Author Topic: GLORY, HALLELUJAH! FDA approves Isentress finally. (Read 10747 times)

Miss Philicia · « **on:** October 12, 2007, 04:33:26 pm »

SOURCE

I can FINALLY stop injecting myself twice each day!

Quote

Merck & Co.'s HIV drug Isentress was approved by U.S. regulators, offering a new option for the thousands of AIDS patients whose virus has developed resistance to other medicines.

Adding Isentress to drugs already on the market can slow the advance of HIV, the virus that causes AIDS, the Food and Drug Administration said today in a statement announcing the approval.

Isentress, Merck's first HIV therapy since 1999, may generate more than $1 billion in annual sales worldwide, analysts said. About 150,000 Americans taking HIV medicines have a hard- to-treat form of the virus and may benefit from the new drug, said Robert Rode, Merck's vice president for infectious disease and hospital products.

``We're pleased that the FDA recognizes the clinical profile of Isentress and the benefits it will bring to patients and physicians who are struggling to keep this disease under control,'' said Amy Rose, a spokeswoman for Merck.

Merck rose 47 cents to $53.51 at 4 p.m. in New York Stock Exchange composite trading and have risen 23 percent this year.

Analysts had expected the FDA to approve Isentress after a panel of advisers recommended in August that the agency do so. The pill is taken twice daily.

The new medicine uses a different method from other AIDS drugs to block the HIV virus from inserting its genetic material into human DNA, allowing replication. Isentress targets an enzyme called integrase that HIV uses to accomplish the task. Studies have shown the medicine helps patients with resistant strains of HIV when used in combination with other drugs.

Miss Philicia · « **Reply #1 on:** October 12, 2007, 05:35:20 pm »

Another interesting article on the pricing angle of Isentress in the Wall Street Journal. Also interesting is that while Isentress is not specifically approved for first line treatment by the FDA, it IS allowed "off label" for that use.

http://online.wsj.com/article/SB119205916392955290.html?mod=googlenews_wsj

allopathicholistic · « **Reply #2 on:** October 12, 2007, 05:53:40 pm »

Quote from: philly267 on October 12, 2007, 04:33:26 pm

I can FINALLY stop injecting myself twice each day!

Good news. Good things come to those who wait. I'm real glad for all you guys who have been waiting patiently for this. I hope everything works out in the highest best

Tim Horn · « **Reply #3 on:** October 12, 2007, 06:30:09 pm »

Here's our AIDSmeds news blurb on the approval:

http://www.aidsmeds.com/articles/HIV_isentress_approval_1667_13219.shtml

And here's a link to the Isentress lesson:

http://www.aidsmeds.com/archive/MK-0518_1639.shtml

Miss Philicia · « **Reply #4 on:** October 12, 2007, 06:33:35 pm »

I wonder how quickly this will get on my ADAP formulary.

RAB · « **Reply #5 on:** October 12, 2007, 07:07:44 pm »

Quote from: Tim Horn on October 12, 2007, 06:30:09 pm

Here's our AIDSmeds news blurb on the approval:

http://www.aidsmeds.com/articles/HIV_isentress_approval_1667_13219.shtml

And here's a link to the Isentress lesson:

http://www.aidsmeds.com/archive/MK-0518_1639.shtml

Tim:

In the first link you've provided comes the following quote:

Quote

has been approved specifically for use in combination with other antiretrovirals (ARVs) to treat HIV-positive patients with detectable viral loads and evidence of resistance to multiple ARVs.

(Note emphasis added for clarity)

Does this mean that if someone is currently on a Fuzeon inclusive treatment regimen that is producing maximum viral suppression (<50), then they will not have the option of using Isentress?

I know you are aware there are some of us here currently using Fuzeon with good suppression results but who have waited for this drug to become available so that we could switch out the Fuzeon for Isentress and avoid those nasty ISRs.

Am I taking the above too literally?

RAB

Tim Horn · « **Reply #6 on:** October 12, 2007, 07:45:05 pm »

Rocky:

That's an excellent question. Here's the language from the offical "label" that the FDA approved for Isentress -

ISENTRESS™ is a human immunodeficiency virus integrase strand transfer inhibitor (HIV-1 INSTI) indicated:
In combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced adult patients who have evidence of viral replication and HIV-1 strains resistant to multiple antiretroviral agents (1).

The "... evidence of viral replication" refers here to detectable viral loads, much like I wrote in the article. This is based on the two Phase III trials, in which all volunteers who entered the studies were "failing" their current regimens and had evidence HIV resistance to multiple drugs. As this was the population studied, this is what the approval ended up being for.

HOWEVER... you're absolutely right and I honestly believe that the approval language is somewhat misleading (in fact, I've edited the "detectable viral loads" bit out of the article). Technically speaking, the drug is approved specifically for the above... but the drug can now be accessed -- once it reaches pharmacies and is picked up by insurance companies and ADAPs, anyway -- by virtually any HIV-positive person (at least in the United States). Even if you have multiple-drug-resistant HIV but have an undetectable viral load, it can be prescribed. I don't imagine that any treatment-experienced people will have difficulty securing access to it. Hell, patients with limited or no drug resistance -- including those starting therapy for the first time -- may also be able to access it, provided that their insurance companies (or ADAP plans) are cool with "off label" prescribing.

It's expected that Isentress will receive FULL approval -- today's approval was based on a priority review (aka: "accelerated approval"), in order to get the drug into the hands of those who really do need new options -- relatively soon, which will include a much more broad label for virtually all HIV-positive people in need of antiretroviral therapy.

Sorry for any confusion,

Tim Horn

Miss Philicia · « **Reply #7 on:** October 12, 2007, 08:15:08 pm »

It states "evidence of resistance to multiple ARVs." -- if you're on Fuzeon you ARE on that because of resistance issues.

AustinWesley · « **Reply #8 on:** October 13, 2007, 12:01:00 am »

Wow, I'm so glad to hear this news for Philly and anyone else who's had to do Fuzeon injections.

I remember having to have those damn allergy shots as a kid as a horrible nightmare which is no comparison, but I am glad this may provide a new solution for those who've been struggling with that.

Wesley

Life · « **Reply #9 on:** October 13, 2007, 12:12:10 am »

Philly when do you pull your switcheroo?

Eric

Miss Philicia · « **Reply #10 on:** October 13, 2007, 12:38:24 am »

Quote from: Life on October 13, 2007, 12:12:10 am

Philly when do you pull your switcheroo?

Eric

If it gets on Pennsylvania's ADAP formulary immediately I could conceivably go and obtain a prescription from my doctor on Monday. I'm really not sure what the actual "true" turn around on such things are though. The last time I went on something right when it was FDA approved was Prezista last year, but I had already been taking it for 6 months in a drug trial so I had an extra month's wiggle room until I had to get it from an actual pharmacy.

It's all been set in stone as far as my doctor is concerned back 5 months ago or so. We've just been waiting for FDA approval -- he's already got 40 patients on it through drug trials but my numbers were too high to get in on that.

Back in the 90's it seemed like months for things to go from FDA approval to getting on HMO prescription plans. Sometimes you'd have to have the doctors insist on "medical necessity" for the first few months. It was a mess.

JamieD · « **Reply #11 on:** October 13, 2007, 12:41:24 am »

Philly,

There have been expanded access programmes for a few months now, why have you not enrolled in one of those?

Miss Philicia · « **Reply #12 on:** October 13, 2007, 12:45:59 am »

I just said why I couldn't do so.

JamieD · « **Reply #13 on:** October 13, 2007, 12:53:27 am »

I was writing my response before that was posted, and I turned off the option to be warned when a new post is made while I was typing.

Night, night, Philly.

Tim Horn · « **Reply #14 on:** October 13, 2007, 06:23:11 am »

Philly (and everyone):

I've put in a follow-up call to Merck to see when the rollout of Isentress will begin. While I haven't heard back, most drugs reach pharmacy shelves within a few weeks of approval, especially when Merck had every indication from the FDA that the drug was going to be approved. As for ADAPs, approval can take a bit longer. To find out when Pennsylvania will start covering it, you might want to give John Folby, the program administrator in Harrisburg, a call: 717-772-6341.

Tim Horn

BT65 · « **Reply #15 on:** October 13, 2007, 07:48:15 am »

This is great news. My recent tests, done in September, showed my viral load to be 224,000. My t-cells were 600, so my ID doctor said he wanted to recheck everything in three months. I've been on Sustiva and Trizivir. I am very treatment experienced, so this might be an option for me. Thanks for the heads-up, Philly.

Tim Horn · « **Reply #16 on:** October 13, 2007, 09:24:06 am »

Just got an e-mail from a Merck spokesperson...

Isentress will hit pharmacy shelves within the next few weeks. Doesn't sound as if it'll be widely available come Monday, but you can at least arm yourself with a prescription -- one 400 mg tablet twice daily -- for when the first shipments arrive.

Oh... and very few drug interactions to consider. It's metabolized so differently than virtually all of the other HIV meds, making it a safe bet with protease inhibitors, non-nucleoside reverse transcriptase inhibitors, methadone, opioid pain relievers, statins, antifungals, proton pump inhibitors, oral contraceptives, and erectile dysfunction drugs.

Tim Horn

Miss Philicia · « **Reply #17 on:** October 13, 2007, 10:39:33 am »

Quote from: Tim Horn on October 13, 2007, 06:23:11 am

Philly (and everyone):

I've put in a follow-up call to Merck to see when the rollout of Isentress will begin. While I haven't heard back, most drugs reach pharmacy shelves within a few weeks of approval, especially when Merck had every indication from the FDA that the drug was going to be approved. As for ADAPs, approval can take a bit longer. To find out when Pennsylvania will start covering it, you might want to give John Folby, the program administrator in Harrisburg, a call: 717-772-6341.

Tim Horn

Thanks Tim. Yes, I actually have Folby's name already -- thankful that someone actually gay is running the program, or at least that's what I've been told. I've never called him direct yet, but I think I may do so with this one.

Frankly as far as I've seen thus far it's all Fuzeon patients that are making the initial switch, so really the quicker they approve Isentress the more money they'll actually save, as I can't imagine that Isentress will be quite as expensive as Fuzeon, which we all know is the priciest of HIV meds.

And yes, from what I've been told by two people I know that are already on Isentress there are practically no side effects. I haven't been this excited over an HIV med since PI's first came out a decade ago.

Tim Horn · « **Reply #18 on:** October 13, 2007, 11:18:54 am »

The wholesale acquisition cost (WAC) of Isentress is $27.00 a day, which makes it much cheaper than Fuzeon ($61.00 a day).

The thing is, a Fuzeon-to-Isentress switch may not be feasible for everyone, given that Fuzeon may be needed as a component of "optimized background therapy" to use with Isentress. This may be especially true for folks who don't qualify for Selzentry therapy, including those with R5/X4 dual-tropic or X4-tropic virus. But for those who can make the switch without compromising their regimen's effectiveness, it's a big plus.

Tim

Miss Philicia · « **Reply #19 on:** October 13, 2007, 12:26:27 pm »

What's wrong with combining Isentress with Prezista? That seems to be what's been done with the people I know taking it, and I'm already on Fuzeon + Prezista. From what I understand from my HIV specialist, who is one of the leading persons here in Philadelphia with drug trials (Presbyterian Medical Center/Univ. of Pennsylvania), it's been a remarkably successful pairing and maintained patients numbers.

Tim Horn · « **Reply #20 on:** October 13, 2007, 12:39:52 pm »

Absolutely nothing's wrong with combining Isentress wtih Prezista -- it will be a dynamite combo for a lot of folks. My point is that, unlike the more-or-less cookie cutter recommendations for HIV-positive folks starting therapy for the first time, selecting drugs to use to treat drug-resistant HIV is so incredibly dependent on an individual's resistance profile and treatmetn history. There are folks who have acquired enough HIV mutations to render Prezista largely ineffective (keep in mind, some folks have already been on this drug and are no longer responding to it), hence they may really need Isentress AND Fuzeon in their regimen if they're to maintain undetectable viral loads. At the same time, there are people with a lot of treatment experience who will still respond to Prezista, have CCR5-tropic virus and will benefit from Selzenty, and with the addition of Isentress, may be able to avoid (or switch off of) Fuzeon altogether.

I guess what I'm trying to say is that Isentress will be used in a variety of ways -- maybe as an alternative to Fuzeon, Selzentry, or Prezista, or maybe as an addition to regimens containing these drugs -- depending on a person's individual needs.

Tim

StrongGuy · « **Reply #21 on:** October 13, 2007, 01:10:37 pm »

Just caught this on the web - great news!

Hope it makes some real improvements in treatment! Definitely getting really great press.

Buckmark · « **Reply #22 on:** October 13, 2007, 02:55:13 pm »

Quote from: Tim Horn on October 13, 2007, 11:18:54 am

The wholesale acquisition cost (WAC) of Isentress is $27.00 a day, which makes it much cheaper than Fuzeon ($61.00 a day).

Call me cynical, but I believe cost is a major (dare I say primary?) consideration of whether APAPs and Insurance companies add a new drug to their formularly. The fact that Isentress is dramatically cheaper likely bodes well for it. While I would expect to see the price of Fuzeon plummet in response, the difference between it and Isentress will be pretty hard to close. What might be a potential concern is that Fuzeon may, some day, no longer be available for folks who really need it, since the manufacturing process is so difficult and likely depends heavily on economy-of-scale.

I'm relieved there are new options out there. Sticking yourself twice a day to deliver Fuzeon sounds annoying and inconvenient, in the very least.

Regards,

Henry

Miss Philicia · « **Reply #23 on:** October 13, 2007, 03:09:48 pm »

Quote from: BuckmarkTX on October 13, 2007, 02:55:13 pm

Sticking yourself twice a day to deliver Fuzeon sounds annoying and inconvenient, in the very least.

True, but it also keeps me off the toilet like I was continually with Kaletra. Everything has a pay off. On balance I'll take the injections over the explosive brown liquid turds three times/day PLULS I now have +1,000 cd4's and an undetectable VL for the first time in my life, now going on over a year, which has completely erased all sense of extreme fatigue and allowed me to go the grocery store with out feeling like I carrying three bags would make me pass out in a pool of diarrhea.

MOONLIGHT1114 · « **Reply #24 on:** October 13, 2007, 05:15:09 pm »

Philly~

I've read of your CD4 count before, and I am so happy that its such a big number. You must be elated. I struggle with fatigue and don't really know where its coming from. Maybe its the Sustiva for five years now, not sure. I see my doc Tuesday.

Anyway, you appear to be like a kid in a candy store and I'm very happy for you!

Yay!

~Cindy

P.S. - I used to stick myself 8x a day for insulin, and 10x a day for sugar testing, so I know you can do this! You've indicated that already! Woo-hoo!

RAB · « **Reply #25 on:** October 28, 2007, 07:40:24 pm »

A quick update.

I did as Tim suggested and called my doctor first thing Monday morning after the drug was approved to ask that a prescription be called into my pharmacy.

That was on October 15th.

Much to my amazement, Merck had the drug to my pharmacy by the 20th. Humana (my Medicare PDP), didn't add the drug to their forumulary till the following Monday, the 22nd, but as soon as they did my pharmacy filled the script.

I was out of town from the 23rd till last Friday so didn't get the message till I returned home.

Long story short, it looks like come tomorrow, for the first time in my treatment history, I actually have an option.

I can stop the Fuzeon, put it back on the shelf for future use if necessary, and switch to Isentress.

Goodbye 4 syringes a day. (two to mix--two to inject)

Goodbye 4 viles a day.

Goodbye alcohol swabs.

BUT MOST IMPORTANTLY

Goodbye ISRs.

Is this possible?

Can I actually continue to achieve optimal viral suppression by substituting Fuzeon and those ISRs with something as simple as one pill twice a day?

I have to admit, I'm somewhat in a state of disbelief. I've been doing this a very long time. I've never actually had any treatment options to be honest.

It kind of feels good.

I hope it works.

Lord how I hope it works.

RAB

(Who will officially switch in 7 days to keep the refllls of his other drugs in synch.)

Robert · « **Reply #26 on:** October 29, 2007, 11:56:36 am »

Hey RAB

Wow. You don't mess around, do you? But then who can blame you? I mean, you've really been through the ringer when it comes to medicate. I am really, really hoping this works out for you, good buddy.

What are you going to do with all the extra time now that you don't have to pump yourself with drugs? Finish the front porch?

take care my friend...robert

Miss Philicia · « **Reply #27 on:** November 09, 2007, 11:33:27 pm »

One month later (no thanks to ADAP) I'm now through with Fuzeon and about to swallow my first Isentress.

Life · « **Reply #28 on:** November 10, 2007, 12:02:42 am »

Hay thats great news Philly! I am sure your abdomen thanks you... I hope you get the results you want...

Eric

Miss Philicia · « **Reply #29 on:** November 10, 2007, 12:04:19 am »

We'll see -- my next labs aren't until January.

milker · « **Reply #30 on:** November 10, 2007, 01:19:22 pm »

This is great, I hope there are no side effects and that the results are good. It must make a huge difference in your day to day life now. I'm so happy for you

Milker.

Miss Philicia · « **Reply #31 on:** November 10, 2007, 02:10:32 pm »

Nope... no side effects thus far ::knock on wood::

MOONLIGHT1114 · « **Reply #32 on:** November 10, 2007, 06:58:08 pm »

Hi Philly~

I'm happy to hear that you've made the switch. Keep us posted as to how you're doing!

~ Cindy

Miss Philicia · « **Reply #33 on:** November 10, 2007, 07:20:47 pm »

I'm feeling a little dizzy... but maybe it's my imagination. I may lay down on the sofa.

Or maybe a beer would help

allanq · « **Reply #34 on:** November 10, 2007, 09:40:57 pm »

It takes a while to get used to substituting a simple pill for a painful Fuzeon injection. You wonder how a painless little purple pill can possibly be a substitute for those damn injections.

I was on Fuzeon for 3½ years before I switched to Isentress last March (on expanded access). My body was really hurting from all the ISR'S. For a few weeks after the switch, I found myself still waking up with the fear of having to inject myself at the usual appointed hour of 10 am. And then the same fear would return at 10 pm, which used to be the time for my evening injection. It takes a while for that fear to go away and to realize that the "no pain, no gain" maxim may apply at the gym, but not when it comes to HIV meds.

I've had no side effects from Isentress, and my VL has been undetectable ever since I made the switch.

So, good luck to RAB and Philly and to everyone else who has made the switch. It is an incredible quality-of-life improvement.

Allan

Miss Philicia · « **Reply #35 on:** November 10, 2007, 10:04:03 pm »

Yeah... you don't know HOW happy I was when ADAP finally got it on the formulary. Can't believe it took them an entire month, considering that Isentress is more than half the cost of Fuzeon. I'm sure the tax paying citizens of Pennsylvania would love knowing about that!

Plus it's not like they didn't know that the FDA approval was going to be in mid-October anyway. So odd. When I went to the pharmacy they told me it was still not approved, as they'd tried the day before but I insisted and they ran it through and it worked. I'd been on the phone with ADAP all morning

I swear my knots on my abdomen are already going down, so maybe in 2 weeks I'll have a normal tummy. Now if only I can slim down 10 lbs. I felt I was eating lots to give myself enough fat there to make the injections less painful.

But yeah, my friend that's been on it for 4 months says his numbers are great -- no VL and his cd4's have gone up in the upper 300's which is high for him.

komnaes · « **Reply #36 on:** November 11, 2007, 07:41:17 am »

Great news Philly!

Get your fabulous body back quick!

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Author Topic: GLORY, HALLELUJAH! FDA approves Isentress finally. (Read 10747 times)