Monday, April 20, 2015

Harvoni Side Effects - Misc Info

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 - 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:

Body System HARVONI 8, 12 or 24 Weeksb
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




I will also list the side effects of Sofosbuvir - though the results were in combination with Ribavirin and others that included interferon.



Table 1. Treatment-Emergent Adverse Drug Reactions (Grade 2 and Higher) Reported in at Least 3% of Subjects in Any Treatment Arma,b PBO (N=71) SOVALDI +RBV 12 weeks (N=650) SOVALDI +RBV 24 weeks (N=250) PEG+RBV 24 weeks (N=243) SOVALDI +PEG+RBV 12 weeks (N=327)
Fatigue 4 (5.6%) 49 (7.5%) 13 (5.2%) 42 (17.3%) 39 (11.9%)
Anaemia 0 31 (4.8%) 7 (2.8%) 14 (5.8%) 46 (14.1%)
Insomnia 1 (1.4%) 19 (2.9%) 11 (4.4%) 22 (9.1%) 20 (6.1%)
Headache 0 22 (3.4%) 7 (2.8%) 15 (6.2%) 26 (8.0%)
Neutropenia 0 1 (0.2%) 0 23 (9.5%) 40 (12.2%)
Nausea 0 16 (2.5%) 4 (1.6%) 10 (4.1%) 18 (5.5%)
Irritability 0 10 (1.5%) 3 (1.2%) 13 (5.3%) 12 (3.7%)
Pruritus 0 7 (1.1%) 10 (4.0%) 8 (3.3%) 8 (2.4%)
Dyspnea 0 11 (1.7%) 5 (2.0%) 3 (1.2%) 13 (4.0%)
Depression 0 7 (1.1%) 2 (0.8%) 17 (7.0%) 5 (1.5%)
Influenza like illness 0 3 (0.5%) 2 (0.8%) 11 (4.5%) 11 (3.4%)
Decreased appetite 1 (1.4%) 7 (1.1%) 1 (0.4%) 12 (4.9%) 5 (1.5%)
Thrombocytopenia 1 (1.4%) 0 0 19 (7.8%) 6 (1.8%)
Myalgia 0 7 (1.1%) 2 (0.8%) 9 (3.7%) 6 (1.8%)
Rash 1 (1.4%) 3 (0.5%) 1 (0.4%) 11 (4.5%) 7 (2.1%)
Asthenia 0 3 (0.5%) 12 (4.8 %) 2 (0.8%) 3 (0.9%)


Less Common Clinical Trial Adverse Drug Reactions (<3 p="">  Treatment-emergent, related (to any active treatment) adverse drug reactions of at least moderate intensity (Grade 2 and higher) occurring in less than 3% of patients receiving SOVALDI are listed below by body system:
 
 

Table 2. Treatment-Emergent Adverse Drug Reactions (Grade 2 and Higher) Reported in < 3% of Subjects Receiving SOVALDI Body System SOVALDI + RBV SOVALDI + PEG-IFN + RBV
Blood and Lymphatic System Disorders Lymphadenopathy, lymphopenia, neutropenia Hemolytic anemia, leukopenia, thrombocytopenia
Ear And Labyrinth Disorders Vertigo N/A

Body System SOVALDI + RBV SOVALDI + PEG-IFN + RBV
Cardiac Disorders Palpitations N/A
Eye Disorders Amaurosis Fugax, dry eye, eye irritation, visual impairment Vision blurred
Gastrointestinal Disorders Abdominal discomfort, abdominal distension, abdominal pain, abdominal pain upper, anal inflammation, constipation, diarrhea, dry mouth, dyspepsia, epigastric discomfort, frequent bowel movements, gastritis, gastroesophageal reflux disease, nausea, stomatitis, tongue ulceration, toothache, vomiting Abdominal pain, abdominal pain lower, abdominal pain upper, aphthous stomatitis, cheilitis, constipation, diarrhea, dyspepsia, gastroesophageal reflux disease, glossitis, vomiting
General Disorders and Administration Site Conditions Asthenia, chest pain, chills, feeling abnormal, feeling cold, influenza like illness, irritability, malaise, nodule, oedema peripheral, pain, pyrexia, xerosis Asthenia, chest discomfort, chills, feeling abnormal, injection site rash, injection site reaction, pain, pyrexia, spinal pain
Hepatobiliary Disorders Hyperbilirubinaemia Hyperbilirubinaemia
Immune System Disorders Sarcoidosis Cryoglobulinaemia
Infections and Infestations Bronchitis, fungal infection, kidney infection, nasopharyngitis, oral herpes, upper respiratory tract infection, urinary tract infection, varicella Folliculitis, gastroenteritis viral, infected skin ulcer, skin bacterial infection, urinary tract infection
Injury, Poisoning and Procedural Complications Excoriation, sunburn, wound N/A
Investigations Blood glucose increased, eosinophil count increased, hemoglobin abnormal, hemoglobin decreased, heart rate increased, thyroid function test abnormal, weight decreased Blood creatinine increased, blood uric acid increased, hemoglobin abnormal, hemoglobin decreased, neutrophil count decreased, platelet count decreased, transaminases increased, weight decreased
Metabolism and Nutrition Disorders Decreased appetite, hyperglycemia, hypokalemia, increased appetite Decreased appetite, hyperglycemia, hyponatremia
Musculoskeletal And Connective Tissue Disorders Arthralgia, flank pain, muscle spasms, muscle twitching, myalgia, pain in extremity Arthralgia, back pain, muscle spasms, muscular weakness, myalgia
Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps) Basal cell carcinoma N/A
Nervous System Disorders Amnesia, burning sensation, disturbance in attention, dizziness, dysgeusia, lethargy, memory impairment, migraine, nerve root compression, neuropathy peripheral, paresis, restless legs syndrome Ageusia, amnesia, disturbance in attention, dizziness, dizziness postural, dysgeusia, loss of consciousness, mental impairment, migraine, sinus headache, tremor
Psychiatric Disorders Abnormal dreams, aggression, agitation, anxiety, apathy, confusional state, depressed mood, depression, hallucination, libido decreased, libido increased, mood altered, mood swings, nightmare, sleep disorder, suicidal ideation, suicide attempt, thinking abnormal
 
 


Affect lability, agitation, anxiety, confusional state, depression, distractibility, libido decreased, mood swings, restlessness, tachyphrenia

Body System SOVALDI + RBV SOVALDI + PEG-IFN + RBV
 
Renal and Urinary Disorders Renal failure N/A
Reproductive System and Breast Disorders N/A Pelvic pain
Respiratory, Thoracic and Mediastinal Disorders Cough, dyspnea, dyspnoea at rest, dyspnea exertional, nasal dryness, oropharyngeal pain Cough, nasal dryness
Skin And Subcutaneous Tissue Disorders Alopecia, asteatosis, dermatitis, dry skin, eczema, erythema, hyperhidrosis, night sweats, onychoclasis, photosensitivity reaction, pruritus, pruritus generalised, psoriasis, rash, rash generalised, rash macular, rash maculo-papular, rash papular, skin fissures Dermatitis, pruritus, psoriasis, rash, rash generalised, rash maculo-papular, urticarial
Vascular Disorders Hematoma, hot flush Hot flush, hypertension



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. 

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.