Transcript of The Body’s Live Chat With Nelson Vergel on Issues for HIVers With Multi-Drug Resistance
Following is the transcript of The Body’s live chat on issues for HIVers with multi-drug resistance, which took place on Feb. 16, 2005, at 9 p.m. Eastern Standard Time. The chat was sponsored by Roche and Trimeris, moderated by The Body’s editorial staff and hosted by Nelson Vergel, a leading treatment advocate who has been HIV positive since 1983. This transcript has been edited for grammar and clarity. In rare occurrences, additional follow-up information was obtained from the host after the chat’s conclusion.
This is the third chat that The Body has moderated; to see transcripts of previous chats, click here.
Moderator 1: Thank you all for coming to The Body’s live chat on HIV treatment issues for people with multi-drug resistance. Tonight’s topic is a broad one; our guest speaker, Nelson Vergel, will discuss HIV drug resistance, new drugs in development, health and nutrition tips, and other issues of importance for treatment-experienced HIVers.
Nelson, before you begin to answer everyone’s questions, would you like to tell the room a little bit about who you are and why you’re here tonight?
While we’re waiting for Nelson to introduce himself, you can read his full bio at: www.thebody.com/bios/vergel.html.
Nelson Vergel: I have been positive for 21 years. Formerly a chemical engineer, I have been active in the HIV field since 1988. I am a co-author of “Built to Survive” and lecture extensively around the country.
Moderator 1: Thanks, Nelson! And with that, let’s open the floor to everyone’s questions.
Original message from Confused: I have been on a HAART regimen that includes Kaletra [generic name: lopinavir/ritonavir] for a few years now, but have NOT had a treatment failure. For a number of reasons (liver toxicity, pill burden, etc.), I have been considering changing to Reyataz [generic name: atazanavir]. Everything I have read about Reyataz, however, lumps “people who have taken HIV drugs in the past” with “people who have experienced a drug failure.” To me those are two different issues. Thus, if I ultimately decide to switch, should I start the regimen of Reyataz boosted with Norvir [generic name: ritonavir] (for treatment-failure patients) or the once-a-day regimen without Norvir (for treatment-naive patients)? OR should I give up the idea entirely, since recent studies tend to suggest that Kaletra isn’t that much more toxic for the liver than Reyataz, and since conventional wisdom suggests that one shouldn’t change in mid stream?
Reply from Nelson Vergel: Please talk to your doctor about this. Kaletra is the protease inhibitor with the most long-term data. It has been shown to be effective in naive and experienced patients. Some people may experience lipid increases and diarrhea with it. It is taken twice a day. Reyataz is a newer protease inhibitor that is taken once a day, usually with Norvir as a booster. It can cause increases in bilirubin in some patients, making them jaundiced (turning their skin and eyes yellow). So far I have not seen studies that show any difference in liver enzyme increases between the two drugs. They seem to have comparable efficacy in a 48-week study. We do not know if that holds for longer periods of time.
Original message from Max: It would seem like many HIV specialists don’t know a lot about resistance. Is this your experience as well? Who should be sought?
Reply from Nelson Vergel: No. I think most HIV physicians who have large practices are pretty well trained in genotype and phenotype testing interpretation. But combining drugs and predicting response is still more of an art than a science in many cases.
Original message from MKNYC: How does one (or DOES one) try to assess in advance any kind of timeline for potentially developing resistance to regimens (assuming excellent adherence)?
Reply from Nelson Vergel: It is impossible to predict how durable a regimen will be, assuming that you are adhering perfectly to your medications.
Original message from Eduardo: Will the oral CCR5 inhibitors make Fuzeon [generic name: enfuvirtide; also known as T-20] obsolete since it is an injectable?
Reply from Nelson Vergel: Currently, there are several oral entry inhibitors in phase II development. They work on different receptors (entry ports) than Fuzeon. We are not sure if they will be effective in people with more advanced disease. Some of these drugs are being researched in combination with Fuzeon.
Moderator 1: For more info on entry inhibitors in development, you can also visit The Body’s collection of articles at: www.thebody.com/treat/fusion.html#other.
Original message from pozington_bear: I hear lots about the up-and-coming DAPYs, including TMC-120 and TMC-125, along with R278474. What do you think will come of them?
Reply from Nelson Vergel: I am very hopeful about these drugs. Tibotec is the first company in AIDS history that has two drugs going through the same phase of development. Both TMC-114 (a protease inhibitor) and TMC-125 (a non-nuke) have shown promising results for multi-drug resistance. They have just completed their phase II studies and are getting ready for phase III and expanded access in the upcoming months.
Original message from ATL650: My mother is resistant to all medications and the doctors say there is nothing else for her to do. Did she develop the resistance from not taking her medications as required? Is she really resistant? Will she be able to use the medicines after being off them for a couple of months, or is there nothing else she can do but wait to die?
Reply from Nelson Vergel: The only way to find out if your mother has indeed developed resistance to medications is to perform a genotype and/or phenotype test while she is on the meds. Her viral load has to be over 1,000 to be able to perform the test(s). There is conflicting data on whether it is a good thing or not to take a break from medications before starting a new regimen, but U.S. data shows that it may not be a good idea. Have her talk to her doctor about this.
Moderator 1: The Body’s “HIV Drug Resistance” page can also provide more info on the basics of resistance and resistance testing: www.thebody.com/treat/resistance.html.
Original message from MOD: With so many new agents in the pipeline, some of which will take a while, should one wait as long as possible before attempting to put together a new regimen?
Reply from Nelson Vergel: I am very hopeful about the new treatments. I have developed resistance to all medications myself and am waiting to access two active drugs in the future. Within the next year we will have access to six [new] drugs via phase III studies and expanded access programs. For those who need something right away and have developed resistance to most medications, Fuzeon and the new protease inhibitor, tipranavir, are good options to consider. Tipranavir is not FDA approved yet, but is available through expanded access.
Moderator 1: You can learn more about tipranavir’s Expanded Access Program at: www.atdn.org/access/ind/tipr.html.
Original message from Shay: Do you live a fairly busy, active full life?
Reply from Nelson Vergel: Yes. I lecture weekly around the country and moderate several Internet groups and Web sites. Keeping busy and having a purpose in life are the best medicines to stay alive.
Original message from clif: I have been through many drug regimens and am about to start yet another. I am going to be on six HIV meds: Sustiva [generic name: efavirenz], emtricitabine [brand name: Emtriva; also known as FTC], Fuzeon, ritonavir, stavudine [brand name: Zerit; also known as d4T] and tipranavir. Is it unusual to be on a combination of so many HIV meds? Also, I heard that there is a new, needleless injection system for Fuzeon using Bioject, which my pharmacy is being trained on now. Is this a viable option to the painful needle?
Reply from Nelson Vergel: Yes, it is usual for people with multi-drug resistance to take more than three drugs. Many times these combinations have not been studied. Yes, Roche is testing a needle-free device to see if people will have fewer injection site reactions. Contact your closest StatScript Pharmacy for details on how to join this phase IV study (go to www.statscript.com for their closest location).
Moderator 1: To add on to Nelson’s response, the brand name for the needle-free device is the Biojector; studies on using it with Fuzeon have just begun, though the device itself is already approved in the United States.
Original message from sissy: I was told I had AIDS in 1989 and have been on just about everything. I had two bad episodes of Stevens-Johnson Syndrome and my viral load recently doubled. I am about to try Lexiva [generic name: fosamprenavir], Fortovase [generic name: saquinavir] and Truvada [generic name: tenofovir/emtricitabine]. My CD4 count is 255 and my viral load is 48,800. I have NEVER been undetectable. I hate to change meds — I feel good on these. Any suggestions?
Reply from Nelson Vergel: Talk with your doctor about this. If you have not developed resistance to Lexiva, Fortovase and Truvada, it may be a good thing for you to start a regimen that will offer you maximum viral suppression.
Original message from justaguy: How did you get HIV?
Reply from Nelson Vergel: From man to man sex.
Original message from Max: Are you using Fuzeon now and how does it affect your lifestyle?
Reply from Nelson Vergel: Yes, I have been on Fuzeon for the past 18 months. It took me a while to get used to it since I travel so much. Fuzeon has stabilized my health. I have also been able to manage injection site reactions. Fuzeon is a drug that works if you have at least one more active agent to start with it.
Original message from sr90650: If your T-cell count stays above 400, are you still able to contract opportunistic infections? Also, how do you deal with the neuropathy in your feet?
Reply from Nelson Vergel: Most opportunistic infections occur at levels under 200 T cells. You can still get several HIV-related complications at 400 T cells, like thrush, neuropathy, lipodystrophy, wasting and many others.
The best way to deal with neuropathy is to avoid Zerit or ddC [generic name: zalcitabine; brand name: Hivid]. Some studies have shown that acetylcarnitine may improve pain and help with nerve regeneration. Some doctors prescribe tricyclic antidepressants and anticonvulsants to manage the pain. There is also data on the use of a red chili pepper gel that may work.
Original message from Joseph: How do you keep up your energy level?
Reply from Nelson Vergel: Fatigue is my main challenge. Exercise has helped me a lot. I must admit that I like coffee — a lot. Supplements like carnitine, co-enzyme Q10 and B vitamins also seem to help me. When I’m really run down and I have a lot to do, I take an attention deficit disorder drug like Adderall [a combination of the generic drugs dextroamphetamine and amphetamine]. Testosterone replacement has also helped me tremendously in the past 11 years. Getting enough sleep is extremely important. Talk with your doctor about all your options to deal with your fatigue.
Moderator 1: You can also learn more about fatigue at The Body (of course!) by visiting www.thebody.com/treat/fatigue.html#fatigue.
Original message from MikeR: Hello Nelson and thank you for doing this. My question: What options are open for someone who had no CD4 response to both T-20 and tipranavir taken together along with Reyataz, Viread [generic name: tenofovir], Videx [generic name: didanosine; also known as ddI], Epivir [generic name: lamivudine; also known as 3TC] and Norvir? I was told by the tipranavir study doctor that I was the “first non-responder” she had seen to that drug. What’s next?
Reply from Nelson Vergel: I know a few people like you. I am very hopeful that Tanox’s TNX-355, a once-a-week IV, Reverset [also known as D-D4FC], a new nucleoside, and other entry inhibitors will provide options for us in the next year or so when these drugs start their phase III studies and expanded access programs.
Original message from sam soriano: How do you reduce or eliminate injection site problems while using Fuzeon?
Reply from Nelson Vergel: I would suggest you join my Fuzeon support group by sending a blank e-mail to firstname.lastname@example.org. I have injected Fuzeon in areas not recommended by the company and have managed to avoid my abdominal area, which seems to be the one that gives me the most trouble. Massaging for at least five minutes after the injections and using insulin syringes have also helped me a lot. Feel free to send questions to my support group. There are many people there that may help you. Also visit the Fuzeon resource center at TheBody.com.
Moderator 1: The Body’s main Fuzeon page is www.thebody.com/treat/t20.html; the Fusion Inhibitor Resource Center lives at www.thebody.com/fuzeon/resource/.
Original message from Confused: Do you have any specific suggestions for nutritional supplements?
Reply from Nelson Vergel: This is a very general question that will take me a long time to answer. I would suggest that you go to my Web site, medibolics.com, and click on the nutritional section. There is a link there that shows all the supplements I’m taking and why.
Original message from Hector: I have been fighting wasting ever since I was told by my doctor. He puts me on Serostim [a growth hormone] 6 mg every other day and only every other month and getting it from him is like pulling strings. Do you know of a doctor that treats wasting and HIV? I hate the way some of these doctors treat us HIVers. Please help me. I am in the HIV field as well. I don’t get hungry, I live alone [and am] very worried about myself.
Reply from Nelson Vergel: I do not know where you live, but I have a list of doctors on medibolics.com who use not only Serostim but anabolic steroids for men and women.
Moderator 1: The Body also has a collection of info on supplements at: www.thebody.com/treat/herbal.html.
Original message from Eduardo: Can you tell us where to apply for studies of new drugs and info on new drugs?
Reply from Nelson Vergel: The best Web sites to find out about studies for new drugs are:
Moderator 1: Also visit www.thebody.com/treat/open_trials.html for a comprehensive listing of clinical trial databases.
Original message from La Rae: If a drug is in Phase III, how long does it normally take to become available? Also, how long typically does it take to get from Phase II to Phase III?
Reply from Nelson Vergel: It depends. A drug that provides new options for people can go through accelerated approval. But usually a phase III may take 24-48 weeks. To go from phase II to phase III usually takes three to six months depending on the company. Phase II studies are meant to determine best dose and find out any side effects. Phase III are larger studies that are done prior to approval.
Moderator 1: New Mexico AIDS InfoNet has written a great overview of the U.S. drug approval process: www.thebody.com/nmai/approval.html.
Original message from poz88: Re-infection. Can two HIV/AIDS people have unprotected sex with each other and one becomes infected with a stronger strain of the virus? I manage several e-groups and several poz couples, and there seems to be varying opinion on this. I personally believe they CAN re-infect one another, but then I have had AIDS since ’88. What do I know?
Reply from Nelson Vergel: This is a very controversial subject and a gray area. All the superinfection reports that we have seen so far have been in people not taking HIV medications. We do not know if HIV medications may protect somebody from superinfection if they decide to have unprotected safe sex. I guess we will have to wait for more data.
Original message from ATL650: Nelson, I am so glad to hear you have been in great health for a long time. My question is do you consider yourself what is called a non-progressor?
Reply from Nelson Vergel: Not at all. If it wasn’t for the HIV medications I am taking, I would be dead. I would consider myself a normal progressor that for some reason has been able to survive for this long even though I have never had an undetectable viral load. I think that good nutrition, exercise, anabolics, stress management and keeping a positive attitude have been key to my survival.
Original message from wendy: What in the world can someone do if they get this multi-resistant HIV transmitted to them now?
Reply from Nelson Vergel: Oh boy, don’t get me started on this one. Nobody can really tell if the New York guy got a superbug or if his immune system was impaired before he got infected due to his crystal use. Around 14% of newly infected people nowadays are getting infected with HIV that is resistant to three of the approved drug classes.
Moderator 1: More info and opinions on this issue are available from our Web site at: www.thebody.com/treat/mdr_hiv.html.
Original message from lisa_89: I’ve been on HIV medication since diagnosed back in 1996. My T cells were around 360 and I’m not sure what my viral load was. I’ve been undetectable for years and had a T-cell count as high as 1,000; however, it hovers mostly around 850-900. My doctor says I’m doing excellent and we’ve been talking about taking a break from medication. I hear so much talk from friends and associates about how they’ve been doing off medication and the controversy about whether the cocktail works better than natural/alternative treatments that I’m confused and concerned about what to do next. Can you shed some light on this issue and help ease my mind about what I should do next?
Reply from Nelson Vergel: This is a very personal decision. There is conflicting data from structured treatment interruption studies. It seems that those with a low nadir (lowest T-cell count you ever had) may be more at risk for losing more T cells when taking a break from medications. Your nadir is not bad, however I would talk with your doctor about monitoring you closely if you decide to take a break from your HIV medications.
Original message from pablo: Did you ever experience any side effects such as facial wasting, buttocks wasting and potbelly? Can one do anything to combat these?
Reply from Nelson Vergel: I have experienced mild facial wasting that I treated 3 years ago in Tiajuana, Mexico with Bio-Alcamid. Now we have an FDA-approved drug in the United States called Sculptra [generic name: poly-L-lactic acid] that you can get for free if you make under $40,000 a year. Visit my Web site facialwasting.org for more information or join my list server by sending a blank e-mail to email@example.com.
I have managed buttock and body wasting with the use of anabolic steroids and exercise. More information about this is at medibolics.com.
Original message from texas: What are the top three supplements you think everyone with HIV should take?
Reply from Nelson Vergel: B-100 supplement, selenium and carnitine. It depends on the side effects that you may have. More information on supplements is at medibolics.com.
Original message from Robert: As a Dutch user of Fuzeon enrolled in the tipranavir trial, I would like to ask you: Besides the above-mentioned new medication, I also take loads of other HIV medications that give me some side effects. Since I started with Fuzeon and tipranavir, many more side effects have become apparent: a neurological condition called Restless Legs Syndrome, an overproduction of stomach juices and an alarmingly high cholesterol level. Is this because of these new medicines (I started taking them since about June of 2003) or is it just because my body cannot cope with yet another huge load of medicines? I am now taking meds to counterattack these side effects, but they in turn cause other effects, so I feel as if I am in some boring vicious circle. What is your opinion and how should I deal best with such a situation?
Reply from Nelson Vergel: So far I have not seen any reports on Restless Legs Syndrome being caused by antiretrovirals, but that does not mean that it may not happen. Tipranavir is well known to have gastrointestinal side effects and to increase lipids. If you have no more options to keep your viral load suppressed, I would try really hard to manage the side effects until new agents that may be more agreeable with you are available in a year or so through different studies.
Original message from Joe: I have been HIV+ for 15 years. My current regimen is Videx EC, Viramune [generic name: nevirapine] and Epzicom [generic name: abacavir/lamivudine]. My CD4 count is 236 and viral load 500. My doctor tells me that I am resistant to my drugs and wants me to switch to Fuzeon and a protease inhibitor, but I am very hesitant. I am 61 years old and have developed many health problems, such as high blood pressure, clogged arteries, PAD, COPD and depression, and I take medications for them. My CD4 count and viral load bounce back and forth. I would of course like to get a boost in my CD4 count and find something to stop the wasting, especially in the face. If I’m resistant to my drugs, why are they holding my numbers at a range I can live with? After all these years I feel if it ain’t broke don’t mess with it. But do you have any suggestions for an easier regimen?
Reply from Nelson Vergel: This is a very good question. Sometimes patients and doctors get very focused on keeping an undetectable viral load. Side effects and quality of life should also be considered when thinking about switching regimens. Some doctors are more conservative and try to keep you on the same combination if your health and numbers are stable. Ultimately, you are the one to make the decision. I would be concerned if I were you if your T cell count dropped below 200 and your viral load kept climbing.
Original message from Warren: I just recently completed drug trials on TMC-114 with no success. My virus has resistance to Fuzeon after nine months as well. Any suggestions?
Reply from Nelson Vergel: I do not know what your numbers are. You may want to wait if you can for future options that are coming up in the next few months. Go to salvagetherapies.org to explore your other options and talk to your doctor about treatment strategies.
Original message from NelsonFan: I just want to say, Nelson, that I admire your courage and commitment!
Reply from Nelson Vergel: Thanks a lot. You’re making me blush.
Original message from Reo: I have kidney failure and test positive for hepatitis C — I have been told by my doctor that my med options are limited. Right now I’m tolerating a Kaletra and Ziagen [generic name: abacavir] combo, but the bathroom routine is driving me crazy because I’m working full time. Being on dialysis, is there any combo I might consider? Sustiva kicked my butt.
Reply from Nelson Vergel: Talk to your doctor about this. There are other protease inhibitors, like Reyataz, that do not cause diarrhea. Try to avoid Viread and Videx, since they may present problems in those with pre-existing kidney disease.
Original message from pozington_bear: I have been on Fuzeon for almost three years. It was very successful at first, but I am now failing. I have been on tipranavir for about two years and have received no noticeable benefit. I just found out that I do not qualify for the CCR5 inhibitor trial because my virus uses mixed CCR5 and CXCR4 attachments. I have been positive for over 25 years. I am using or resistant to everything currently available. My viral load is 466,000. I have FOUR CD4s. What should I do next?
Reply from Nelson Vergel: I am sorry to hear that those combinations have failed you. I would keep my eye open for TMC-114, TMC-125, TNX-355, Reverset and other new agents coming soon. Go to salvagetherapies.org/newrx.html to see all the new drugs that are getting close to phase III. Talk to your doctor about keeping your replication capacity low with current HIV medications. Replication capacity measures how fast your virus multiplies and it is included in the phenotype test, Phenosense.
Moderator 1: You can also learn a little more about replication capacity by reading this article from Project Inform: www.thebody.com/pinf/nov04/replication.html.
Original message from wendy: Hi Nelson: How do you keep feeling so optimistic when you are really struggling to find treatment that works? Any tips you can share?
Reply from Nelson Vergel: Well, my T cells are still over 200 and my viral load is under 20,000, so I consider myself pretty stable. I am very fortunate to be very close to research data through my work at the drug development committee of the AIDS Treatment Activist Coalition (www.atac-usa.org). My activist work has given me a lot of hope about the future. We are looking for people who want to volunteer as treatment activists. We train people on how to become savvy about treatment information and how to deal with the pharmaceutical industry in different stages of research. In short, education and empowerment keep me optimistic.
Moderator 1: Tonight’s interactive chat on HIV treatment issues for people with multi-drug resistance has now concluded. Thank you, Nelson, for taking the time to answer all these questions — and thank you to everyone who asked questions or took the time to join our chat tonight!
My apologies to all of you who have submitted excellent questions we couldn’t get to tonight! I hope you’ll consider using The Body’s “Ask the Experts” area at www.thebody.com/experts.shtml to get the answers to your questions.
Nelson Vergel: I want to thank TheBody.com and the sponsors for this opportunity. Thanks to all of you for giving up your TV time to chat with me. I am looking forward to other chats in the future. Love and health to all.
Moderator 1: Thank you all again; enjoy the rest of your night!
These questions were submitted before or during the chat, but because of time limitations, Nelson did not have the chance to answer them.
Original message from alvy241: Are there going to be any fusion inhibitor drugs like Fuzeon in pill form in the near future (six months or less)?
Reply from Nelson Vergel: Currently, there are several companies developing CCR5 and CRX4 inhibitors that will be taken by mouth, but they will not be approved until 2007-2008. They will be available in probably six to 10 months in larger phase III studies and then in expanded access programs. Fuzeon acts on the gp41 protein of the virus, so it acts on a different site. Some of these companies are looking at combining Fuzeon with their inhibitors in the hope that there will be a stronger response. All of these oral inhibitors need to be taken with “optimized background therapy” (OBT) that may include the currently available drugs.
Original message from phillippe: Is Fuzeon a “last resort” drug?
Reply from Nelson Vergel: Well, that is what most of us used to think. But after looking at the data from Roche’s TORO studies (to review these studies, visit www.thebody.com/treat/t20_research.html), we have seen that those people who had over 100 T cells and a viral load of under 100,000 and who started a new drug with it had a better response. Also, those who started a combo without Fuzeon (the best possible combo as determined by genotype resistance testing and a patient’s medication history) and were switched to the Fuzeon arm (plus their regimen) later did not benefit from Fuzeon as much as those who had started it with one or more active drugs. So the message is to start Fuzeon when you can get the maximum response. Although, I have to admit, it is a big commitment for many people to begin an injectable drug. Personally, I decided to do whatever it takes to keep myself healthy, no matter how much discipline I needed to acquire to get there. I believe that HIV is a disease that really tests your level of commitment to your own health.
Original message from Max: I read in the newspaper the other day that one in four Fuzeon users drop it after the first month. Is this true, and if so, why? Because of pain? Because it’s not effective? Because it’s too tiresome to use?
Reply from Nelson Vergel: I am not sure that I have seen these data, but people probably drop out due to schedule conflicts that make it hard for them to mix and inject a drug twice a day, site reactions, fear of needles, or plain injection fatigue. It is definitely a commitment that some people may not be able to handle. I know flight attendants who have to inject in airplane bathrooms, so that shows you how committed some people are!
Original message from richardIII: Will site reactions no longer occur with the new Biojector device for T-20? That would be a godsend!
Reply from Nelson Vergel: So far the feedback I am getting at fuzeonsupport at yahoogroups.com is positive. We will have to wait and see until more people use the device to know if there are any interpersonal variations.
Original message from rfourniers: What’s the lowest your CD4 count has been?
Reply from Nelson Vergel: The lowest was 180, 10 years ago when I was only taking AZT plus 3TC.
Original message from La Rae: I have taken many drug combinations over the past 14 years. Now my strain is resistant to all drugs currently available. I am trying to get to Fuzeon and tipranavir, but I don’t even know if tipranavir will be effective. My doctor says that the test to determine whether I am resistant is not readily available. Can you suggest a process for me to get such a test?
Reply from Nelson Vergel: So far, I do not think that the currently available genotype tests include tipranavir. The maker of tipranavir thought that certain mutations might impair individual responses to the drug, but lately they have found that this is not the case. Tipranavir works pretty well when you start it with Fuzeon and possibly a background regimen that can lower your viral replication capacity. You may want to join my online support groups pozhealth or fuzeonsupport and ask others who may be on the combo already. You can do so by sending a blank e-mail to firstname.lastname@example.org or to email@example.com.
Original message from Sam: Hi Nelson! Do you think that we’ll get to the point of having medicine regimens tailored to the individual instead of for general use? Seems that the medications would work better if the doctor had a DNA and genetic profile of the person being treated. Any comment?
Reply from Nelson Vergel: I certainly think treatments tailored to individuals would be more effective. We are finding out about genes that affect drug metabolism. Also, the use of therapeutic drug monitoring (testing for drug levels in your blood) will become more widely used in the United States. Roche got approval from the FDA in January for their first test that actually determines if individuals will be able to respond to certain drugs just by looking at their liver enzymes and metabolism. So I think that in about five to 10 years, we will have customized combos designed just for each individual.
Original message from Raffaele: I have recently read in The New York Times about an alleged vaccine, produced by a duo in Brazil, that is said to have been quite successful and is in phase II trials. Essentially it is purported to be administered once a year to an infected individual and assists the immune system in fighting HIV. I haven’t been able to discern more information or truths about it in recent days and my doctor hasn’t heard of it either … was it a bogus story?
Reply from Nelson Vergel: Actually I am very excited about this. The vaccine is made from a patient’s own dendritic cells and HIV isolated from the patient’s own blood. Dendritic cells are crucial to the immune response. They grab foreign bodies in the blood and present them to other immune cells to trigger powerful immune system responses to destroy the foreign invaders. It may be a costly option, but it sounds very promising for those of us who want to keep our immune systems from deteriorating. Please read more details at: www.thebody.com/kaiser/2004/nov30_04/hiv_vaccine.html.
Original message from La Rae: Is it possible to successfully apply for and get into phase III trials or expanded access programs in different parts of the country, regardless of where you live and what programs may be available in your immediate area? If so, how would one make such applications?
Reply from Nelson Vergel: For phase III studies, you have to be close to a research site (for a list, see www.salvagetherapies.org). For expanded access programs, it does not matter where you live, since your doctor can get the drug sent to his or her office. Right now there are close to eight phase II protocols and there may be four phase III protocols starting soon. Tipranavir is in expanded access.
Moderator 1: For more information about the program, healthcare professionals treating HIV-infected patients may obtain information by calling 1-888-524-8675 or visiting www.tpv-eap.com or www.clinicaltrials.gov. To find out particularly about tipranavir studies, click here.
Original message from MKNYC: Isn’t it true that 14% of those newly infected are resistant to three classes of HIV medications? And if so, then why are we just hearing about this one New York case as if it were something new?
Reply from Nelson Vergel: Yeah, about 14% of newly infected patients in a San Francisco cohort had resistance to three classes of drugs. But the alarming thing about the New York case is that the patient progressed to AIDS in two months instead of years. He got infected with a dual tropic virus that is more commonly found in later stages of HIV disease. He was also using crystal meth and had multiple sex partners. This, in combination with potential genetic factors, may have been responsible for his fast decline. He is being treated now with Fuzeon and Sustiva and his T cells are starting to increase. We will have to wait and see what happens in this case.
Original message from JDSmiami: How can you get Fuzeon if your state AIDS Drug Assistance Program (ADAP) doesn’t cover it?
Reply from Nelson Vergel: Most ADAP programs cover it. If not, you can contact Roche’s patient assistance program at:
Fuzeon Reimbursement Assistance Program; PO Box 221769; Charlotte, NC 28222; Phone: 866-487-8591; Fax: 866-487-8592.
Original message from George: Nelson, do you think that people like you and me, with lots of resistance, really have a chance to live 10 or more years?
Reply from Nelson Vergel: I am starting to believe so. I just came from the most important HIV research conference in the world and saw presentations on five new classes that are being studied in people. I think the key for most of us is how to buy time until we get there and how to stay healthy with failing drug regimens. I try to eat well, exercise, manage stress, take supplements, and take the best combo that can keep my viral replication capacity to a minimum (talk to your doctor about getting a replication capacity test). I think some of us may die, but many will make it to the day that there will be more than two new classes that will save our lives until a vaccine is developed. That is why I am so obsessed with getting the latest information, even before doctors see it. The next two to three years is a time of limbo for many of us, and we need to think positively and stay informed.
Original message from miamigo: My question has to do with staying on a regimen that is not working. Wouldn’t it make more sense to stop the regimen (because of toxicity) and just practice preventive measures to try and avoid opportunistic infections (my viral load is 750,000+ and CD4 below 20)?
Reply from Nelson Vergel: Taking a failing combo that your virus may have resistance to, assuming you can tolerate it, may still provide benefits. It can lower the speed at which the virus is replicating. So, the answer to your question is: Stay on drugs if you can, even if they are not working when it comes to keeping your viral load down and your T cells up. Just keep an eye on that replication capacity and try to start two new drugs together that you have sensitivity to.
Original message from JDSmiami: What do you think the hardest thing is about living with HIV?
Reply from Nelson Vergel: The hardest thing for me is the fear I have when I am sick. I always assume the worst and hate being sick. In 21 years of infection I have not learned how to be humble. I have a huge fear of depending on others for my care. That is what drives me to learn everything I can about my options, since doctors are too busy to tell us all of them, or they may not even know what’s coming up! Empower yourself and live!