Regards,

Nelson Vergel
powerusa dot org

Hi Nelson,

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.

Sincerely,
Jeffrey Young

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.

Gary Bischop
Los Angeles