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Post Info TOPIC: Abbvie announce New Drug Application for once daily, fixed-dose formulation for Viekira Pak accepted by FDA
Tig


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RE: Abbvie announce New Drug Application for once daily, fixed-dose formulation for Viekira Pak accepted by FDA
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Mike,

VPak has the potential to be toxic in people with severe hepatic impairment. It's the manner in which the drugs are eliminated that may lead to the toxicity. Here's the wtitten warning on it:

"2.3 Hepatic Impairment    No dosage adjustment of VIEKIRA PAK is required in patients with mild hepatic impairment (Child-Pugh A). VIEKIRA PAK is not recommended in patients with moderate hepatic impairment (Child-Pugh B). VIEKIRA PAK is contraindicated in patients with severe hepatic impairment (Child-Pugh C).

 

CONTRAINDICATIONS

  • If VIEKIRA PAK is administered with ribavirin, the contraindications to ribavirin also apply to this combination regimen. Refer to the ribavirin prescribing information for a list of contraindications for ribavirin.
  • VIEKIRA PAK is contraindicated in patients with severe hepatic impairment due to risk of potential toxicity.  VIEKIRA PAK is contraindicated with: 
    • Drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events.
    • Drugs that are strong inducers of CYP3A and CYP2C8 and may lead to reduced efficacy of VIEKIRA PAK.Drugs that are strong inhibitors of CYP2C8 and may increase dasabuvir plasma concentrations and the risk of QT prolongation

- See more at: http://hepatitiscnewdrugresearch.com/viekira-pakombitasvir-paritaprevir-dasabuvir.html#.dpuf"



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Tig

66 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 8+ years!

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VIEKIRA PAK is not for people with decompensated cirrhosis.

 What is the reason for this? What other treatment option would be preferred? Some form of Hep C treatment would be required even with a transplant. I don't understand what disqualifies this regimen for those with decompensated cirrhosis. I'm glad I wasn't disqualified for Sov / Riba last year.



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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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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.

Tig


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Thanks for the update Jill. This is a good improvement for this protocol. It will provide a simpler dosing schedule which should improve compliance. Those on Ribavirin will still have to dose twice daily, but still, the main drug components of the V Pak Tx will be reduced to once daily. To me "Simpler = Better" *

 

*especially for the brain fogged smile

 



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Tig

66 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 8+ years!

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Dec. 2, 2015 - AbbVie today announced its New Drug Application has been accepted by the U.S. FDA for a once-daily, fixed-dose formulation of the components of VIEKIRA PAK (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets).  VIEKIRA PAK is an all-oral, interferon-free treatment approved with or without ribavirin in the U.S. for patients with gen 1 chronic hep C infection, including those with compensated cirrhosis. VIEKIRA PAK is not for people with decompensated cirrhosis.

The proposed dosing for the fixed-dose formulation (dasabuvir, ombitasvir, paritaprevir, ritonavir tablets) is three oral tablets once daily with a meal, with or without twice-daily RBV, potentially offering another important treatment option for people living with GT1 HCV.  The NDA filing is supported by data from two bioavailability studies.

Currently, VIEKIRA PAK is taken twice daily as three tablets in the morning and one tablet in the evening, taken with a meal.

Link to full press release...

 

AbbVie Press Release



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Jill 

(71 yo, lives in UK)

Was Gen 3a, 

24wks Peg Ifn/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT, 

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

 

 

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