Isentress Gets FDA Approval for First-Line Use

[Inchlingblue]

My doctor gave me a hard time last month but ultimately agreed to prescribe Isentress/Truvada. He even said he would have to make a note in my file that he did it despite preferring I start with "more proven" combos. I told him it was expected to be approved for first-line in July so I'm glad it happened. Even though according to this article they approved it based on 48 weeks of the STARTMRK study, it has actually stacked up against efavirenz for 96 weeks. Next step: Once-daily dosing.

Isentress Gets FDA Approval for Treatment Newbies

July 10, 2009

Merck & Co. yesterday received approval by the U.S. Food and Drug Administration (FDA) to market its integrase inhibitor, Isentress (raltegravir), for people who have never taken HIV treatment. Isentress was previously approved only to treat people who have used and become resistant to other antiretroviral therapies.

The approval was based on 48 week data from the STARTMRK study comparing Isentress and Truvada (tenofovir plus emtricitabine) with Sustiva (efavirenz) and Truvada. The Isentress dose was 400 mg twice daily. In that study, 87 percent of those taking Isentress had an undetectable viral load after 48 weeks of treatment compared with 82 percent of those taking Sustiva. Isentress was therefore judged to have equivalent effectiveness to Sustiva.

Side effects from Isentress in the study were generally mild, including headache and nausea, but there were significantly fewer central nervous system side effects in people taking Isentress than in people taking Sustiva.

LINK:

http://www.poz.com/articles/hiv_isentress_raltegravir_761_16899.shtml

LINK TO 96-WEEK DATA:

http://www.aidsmap.com/en/news/82A67A30-B689-46D7-9BAB-2DE43B46AA8C.asp

[Miss Philicia]

You know, that's tired he gave you a hard tiime.  He should have been able to easily learn that it was imminent for FDA approval.  Sounds like he was just being weird.  Is his even a large practice?

[Inchlingblue]

You know, that's tired he gave you a hard tiime.  He should have been able to easily learn that it was imminent for FDA approval.  Sounds like he was just being weird.  Is his even a large practice?

At the risk of boring you with the whole story, lol.  Here goes: he does actually have a large HIV practice and he is considered reputable, attends many of the HIV conferences and is the head of the local chapter of the American Academy of HIV Medicine.  He also initially said, "no problem" when I said I wanted Isentress.

Because he has such a large HIV practice he employs a man, a gay man who might be poz himself, I'm not sure, to be a sort of liaison with all of his HIV patients so that if any of the HIV patients have any concerns and the doctor is busy, this other guy can usually deal with it or make sure you see the doctor if it's something important etc.

What ended up happening is the doc said fine to Isentress but when he stepped out, I think this other guy suggested it was not a good idea, yada yada. They then tried to convince me based on the SWITCHMRK study but little do they know that I spend like 5 hours a day reading about HIV/AIDS so I was able to counter their quite frankly irrelevant arguments about SWITCHMRK (which do not in any way apply to my situation).

They said it has a low barrier to resistance, which is technically true but I countered that it also happens to be very potent because of it's long "off rate" to the integrase enzyme.  Basically I became an advocate for my own care and if I had not been as informed as I happen to be (if I say so myself) I would probably be on Atripla or a boosted PI with Truvada. Nothing wrong with any of those and God knows, I may someday make use of them but I am very confident that Isentress is the best choice.

He also said, "I wouldn't want you to lose a whole class," meaning integrase inhibitors, if I become resistant. Which is a legitimate concern but I do know that I will be as adherent as humanly possible. I guess this is a concern for those people that might have a problem with twice a day dosing.

There are no guarantees, I know it has not been used for as many years as some others but based on lots and lots of research I do think it's the best choice. Hope I don't end up eating my words.

I think if this had been one month later, i.e. now, when it is actually officially approved for first-line, they would not have said anything. Why the doctor would put so much stock in what this helpful but not super well-informed "assistant" had to say, I don't know.

[Miss Philicia]

I know it has not been used for as many years as some others but based on lots and lots of research I do think it's the best choice. Hope I don't end up eating my words.

Yeah, I'm very "meh" on these lines.  I've been on it almost 2 years, which I know isn't indicative of what long term effects might pop up, but I figure the folks that went on it pre-FDA approval were on it for "x" years (what is the time period for all phases of trials put together? I don't know) so I'd figure with all of that added up it should satisfy anyone by now.  I've yet to read anything scary surface on Isentress except four over-hyped instances of increased depression in people with pre-existing cases of mental health issues, which means basically nothing.

If anything my facial lipo has improved one grade on this.

[AndyArrow]

Good for you for being your own health advocate. 

I have found Isentress to be a very friendly side effect free drug for me.

[AboutToStart]

Isentress Gets FDA Approval for Treatment Newbies

Great News!! Good to know!! I'm about to start with the Atripla myself, but good to know there's a good non-norvir "back-up", in case Atripla don't go well...

Thanks for sharing that!

[risred1]

My experience with my doctor's mis-prescribing me Reyataz/Truvada without Norvir, from a man who is a reputable HIV specialist, shows that even doctors get confused, and/or develop bias's based upon the experiences in their practice.

Doctors will be conservative. I brought up Reyataz 2-3 years ago after reading favorable results, and after it made it to the front line list as an alternative therapy.

But these recommendations have hidden messages. Alternative simply has a connotation to it, and of course folks pick up on that. Its not the Stated Recommendation, but the Stated Alternative.

I fully expect doctors who have come through the difficult 90's and early 2000's practice are well versed in the difficulties in dealing with failing treatments and once they have a real performer like Kaletra, well, they are going to stick with that until they know for sure that the decision is solid, especially for first treatment. They want durability! And to this day, Kaletra still has that allure.

Of course Kaletra has some legendary sides, and Reyataz seemed to be devoid of these for the most part, thus my interest in it.

So as this year turned out to be the year for me to go on meds, the new bias presented itself. ATRIPLA! Although he supported my reasoning for going PI based, Atripla is in such wide use, that simply put, Doctors aren't thinking enough about how to use PI based as the first treatment, because it seems like a very high percentage of folks go Atripla.

My doc got caught between a confident patient, me, a rushed appointment, and a pharmacy practice that he called into question at the hospital. I was even to get a call from the director. Even the nurse practitioner didn't pick up on it, when I called in. Until I pointed out what the board pointed out to me, that I was on the wrong combo.

If you look at the sheer number of drugs in play, concerns that doctors have for new treatments vs. tried and true ones, and that their interest is largely focused on patients with complications vs newbies that don't present too many difficulties, I would expect that their bias's and concerns can take stances that may be at odds with what we want as a patient.

My last visit, my doctor again brought it up and apologized. He says, bottom-line, he missed it, and he's really at a loss as to why he did.

The lesson i learned is that things we study from a couple of years ago in preparation needs to be reviewed again and not taken for granted. memory can play tricks on you! That doctors can make mistakes for any host of reasons. Practices can make mistakes for a whole host of reasons. It pays to double and triple check your meds, dosages, your resistance profile and read the specs and cautions for the meds.

This also raises the use of supplements in the mix as well. Some of us took alot of supps during non treatment periods. Interaction with meds can be a concern, and our doctors may not be all that up to date with how supplements mix with meds. There are so many drugs to worry about, the combination are immense between HIV drugs and other meds we may be inclined to take. Asking a doctor about supplements may not yield much more information than we can discern on the web.

I've stopped herbals as my energy issues have improved, but still take a few supplements. But I had to think about these things carefully, and should keep reviewing with my doctor. I'm making my list and going to have it updated in my file.

My 2 cents.

[Inchlingblue]

Raltegravir moves closer to approval for first-line use in Europe
        
Michael Carter, Monday, July 27, 2009

The integrase inhibitor raltegravir (Isentress) has taken a key step towards approval for use in first-line HIV therapy in Europe. The EMEA's Committee for Medicinal Products for Human Use (CHMP) has recommended expanding its marketing authorisation as part of combination antiretroviral therapy by individuals initiating such treatment. Currently its European licence restricts its use to treatment-experienced patients.

This recommendation comes days after the International AIDS Society’s conference in Cape Town was presented with trial data about the safety and efficacy of the drug in treatment-naive patients. Interim three-year results from an ongoing study showed that raltegravir was as effective as efavirenz as part of antiretroviral therapy for patients starting HIV treatment.

Continued....

LINK:

http://www.aidsmap.com/en/news/DA76055A-C70E-4516-B179-FF100DDF3A02.asp