It's official: Harvoni issued FDA approval!!!!!

[Mike]

New Once-a-Day Pill for Hepatitis C Wins FDA OK
WASHINGTON — Oct 10, 2014, 2:53 PM ET
By MATTHEW PERRONE AP Health Writer
 Associated Press

Federal health officials have approved a daily pill that can cure the most common form of hepatitis C without the grueling pill-and-injection cocktail long used to treat the virus.

But the drug's $1,125-per-pill price is sure to increase criticism of drugmaker Gilead Sciences, whose pricing strategy for an older hepatitis drug has already drawn scorn from patient groups, insurers and politicians worldwide.

The Food and Drug Administration said Friday it cleared Gilead's Harvoni combination pill for patients with genotype 1 of hepatitis C, a form of the liver-destroying virus that accounts for 70 percent of the estimated 3.2 million cases in the U.S. For the first time ever, these patients will not have to take a decades-old combination of antiviral pills and shots that causes flu-like side effects.

The new pill combines Gilead's blockbuster Sovaldi, approved last December, with a new antiviral drug called ledipasvir, which attacks the virus using a different mechanism. The dual-acting approach mimics drug combinations Gilead has long used to treat HIV.

It's another breakthrough for Foster City, California-based Gilead, which analysts expect to bring in billions of dollars in new sales. The company says the new drug will cost $94,500 for a 12-week supply. About 40 percent of patients may be able to take the drug for eight weeks, reducing the price to about $63,000.

But patient advocates on Friday renewed their criticism of Gilead and the pharmaceutical industry trend toward sky-high drug pricing.

"When history is written, this is going to be the breaking point where drug prices went completely out of control and nobody did anything about it," said Michael Weinstein, president of the AIDS Healthcare Foundation. "Never before has a drug been priced at this level for such a large population." About 25 percent of people with HIV infection are also infected with hepatitis C.

But other groups noted that the eight-week regimen could make the medicine more palatable to insurers, improving access.

"With the eight-week course the price actually offers relief to 40 percent of the population who will be taking this drug — that's significant," said Ryan Clary, executive director of the National Viral Hepatitis Roundtable, a coalition group which accepts funding from drugmakers, including Gilead.

The shorter treatment option is recommended for patients who have not been treated for the disease before and don't have advanced liver damage.

Gilead executives say Harvoni's price is actually slightly lower than the current standard treatment: Sovaldi plus a cocktail of two other drugs, which the company estimates comes to $95,000 for 12 weeks, on average. Despite such explanations, the new drug's approval is sure to renew scrutiny of prices for life-saving drugs.

Members of the Senate have already asked Gilead to hand over documents detailing its decision to price Sovaldi at $84,000 for one 12-week regimen.

The health insurance industry has been blasting Gilead for months over Sovaldi's price, and most insurers require prior authorization before they will pay for it. Three state Medicaid programs refuse to pay for the drug.

Gilead executives say their drugs are cost effective, despite their large upfront cost, because they cure more patients in less time than older drugs, and prevent the catastrophic problems for patients like liver failure.

[Deck]

Does anybody know if Harvoni is also approved for genotype 2, or is it still sovaldi and ribavirin?

[johnsshutts]

I am ready to start Harvoni  real soon, appt. on the 28th. I seen my Doctor in Feb., he advised me to wait. I was on peg and copeg over 10 years ago, for 14 months, not cured. It was a very rough 14 months. I was a supervisor with TSA, that didn't help. I didn't take much time off from work. I am a geno 1a with a viral load around 7 million. I been keeping my hep c under control, I do have my good days and bad days! I have been taking herbs everyday for around 7 years. Max Milk Thistle, and liver care. I truely believe these herbs have helps keep it under control. I am so thrilled that there is a great chance of being cures. I only had a 40% chance last time, and terrible side effects. This will be a piece of cake, 12 weeks, with mild side affects! I will be cured! I will be starting a new fresh life, and I will retire in January!

[johnsshutts]

Does anybody know if Harvoni is also approved for genotype 2, or is it still sovaldi and ribavirin?

FOSTER CITY, Calif.--(BUSINESS WIRE)--Oct. 10, 2014-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg), the first once-daily single tablet regimen for the treatment of chronic hepatitis C genotype 1 infection in adults. - See more at: http://www.gilead.com/news/press-releases/2014/10/us-food-and-drug-administration-approves-gileads-harvoni-ledipasvirsofosbuvir-the-first-oncedaily-single-tablet-regimen-for-the-treatment-of-genotype-1-chronic-hepatitis-c#sthash.vbrCSpxu.dpuf

[iana5252]

Does anybody know if Harvoni is also approved for genotype 2, or is it still sovaldi and ribavirin?

The current approval was only for genotype 1. There are several clinical trials actively exploring Harvoni for use with other genotypes. Watch for our coverage from the big Liver Meeting (AASLD) in Boston next month for more specific news on when you might expect approval for expanded use for Harvoni.

Here's a complete list of our recent conference coverage...
http://www.hepmag.com/conference_coverage.shtml

[Tess1971]

Unfortunately type 2 people are still stuck with ribavirin sovaldi combo.  I am sure that will change down the road, but, as to how to how long that road will be is the question.  $$ will sway things.

[Anand]

Hello, It has been a while.

Question about insurance and Doctor’s prescription:  Currently I have Cigna-Medicare drug insurance plan for my medicines. It is quite possible that I will have treatment with Harvoni for 6 weeks in 2014 and the balance of 6 weeks in 2015.  I am forced to change to a new, yet to be determined, insurance company as Cigna-Medicare will be no longer  available after 2014, as determined by my former employer.  To avoid front-end loaded sticker shock to the new medical insurance is it possible that my doctor write a prescription for 12 weeks at one stretch so that Cigna-Medicare picks up the whole tab.  Can anyone kindly explain how the prescription duration works.  Thanks      Anand

[lporterrn]

It could get messy. It may be better to do the entire thing in 2015. My concern is that you would have a delay in getting the drugs in 2015, and that would not be good. I hope Mike weighs in on this - he's much better at these questions than I am.

[Bucky]

Lucinda,
I can't remember, but has anyone on here with type 2 used S&O as a treatment option?
Bucky

[lporterrn]

Although I can't answer your question directly, I can tell you that Olysio is not recommended for GT-2, so if anyone is on it, they are doing so outside of the guidelines.

[Tess1971]

My insurance guideline shows it would only be covered for type 2 if it is shown and verified by doctor that patient cannot take ribavirin (allergic, contraindicated etc).  Also doctor would have to apply for pre approval on that basis.  I am sure this is hard to show unless you have used it and had a bad reaction etc….

[Bucky]

Money, money, money!

http://www.fool.com/investing/general/2014/11/07/why-abbvie-incs-game-changing-new-drug-could-be-a.aspx

Bucky

[Tess1971]

Well I had bloodwork yesterday and will have results by Monday - and Dr did finally do a pcr-viral load since I am in 11th week.  Yowsers !  I am really hoping on this since I have had this virus over 40 yrs……….gonna be a long weekend.

[Tess1971]

Well, I take it back, Dr office called and said they cancelled metabolic and pcr as it was not to be done until Dec 12, 4 weeks after treatment is done.  Desk gave me Dec 12 sheet and not Nov 6 sheet.  I am so disappointed now that blood was drawn for nothing.  She said she call lab and cancelled all that was not done yet this morning and that neither my insurance nor I would be billed.  I told them I would have liked to know and she said dr told her this is not a viral load driven treatment to him that he would continue no matter what and preferred not to check until 4 weeks after and then 6 months .  I am so disappointed now as I was looking forward t0  knowing something next week.  I wish I knew if there was somewhere I else I could have a per done.