What's
New?
October
1999
Excerpts From Hotline
Memos of September 1999
From the Information Department of Project
Inform
view PDF
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What's
New? Excerpts From Hotline
Memos of September 1999 view PDF |
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What's New in Treatment Information? Nationwide Medicaid Coverage for Human growth hormone was approved by the Food and Drug Administration (FDA) in 1996 for the treatment of AIDS wasting syndrome (cachexia), which is associated with increased rates of illness and death. In a recent ruling, the Health Care Financing Administration (HCFA), which administers Medicaid (known as MediCal in California), relied on this technical point of FDA labeling. Seen this way, the drug cannot be dismissed as solely a weight-gain drug used for cosmetic reasons. "AIDS wasting syndrome" is a destructive metabolic process in which the body feeds on its own tissues, muscles and organs to meet energy demands. This results in weight loss of at least 10% of a person's `normal' body weight. Wasting is a major contributing factor to disease progression and death among people with AIDS. Over time, a person loses weight and strength and becomes more susceptible to life-threatening infections. A number of approaches, including growth hormone therapy, might help reverse this process in some people. It is unclear whether the logic of the new HCFA ruling will extend to Medicaid reimbursement for medications used "off label" against AIDS wasting syndrome, such as anabolic steroids. Other drugs currently FDA-approved for the management of HIV-associated wasting syndrome include megestrol (Megace) and dronabinol (Marinol). Unwanted weight loss in HIV disease may have many causes. It is important to appropriately identify the cause or causes and treat them appropriately. Treating the symptom of weight loss with drugs like human growth hormone—which has been shown to increase weight—without identifying the cause of the weight loss can do more harm than good. Perhaps the best way to treat unwanted weight loss is to prevent it. Pay careful attention to diet and monitor weight on a regular basis to detect early signs of unwanted weight loss. Intervening with drug therapies, such as human growth hormone and the other drugs mentioned here, is probably not the best first line of attack against wasting. Developing a comprehensive nutritional and weight maintenance strategy, which includes preventing weight loss and intervening with less aggressive measures first, is a wise plan of attack. If weight loss should occur, pursue aggressive diagnosis and treat the cause appropriately. For example, if weight loss is caused by parasites, anti-parasitic medication is a key toward truly eliminating the problem. If weight loss is a consequence of the affects of an HIV-related cancer, treating weight loss with anabolic steroids or human growth hormone could stimulate cancer growth. If weight loss is associated with a lack of appetite, using an appetite stimulant (such as dronabonil) may be sufficient in dealing with the problem. For more information on developing a weight maintenance plan, call Project Inform's National HIV/AIDS Treatment Hotline. This change in federal policy was largely due to pressure from AIDS patients, activists and political leaders—further proof that the "right" result is often dependent on cooperative vigilance and hard work. Kudos to the National Association of People with AIDS for leading the charge. Answers to Questions from the Project Inform
Hotline I've heard that there is some kind of interaction between drinking grapefruit juice and taking efavirenz (Sustiva). Is it okay to drink grapefruit juice while you take this drug? It is reasonable to expect some interaction between efavirenz (Sustiva) and grapefruit juice if they are both taken at the same time. However, the risk of interactions is greatly diminished if efavirenz is taken two hours before or two hours after drinking grapefruit juice. There have been a number of reports that d4T (Stavudine, Zerit) causes facial wasting. Is this true? At the Lipodystrophy workshop held in San Diego in June, a few association studies found that d4T (stavudine, Zerit) was an independent risk factor for lipodystrophy. However, these studies are not always the most reliable in providing accurate information. Additionally, almost all of the studies were retrospective (in other words, people went back and analyzed their databases), and they have a high probability of merely finding the next potential culprit and not necessarily the cause. Leading researchers in this field believe that, based on the biology of these drugs, there is little reason not to think that the entire class of nucleoside analogue drugs will have the same effects. Another variable to consider in these studies is that a lot of the people had previously been on AZT (zidovudine, Retrovir) either as a monotherapy or as part of a two-drug combination and had switched to d4T as part of a new regimen. Another study reported at the workshop suggested that people on 3TC were more likely to develop lipodystrophy. Only head to head comparative studies with drugs that have similar effects in lowering HIV levels will give us a good understanding of the contribution of each drug (or HIV itself) to lipodystrophy. These studies have now started and some preliminary information may be available in the near future. Any data on side effects of combination regimens being different than for individual drugs? There are no data describing side effects associated with a combination therapy that has not been seen with individual drugs, with perhaps the exception of lipodystrophy which may become a greater concern among people using combinations. When two drugs are combined, however, there may be drug interactions which might increase the likelihood of drug side effects or decrease the effectiveness of individual drugs in a regimen. When three drugs are combined, there may be multiple drug interactions confounding the picture that are unexpected. Information about drug interaction in multiple combinations regimens is only just becoming available. What is known was published in the Project Inform Community ALERT, August 1999, which was mailed to the entire Project Inform mailing list and is available through the Project Inform hotline. Any update on IL-2 + hydroxyurea studies on terminating anti-HIV medication? No. There have been no studies which have involved IL-2 and hydroxyurea that have involved a structured therapy interruption. It is unlikely that such studies will be conducted in the near future. One recently reported study, conducted by the National Institutes of Health, included people who had been on successful anti-HIV therapy for a prolonged period who then stopped therapy. Some of these people had also been on extensive prior IL-2 therapy. In all people, after stopping therapy, there was a reemergence of detectable viral levels. Studies are only just beginning to assess the safety of using IL-2 and hydroxyurea in combination with one another. These studies will not evaluate structured therapy interruptions. Are ingrown toe nails a side effect of indinavir (Crixivan)? Ingrown toe nails have been reported with other drugs as well as indinavir (Crixivan). It is one of the side effects which some researchers believe is associated with lipodystrophy syndrome. At the Lipodystrophy workshop in June in San Diego, ingrown toe nails was identified as something that has been observed with all the protease inhibitors and something that will be monitored in future lipodystrophy studies. New federal treatment guidelines: Table X says of lipid lowering
agents simvastatin and lovastatin "avoid concomitant use" with IDV, RTV,
SQV, NFV, and DLV due to "potential for large increase in statin levels,"
then suggests four other statin drugs as alternatives, but also says they
"should be used with caution." Any more information on this? After
consultations with a number of pharmacologists they have categorized the
statin drugs into the following categories:
However, it is important to bear in mind that these drugs also have different levels of potency in lowering lipid levels. Any information on dark or white patches on skin from anti-HIV meds among African Americans/Latinos? To date there have not been reports, that we know of, demonstrating that African Americans or Latinos experience skin conditions associated with the use of anti-HIV therapy that are unique, based on race or ethnicity. Rash, dry skin and other skin conditions are common side effects of many anti-HIV therapies, particularly therapies in the Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) class of drug. The way a rash is experienced, alterations in skin coloration, etc., does vary between people of different races. As an example, typically when a white person has a skin reaction that leaves scarring, often the scarred area is lighter than the skin around it. When a black person has scarring, often the scarred area is darker than the skin around it. Rashes associated with anti-HIV therapies can change skin tones, including darkening or lightening of the area affected by the rash. Typically these changes in skin tone go away when the rash resolves. When skin becomes dry, either because of a drug side effect or because of the effects of HIV and/or immune suppression on the skin, skin tone often changes. Is there updated information for experimental combination dosing? Yes, there is updated information. It was published in the recent Project Inform ALERT, August 1999, which is available through the Project Inform hotline. Currently Project Inform has a Drug Side Effect Chart, which includes added narrative materials about lipodystrophy. Lipodystrophy is not noted on the chart as one of the drug side effects so there isn't a way to tell which drugs might cause lipodystrophy. Can the Side Effect Chart be updated to include lipodystrophy? No. The Drug Side Effect Chart does include a listing of drugs which are known to increase cholesterol and tryglycerides levels, laboratory markers which have sometimes been associated with body composition changes that are being called lipodystrophy. No individual drug, however, has been shown to uniquely cause these body composition changes, so for the current time we cannot attribute lipodystrophy to any individual drug. At the recent Lipodystrophy Workshop in San Diego (reviewed in the PI Perspective #28), researchers showed that body composition changes have been seen with virtually every combination of anti-HIV therapies, including combinations which only included two of the older class of drugs (e.g. AZT, 3TC, ddI, d4T). Body composition changes have also been noted among people with HIV who have not taken any anti-HIV therapies. Until more is known about this syndrome and its causes, it would be irresponsible of Project Inform to put out information uniquely attributing lipodystrophy to individual drugs. Where there may be emerging associations between lipodystrophy and an individual drug, this is discussed in the narrative of the materials about lipodystrophy which have been added to the Side Effect Chart. Can Project Inform's Drug Side Effect Chart be updated to include side effects of the new anti-HIV therapy amprenavir (Agenerase)? Yes. The Drug Side Effect Chart is now updated and includes information about amprenavir's side effects. The new Drug Side Effect Chart is available through the Project Inform hotline and through the PI Website. Can Project Inform develop a resource sheet directed toward prisoners living with HIV who call the Project Inform hotline? This will take awhile. Previously we put together materials, with special emphasis on resources for prisoners, as a packet to be mailed to people living with HIV calling from prison. Upon initial review, we received good feedback that the materials that were selected would benefit prisoners living with HIV. Subsequent review by groups who work extensively with the prison system and prisoners living with HIV was not as positive. Project Inform staff, lead by Program Services Director, David Evans, is working to develop materials, in conjunction with agencies and individuals who serve the prison population. This will take some time, but hopefully we'll get it right and develop a useful and relevant resource packet. Is there anything new on the new class of anti-HIV drugs called fusion inhibitors, pentafuside (T-20) or T-1249? Anything new on the new protease inhibitor tripanavir? There is a little new information and it's covered in PI Perspective #28. PI Perspective is mailed to people, free of charge. To get on the mailing list, all someone need do is call the Project Inform hotline. Once PI Perspective is finalized (in a few weeks), we'll also update the New Antivirals Quick Sheet to include the new information of these fusion inhibitors, protease inhibitors and other new anti-HIV drugs on the horizon. This will be available through the Project Inform hotline and the website. Any information on nerve growth factor or gabapentin (Neurontin) for treating peripheral neuropathy? Peripheral neuropathy is nerve damage resulting in pain, tingling or numbness in the feet, legs and/or hands, that ranges in severity from mild and bothersome to quite severe and debilitating. Peripheral neuropathy can be caused by HIV itself. It can also be a side effect of commonly used anti-HIV therapies (particularly ddI [Videx], ddC [Hivid], d4T [stavudine] and 3TC [Epivir or in combination with AZT as Combivir]). Nerve growth factor (NGF) has been studied for the treatment of peripheral neuropathy associated with diabetes, as well as in people with HIV-associated peripheral neuropathy. In a very large study in people with diabetes-associated peripheral neuropathy, NGF did not appear to have any affect on reducing pain associated with neuropathy. In a small study of NGF in people with HIV-associated peripheral neuropathy, while overall no measurable differences were observed between those who received NGF and those who did not, it did appear as though people with the most severe neuropathy upon study entry experienced some benefit from NGF. While Genentech, the company that is developing NGF, has halted all studies based on these overall unimpressive study results, a small continuation program is ongoing to supply the drug to volunteers in the HIV study. Genentech is now reevaluating their development strategies and considering whether or not to continue investing resources in the further development of NGF. Some HIV researchers who specialize in peripheral neuropathy feel that it is critical that study continue, particularly among people with the most severe forms of neuropathy. Gabapentin (Neurontin) is an FDA approved anti-seizure medication. In addition to having anti-seizure and mood stabilizing effects, some people have noted success with this drug in treating peripheral neuropathy. The drug is sometimes a drug of choice in preventing seizures in people with HIV because it does not interfere with commonly used anti-HIV medications. Dilantin, another anti-seizure medication, can alter blood levels of many anti-HIV therapies, which may necessitate dose adjustments in medications.
Partners In Hope Partners In Hope is the leading circle of donors for Project Inform. Your support can go even further this year with the help of the B. W. Bastian Foundation matching grant in memory of Dr. Robert Perkins, a good friend of Project Inform who recently died. For any increase in renewal of last year's contribution or a new Partners In Hope donation, the B. W. Bastian Foundation will match each dollar with two dollars. Support from Partners In Hope members is critical in providing of up-to-date treatment information to individuals living with HIV/AIDS. With an annual contribution of $500 or more, you receive special recognition and a variety of benefits, such as special publications, invitations to events and seminars and public acknowledgement for donor support. To get involved in this distinguished circle, please contact Brian Byrdsong at 415-558-8669 x229. Workplace Campaign Evening of Hope Annual Dinner - The featured guests this year include Gene Shearer, PhD, an internationally known AIDS researcher at the Experimental Immunology Branch of the National Cancer Institute. Dr. Shearer has made numerous contributions in cell and immune research during his 27 years at the National Cancer Institute. The second featured guest will be Assemblywoman Carole Migden, Chairwoman of the State of California Assembly Committee on Appropriations. Ms. Migden has made many outstanding contributions over the years, including her recent leadership role in securing a multi-million dollar increase for HIV programs in this year's state budget. We will also be honoring Ben Cheng, Assistant Director for Information & Advocacy at Project Inform, for his long-time outstanding contributions to HIV research and treatment activism. Project Inform's Founding Director, Martin Delaney, will speak on new trends in HIV/ AIDS treatments. For the first time, a commemorative Tribute Journal will be published for San Francisco Evening of Hope and the Los Angeles Awards dinner. Corporations will be able to purchase advertising space in which to publish thank yous or acknowledgements to these events and their guest speakers. For information about ad spaces, or to receive an invitation to Evening of Hope, please contact Julie Doherty at 415-558-8669 x223. Corporate Sponsorship Project Inform's Holiday Card Project It's not too early to start planning for the holidays! Now you can take the hassle out of sending holiday cards to clients, customers and friends—and feel good doing it—by participating in Project Inform's Holiday Card Program. Here's how you can get involved: Buy Project Inform Holiday Cards Use the Project Inform Holiday Card Service Ask your company to participate For more information regarding this special program and others, please contact Julie Doherty at 415-558-8669 ext.223.
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