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Hep C Discussion Forum -> Hep C News -> FDA Warning Issued over Viekira Pak/Technivie
Post Info TOPIC: FDA Warning Issued over Viekira Pak/Technivie
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RE: FDA Warning Issued over Viekira Pak/Technivie
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Rest assured, this warning was already supplied to the pharmacy and patient when the prescription was issued. Looks like there may be some misdiagnosed people out there or this could be just Big Pharma.   Stay educated. Know your Doctor.  It's not he end of the world.  "I feel Fine".



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60 yrs. Geno1b 2001. 9mil. VL. �Failed Post Riba/Peg tx. 2006 46 weeks. Diagnosed 1A 2015(?) F3 fibr. 225k VL. Vikera/Riba 12 weeks 3/20/2015. "Undetected" start to finish. Undetected 1yr post tx.
Penelope PePod


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Thanks, Mike.  Living my life, being positive, no worries.  Feels better!



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65;  Dx 1997 1a; VL 1.1m; TX naïve; SOT 7/20/15; 12 wks viek/riba 1200mg

09/14/15 draw: Undetected 8 wks into tx

10/12/15 draw: Undetected at EOT

01/05/16 draw: Undetected at E0T+12
wmlj1960


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Penelope PePod wrote:

Seems like I'm always thanking you.  You're like a knight in shining armor!

 We all are Penny. Dr. Tig takes very good care of all of his patients on here. smile Now you do like the doctor says and live your life. Worry will do nothing but rain on your parade. Be careful on your way to Texas and ENJOY!



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60 yo, geno 1a, Dx 1994 HCV-HIV co-inf, Dx 2013 decompensated cirrhosis
Tx #1 - 24wks Sov+Riba /SOT 7-24-2014/UND@EOT/DETECTED@EOT+16 wks
Tx #2 - 24wks Harvoni /SOT 7-25-2015/UND@EOT,+12,+24,+52 = SVR

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Penelope PePod


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Seems like I'm always thanking you.  You're like a knight in shining armor! ..... and that's a negative on the riba rocket! 



-- Edited by Penelope PePod on Friday 23rd of October 2015 06:11:55 AM

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65;  Dx 1997 1a; VL 1.1m; TX naïve; SOT 7/20/15; 12 wks viek/riba 1200mg

09/14/15 draw: Undetected 8 wks into tx

10/12/15 draw: Undetected at EOT

01/05/16 draw: Undetected at E0T+12
Tig


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Rest easy my friend! You're not driving that 12 ton Riba Rocket are you? LOL! Drive safe and don't let this get you flustered. It's going to be fine!



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Tig

67yo 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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Penelope PePod


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Tig,

Paul is a Childs Pugh class A cirrhotic, so it looks like I'm worrying for nothing, as usual.  Gonna try to get some sleep now.  Starting our drive to Texas tomorrow morning.

Thanks again, P. 



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65;  Dx 1997 1a; VL 1.1m; TX naïve; SOT 7/20/15; 12 wks viek/riba 1200mg

09/14/15 draw: Undetected 8 wks into tx

10/12/15 draw: Undetected at EOT

01/05/16 draw: Undetected at E0T+12
Tig


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Penny,

The data indicates that the possibility of adverse events in the Childs Pugh classes B and C. I'll add a link to a Medscape article that describes it in a bit more detail. I want you to remember that this isn't a warning that indicates this will cause these adverse events, but warns of the possibility and to be aware of it. While the incidence remains low, they still have to make the announcement. Chances are good that no issues will occur at all, but doctors are now being advised to watch for these potential problems in all of their cirrhotic patients, particularly the advanced cirrhotics, classes B and C. It is still indicated for administration for those considered a a Childs-Pugh class A cirrhotic. This warning adds additional monitoring for the patient with cirrhosis, that's all. The more monitoring and attention to detail is good for the patient.

"[T]he labels now state a [contraindication] in patients with moderate to severe hepatic impairment (Child-Pugh B and C). The label previously did not recommend Viekira Pak in Child-Pugh B and was contraindicated in Child-Pugh C," according to an AbbVie statement"

Viekira Pak, Technivie May Up Serious Liver Injury Risk: FDA      (May have to register for this Medscape site)



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Tig

67yo 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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Penelope PePod


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Tig,

Can you define 'advanced'?  My husband Paul has had cirrhosis for 10 or 15 years, portal hypertension and esophageal varices, but he is not decompensated. Do you think that would be considered advanced?  I'm gonna put a call in to the PA at his doc's office right now.

Thanks, P. 



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65;  Dx 1997 1a; VL 1.1m; TX naïve; SOT 7/20/15; 12 wks viek/riba 1200mg

09/14/15 draw: Undetected 8 wks into tx

10/12/15 draw: Undetected at EOT

01/05/16 draw: Undetected at E0T+12
Tig


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Here is the update AbbVie applied to their prescribing information. From their admission, it appears that it applies to those with advanced cirrhosis.

"WARNINGS AND PRECAUTIONS Hepatic Decompensation and Hepatic Failure in Patient with Cirrhosis: Hepatic decompensation and hepatic failure, including liver transplantation or fatal outcomes, have been reported mostly in patients with advanced cirrhosis. Monitor for clinical signs and symptoms of hepatic decompensation."

HIGHLIGHTS OF PRESCRIBING INFORMATION



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Tig

67yo 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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Tig


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The FDA just issued a warning regarding a potential risk to patients with cirrhosis (advanced fibrosis) that are taking the Abbvie drug protocols Viekira Pak and Technivie. Abbvie is updating their literature and notifying physicians of this possible adverse reaction. If you fall into this category and have questions or problems you think may be related to this, don't hesitate to contact your doctor. This states that it only applies to advanced cirrhosis. We'll keep a close eye on this.

FDA warns of serious liver injury risk with AbbVie hep C drugs

FDA Warning - AbbVie



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Tig

67yo 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!

Hep C FAQ   Lab Ref. Ranges  HCV Resistance

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