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Hep C Discussion Forum -> Hep C News -> Gilead Warning from FDA
Post Info TOPIC: Gilead Warning from FDA
Miracleinprogress


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RE: Gilead Warning from FDA
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Thanks Tig....Waiting for results so when he calls I have numerous things to talk about
1. Referral to a Gastroenterologist
2. I think an EKG would be smart
3. Viral Load since they missed that in the lab tests
4. Like to try the Fibroscan and not fibrosure
5. Let him know I don't want to put my body through the Sovaldi/Oylsio since it's not approved.

Alot of those questions, you guys helped my mind think of

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Genotype 2b. Not in treatment yet. F4-Cirrhosis (they say) Unknown years. Could be 51 or 35 years.
Tig


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Hi Taylor,

The warning only addresses the adverse reaction (slow heartbeat) with the medication Amiodarone. It makes no mention of any other cardiac issues related to Harvoni. Did your doctor perform an EKG before you started treatment? If not you might mention your concern to your doctor next time. I don't think you have anything to be concerned about, but always check with your doctor for confirmation.

Tig



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Tig

68yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 9+ years!

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Miracleinprogress


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So does this mean it only interacts with the amiodarone and not someone who may have an undiagnosed irregular heart beat (A-Fib)? Just curious. I know the drug as my mom was on it and knew it caused respiratory problems as well. Also, does the drug lower heart rate for normal users?



-- Edited by Miracleinprogress on Monday 23rd of March 2015 07:29:47 PM

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Genotype 2b. Not in treatment yet. F4-Cirrhosis (they say) Unknown years. Could be 51 or 35 years.
Tig


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Hi Susan,

Thank you for the information. We were notified of this yesterday. We always appreciate your  informational posts. This is an important update from both Gilead and the FDA and anyone that missed the link posted yesterday should take the time to read this warning. It's important to note that these are new protocols and those of you taking these medications need to tell your doctor about any side effects you're experiencing! 

Tig



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Tig

68yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 9+ years!

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suziq


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Its never good news when one of your drugs turns out to have caused the death of a patienteven if there are extenuating circumstancesand thats certainly the case for Gilead Sciences (GILD) today.
Gilead Sciences
Gileads shares have dropped 1.9% to $100.36 at 10:30 a.m. after the biotech giant disclosed that its hepatitis-C treatmentsHarvoni and Sovaldihad caused a slowing heart rate in patients taking amiodarone for irregular heartbeats. The problem caused one death, and required other patients to have pacemakers installed.
Bernsteins Geoffrey Porges and team, however, call the news a non-event for Gilead, and dont believe it will give an advantage to AbbVie (ABBV). For starters, the number of patients who use amiodarone is quite small, they say, while its unlikely that patients with hepatitis-C have higher instances of its use. Finally, the riskiness of combining these type of treatments with amiodarone are already well known, and even included on the label for AbbVies Viekera Pak. Its hard to make the case that AbbVies drug is any safer for the few HCV patients taking amiodarone than Sovaldi/Harvoni,


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Geno 1A  Age 82 Treatment naive Cirrhotic Told I had liver disease in 1966. Diagnosed as Hep C 1999.Started Merck clinical trial with Riba on 9/9/2013 Week 1 and 2 <25  Weeks 4, 8, 12,16,18 UND.  EOT Jan 14,2014  EOT +12 UND   JULY 1 2014 EOT+24= SVR
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