd love to be able to afford to go back to my integrative doc, who would run a lot more tests! Vitamin D3, Magnesium, all of the B vitamins, and all of the thyroid tests besides the TSH, Iron and Ferritin, etc. Although my labs were pretty much perfect, I'd like to know if and what I am or have become deficient in. I do feel much better - don't know if it's because of no longer having HCV or just that I felt so crappy during and after treatment.
I guess that I am cured - or just have such a low percentage of virus left that it can't be measured. On the other hand, I "feel" cured. I have felt much better these last few weeks.
I had labs done on Monday (were supposed to have been done 2 weeks previously) and was expecting results - I got an email to check my "Patient Portal" - and the big U/D report was there.
I am very happy for sure....however, it will always be in the back of my mind...
So, we shall see - hopefully, 5 years down the line, if I am even still here, I will still remain negative for HCV - and forever. Much more will be learned in the future.
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
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.
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:
Conclusions:
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.
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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!
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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.
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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
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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.
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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.
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