I wrote this for Test Positive Aware Network's Positive Aware magazine, one of the best free HIV magazines in the country. Their link is http://www.tpan.com/
Sustiva
One of the “preferred drugs” in the DHHS guidelines due to its very good efficacy. It was the first drug to be approved for once-a-day dosing, so everyone jumped on it. Some people seem to get over the nightmares and fatigue in the first 2-3 weeks, but others seem not so lucky. Sustiva put a stop to my life for four months due to depression and fatigue, so I have my biases. But I have met many people who love it and are doing great on it. Also, unlike Viramune, Sustiva can increase lipids just like most protease inhibitors. I am waiting to see when BMS and Gilead will successfully co-formulate Truvada with Sustiva, since I think that will revolutionize the market with a convenient once-a-day pill to treat HIV with three meds. This will probably shift the paradigm in the industry to collaborate to improve patient adherence and pill burden. I just hope these two companies do the right thing and make that combo available to developing countries at low cost.—
KALETRA
Still the PI with the most robust long-term data and a “preferred” drug for treatment naïve patients. A tablet formulation of Kaletra was approved in the United States in October 2005. Abbott hopes to replace the original capsule formulation with the new tablets soon. The new formulation requires two fewer tablets a day and no refrigeration. The most common side effects of Kaletra in the past have been diarrhea and increases in cholesterol and triglycerides. Abbott claims that the new formulation may have fewer GI side effects but no improvements in triglycerides. The Kaletra market share is being eroded by Reyataz and may be further decreased with the introduction of TMC-114
FUZEON
This injectable product has had a difficult uptake in the community due to fear of needles, injection site reactions, and the fear that it is a “last resort drug before you die.” Studies have shown the obvious: starting Fuzeon with at least one more active agent may improve the duration of response. Unfortunately, most people who started it after approval did not have any other active agent left in their genotype, so they had to start it on top of a failing regimen, which only provided viral control for a few weeks. We have now seen the Aptivus RESIST and the TMC-114 POWER studies say the same thing: those who used these products with Fuzeon did better. I am happy to see that those who are running out of options can start Fuzeon with Aptivus or TMC-114, and possibly entry inhibitors soon. To minimize ISRs, people stopped using the needles provided in the kit and went for smaller insulin syringes. Also, a bioinjector needle-free device which is expected to be launched soon may help some people. Fuzeon is the most expensive single drug in the market at $26,000 a year (Aptivus plus Norvir is the highest boosted PI at $28,000). A very huge problem has been access for patients who do not have insurance in states with ADAP systems that have a cap on the number of people who can get Fuzeon. Roche would not give free drugs to those who apply after the cap has been met in those states.
Fuzeon is here to stay as a backbone to new drugs in the pipeline. But its price, administration and difficult access need to improve for it to be accepted as part of standard of care in the U.S.
REYATAZ
The new darling in the PI class. It is taken once a day, does not have food restrictions and has little effect on lipids. If you are taking antacids or PPIs, you need to talk to your doctor, since many of them are contraindicated with Reyataz. Also, many people have increases in bilirubin that may make them jaundiced. As an activist, I have been concerned about how BMS priced this expensive PI and how they have marketed this drug by implying it does not cause lipodystrophy. The price is the highest for a protease inhibitor and set the tone for all drugs approved later, so it was a terrible hit to publicly funded programs. Also, there is not a single study that proves that Reyataz does not cause lipodystrophy. Actually, Reyataz showed the same high incidence of lipodystrophy as Viracept (a well-known PI that can cause lipo). Just because this drug may not have the negative lipid effects caused by most PIs, it does not mean that it may not cause fat accumulation. If it was that easy, lipid lowering drugs could prevent or reverse lipo, and they have not shown to do that! I would love to see lipo data on Reyataz/Norvir + Truvada, a popular once a day combo that doctors prescribe hoping that it does not cause body changes. Reyataz is here to stay and growing stronger as more comparison data against Kaletra are generated
INVIRASE
Invirase is a protease that has been reformulated three times. I remember being in the first study in 1995 with high hopes. Unfortunately we found out later that very little of the drug got absorbed, so I developed PI resistance early. Roche reformulated it in capsules later for better absorption, but with greater pill burden and GI side effects. The latest formulation seems to be the friendliest of all, taken with Norvir boosting, with lower GI side effects and pill burden. Too bad Roche launched this last formulation with little exciting data for doctors to prescribe it, since the drug has been around for so long. I would love to see comparison data with Kaletra and Reyataz for efficacy and lipids. The new Invirase formulation could find its niche for those who have to stop Kaletra for GI and lipid side effects, or Reyataz for bilirubin. It is also important to see more solid data on double PI boosted combos for salvage patients
APTIVUS
The first protease inhibitor exclusively approved for patients who have developed PI resistance. Two 250 mg capsules of Aptivus plus two 100 mg capsules of Norvir should be taken with food twice a day. Like Norvir, it requires refrigeration. It can cause diarrhea, increased cholesterol and triglycerides, and liver problems. Close monitoring of liver enzymes is imperative with this drug. It works a lot better if started with another drug that shows up as active in your genotype test. Those taking Fuzeon with it had a better response than those who started Aptivus with drugs that they had resistance to. One big problem with Aptivus is that it does not play well with others, so the list of contraindicated drugs is long. Aptivus should never be taken with another protease inhibitor, since it decreases PI blood levels. Aptivus is a complicated drug, but I welcome its introduction in the market for a population that has few to no options left. Too bad it is the most expensive protease inhibitor, with an annual wholesale cost (with Norvir) of $28,840 as of October 2005. If you use it with Truvada and Fuzeon, the total annual wholesale cost jumps up to $66,000, an exorbitant amount for salvage therapy
LEXIVA
It was hard to say anything about Lexiva. It is a second generation Agenerase with fewer side effects and lower pill count. It has not gained the acceptance that Reyataz and Kaletra have gained in the market. It has interactions with Kaletra and Sustiva. I took it with Norvir for a few months, but had to stop it due to severe fatigue, a side effect not usually reported with this PI (we are all very different in how we respond to meds). But many people are taking it successfully and like its lower incidence of GI side effects and lipids. It can be used with or without Norvir. It can cause rash in some patients, especially if you are allergic to sulfa drugs, such as Bactrim
TMC 114 (NOT YET APPROVED AS OF APRIL 2006)
This new promising PI has not been approved yet but is available through expanded access for those with CD4 cells of 200 or under, and who have failed most drugs available in the market. So far, Phase II data look very good in those patients with multi-drug resistance. It seems to have most of the common PI-related side effects. The most commonly used dose will be 600 mg along with 100 mg of Norvir as a booster, both twice a day. I am looking forward to seeing more data of TMC-114 plus entry inhibitor combinations in salvage patients soon. Tibotec is also starting a combination study of its non-nuke TMC-125 plus TMC-114, a first in the HIV drug development world where two investigational agents are combined prior to approval. I applaud Tibotec for this courageous step, which will set the tone for future research studies encouraging Multi-Experimental Agent Trials (MEAT)
TRUVADA
This is one of the bestselling HIV drugs nowadays, and for many reasons. It is taken once a day, is durable, can treat hepatitis B, and does not cause lipoatrophy, neuropathy, and lipid problems. Many doctors are switching their patients from drugs that may cause lipoatrophy (d4T and AZT) to this drug since some studies show that lipoatrophy may improve slowly after that switch. But Viread is starting to worry some people when it comes to kidney dysfunction, especially in the older and more advanced patient population. Be very careful if you are still taking it with ddI, even at 250 mg of ddI (see ddI). Also, have your doctor calculate your creatinine clearance every three months just to make sure you are not developing early kidney disease. You can visit this web site for an easy calculation of your creatinine clearance: http://www.intmed.mcw.edu/clincalc/creatinine.html
VIRAMUNE
Viramune was the first non-nuke to be approved, and has proven to work as well as Sustiva, although some docs may not think it has the same “punch” as its competitor. It can cause a rash that can be treated without discontinuation. Viramune may have a higher incidence of symptomatic liver toxicity which consists of elevated liver enzymes plus at least one symptom, typically rash, but may include flu-like symptoms or fever. The severity of symptomatic liver toxicity ranges from mild symptoms with liver enzyme abnormalities to rapidly occurring liver failure and death. Studies have found that females have a three-fold higher risk of symptomatic Viramune liver toxicity than males, and females with CD4+ counts above 250 T-cells have a 12-fold higher risk of symptomatic liver toxicity than those with less. Males with CD4+ counts above 400 T-cells have a five-fold higher risk of symptomatic liver toxicity than those with less. Viramune has been found to prevent mother-to-child transmission in a single dose, although it needs to be used with nukes to prevent the easy emergence of HIV resistance. Because of its seeming lack of negative effects on the central nervous system, cholesterol, triglycerides, glucose, and possible lipodystrophy, Viramune is still a popular drug 10 years after approval. I would love to see studies looking at Viramune+Truvada and its effect on lipodystrophy and long term viral suppression. Many doctors are prescribing this combo without any research data backing it up
ZERIT
Zerit (d4T) has fallen out of grace after years of reports of lipoatrophy, neuropathy and higher lipids due to toxic effects on the cells’ mitochondria (energy factories of our cells). It was dropped from a “preferred drug” to an “alternate” one by the DHHS guidelines committee for the treatment of naïve patients. I just wish that they had done it sooner, since this fact has been known well since 2001. Unfortunately, Zerit is becoming one of the most commonly used drugs in the developing world. I feel horrible for people in countries like mine (Venezuela) who will endure these side effects even after we have learned so much in the developed world. Zerit is still a valuable drug in salvage therapy, when the benefits outweigh the risks. Some studies seem to indicate that lower-dose Zerit may work as well without as many side effects, but I do not think doctors are totally buying that concept
VIDEX- DDI
I have a lot of biases against this drug and get criticized for it sometimes. It is known to increase the chances of pancreatitis and neuropathy, and its role on lipoatrophy is not well known yet. The good thing is that it is a great nucleoside that can control HIV in a once-a-day dose. After years of being exposed to the ddI+d4T combo, many people developed facial wasting and general lipoatrophy, and irreversible neuropathy, so the DHHS guidelines panel prohibited its use in that combo. Too bad for those thousands of patients who were exposed to it. I have the strong feeling that we will soon see a ban on the ddI+Viread combo, even at lower ddI doses. This combo can increase the ddI blood levels too high in some, which can increase risk of pancreatitis. Kidney dysfunction due to potential intracellular interaction with Viread is also being observed. For some strange reason that no one can answer for me yet, many people I have met in the past year on that combo are also experiencing involuntary weight loss on ddI+Viread. Just make sure that you are taking a lower dose of 250 mg or below (depends on body weight) if you are taking ddI with Viread and that your T-cells and weight are not decreasing. We have a lot better nucleosides in the developed world now to not have to endure all the risks I have mentioned
AZT
I am one of the people who are still alive from the original high dose placebo-controlled AZT study in the late ‘80s and early ‘90s. In 1993 we were shocked and depressed after finding out that high dose AZT was killing us faster. Fortunately, we later found out that a lower dose would work well in combination with other meds. AZT is now available alone or in a combo of AZT + Epivir called Combivir. There is also a new generic version available that may be lower in price (we are waiting to see). It is one of the few drugs shown to penetrate the blood-brain barrier, so it may have some protective effects on neurological complications like dementia. Too bad it can cause anemia, muscle weakness, and fatigue in some, and now we are also learning that it may cause lipoatrophy. There are also some studies suggesting that AZT may have a “protective role” in preventing a key mutation, K65R, in all nuke regimens. This mutation may render most HIV resistant to several nucleosides
ZIAGEN
Another very effective nucleoside analog that has shown to be key to many backbones for NNRTIs and PIs. But it can cause a hypersensitivity reaction that can be lethal if not dealt with quickly. If you feel like you are coming down with the flu a few days after starting the drug, call your doctor immediately. This problem occurs in less than 10% of people. Ziagen is now gaining a lot more momentum after several studies showed that it may not cause lipoatrophy. I have my own biases about this drug, however. I experienced increased anxiety while on it. I am glad that a few reports came up in the literature about this problem after that, but it is something that has not been studied at all and that is ignored by doctors due to lack of information. Ziagen is available alone or in a combo with Epivir (Epzicom) or in a 3-drug combo with AZT and Epivir (Trizivir). Warning: Trizivir alone may not be effective to treat HIV in most patients. Also, do not take Epzicom plus Viread, since you may fail this regimen too quickly and develop resistance to most nucleosides
EPIVIR
We used to think this was a wimpy drug back a few years ago, since resistance to it is developed quite easily. But we have learned that virus resistant to 3TC seems to be weaker than ones that are not, so doctors still prescribe it even if you have resistance to it (the mutation is 184V). It does not seem to cause severe side effects, although some people have reported fatigue and changes in pigmentation in the palms of their hands. It can treat hepatitis B also. It is available alone or in combination with Ziagen (Epzicom) or AZT (Combivir) or in a three-drug combo with Ziagen + AZT (Trizivir). An interesting study showed that people who have to stop their meds due to toxicity but kept taking Epivir had a lower CD4 cell drop than those who stopped all drugs
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The untold Side of the movie "Dallas Buyers Club"
The movie Dallas Buyers Club brings attention to a little-recognized part of the AIDS activist movement: ....
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Exhorbitant Price New Hepatitis C Drug
Fair Pricing Coalition Condemns Gilead Sciences on the High Price of New Hepatitis C Drug Sovaldi™...
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Six Promising HIV Drugs in the Pipeline (2013-2014)
What new HIV medications do we have to look forward to over the next few years? How will these newer drugs improve upon the older ones? To shed some light on these questions....
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What Can We Look Forward to in HIV Cure Research
TheBodyPRO.com's Nelson Vergel sat down with leading HIV cure research activist Richard Jefferys for an update on current important aspects, and controversies, in HIV cure research....
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What Supplements Can I take with HIV medications?
Is it ok to supplement with Creatine (Cell-Tech), and Protein (Nitro-Tech) along with Glutamine...
Wednesday, April 19, 2006
I am so tired of price gauging in HIV!
AIDS Activists Cry Foul as Drug Companies Push Prices to Record LevelsPosted
Topic Health
The following was released by AIDS Treatment Activists Coalition:
A steady onslaught of "unreasonable, unacceptable, and unjustified" increases in the price of therapies to treat HIV has caused activists in the US to accuse drugmakers of artificially inflating the market at the expense of people living with HIV/AIDS. As an example, activists point to the recent launch of the new drug Aptivus, a protease inhibitor developed by Boehringer-Ingelheim, which came in at the highest price ever for this class of medication -- more than $13,000 per year, which does not include the cost of other medications that must be taken in combination with Aptivus.
"We are approaching the point where a year's worth of HIV medications in the US will cost anywhere from $30,000 to $50,000 a year. Every time a new medication is made available, it usually comes in at a new higher price than others in its class," stated Nelson Vergel, a member of the AIDS Treatment Activists Coalition. "The same thing happened with Reyataz, another protease inhibitor made by Bristol-Myers Squibb. It was the first once-daily medication of this kind, and the company priced it at an all-time high, with regular increases since then. It now costs almost $11,000 per year. This behavior is simply unreasonable, unacceptable, and unjustified."
Indeed, many healthcare and community groups question why there is no guidance for drug pricing based on type of medication or disease. In the US, prices charged for medications are often much higher than in other developed countries. This tends to work against patients, even those who have insurance. Howard Grossman, MD, Executive Director of the American Academy of HIV Medicine notes, "Many insurance companies have focused on the high price of drugs to treat HIV. Healthcare providers are finding their choices increasingly limited as higher-priced drugs are taken off 'preferred' lists, in some cases raising patient copays from $20 to $75 or more per prescription. Anything that prevents doctors from prescribing the properly-indicated drugs reduces our chance of controlling HIV. High prices are driving this."
But privately insured patients aren't the only ones suffering under this no-hold-barred system of pricing for life-saving and medically necessary medications. Public payer systems, such as the underfunded AIDS Drug Assistance Programs (ADAPs), provide medications for more than half of all patients with HIV/AIDS in the US. These programs must renegotiate prices regularly with drug companies, and steep increases in medication prices make it difficult to provide medication to the same number of people each year. With numbers of new infections increasing steadily and flat funding for ADAPs, medication waiting lists have developed in several states.
To make matters worse, new legislation forbids government negotiation with drug companies on prices. In other words, patients receiving government assistance for healthcare may not have access to new and better medications if excluded from formulary because of expense. Even if the medications are added, they will cause patients to meet individual spending caps even more quickly and will use up allotted budgets.
"Sadly, Boehringer-Ingelheim failed to realize that the size of the potential Aptivus market is directly tied to patients' access through publicly funded programs, and they just made that market a lot smaller," said Lei Chou, Director of Mobilization at the Community HIV/AIDS Mobilization Project (CHAMP). "State Medicaid Programs will delay coverage of the drug for months, AIDS Drug Assistance Programs will have to place access restrictions or may not cover it at all. This pricing decision will put Aptivus out of reach for the majority of patients who can benefit from it."
As companies continue to create a system of haves and have-nots for people living with HIV/AIDS, activists plans to redouble their efforts against price-gouging and profiteering. By working with legislators, consumer protection groups, and other advocacy groups, AIDS activists envision a future where unbridled greed does not dictate what treatments patients can afford or how public resources are spent in the effort to keep people alive.
The AIDS Treatment Activists Coalition is a national coalition of AIDS activists, many living with HIV/AIDS, working together to end the AIDS epidemic by advancing research on HIV/AIDS.
Topic Health
The following was released by AIDS Treatment Activists Coalition:
A steady onslaught of "unreasonable, unacceptable, and unjustified" increases in the price of therapies to treat HIV has caused activists in the US to accuse drugmakers of artificially inflating the market at the expense of people living with HIV/AIDS. As an example, activists point to the recent launch of the new drug Aptivus, a protease inhibitor developed by Boehringer-Ingelheim, which came in at the highest price ever for this class of medication -- more than $13,000 per year, which does not include the cost of other medications that must be taken in combination with Aptivus.
"We are approaching the point where a year's worth of HIV medications in the US will cost anywhere from $30,000 to $50,000 a year. Every time a new medication is made available, it usually comes in at a new higher price than others in its class," stated Nelson Vergel, a member of the AIDS Treatment Activists Coalition. "The same thing happened with Reyataz, another protease inhibitor made by Bristol-Myers Squibb. It was the first once-daily medication of this kind, and the company priced it at an all-time high, with regular increases since then. It now costs almost $11,000 per year. This behavior is simply unreasonable, unacceptable, and unjustified."
Indeed, many healthcare and community groups question why there is no guidance for drug pricing based on type of medication or disease. In the US, prices charged for medications are often much higher than in other developed countries. This tends to work against patients, even those who have insurance. Howard Grossman, MD, Executive Director of the American Academy of HIV Medicine notes, "Many insurance companies have focused on the high price of drugs to treat HIV. Healthcare providers are finding their choices increasingly limited as higher-priced drugs are taken off 'preferred' lists, in some cases raising patient copays from $20 to $75 or more per prescription. Anything that prevents doctors from prescribing the properly-indicated drugs reduces our chance of controlling HIV. High prices are driving this."
But privately insured patients aren't the only ones suffering under this no-hold-barred system of pricing for life-saving and medically necessary medications. Public payer systems, such as the underfunded AIDS Drug Assistance Programs (ADAPs), provide medications for more than half of all patients with HIV/AIDS in the US. These programs must renegotiate prices regularly with drug companies, and steep increases in medication prices make it difficult to provide medication to the same number of people each year. With numbers of new infections increasing steadily and flat funding for ADAPs, medication waiting lists have developed in several states.
To make matters worse, new legislation forbids government negotiation with drug companies on prices. In other words, patients receiving government assistance for healthcare may not have access to new and better medications if excluded from formulary because of expense. Even if the medications are added, they will cause patients to meet individual spending caps even more quickly and will use up allotted budgets.
"Sadly, Boehringer-Ingelheim failed to realize that the size of the potential Aptivus market is directly tied to patients' access through publicly funded programs, and they just made that market a lot smaller," said Lei Chou, Director of Mobilization at the Community HIV/AIDS Mobilization Project (CHAMP). "State Medicaid Programs will delay coverage of the drug for months, AIDS Drug Assistance Programs will have to place access restrictions or may not cover it at all. This pricing decision will put Aptivus out of reach for the majority of patients who can benefit from it."
As companies continue to create a system of haves and have-nots for people living with HIV/AIDS, activists plans to redouble their efforts against price-gouging and profiteering. By working with legislators, consumer protection groups, and other advocacy groups, AIDS activists envision a future where unbridled greed does not dictate what treatments patients can afford or how public resources are spent in the effort to keep people alive.
The AIDS Treatment Activists Coalition is a national coalition of AIDS activists, many living with HIV/AIDS, working together to end the AIDS epidemic by advancing research on HIV/AIDS.
Salvage Therapies - New drugs offer hope to patients with multiple-drug resistance HIV virus. By Nelson Vergel
I have been HIV positive since 1983 and tested in 1986. Like many long- term survivors who started nucleoside monotherapy (AZT, D4T, DDI) in the late '80s/early '90s, I have developed multi-drug resistance. Over 40 of my friends have died either of opportunistic infections or drug resistance. Many of my friends who are living now have under 50 CD4 and are trying to survive. Most of us have added every new drug as it got approved to failing regimens (what we call sequential or virtual monotherapy), which rendered them useless in a few weeks or months. Most of us are taking drugs that we have resistance to in hopes that they keep viral replication capacity (viral fitness) down. Many of the people who show up to my lectures are also going through this problem, yet all we hear in the media and conferences is how well people with HIV in the developed world are doing!
After 25 years of the AIDS epidemic, 17 new drugs belonging to four drug classes are available in the U.S. As a result, mortality and morbidity have decreased significantly in the HIV-infected patient population. Unfortunately, an increasing number of patients living with HIV are developing resistance to all available nucleosides, non-nucleosides, protease inhibitors, and the latest fusion inhibitor (Fuzeon), making it impossible for them to construct viable drug combinations for effective control of HIV replication. Of an estimated 400,000 people under treatment for HIV in the United States, 14-20% of these may have multi-drug resistance (MDR). This means that as many as 80,000 patients are running out of life-saving options, increasing the risks of opportunistic infections and death. Additionally, an estimated 40,000 new HIV infections occur in the U.S. annually. Up to 14% of these, or 5,600 patients per year, have acquired resistance to three drug classes.
Fortunately, there are eight new agents offering hope to patients with MDR virus. These include one fusion inhibitor (Fuzeon), one protease inhibitor (Tipranavir-Aptivus) that got approved last year, and several drugs in Phase III trials (one protease inhibitor called TMC 114, one non nucleoside called TMC 125, an integrase inhibitor called MRK-518, two entry inhibitors called Maraviroc and Vicriviroc, and a CD4 antagonist called TNX-355 that will be given only every two weeks). Within a year, all or most of these products will be available to patients in need via expanded access programs. The key for many is to buy time and stay healthy until this new wave comes through!
Clinical guidelines dictate that at least two to three active medicines (that your virus does not have resistance to) be present in a drug combination for patients with multiple drug resistance (MDR). Unfortunately, these new drugs have been only available in a sequential monotherapy manner (adding one "active" drug to a failing combo) through clinical research. Most studies do not allow the use of other investigational agents in combination, making it impossible in many cases for MDR patients to avoid sequential monotherapy. This approach encourages further development of drug resistance in patients participating in such research protocols and will not help us survive.
Luckily, we will be able to combine several new medications in the next year, so I encourage everyone to talk to their doctor and also keep abreast of the latest information. For those who have low T cells and have declining health, doctors can access some of these new drugs through emergency access.
For more information, e-mail Nelson Vergel at nelsonvergel@yahoo.com and visit his web site www.salvagetherapies.org.
I have been HIV positive since 1983 and tested in 1986. Like many long- term survivors who started nucleoside monotherapy (AZT, D4T, DDI) in the late '80s/early '90s, I have developed multi-drug resistance. Over 40 of my friends have died either of opportunistic infections or drug resistance. Many of my friends who are living now have under 50 CD4 and are trying to survive. Most of us have added every new drug as it got approved to failing regimens (what we call sequential or virtual monotherapy), which rendered them useless in a few weeks or months. Most of us are taking drugs that we have resistance to in hopes that they keep viral replication capacity (viral fitness) down. Many of the people who show up to my lectures are also going through this problem, yet all we hear in the media and conferences is how well people with HIV in the developed world are doing!
After 25 years of the AIDS epidemic, 17 new drugs belonging to four drug classes are available in the U.S. As a result, mortality and morbidity have decreased significantly in the HIV-infected patient population. Unfortunately, an increasing number of patients living with HIV are developing resistance to all available nucleosides, non-nucleosides, protease inhibitors, and the latest fusion inhibitor (Fuzeon), making it impossible for them to construct viable drug combinations for effective control of HIV replication. Of an estimated 400,000 people under treatment for HIV in the United States, 14-20% of these may have multi-drug resistance (MDR). This means that as many as 80,000 patients are running out of life-saving options, increasing the risks of opportunistic infections and death. Additionally, an estimated 40,000 new HIV infections occur in the U.S. annually. Up to 14% of these, or 5,600 patients per year, have acquired resistance to three drug classes.
Fortunately, there are eight new agents offering hope to patients with MDR virus. These include one fusion inhibitor (Fuzeon), one protease inhibitor (Tipranavir-Aptivus) that got approved last year, and several drugs in Phase III trials (one protease inhibitor called TMC 114, one non nucleoside called TMC 125, an integrase inhibitor called MRK-518, two entry inhibitors called Maraviroc and Vicriviroc, and a CD4 antagonist called TNX-355 that will be given only every two weeks). Within a year, all or most of these products will be available to patients in need via expanded access programs. The key for many is to buy time and stay healthy until this new wave comes through!
Clinical guidelines dictate that at least two to three active medicines (that your virus does not have resistance to) be present in a drug combination for patients with multiple drug resistance (MDR). Unfortunately, these new drugs have been only available in a sequential monotherapy manner (adding one "active" drug to a failing combo) through clinical research. Most studies do not allow the use of other investigational agents in combination, making it impossible in many cases for MDR patients to avoid sequential monotherapy. This approach encourages further development of drug resistance in patients participating in such research protocols and will not help us survive.
Luckily, we will be able to combine several new medications in the next year, so I encourage everyone to talk to their doctor and also keep abreast of the latest information. For those who have low T cells and have declining health, doctors can access some of these new drugs through emergency access.
For more information, e-mail Nelson Vergel at nelsonvergel@yahoo.com and visit his web site www.salvagetherapies.org.
Zerit and Facial Wasting- I guess I had reached the limit
From Treatment Issues
It's Time to Face the Zerit Problem
Treatment Issues: Newsletter of Experimental AIDS Therapies - Volume 17, Number 3, March 2003Nelson Vergel
When I give lectures on how to manage the side effects of HIV medications, I am constantly reminded of how widespread the "sunken cheek" look has become. Many if not most of the men and women sitting in front of me show the severe facial wasting which has become HIV's Scarlet Letter. Some, self conscious of their gaunt features, have begun to isolate themselves at home lest their HIV status be "outed" to a public that is increasingly aware of "that look" and what it means. The City of San Francisco put up billboards featuring repellant photographs of people with facial wasting and grotesque lipodystrophic bellies. The ads were designed to scare HIV-negative people away from engaging in unsafe sex. I hope they're effective, but these campaigns certainly further stigmatize those who live with body changes induced by HIV and its medications.
During my talks I review the existing data that tie lipoatrophy (subcutaneous fat loss) to the class of HIV therapies called nucleoside analogs (NRTIs) and I discuss the increasing body of evidence pointing to one drug in particular: Zerit (d4T, stavudine). Although other NRTI drugs have been implicated in facial wasting, it now seems clear that, if it's going to happen, it will happen faster on Zerit. Many people in my audiences have taken Zerit and they often wonder why people newly starting HAART are rarely informed about the apparently irreversible disfiguration that facial wasting brings, or about thinning limbs and the psychological impact to a woman who develops the "veiny" arms of a weightlifter. Some say that we are complaining about superficialities, that we should be grateful the drugs have kept us alive, but for a complication that may be preventable, facial wasting has made far too many lives miserable.
Many people, now with undetectable levels of HIV in their blood, desperately search for ways to repair their faces — to have them "match their immune system," as several have told me. The search for the perfect facial filler has become one of the most asked about topics on Internet discussion groups and in treatment seminars. None of the restorative medical options available — products such as silicone injections, NewFill, Bio-Alcamid and Artecoll — are FDA approved. Long-term effects are unknown. At over $4,000 for a course of treatment, they are not cheap. Strong activism is needed to get third-party payers to acknowledge this drug-related side effect and pay for restorative therapy.
Research into reversing lipoatrophy has not been promising. A few studies suggest that switching from Zerit to AZT or Ziagen may reverse subcutaneous fat loss after 48 weeks. However most patients in those studies reported little visible change in their appearance. And unfortunately, therapies intended to improve body shape, such as exercise, anabolic steroids, and growth hormone, actually seem to worsen subcutaneous fat loss.
There is currently little research on ways to prevent lipoatrophy in those who are just starting treatment with Zerit or the other nucleoside analogs. Scientists have looked for the cause of lipoatrophy in mitochondrial toxicity, impaired fatty acid oxidation, increased TNF production, and the normal effects of aging. Some have proposed that supplements like L-carnitine or B vitamins might have a protective effect on mitochondria and may slow or prevent lipoatrophy. Many questions remain.
Researching ways to maximize Zerit's benefits while minimizing its side effects must become a priority for the drug's manufacturer, Bristol-Myers Squibb. While that is ongoing, I believe this drug should no longer be given to treatment-naive patients unless they have been fully informed and agree to accept the risk of potentially irreversible facial wasting. The FDA should examine the evidence and, if warranted, add a specific caution to Zerit's label about facial wasting. A federal HHS committee is set to issue an updated version of their treatment guidelines. At the very least, that document should reflect the growing consensus expressed by Martin Hirsch at the recent Retrovirus Conference that "the combination of ddI and d4T should not be used as part of an initial antiretroviral regimen." Research studies involving previously untreated patients should avoid the use of Zerit. Until we can predict who will have an increased risk of developing lipoatrophy from Zerit, or until there is an effective method of managing those complications, Zerit should be dropped from the list of preferred drugs for use in treatment-naive patients and only used for salvage situations in which the benefits will outweigh the risks.
Nelson Vergel lectures frequently on lipodystrophy and HIV treatment side-effect management from a consumer's point of view. For more information, visit: http://www.facialwasting.org/.
It's Time to Face the Zerit Problem
Treatment Issues: Newsletter of Experimental AIDS Therapies - Volume 17, Number 3, March 2003Nelson Vergel
When I give lectures on how to manage the side effects of HIV medications, I am constantly reminded of how widespread the "sunken cheek" look has become. Many if not most of the men and women sitting in front of me show the severe facial wasting which has become HIV's Scarlet Letter. Some, self conscious of their gaunt features, have begun to isolate themselves at home lest their HIV status be "outed" to a public that is increasingly aware of "that look" and what it means. The City of San Francisco put up billboards featuring repellant photographs of people with facial wasting and grotesque lipodystrophic bellies. The ads were designed to scare HIV-negative people away from engaging in unsafe sex. I hope they're effective, but these campaigns certainly further stigmatize those who live with body changes induced by HIV and its medications.
During my talks I review the existing data that tie lipoatrophy (subcutaneous fat loss) to the class of HIV therapies called nucleoside analogs (NRTIs) and I discuss the increasing body of evidence pointing to one drug in particular: Zerit (d4T, stavudine). Although other NRTI drugs have been implicated in facial wasting, it now seems clear that, if it's going to happen, it will happen faster on Zerit. Many people in my audiences have taken Zerit and they often wonder why people newly starting HAART are rarely informed about the apparently irreversible disfiguration that facial wasting brings, or about thinning limbs and the psychological impact to a woman who develops the "veiny" arms of a weightlifter. Some say that we are complaining about superficialities, that we should be grateful the drugs have kept us alive, but for a complication that may be preventable, facial wasting has made far too many lives miserable.
Many people, now with undetectable levels of HIV in their blood, desperately search for ways to repair their faces — to have them "match their immune system," as several have told me. The search for the perfect facial filler has become one of the most asked about topics on Internet discussion groups and in treatment seminars. None of the restorative medical options available — products such as silicone injections, NewFill, Bio-Alcamid and Artecoll — are FDA approved. Long-term effects are unknown. At over $4,000 for a course of treatment, they are not cheap. Strong activism is needed to get third-party payers to acknowledge this drug-related side effect and pay for restorative therapy.
Research into reversing lipoatrophy has not been promising. A few studies suggest that switching from Zerit to AZT or Ziagen may reverse subcutaneous fat loss after 48 weeks. However most patients in those studies reported little visible change in their appearance. And unfortunately, therapies intended to improve body shape, such as exercise, anabolic steroids, and growth hormone, actually seem to worsen subcutaneous fat loss.
There is currently little research on ways to prevent lipoatrophy in those who are just starting treatment with Zerit or the other nucleoside analogs. Scientists have looked for the cause of lipoatrophy in mitochondrial toxicity, impaired fatty acid oxidation, increased TNF production, and the normal effects of aging. Some have proposed that supplements like L-carnitine or B vitamins might have a protective effect on mitochondria and may slow or prevent lipoatrophy. Many questions remain.
Researching ways to maximize Zerit's benefits while minimizing its side effects must become a priority for the drug's manufacturer, Bristol-Myers Squibb. While that is ongoing, I believe this drug should no longer be given to treatment-naive patients unless they have been fully informed and agree to accept the risk of potentially irreversible facial wasting. The FDA should examine the evidence and, if warranted, add a specific caution to Zerit's label about facial wasting. A federal HHS committee is set to issue an updated version of their treatment guidelines. At the very least, that document should reflect the growing consensus expressed by Martin Hirsch at the recent Retrovirus Conference that "the combination of ddI and d4T should not be used as part of an initial antiretroviral regimen." Research studies involving previously untreated patients should avoid the use of Zerit. Until we can predict who will have an increased risk of developing lipoatrophy from Zerit, or until there is an effective method of managing those complications, Zerit should be dropped from the list of preferred drugs for use in treatment-naive patients and only used for salvage situations in which the benefits will outweigh the risks.
Nelson Vergel lectures frequently on lipodystrophy and HIV treatment side-effect management from a consumer's point of view. For more information, visit: http://www.facialwasting.org/.
From HIV PLus- My Salvage Work
Survivor
Treatment Advocate Nelson Vergel Wants the Experimental Drug Pipeline Opened Up for Patients Like Himself Who Are in Need of Salvage Therapy
By By Benjamin Ryan
Nelson Vergel is trapped in medical limbo. The 46-year-old treatment advocate expects to remain there for the next two or three years unless he can successfully use his activist chops to change the drug research system. In doing so, he hopes to allow thousands of other HIVers like himself to cut to the front of the antiretroviral waiting line. Vergel is one of those unlucky guys known as salvage patients--those who, during their long history with the virus, have knocked down every available anti-HIV medication like so many dominoes, developing increasing genetic resistance as their treatment options dwindle toward zero. His goal: to get access to experimental meds in clinical trials for salvage patients.Opinions differ widely on the prevalence of people like Vergel, but studies have shown that 14% to 20% of medicated HIVers who have a detectable viral load are resistant to three of the four current classes of antiretrovirals. (Testing for drug resistance cannot be performed on patients with an undetectable viral load, so it is impossible to get exact figures on the HIV-positive population as a whole.)“I hate when people say, ‘Well, you know, salvage therapy is not a big problem. All those people have died off. Everybody’s kind of stable,’ ” Vergel says of attitudes he’s encountered in his efforts to get people on board with his mission. “Where do they live?”The imminent release of Aptivus (tipranavir), a new protease inhibitor, gives Vergel little hope. As an advocate for patients who need salvage therapy, he knows that adding a single new drug to a failing regimen--known as sequential monotherapy--is a surefire way to develop resistance to that medication. The best way for multidrug-resistant HIVers to achieve an undetectable viral load, which will in turn help them avoid further drug resistance, is to begin two or three new drugs at once.Such an opportunity is unlikely until 2007 or 2008, when a revolution in HIV treatment could occur: up to nine novel therapies hitting the market at once. Some of these drugs will belong to new classes, attacking the virus in unique ways and thus reducing the likelihood that HIVers will have existing cross-resistance to them. However, until these drugs are green-lighted by the Food and Drug Administration, they will be available only to patients lucky enough to gain entry to clinical trials.“I really hope that in four years we do not need to worry about salvage therapy,” Vergel says, “but right now we do. We are the patients who need these new drugs the most.”Health ConcernsSalvage patients are often left out of drug trials because pharmaceutical companies typically specify exclusions that make patients in late-stage disease ineligible: those with extensive liver damage, diabetes, hepatitis C coinfection, or T-cell counts below 50.An even more important concern for salvage patients is that no pharmaceutical company has ever studied an antiretroviral in combination with another experimental agent. For someone like Vergel, entry into such a trial would be ideal, since he would be able to take two or more new therapies at once. So he has been traveling around the country, meeting with pharmaceutical representatives and urging them to develop research models that would allow such combinations, even if that means incorporating one or more drugs from other companies.“I have my own interest as a patient,” Vergel says of the passion behind his activism, but he adds, “I have met people everywhere I go who want this really badly and are desperate.”He has the FDA on his side. The agency has supported such research models for several years, but no one has risen to the challenge--yet.One pharmaceutical company, Tibotec, is set to be the first to perform such research. It has a nonnuke (TMC-125) in phase IIb trials and a protease inhibitor (TMC-114) in phase III. Motivated both by hopes of helping desperate patients and of finding a marketable combination therapy, Tibotec is designing a phase III trial that will administer both drugs to patients.Other companies are generally receptive to the idea of studying combinations of experimental drugs, but they must worry about the details of designing successful trials that will both protect the safety of patients and get the drug to market as quickly as possible.Martin Delaney, founding director of Project Inform, says, “In many cases the companies are reluctant” to do this kind of research, “because they fear that they will get blamed for the other [company’s drug’s] toxicity.”The Risks InvolvedPatient safety is a key issue that gives drug companies pause. Researchers are wary of potential drug interactions when combining two drugs they do not yet fully understand. These interactions are especially risky in salvage-therapy patients, whose often damaged bodies are already highly sensitive.Timing is another problem. To avoid slowing down respective approval processes, the drugs need to be in the same stage of development. Although there are currently nine drugs belonging to four classes in phase II trials, they are each moving along at their own pace.Pharmaceutical companies also worry that increasing the complexity of studies would slow down research. Scientists strive to reduce the number of variables when studying how drugs work. So it may be counterproductive to research two new agents at once, especially when corresponding study subjects are likely to have a range of medical complications and medications beyond the purview of the study.“A program like that may be compassionate for the short term, in terms of helping people right now who need it,” says Michael J. Abrams, CEO of drugmaker AnorMed Inc. “But it potentially is not compassionate in the long term. If it slows down or even causes a problem that prevents the drug from being approved, then it is going to deny the access to a much larger group that is going to need it eventually.”AnorMed is developing antiretrovirals called coreceptor antagonists, which block HIV’s ability to latch onto coreceptors R5 and X4 on the CD4-cell molecule. Each drug blocks only one coreceptor, so research suggests that it would be best to take the drugs in combination. Consequently, Abrams says he is interested in conducting combination research.Companies researching protease inhibitors or nucleoside and nonnucleoside analogs are less interested in teasing apart how the drugs function in combination since there is already a wealth of information about how these drugs work.Beyond the Bottom LineStill, Richard Levy, MD, senior vice president of drug development at Incyte, whose Reverset nuke is in phase II trials, says people should not view pharmaceutical companies as Big Brother organizations worried only about profits. “I do not think that companies do not want to help. The question is,” he says, “how can they help best?” He believes that whenever possible patients participating in clinical trials should be given the most potent possible multidrug regimen.Vergel, with support from other less-vocal quarters, argues that studies can be designed to include a subset of salvage patients. The data gathered would not necessarily be pivotal for the FDA’s approval but could bring greater insight to the subtleties of a drug’s usage, information pharmaceutical companies could use in their marketing.“It can be only a win-win for the company and patients,” says Rob Camp, the antiretroviral project director with Treatment Action Group, an AIDS activist coalition. “Since most drugs today need to show some added value--usually in the resistance, adherence, price, or side effects areas--putting two new agents together makes nothing but sense as long as some basic interactions and safety guidelines have been looked at.”Meanwhile, Vergel has no plans to halt his efforts, even if not everyone is on board. He believes he is making headway. “I am hopeful,” he says. “I just thought I was going to have more people working with me” to achieve the goal.
Treatment Advocate Nelson Vergel Wants the Experimental Drug Pipeline Opened Up for Patients Like Himself Who Are in Need of Salvage Therapy
By By Benjamin Ryan
Nelson Vergel is trapped in medical limbo. The 46-year-old treatment advocate expects to remain there for the next two or three years unless he can successfully use his activist chops to change the drug research system. In doing so, he hopes to allow thousands of other HIVers like himself to cut to the front of the antiretroviral waiting line. Vergel is one of those unlucky guys known as salvage patients--those who, during their long history with the virus, have knocked down every available anti-HIV medication like so many dominoes, developing increasing genetic resistance as their treatment options dwindle toward zero. His goal: to get access to experimental meds in clinical trials for salvage patients.Opinions differ widely on the prevalence of people like Vergel, but studies have shown that 14% to 20% of medicated HIVers who have a detectable viral load are resistant to three of the four current classes of antiretrovirals. (Testing for drug resistance cannot be performed on patients with an undetectable viral load, so it is impossible to get exact figures on the HIV-positive population as a whole.)“I hate when people say, ‘Well, you know, salvage therapy is not a big problem. All those people have died off. Everybody’s kind of stable,’ ” Vergel says of attitudes he’s encountered in his efforts to get people on board with his mission. “Where do they live?”The imminent release of Aptivus (tipranavir), a new protease inhibitor, gives Vergel little hope. As an advocate for patients who need salvage therapy, he knows that adding a single new drug to a failing regimen--known as sequential monotherapy--is a surefire way to develop resistance to that medication. The best way for multidrug-resistant HIVers to achieve an undetectable viral load, which will in turn help them avoid further drug resistance, is to begin two or three new drugs at once.Such an opportunity is unlikely until 2007 or 2008, when a revolution in HIV treatment could occur: up to nine novel therapies hitting the market at once. Some of these drugs will belong to new classes, attacking the virus in unique ways and thus reducing the likelihood that HIVers will have existing cross-resistance to them. However, until these drugs are green-lighted by the Food and Drug Administration, they will be available only to patients lucky enough to gain entry to clinical trials.“I really hope that in four years we do not need to worry about salvage therapy,” Vergel says, “but right now we do. We are the patients who need these new drugs the most.”Health ConcernsSalvage patients are often left out of drug trials because pharmaceutical companies typically specify exclusions that make patients in late-stage disease ineligible: those with extensive liver damage, diabetes, hepatitis C coinfection, or T-cell counts below 50.An even more important concern for salvage patients is that no pharmaceutical company has ever studied an antiretroviral in combination with another experimental agent. For someone like Vergel, entry into such a trial would be ideal, since he would be able to take two or more new therapies at once. So he has been traveling around the country, meeting with pharmaceutical representatives and urging them to develop research models that would allow such combinations, even if that means incorporating one or more drugs from other companies.“I have my own interest as a patient,” Vergel says of the passion behind his activism, but he adds, “I have met people everywhere I go who want this really badly and are desperate.”He has the FDA on his side. The agency has supported such research models for several years, but no one has risen to the challenge--yet.One pharmaceutical company, Tibotec, is set to be the first to perform such research. It has a nonnuke (TMC-125) in phase IIb trials and a protease inhibitor (TMC-114) in phase III. Motivated both by hopes of helping desperate patients and of finding a marketable combination therapy, Tibotec is designing a phase III trial that will administer both drugs to patients.Other companies are generally receptive to the idea of studying combinations of experimental drugs, but they must worry about the details of designing successful trials that will both protect the safety of patients and get the drug to market as quickly as possible.Martin Delaney, founding director of Project Inform, says, “In many cases the companies are reluctant” to do this kind of research, “because they fear that they will get blamed for the other [company’s drug’s] toxicity.”The Risks InvolvedPatient safety is a key issue that gives drug companies pause. Researchers are wary of potential drug interactions when combining two drugs they do not yet fully understand. These interactions are especially risky in salvage-therapy patients, whose often damaged bodies are already highly sensitive.Timing is another problem. To avoid slowing down respective approval processes, the drugs need to be in the same stage of development. Although there are currently nine drugs belonging to four classes in phase II trials, they are each moving along at their own pace.Pharmaceutical companies also worry that increasing the complexity of studies would slow down research. Scientists strive to reduce the number of variables when studying how drugs work. So it may be counterproductive to research two new agents at once, especially when corresponding study subjects are likely to have a range of medical complications and medications beyond the purview of the study.“A program like that may be compassionate for the short term, in terms of helping people right now who need it,” says Michael J. Abrams, CEO of drugmaker AnorMed Inc. “But it potentially is not compassionate in the long term. If it slows down or even causes a problem that prevents the drug from being approved, then it is going to deny the access to a much larger group that is going to need it eventually.”AnorMed is developing antiretrovirals called coreceptor antagonists, which block HIV’s ability to latch onto coreceptors R5 and X4 on the CD4-cell molecule. Each drug blocks only one coreceptor, so research suggests that it would be best to take the drugs in combination. Consequently, Abrams says he is interested in conducting combination research.Companies researching protease inhibitors or nucleoside and nonnucleoside analogs are less interested in teasing apart how the drugs function in combination since there is already a wealth of information about how these drugs work.Beyond the Bottom LineStill, Richard Levy, MD, senior vice president of drug development at Incyte, whose Reverset nuke is in phase II trials, says people should not view pharmaceutical companies as Big Brother organizations worried only about profits. “I do not think that companies do not want to help. The question is,” he says, “how can they help best?” He believes that whenever possible patients participating in clinical trials should be given the most potent possible multidrug regimen.Vergel, with support from other less-vocal quarters, argues that studies can be designed to include a subset of salvage patients. The data gathered would not necessarily be pivotal for the FDA’s approval but could bring greater insight to the subtleties of a drug’s usage, information pharmaceutical companies could use in their marketing.“It can be only a win-win for the company and patients,” says Rob Camp, the antiretroviral project director with Treatment Action Group, an AIDS activist coalition. “Since most drugs today need to show some added value--usually in the resistance, adherence, price, or side effects areas--putting two new agents together makes nothing but sense as long as some basic interactions and safety guidelines have been looked at.”Meanwhile, Vergel has no plans to halt his efforts, even if not everyone is on board. He believes he is making headway. “I am hopeful,” he says. “I just thought I was going to have more people working with me” to achieve the goal.
Anabolic Steroids and HIV
You guys may want to read this really good article about steroids and HIV wasting...
For some, steroid use builds hope
Treatment: Doctors find medical value in the drugs to restore muscle patients lose to diseases
The Baltimore SunBy Erika NiedowskiFebruary 20, 2005
A few years after his HIV diagnosis, Nelson Vergel began wasting away. No matter how much he ate, no matter how many protein shakes he added to his diet, no matter how much iron he pumped, the chemical engineer could not regain 25 pounds the virus had stripped from his 5-foot-7 frame. He watched as dozens of HIV-infected friends progressively lost body fat and muscle -- and, ultimately, their lives.
"Either I have to do something," Vergel thought, "or I'll be the next one."
Then he found steroids.
For more than a decade, Vergel has been among the chronically ill patients who take anabolic steroids -- legally -- for the same fundamental reason some athletes use them on the sly: to build up their bodies.
A storm of attention has been paid of late to illicit use of steroids among athletes, who forever want to run faster and hit balls farther. But at the same time, a quiet movement is under way to discover what legitimate role the drugs can play in mainstream medicine.
For years, doctors have prescribed anabolic steroids for those with HIV or AIDS, kidney disease, cancer and other illnesses that cause malnutrition or muscle wasting that can leave patients dangerously thin. And, although the long-term side effects of anabolics aren't fully known -- even at low doses -- some physicians see definite therapeutic benefits.
"Not only do they help rebuild muscle, they make you feel better," said Dr. Bruce Rashbaum, a Washington internist who has prescribed anabolic steroids to HIV and AIDS patients for 15 years. "It's not as if these patients are going to become Hercules, because they aren't going to be."
Not all doctors think the benefits of prescribing steroids for chronic conditions outweigh the potential risks, however. What's more, they say, simply adding muscle to a frail body isn't necessarily going to help someone who is dying from a disease anyway.
But given the difficulty physicians have had in helping severely malnourished people gain lean muscle tissue -- as opposed to fat -- scientists are continuing to study whether steroids might be among the answers.
Said Rashbaum: "Everyone has this notion that these drugs are taboo, and they don't even entertain the idea of learning about it. I really think in the short and long run the benefit certainly outweighs the risk for those patients that really need them."
In 1999, Dr. Kirsten L. Johansen, director of dialysis at the San Francisco VA Medical Center, led a study of 29 patients with kidney failure. Over six months, they were either injected with an anabolic steroid or given a dummy pill.
Those in the drug group gained an average of nearly six pounds more in lean body mass -- and reported less fatigue -- than those taking the placebo.
Johansen has been following up on that research to determine whether the patients' boost in weight was attributable to muscle and whether it translated into better physical function and quality of life.
"We know that people who lose muscle mass tend to die sooner," she said. "But what we really don't know is: If we build muscle mass, are we helping them? These patients are really debilitated. For some of them, that's just such an issue that they really might benefit from this."
Anabolic steroids date to the 1930s, when scientists created a synthetic form of the male hormone testosterone. They were targeting hypogonadism, a condition in which the testes don't produce enough testosterone for normal growth and sexual function. Soon, researchers discovered that the drug aided the growth of skeletal muscle, too.
But not without a price: Anabolic steroids have been linked to side effects ranging from acne and aggression to cardiovascular disease and liver cancer.
This type of steroid -- which differs chemically from the corticosteroids commonly used to treat inflammation -- is available legally in the United States only by prescription. And athletes typically take doses considerably higher than those prescribed for medical purposes.
Dr. Marc K. Hellerstein, professor of medicine at the University of California, San Francisco, said modest doses of anabolics, combined with weight training -- if patients are well enough to exercise -- yield the best result.
He has used that approach for patients with HIV and AIDS. In a 1999 study he led, 22 men lifted weights and received testosterone by injection. Half also took an oral anabolic steroid.
Both groups increased their lean body mass, weight and strength. But those in the steroid group had significantly larger gains. "It was not just cosmetic; this was useful muscle," Hellerstein said.
Even at low doses, anabolic steroids can have unpleasant or dangerous side effects, including liver damage and prostate cancer, and doctors who prescribe them have to monitor their patients closely.
In Hellerstein's study, those side effects included a drop in HDL (the "good" cholesterol), as well as irritability and overly aggressive behavior. In general, some patients don't like steroids because the drugs can cause sleep problems or make them more likely to pick fights with their partners. But others thrive on them.
Dr. Adrian S. Dobs, an endocrinologist at the Johns Hopkins School of Medicine, said she believes there's a limited role for anabolics in medicine, including with HIV and AIDS patients.
But in other cases, she says, the long-term risks -- which are still unknown -- might be too great.
"I just don't think there's good data to say it's really worth doing, with the exception of a few disease states," she said. "Increasing muscle mass per se is not a benefit. ... Are you doing any good? What's going on with the underlying disease?"
Vergel, who has been taking anabolic steroids since 1994, credits them with helping him through a difficult period before the advent of effective antiviral treatments that helped reduce chronic wasting.
During his first four months injecting anabolics, Vergel put on 35 pounds -- enough to push him up to 175, more than he weighed when he was healthy. The 46-year-old, who lives in Houston, kept up with the drug regimen and saw his white blood cell count climb. His energy and appetite improved. "I was looking great," he said. "For the first time, I was looking like I was not HIV-positive. I just felt like a superman. I just thought, 'Maybe I'll survive.'"
Vergel, who still takes a regular course of anti-HIV drugs, weighs 190 pounds and looks like a bodybuilder, founded a nonprofit group called PoWeR -- Program for Wellness Restoration.
He eventually left his job and wrote a book outlining a health plan for HIV-positive people based on steroids, exercise and nutrition. Anabolics, he says, are only a part of the equation.
A doctor supervises his use of the drugs, regularly checking for changes in liver function and blood pressure and screening for prostate cancer. "When you're sick, the risk-to-benefit ratio changes in your mind," Vergel said. "I have no doubt that my quality of life -- and my life -- have been extended."
[Link]
For some, steroid use builds hope
Treatment: Doctors find medical value in the drugs to restore muscle patients lose to diseases
The Baltimore SunBy Erika NiedowskiFebruary 20, 2005
A few years after his HIV diagnosis, Nelson Vergel began wasting away. No matter how much he ate, no matter how many protein shakes he added to his diet, no matter how much iron he pumped, the chemical engineer could not regain 25 pounds the virus had stripped from his 5-foot-7 frame. He watched as dozens of HIV-infected friends progressively lost body fat and muscle -- and, ultimately, their lives.
"Either I have to do something," Vergel thought, "or I'll be the next one."
Then he found steroids.
For more than a decade, Vergel has been among the chronically ill patients who take anabolic steroids -- legally -- for the same fundamental reason some athletes use them on the sly: to build up their bodies.
A storm of attention has been paid of late to illicit use of steroids among athletes, who forever want to run faster and hit balls farther. But at the same time, a quiet movement is under way to discover what legitimate role the drugs can play in mainstream medicine.
For years, doctors have prescribed anabolic steroids for those with HIV or AIDS, kidney disease, cancer and other illnesses that cause malnutrition or muscle wasting that can leave patients dangerously thin. And, although the long-term side effects of anabolics aren't fully known -- even at low doses -- some physicians see definite therapeutic benefits.
"Not only do they help rebuild muscle, they make you feel better," said Dr. Bruce Rashbaum, a Washington internist who has prescribed anabolic steroids to HIV and AIDS patients for 15 years. "It's not as if these patients are going to become Hercules, because they aren't going to be."
Not all doctors think the benefits of prescribing steroids for chronic conditions outweigh the potential risks, however. What's more, they say, simply adding muscle to a frail body isn't necessarily going to help someone who is dying from a disease anyway.
But given the difficulty physicians have had in helping severely malnourished people gain lean muscle tissue -- as opposed to fat -- scientists are continuing to study whether steroids might be among the answers.
Said Rashbaum: "Everyone has this notion that these drugs are taboo, and they don't even entertain the idea of learning about it. I really think in the short and long run the benefit certainly outweighs the risk for those patients that really need them."
In 1999, Dr. Kirsten L. Johansen, director of dialysis at the San Francisco VA Medical Center, led a study of 29 patients with kidney failure. Over six months, they were either injected with an anabolic steroid or given a dummy pill.
Those in the drug group gained an average of nearly six pounds more in lean body mass -- and reported less fatigue -- than those taking the placebo.
Johansen has been following up on that research to determine whether the patients' boost in weight was attributable to muscle and whether it translated into better physical function and quality of life.
"We know that people who lose muscle mass tend to die sooner," she said. "But what we really don't know is: If we build muscle mass, are we helping them? These patients are really debilitated. For some of them, that's just such an issue that they really might benefit from this."
Anabolic steroids date to the 1930s, when scientists created a synthetic form of the male hormone testosterone. They were targeting hypogonadism, a condition in which the testes don't produce enough testosterone for normal growth and sexual function. Soon, researchers discovered that the drug aided the growth of skeletal muscle, too.
But not without a price: Anabolic steroids have been linked to side effects ranging from acne and aggression to cardiovascular disease and liver cancer.
This type of steroid -- which differs chemically from the corticosteroids commonly used to treat inflammation -- is available legally in the United States only by prescription. And athletes typically take doses considerably higher than those prescribed for medical purposes.
Dr. Marc K. Hellerstein, professor of medicine at the University of California, San Francisco, said modest doses of anabolics, combined with weight training -- if patients are well enough to exercise -- yield the best result.
He has used that approach for patients with HIV and AIDS. In a 1999 study he led, 22 men lifted weights and received testosterone by injection. Half also took an oral anabolic steroid.
Both groups increased their lean body mass, weight and strength. But those in the steroid group had significantly larger gains. "It was not just cosmetic; this was useful muscle," Hellerstein said.
Even at low doses, anabolic steroids can have unpleasant or dangerous side effects, including liver damage and prostate cancer, and doctors who prescribe them have to monitor their patients closely.
In Hellerstein's study, those side effects included a drop in HDL (the "good" cholesterol), as well as irritability and overly aggressive behavior. In general, some patients don't like steroids because the drugs can cause sleep problems or make them more likely to pick fights with their partners. But others thrive on them.
Dr. Adrian S. Dobs, an endocrinologist at the Johns Hopkins School of Medicine, said she believes there's a limited role for anabolics in medicine, including with HIV and AIDS patients.
But in other cases, she says, the long-term risks -- which are still unknown -- might be too great.
"I just don't think there's good data to say it's really worth doing, with the exception of a few disease states," she said. "Increasing muscle mass per se is not a benefit. ... Are you doing any good? What's going on with the underlying disease?"
Vergel, who has been taking anabolic steroids since 1994, credits them with helping him through a difficult period before the advent of effective antiviral treatments that helped reduce chronic wasting.
During his first four months injecting anabolics, Vergel put on 35 pounds -- enough to push him up to 175, more than he weighed when he was healthy. The 46-year-old, who lives in Houston, kept up with the drug regimen and saw his white blood cell count climb. His energy and appetite improved. "I was looking great," he said. "For the first time, I was looking like I was not HIV-positive. I just felt like a superman. I just thought, 'Maybe I'll survive.'"
Vergel, who still takes a regular course of anti-HIV drugs, weighs 190 pounds and looks like a bodybuilder, founded a nonprofit group called PoWeR -- Program for Wellness Restoration.
He eventually left his job and wrote a book outlining a health plan for HIV-positive people based on steroids, exercise and nutrition. Anabolics, he says, are only a part of the equation.
A doctor supervises his use of the drugs, regularly checking for changes in liver function and blood pressure and screening for prostate cancer. "When you're sick, the risk-to-benefit ratio changes in your mind," Vergel said. "I have no doubt that my quality of life -- and my life -- have been extended."
[Link]
Pill Popper me....
Nelson Vergel's Vitamin and Mineral Supplement Regimen
August 2001
This is the second installment in our series "What Supplements I Take and Why." This article looks at the supplement regimen taken by Nelson Vergel. Nelson, a native of Venezuela and 17-year survivor of HIV, is a leading treatment advocate for HIV-related wasting, lipodystrophy, and wellness in HIV disease. He created the non-profit organization Program for Wellness Restoration (PoWeR) to help persons living with HIV disease rebuild their lives and health. Nelson and co-author Michael Mooney published the book Built to Survive!: A Comprehensive Guide to the Medical Use of Anabolic Steroids, Nutrition, and Exercise for HIV+ Men and Women. Popular lecturers, Nelson and Michael have collectively given over 300 lectures around the United States, including annual community treatment forums in Atlanta co-sponsored by AIDS Survival Project and AIDS Treatment Initiatives.
This series of personal supplement regimens is not intended to endorse any particular supplements or advise readers what supplements to take. The goal is to create a mosaic of perspectives that will raise provocative questions about complementary therapies and further entice readers to think critically about supplements and the role they play in our health and wellness.
Nelson Vergel's Daily NutrientsThese are the vitamins, minerals, and special nutrients Nelson takes and the reasons he takes them.
B-Complex: includes 100mg of each B vitamin -- possibly reduces mitochondrial toxicity and lipodystrophy, and for overall health, energy metabolism cardiovascular health and brain function. One tablet twice per day.
SuperNutrition Super Blend complete daily multi-vitamin, multi-mineral, antioxidant formula: for overall health and to improve insulin sensitivity. Two tablets twice per day.
Carnitine: to reduce the potential for mitochondrial toxicity and lipodystrophy, to improve insulin sensitivity, and improve fat/triglyceride metabolism. 1,000mg twice per day.
Coenzyme Q10: to reduce the potential for mitochondrial toxicity and lipodystrophy, improve insulin sensitivity, and as an antioxidant. 200mg twice per day. CoQ10 also increases energy at this high dose. People usually report that the dose has to be above 200mg per day to increase the feeling of energy.
Zinc/Copper: for appetite, and sexual function. 50/5mg per day. (Be sure to take antioxidants like alpha lipoic acid, if you take copper, which can increase free radicals.)
Silymarin: for liver health and to improve insulin sensitivity. 160mg three times per day.
Alpha Lipoic: to reduce the potential for mitochondrial toxicity and lipodystrophy, and to improve insulin sensitivity. 200mg twice per day.
Calcium/Magnesium: to improve overall health and to improve insulin sensitivity. 1000/400mg total per day, split into two doses.
Digestive enzymes with each meal -- for digestion and to reduce bloating.
Experimenting with SAMe for energy and mood.
Chromium: to support insulin sensitivity. 400mcg total per day spread out throughout the day, part from the Super Blend and part added.
Selenium: anti-viral protection, improves glutathione. 400mcg per day total.
Nelson Vergel is co-author of Built to Survive!, Michael Mooney, comments that Nelson does not appear to have symptoms of lipodystrophy. He says, "I wonder if this is because he has been taking high doses of nutrients for a long time. While he has taken N-acetyl-l-cysteine in the past, in an effort to reduce his total pill burden he has decreased his supplements to what is listed. Notice that he has taken the three nutrients we think have the most potential to reduce lipodystrophy: carnitine, CoQ-10, and B-vitamins for a long time."
Read Guy Pujol's Supplement Regimen from AIDS Treatment Initiative.
This article is a part of the publication Survival News.
August 2001
This is the second installment in our series "What Supplements I Take and Why." This article looks at the supplement regimen taken by Nelson Vergel. Nelson, a native of Venezuela and 17-year survivor of HIV, is a leading treatment advocate for HIV-related wasting, lipodystrophy, and wellness in HIV disease. He created the non-profit organization Program for Wellness Restoration (PoWeR) to help persons living with HIV disease rebuild their lives and health. Nelson and co-author Michael Mooney published the book Built to Survive!: A Comprehensive Guide to the Medical Use of Anabolic Steroids, Nutrition, and Exercise for HIV+ Men and Women. Popular lecturers, Nelson and Michael have collectively given over 300 lectures around the United States, including annual community treatment forums in Atlanta co-sponsored by AIDS Survival Project and AIDS Treatment Initiatives.
This series of personal supplement regimens is not intended to endorse any particular supplements or advise readers what supplements to take. The goal is to create a mosaic of perspectives that will raise provocative questions about complementary therapies and further entice readers to think critically about supplements and the role they play in our health and wellness.
Nelson Vergel's Daily NutrientsThese are the vitamins, minerals, and special nutrients Nelson takes and the reasons he takes them.
B-Complex: includes 100mg of each B vitamin -- possibly reduces mitochondrial toxicity and lipodystrophy, and for overall health, energy metabolism cardiovascular health and brain function. One tablet twice per day.
SuperNutrition Super Blend complete daily multi-vitamin, multi-mineral, antioxidant formula: for overall health and to improve insulin sensitivity. Two tablets twice per day.
Carnitine: to reduce the potential for mitochondrial toxicity and lipodystrophy, to improve insulin sensitivity, and improve fat/triglyceride metabolism. 1,000mg twice per day.
Coenzyme Q10: to reduce the potential for mitochondrial toxicity and lipodystrophy, improve insulin sensitivity, and as an antioxidant. 200mg twice per day. CoQ10 also increases energy at this high dose. People usually report that the dose has to be above 200mg per day to increase the feeling of energy.
Zinc/Copper: for appetite, and sexual function. 50/5mg per day. (Be sure to take antioxidants like alpha lipoic acid, if you take copper, which can increase free radicals.)
Silymarin: for liver health and to improve insulin sensitivity. 160mg three times per day.
Alpha Lipoic: to reduce the potential for mitochondrial toxicity and lipodystrophy, and to improve insulin sensitivity. 200mg twice per day.
Calcium/Magnesium: to improve overall health and to improve insulin sensitivity. 1000/400mg total per day, split into two doses.
Digestive enzymes with each meal -- for digestion and to reduce bloating.
Experimenting with SAMe for energy and mood.
Chromium: to support insulin sensitivity. 400mcg total per day spread out throughout the day, part from the Super Blend and part added.
Selenium: anti-viral protection, improves glutathione. 400mcg per day total.
Nelson Vergel is co-author of Built to Survive!, Michael Mooney, comments that Nelson does not appear to have symptoms of lipodystrophy. He says, "I wonder if this is because he has been taking high doses of nutrients for a long time. While he has taken N-acetyl-l-cysteine in the past, in an effort to reduce his total pill burden he has decreased his supplements to what is listed. Notice that he has taken the three nutrients we think have the most potential to reduce lipodystrophy: carnitine, CoQ-10, and B-vitamins for a long time."
Read Guy Pujol's Supplement Regimen from AIDS Treatment Initiative.
This article is a part of the publication Survival News.
My Next HIV Cruise- Can't wait!
Title: 9th Annual POZ Cruise Wellness RetreatCity: Los AngelesState: CACountry: United StatesDates: 10/21/2006 - 10/29/2006Event Type: Special EventSubject: Peer Support; Persons with HIV/AIDS; Support GroupsDescription: This eight-day cruise aboard the Norwegian Star is a retreat for the HIV community, either straight or gay, and their friends and family. The group will be confidential and provide a safe, supportive learning and social environment as well as the opportunity to meet others living with HIV. Nelson Vergel, a 22-year survivor and nationally recognized HIV specialist will be the guest lecturer. He will talk about how to stay healthy and fit while living with HIV. For additional information access www.positiveconnections.org/cruise.htm#cruise.Sponsor: Center for Positive Connections.Contact: For additional information contact the Paul Stalbaum travel agent at (800) 735-0401, ext. 241 or e-mail: paul@universal-travel.comor contact the Center for Positive Connections by phone: 1-888-pos-conn (767-2666) or (305) 891-2066 or e-mail@positiveconnections.org or access the Web site at www.positiveconnections.org.Notes: Rates per person: Inside cabins: $565. Outside cabins: $735. Balcony: $929. Mini Suites: On request. Port taxes: an additional $222.88 per person.
Towards the path of least resistance
I’ve been positive since 1983, and like many other long-term survivors, I took each new drug as soon as it became available. Even after combo therapy arrived, I often mixed one new med that worked with others that were already failing. The practice proved to be a recipe for resistance. In the past two years, my T cells have dropped from 580 to 200, and I’m in “salvage therapy,” meaning that I take a combo of drugs to which I have resistance, hoping that together they’ll provide some antiviral action.But soon, I’ll have a new approach to consider. Eight new meds are either currently FDA-approved or will, within the next year or so, be approved or be available in expanded access, a program to get preapproval drugs to those in dire need. There are three fusion, attachment or entry inhibitors; three protease inhibitors (PIs); a non-nuke; and an integrase inhibitor. In the past, each new med was tested in combination with older ones. Now, some trials will test a combination that includes several new meds. In addition, long-termers like me can combine several new drugs that are in expanded access. I plan to wait for the expanded-access availability of a new integrase inhibitor, MK-0518, and team it with a new PI, TMC-114 (darunavir), which should be approved later this year. It seems like a blueprint for a working combo—and boy, will I work it.
Monday, April 10, 2006
Tibotec, the company that could, but didn't
New Drugs Can Save Lives; AIDS Activists Urge Tibotec to Be Compassionate Towards HIV Salvage Patients
HOUSTON, March 8 /PRNewswire/ -- AIDS Activists, seeking to expand access to new drugs for people living with HIV who have run out of treatment options, are urging Tibotec Pharmaceuticals, a subsidiary of Johnson and Johnson, to provide compassionate access to their TMC 125 non-nucleoside HIV investigational drug. Compassionate access is often the difference between life and death to help those patients.
Tibotec is the first company in the battle against AIDS to have two promising new drugs simultaneously under development (TMC 114, a protease inhibitor, and TMC 125, a non-nucleoside). This is good news for patients who need access to more than one active drug to improve control of their multiple drug resistant HIV. In separate studies, both drugs have shown to help reduce viral replication in treatment-experienced patients. A small pilot study has shown that the combination of the two drugs can suppress the virus to undetectable levels at week 16 in patients who have failed all commercially available drugs. TMC 114 is now available via expanded access and TMC 125 is available through a phase III study. But getting the combination of the two drugs to people in need is still a challenge.
"Patients that have developed HIV drug resistance to all commercially available antiretroviral medications require access to at least two new active drugs to maximize their chances for treatment response and survival," said Nelson Vergel, a salvage patient who founded SalvageTherapies.org and board member of the ATAC. "Commercial access to Tibotec's drug combination will not be available for over a year, and many patients cannot wait that long," added Vergel.
The Drug Development Committee of the AIDS Treatment Activists Coalition (ATAC-DDC) and the European Community Advisory Board (ECAB) met with Tibotec a year ago, where they requested early access to both TMC drugs in combination for those who have run out of treatment options so that these patients would not be exposed to the risk of having only one active agent. Unfortunately, Tibotec did not accept this request and instead decided to open a placebo- controlled study (DUET) that provides a 50% chance of getting TMC 114 as a sole active agent. While ATAC welcomes Tibotec's decision to combine both of their drugs in a study, it cautions that the placebo arm will fail to help those HIV patients most in need.
Drug resistance and its impact on HIV treatment are major concerns among AIDS activists. More often antiretroviral medications stop working as a result of drug resistance. In fact, national statistics show that at least 46 percent of people failing HIV medications and 13 percent of newly diagnosed patients have drug resistance. Some estimate the number of people living with multiple drug resistance at 64,000 in the United States, many of who have gone through at least four HIV medication regimens already.
"When patients do not have active agents in their optimized background treatment regimen, adding one new active drug to that OBT is considered to be 'virtual mono-therapy.' As observed in many previous studies, some of the 600 patients randomized to Tibotec's placebo arm will obtain a degree of viral suppression in the short term, but benefits may be short-lived and resistance to TMC 114 can emerge in those with no other active agent in their OBT," summarized Fred Schaich, a long term treatment activist and founder of the International Foundation for Alternative Research in AIDS (IFARA). He added, "This problem will limit the use of TMC 114 in the future as part of a fully suppressive regimen."
The DUET studies are important clinical trials for Tibotec; they need to be completed successfully so that etravirine (TMC 125) can be approved. They are also placebo-controlled studies. This means that half of the group of patients will receive etravirine (TMC 125) and the other half will receive a placebo of TMC 125. Patients in both groups will receive darunavir (TMC 114) and any approved nucleoside reverse transcriptase inhibitor and/or the entry inhibitor Fuzeon.
To get around Tibotec's lack of a formal compassionate program, activists are trying to make people aware of a little known process called Emergency IND (EIND) that doctors can use to get access to an investigational drug, provided that the patient meets the criteria and that the manufacturer agrees to provide the drug. This system should help those with little chance of survival and who have no time to wait for drug approval. Unfortunately, EINDs are time consuming and require approval from the manufacturer, the FDA, and local institutional review board. For more information of this procedure and other options soon to be available, go to http://www.salvagetherapies.org/announcements.htm .
"With hardly any immune system left and resistance to all approved HIV medications, I have tried desperately to get access to both TMC drugs to help save my life, but my doctor tells me that I have little choice but to join the DUET study and take a 50% chance that I may get better," said Gary Bishop, a patient in dire need in Los Angeles who feels time is running out for him.
"We have received and facilitated Emergency IND requests for our compounds and will continue to do so on an individual patient basis if a physician calls us. But note that patients who are eligible but choose not to participate in the DUET trials would not normally be candidates for an EIND," said Lew Sibert from Tibotec. "Patients should discuss all of their options carefully with their physicians before determining the best course of action."
"It would be a lot easier for patients and doctors if Tibotec did the right thing and agreed to ATAC's and ECAB's original request to have a formal open label compassionate program as soon as possible. This will remove any obstacles due to EIND's extensive paper work, doctors' time and confusion by providing access to several patients at once instead of on a case-by-case basis," said Nelson Vergel. "It is the most humane and ethical thing to do," he added.
For additional information, contact Nelson Vergel by phone at 713-539-1978, or email at nelsonvergel@yahoo.com .
CONTACT: Nelson Vergel of SalvageTherapies.org, +1-713-539-1978, or nelsonvergel@yahoo.com
Web site: http://www.SalvageTherapies.org/ http://www.salvagetherapies.org/announcements.htm/
HOUSTON, March 8 /PRNewswire/ -- AIDS Activists, seeking to expand access to new drugs for people living with HIV who have run out of treatment options, are urging Tibotec Pharmaceuticals, a subsidiary of Johnson and Johnson, to provide compassionate access to their TMC 125 non-nucleoside HIV investigational drug. Compassionate access is often the difference between life and death to help those patients.
Tibotec is the first company in the battle against AIDS to have two promising new drugs simultaneously under development (TMC 114, a protease inhibitor, and TMC 125, a non-nucleoside). This is good news for patients who need access to more than one active drug to improve control of their multiple drug resistant HIV. In separate studies, both drugs have shown to help reduce viral replication in treatment-experienced patients. A small pilot study has shown that the combination of the two drugs can suppress the virus to undetectable levels at week 16 in patients who have failed all commercially available drugs. TMC 114 is now available via expanded access and TMC 125 is available through a phase III study. But getting the combination of the two drugs to people in need is still a challenge.
"Patients that have developed HIV drug resistance to all commercially available antiretroviral medications require access to at least two new active drugs to maximize their chances for treatment response and survival," said Nelson Vergel, a salvage patient who founded SalvageTherapies.org and board member of the ATAC. "Commercial access to Tibotec's drug combination will not be available for over a year, and many patients cannot wait that long," added Vergel.
The Drug Development Committee of the AIDS Treatment Activists Coalition (ATAC-DDC) and the European Community Advisory Board (ECAB) met with Tibotec a year ago, where they requested early access to both TMC drugs in combination for those who have run out of treatment options so that these patients would not be exposed to the risk of having only one active agent. Unfortunately, Tibotec did not accept this request and instead decided to open a placebo- controlled study (DUET) that provides a 50% chance of getting TMC 114 as a sole active agent. While ATAC welcomes Tibotec's decision to combine both of their drugs in a study, it cautions that the placebo arm will fail to help those HIV patients most in need.
Drug resistance and its impact on HIV treatment are major concerns among AIDS activists. More often antiretroviral medications stop working as a result of drug resistance. In fact, national statistics show that at least 46 percent of people failing HIV medications and 13 percent of newly diagnosed patients have drug resistance. Some estimate the number of people living with multiple drug resistance at 64,000 in the United States, many of who have gone through at least four HIV medication regimens already.
"When patients do not have active agents in their optimized background treatment regimen, adding one new active drug to that OBT is considered to be 'virtual mono-therapy.' As observed in many previous studies, some of the 600 patients randomized to Tibotec's placebo arm will obtain a degree of viral suppression in the short term, but benefits may be short-lived and resistance to TMC 114 can emerge in those with no other active agent in their OBT," summarized Fred Schaich, a long term treatment activist and founder of the International Foundation for Alternative Research in AIDS (IFARA). He added, "This problem will limit the use of TMC 114 in the future as part of a fully suppressive regimen."
The DUET studies are important clinical trials for Tibotec; they need to be completed successfully so that etravirine (TMC 125) can be approved. They are also placebo-controlled studies. This means that half of the group of patients will receive etravirine (TMC 125) and the other half will receive a placebo of TMC 125. Patients in both groups will receive darunavir (TMC 114) and any approved nucleoside reverse transcriptase inhibitor and/or the entry inhibitor Fuzeon.
To get around Tibotec's lack of a formal compassionate program, activists are trying to make people aware of a little known process called Emergency IND (EIND) that doctors can use to get access to an investigational drug, provided that the patient meets the criteria and that the manufacturer agrees to provide the drug. This system should help those with little chance of survival and who have no time to wait for drug approval. Unfortunately, EINDs are time consuming and require approval from the manufacturer, the FDA, and local institutional review board. For more information of this procedure and other options soon to be available, go to http://www.salvagetherapies.org/announcements.htm .
"With hardly any immune system left and resistance to all approved HIV medications, I have tried desperately to get access to both TMC drugs to help save my life, but my doctor tells me that I have little choice but to join the DUET study and take a 50% chance that I may get better," said Gary Bishop, a patient in dire need in Los Angeles who feels time is running out for him.
"We have received and facilitated Emergency IND requests for our compounds and will continue to do so on an individual patient basis if a physician calls us. But note that patients who are eligible but choose not to participate in the DUET trials would not normally be candidates for an EIND," said Lew Sibert from Tibotec. "Patients should discuss all of their options carefully with their physicians before determining the best course of action."
"It would be a lot easier for patients and doctors if Tibotec did the right thing and agreed to ATAC's and ECAB's original request to have a formal open label compassionate program as soon as possible. This will remove any obstacles due to EIND's extensive paper work, doctors' time and confusion by providing access to several patients at once instead of on a case-by-case basis," said Nelson Vergel. "It is the most humane and ethical thing to do," he added.
For additional information, contact Nelson Vergel by phone at 713-539-1978, or email at nelsonvergel@yahoo.com .
CONTACT: Nelson Vergel of SalvageTherapies.org, +1-713-539-1978, or nelsonvergel@yahoo.com
Web site: http://www.SalvageTherapies.org/ http://www.salvagetherapies.org/announcements.htm/
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