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Transcript of The Body's Live Chat on HIV Treatment With Dr. Edwin DeJesus

June 27, 2007

Edwin DeJesus, M.D., F.A.C.P.
Following is the transcript of The Body's live chat on HIV treatment, which took place on June 27, 2007, at 7 p.m. Eastern Time. The chat was sponsored by Gilead Sciences, Inc., moderated by The Body's editorial staff and hosted by Dr. Edwin DeJesus. This transcript has been edited for grammar and clarity.

This is the ninth chat that The Body has moderated; to see transcripts of previous chats, click here.

Moderator: Thank you all for coming to TheBody.com's live, interactive chat on HIV treatment! A quick note before we get started: Please keep in mind that the information we provide in this chat is not meant to replace the attention or advice of a doctor or another health care professional. Make sure you consult with a qualified health care professional before making any dietary, drug, exercise or other lifestyle change!

I'd like to introduce everybody to Dr. Edwin DeJesus, the medical director of the Orlando Immunology Center in downtown Orlando, Fla., and the medical director of the HUG-Me Program's adult clinic at Orlando Regional Medical Center. Dr. DeJesus has been caring for HIV-positive people since 1993, and is also deeply involved in cutting-edge HIV-related research. He's an expert on HIV medications and HIV treatment strategies -- and we're honored to have him join us for tonight's chat. Dr. DeJesus, welcome!

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Dr. Edwin DeJesus: It is a pleasure for me to be here tonight and to have the opportunity to answer some of your questions.

Question from anonymous: I have been on a successful regimen of Kaletra [lopinavir/ritonavir] and Epzicom [abacavir/3TC, Kivexa] for four years. Three months ago, I quit taking every medicine I was prescribed. My body and psyche had to have a break for a period of time, but I am sure I will need to go back on the meds eventually. What should I look for when I need to go back on the meds? My CD4 is 600 but I guess it will not be for long.

Answer from Dr. Edwin DeJesus: Unfortunately your situation is very familiar to many HIV providers. "Pill fatigue" occurs with some frequency in patients receiving various antiretroviral regimens. The likelihood a patient will decide to interrupt HIV treatment is even higher if the patient is also experiencing some side effects. For the most part, after you stop your HIV meds, you tend to lose most, if not all, of the CD4 cells you gained while in therapy. Your CD4 numbers will return to your baseline levels (called nadir). How long this process will take is highly variable between patients; it mostly depends on the CD4 count you had before starting therapy, as well as the CD4 count you had at the time you stopped your meds. With a CD4 count of 600 cells you are very safe. I would advise you to have your labs checked at least every three months, and more frequently if your numbers are dropping. If your numbers start to drop significantly, your viral load increases to very high numbers or you develop any symptoms, you should discuss with your doctor restarting ARV [antiretroviral] meds again. But it seems you should be OK for a while.

Question from Jeff: I take Atripla and I really like this regimen except insomnia and crazy dreams are a continuing problem. What can I do?

Answer from Dr. Edwin DeJesus: There are several ways in which you can decrease these side effects. You could try to make sure you take the medication on an empty stomach. This will slow down the drug's absorption into your system, which may reduce your symptoms. Some people have tried taking it a bit earlier, and that may also help. Your doctor can also prescribe a very mild hypnotic medication (sleeping pill). But if these symptoms persist, you can discuss with your doctor a switch to other regimens that are not associated with these side effects.

Question from Survivor: Which regimen causes the least lipoatrophy [loss of fat in the face, arms, legs or butt] and fat accumulation [hyperadiposity]?

Answer from Dr. Edwin DeJesus: The absolute cause of fat wasting and/or fat accumulation seen in people on HIV treatment is not completely understood. That is why, at the present time, it is safe to say that most, if not all, available antiretrovirals could potentially cause some degree of fat alteration -- thus the general warning we read on the label of all these agents. But in general, [regimens containing] thymidine analogs seem to be the main culprit for causing lipoatrophy. Thymidine analogs are drugs like AZT (Retrovir) and d4T (stavudine, or Zerit). These drugs are the ones mostly associated with fat wasting and lipoatrophic changes seen in many treated patients. Fat accumulation has also been seen with the use of these agents in combination with some protease inhibitors, particularly older protease inhibitors such as indinavir (Crixivan). It appears that the new generation of protease inhibitors (such as Kaletra, Lexiva and Reyataz) are less likely to cause this fat accumulation.

Question from anonymous: Hello, Dr. DeJesus. I just read with interest a report on the possibilities of HIV eradication if treatment starts early. I was infected in December 2006, diagnosed in February 2007. My VL [viral load] is undetectable and my CD4 count is 729. Will it be advisable for me to start treatment now? If yes, how can I contact that research group to volunteer?

Answer from Dr. Edwin DeJesus: The studies looking at the possibility of viral "eradication" have been conducted mostly in people diagnosed within weeks of infection. Those studies have been very controversial and the results inconsistent. Unfortunately, at this time there is little evidence that HIV can be eradicated, regardless of when treatment is started. In your case, it seems like you have been infected for over six months, which makes you unlikely to be a candidate for any studies exploring this type of approach.

It seems like your body is handling the HIV infection well if your VL is undetectable without taking any meds. At this point, the benefits of initiating therapy for you are arguable, and I would not recommend starting medication outside a specific clinical trial. I give you kudos for wanting to volunteer for a clinical trial. To receive more information about ongoing clinical trials you can visit the Clinicaltrials.gov Web site.

Question from charlie: Hi, Dr. DeJesus. What do you think is the best first-line regimen?

Answer from Dr. Edwin DeJesus: There are several regimens that are excellent candidates for first-line therapy, including a non-nucleoside-based regimen, either containing efavirenz (Sustiva) or nevirapine (Viramune), or a regimen containing a boosted protease inhibitor.These regimens need to be combined with two more drugs we currently call "nucleoside backbones".

There are guidelines written by panels of experts to educate patients and HIV providers on the best regimens that we currently have available.

Among the options for these nucleoside backbones, it appears that the two best options are 1) the combination of abacavir (Ziagen) and [lamivudine] (Epivir) (coformulated in a single pill called Epzicom) and 2) another coformulated pill, called Truvada, which contains a combination of tenofovir (Viread) and [emtricitabine] (Emtriva). This last nucleoside backbone, when combined with Sustiva, has the advantage of being available in a single tablet called Atripla. Thus it is preferred by many practitioners and patients.

Question from anonymous: I was diagnosed during acute HIV infection and put on Atripla with the plan of going off the medicine after two years. Is this reasonable? I have not had any bad side effects on the medication.

Answer from Dr. Edwin DeJesus: The strategy of starting meds very early after seroconversion (recent diagnosis) is controversial, not because it can hurt you, but because we do not know if indeed it will help. It appears, at least to me, logical that this approach may be beneficial, but unfortunately the data regarding this approach have not resulted in viral eradication or disease remission, as many people were hoping. I have done this with a few of my patients. It is important that patients understand that there are no formal recommendations and that this approach may or may not work in delaying disease progression once your meds are discontinued. Every time you stop a regimen, there is also a small risk of the development of resistance to the antiretrovirals you had been taking. So some of the risks may overweigh the benefits.

Question from anonymous: Fifteen years ago I was diagnosed with hepatitis B and HIV at the same time. My last two blood tests have proven the HIV has become very active, with my VL at 77,000 and T cells at 300. I take Zoloft for anxiety and Adderall for ADD [attention deficit disorder]. I have lost my sex drive and overall interest in intimacy due to the Zoloft. What side effects do I have to look forward to with an HIV cocktail? Thanks from East Bay, Calif., Kevin.

Answer from Dr. Edwin DeJesus: Kevin: Based on your HIV infection alone, you should seriously consider starting ARV meds soon. You are from California, where there is an ample range of HIV drugs that are not only very effective in controlling the HIV infection, but also very safe. I would advise you to NOT LOOK FORWARD to developing side effects, because in fact, most patients starting HIV meds these days experience very minimal side effects, if any at all.

Regarding the hepatitis: You need to find out if this hepatitis B is active or not. If it is active, this gives you even more reason to consider starting HIV treatment soon. Luckily, there are several anti-HIV meds that are effective at treating both HIV and hepatitis B. So for the most part, your doctor may be able to treat both diseases with the same meds. By the way, it is possible that starting HIV meds may help you with some of your other medical problems. Just make sure that when you finally start your HIV meds, you are very adherent to your regimen.

Question from anonymous: I will be choosing a first-time treatment regimen next week. I was diagnosed January 2007. The genotype shows my virus as the "wild" strain. I've had no OIs [opportunistic infections] and had no obvious "conversion illness." My viral load has held steady at about 50,000, my CD4 count has varied from 228 to 348 but my percentage of CD4 cells has gone down from 18 to 12. My doctor has recommended that I choose between these two regimens: Atripla or Epzicom + Viramune. Everything I read indicates Atripla as the "preferred" choice as a first treatment for someone in my position. It seems Atripla has all the marketing and "buzz" but I don't want to make my choice based on that! Are there any reasons not to choose Epzicom + Viramune instead?

Answer from Dr. Edwin DeJesus: You and your doctor are both right. The recommendation of Epzicom and Viramune is appropriate given your disease stage. It is simple and well tolerated. There is a slightly higher chance of rash or allergic reaction with that combination over the Atripla. Epzicom can also be combined with Sustiva, which is one of the medications included in Atripla. If your doctor has no concerns about you taking Sustiva, then I would suggest a combination of Epzicom + Sustiva over Epzicom + Viramune.

Atripla, on the other hand, is more widely recommended for a larger spectrum of patients. It has been found to be probably safer than Viramune and Epzicom given together. So yes, there is a "buzz" surrounding Atripla, but there is a good reason for that "buzz." Atripla indeed has been found not only to be very effective in treating HIV infection in treatment-naive patients (patients with no previous experience to anti-HIV meds), but also very safe and simple. You will probably do well with either Atripla (one pill a day) or Epzicom + Sustiva (two pills a day).

Question from Since4Ever: I take Atripla and once or twice I believe I took the medicine twice in one night. I believe I've worked out a strategy to keep this from happening again, and I didn't seem to have any problem. Is that a dangerous dose of Atripla, two in one night?

Answer from Dr. Edwin DeJesus: Everybody responds to HIV medications and drug concentration levels in a different way. The likelihood that you will confront a problem with a sporadic "double dosing" of your HIV meds in a single day is very small, as long as this is infrequent. That said, you need to work out a system to prevent this from continuing to happen. While some patients are not even able to tolerate a short course of Sustiva (one of the components of Atripla), some people (like you) can take two in a night without problems. Other components in Atripla, like tenofovir (Viread), can cause problems if you take them frequently at dosages higher than what is indicated. So it is the frequency of this that could cause a problem.

Question from anonymous: My T cells are over 1,200 and my viral load is undetectable. I've been on Viramune and Truvada for five years. My only complaint is fatigue. I think I'm an excellent candidate for a drug holiday and would like to see if the fatigue would go away with taking a medication break. I'm 58 and female.

Answer from Dr. Edwin DeJesus: Certainly there is a possibility that the fatigue you are experiencing may be caused by your current meds. If this is the case, switching to another regimen may resolve the problem without the risk of developing resistance when you come off the meds. I would rule out other potential causes for fatigue, such as hormonal or nutritional factors, first. Remember that interrupting your regimen, especially a Viramune-containing regimen, can come with a price: There is a small chance you may develop resistance after stopping your meds. On the other hand, I agree that your numbers (CD4 and viral load) are very good, and if other causes for your fatigue have been ruled out, you can discuss with your doctor the safest way to interrupt your meds.

Question from allie: I am a long-term HIVer. HIV meds are working, but are causing serious side effects (high cholesterol and triglyceride levels). I have had two angioplasties and stents. My doctor wants to switch me from Norvir [ritonavir], Prezista [darunavir, TMC114] and Rescriptor [delavirdine] to Merck's expanded access drug raltegravir [MK-0518], which supposedly doesn't affect lipid levels. What can you tell me about the safety of raltegravir?

Answer from Dr. Edwin DeJesus: Raltegravir has been found to be quite safe for a new drug category with such a high potency. It appears to be quite lipid friendly, in studies conducted in naive and experienced patients. I cannot comment if this is the best regimen for you given that I do not have all the information, but it appears to be a very effective and potent regimen. Also important: It will probably not cause much dyslipidemia (alteration in lipids).

On the other hand, in studies conducted in healthy volunteers, Prezista also did not appear to cause much alteration in lipids, so maybe a change from Prezista to raltegravir is not the answer. There are going to be data presented in September 2007 (at the next ICAAC conference) on the effects of Prezista boosted with Norvir on lipids in treatment-naive patients. I would advise your doctor to wait until those data are presented, to assure you both that Prezista indeed may (or may not) be a culprit for your dyslipidemia.

I am assuming that your viral load is undetectable at the present time. If so, you should know that raltegravir is currently available under expanded access only for patients with evidence of virologic failure, not just because they want to switch due to dyslipidemia. So you may have to wait until this drug receives FDA [U.S. Food and Drug Administration] approval, hopefully late this year.

If your current viral load is detectable, I would be careful just substituting one drug (Prezista boosted with Norvir) with raltegravir, as there would be a good possibility you may end up developing resistance to the new drug class raltegravir is a member of (integrase inhibitors).

Question from anonymous: I take three protease inhibitors, all of which must be taken with food. Will a glass of milk or a bottle of Ensure or something like that do it? Sometimes I just can't eat when I'm supposed to take my meds.

Answer from Dr. Edwin DeJesus: It really depends on which protease inhibitors you are taking, as not all protease inhibitors are the same. Some are required to be taken on an empty stomach (Crixivan), while others with at least a light meal (Prezista, Reyataz, Viracept [nelfinavir]), others with a heavier meal (Invirase, Aptivus), while for others food has no effect (Lexiva [fosamprenavir, Telzir], Kaletra, Norvir). But for most protease inhibitors requiring Norvir boosting, taking them with food makes them more tolerable. An Ensure supplement has enough fat (~50 grams) and calories (250) to meet that food requirement. A full glass of whole milk has about 15-20 grams of fat (depending on what type of milk and the amount you take) and ~300 calories, which should be enough for those protease inhibitors with less food requirements.

Question from anonymous: I started Reyataz + Norvir and Epzicom once daily and I'm really worried about lipodystrophy [fat redistribution, either in the form of fat wasting or accumulation]. I'm not undetectable yet -- viral load at 132. Can these medicines cause lipo? And why is it taking so long to get undetectable? I'm 25 years old, started treatment last year in September, and it's been two months on the new regimen.

Answer from Dr. Edwin DeJesus: You need to have patience. It usually takes 16 to 24 weeks to get to undetectable, and 124 copies at two months is an excellent response. The medications you are taking are very safe, and very unlikely to cause lipoatrophy. Keep taking them as instructed. You should experience very good results. Good luck.

Question from anonymous: I have started ARVs and what surprises me is that I don't have any side effects. Is it working or am I resistant to drugs? T.M., South Africa.

Answer from Dr. Edwin DeJesus: Interesting question and good news for you: If you are taking your meds the way you are supposed to take them, the likelihood is that they are working very well! Having resistance to HIV meds has NOTHING to do with the likelihood of experiencing any side effects. In fact, MOST patients are able to take the newest HIV medications WITHOUT side effects, so you are not alone and your case is not unique. We just happen to hear a lot about the people who have problems with them, not about the people who do extremely well, like you.

There is a very small possibility that you may be resistant to your initial HIV meds (and it is possible your doctor may have checked for that before starting your meds). For the time being, if I were you, I would not worry about resistance. Continue to take your meds, and be grateful that you are tolerating them well. Shortly you will learn if they are working or not; I will bet they are!

Question from anonymous: Hello, I'm a 42-year-old female that has been on a regimen of Stocrin (Sustiva) and Truvada for about four months. But lately my doctor here in Europe (I'm Swedish) was suggesting that I should change the Truvada for Kivexa instead, which he said had longer-term safety documentation. What is your opinion about this?

Answer from Dr. Edwin DeJesus: Both Truvada and Kivexa have a very long and safe profile. If you are doing well on Truvada and Stocrin, I would recommend you not switch to Kivexa. By the same token, if you were taking, and doing well on, Kivexa then I would not recommend a switch to Truvada.

These regimens (those that are based on Kivexa and Truvada) have been found to have similar long-term safety. There is a slight chance of a mild decreased renal (kidney) function that has been seen in some patients taking a regimen that contains Truvada. This potential problem can be easily identified in routine lab work that your doctor normally orders during a typical visit. In most patients, this small decrease in renal function does not appear to have any long-term clinical consequences, and it is reversible upon discontinuation of the medication. Maybe your doctor has identified you as one of those patients with decreasing renal function, but if this is not the case, I see no reason to switch regimens now.

Question from anonymous: I have been HIV positive for close to 10 years. I have been lucky and have not had to take any medicines all that time. I just moved to a new area and my doctor told me my latest HIV numbers were CD4 315 and viral load 60,000. I am trying to wait till the furthest point necessary to take medicines, but my new doctor suggests I start taking meds. Would you say at this point it is necessary for me to start treatment?

Answer from Dr. Edwin DeJesus: Your doctor is right. Many physicians, myself included, believe that if there are no other contraindications to start therapy, a patient with a CD4 count less than 350 should seriously consider starting, or restarting, HIV meds to prevent further deterioration of the immune system and the loss of more CD4 cells. The revised HIV guidelines also support this approach. The reason why we previously favored waiting until the CD4 counts were lower was to avoid medications that could potentially cause adverse events. The regimens that we have available today are very well tolerated and safer. The benefits of starting meds with those numbers (CD4 and viral load) you have outweigh any potential risks. So, if I were you, with what I know, I would definitely start HIV treatment now. Just make sure that when you finally start your HIV meds, you are very adherent to your regimen so you do not develop resistance.

Question from anonymous: Dear Doctor: My HIV specialist tells me that there are now so many meds available with less toxicity that he expects that newly-diagnosed positive people with a normal lifestyle [can have a good quality of life] and live out their life span. How can he expect that since meds have been available for 12 years?

Answer from Dr. Edwin DeJesus: The efficacy and safety of current HIV meds have been studied and observed in prospective clinical trials lasting for many years (more than five years). We now know that HIV meds usually do not fail patients, rather "patients fail medications." By this I mean that if a patient is doing well with HIV meds for several years, the likelihood is that those HIV medications will continue to work, hopefully indefinitely.

Assuming that there are no complications emerging from the treatment or other comorbid conditions (medical problems) that can affect this response.

It is possible that low, progressive complications -- or even resistance -- can occur in the future, but the good news is that the pipeline for ARV development continues to produce new and effective anti-HIV meds almost every year. So, if something was to happen with the regimen you are taking now, there are more future drugs ready to replace those drugs you are taking now, with potentially better safety and tolerability profiles. So, the future looks very promising.

Moderator: Our live chat on HIV treatment has now concluded. Dr. DeJesus, we can't thank you enough for taking the time to answer everyone's questions!

Answer from Dr. Edwin DeJesus: It was a pleasure for me to be here and respond to some of your interesting and challenging questions. Remember that adherence is the key to success in HIV therapy. Good luck and God bless!


Copyright © 2007 Body Health Resources Corporation. All rights reserved.


  
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