|"About 35 days ago I started a new drug regimen. I am
one of those unlucky ones that is resistant to most HIV drugs
so I participate in drug trials. My current regimin is Prezista
w/Norvir boost, Reyataz, Truvada and the Merck Integrase Inhibitor
- MK518. Prior to starting this regimen my CD4 percentage was
less than 1% (3 T-cells Larry, Moe, & Curly) and a viral
load of 37,000. Friday, my doctor called to inform me that I
am now UNDETECTABLE! My CD4 percentage is 3%. I've always had
a very high viral load since they began testing viral loads.
Needless to say I am overjoyed with the good news. I realize
I am not out-of-the-woods as of yet but my train is finally
on the right track and pointing in the right direction. Restoration
here I come! It was not easy getting to this point. I have had
7 hospital stays since August of 2006 starting with a very bad
case of PCP. I wasn't expected to make it through the night.
The point here is that I did not give up. My doctor and his
excellent team of experts did not give up. Nelson Vergel did
not give up on me and neither did my rock and partner Robert.
I am truly blessed to have such great people in my life.
If anyone else is in a similar predicament with the FDA approved
drugs, I would encourage you to investigate MK518 and sit down
with your doc to make a plan. I know several other people who
participate in this trial and they also have experienced great
powerusa dot org
I just wanted to thank you and express my sincerest gratitude
for all that you have been doing to help me obtain the
two Tibotec drugs. It is my firm belief that the hard work
that you, Robert Earl, and all the great people at the
Schrader Clinic have done on my behalf will pay off in
a big way. You have been like a shining beacon of light
and I now can see the day when I feel healthy and energetic
again. The day is closer than ever and I am so excited.
I’m sure there are days when you wonder if the fight
you fight is worth it. I assure you it is. I can’t
possibly thank you enough for your compassion and tireless
drive to help AIDS patients everywhere. I may not be able
to ever express how important obtaining the Emergency IND
for TMC-125 is to me but I can make a commitment to you
that once I am feeling like my old self again, I want to
help you in anyway to spread the word that those of us
with few CD4 cells and overwhelming viral loads should
not be counted out. I want to help those that are desperate
for investigational new drugs to obtain them with absolute
expediency. I want to prove to doctors all over the country
that the Emergency IND is not as complicated as they may
believe. I want the drug companies to realize that we who
need the new drugs more than anyone should not be excluded
from research. My restoration of health will be a perfect
example of how this is possible.
I am one among so many that has been truly blessed by
your steadfast commitment to fight the good fight. My personal
journey on the road to wellness has been difficult but
a conversation with you out at sea last October helped
shed any doubt that I will survive and I will thrive once
again. You restored my hope and inspired me. Once more,
I would like to try to express my appreciation for all
that you do. You make a difference.
I live in Los Angeles and I have been dealing with HIV
and AIDS since my HIV+ diagnosis in 1988. I lost my first
partner to the disease in 1991. During the early years
there was very little effective medication against this
disease, especially if you had full blown AIDS. Many of
us remember it as a very difficult time.
In 1995, I advanced to having AIDS with the diagnosis of Kaposi’s Sarcoma,
followed within months by a serious bout with Cryptococcal Meningitis. I lost
50 lbs, had a fever of 104, T cells were under 20, and my viral load was astronomical.
Protease Inhibitors and a new 3 drug cocktail came along in 1996 and turned
those numbers around, saving my life for the time being. I returned to work
and completed my Masters degree in night school. Life was good.
I followed my drug regimen religiously, but I seemed to become resistant to
drug classes fairly quickly with each single new drug I received. By late 2002,
I had a precipitous drop in T cells accompanied by a high rise in viral load.
I was still working and the doctor thought it best I again try a single new
study drug called Fuzeon (also called T-20 or enfuvirtide), a fusion inhibitor.
I started this single new drug in October 2002, and within a month my numbers
improved dramatically. One month after that my T cells again started to crash,
my viral load went through the roof, and I developed something called “Immune
Reconstitution Syndrome”. At the same time I developed non-Hodgkins Lymphoma,
which no one thought I would survive. I left work on disability in February
2003 and six months later I completed regular as well as spinal chemotherapy.
I have had no recurrence of my malignancy – I beat the odds – again.
For the last 3 years, my HIV drug regimen has consisted of what is commonly
called “Salvage Therapy”. In other words, I am resistant to all
classes of HIV medications. At his point, nothing works well at all for me
and others in my situation. Studies show it is still better to be on a failing
regimen than none at all, so I continue with a heavy failing regimen. My T
cells continue to be less than 10, while my viral load is consistently over
200,000. Lately, I experienced a mysterious (ie: doctors cant figure it out)
20lb weight loss, followed shortly thereafter by a progressive and permanent
loss of vision from both eyes caused by a new opportunistic infection, namely
Cyomegalovirus, commonly called CMV. CMV is a serious end stage illness, which
means time is really running out for me and others in my situation. We has
temporarily arrested the CMV infection, but its clear that folks in my stage
of illness need more options. The new drugs cannot come fast enough.
As you can see from my story, life has a way of repeating itself for some of
us long-term AIDS survivors. Many of us are not the cheery, healthy, HIV positive
folks you hear about, hiking and taking picnics on the beach because of our
new meds. No, many long-term AIDS survivors live to hop from one new drug set
to the next, with drug resistance developing to each new drug, hoping to survive
to the next advancement in treatment.
For those of us in my situation, our best hope is to get our hands on TWO new
HIV drugs to restore our health. Unfortunately, many of the new drugs become
available only as single agents. Many of us simply can’t afford single
new drugs as part of our regimen. I have less than 10 T cells and I have a
viral load of over 200,000. I need at least 2 new drugs to have any hope of
surviving long enough for better treatments. Two new drugs will probably save
my eyesight in the short run, and give me and others the lease on life we need
to make it to the new classes of drugs which are still one or two years away.
As of this date, there is a 50:50 chance that an average patient like me entering
a randomized study with 2 new drugs will receive one new drug and one placebo
as opposed to TWO new drugs. One new drug means virtual monotherapy, quick
resistance, and loss of time.
Luckily for me, I contacted an Internet discussion group called ATAC. I asked
for help with my situation and I learned through an email from Nelson Vergel
that there was a possibility I could acquire 2 new drugs through a company
called Tibotec. I knew Tibotec was conducting something called the “DUET
study”, but it was my understanding prior to talking to Nelson that there
was no way I could be guaranteed I would receive both TMC114 AND TMC125 together
as my 2 new drugs. I knew I could certainly get TMC114 by expanded access means,
and then only by a roll of the dice I would have a 50% chance of receiving
TMC125, as well as a 50% chance of receiving a placebo as the second drug in
my new “regimen”. As I discussed earlier, I cant afford making
myself resistant to a new drug overnight, so I considered not participating
in the DUET study at all. Instead, I considered the strategy of trying to hold
out until the end of summer when I might receive both drugs together.
Thankfully, I don’t have to face the dim prospect of monotherapy again.
Nelson informed me and the ATAC discussion group about a process called Emergency
Investigational New Drug (EIND) access. So I approached my doctor with this
idea. He was hesitant at first, but finally he did apply for the EIND in the
beginning of March 2006 and within a week and a half we had permission from
Tibotec, the FDA, and my medical Center’s Internal Review Board to proceed
with the EIND. That means I will receive my TWO new drugs by the end of this
month, March 2006. There is hope after all. Thank you Nelson and Barry for
all of your help.