Distributed by AEGIS, your online gateway to a world of people, information, and resources. 714.248.2836 * 8N1/Full Duplex * v.34+ *************************************************************************** AIDS Treatment News Issue #227, July 21, 1995 phone 800/TREAT-1-2, or 415/255-0588 CONTENTS: Merck Protease Inhibitor Available to Persons with CD4 Count 50 or Less -- Must Register by August 11 Combination Treatment and Single Drugs: Interview with Margaret Poscher, M.D. (Part II of II) Exon Amendment: Threat to AIDS Prevention and Activism? NAPWA Opens Pharmacy AIDS Research "Spin-off" -- Ganciclovir for Preventing CMV After Liver Transplantation Cryptosporidium in Water: CDC Guidelines on How to Protect Yourself ***** Merck Protease Inhibitor Available to Persons with CD4 Count 50 or Less -- Must Register by August 11 Merck & Co. has announced an open-label (expanded-access) program to make its experimental protease inhibitor available to persons with a CD4 (T-helper) count of 50 or below. This drug, now called Crixivan (TM) (generic name, indinavir sulfate; previous names were MK-639 and L-735,524) has been one of the most sought-after experimental treatments, but it has not been widely available because of manufacturing difficulties. The new program will supply the drug to 1,100 people in the U.S., and 650 others in 23 countries; if more people register, they will be chosen by random selection. U.S. participants must register by August 11 by calling 800/497-8383 to be included in the selection; those who register later will be placed on the end of a waiting list and have the lowest priority. [Note: An additional 300 U.S. slots, and 100 abroad, will be available for patients who tried to enroll in Merck's "Protocol 39" clinical trial, but failed to qualify for it.] [Note: Outside the U.S., the deadline dates for the open-label program differ; for more information, contact the local MSD (Merck Sharp & Dohme) subsidiary.] To be eligible for this program, you must have a CD4 count less than 50, on two measurements taken at least a week apart. You must be at least 18 years old. You cannot have acute hepatitis; if you have an infection or AIDS-related condition, it must be treated if appropriate before you can enter this program. You cannot be pregnant or breastfeeding, and you must have an address where you can be reached. There are some other entry criteria, based on laboratory tests; these required tests will be paid for by Merck. You are allowed to combine the Crixivan with most other drugs, including the antiretrovirals AZT, ddI, ddC, d4T, and 3TC -- but not with any other protease inhibitor. And if you do not have a doctor, you can still register -- but tell the registration center, so that they can help you find one. The first step to enter this program is to call and register by August 11. You do not need to see your doctor first, as there will be time later to talk with your doctor, decide if you want to be in the program, and take additional tests required to qualify. If you cannot call yourself, your doctor or a third party can call for you, with your permission. After you register, you (or the caller, if someone else called) will be mailed a simple one-page patient qualification form, which must be filled out by you and your doctor, and faxed or postmarked by September 8. Your physician must certify that you have a CD4 count under 50 on two separate tests at least a week apart, so be sure to leave time to get results back if you need to have another test. You may be able to schedule the doctors' appointment for a date after you have learned the result of the selection. (If you do get put on the waiting list, keep in mind that a low number probably means you have a reasonable chance to get into the program. There are likely to be quite a few dropouts, especially since it is so easy to register by phone; many people will register to hold the option open, waiting until later to make sure that they qualify, and that they want the drug.) Patients in the open-label study will be treated by their own doctors; these physicians must have experience in treating HIV to qualify for this program, and must complete an investigator qualification form. Merck has set up a central IRB (institutional review board) for this program, although local rules may require some physicians to use their local IRB instead. To start the process, register by calling 800/497-8383 between 8 a.m. and 11 p.m. Eastern time, seven days a week, no later than August 11. You will be asked for your name, phone number, and address, and will be given a patient registration number, and receive further information by mail. ***** Combination Treatment and Single Drugs: Interview with Margaret Poscher, M.D. (Part II of II) In Part I of this interview, in AIDS TREATMENT NEWS #226, Dr. Poscher discussed treatment strategies, including her use of combination antiretrovirals, and the role of acyclovir, ganciclovir, and some other treatments. That interview is continued, below. AZT Plus 3TC Possible Side Effects ATN: I heard about one case -- and then I heard this morning that six cases were known -- of someone's viral load going down on treatment with AZT plus 3TC, but their total lymphocyte counts also going down, sometimes as much as 50 percent, although then they tend to rise again over the next several months. Often the CD4 and CD8 counts stay about the same, or decline only slightly. This is mostly in people who start with a very low CD4 count. Dr. Poscher: I haven't noticed that, so I cannot comment on it. We have quite a few patients on that combination. The complication we have seen with AZT plus 3TC -- and others have often not seen, so we tell them to watch out for it -- is anemia, and it comes on very quickly. All of these patients have had very low CD4 counts, way less than 50; and they have been on the anemic side anyway, with 11 or so hemoglobin. But then they will drop down to six or seven hemoglobin in less than a month. ATN: Do you have to discontinue the drugs? Poscher: You have to stop. I have not been able to maintain anybody with anemia on AZT plus 3TC, even with Procrit (erythropoietin) and transfusions. I'm switching these people to d4T plus 3TC, and they are doing fine. Sudden CD4 Drop ATN: We often get calls from someone who has never been on treatment, but they have had a big, sudden drop in CD4, going down as much as half or so in a few months. What treatments do you consider for people in that situation? Dr. Poscher: It would be interesting to know what their viral load was. If they have never been on any antiretroviral, and they have been HIV-infected for a long time, then if their viral load was very high, around 500,000 or a million, I would use the triple combination AZT plus 3TC plus ddI, if at all possible. If they had only a moderate viral load, I would use AZT plus 3TC. If their CD4 count is not below 100, unfortunately, they will have trouble getting 3TC, until it's approved (because the expanded-access program is now limited to those under 100, due to limited supply of the drug). Glaxo could have facilitated expanded access for sicker patients, without cutting it off completely for those over 100. But hopefully the drug will be approved this summer, and we will not have to deal with this problem any more. Approval; Reimbursement; Expanded Access ATN: I heard that Glaxo Wellcome will ask the FDA to approve 3TC for initial therapy in combination with AZT, for people with CD4 counts all the way from zero to 500. [Since the interview was conducted, the company has applied for this indication.] Dr. Poscher: I also heard that they might manufacture a single capsule with both drugs together. I think this combination will be the initial treatment. Then if the patient breaks through on AZT plus 3TC, the standard will probably be to add a protease to it. ATN: For getting combination treatments paid for, what has worked and what hasn't, in your experience? Dr. Poscher: We have not had a problem. I have not yet had a patient whose insurance company refused to pay for combination therapy. And we deal with all kinds of insurance companies here -- about every HMO, and Medicare, and Medi-Cal (Medicaid). There are a few HMOs who strictly regulate combination antivirals. But usually with a letter from the physician, documenting medical necessity, that can be overcome. 3TC is a problem. I see patients as a consultant, whose personal physicians are not part of the expanded access program, who do not want to deal with that. It is true of all these parallel-track programs. The one for growth hormone is a pain. The oral ganciclovir prophylaxis program is a big inconvenience for physicians offices. So a number of patients have trouble accessing these drugs, because the physicians they are going to are not willing to provide the staff to get these drugs for their patients. And it's hard to blame them; I have a full-time nurse who deals with growth hormone, 3TC, etc. It is a full-time job, and not every office has the volume of patients to support that. Managed Care ATN: Concerning managed care, how do you get around the problem that many managed-care systems only want to deal with large practices, and are not interested in providing good care for AIDS, cancer, and other expensive diseases, because they do not want to attract those patients. Dr. Poscher: Managed care is going to be a big problem for people with HIV. It's only just beginning; we are only seeing the tip of the iceberg. I see it now in my role at the University of California; I am the director of HIV managed care at Mt. Zion hospital. The University could lose a lot of money if it provides certain laboratory tests for patients; the same is true of any other managed medical group. They are being given a certain amount of money to take care of people with HIV; and if it costs more to take care of those patients, they lose money. So the outcome, eventually, is that they will make it cost less. This means, for example, that viral RNA studies will not get done for people with managed-care insurance. If a medical group can save a million dollars a year and turn that into profit, they would rather do that. I see that happening -- and I also see patients choosing managed care insurance, when their employer offers them a choice of health coverage. They see $5 co-pay, free prescriptions, etc.; it looks appealing that they will not have to pay 20 percent, they will not have a deductible. It looks terrific. But the problem is that when they get sick, they will not be able to get the care they need. I have patients now for whom I want to get a viral load test. But because of their insurance, they cannot get that test, unless they are willing to pay $200 out of pocket, which is abhorrent. That is one example of things to come. If growth hormone is approved, the companies will not want to pay for it. TPN (total parenteral nutrition) will become too expensive; if a patient has cryptosporidium and needs to have TPN as a lifeline, it will be not indicated because the patient is terminally ill. It will be like Oregon, where care will be rationed; but there will be no policy coming from a higher power dictating the rationing. It will come from financial decision-making within medical groups. ATN: How have you been able to get combination treatments paid for so far? Dr. Poscher: So far the HMOs have been willing to pay. The money used to pay for hospital care, or doctors' visits, or home infusion therapies, is one pool; the money for prescription drugs is another pool. The people minding that pool are mainly looking for certain expensive drugs like itraconazole, or fluconazole, or erythropoietin, or Neupogen. There are certain trigger drugs that are carefully controlled; you have to jump through hoops of fire to get your patients on them. How do you do it? You sit on the phone for an hour, you call the utilization review person, then you have to write a letter, and send copies of lab work. Then several days later, your patient has erythropoietin. You're persistent, that's how you do it. Sometimes I have to call the medical director of the insurance company, and talk doctor to doctor, and explain the situation, that this is what the patient needs. It takes a lot of time. People don't realize this when they check off the HMO (health maintenance organization), instead of a PPO (preferred provider organization). There is a big difference between those two in what you will be able to get. ATN: What about G-CSF (Neupogen) for treating neutropenia in HIV disease, as opposed to other neutropenia. Is it a problem getting that paid for? Dr. Poscher: It used to be a big problem. It's getting much easier now, as it becomes more accepted. Several years ago, if somebody became neutropenic from ganciclovir, you had to switch them to foscarnet. Now it is totally accepted to use G-CSF. Even though it is not FDA-approved for that indication, because everybody uses it that way, the insurance company pays for it. But they are very strict about it. If the patient's neutrophil count goes above 1,000 once, they will cut off the G-CSF; you have to hold it, get their count back below 500, and then send a copy of the lab slip, and they will authorize it again. It's a pain; and it increases the administrative load, and administrative cost. We have a full-time person just doing authorizations. Today I had a patient who was lost to followup for six months. Meantime, his insurance changed; there are now only five doctors in the city he can see. He asked me which doctor he should choose; he read me the names, and I told him I didn't know. He told me he cannot breathe, he is coughing, he has a fever; he thought he needed to see a doctor. I told him he certainly did. He had had no pneumocystis prophylaxis, though his last CD4 count, in January, was 200; no one put him on prophylaxis. Fortunately his insurance did have the option to see any physician, with payment of a substantial fee. We did his X-ray and blood work; he probably has pneumocystis. I was ready to start treating him here, but his insurance company said no, he had to go to an in-plan provider. But nobody on that list was set up for outpatient treatment of pneumocystis. So we had to admit him to the hospital; he could easily have been treated as an outpatient [at far less expense]. But the doctors who are part of that plan don't do that; they see maybe two HIV patients a year. If people could just go where they wanted to go, patients would generally get to the right people. They usually can choose the right provider. And when they are restricted, it can cost the system a lot more money, if they are not getting the right attention to their needs. ATN: One expert recently was quoted as saying that managed care saves money because it doesn't pay for medical education. And it doesn't pay for research, or help with the care of the indigent. Dr. Poscher: Exactly. Use of Combinations ATN: For this article, I asked around for people to recommend doctors who have much experience with triple combination therapies. And the same few names keep coming up. So it seems that not many physicians are using the aggressive combination treatments. Dr. Poscher: I would agree. Because of my role at Mt. Zion, I watch the care of many patients. The average internist who is taking care of people with HIV is not doing any combination therapy. They are barely doing what I consider to be minimal standard therapy. Many patients are not on antiretrovirals; and those who are, are either on AZT monotherapy, or on ddC monotherapy. There is lots of ddC monotherapy, which I think is useless. It is because many physicians do not want to get involved in the 3TC expanded-access program, because of the paperwork. And when general internists have only ten or twenty AIDS patients, it is hard for them to keep up with what is going on in the world of AIDS. They fall behind, even though they may be excellent physicians, and their patients suffer because of it, they are not getting state of the art care. ATN: You mentioned triple combination treatments. One person's CD4 count went from 70 to about 500, with AZT plus 3TC plus ddC; he was also taking acyclovir. Dr. Poscher: Was he treatment naive? ATN: Yes. Dr. Poscher: You can see that with naive patients. I know a patient who had a similar experience with AZT plus 3TC plus ddI. He went down to the mid hundreds, and went on triple therapy, full dose with all three from day one. His T-cell count went way up, and he is doing great. ATN: Do you have patients on triple combination therapy who were not naive, who had been on AZT already? Dr. Poscher: I have a couple such patients. The rise in CD4 is not fantastic, it is OK. One patient had dipped to 175, and got back up to 325 for about a month, and is hovering around 250 now. But his viral load dropped, almost a log. ATN: Do you have any final comments? Dr. Poscher: More drugs and different classes of drugs (especially protease inhibitors) are close to becoming available. These will increase treatment options, improving combination therapy and hopefully increasing survival. ***** Exon Amendment: Threat to AIDS Prevention and Activism? by Bruce Mirken The controversial "Communications Decency Act of 1995," frequently referred to as the "Exon amendment," after its author, Sen. James Exon of Nebraska, may interfere with both AIDS prevention efforts and the work of AIDS activists if it becomes law. The measure, an amendment to the Telecommunications Competition and Deregulation Act of 1995, passed the Senate overwhelmingly and may be considered shortly by the House of Representatives. The measure has gotten little attention from AIDS lobbyists, who have been busy fighting Republican sponsored attacks on a variety of AIDS programs, but contains a number of provisions which may prove problematic to people working on AIDS issues. And contrary to some press accounts, it affects not just the Internet but communications using any "telecommunications device," including phones and fax machines. Among other things, the amendment makes it a crime to "make or make available any obscene communication in any form" as well as "any indecent communication in any form... to a person under 18 years of age regardless of whether the maker of such communication placed the call or initiated the communication."[emphasis added] The measure also criminalizes the owners or operators of any "telecommunications facility" used for such purposes. In addition, the proposal contains broad language banning communications intended to "harass," including criminal penalties for anyone who "makes repeated telephone calls or repeatedly initiates communication with a telecommunications device" for such purposes. A number of aspects of the bill are problematic for those doing AIDS work, starting with the fact that courts continually struggle to define what is "obscene." Further, efforts by the Federal Communications Commission to enforce bans on "indecent" material--essentially material considered objectionable but falling short of being "obscene"--have been so inconsistent that they once inspired an entire comedy routine: George Carlin's famous "seven words you can never say on television." It is hard to gauge how much AIDS-related material available online might be considered indecent, and many AIDS groups are only beginning to use this means of communication. But there are already many AIDS bulletin boards and Internet news groups, and several online services have HIV/AIDS discussion and information boards as well. A quick and far from complete scan by AIDS TREATMENT NEWS came upon a number of sites containing frank, graphic discussions of the HIV risks involved in various sexual acts, for example. Is such material "obscene" or "indecent?" We don't know, and most likely it will be up to the courts to decide. That prospect makes AIDS educators nervous. At the San Francisco AIDS Foundation, which is in the process of creating a World Wide Web page expected to go online this fall, spokesman Derek Gordon worries, "Almost everything we do might involve frank discussions of sex and sexuality, even 'AIDS 101.' We need to be able to say, 'If you're going to get fucked, get fucked with a condom.' We can't have Congress saying, 'We don't like the F word and we really don't like the C word.'" And although online communication may not yet be a major vehicle for AIDS prevention information, Pat Franks of the University of California at San Francisco Institute for Health Policy Studies expects it to grow more important--and worries about the effects of restricting online information. "As we all use the computer more and more to share information, I think the potential for restricting access is there," she observes. Jeff McElroy, who coordinates the HIV/AIDS forums on America Online, says the huge online service is "concerned about the ramifications of the amendment." He notes that although AOL already restricts sexually explicit messages, "we are less stringent" when the subject is HIV/AIDS because "such communications save lives." Even in the best of circumstances it would likely take some time to work out what is legal under the new rules. Although at least some material with a legitimate educational purpose might well eventually be deemed acceptable, many worry that in the meantime online services--who would be held criminally liable for "obscene" or "indecent" material transmitted via their networks--would see no option but to bar many types of material entirely. Equally problematic for AIDS activists are the provisions dealing with "harassing" communications. Treatment activists have repeatedly used phone and fax "zaps" of government officials or drug company executives to press for improved research or for access to new treatments, bombarding the officials with messages urging, for example, an expanded access program for a promising new drug. The tactic has been successful on many occasions, and AIDS TREATMENT NEWS has at times carried notices of such actions. Again, Exon's language is broad enough and imprecise enough that it is difficult to know exactly what would become illegal. Does repeatedly calling or faxing a drug company executive with the same message about a potentially life- saving drug constitute "intent to harass"? Arguably it could, but no one can say definitively. Former Northern California American Civil Liberties Union board member Barbara Brenner thinks it is no accident that such activist work might fall under the scope of Exon's proposal. "The ability to do political organizing online is enormous, and I think they're afraid of that," she argues. She adds that not only AIDS work may be affected by the "indecency" provisions, pointing to material she has read online dealing with breast cancer. "People post a lot of things," she explains. "I've been reading a lot of stuff about vaginal dryness as a consequence of chemotherapy." While common sense might indicate that such discussions of health concerns shouldn't be tagged as "indecent," the history of both AIDS education and women's health issues in this country suggests that common sense does not always prevail. The measure now moves to the House of Representatives. As of the AIDS TREATMENT NEWS deadline, Russ Rader of Senator Exon's office was unsure of exactly when a House version of the "Communications Decency Act" would be considered, but thought it could happen as soon as late July. But Perry Plumart, press secretary to California Congresswoman Nancy Pelosi (who opposes the measure), thinks the contentious debate over various appropriations bills might delay consideration of the Telecommunications Act until after the August Congressional recess. Such a delay might be advantageous, as it would allow AIDS lobbyists to regroup after the funding battles and, perhaps, put some effort into mobilizing opposition to the proposal. ***** NAPWA Opens Pharmacy On July 17, the National Association of People with AIDS (NAPWA) opened MedExpress, an air-express pharmacy, which will focus on services to people with HIV, as well as on providing low-cost medications. "In addition to all FDA-approved medications, nutrients, and supplements at low prices, MedExpress will provide each patient with a personal representative who will help them access an array of information and services ... on the latest in treatment and alternative therapies, stress management, nutrition, legal issues, the work environment, medication interactions and reactions, relationships, and living more healthfully with HIV/AIDS." MedExpress can accept most insurance companies, and will do the insurance paperwork. For more information, call MedExpress at 800/808-8060 Monday through Friday from 9:00 a.m. to 9:00 p.m. Eastern time. ***** AIDS Research "Spin-off" -- Ganciclovir CMV Prevention After Liver Transplantation by John S. James One part of the case for AIDS research funding is that this research advances our understanding of the immune system, which is critically important in many other diseases, including cancer and many autoimmune conditions. But it can be hard to identify concrete benefits, because it takes time for the new knowledge to be applied in other diseases -- especially so for results from basic research, which can ultimately be most important. One clear example of an AIDS research "spin-off" helping in the treatment of other conditions is the use of ganciclovir for preventing CMV infection in transplant patients -- who are vulnerable to infections because of the immune- suppressive drugs they must take. A recent study tested ganciclovir in 250 liver-transplant patients.(1) Despite conventional preventive treatment with high-dose acyclovir, CMV infection occurs in 10 to 50 percent of these patients. When CMV disease develops, it can cause death; and hospitalization costs are estimated at $10,000 to $50,000 per case. Ganciclovir prophylaxis for 100 days after surgery greatly reduced CMV infection (to 5%, vs. 38% with acyclovir) and symptomatic CMV disease (to less than 1%, from 10% with acyclovir; the only patient who got CMV disease while taking ganciclovir had received a liver from a donor with CMV hepatitis). Side effects were minimal. Intravenous ganciclovir was used in this research, but oral ganciclovir, now being tested in other studies, may also prove effective. Ganciclovir would probably never have been developed if it had not been needed for AIDS. Now it has proven benefit in liver transplantation, and probably equal benefit in other organ transplantation as well. References 1. Winston DJ, Wirin D, Shaked A, and Busuttil RW. Randomized comparison of ganciclovir and high-dose acyclovir for long- term cytomegalovirus prophylaxis in liver-transplant recipients. The Lancet. July 8, 1995; volume 346, page 69. ***** Cryptosporidium in Water: CDC Guidelines on How to Protect Yourself Cryptosporidiosis is caused by a microscopic parasite, Cryptosporidium parvum, and may cause severe diarrhea. Persons with normal immunity get cryptosporidiosis, but recover without treatment within several weeks. In persons with immune deficiency, however, the disease can be life- threatening; there are treatments which sometimes reduce the symptoms, but no known treatment is effective in getting rid of the parasite in severely immunosuppressed persons. Cryptosporidium is spread by contaminated water, as well as by contact with infected persons or animals. The risk from water came to national attention in 1993, when over 400,000 people got cryptosporidiosis from the Milwaukee water supply, despite purification according to Federal standards. Cryptosporidium can be found in most U.S. rivers, lakes, and streams. While a well-operated and equipped municipal water purification system can remove most of it in drinking water, these systems cannot guarantee its complete removal. On June 16, 1995, the U.S. Centers for Disease Control and Prevention (CDC) issued guidance regarding Cryptosporidium and water supplies.(1) This 19-page document includes two and a half pages concerning immunocompromised persons. Points include: * "All immunocompromised persons should be educated and counseled about the ways that Cryptosporidium can be transmitted (e.g., sexual practices involving fecal exposure, contact with infected adults or with infected children who wear diapers, contact with infected animals, drinking or eating contaminated water or food, and exposure to contaminated recreational water." * "All persons, especially immunocompromised persons, should avoid drinking water directly from lakes or rivers. Because water can be ingested unintentionally, immunocompromised persons should be advised that swimming in lakes, rivers, or public swimming pools can also place them at increased risk for infection." * "During waterborne outbreaks or other situations in which a community boil-water advisory is issued, immunocompromised persons should boil water for 1 minute to eliminate the risk for acquiring cryptosporidiosis. Using submicron, personal- use filters (i.e., home or office types of water filters) or high-quality bottled water also can reduce the risk for transmission. However, boiling water is the most certain method of killing Cryptosporidium oocysts [the infectious stage of the parasite's life cycle]." * "Only microstraining filters capable of removing particles less than or equal to 1 micrometer in size should be used by immunocompromised persons and other persons who choose to use a personal-use filter (i.e., home or office water filters) to reduce the risk for transmission of Cryptosporidium. Filters in this category that provide the greatest certainty of Cryptosporidium removal include those that produce water by reverse osmosis, those labeled according to filter manufacturing industry standards as "Absolute" 1 micrometer filters, and those labeled as meeting American National Standards Institute (ANSI)/NSF (formerly the National Sanitary Foundation) International Standard #53 for "Cyst Removal." [Footnote: NSF International certifies water filters according to the ANSI/NSF International Standard #53: Drinking Water Treatment Units -- Health Effects. To obtain information regarding the current status of any water filter, contact NSF International, 3475 Plymouth Road, P.O. Box 130140, Ann Arbor, Michigan 48113-0140. Telephone 800/673- 8010.] The "Nominal" 1 micrometer filter rating is not standardized, and many filters in this category might not reliably remove oocysts. Filters that only employ ultraviolet light, activated carbon, or pentiodide-impregnated resins are not effective against Cryptosporidium. Not all filters advertised as effective against Giardia are effective against Cryptosporidium. Because bacterial overgrowth on filters can be a additional health risk and oocysts are likely to concentrate on the outside of filter cartridges, persons should carefully follow the manufacturer's instructions for filter replacement and use. Immunocompromised patients should either have someone else change the used cartridges or use disposable gloves if they themselves change the cartridges." * In a longer discussion on bottled water, the CDC recommendations noted, "Many brands of bottled water adequately reduce the risk for cryptosporidiosis and, thus, provide a reasonable alternative to boiling tap water. However, labeling of bottled water is not standardized with regard to the manufacturing practices used to test for and remove or kill Cryptosporidium oocysts...." The recommendation discusses risks from different sources of bottled water. But whatever the source, "Bottlers who treat water before bottling by distillation or reverse osmosis filtration, regardless of the source (e.g. well, spring, and municipal tap water), insure removal of oocysts if they are present. Similarly, water that has been passaged through an "Absolute" 1 micrometer or smaller filter or through a filter labeled as meeting ANSI/NSF International Standard #53 for "Cyst Removal" before bottling will provide almost the same level of oocyst removal..." The document suggests, "Persons who use bottled water as an alternative to tap water that has been boiled must carefully research and choose their supplier." Unfortunately no list of safe waters is provided; there is a voluntary effort by the bottling industry to improve labeling, but it will probably take about a year to put into place. "Current data are inadequate to make a general recommendation that immunocompromised persons in the United States boil or avoid drinking tap water in nonoutbreak settings. However, immunocompromised persons should be advised that the risk for waterborne transmission is possible and that they can choose to reduce their risk for waterborne cryptosporidiosis by using precautions similar to those recommended during outbreaks. Immunocompromised persons should consult their health-care provider before making such a decision." Whatever precaution one uses, it is important to use them for all water consumed. "Preliminary data from outbreak investigations indicate that persons who did not consistently use bottled water or filters were as likely to become ill as those who did not use such products." Who Is at Risk? We asked Dr. Dennis D. Juranek at the CDC who should be most concerned about water safety -- is there any agreement that people below a certain CD4 (T-helper) count should take the special precautions? He said that had been discussed in the workshop which developed the guidelines. But while clearly those with low CD4 counts -- under 200, or especially under 100 -- are at greater risk for getting serious illness immediately from Cryptosporidium, it may be possible that persons earlier in HIV disease could recover from cryptosporidiosis but not clear the parasite completely, allowing it to cause serious illness later. Until more is known about this possibility, the guidelines are targeted at everyone with HIV. Dr. Juranek explained that the CDC did not have enough information to issue a "recommendation" that immunocompromised persons not use tap water everywhere in the U.S., and issued "guidance" instead. "Basically the reason is that we do not know what the magnitude of risk is for acquiring Cryptosporidium from drinking water during non- outbreak periods, and we do not know what percent of Cryptosporidium infections are acquired from drinking water vs. the other modes of transmission. We have some preliminary data indicating that sexual practices that result in fecal exposure may be among the highest risk activities; remember that not all Cryptosporidium infections in HIV/AIDS patients are symptomatic... "Also, the risk of waterborne infection is likely to vary considerably from city to city depending on the quality of a city's source of drinking water and water treatment processes. For example, in some cities water comes from high- quality well water (no evidence of fecal contamination ever). Persons in such towns would not be at risk for waterborne cryptosporidiosis. Other towns have a lot of human sewage discharge upstream (sewage treatment does not kill all Cryptosporidium), and even brief treatment interruptions at a water treatment plant using such water may place AIDS patients at high risk. "We are also concerned about the life-style changes that may be necessary for a person to make sure that all his/her drinking water is boiled/filtered/bottled. This basically means that one has to carry water to work and for recreation, e.g. no fountain drinks (syrup mixed with carbonated tap water) at fast food establishments, restaurants, movie theaters, etc. At home people would have to remember to use boiled, etc., water to prepare juices or other cold beverages normally reconstituted with tap water. "So the question each person must ask him/herself is, 'Is this worth it? Is the waterborne risk in my town great enough for me to do this?' We would not answer these questions for immunosuppressed persons who live a variety of life styles in cities whose water quality is also highly variable." Bottled Water Quality We also asked Dr. Juranek about choice of bottled water. He said that there is no adequate technology today for testing either bottled or city water to see if it is safe. Water treated by distillation or reverse osmosis should be OK -- but if the label says it is treated by ultraviolet light, ozone, or microfiltration, that may not be enough to remove or kill the parasite. Also, the source of the water is important. Water from a well which is tested twice a week for years and has shown no fecal contamination ever is probably free of the parasite. Some of the major bottlers in Europe and the U.S. take pride in their wells; they own the land around the site and take care of it to maintain their water quality. Another View AIDS TREATMENT NEWS spoke with Donald P. Kotler, M.D., a leading AIDS gastroenterologist. He is not happy that the CDC refuses to make a recommendation on drinking water and leaves it to each patient to make his or her own decision. Dr. Kotler recommends taking the special precautions with drinking water if one's CD4 count is below 200. This is based on a study which found that above 190, people usually recovered from cryptosporidiosis spontaneously, while below 190 they seldom did. Dr. Kotler said there is little evidence that Cryptosporidium not being completely cleared is a common problem, although of course there are asymptomatic cases. And if a person is exposed to the parasite in the course of their usual lifestyle, they have probably been exposed to it already. ***** AIDS TREATMENT NEWS Published twice monthly Subscription and Editorial Office: P.O. Box 411256 San Francisco, CA 94141 800/TREAT-1-2 toll-free U.S. and Canada 415/255-0588 regular office number fax: 415/255-4659 Internet: aidsnews@aidsnews.org Editor and Publisher: John S. James Reader Services and Business: Richard Copeland Thom Fontaine Denny Smith Tadd Tobias Statement of Purpose: AIDS TREATMENT NEWS reports on experimental and standard treatments, especially those available now. We interview physicians, scientists, other health professionals, and persons with AIDS or HIV; we also collect information from meetings and conferences, medical journals, and computer databases. Long-term survivors have usually tried many different treatments, and found combinations which work for them. AIDS Treatment News does not recommend particular therapies, but seeks to increase the options available. Subscription Information: Call 800/TREAT-1-2 Businesses, Institutions, Professionals: $230/year. Nonprofit organizations: $115/year. Individuals: $100/year, or $60 for six months. Special discount for persons with financial difficulties: $45/year, or $24 for six months. If you cannot afford a subscription, please write or call. Outside North, Central, or South America, add air mail postage: $20/year, $10 for six months. Back issues available. Fax subscriptions, bulk rates, and multiple subscriptions are available; contact our office for details. Please send U.S. funds: personal check or bank draft, international postal money order, or travelers checks. VISA, Mastercard, and purchase orders also accepted. ISSN # 1052-4207 Copyright 1995 by John S. James. Permission granted for noncommercial reproduction, provided that our address and phone number are included if more than short quotations are used.