Needleless Fuzeon-Biojector 2000 (Reposted from the old forums)

[gerry]

Topic Title Needleless Fuzeon--UPDATED--Now using the Biojector 2000

Date Posted: Wednesday June 15, 2005 9:33 AM
Posted By: rab

Is there anyone currently on Fuzeon using the needleless administration method (that CO2 charged pistol thing)

There was a story about this awhile back but I haven't heard anymore. I did call the Fuzeon help desk and they said they have concluded that study but they thought there were some phamacies running programs (Statscript being one of them). I'd be interested in hearing if anyone is doing this and how it is going.

Anyone?

RAB

Date Posted: Wednesday June 15, 2005 1:48 PM
Posted By: gecko31

Can't help you there Rab, but it does sound like a wonder invention, doesn't it? I could certainly use a different way of getting the stuff into me - I may have to rename myself "James, the amazing human pincushion" and run away to join the circus soon. I know they currently have no plans to release the needle-less thingy here in the UK though.

Good luck in the quest for further info

James

Date Posted: Monday June 20, 2005 9:04 PM
Posted By: DingoBoi

it's called the Biojector. Star Trek is here today!

Looks kinda cool, plus I know I couldn't use needles. I saw some adverts for it at statscript when I first started my meds, before switching to mail order.

Date Posted: Monday June 20, 2005 9:23 PM
Posted By: DingoBoi

http://www.bioject.com/


Date Posted: Monday June 20, 2005 9:56 PM
Posted By: rab

Thanks Dingo

I'll check it out.

RAB

Date Posted: Monday July 18, 2005 6:13 PM
Posted By: Tim Horn

Rab:

I received some information today from the folks at Roche that I thought you might be interested in. Apparently, Roche and Trimeris has filed a supplemental new drug application with the FDA in support of the Biojector 2000 (B2000) needle-free injection device (it's manufactured by Bioject Medical Technologies and is a CO2-powered injector that disperses liquid medication through the skin). The filing is based on data from the T20-405 study, a single-dose, comparative pharmacokinetic study of Fuzeon administered via the needle-free device compared to standard needle-syringe administration. The companies anticipate that the FDA will provide feedback and a decision on the sNDA later this year.

Trimeris and Roche also plan to begin enrollment of a new trial – the Fuzeon WAND (Fuzeon with a needle-free device) study, assessing patient acceptance and experience in administration of Fuzeon via the B2000 needle-free device compared to standard needle and syringe administration. It will be starting next month and will 40 patients, in a month-long, cross-over design evaluation.

Just wanted to provide you with an update,

Tim Horn

Date Posted: Monday July 18, 2005 10:07 PM
Posted By: rab

Tim

Thanks for the update.

So they are calling it the "Fuzeon Wand"? Hmm, gay men waving a wand. Now there's a marketing strategy I wouldn't have thought of!

LOL

RAB

Date Posted: Tuesday July 19, 2005 7:16 AM
Posted By: Tim Horn

Rab:

Actually, it sounds as if Roche/Trimeris are sticking with the much more butch/sci-fi sounding "Biojector 2000." Fuzeon WAND is the acronym they're using for the study that's starting up: the Fuzeon With A Needle-free Device). Now you know why these drugs are so expensive... they need to pay someone to come up with this clever names!

Tim Horn

Date Posted: Tuesday July 19, 2005 10:09 AM
Posted By: rab

I'm going to be so bad:

What about the Fuzeon "Drug Injection Like Double Orgasm" Study?

(I don't know how to put the appropriate letters in BOLD so this may take some work.)

RAB
(Who is pretending to be ashamed)

On a more serious note. I just left a message for the doctor at Bioject. Their offices, as it turns out are very close to me (Tualatin Oregon), so I'll let you know if I learn anything more.

RAB

Date Posted: Tuesday July 19, 2005 5:22 PM
Posted By: rab

Tim et al

The information I've got is the following (although it did not come from Roche)

The WAND study will be for Fuzeon naive patients only. It will last 30 days. Bioject's participation is to supply the injector.

There is an ongoing study which is being conducted through Cronimed (Statscript) which I can qualify for as the protocol is pretty broad:

1. Phobia about needles (not me)
2. Needle fatigue (me)
3. Desire to reduce ISR (Injection Site Reactions) (Also me)

There are some spots still open, however each Statscript Pharmacy currently has a waiting list (not sure what that means as those two statements seem to contradict each other). I've called the Statscript Pharmacy in Seattle (nearest to me) and am waiting to hear back from the Pharmacist who is directing it there.

Supposedly according to the doctor I spoke with at Bioject, these little devices (they aren't so much like pistols as they are like large pen shaped thingys), do significantly reduce ISRs. And I swear she also said something about it being completely needleless "including the reconstitution part" which baffled me, but I forgot to ask her to clarify.

RAB

Date Posted: Thursday July 21, 2005 6:03 PM
Posted By: rab

O.K. now I've got more information.
The pharmacist at Statscript in Seattle just called me.

A. It is a CO2 charged pistol like device. (Dingo was right.)
B. It weighs approximately 1 lb.
C. You do use a needle to reconsitute the Fuzeon, just a "different" type of needle. You also use that same needle to load the dissolved Fuzeon into the Biojector.
D. Using the device only requires on hand, which means you can inject the back of your arm yourself.
D 1/2. Because the ISRs are significantly reduced you can also inject in your leg if you were unable to do so before. You can also inject in your bum bum (although since that isn't an approved injection site Roche can't tell you that.)
E. The study is accepting participants and the do have the devices currently available (at least in Seattle)
F. If you go with the study you HAVE to get your Fuzeon from a Statscript Pharmacy.
G. The study is for a year and provides you with the device and materials free of charge, but not the Fuzeon.
H. It is for people who are currently using Fuzeon, but who fit one of the 3 criteria I mentioned above.
I. The are faxing the paperwork to my doctor in Portland, and if he o.k.s it, I'll go to Seattle next week to learn how to use the thing.

That's all I know so far.

RAB

Later: My only concern is this: I can't risk losing my current regimen. My resistance profile makes this one the only one currently available. Does this way of delivering the drug present that possibility? Do we know for certain the right dosage is received? Do we know for certain it doesn't alter the molecular composition of Fuzeon as it passes through the skin? Crap! The more I think about this the more I am rethinking it. Anyone know?

Date Posted: Friday July 22, 2005 9:09 AM
Posted By: Britboi

Does anyone in the uk have any experience of the biojector because it would be of great help to me??

-------------------------
33 yr old hiv+ bloke from london, diagnosed positive 9 years currently taking abacavir, ataznavir,tenofovir, low dose ritonavir an T20. highly experianced in hiv therapy. Also suffering sclorosing cholangitis and just finished a course of liposomal doxirubicin chemotherapy for KS... Please say Hello!!!! xxx


Date Posted: Friday July 22, 2005 10:05 AM
Posted By: newt

The next UK Community Advisory Board on 19 August (in London) will have a presentation from Roche on T-20 and hopefully an update on needle-free delivery. Support material for UK CAB meetings is usually posted on the i-Base website in advance. The meeting will be written up afterwards. www.ukcab.org for a direct link to the right part of the website.

Biojector 2000 has a CE mark (has had for someyears), which means it can be marketed in the European Union, but it's considerably more expensive than simpler needle based systems so has a hard fight ahead. If significant benefits can be shown from the needle-free system, then perhaps it will get into NHS clinics, although there is nothing to stop clinics using the device if they want. I imagine many docs will want to wait for some trials of Biojector+T-20 to establish equivalent drug delivery and get data on reduced ISRs etc before speaking to their budget-holders about coughing up for the zappy little gun. The Biojector seems popular on various European vaccine/drug trials, though these studies are generally about coverage and ease-of-use in community settings rather than effective delivery for a particular drug. - matt


Date Posted: Friday July 22, 2005 10:14 AM
Posted By: Britboi

cheers newt I'll keep on at my docs...


Date Posted: Monday July 25, 2005 11:35 AM
Posted By: Britboi

Hi matt,
Spoken to my docs today and yes he wants to wait until a conference next week where theres a workshop with data on the subject of needlefree fuzeon, but he says if the data looks ok then he will see if he can import one for me cos aparantly you can't get them here in the uk at all. so all in all it sounds quite promising and my legs won't stand much more I don't think, and also i don't want to become needle phobic.

Regards
Carl x

Date Posted: Thursday July 28, 2005 9:09 AM
Posted By: rab

Hello Everyone

I've just returned from Seattle where I picked up my Biojector 2000. The training took about an hour. It's a fairly simple process, although the type of syringe you use to reconstitute and inject is entirely different (you use the same syringe for both), and that difference will take some getting used to.

I've done 2 needleless injections. I'm going to use it for a full 2 weeks before I offer any personal opinions about whether it improves the ISR issue or the overall ease of administration.

Stay turned.

RAB

Date Posted: Thursday July 28, 2005 10:29 AM
Posted By: Britboi

Hi Rab.
I'm pleased you've got your biojector, let us know if it makes your life easier as regards to isr's etc as i'm watching with interest and if anyone knows of any data regarding the effacacy of fuzeon administered in this way , that I can show my docs over here in the uk that woulkd be brilliant

Cheers...
Carlxx

Date Posted: Friday July 29, 2005 2:18 PM
Posted By: DingoBoi

Yay rab! I hope you find it much easier than the needles. Keep us posted!

Date Posted: Monday August 01, 2005 8:49 AM
Posted By: lowtidebeach

HI,
I've been using the bioJector for the last 2 months. I have to admit that the ISR are much less than with a needle. I had been using 30 guage needles which was also helpfull for the prior 3 months. I also find that after mixing putting the vial in the refrig. for awhile also helps.

I have problems finding sites because i'm very lean on the arms and thighs (thanks to the PI's) but of course my belly is full fatty tissue.
I do notice that the Bumps are much smaller and do not last as long as with a needle and the "pain" of injection is quite different (it's like someone snaps a rubber band on your skin aggressively) I have a problem finding a place on my belly due to the large incision scars from my liver transplant but it just means a much more carefull selection for available areas for injection.

I tried to inject on my thigh once by grabbing a bit of skin and shooting the biojector into what i thought was a bit of fatty tissue but ended up with one huge swollen area for about a week (4inches in diam.)

overall i'd never swith back to a needle.

rick

Pos since 1986: Fuzeon, Kaletra, Rescriptor, Viread/Epivir (for hepB), Dapsone/PennVK, Acylovir (for herp.simp) more more....


Date Posted: Monday August 01, 2005 7:09 PM
Posted By: rab

Lowtide

Thank you for sharing your experiences. I've only been using the bioject since Wednesday, but so far I gotta say I'm impressed. The ISRs are reduced in frequency, duration, and severity. (I was still using the needles that come with the kit, hadn't switched to the smaller gauge like you.) I still want to wait two full weeks before I make up my mind, but so far so good.

Now, I have had one problem. I call it the dribbles. It has happened to me twice. Both times while injecting in my stomach. After the syringe in fully emptied and I pull away the bioject, I have drops running down my skin. I can't estimate what % of the liquid it is, but obviously some of it didn't get into me. If it didn't then I'm obviously not getting a full dose. That concerns me! Have you experienced anything like this? If so have you figured out why?

RAB

Date Posted: Monday August 01, 2005 7:56 PM
Posted By: TexMan

RAB,

Okay I must have missed something because I didn't even catch until just now that you are trying the new Biojector. I hope it works better for you and reduces the site reactions. Keep us posted.

Cliff

Date Posted: Tuesday August 02, 2005 4:43 PM
Posted By: pearson

Dear Rab,

I stumbled across your website while I was gathering additional information on the Bioject. I am in the health care arena working with a large HIV population. We have several people on Fuzeon - - Roche is wrapping up a study switching to small, short insulin needles (31 guage, ultrafine, short insulin needles) which has helped to reduce the site reactions - in addition to administering the medication at a 90 degree angle - straight in verses the 45 degree angle. The Biojects are currently being studied - Statscripts - across the nation - enrolled 200 patients to see if this method of delivery reduces site reactions. Some other key elements that help reduce site reactions - medication must be missed well - Fuzeon needs to sit for a full hour prior to injecting after mixing OR ACTIVELY rolled for 15 minutes. Massaging after injection helps as well - either by hand or with a small battery operated massager. Roche is also providing funding for Maxim healthcare to provide home visits to help person on Fuzeon get a few of the "off label - non published" information - for example the insulin needle at 90 degree angle. Hope this helps.

[gerry]

Part II
---------------------

Date Posted: Thursday August 04, 2005 7:21 AM
Posted By: lowtidebeach

RAB,
- yea, I'm ocasionally having the same problem. I agree it's a concern because when it "dribbles" it can be quite a bit of fluid and percentage-wise it can be a siginificant amount of medicine. I think in my situation it happens when I hit a previously used area. Kinda like a spot where there is minimally leftover ISR (like a cyst that is almost gone but it's sill a bit hard under the surface of the skin) AND when this happens I know that I am putting enough pressure on my skin (belly in this situation) so it's not because of leaking, it more like the injector cannot push more fluid into the skin in that area.


I'm curious if you agree...

(slight RANT about training below - to Statscript staff)

I think it's time to call someone - that's the problem, at least for me, i'm not sure who to contact ...My "trainer" was not too explicit in the training sessionabout who to call if i had a problem.

Also He showed me how to shoot the biojector into a napkin - it would have been much more helpfull if the training session was an actual injection of my fuzeon into Me (not a demo of how to shoot a napkin - i'm sure that napkin is real healthy at this point with a bit of biojected H2O in it's fibers.... )

(ok i'm done)

ALSO I hope someone will figure out how to avoid this problem:
- I noticed that over long term usage (injections of fuzeon - either by needle or injector, I build up a layer of tough tissue. It's like a layer of muscle that's thin but tough and its between my skin and the actual layer of abdomen muscle (with fat between both of course) It's like a bunch of the cysts from the injections have melded together and it don't go away unless you stop injecting. IMHO i think that people will need to take a respit from injections to let this heal/dissolve over time (like 1-2mos) - its just a outlandish GUESS - but...


rick

Date Posted: Thursday August 04, 2005 7:24 AM
Posted By: J.R.E.

Rab,

Had this in my mail box today, Not sure if it is helpful to you ,or not...

http://www.aidsmap.com/en/news/5AD7C48F-7387-4E71-868A-5B251E6A6079.asp

----Ray----

Date Posted: Thursday August 04, 2005 8:51 AM
Posted By: rab

Ray::
Thanks for the link. I agree with what it said, the Bioject 2000 does reduce ISRs.

Rick:

You may have a point about my dribble problems maybe being caused by attempting to inject over a previous ISR (you know that little hard bump that remains). I'll feel around and be more careful. Also I've taken to sitting down when I inject in my stomach which helps relax those abdominal muscles and that seems to help.

When I did my training they had me use a sponge (my sponge was just as healthy as your napkin I suspect--) but they also had me inject saline into myself. I'm glad they actually made me do a trial run on myself while they were there watching.

A # to call for help is an excellent idea. I've talked to the pharmacy in Seattle, and both the pharmacists there have been great in helping me. They take however much time is required, (meanwhile I hear the phones rining off the hook in the background) and they both communicate things clearly. So if you haven't done so, try calling your local statscripts first. Also I have the # of the doctor who is conducting the study for Bioject (their offices are just across the river from me in Tualatin Oregon--if you want I can get that to you.)


Finally to everyone else. I was going to use this for 2 weeks before I really decided, but I don't need to. This thing absolutely (as Rick has already said) reduces the # of ISRs, when I do get them they are not as severe. I love this thing, it really is working out great.

At the end of the year when I have to give it back (nope--don't get to keep it) I'll be missing it a lot.

RAB

Date Posted: Thursday August 04, 2005 5:52 PM
Posted By: DingoBoi

tell em it got stolen

Date Posted: Wednesday August 10, 2005 7:39 AM
Posted By: lowtidebeach

RAB, Ray, (and DingoBoi -> I'm definitley considering your idea),

Thanks for the info, and the Link was a great too...

Funny thing, after reading your original note about "dribbles" - that's what happend to me that night... haven't called yet...
But I'm really having problems finding a place to "inject" again. I get really frustrated 'cause you know if you miss too many of these injections nasty things could/would happen...

My problem is that tough layer of skin happening again under my belly area and finding an area is not easy. I've spoken to my doc about it and they don't think there's much to do about it... :'-(

-rick

Date Posted: Tuesday August 16, 2005 3:55 PM
Posted By: Fiona

Further to Newt's posting of the 22nd July about the UKCAB meeting this coming Friday which will have a focus on T20/Biojector, if anyone living in the UK wants to attend the meeting and learn more plus have an opportunity to ask questions of the Roche representative who will be there, you can register for the meeting via the UKCAB website address in Newt's message. Best wishes, Fiona


Date Posted: Tuesday August 16, 2005 4:18 PM
Posted By: Fiona

Here's a bit more information about the meeting:

The UK-CAB (UK Community Advisory Board) is meeting with Roche on Friday 19th.

CAB meetings are for advocates in the UK and include training and talks on
different aspects of HIV treatment, and this meeting will focus on access to
Biojector in the UK.

Details for the meeting are at the following link:
http://www.i-base.info/ukcab/index.html

If anyone in the UK on the FuzeonSupoort email list who currently uses T-20
would like to attend this meeting, please register online using the link on the
above page.

Meeting usually include about 20-25 people, most of whom are also HIV+ and early
registration is recommended. You are welcome to attend the while meeting or just
thee T-20 part.

If you'd like more information about the group please contact me personally by
email or call the i-Base office.

Thanks

Simon

Date Posted: Monday August 29, 2005 4:12 PM
Posted By: thithirph

Hi, I ran across this board while researching Fuzeon and thought I would add my two cents as a HIV pharmacist. I strongly urge patients who are on Fuzeon to use the Nurse-to-patient Connections program available by Roche. It's a free service that will send a nurse to your home or anywhere you feel comfortable to train you on how to use Fuzeon correctly and to avoid ISR. I recommend it to all my patients, naive or not, especially as a refresher because some patientsare known to accidentally develop bad habits.

If you cannot get into the Biojector trial, definitely try using the 31G needles, this will help reduce ISR by up to 60% compared to the 27G that comes with the Fuzeon. I've heard to avoid ISR after the injection, massage the area with your fingertips or with a massager. The Roche training program will provide you with a free massager. This might help with that tough tissue that is developing from repeated injections.

The Fuzeon Nurse program is 1-888-321-2233.

Date Posted: Thursday September 29, 2005 1:08 AM
Posted By: chenxinchx

I am interested in Biojector 2000. May I raise a question? Whether the user rub the injection area with a alchol cotten before or after the injection?

Date Posted: Thursday September 29, 2005 8:36 AM
Posted By: lowtidebeach

Hi,

Obviously everything needs to be as clean as possible : device(s), hands, injection area, work area etc...

I Swab my injection site prior to injecting and I've had the habit of swabbing Post Injection - But my nurse told me that alcohol works like an anticogulant and if there is any blood post injection it could hinder clotting.

IMHO : After injecting I usually swab with alcohol then apply pressure with a sterile gause or band-aid or clean tissue until bleeding stops (I usually have to keep something on the site because my clotting time is quite long in general anyway)

rick

Date Posted: Thursday September 29, 2005 8:09 PM
Posted By: chenxinchx

Thanks,rick. But I am a little confused. People swab the injection area too after using Biojector2000? If there is no physical harm,why swabbing? Thank you!

xin

Date Posted: Saturday October 01, 2005 4:59 PM
Posted By: rab

xin

You asked:

If there is no physical harm,why swabbing?

The biojector blasts the fuzeon through the surface of the skin so there is the possibility of bleeding. After applying pressure for 1 minute post injection I then cover the injection site with a small round bandaid. I don't "swab" after the injection because as others have said the alcohol swab will hinder clotting.

Just to clarify, the advantage for me with the biojector is not that the pain of injection is reduced (in fact in some ways it hurts more) the advantage I've experienced is that the injection site reactions are significantly reduced in both severity and duration.

RAB


Date Posted: Friday October 07, 2005 5:30 PM
Posted By: chenxinchx

Thank you ?RAB!

Date Posted: Tuesday November 29, 2005 5:06 PM
Posted By: chenxinchx

FDA Issues Approvable Letter in Response to Application for Use of  FUZEON With Needle-Free Injection Device (2005-11-24)
---Hope more people can benefit from that

Source:http://www.lifesciencesworld.com/news/news-Roche-and-Trimeris-FDA-Approval-6624.htm

Date Posted: Saturday December 03, 2005 8:14 AM
Posted By: rab

Thanks Chen for the update.
RAB

Date Posted: Friday December 16, 2005 11:34 AM
Posted By: Ashman39

hey guys,

I have been using fuzeon for about 2 years now , injection with needles , i havent had a problem , but i have my partner help me with it , find fatty areas to inject , like under arm , in the back etc...

I chose fuzeon over the next pi because i was tired of the side effects , is there anyone that has been on fizeon for longer than 2 years with no mutation problems?

andy

Date Posted: Saturday December 17, 2005 1:03 PM
Posted By: outwest

Hi -

I work at one of the sites - and largest enroller - which developed Fuzeon. If you live in San Francisco or nearby, we will be starting the Bioinjector study early in 2006. If interested, let me know.

I have heard that although it is needleless it is not painless, its not a patch - its a Bioinjector - the future is now.

Also if people are having problems with injection site reactions or even using fuzeon, I can get good information for you.

Peace

Date Posted: Tuesday December 27, 2005 7:05 AM
Posted By: rab

Ashman

You asked if anyone has been on Fuzeon for 2 years with no mutation problems. I just passed my two year mark, so far my Fuzeon/dual PI regimen is achieving maximum viral suppression (i.e. less than 50). My guess would be that the durability of a Fuzeon regimen would be determined not just by the Fuzeon but also by the other drugs in your current regimen and your specific resistance profile. Hope this helps.

Outwest:

Thanks for the offer. ISR's are, in my experience, the only real "side affect", of Fuzeon. Any guidance you can give to individuals struggling with them would be helpful. As I said earlier, the biojector has significantly reduced the severity and duration of my ISRs. But you are right, the actual injection isn't painless.

RAB

Date Posted: Tuesday December 27, 2005 11:09 AM
Posted By: jjmcm

Hi Rab. On Thanksgiving I was forced to switch regimens because my VL had shot up to 700,000 when Reyataz, Viread, Emtriva, Norvir failed. My CD4's dropped to 128 which was the first time I was under 200 in eight years.

I switched to the new Kaletra tablets at 125% of the normal dose, Saquinavir, and Combivir, along with Fuzeon. After three weeks on the new meds, my CD4's were back up to 213, and my VL had dropped from 700,000 to 417. I will get labs done in four weeks to confirm this trend.

Since you are undetectable, I was wondering if your doctor ever mentioned cycling off the Fuzeon after three or four months. A lot of people I have talked to tell me that after that you begin to develop resistance to Fuzeon which makes it unavailable for future regimen changes. The case they make is that by stopping it after the VL is down, you can save it for future use when you switch regimens in the future. I was told you begin to resensitize after sixteen weeks off of Fuzeon.

Anyone else have any information regarding this?

--JJ

Date Posted: Thursday February 02, 2006 9:04 AM
Posted By: clayew

RAB --

Thanks for posting your experiences regarding needle-free Fuzeon. I have a question. I am about to start using the device, and have the same worry that you referred to back in July 2005 - this is my only choice for a regimen and I don't want to lose it. However, the reactions are getting bad enough that I'm losing spots to inject (I've been injecting for 20 months.)

Have you found that your regimen was basically unaffected in terms of efficacy after you switched to the Biojector 2000?

Thanks --

Clay

Date Posted: Thursday February 02, 2006 9:40 AM
Posted By: rab

Hello Clay

Welcome to the Forums!

The Biojector has not affected the efficacy of my treatment as far as I can tell. My VL is still <50. I have had concerns regarding "dribbles" as I mentioned, but apparently they aren't happening frequently enough or even when they do I am still receiving enough Fuzeon. Anyway as I mentioned, my regimen is still working.

I think you'll find the Biojector will give you relief from the ISRs. You will still get them, but they will not be as severe or last as long. Also with the Biojector you can inject in your bum bum. (You can not however, inject in your chest anymore--if you were doing so with the needles.) I never could inject in my legs (welts were damn awful), so I haven't even tried using the Biojector there.

[gerry]

Part III
--------------------

Date Posted: Thursday February 02, 2006 10:59 AM
Posted By: clayew

Thanks a bunch for the info. I get trained on Thursday (2/9) and I plan on posting my experiences.

Thanks again -

Clay

Date Posted: Thursday February 02, 2006 4:14 PM
Posted By: whizzer

Hey Clay,
I started Fuzeon this past Monday, using the Biojector. I have yet to have a site reaction (knock wood). I find if I shower before I use it my skin is all soft and it is almost painless. I still jump from the hissing sound though.

I thought about using a needle one day just for comparison, but, realistically, I probably won't. The biojector is easy (and FAST). Plus there's no sharps container to have on the counter (mine uses no needles at all-not even to draw up the solutions).

-Whiz

Date Posted: Friday February 03, 2006 11:29 AM
Posted By: safford

hello everyone-

I just joines the forum today and boy what a great place to get info and share experiences. I just started a new Tibotec trial and regimen on January 26--TMC 114/TMC 125 with Fuzeon and Truvada. The Fuzeon Bioinjector is great. I am just so grateful for another option, as I was running out of viable alternatives. My T-cells had dropped to 8 and my VL was 345,000. The new regimen seems to eliminate a lot of the gastrointestinal problems i had before. I feel much better even after a week.

Date Posted: Friday February 03, 2006 7:33 PM
Posted By: clayew

Hi Whiz --

Thanks for the info and the tip about biojecting after the shower. I'm really excited to be leaving needles behind - my training is next Thursday after which I'll report on my experience.

Clay

Date Posted: Saturday February 04, 2006 4:47 PM
Posted By: whizzer

Hey Clay,
For your training you will get to inject sterile saline to practice with. It stings more than fuzeon does, so don't get discouraged (I said very bad words when I pulled the trigger the first time) if it seems a bit uncomfortable. The actual fuzeon going in doesn't sting like saline, for some reason, even though you mix it up with saline. I think maybe it's because the fuzeon is thicker and doesn't go in quite as fast. Good luck with the training.

-Whiz

Date Posted: Thursday February 09, 2006 10:44 AM
Posted By: safford

hello everyone--

i have been on the new needless Fuzeon Bioinjector for 2 weeks now and while working out at the gym today I realized I may be working somewhat at cross purposes to the requirements of the injection (i.e available body fat). I am extremely lean, 6'1", 170 lbs very defined and muscular with little or no body fat. I find the Bioinject hits muscle or residual cyst-like tissue (from previous injections) a lot of the time and I lose some of the dosage (i.e. "dribble"). I am concerned that as i tend to develop muscle easily (i am on oxandrin and androgel) I am taking away necessary body fat I need for the injections. I am currently enrolled in the new Tibotec TMC 114/TMC 125 trial. My background regimen includes the aforementioned Fuzeon and Truvada.

Has anyone heard anything about this? I am wondering if I ought to consider the old-fashioned syringe. Any help is much appreciated. thanks!

--Paul

Date Posted: Friday February 10, 2006 7:33 AM
Posted By: jjmcm

Hey Paul. I am now into my third month using Fuzeon. I have been working out for 25 years and also have almost no body fat. I will give you the flip side of the Bioinjector, the 31 gauge X 5/16" X 1 cc insulin syringe. My partner injects me so we can maximize the rotation. I generally use the left side of my body in the morning and right at night. I alternate between the chest, back of my upper arms, abs, then my butt. I do not touch the thighs because I have had very bad reactions there.

While my immune system was down (CD4's under 100 and VL over 700,000) my reactions were minimal. But, as my immune system has strengthened, the ISRs have been getting worse over the last few weeks. If you try a syringe, I recommend the chest or back of the arms. In general, most people I know have a stronger reaction in the abs and thighs. However, lately, even my tush is getting pretty sore.

Since I have responded well to my new treatment (CD4's back over 200 and VL down to 89), my doctor has mentioned taking a few weeks off of the Fuzeon to determine if the VL will stay down without it. If possible, I am going to try and save it for use down the road. I asked him about the Bioinjector if I stay on it. He has some patients using it now. He did say though that because I have virtually no fat that I might not be the best candidate to use it. From his experience with other patients, he believes the Bioinjector works better with those with at least a little layer of fat.

If you do try the syringe in your abs, I would try to stay away from the center area where I get more reactions. Also, if you inject in the thighs, watch out for blood vessels. Fortunately, mine are quite obvious. And whatever you do, use the insulin syringes I referred to. Never ever use the 27 gauge syringes they give you in the Fuzeon box.

--JJ

Date Posted: Sunday February 12, 2006 10:31 AM
Posted By: rab

Paul

I have very little body fat (<8%). The only place I do have some fat is across the abdomen, ironically this is where I get some of the hashest ISRs.

The thing I have discovered is my ISRs are reduced both in severity and duration using the biojector. So I'm not sure if having little or no body fat would preclude you from using the Biojector. Or at least it hasn't me.

Since starting using the Biojector I have switched back to the syringes twice for 2 days so that I could inject in my chest and allow the arms, bum bum, and abdomen a little extra time to heal. That's worked out pretty well for me. (Like JJ, I never inject in the thighs, the welts are just plain awful!)

I am concerned about hitting muscle tissue (especially in by bum) because I worry about scar tissue forming, which isn't what I want at all.

RAB

Date Posted: Monday February 13, 2006 10:00 AM
Posted By: jjmcm

Hi Rab, nice to hear from you again.

I think my doctor was worried about what you said: That my skin is so thin in areas that I might be hitting the underlying muscle with the Bioinjector. And, from the people on Fuzeon that I have talked to, most seem to have more reactions in the center of the abs and the thighs in general. I can tell you that I might seriously consider the Bioinjector if I stay on the Fuzeon. (my chest is probably my least reactive area though) I feel lucky; typically, I only have one injection site that might hurt for more than two days in any given week.

I was wondering what your OBR was? Since I had almost nothing left except Kaletra which I had been saving, we decided to do the new Kaletra tablets (at 125% normal dose), Invirase, with Combivir. My last VL went down to 89 from over 700,000 (CD4's 223) and my doctor has given me an option to stop the Fuzeon for a brief period to see what happens. Has your doctor or your labs given you a reason to consider this? I am thinking about trying it when my partner and I go on vacation in March. I really hate the thought of having to drag all the required stuff with my on a longer trip. Especially, since we plan to be very active.

My doctor and I had considered the new TMC 114 trial with the possibility of getting TMC125 also. I think as long as I continue to get good results with this OBR than I will probably stay on it. I am hoping that if it were to fail I would have access to TMC 114, TMC125, and the new Merck Integrase at the same time.

--JJ

Date Posted: Tuesday February 14, 2006 6:18 AM
Posted By: rab

JJ

Currently I am taking Kaletra, Invirase, Epivir, Viread and Fuzeon (sound familiar? )

I've now been on this regimen for over 2 years (December 2003). It's been a good durable regimen, with maximum viral suppression so far. (Had blood drawn yesterday---waiting for results= anticipation anxiety. You know how it goes.) The option of stopping the Fuzeon probably wouldn't be a good idea for me. It would leave me on what is essentially a PI only regimen. I can't risk losing the PI class. (Or as my doctor said when I brought the subject up "It wasn't easy to get you back to this point, why the hell would you want to fuck with it?")

The new TMC drugs and well as the other inhibitor class drugs will be my next option. I'm glad (grateful, estatic, relieved, etc etc) a plan B appears to be emerging for people like you and me.

I understand your desire to save the Fuzeon by considering discontinuation. I'll be curious to see what you decide.

RAB

(If you stay on the Fuzeon and opt for the biojector do you have to pay for it? Or would you be part of a study? Would your insurance pay for it? Just curious.)


Edit to add: VL from 700,000 to 89? WOW! You go guy! That's fantastic. Fuzeon, despite some of it's early PR, is turning out to be a very powerful and easy to take weapon isn't it? Congrats on those great numbers!

Date Posted: Tuesday February 14, 2006 11:06 AM
Posted By: jjmcm

Thanks Rab for your detailed response. Yes, your regimen sounds very familiar. I just got through burning down Reyataz and Viread together before this. So, we decided to move to Combivir because I only had four months of AZT treatment during the last nine years. AZT is the only thing I ever switched off of because of the regular nausea.

I am glad to hear that you have had a durable regimen with the Kaletra and Invirase. I believe it is becoming a well respected combination.

I know the part about waiting for lab results. My partner went with me for the first doctor's visit after I started the new regimen. It was only the second time in five years I asked him to do so. I was a nervous wreck the day my doctor told me that my CD4's had dropped from the 300's down to 128. (VL=700,000+) I am allergic to both sulfa and dapsone. So, the next thing was back on the pentamidine treatment with a shot of Mepron on the side. My doctor discontinued both at our last visit because my CD4's moved back above 200 for two months.

I was very excited to see my VL retrace so quickly. I think my doctor was amazed. We tried an unconventional approach when I switched regimens. He wanted to maximize the effect of the new meds and asked if I would do two weeks of Foscarnet IV treatment also. He claimed the Dutch had research to support strong anti-HIV properties of its own. I agreed (reluctantly to the IV) and started everything on Thanksgiving Day. Thank God the med-line made my arm swell up so large that I had to stop the Foscarnet after one week. I don't know how anyone can manage that every day.

As far as the Fuzeon, you make an extremely valid point in regard to the PI only treatment. I want to see a more detailed analysis of my last resistance test results. Especially in regard to the AZT. However, a good friend of mine "in the know" tells me that in many cases, Fuzeon loses significant effectiveness by the 26th week and becomes marginal for most at about a year. I don't know how long I want to keep dealing with the ISR's if that is the case. My doctor made a statement that once the "fire" dies down some, it is definitely worth considering a break. I am going to ask him the percentage of his patients that have successfully stopped without a loss of viral suppression. I will keep you informed.

I had not thought about the acquisition of the Bioinjector. I use Statscript also. Do you have to give the injector back at the end of a year? I am still reeling from hitting the "doughnut hole" on my Medicare Part D. Last week I had to pony up over $2300. Ouch! Another $1000 to go before my catastrophic kicks in.

Best of luck on your labs. Do you mind sharing where you were before this regimen and now?

And, I am ALWAYS happy to see a plan B forming on the horizon. I just hope that some type of good immune therapy surfaces before these meds kill us all.

Take care,

--JJ

Date Posted: Tuesday February 14, 2006 2:53 PM
Posted By: picou

Hi everyone,

I am taking fuzeon since sept 2003 (!) along with Invirase, Norvir and Viread. My T4s went up from 80 to 450 and my VL is zero. I have been HIV since 1983 and went through ups and downs, while my friends, more unlucky, were dying. I have taken so many medications that I don't remember all their names. Each time they were becoming less effective, something new popped up! So here I am at 55 contemplating plans for retirement, as 23 years ago I could'nt even think of tomorrow! Miracles do happen, God bless!:

Date Posted: Wednesday March 01, 2006 12:12 PM
Posted By: safford

hello all--

just wanted to share with you all that I had the Fuzeon visiting nurse come by to help me with the correct Bio-Injector procedure. I had been losing a lot through "dribble" effect. turns out it is simply an issue of pressure: a VERY HARD PRESSURE on the area is required to get it all in. i was not aware of that as i was simply placing the injector against the skin and firing away. i haven't missed a drop since i improved my technique.

--Paul

[Jerry71]

Bump to bring out for more people who are on Fuzeon to read and get great infor on Fuzeon