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  • #13352
    dope-on-a-rope.jpgDr James
    • Guardian Angel
    • ★★★★★
    @fixhepc

    Greg Jefferys pass along a Freedom of Information Request made to the FDA relating to reported side effects (adverse drug reactions for Harvoni).

    Here it is in the form delivered:

    Harvoni(2275)-DetailedReport.pdf

    Which is a bit hard to get your head round, but here is what happens if you run it through a bit of software to calculate the frequency of the reports (anything that was reported < 3 times has been ignored. 20.8% (158/759) Headache 18.1% (137/759) Fatigue 5.9% (45/759) Insomnia 5.7% (43/759) Nausea 5.7% (43/759) Diarrhoea 3.7% (28/759) Rash 3.2% (24/759) Anxiety 2.8% (21/759) Vomiting 2.0% (15/759) Nasopharyngitis 2.0% (15/759) Pain 1.8% (14/759) Dyspnoea 1.8% (14/759) Dizziness 1.8% (14/759) Dyspepsia 1.7% (13/759) Abdominal pain 1.7% (13/759) Hypertension 1.7% (13/759) Blood pressure increased 1.7% (13/759) Pruritus 1.4% (11/759) Pyrexia 1.4% (11/759) Depression 1.4% (11/759) Myalgia 1.4% (11/759) Feeling abnormal 1.4% (11/759) Peripheral swelling 1.4% (11/759) Chest pain 1.4% (11/759) Abdominal pain upper 1.3% (10/759) Tinnitus 1.3% (10/759) Influenza 1.3% (10/759) Hepatitis 1.2% (9/759) Cough 1.2% (9/759) Malaise 1.2% (9/759) Arthralgia 1.2% (9/759) Back pain 1.2% (9/759) Weight decreased 1.2% (9/759) Chills 1.2% (9/759) Abdominal discomfort 1.2% (9/759) Confusional state 1.2% (9/759) Pain in extremity 1.2% (9/759) Overdose 1.1% (8/759) Muscle spasms 1.1% (8/759) Constipation 1.1% (8/759) Drug dose omission 1.1% (8/759) Irritability 1.1% (8/759) Influenza like illness 1.1% (8/759) Accidental overdose 1.1% (8/759) Encephalopathy 1.1% (8/759) Somnolence 1.1% (8/759) Rash generalised 0.9% (7/759) Asthenia 0.9% (7/759) Alopecia 0.9% (7/759) Sleep disorder 0.9% (7/759) Drug interaction 0.9% (7/759) Aspartate aminotransferase increased 0.9% (7/759) Decreased appetite 0.8% (6/759) Gastrooesophageal reflux disease 0.8% (6/759) Alanine aminotransferase increased 0.8% (6/759) Death 0.8% (6/759) Convulsion 0.8% (6/759) Sinusitis 0.8% (6/759) Migraine 0.8% (6/759) Ascites 0.8% (6/759) Drug ineffective
    0.8% (6/759) Agitation
    0.7% (5/759) Flatulence
    0.7% (5/759) Pneumonia
    0.7% (5/759) Blood bilirubin increased
    0.7% (5/759) Dysphagia
    0.7% (5/759) Haemoglobin decreased
    0.7% (5/759) Rash erythematous
    0.7% (5/759) Chest discomfort
    0.7% (5/759) Oropharyngeal pain
    0.7% (5/759) Abdominal distension
    0.7% (5/759) Vision blurred
    0.7% (5/759) Blood glucose increased
    0.7% (5/759) Visual impairment
    0.7% (5/759) Blood creatinine increased
    0.5% (4/759) Hyperhidrosis
    0.5% (4/759) Abnormal dreams
    0.5% (4/759) Cardiac failure congestive
    0.5% (4/759) Sepsis
    0.5% (4/759) Unknown
    0.5% (4/759) Syncope
    0.5% (4/759) Nightmare
    0.5% (4/759) Lower respiratory tract infection
    0.5% (4/759) Lymphadenopathy
    0.5% (4/759) Condition aggravated
    0.5% (4/759) Stomatitis
    0.5% (4/759) Palpitations
    0.5% (4/759) Hot flush
    0.5% (4/759) Renal impairment
    0.5% (4/759) Fluid retention
    0.5% (4/759) Pruritus generalised
    0.4% (3/759) Renal failure acute
    0.4% (3/759) Local swelling
    0.4% (3/759) Blood phosphorus decreased
    0.4% (3/759) Hypoglycaemia
    0.4% (3/759) Retching
    0.4% (3/759) Balance disorder
    0.4% (3/759) Chromaturia
    0.4% (3/759) Memory impairment
    0.4% (3/759) Hepatic failure
    0.4% (3/759) Product
    0.4% (3/759) Bronchitis
    0.4% (3/759) Rash pruritic
    0.4% (3/759) Blood alkaline phosphatase increased
    0.4% (3/759) Dermatitis bullous
    0.4% (3/759) Anaemia
    0.4% (3/759) Epistaxis
    0.4% (3/759) Blood potassium decreased
    0.4% (3/759) Epilepsy
    0.4% (3/759) Toxicity to various agents
    0.4% (3/759) Vertigo
    0.4% (3/759) Dehydration
    0.4% (3/759) Cerebral haemorrhage
    0.4% (3/759) Asterixis
    0.4% (3/759) Psychomotor hyperactivity
    0.4% (3/759) Blood pressure fluctuation
    0.4% (3/759) Urticaria
    0.4% (3/759) Feeling cold
    0.4% (3/759) Cardiac arrest
    0.4% (3/759) Upper respiratory tract infection
    0.4% (3/759) Unevaluable event
    0.4% (3/759) Disorientation
    0.4% (3/759) Speech disorder
    0.4% (3/759) Diazepam
    0.4% (3/759) Cognitive disorder
    0.4% (3/759) Nephrotic syndrome
    0.4% (3/759) Hepatic cirrhosis


    YMMV

    #13356
    Avatar photoLondonGirl
    • Guardian Angel
    • ★★★★★
    @londongirl

    “Sinusitis” and “Lower resporatory tract infection/ Bronchitis” – Tick tick Plus others….”Feeling cold” !
    Had the former for 4 weeks now, in afyone is suffering Saline solution spray gelps, natural sea salt.

    Interesting for Dan – “Balance disorder”


    GT1a Dec14 F2/8.7 VL 900000-2.5M
    Jan16 Hepcivir-L MonkMed/Redemption
    Baseline: VL 913575 Alt 76 Platelets low
    Wk2 VL1157 Alt 23
    DET Wk 8 VL 32 Alt19 ‘In the slow lane’
    June16 Fibro 5.7 F0/1 LIF 1.5
    Wk 11 VL<12 Alt 13 Det/Unq
    Extending tx 12 wks Mylan Sofo/Dac MonkMed
    Wk 14 VL <12 Det/Unq
    Wk 16 VL UNDETECTED
    Wk 22 + 4 Wks Sunprevir FixHepC
    Wk 24 UNDETECTED Alt 13
    Wk 12 post tx SVR12 Wk 26 SVR24
    Thank-you Tim, Dr Debasis @ MonkMed & Dr Freeman @ Fix HepC

    #13361
    Avatar photodarbara
    • Guardian Angel
    • ★★★★★
    @darbara

    Edema


    Treatment naive
    F 3/4
    Genotype 1 a & b
    V/L 17 MILLION
    Started Harvoni 11th Dec 2015 for 12 weeks
    4 weeks VL UND
    6 WEEKS ALT 32, AST 34
    EOT 03/03 2016 ! UND
    ALT 34, AST 26
    04.04.2016 SVR 4
    26.05.2016 SVR 12
    16.08.2016 SVR 24

    #13366
    dope-on-a-rope.jpgDr James
    • Guardian Angel
    • ★★★★★
    @fixhepc

    Edema

    If you add up all of these different ways of saying it you get to perhaps as much as 4.7%

    1.4% (11/759) Peripheral swelling
    0.8% (6/759) Ascites
    0.7% (5/759) Abdominal distension
    0.5% (4/759) Cardiac failure congestive
    0.5% (4/759) Fluid retention
    0.4% (3/759) Local swelling
    0.4% (3/759) Nephrotic syndrome


    YMMV

    #16423
    Avatar photoPrice
    • Guardian Angel
    • ★★★★★
    @price

    Have you heard of anybody having cardiac problems AFTER they finish treating with Harvoni?

    P.

    #16430
    Avatar phototweakmax
    • Guardian Angel
    • ★★★★★
    @tweakmax

    Maybe before they start treatment, when they find out the price.

    #16432
    avatar876.jpegGaj
    • Guardian Angel
    • ★★★★★
    @gaj

    #roflmao

    Thanks tweakmax, that made my evening!

    (Given the overall patient profile involved, a few cardiac problems are probably par for the course but I suspect there have been no instances directly attributed to the Harvoni as yet or we would likely have heard)


    G3a since ’78 – Dx ’12 – F4 (2xHCC)
    24wk Tx – PEG/Riba/Dac 2013 relapsed
    24wk Tx – Generic Sof/Dac/Riba 2015/16 relapsed
    16wk Tx – 12/01/17 -> 03/05/17 NS3/NS5a + Generic Sof
    SVR7 – 22/06/17 UND
    SRV12 – 27/07/17 UND
    SVR24 – 26/10/17 UND
    :cheer: :cheer: :cheer:

    #20663
    Jony0081
    • Topics: 0
    • Replies: 1
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    • Novice
    @jony0081

    Thanks this is very useful information for me..

    #20690
    Avatar photoSven
    • Guardian Angel
    • ★★★★★
    @sven

    Now that is funny!


    Contracted HCV 1980’s
    Geno Type 1a
    F3 ( doc says once treated I’ll be F2 maybe F1)
    Meds shipped 6/17/2016 arrived early 7/2016

    Viral count – 3,471,080

    4 week quantitative bloods: August 17, 2016. I have been diagnosed as <15 (told undetected)

    8 week quantitative bloods: September 14th. I have been diagnosed as <15 (told undetected)

    11 week PCR RNA Qualitative bloods: September 26th 2016 – Undetected

    December 19th 2016: Cured!
    Viral count: zero!!!
    2018 viral count: still zero!
    Cured!

    #20753
    Avatar phototweakmax
    • Guardian Angel
    • ★★★★★
    @tweakmax

    i have hypertension after treatment

    146/96

    #20832
    dope-on-a-rope.jpgDr James
    • Guardian Angel
    • ★★★★★
    @fixhepc

    Borderline. After you get your SVR12 and relax check it again


    YMMV

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