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Post Info TOPIC: New AbbVie drug approval and price


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New AbbVie drug approval and price
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Abbvie's Viekira Pak

Dec 19 (Reuters) - U.S. health regulators on Friday approved AbbVie's all-oral treatment for hepatitis C, and the company said the drug would cost $83,319 for a typical 12-week plan. Some insurers and analysts had said that AbbVie might price its drug, which will be sold under the brand name Viekira Pak, lower than Gilead because of pricing pressure. An AbbVie spokeswoman said the company considered many factors in setting the price such as the cost effectiveness of the treatment and its value in offsetting other short and long term costs. The AbbVie regimen consists of four different anti-viral drugs to be taken as three pills in the morning and one in the evening. The U.S. Food and Drug Administration approved the regimen for patients with genotype 1 form of the virus.The AbbVie regimen has demonstrated similar efficacy to Gilead's, with cure rates of 95 to 100 percent, the company said, and minimal negative side effects. AbbVie said that 95 percent of patients will require a 12 week treatment.

Looks like Genotype 1A with and w/o cirrhosis will need to also take ribavirin for 24 or 12 weeks respectively. GT 1B's w/o cirrhosis take no ribavirin and those with cirrhosis take ribavirin, both for 12 wks.

DOSAGE AND ADMINISTRATION
Recommended Dosage in Adults
VIEKIRA PAK is ombitasvir, paritaprevir, ritonavir fixed dose combination tablets copackaged with dasabuvir tablets.
The recommended oral dosage of VIEKIRA PAK is two ombitasvir, paritaprevir, ritonavir tablets once daily (in the morning) and one dasabuvir tablet twice daily (morning and evening). Take VIEKIRA PAK with a meal without regard to fat or calorie content  
VIEKIRA PAK is used in combination with ribavirin (RBV) in certain patient populations (see Table 1).  When administered with VIEKIRA PAK, the recommended dosage of RBV is based on weight: 1000 mg for subjects 75 kg and 1200 mg/day for those >75 kg, divided and administered twice-daily with food.

It's good to know that there are alternatives, but this is going to be a bit tougher regimen to adhere to and add on the price of

the ribavirin and the price is going to be closer to Harvoni's price than payers may have been hoping for.

Whoops this should have been added to Mallini's post, sorry about that. 



-- Edited by Beacon on Saturday 20th of December 2014 02:52:43 AM

__________________

GT 1a, was tx naļve, cirrhotic(Fibrosure), 64 y.o. Started Harvoni 12/12/14 for 12 wks. EOT weeks 4, 13, and 24 HCV not detected! HVC not detected EOT plus one year.

A smooth sea doesn't make for a skillful sailor.

 

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