Official FOI FDA Side Effect Reports

This topic has 10 replies, 8 voices, and was last updated 8 years, 9 months ago by Dr James.

Viewing 10 posts - 1 through 10 (of 10 total)

Author

Posts
5 March 2016 at 11:18 am #13356
LondonGirl
- Topics: 16
- Replies: 1,348
- Total: 1,364
- 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
5 March 2016 at 12:33 pm #13361
darbara
- Topics: 6
- Replies: 166
- Total: 172
- 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
5 March 2016 at 1:33 pm #13366
Dr James
- Topics: 264
- Replies: 1,968
- Total: 2,232
- 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
30 April 2016 at 10:10 am #16423
Price
- Topics: 6
- Replies: 231
- Total: 237
- Guardian Angel
@price
Have you heard of anybody having cardiac problems AFTER they finish treating with Harvoni?

P.
30 April 2016 at 1:06 pm #16430
tweakmax
- Topics: 18
- Replies: 238
- Total: 256
- Guardian Angel
@tweakmax
Maybe before they start treatment, when they find out the price.
30 April 2016 at 1:22 pm #16432
Gaj
- Topics: 29
- Replies: 1,402
- Total: 1,431
- Guardian Angel
@gaj
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
7 July 2016 at 4:29 pm #20663
Jony0081
- Topics: 0
- Replies: 1
- Total: 1
- Novice
@jony0081
Thanks this is very useful information for me..
8 July 2016 at 6:45 am #20690
Sven
- Topics: 6
- Replies: 327
- Total: 333
- 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!
9 July 2016 at 7:06 pm #20753
tweakmax
- Topics: 18
- Replies: 238
- Total: 256
- Guardian Angel
@tweakmax
i have hypertension after treatment

146/96
11 July 2016 at 9:29 pm #20832
Dr James
- Topics: 264
- Replies: 1,968
- Total: 2,232
- Guardian Angel
@fixhepc
Borderline. After you get your SVR12 and relax check it again

YMMV
Author

Posts

Viewing 10 posts - 1 through 10 (of 10 total)

You must be logged in to reply to this topic.