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September/October 2000 Inside this Issue
APPLICANTS NEEDED FOR PEER NATURAL LEADERS TSWN is now accepting applications for Peer Natural Leaders. PNL's are individuals living with HIV and/or
hepatitis. PNL's work at least 10 hours per month and receive compensation and reimbursement for some expenses.
There is a PNL training program starting this November. TSWN also provides ongoing support, supervision and
continuing education for all its peers. If you are interested, please call our office (888-338-TSWN) for an
application. TELEPHONE SUPPORT GROUP IN OCTOBER and NEW ON-LINE CHAT Our Telephone Support Group will be returning on Tuesday, October 24th in a new format. Every other month we will host an hourly telephone chat that will feature a guest speaker. Anyone can call in to ask questions and talkabout issues that affect your life. Our first group on the 24th will feature Sarah Duffley of the NH Dept of Health and Mary Pierce from the Vt. Dept. of Health. They will be answering questions about services available in each of their states. To participate call 800-xxx-xxxx at 8:30 PM. Coming in November will be our first On-line Chat. These hourly sessions will offer participants a chance to communicate on-line. If you don't have your own computer, try using a friend's. Details on how to participate will be in the next issue of AWARE. We'll be looking for your input as the year progresses to see how you like our telephone and on-line support groups. If at any time you'd like to give us feedback or suggestions, you can reach us by phone or email. PEOPLE NEWS A few words from Jean Carr who stepped down from her position as TSWN Grief/loss counselor. Greetings sisters! TSWN is pleased Although I have chosen to return to volunteer status in TSWN, I am no less committed to this super network of women. Hospice in all its many facets continues to be my vocation, and Mom is resourcing me from the other side of death's door. My life is rich and I pray that yours is too. HOLIDAY PARTIES IN OCTOBER AND DECEMBER We're kicking off the fall with our Halloween bash on Saturday, October 21st at St. Paul's Church in White River Junction, Vermont.. Then on December 9th our most exciting Holiday party ever at the Montshire Museum of Science in Norwich, VT. It's a fabulous hands-on science museum for kids and adults alike.
SEX POSITIVE RESOURCE CENTER (SPRC) FEATURE Now that life expectancy has significantly increased for people living with HIV, the desire to become pregnant has become a real consideration for many positive people. For magnetic couples, where one partner is positive for HIV and the other negative, the question, how can we have a baby of our own without risking transmission, is frequently being asked. When the woman is infected, it is a bit simpler as the man's sperm can be taken and manually inserted into the woman-the old Turkey baster concept. However, it's a bit more complex when the men is positive and the woman negative. It should also be noted, that the technique described below is also being used for men who have hepatitis or another transmissible disease. There's more than one way for positive couples to attempt a safe pregnancy. In theory, procedures like sperm washing are fairly straightforward -- collect the semen of an HIV-positive man and rinse away the parts of it that carry the virus. In practice, though, the undertaking raises complicated questions. Sperm washing is actually a common technique. It's been used for years by infertility clinics to boost the potency of a man's semen when trying to help his female partner conceive. It takes advantage of the fact that sperm are small and heavy, and can move like tadpoles. The semen is put in a test tube which is then spun in a centrifuge to separate the sperm from the other cells and fluids. The non-sperm part of the semen is removed, and each fraction is tested for HIV. If both parts are negative, the isolate sperm are covered with a new solution, which the healthiest cells will swim their way into. If no virus is found in a second test on the sperm, they can be used to fertilize the woman's egg cells. There are currently three ways to attempt pregnancy using washed sperm. A common method used for years is intravaginal insemination, which involves holding a cervical cap full of live sperm near a woman's cervix and allowing them to swim into the uterus. Dr. Ann Kiessling, director of the Assisted Reproduction Foundation in Boston, says this procedure may be safe, but hasn't been tried. But, she adds, the safest method is in vitro fertilization, which only exposes the woman to fertilized eggs, and not to live sperm cells. A third method,called "intrauterine insemination," or IUI, has been used by HIV couples in Italy, the UK, Spain and Switzerland. It involves inserting a catheter filled with washed sperm directly into the woman's uterus. Dr. Augusto Semprini, an Italian researcher who first applied IUI to HIV cases, claims to have achieved more than 250 pregnancies without a single viral transmission to either mother or child. But Dr. Kiessling remains cautious. IUI, she says, can leave the woman exposed to any trace cells that aren't filtered out in the washing process or detected by microscopic evaluation. And, she adds, it requires about ten times as many sperm cells as IVF, and can be an uncomfortable, invasive procedure. All three of these methods rely on the belief, shared by many researchers, that HIV lurks in white blood cells and the fluid parts of semen. That would make sperm-washing a potentially safe way to impregnate an HIV-negative woman with the sperm of her HIV-positive partner. Some scientists believe that sperm-washing can reduce the level of HIV in an infected man's semen by 100,000-fold. But that's not enough to convince the Centers for Disease Control and Prevention in the United States, and the legality of IUI stands on shaky ground in the U.S., where it's illegal in some states to transfer HIV-infected blood or tissue from one person to another. Those laws could be interpreted to include methods like this one, that assist in reproduction. Beyond the legal questions are the scientific ones. Sperm washing appears to effectively separate sperm cells from infectious agents in semen, but exactly how thorough it is hasn't been quantified. Some researchers also wonder whether HIV can be carried in the actual sperm cells of men who have been infected for a long time. If that were the case, then separating those cells from white blood cells and other fluids would still leave the mother and her child open to infection. Sperm-washing combined with IUI did result in one man passing the virus to his partner in Britain. The woman sued her doctor, though it remains unclear whether her infection was caused by the procedure. Health care professionals willing to undertake the sperm-washing venture are quick to remind their patients that it is only a risk-reduction method, and that no procedure is entirely risk-free. For couples in VT and NH that want to try the sperm washing technique, they can consult with The Special Program of Assisted Reproduction (SPAR) in Boston, Ma. SPAR is sponsored in part by the Assisted Reproduction Foundation, a nonprofit, tax-exempt 501(c)(3) organization founded in 1996 to raise money and sponsor research and teaching in reproduction, particularly those areas of human reproduction not funded by grants from the National Institutes of Health (NIH). SPAR's procedure for working with couples desiring the sperm washing technique is as follows:
Program Costs: While many of the specialized laboratory tests to evaluate the sperm will be paid for by contributions to the Assisted Reproduction Foundation, some costs may be a direct patient responsibility. The medical examinations and procedures, including the clinical aspects of the IVF cycle, will be billed according to standard practice and may be covered by some insurance plans. It is anticipated that a full IVF cycle will cost approximately $8,000 including medications and the stay in Boston. SPAR can be contacted as follows: info@reproduction.org; 617/947-8844, Fax 781/275-5978 or The Assisted Reproduction Foundation, 423 Brookline Ave., Boston, MA 02215.
HIV Vaccines Past and Present
Much money has been spent on vaccine research over the last decade. Some of the approaches have been controversial. In the beginning approaches to HIV vaccine development was slow due to the complexity of HIV-1 as an immunogen and, in part, due to somewhat simplistic research approaches. With new insights into HIV pathogenesis, new research tools, new resources, and new commitment from the U.S. government, from research administrators at the National Institutes of Health (NIH), and from the non-governmental and multilateral sectors, AIDS vaccine research is finally getting the attention, resources, and emphasis it deserves. The National Institute of Allergy and Infectious Diseases (NIAID) announced four public-private partnerships to accelerate development of promising HIV/AIDS vaccines for use around the world. The new partnerships, called HIV Vaccine Design and Development Teams (HVDDT), tap the different skills and talents of private industry and academic research centers, and provide incentive to move strong HIV/AIDS vaccine candidates out of the laboratory and into human testing. NIAID has committed to spend approximately $70 million over the next five years on the four HVDDT contracts that have been awarded. Although some media reports have called the future trials a lavish misuse of government funds considering the Gp-120 proteins used in the nearly two dozen prior vaccines have not prevented contracting the disease. In 1998 at the 12th World AIDS Conference in Geneva, Switzerland researchers learned that vaccines from a weakened variant of HIV actually may cause the disease. The current AIDS vaccines now being tested on humans is genetically engineered. For example, Aidsvax (VaxGen,) cannot replicate itself, and therefore cannot infect people with HIV. The idea behind an AIDS vaccine is to inject a virus into the body that will teach the immune system to create antibodies that can attack the virus in the future. Two main drug companies backing the joint government/private sector venture pulled out in late April, saying the trials showed too little progress to warrant any further support. Microgenesys of Connecticut, who makes the Gp-160 protein derived vaccine, is restructuring its portfolio in hopes of offsetting multi-million dollar losses. South San Francisco based Genentech has also redirected its GP-120 vaccine development with a spin-off company Genevax, whose sole purpose will be HIV vaccine development. Genentech's decision to rekindle the Gp-120 vaccines after members of the scientific community called the trials a "flop", is still viewed as controversial. A leading independent scientist, and Gp160 manufacturing expert, suggests that a massive campaign to vaccinate for a retrovirus is simply a bottomless pit of wasted energy and funding. "Making a soluble form of Gp160 is like rearranging the deck chairs on the Titanic", says Dr. Urnovitz. The Gp-120 vaccine line still headed for trials is called "prime-plus-boost". This experiment genetically engineers a virus to emit several HIV proteins that theoretically will prime the immune system to recognize and fight HIV. Beginning next year, some 500 American and French volunteers at high risk for HIV infection will get this shot (made by Pasteur-Meriuex). Then they will get Biocine's booster shot which contains Gp120. Mathieson pointed out, "It has already been proven that Gp-120 stimulates some immune response against HIV whether or not the specific trials are successful. There is a very good chance a successful approach will be found." The NIH clings to that hope despite the criticism. Susan Barnett, Ph.D., and colleagues at Chiron will produce a DNA vaccine candidate based on a common U.S. HIV subtype called clade B. They will also work on a vaccine based on a clade C virus, the most common HIV subtype in sub-Saharan Africa and India. Advanced BioScience Laboratories, Inc. under the direction of Phillip Markham, Ph.D., and researchers from the University of Mass. Medical School will develop and test a DNA vaccine containing genes for envelope proteins from HIV strains isolated around the world. An oral AIDS vaccine is expected to undergo human tests in Uganda in as little as 18 months, and could provide an inexpensive form of prevention in poor countries hit hard by the disease. The vaccine, which could cost $1 per dose or less, is being developed by the institute headed by Dr. Robert Gallo, one of the co-discoverers of AIDS. This August, an AIDS vaccine designed for Africa cleared for testing in humans from the International AIDS Vaccine Initiative The International AIDS Vaccine Initiative (IAVI) announced that the Medicines Control Agency (MCA) of the United Kingdom has approved Phase I testing of a DNA vaccine based on HIV subtype A, the most common strain in Kenya and in many other parts of Africa. In America, Agouron Pharmaceuticals has a trial whose purpose is to study if it is effective to add an HIV vaccine (Remune) to the anti-HIV drug combination of Combivir (zidovudine plus lamivudine) and nelfinavir for HIV-Positive people. One of NIAID s trial uses Remune on hiv + people, and a phase 1 trial seeks HIV-Negative volunteers to see if it is safe and effective to give the APL 400-003 HIV vaccine to HIV-negative people. There is a vaccine trial for infants, and one to see if giving two HIV Vaccines to Patients with early HIV infection will help. Only one vaccine has advanced to large-scale testing. Results of trials of that vaccine, produced by Vaxgen, should be available in late 2002 or early 2003. In May of 2000, VaxGen won in two separate European patent disputes, confirming its exclusive rights to vaccines containing key proteins for preventing AIDS. Following arguments in Munich, Germany, on May 9 and May 18, the Opposition Division of the European Patent Office upheld two patents originally filed by Genentech Inc. and now licensed exclusively to VaxGen for its use in making preventive HIV/AIDS vaccines. The patents have also been challenged by Chiron Corp., and cover specific forms of the envelope proteins known as gp120 and gp160. Early research and vaccine development, with gp120 and gp160 envelope proteins yielded many vaccine candidates, but all of them failed to prevent HIV infection. A breakthrough occurred when a team of Genentech scientists that included Dr. Phillip Berman, now with VaxGen, identified the specific molecular forms of gp120 and gp160 that were required for a protective vaccine. Berman went on to lead the team that developed the first vaccine capable of protecting chimpanzees against HIV infection and later developed AIDSVAX¨, which is currently undergoing phase III clinical trials to determine how well it prevents HIV infection. What are Clinical Trials? In some of these trials, the volunteer must be hiv negative and in some hiv positive. After an experimental vaccine has been tested in laboratory and animal studies to determine its safety and immunogenicity, it must successfully complete three stages of testing in people before it can be licensed. A Phase 1 trial is the first setting where an experimental HIV vaccine is given to people. Such a trial usually enrolls about 20 to 80 non-HIV-infected volunteers at apparent low risk of HIV infection. A Phase 1 trial may last one to two years. After a Phase 1 trial shows the experimental HIV vaccine is well-tolerated, it can advance into Phase 2 trials. These trials enroll more people, up to a few hundred, and often include some volunteers at higher risk for acquiring HIV. Phase 3 or efficacy trials, enroll large numbers of non-HIV-infected people at high risk for exposure to the virus. A Phase 3 trial usually is designed to ensure enough data is collected on safety and effectiveness to support a license application. Types of Experimental AIDS Vaccines:
Herbs, Supplements and HIV
Vitamins, supplements and herbs have long been used by people with HIV in hopes of helping manage side effects of other therapies and/or improve overall general health. In fact, studies suggest that upwards of 70% of people living with HIV and about 50% of the general population use some form of complementary therapy, with the most common being approaches such as massage and acupuncture. Unfortunately, not many approaches have been studied in people with HIV or been looked at to see how they might interact with commonly used medications, or whether they add to the overall benefits of therapy. Recently, a number of reports have questioned the safety of some complementary approaches in the setting of HIV and beyond. The intention of this article is not to discourage the use of complementary therapy, but rather to supply some food for thought when contemplating decisions about these remedies. The companies that promote herbs, supplements and vitamins advertise the potentialbenefits of the products but the consumer has very little information about the products themselves-their true value for treating specific conditions or even information about the actual content of the products they are buying. Promoters of supplements and herbs are often the first to criticize prescription drugs as the products of "big business," but supplements and herbs are themselves part of a huge industry with annual sales of around $20 billion. This article will highlight emerging concerns about the use of various complementary approaches and also address ways to minimize potential risks associated with the use of these therapies, where possible. A Little Background... Under current law, vitamins, supplements and herbs do not have to be evaluated by any regulatory agency (e.g. the Food and Drug Administration) prior to their sale. All they need do is assert that the product is "generally regarded as safe." What this means is that there is no requirement for studies to demonstrate the effectiveness and safety of these products-leaving the consumer with little or no meaningful information about benefits or side effects of therapy. Some manufacturers vaguely reference "studies" in their promotional literature, but these are seldom more than very small, uncontrolled studies. Also, these products do not have to be manufactured in accordance with the rigid guidelines established for the manufacturing of pharmaceutical products, called Good Manufacturing Practices. As a consequence, there is extremely wide variability between products in terms of their active ingredients, and even between batches of the same product from a single manufacturer. In fact, studies have shown that some of the products being sold on the market today contain no amount of the claimed active ingredients, whatsoever. Other products being sold as herbal supplements have been shown to contain dangerous chemicals (e.g. arsenic and lead, both potentially deadly). Still other products have been shown to actually contain pharmaceutical medications. The best manufacturers, however, make a serious effort to deliver the real product in the amounts claimed, but due to the lack of regulatory requirements, there is no simple way to determine who is telling the truth. People should be aware of these things and take measures to reduce their risk of buying contaminated products or products without active ingredients by seeking out reputable sellers of herbs, vitamins and supplements. Seek guidance from a trained alternative medicine practitioner (e.g. an herbalist or nutritionist who specializes in HIV) and gather information about the products you are considering using. Taking the word of people selling the product in stores is no guarantee of accuracy. On the actual package, or on their websites, some manufacturers of herbs and supplements will claim that their products have been tested for active ingredients. Do a little research and see what you can learn. For example, some consumer publications, such as Consumer Reports and other similar groups like consumerlab.com, periodically test supplements and list what is actually in various brands. Even this, however, doesn't tell you whether the product will benefit you. As a general rule of thumb, if a company has shown integrity in some of its products that have been tested by consumer groups, it is a reasonable sign that they maintain similar standards for other products in their line. According to researchers who are evaluating these therapies, the quality products that undergo evaluation by the manufacturer are in general not the ones that you'll find at your average grocery store or pharmacy. Drug Interactions St. John's Wort, a popular over-the-counter herbal supplement (also known as hypericin) used for mild depression, has been shown to have potentially serious interactions with protease inhibitors and non-nucleoside reverse transcriptase inhibitors (NNRTIs). See PI Perspective 29 for more details of this study. This doesn't mean that St. John's Wort doesn't "work" for helping people deal with depression, but rather it poses a serious drug interaction problem that could jeopardize the effectiveness of anti-HIV therapy. Part of what led researchers to look at St. John's Wort for potential interactions with anti-HIV therapy is that the herb is processed in the body by the same enzyme used for processing many drugs, including protease inhibitors and most NNRTIs. This enzyme is called the p450 enzyme. A number of dietary supplements and herbs have reported effects on the p450 enzyme. Depending on how they interact with p450, using anti-HIV therapies with these products could lower the blood levels of the anti-HIV therapies (possibly putting people at risk for developing resistance to their anti-HIV drugs). Or they could increase the blood levels of the anti-HIV therapies (putting people at greater risk for serious side effects). Herbs with reported effects on the p450 enzyme include: St. John's Wort; Garlic;Ginseng;Melatonin;Milk Thistle (silymarin);Geniposide ; and Skullcap. Dr. Piscitelli of the National Institutes of Health (NIH) is championing a series of interaction studies to provide people with HIV information to enhance the safe use of complementary therapies with anti-HIV medication. In a recent presentation, Piscitelli noted that the most common supplement used by people attending the NIH's HIV clinic is garlic. Piscitelli will evaluate this in future studies. A woman recently initiated a ritonavir (Norvir)-containing anti-HIV regimen and then began garlic supplementation. After starting the garlic, she developed severe nausea and vomiting which resolved after she stopped the garlic. It may be that garlic increased the levels of ritonavir, and thus its side effects. There has also been a second report where it appears garlic supplementation may have enhanced the side effects associated with ritonavir. Garlic may also increase the risk of side effects associated with other anti-HIV therapies. This information, coupled with knowledge that garlic has a reported effect on p450, suggests that until more is known people should use caution when combining high doses of garlic with anti-HIV therapies that use the p450 pathway (e.g. protease inhibitors and NNRTIs). Moreover, people using the supplement with anti-HIV drugs who experience serious stomach problems (diarrhea, nausea or vomiting) might consider discontinuing it to see if these symptoms lessen. According to a recent article in the medical journal, The Lancet, there are a number of reported herb-drug interactions that include the following herbs: Betel Nut; Devil's claw; Garlic; Ginseng; Kava; Psyllium ; Saiboku-to; Sho-saiko-to; Valerian; Chili Pepper; Dong quai; Ginkgo ; Guar gum; Papaya; St. John's Wort; Shankhapushpi; Xiao chai hu tang; and Yohimbine To lessen the likelihood of herb-drug interactions, Dr. Piscitelli encourages people to have more in-depth discussions about the use of complementary therapy with their doctors and pharmacists. This may take some getting used to for both patients and doctors. Doctors may need to learn to listen and support their patients, in a non judgmental way, about the use of complementary therapy. Undoubtedly it may well be patients who drive this learning curve. Patients need to be open and honest about what they are using and considering. The only way to capture information about drug interactions and side effects is if they are recorded in a complete drug history, including herbs, vitamins and supplements that you are using. It's also important for patients, doctors and pharmacists to keep up on the latest information about drug-herb interaction studies. What About Side Effects? The biggest myth about complementary therapies is that they are non-toxic. There is a widely held misconception that because something is natural, or sold over-the-counter, that it doesn't have side effects. To the contrary, there have been numerous reported cases of people with HIV experiencing side effects from complementary therapy. Chinese herb preparations that contain deer antler, for example, can cause nausea, diarrhea and other kinds of stomach upset. One man stopped all his anti-HIV medication in an attempt to determine which of his medicines was upsetting his stomach and quality of life. It turned out that when he stopped his Chinese herbal preparation (that contained deer antler), his problems cleared-it wasn't the anti-HIV therapies causing the problems at all. High doses of vitamin C can cause severe diarrhea. Taking too many B vitamins can lead to a complication that lands one in the hospital and excessive levels of vitamin A can be highly toxic to the liver. Side effects associated with herbs, vitamins and supplements might not reveal themselves immediately. It may take a number of weeks after starting a therapy for side effects to emerge as a problem. Keeping an accurate record of every therapy you are taking, including when you start and stop therapies and documenting the onset of side effects may help to sort out which therapy is causing the problem. The following is a list of herbs with known serious side effects:
Below is a list of vitamins with known side effects
Unlike pharmaceutical products, large studies are not required to document side effects associated with complementary therapy and potential side effects are typically not noted on the package materials. The key to minimizing the risk of potential side effects with these therapies is to learn about them, monitor for early signs and implement measures to minimize the risk. Buyer Beware! Recently, a number of Chinese herb supplements to manage diabetes have been pulled from the shelves by the California Food and Drug Board (FDB), a state equivalent to the Food and Drug Administration (FDA). The action followed an incident where a person with diabetes was hospitalized after taking one of the supplements. The supplements were tested and found to contain pharmaceutical medication used to treat diabetes. The additional medication in the claimed "natural" product lead to an overdose of medication for the individual. There are numerous herbal remedies that contain controlled and potentially dangerous substances that are banned by the FDA. The FDA readily admits that it simply doesn't have the enforcement potential to ensure that these products stay off the shelves of some stores. Media exposés on this topic in California reveal countless tales of people harmed by such products that contain lead, arsenic, anabolic steroids and other controlled and potentially dangerous substances. To protect yourself, seek reputable sellers, investigate the product and seek guidance from trained professionals. Conclusion Herbal remedies and other vitamins are sold as "food supplements" and do not undergo the rigorous testing that other medications do. They are not regulated and may not reveal on the label all of the product's contents, nor do they necessarily contain the ingredient listed or the amount of it claimed. Don't assume that simply because something is available over-the-counter or is natural that it doesn't have side effects or won't interact negatively with other medications that you are taking. In the United States alone, it's estimated that $20 billion dollars were spent on complementary therapies last year. The use of complementary therapies has risen almost 400% in the past eight years and it's estimated that 50% of people in the US use complementary therapies. The sale of complementary products is an ever growing industry and at the current time that industry has done very little to document the safe and effective use of its products. It's unlikely that it ever will. The U.S Government, through the NIH, has established two botanical centers to evaluate complementary and alternative therapies with a budget of $68 million dollars. A third center will be funded shortly. Every few years, new discussions are held about whether and how to better regulate the marketing of nutritional supplements and herbs. There is a great difficulty in evaluating herbs and herb-drug interactions because often times the active ingredient of the products and its dose are not known. Moreover, drug interaction studies for pharmaceutical products typically take a matter of a week to ten days. Drug-herb interaction studies are expected to take much longer, and as a consequence be more expensive, as it's likely that people will have to be taking herbs for a matter of weeks before an effect is seen. Even when the interactions are determined for one particular product, it is unclear how they will relate to other similar products because of the lack of control over dosing. Because no studies have determined the appropriate or best dose of many complementary therapies, researchers face an additional challenge in first selecting the dose of herbs to use in studies. Necessary funding for the studies will remain a problem and limitation to moving forward rapidly. Many companies selling herbal and other complementary approaches are reluctant to fund studies that may reveal that their products are not useful, have side effects or have interactions with commonly used medications. This information could hurt their "bottom line" of profit. Pharmaceutical companies are also unwilling to fund these studies for many of the same reasons, and the FDA does not require them. Whatever the possible benefits of herbs, vitamins and supplements, there simply is no information to guide decision-making with regard to using these remedies. Be aware that using them entails some element of risk. HIV NEW RESEARCH LEADS TO FIRST GUIDELINES ON TREATING HIV/HCV The Hepatitis Resource Network (HRN), a non-profit alliance for research, treatment and prevention of viral hepatitis, with more than 84 member institutions, held a symposium on Thursday, September 7 titled "Issues and Controversies in Hepatitis C and HIV/HCV Co-infection." During a presentation at Infectious Disease Society of America meeting in New Olrleans, September 8, HRN President Douglas Dieterich, MD, Chief of Gastroenterology and Hepatology at Cabrini Medical Center, presented the results of a new clinical study that found hepatitis C treatment to be just as effective in patients with HIV as in those without it. Strategies for the Management of HIV/HCV Coinfection Monograph, released July 12, 2000, makes the following recommendations for treatment of co-infection:
If you are co-infected, and have not received a copy of Double Jeopardy, call TSWN for a free copy. RESOURCE GUIDE AND OTHER MATERIALS FOR PERSONS WITH HCV TSN has developed a variety of materials for persons living with HCV. To obtain copies of any of the following, please call 888/338-TSWN:
ONCE DAILY HIV DRUG SEEN SAFE, WELL TOLERATED Bristol-Myers Squibb's investigational compound BMS 232632, a once-daily HIV medicine, appears to be safe and easily tolerated by patients involved in an ongoing Phase II clinical trial. The protease inhibitor, potentially the first once-daily drug in that class, did not affect patients' cholesterol or triglyceride levels, a common problem among existing protease inhibitors. After 24 weeks of the trial, University of Witswatersrand Clinical HIV Research Unit head Ian Sanne said that the compound seems to be effective while remaining safe and tolerable. Presented at the annual Interscience Conference on Anti- microbial Agents and Chemotherapy (ICAAC) in Toronto, the study results showed that the 98 HIV-positive patients given BMS 232632 in combination with didanosine and stavudine had results similar to another protease inhibitor, nelfinavir. INTERRUPTING HIV THERAPY LESS RISKY THAN FEARED In a small study of HIV-infected patients, Alabama researchers found that most patients who stopped taking HIV-fighting drugs--sometimes for up to 2 months--still could achieve low levels of the virus in their blood when they restarted their medication. At the same time, most patients also were able to return to their previous level of CD4 positive cells, the infection-fighting helper T cells that are attacked by HIV. However, a study in the Annals of Internal Medicine, notes that HIV patients who halt their medication temporarily may experience fever, chills, aches and diarrhea--a syndrome similar to that seen in patients shortly after they contract the virus. HIV-infected patients may suffer from a variety of complications due to their antiviral medications, and many are forced to quit taking the drugs until the side effects subside. Many researchers are trying to determine if halting drugs temporarily is safe. The Alabama study suggests that at least some--but not all patients--will be able to resume their treatment successfully. ``The good news is that there doesn't seem to be a great amount of harm with the treatment interruption. The bad news is that we cannot say what to look for to predict which patients would not be able to show immune system rebound,'' Saag said. They found that the immune systems of 59% of the patients were able to rebound to levels seen prior to stopping treatment. These patients achieved 90% of what their previous T cell levels had been. ``However, there were eight patients who were not able to achieve even 50 of the levels of T cells that they once had and these patients are of concern,'' Saag commented. ``We later tried to predict what factors would cause a person who went off treatment and back on again not to rebound,'' Saag told said. ``Despite looking at a number of different variables, we could find nothing of significance. The length of time off did not play a role, nor did the length of time that the patient was followed after restarting therapy.
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© 2001-2002 Twin States Network, all rights reserved.
Last Modified:
February 5, 2002.