Being Alive Newsletter People with HIV/AIDS Action Coalition * June 1995 ------------------------------------------------- Contents Inside... President's Notes 2 Women's Conference 3 Oral Ganciclovir 4 Nutrition Power 6 Partner Relationships 8 Integrase Inhibitors 9 Spanish Pages 10 Fran McDonald 13 Upcoming Activities 15 Support Groups 16 Bulletin Board 17 Announcements 20 ========================= * Correction * On page 3 of the April Newsletter, we printed Brent Grodeck's excellent report on d4T (Zerit). The article originally appeared in Positively Aware. In re-entering the text, we made an error in the second paragraph. It should read, "After two months of d4T therapy, Alan's count rose from 189 to 237." In one keystroke, we had inflated the gentleman's T-cell count to 337. Our colleague Steve McGuire, Positively Aware's editor, correctly points out, "An increase of 48 cells is entirely within the range of typical expectations for initial therapy with d4T. While an increase of 148 cells may not be unheard of, it would be unusual." We regret the error and apologize for any confusion this may have caused our readers. ========================= Medical Update - June 26 Mark Katz, MD General Update Dale Prokupek, MD Gastrointestinal Issues 7 pm, Monday; Plummer Park, West Hollywood ================== Medical Update - May 22, 1995 presented by Mark Katz MD and reported by Jim Stoecker ---------------------------------------- Survival After CD4 Count Falls Below 200 A recent report in the journal AIDS (February 1995) evaluated 579 men in the MACS study after their CD4 count dropped below 200. (For those not familiar, MACS stands for Multicenter AIDS Cohort Study and is a long term look at over 5000 gay/bisexual men in four US cities.) The subset studied were followed for three years after their initial drop in CD4 count. Researchers found that 20% of the group did not have an AIDS-defining condition at the end of the three years. Some 28% of the men received an AIDS diagnosis within one year of the study, and 29% within two to three years. The rest of the group already had an AIDS-defining condition at the start of the study period. Researchers noted that correlated with a longer time to an AIDS-defining condition were slower declining CD4 count, higher body mass index, and lower incidence of thrush. On the other hand, they found no correlation between disease progression and use of tobacco or alcohol or a history of sexually transmitted diseases. And interestingly, they found that 45% of the men who remained AIDS free used neither prophylaxis for opportunistic infections nor antivirals. It should be noted that the researchers took their data from the earlier years of the MACS study (which began collecting data in 1984). If we looked at the data today, one suspects that we would see a different distribution than reported in this article and that a larger percentage would be without an AIDS-defining condition. -------------------------------------------- Stress as a Cofactor for Disease Progression What makes one person advance quickly to an AIDS-defining condition while another person remains asymptomatic for years? What are the cofactors for HIV disease progression? We know that age, viral strains, and genetic factors are important considerations. Common wisdom has said that stress might also be a cofactor, but there has not been any proof of this. Now we read a study in the American Journal of Psychiatry (April 1995) that appears to offer some proof about the effects of stress on a person with HIV. In this study, 99 HIV+ men without symptoms were compared to 65 seronegative men. In order to measure stress, the researchers used a standardized test that identifies 111 so-called "stressors." Each person in the study was rated on each stressor on a scale of zero to four. Interviews were given over a period of time; at the end of the study, each participant received an overall stress rating. Not surprisingly, researchers found that the seropositive group had a much higher stress rating overall than the seronegative group. (We perhaps did not need a study to know this.) What is important is that they also found that those with higher stress ratings had statistically significant reductions in NK (natural killer) cells. This is the most objective data that we have to date that stress does have an effect on T-cell function. --------------------------- More About Viral Load Tests Everyone at this point has probably heard about the new viral load tests that measure the actual quantity of HIV in the blood. Though these test are still experimental and are not yet approved by the FDA, most studies underway are using this measure to help assess efficacy. As study data are released, we learn more about the significance of viral load measures. Is viral load a better predictor of the course of HIV infection than the CD4 count? We are beginning to learn more. A study in the Annals of Internal Medicine (April 15, 1995) went back and looked at the plasma of 62 men whose dates of seroconversion were known. Blood samples that were taken every six months for 5 to 7 years were submitted to viral load testing. About a third of the men developed AIDS over this period; in fact, 16 of the 18 in this group had high levels of viral RNA throughout the testing period. Another third of the study group had drops in CD4 count, while the remaining men remained stable throughout the study period. Those in the stable group had consistently low levels of virus, and 19 of the 23 in this group had no detectable viral RNA. The researchers concluded that a viral RNA count of over 100,000 per milliliter of blood was the most powerful predictor of progression to AIDS. In a study published in the journal AIDS (February 1995), researchers looked at 43 HIV+ people who were placed on ddI. They determined the median drop in viral RNA for the group at the end of one month of ddI therapy. In a long term look at the group, they found that those with more than the median drop in viral DNA had a median survival of 35 months from the start of the study. On the other hand, for those whose viral load dropped less than the median amount, the median survival was only 14 months. Both these studies point to the predictive value of viral load testing. But these tests also have another important value. They can tell us quickly if a particular antiviral regimen is working for an individual. A study in the Journal of AIDS (April 1995) reports on 14 people who had at least 9 months of AZT therapy and were switched to ddI. This group had a mean drop of 70% in viral RNA after one year. Within this group, however, five had no drop at all. These non-responders can now be identified so that a different regimen can be tried. We all know that what works for one person with HIV may not work for another. Viral load testing has the very practical value of letting us quickly know what works and what doesn't. ----------------------- Some News on Antivirals We have explained before that two drugs can be additive (each brings their own efficacy), synergistic (together they raise the efficacy of each alone), or antagonistic (efficacy is reduced). In combination antiviral therapy, we want to avoid antagonistic drugs and search for synergistic combinations. In a study reported at the recent Conference on Antiviral Research in Santa Fe, researchers reported synergy in a combination of AZT and a protease inhibitor. This was, however, a test tube study, but it does offer hope that once protease inhibitors become available, we may have a powerful combination to fight HIV. At the same conference, Burroughs-Wellcome reported on early studies of its latest antiviral, 935U83. After 24 weeks of study, no resistance has developed and side effects are less than what we have seen with earlier antivirals. Researchers also report that in the test tube the drug remains active against viral strains resistant to AZT, ddI and ddC. We should be hearing more about this new antiviral as testing continues. On the down side, Merck did report that when resistance develops to its protease inhibitor, viral strains can develop that are resistant to all protease inhibitors. -------------------------------- Glaxo Limits 3TC Expanded Access As we reported some months back, the manufacturers of 3TC, Glaxo Labs, put in place a program that made 3TC available to those with less than 300 T-cells who had gone through AZT, ddI and ddC. The response to this expanded access program apparently overwhelmed Glaxo. They put a limit on new access to 350 people per week. If you were caller number 351, you were placed at the top of the list for the next week. Now, in a further effort to limit the number of participants, Glaxo has announced that you must have less than 100 (rather than 300) T-cells to qualify for this program. -------------------------- Protease Inhibitor Studies The Merck protease inhibitor is being studied locally at Pacific Oaks and at Kraus Partners. For this available study, CD4 count must be between 50 and 500. Further, participants cannot have used AZT prior to the study. This particular trial has three arms: AZT alone, the Merck protease inhibitor alone, a combination of AZT and the protease inhibitor. There is also another trial of the Merck protease inhibitor for those who have been on AZT for at least 6 months prior to the study. Participants receive the Merck protease inhibitor or a combination of 3TC and AZT or a combination of 3TC, AZT and the protease inhibitor. We are not aware of local sites for this particular study. Abbott Laboratories are sponsoring open label studies of their protease inhibitor. One study is for those with less than 100 T-cells and previous antiviral therapy of more than nine months. Locally, you can call either Cedars-Sinai (310.358.2300) or COMBAT (213.469.5888) for more information. There is also a Phase III study of Abbott's protease inhibitor (ABT-538) for those with 200-700 T-cells and no prior antiviral therapy. Participants receive ABT-538 or AZT or a combination of the two drugs. For information, you can call COMBAT. SPV-30: Made in France and Testing in America Finally, we have news of a new drug called SPV-30 that is an extract from the boxwood tree. This drug is made in France and a phase I trial there showed an average CD4 count rise of 100 for those on the drug and a drop of 50 for those on placebo. Noted French AIDS researcher Luc Montagnier is very interested in this particular drug and is planning more trials. Meanwhile, a study is forming in the US. You can get a free six month supply of the drug in return for providing regular blood work results to the researchers. For information on this study, you can call David Stokes in Boston at 617.424.9195. ================== President's Column by Walt Senterfitt Being Alive Brings Phone Service to LAC/USC AIDS Patients At long last, on May 20, private bedside telephone service was inaugurated in Ward 6700, the inpatient AIDS floor of LA County/USC Medical Center. Previously, the only phone service available was one instrument at the nurses' station and one pay phone in the corridor outside the wall. Often, patients are too ill to walk out to these phones, where they face a waiting line anyway. Now, each patient is given his/her own private number at the time of check-in to the unit and can make unlimited local area calls and receive calls from anywhere. It is the only bedside phone service anywhere in the sprawling county hospital, the largest in the nation. The new service is a cooperative venture of Being Alive and the Disney Company, brought together by the Community Advisory Committee for AIDS Care at the medical center. Our Board voted nearly two years ago to explore establishing this service, after noting how often our members and other PWAs become isolated in the hospital at the very time when contact with friends and loved ones can be most precious. The contributions to Being Alive in memory of my late lover and Being Alive volunteer (and LAC/USC client), Jorge Correa, were dedicated to this project. Numerous delays and complications arose. Finally, another client persuaded his former employer, Disney, to donate necessary equipment and labor through their telephone services supplier. Being Alive paid for the start-up costs for the 20 phone lines and will pay the monthly basic service charges, as well as expanded metropolitan area service from northern San Diego to southern Ventura Counties. We committed ourselves to underwrite the service for at least one year. We will evaluate the effectiveness and the costs after six months, and then decide whether we can continue to pay it out of our general funds, or whether we need to establish a special general community fund. Early returns from the patients show enthusiastic support and gratitude. They couldn't believe that they would get a service "just like in a real hospital"! For me, it's personally gratifying to bring to fruition a memorial to Jorge, who fought with dignity for life and for the right to decent health care for himself and his Latino brothers and sisters. It makes me proud to be associated with Being Alive. It is another example of our fulfilling a part of our mission statement: "Being Alive is the means we have created to help us connect with each other, bring others like us out of isolation, and take charge of our lives, our care and our destiny." ---------------- Keith Brier Dies It is with sadness I inform you of the passing on June 1 of former Board member and active volunteer Keith Brier. Keith came around Being Alive after several years of intense depression following the loss of his lover. He gradually found a home here, and pitched in with his diverse skills, particularly in computers and in task organizing. He was the lead volunteer for the Connect! newsletter. He helped set up our computer network. He organized the spectacularly beautiful Christmas party at Castle Green in Pasadena in 1993, and advised the following year's committee on how to replicate and surpass the first event. He helped bring pressure to bear on APLA to become more sensitive to and inclusive of its clients and the entire HIV-community. He made contributions to other organizations as well, LA Shanti most notably. We will miss him. ---------- CSW Parade Being Alive will have a splashy contingent in the annual CSW Parade in West Hollywood on Sunday, June 25. We won't have a float this year, but we will have convertibles and jeeps to ride in, with banners, signs and energy. We will have an active booth at the festival throughout the weekend, and can always use more volunteers. Join us! Call Being Alive's Silver Lake office for more details. ======================================== National Conference on HIV/AIDS in Women An Overview by Walt Senterfitt The Second Conference on HIV Infection in Women, held in Washington, D.C. earlier this year, underscored two essential facts, one painful, one hopeful. Laboratory and clinical research on HIV infection in women is several years behind information about men. "Old-fashioned," heartfelt, "in-your-face" activism is alive and well among the increasingly conscious communities of women living with HIV/AIDS. Women Alive was responsible for organizing and raising funds for a delegation of 35 HIV+ women from Southern California-by far the largest single contingent of positive women at the Conference. Some were veteran activists; many were attending an AIDS conference (and visiting Washington) for the first time. Their presence was felt throughout the Conference. Mary Lucey was a keynote speaker at the opening plenary session, a frequent speaker from the floor microphones in various sessions and a tireless leader of her delegation throughout the Conference. ---------------- Plenary Sessions The featured keynote speaker at the opening plenary was Patricia (Patsy) Fleming, President Clinton's new Director of National AIDS Policy (once known as the AIDS czar or czarina). She had a tough row to hoe, trying to defend the disappointing record of her boss and minimizing the controversy over mandatory testing of pregnant women. The other bureaucrats and some researchers in the audience cheered Fleming, whereas most of the infected women and the more activist researchers sat on their hands and let out occasional groans and hisses. She angered everyone by leaving the room immediately after she spoke, which just happened to be immediately before activists Maxine Wolfe and Mary Lucey spoke forcefully. A subsequent statement of the entire Conference steering committee chastised her for this act in strong language. Also impressive at the opening were talks by Kathy Anastos of the Bronx and Mardge Cohen of Chicago, both prominent women physicians and researchers in large county hospitals treating large numbers of positive women from impoverished communities. It is clear their hearts and minds are with their women patients and with the activists, rather than with the bureaucrats or their more privileged and conservative colleagues (male and female). They each spoke out clearly against using the ACTG 076 results as the basis for a new mandatory testing campaign, on grounds of both science and public policy. The presence and message of Anastos and Cohen underscored their role in an alliance between infected women and their advocates on the one hand, and women (plus a few male) doctors on the other. ------------------------------------------------------- Do Women With HIV Get Sick Faster and Get AIDS Quicker? Unfortunately, solid answers to this question must await further data from two recently-initiated natural history studies of HIV infection in women. These studies, known as "HERS" and "WIHS," are patterned after the 10-year-old MACS study in men (and many similar male cohort studies). HERS had some very preliminary data to report; WIHS is still enrolling. Both were begun several years later than they should have been, and then only because of relentless pressure from women activists and their small band of supportive researchers. Several smaller studies tended to answer the above question "No." If women have similar access to health care as do the men they're compared to, they get sick or get AIDS at about the same rate as men. In a Baltimore study of men and women getting care in the same clinic between 1989 and 1993, men took an average of 2.8 years to progress from early symptomatic disease to AIDS; women took slightly longer, 3.1 years. The median survival time after an AIDS diagnosis was identical for men and women, 1.8 years. Both studies noted some differences in the incidence rates of AIDS-defining OIs. More men presented with PCP, more women with esophageal candidiasis. In non-AIDS-defining symptoms, more women had sinusitis and genital warts, whereas more men had skin diseases and oral hairy leukoplakia. A larger but less well-controlled study reported that the women were likelier than the men to die from their first OI (which was most often bacterial pneumonia). However, for those who survived their first OI, the women progressed more slowly and lived a little longer. The worse mortality in the initial episode was attributed to the fact that more of the women had a history of active IV drug use, and in general had less access to health care. Another study of positive women in the military found that about 5% were "long-term non-progressors," that is they had documented HIV infection for at least seven years with no symptoms or T-cell decline. This is about the same as among similarly cared-for men. ---------------------------------- Do Women Lose Less Lean Body Mass? Results presented conflicted with each other. Don Kotler's group in New York found in a smallish retrospective study that 40% of the weight loss among men was due to loss of lean body mass vs. only 8% among women. They concluded that women lose proportionately more body fat and less lean body mass than do men. The pattern suggested that weight loss in women may be partly due to low levels of sex hormones, analogous to the relationship of low testosterone levels to loss of lean body mass in men. An ongoing prospective study in San Francisco, however, found no such difference. This study found that women lost lean body mass to the same degree and in roughly the same pattern as men. --------------------------------------------- Do Positive Women Get More Genital Infections Than Negative Women? Several studies compared the incidence of syphilis, gonorrhea, chlamydia, trichomonas, candida (yeast) and bacterial vaginitis in HIV+ women to control groups of HIV- women. Only candida vaginitis occurred more frequently among the positive women. ---------------------------------------- Does Pregnancy Drive T-cell Counts Down? According to a longitudinal study at the University of Miami, single or multiple pregnancy had no effect on CD4 or CD8 counts. The counts declined at the same rate in women who were pregnant as in those who were not. Further, there was no difference in rate of progression to AIDS. Are Pap Smears Good Enough Screening For Cervical Disease? Ample evidence has been reported on the association between HIV infection and the risk of cervical cancer and precancerous growths (the latter known as CIN, cervical intraepithelial neoplasia). The lower the CD4 cell count and function, the higher the risk of CIN. It is important to know whether regular Pap smears are adequate monitoring for CIN, or whether the more invasive colposcopy is necessary. The jury is still out on the question. Latest results from an ongoing cohort study presented at the conference shed light on, but did not answer, this question. A group at Columbia University in New York has been following two groups of 400 women (one group HIV+, the other HIV-) every six months since 1991. Overall, 20% of the positive women have had CIN, compared to 4% of the negative women. The annualized incidence rate of new cases of CIN was 8.1% among the positive women and 1.1% in the negatives. Pap-smear screening correctly identified 81% of the true CIN cases, and correctly labeled as non-CIN 87% of the true non-cases. These rates are decidedly less than optimal, but are comparable to many previous studies of Pap-smear effectiveness in uninfected women. ------------------------------ Mother-To-Infant Transmissions This was one of the hottest topics of the conference, because of the current controversy over the results of ACTG 076 and the move to mandate HIV testing for all or "at risk" pregnant women (see related articles in Spring 1995, Women Alive and March 1995, Being Alive newsletters). The scientific reports at the conference emphasized that there are a number of factors involved in whether or not HIV is transmitted during a particular pregnancy or childbirth. These factors include viral load, previous use of antiretroviral drugs, AZT resistance, Vitamin A levels and the quality of prenatal care available. Collectively, these studies argue strongly against the current simplified message being touted by media and clinicians alike ("AZT in pregnancy prevents infection of babies"). It argues for the more logical and empirical proposition that minimizing risk of vertical transmission requires use of a variety of strategies, individually tailored to the status and history of the particular pregnant woman. ---------- Conclusion The closing plenary featured a government doctor/official, Felicia Stewart, summarizing the research and action remaining to be undertaken on behalf of women. She was somewhat less defensive and more honest than Fleming was at the opening. However, far more moving was a tub-thumping, grassroots speech by the head of a community-based outreach organization in Atlanta, Sandra McDonald. She brought the infected women in the audience to their feet with her message of mutual self-help and partnerships with our communities. Our marching orders following the famous axioms of Frederick Douglass, "Power concedes nothing without a struggle," and Mother Jones, "Don't mourn, organize!" Thirty-five "Women Alive" and one representative of their male comrades-in-arms returned to LA in high spirits, with renewed energy and some newly-minted activists among us. ==================================================== How You Can Get Oral Ganciclovir for CMV Prophylaxis And Other Things Roche is Doing by Walt Senterfitt The Roche pharmaceutical company, also known as Hoffman LaRoche, held another in their series of briefings and consultations with AIDS community treatment activists and reporters last month in San Francisco. Being Alive was there. We pass along the most interesting bits and pieces we heard. ----------------------------- CMV Treatment and Prophylaxis Roche recently purchased the Syntex drug company, which developed ganciclovir (GCV) as the front-line treatment for CMV retinitis and other sites of CMV disease. Until recently, ganciclovir had to be administered intravenously. An oral form of the drug, hampered by its poor absorption in the intestine, was nevertheless found to be almost as effective as the IV form in preventing recurrences of CMV retinitis. The FDA approved the marketing of oral ganciclovir (trade name Cytovene) as maintenance therapy for CMV retinitis in January of this year. This was and is good news for people who would rather run the risk of somewhat faster recurrence of symptoms in exchange for not putting up with the inconvenience and infection risks of a PICC or Hickman catheter and regular IV infusions. Another form of ganciclovir, intravitreal implants, is currently in clinical trials and promises to be at least as good as the oral form in preventing recurrent retinitis. A tiny capsule of the drug is inserted in the eye under local anesthesia and is slowly released into the fluid which bathes the retina. It makes sense that this method might be the most efficient, permitting much less of the drug to reach the bloodstream where it causes in some people the serious side effect of lowering the white blood cell count. The flip side of this advantage of localization is that the drug would have little chance to fight symptomatic CMV infection in other organs of the body. While less common than retinitis, CMV can also cause colitis, pneumonia and disease of the gallbladder, liver and kidney. The implants are currently available only at institutions enrolled in a formal clinical trial. For information on the nearest one to you, call Ronnie Chin at Syntex, 415.852.1392. Returning to oral ganciclovir, we were all heartened last summer by the news that when taken prophylactically, this drug prevented about half the cases of retinitis that would otherwise have occurred in a given time period. Roche, however, decided to delay asking the FDA approval for marketing of oral GCV. They felt they needed more data than the one completed study and did not want to complicate the application for oral GCV as maintenance treatment. Some people have already to begun to use oral GCV for prophylaxis, especially those with private physicians and generous insurance policies. Since the drug is FDA-approved and on the market, a physician can legally prescribe it for anyone. This is known as "off label" prescribing. However, it is very expensive, as much as $50 for a day's supply. (Needless to say, we activists took the company to task in no uncertain terms for this outrageous pricing.) In these days of managed care and cost containment, the majority of people do not have access to oral GCV for prophylaxis until and unless it becomes approved by the FDA for such use, and insurers, HMOs and Medi-Cal (Medicaid in other states) agree to pay for it. But wait, there's a way around this obstacle right now. Roche is conducting what they call "An Open-Label Study of the Safety of Oral Ganciclovir for the Prevention of CMV Disease in People Infected with HIV." Open-label means there is no blinding or placebo involved; everyone gets the drug. What this amounts to is a form of "parallel-track" trial of the drug, which in turn amounts to free expanded access-if your physician or clinic is willing and able to do the necessary paperwork. Enrollment is open through any licensed physician in the U.S. The doctor or clinic must complete registration procedures with Syntex and agree to submit regular report forms. The company claims the data collection required of the doctor is minimal, except that they need complete information on any changes in dose and any adverse side effects. An eye exam is required at the time of entry into the program, and doctor's visits are required every month for the first two months and then every two months. (This last bit doesn't seem too burdensome, because people at severe risk for retinitis are probably visiting their doctor at least monthly anyway.) To be eligible, a person must be 13 or older, have less than 50 CD4 cells, be CMV positive by culture or blood test, have no CMV retinitis, have no other CMV disease which has required treatment in the preceding 30 days, have an Absolute Neutrophil Count (the kind of whiteblood cells which fight off most bacterial infections) of more than 750 and a platelet count of more than 50,000, and have no history of hypersensitivity to acyclovir or ganciclovir. Enrollment is limited to 5,000 patients, but so far they've only enrolled 150 in the first two months. For information, call or have your physician call the Syntex Study Center at 800.569.4630. Roche's Protease Inhibitor Saqinavir (trade name Invirase), Roche's protease inhibitor, is the furthest along in development of any drug in this new class. They plan to file an FDA application for accelerated approval in late 1995. Questions remain about its relative effectiveness, compared to other protease inhibitors, and about the optimal dose. Trials are underway at Stanford with a daily dose three times higher than that used in other clinical trials, which showed the drug moderately effective when used in combination with a nucleoside analog reverse transcriptase inhibitor (like AZT, ddI, ddC, d4T, and 3TC). They are also testing a new formulation of the drug that makes it better absorbed in the intestine. Despite these uncertainties, the group of activists at the San Francisco meeting, when asked by Roche, strongly and unanimously supported the company's applying for accelerated approval as soon as possible. (At the same time we could not promise, of course, to recommend it highly once it's on the market. That depends on the alternatives available at that time and on new data on saquinavir as it becomes available. But we sure as hell need the drug readily available for those whom it might benefit.) Roche announced at this meeting that they will begin an expanded access program for saquinavir in "the third quarter of 1995," that is sometime between July 1 and September 30. Expecting a huge demand, they will limit the program to 4000 people, using a lottery if necessary. (The drug is quite expensive to manufacture, according to the company.) The program would have minimal eligibility requirements, basically open to anyone with a declining CD4 count of 300 or less who is not eligible for any open clinical trial of the drug. There will be no restrictions on what else a person is taking or not taking. ----------------------------------------- PCR Technology for Viral Load Measurement Roche owns one of the two technologies now being widely used experimentally to directly measure HIV viral load. The other, bDNA, was developed by the biotech company Chiron. Roche's test is based on PCR (polymerase chain reaction) which amplifies HIV RNA many millions of times and then counts it. In retrospective analysis of some clinical trial data, those participants whose viral load (as measured by the Roche PCR test) dropped sharply soon after starting a new antiviral drug were the ones who ended up having clinical benefit from the drug. In other words, the test tended to distinguish those who would live longer or get extra time without an OI from those who wouldn't. Since retrospective data can be misleading, prospective clinical trials are underway currently to see if this predictive power still holds. If it does, then it may well indicate that those whose viral load doesn't drop quickly should not waste time and put up with side effects but should instead try something else. Many believe that the viral load test may be of even broader benefit in individualizing treatment. Assuming regular monitoring as is now done with CD4 counts, when viral load starts to rise it may mean it's time to switch drug regimens or add a new one to the "cocktail." Similarly, we may be able to figure out very quickly whether the new regimen is working, without waiting for CD4 changes or the development of new symptoms. However, this hope has yet to be confirmed in practice. It was rather disturbing that Roche did not have underway any tests of this individualization strategy. We'd bloody well better have some evidence that it's worth it before we recommend that everyone add this expensive new test to their regular care and disease management, and thus dump millions into any company's coffers. It's expensive, and we'll have another fight on our hands to get insurers, HMO's and Medi-Cal to pay for it. I will say for Roche scientists and managers that they immediately realized this weakness in their development plan, and invited the community to help them come up with practical, beneficial testing strategies. I got a call the next day from the senior scientist in charge of developing their PCR test kits, and I'd welcome the help and advice of anyone interested. They are in discussion with the FDA about what exactly will be required for approval of the kit (to be used by any lab with PCR capability) and of their parallel plan to market the services of their diagnostic laboratories to do the tests centrally. They hope to apply for FDA approval sometime before the end of 1995. ------------------ Concluding Thought I realize much of this report is technical and arcane unless you've been following it, but it is interesting to follow how the drug development and marketing process works in practice. Roche has come a long way in opening itself to community input and dialogue. If you want to get involved in this particular process or in similar ones concerning other drugs and companies, consider joining our new treatment study and action group. I'm jocularly referring to it as the "Being Alive Irregulars" (with apologies to Arthur Conan Doyle), and it's just about to leap off the drawing boards. Watch for an announcement of the first meeting. ========================= Travelling with HIV by Jennifer Jensen, MS, RD ------------- Summer Travel Last year, Positively Aware's Timothy Frick quoted Ernest Hemingway when he characterized the Paris arts community as a "moveable feast." If you are travelling to Paris, however, and you feast on the wrong French pastry, the movement you experience may not be an artistic one! Food for thought? Summer vacation is here and that means that people living with HIV are well advised to start getting "appropriately neurotic" about food safety concerns. We do want you to get back home in good health, well fed, and without any travellers' diseases. Also, it's a bummer to find yourself sick and in bed while taking the vacation of your dreams -- because bad food got to you before the fun started. Here, then, are some reminders on how we really can have it all and remain in good health. But it's like everything else in HIV-life; travelling and staying well is more of a job and much more tedious than for HIV-negatives. One trick that may be helpful is to behave as if your vacation dreamland is like a third-world country; all bets are off -- assume that most of the food you find there is suspicious, and act accordingly. ------------------------------------ Preparing to Travel: See Your Doctor Being prepared's first consideration, and a suggested travel-safety requirement, is a visit to your doctor. Tell this member of your healthcare team where you're planning to go, and discuss any prophylaxis that may be warranted to make sure you return home safely and, of course, to maintain your "personal best" health while you're away. This medical visit should occur, ideally, about six months prior to your planned excursion -- but ideal timing notwithstanding, always better late than never! Call today! If your travel involves a foreign country (especially Mexico and other "south of the border" vacation sites), medical prophylaxis may be indicated. Often Bactrim is the preventive of choice, but many of us are already using this agent for PCP prophylaxis. If that is the case, or you can't tolerate Bactrim, a different preventive antibiotic may be recommended. Call your doctor. Start preparing early! If you need preventive antibiotics for "travellers trots," it may be wise to try for tolerance to other preventive options like Ciprofloxacin, Norfloxican, or other remedies. Since many antibiotics can trigger allergic reactions, a "tolerance test" may be indicated. Please don't assume that you're safe just because you're travelling to a familiar location. The transportation experience itself may pose risks-read on. When travelling to some countries, vaccinations may be required. Included in this list,you may need inactivated versions of polio and typhoid vaccines, hepatitis preventives and perhaps the "measles/mumps/rubella" triple-combo protection. Also, depending on your destination, protection from cholera, rabies, and plague and yellow fever may be warranted. Don't tempt fate: prevent any uninvited medical condition for which there is a safe vaccine. Take the protection approach and do as your doctor advises. Your prescription medications should be going with you, and preferably in their original containers (so as to avoid going to jail). Discreetly packed prescription bottle labels may help out with this situation. If your destination is not an HIV-friendly locale, although we'd never encourage you to fib a bit, you may want to use a creative success approach: Put meds into vitamin bottles and, of course, include the vitamins too. Get a list of medical services and with luck, the names and numbers of HIV-savvy doctors along the way to your destination. Other sources of information on vacation safety are available. You may wish to call the country's embassy in Washington, D.C. or its local consulate to find out their policy on tourism and immigration for HIV+ travellers. The place you want to visit may have restrictive immigration policies, while other destinations may be more HIV-friendly. Another good information source is the Centers for Disease Control (CDC) in Atlanta. Calling them at 404.332.4555 is a good safety idea. ----------- On Your Way Travel by plane may pose health problems. Airplane food is usually sufficiently awful that not eating it shouldn't be a problem. However, if you do like the air-fare, don't eat anything unless it's hot; cold airplane food may pose very real safety risks-regardless of HIV status. It's been reported that on some flights HIV-negative cold food eaters have gotten sick-probably from neglected meats, lettuce, mayonnaise, or just plain sloppiness. Rolls and breads are usually OK, but don't trust the junk they send with it-eat it plain on the plane. And otherwise eat hot food offerings. Another important consideration about air travel is recirculated air, which may pose health risks. A risk that you may be able to avoid is the "droplet" type of infection. Suppose you're seated near a coughing person. You may never know why the person is coughing, but if he or she is seated near you and has anything from a cold to pneumonia to tuberculosis, they can potentially spread germs to nearby passengers. Should you find yourself in such a situation, request reseating. If this means disclosing a health condition, and if you don't want to disclose your HIV status, you could claim that you're going through chemotherapy or organ transplantation-there's less stigma around those conditions and the possibly homophobic/AIDS-phobic crew and passengers won't be as likely to discriminate. It's your call; say what they need to hear! Maintain your anonymity. More than likely, your sky host or hostess will be happy to oblige your request. Did I say demand to be reseated? Take it to the cockpit crew if you must. You do want to return from your travels unharmed? ----------------------------------------- Land Travel (Car, Bus, Train, and Trails) Being prepared here is inspired! We can always take safe food along for the ride. It's not expensive to get a cooler (whatever suits your needs and space-from very small to quite large). Taking your food with you saves quite a lot: Money for one-from fine restaurants to roadside diners, the food is more costly than your "bring-along" fare. Your major expense may be buying ice-good advice-lots of ice. Nice things to keep on ice might include sandwich fixings. Breads and rolls are usually safe for a day or two with or without ice, but what goes into the sandwich may not be. Tuna sandwiches can be great-and are a good health choice too. Keep everything for this sandwich in your cooler. Small 3.5 ounce tuna cans are a nearly-perfect sandwich size container (fish-oil power!). Add mayonnaise, maybe some chopped up hard-boiled eggs (protein power!), tomato slices (vitamin C power!), avocados (calorie/nutrient power!), onions (flavor power!), and maybe even some water chestnuts (crunch power!). Other nice ice things include potato/pasta salads, yogurt, peanut butter, carrot sticks, cottage cheese, cole-slaw, avocadoes, grapes, apples, oranges, peaches/nectarines, pears, bananas and other assorted fruits and vegetables. If you have diarrhea, leave out most of the vegetables and peel the fruits if you can (a knife for peeling is an easy-to-pack tool). If your produce has seeds (eg. grapes, berries, tomatoes) this might not work too well on your food-bringing list. Canned fruits often travel even better than fresh-they don't need ice, they won't rot on you, and since you may not be able to buy fresh produce during your "dream" trip, packing in some canned goods may be just the thing for this vacation. Many food-peeling knives come equipped with can opener options too! Yogurt (protein and calcium power!) and multi-packs of chips (with dips from the cooler) can be good snacks, and trail mix (calorie, mineral and vitamin power!) can come in handy too. Pureed foods often work well; already pre-packaged and safe, they can be found in the baby-food aisle of your market. If the aisle also has some Infalyte, pick up a bottle or two-just in case diarrhea happens. ----------------------------------------------------- Three Words may save your vacation: Heat Kills Germs If food or fluids have been heat-treated (like distilled water, for example), you have a guarantee of automatic safety-unless someone else exposed it to germ warfare. Take your own "safe water" or canned sodas. Whether in the Third World or the Great Plains, water safety is a must! If you don't have access to distilled water, boil your own. A lot of fluids are available packaged in "tetra-brik" boxes. This is a very user- friendly and packing-friendly container type. Risk of spillage is very minimal, the packaging is safe enough to not require refrigeration, and you'll always have "safe fluids" to drink. If in a restaurant, you may want to drink this beverage from a glass-just request a "no-ice" clean glass. A news report from June 1 (1995) gave municipal water standards a huge thumbs-down. Across the country, expect that water from the tap is deadly - boil it and it's safe. Heat kills germs. If you're in a foreign country, be especially careful-drink sodas from the bottle or can, and wipe the lip surface with a wet wipe-a good thing to have with you no matter how far from home you go. One client recently took off for a backpacking trip with plans for campfire-based water boiling and lots of powdered supplements, including single- serving size mixes such as Met-RX, (available in many pharmacies), cheap and easy instant breakfast, and dehydrated soups. Instant oatmeal and other single-serving packets are easy to pack, lightweight, and safe when made with hot water. Clintec Nutrition company has just introduced a "New Basics" product line including soups (tomato and chicken), and really good-tasting chocolate bars. Also, NCI has NuBars in coffee crunch and vanilla caramel flavors. Pre- packaged individually, these meal augmentations can help with fatigue prevention and weight-loss protection. For this trekking-type of vacation trip, insect repellant is an important provision. Dr. Jeffery Karaban, a dermatologist, warns that people with HIV get bigger, more itchy bites-and these, in turn, may require high-potency cortisone treatments as well. He adds that we're also more sensitive to sun exposure, especially if taking Bactrim or other antibiotics. Decreases in CD4 counts have been noted after significant sun exposure. ---------- About Meat Well done is the request of choice, relying on the fact that heat kills germs. If the meat is well-cooked, the bugs are dead. If the meat is slightly rare, send it back-tell them you just love well-done meats. Be especially careful about ground meat like in hamburgers. Here, the meat cannot have even the tiniest bit of pink. E. coli has recently been reported to have caused some deaths, as well as a lot of harm to HIV-negative people. That same harm could be even more costly with HIV positivity inmind. If fish is for you, double your demands for doneness. Just knowing about our globe's polluted waters may be enough to cause avoidance behavior, but if you need fish, it must be flaky. If there's even one little "soft-spot" it's too suspicious to eat. Send it back for better cooking. The same applies to poultry. Even in the US, poultry can be hazardous to our health. Away from home, the risk goes up the further into the third world you get. From Mexico to Morocco, you may assume (usually correctly) that poultry has been stored and/or prepared un-hygienically. If there's the tiniest bit of pink near the bone (check this out before you begin to eat), send it back. Contaminated food that you don't eat won't hurt you. Don't be afraid to demand safety. You'll be happier spending your vacation traveling and enjoying your vacation paradise of interest rather than just looking at it through your hospital window. By the way, no matter where you are, hospitals are not germ-free environments-just being in one can add to your risk of contracting bacteria, parasites and other germfare. Have a great trip! Stay safe, enjoy your vacation, and return home with your "best health" still intact. Personally, I'll be working all summer, so have one on me! As always, first do no harm. If this advice is unclear or seems to be related to any adverse consequences, consult your doctor or nutritionist. And, have fun. (Jennifer Jensen, MS, RD, CNSD is in private practice. She offers a sliding scale payment plan for people living with HIV/AIDS. And she welcomes your call at 310.450.5581.) ============================== AIDS and Partner Relationships by Mike Tyoran, LCSW (Last of a two-part series) Last month, we discussed the challenges and rewards of persons living with AIDS (PLWA's) and in a partner relationship. The indications for individual and conjoint counseling as well as support groups were identified. Communication between partners was stressed. Nine suggestions were made for well-partners in their caregiving roles. This month, we explore the nine stages couples experience when a partner is diagnosed with AIDS. These stages were identified by R. Dennis Shelby, Ph.D., in his excellent book, If a Partner Has AIDS (Harrington Press, 1992). These stages are predictable as both partners deal with various issues for varying lengths of time. There are many life situations that can powerfully bond a couple, and AIDS is such a situation. The bond takes the form of "we are in this together." In the Wondering Stage, there is an increasing anxiety that something may be terribly wrong, as certain symptoms indicating possible HIV infection are noticed. There is the fear and dread that one or both partners may be infected and need to be tested for the HIV antibody. Waiting for the test results, couples feel as if a bomb were ready to drop. They may be confused about when HIV infections actually results in the disease state. The Confirmation Stage encompasses the initial diagnosis of AIDS and the emotional upheaval that follows. The actual diagnosis is a shock and is felt like a slap in the face. Anxiety and fear run high. Assumptions of longevity and growing old together are dashed and replaced by uncertainty about the future. Well-partners hide the depth of their initial despair, saving it for a time when they are alone. Their overriding concern is to "be there" for the newly diagnosed partner. Well-partners tend to assume that they, too, are positive, regardless of prior test results. Some will be re-tested right away; others will wait. The medical status and emotional needs of the newly-diagnosed partner become central to the relationship and define each partner's duties and responsibilities to each other. The diagnosis draws couples together quite intensely as they start to close ranks, deal with the threat, and vow to "beat this thing." Some couples may decide out of need or fear not to share any information about their situation with friends or family, at least for a time. This decision further unites them emotionally but also isolates them socially. While couples rally their optimism and resources, there is still a sense of disbelief in the reality of the diagnosis, wishing it were only a bad dream. The Long Haul Stage covers the period of time between the decline of the initial shock to the diagnosis and the declining health of the ill-partner. Well-partners start to accept the gravity of the situation, and take their caregiving roles quite seriously. They tend to ignore their own needs as they focus on the needs of the ill-partner. The goal initially is to sustain the ill-partner until a cure is found. Later, the goal is to maintain hope in light of the ever-increasing responsibilities of the caregiving partner and the worsening medical situation. Couples devise a game plan with carefully defined roles to manage the illness. The caregiving partner becomes the primary energizer in the relationship and can staunchly enforce the game plan with a desperate, if not obsessional, quality. The plan includes rules about eating, vitamins, health food, exercise, medication compliance, and prohibitions against drinking, drugs, and smoking, for example. The plan reassures ill-partners that someone who loves them dearly will be there to care for them. The plan gives caregiving partners a desperately needed map to follow during periods of uncertainty, and reassures them that they are doing everything possible to help. The ill-partner may experience long periods of relatively good health, followed by periods of acute illness. Holidays and vacations are greatly appreciated, but at the same time, a certain sadness and sense of foreboding periodically surface. Recurring medical problems result in discouragement. Family and friends eventually will need to be informed of the diagnosis, and those relationships will need to be re-negotiated. The partner relationship itself deepens with the resolution of each medical crisis. However, there are periods of derailment in which couples are not prepared for the next medical emergency. It becomes increasingly difficult to maintain hope. The Fever Pitch Stage encompasses the experiences of the caregiving partner during the last weeks or days of the ill-partner's life. Usually by this time, the ill-partner is gravely ill and communication is substantially reduced. Simply holding hands, hugging, reminiscing about the past, and just being with each other take on major importance. An increasing sense of aloneness and fear comes to dominate the thinking of the caregiving partner who somehow continues to meet life's daily tasks as well as the needs of the ill-partner. Juggling these tasks is particularly difficult for the caregiving partner who continues to work. While work may be a safe refuge for a time, panic is only a phone call away. This stage is a period of sharp emotional contrasts of hope and despair and. at times, almost frenzied activity. Anxiety often runs high and sadness begins to mount. Exhaustion, followed by a sense of detachment, results. It is as if the life of the caregiving partner is also coming to and end. The Calm and Peace Stage starts as the death of the ill-partner approaches. The caregiving partner often has a considerable number of tasks to attend to, such as whom to contact and making arrangements. Yet, despite the activity, the caregiving partner feels a sense of calm and, perhaps for the first time in many months, a sense of peace. There is a feeling that a long, arduous journey is finally coming to an end. Often both partners are surrounded by family and friends for comfort and support. For the first time in a long time, as death occurs, the surviving partner is alone. While the first five stages are determined by the course of the disease, the last four stages are aftermaths. These stages are quite fluid in their boundaries and include the mourning process. Over a period of time, memories of the deceased partner and a profound sense of loss come to occupy a less central position in the life of the surviving partner. Family, friends, and, for some surviving partners, the AIDS Memorial Quilt facilitate the healing process. The presence or absence of HIV infection can also have a powerful impact on the process. The Chaos Stage is characterized by the first real experience of aloneness and an intense, sometimes all-pervasive longing for the deceased partner. The world at times seems unreal. Time is distorted and the surviving partner feels horribly insecure. The Retreat Stage is marked by withdrawal from a world which no longer feels safe or meaningful. The surviving partner withdraws into an intense, almost all-consuming dialogue with the deceased partner. Yet, while surviving partners want desperately to hold on to the past, they also feel somehow compelled to move on with their lives. The Exploration Stage is a time of transformation. Surviving partners begin to try out life again on their own. There is a gradual waning of intense thinking about the lost partner and the relationship. They start to feel more self-confident and hopeful for the future. The thought of dating periodically surfaces. If they have not already done so, surviving partners are HIV-tested for their own future plans. Finally, the Back into the World Stage is an on-going, evolving process. There is an emerging excitement at once again feeling whole and sensing a future with unfolding possibilities. Surviving partners develop new career goals and new interests. They become increasingly aware of their emotional and physical needs. They start to find new love attachments or decide to pass on relationships for the time being. Surviving partners are a tribute to the indomitable nature of the human spirit. They are the true heroes. They are shining examples of love and courage. ===================================== Integrase: The Third Enzymatic Target HIV causes its "host" cell to make three enzymes that are necessary for infection and replication. These enzymes are reverse transcriptase, protease and integrase. While the reverse transcriptase and protease activities have been extensively studied, the process of integration is less well understood. Once HIV's genetic material is transcribed into DNA by reverse transcriptase, the DNA is inserted into the host cell's DNA by the process called integration. HIV integrase is absolutely necessary for viral infectivity and replication; it is responsible for cutting the host DNA and splicing the HIV DNA into the host cell's genetic material. Only after this insertion or integration process is complete can new HIV proteins be manufactured and assembled into daughter viruses. Blocking integrase is widely considered a viable target for potential anti-HIV drugs. Genetically altered HIV that lacks the integrase gene is incapable of infecting and killing cells. As integrase is responsible for carrying out several distinct enzymatic steps involved in DNA integration, blocking any one of these steps would likely interfere with DNA integration and, as a result, HIV infection. Since recent studies indicate that infected cells turn over (die) at a rapid rate which is matched by (and eventually exceeds) the rate of new infection, reducing the rate of infection could maintain a state of homeostasis that could result in a stabilized immune defense condition. Integrase is also an attractive target because, like reverse transcriptase, no integrase activity is normally present in human cells. And this fact could reduce the side effects of integrase inhibitors used to treat HIV infection. There are, however, potential problems with an anti-integrase strategy. Integration only needs to happen once for a cell to become infected. Once a cell is infected, an integrase inhibitor would not help the infected cell or reduce its production of new viral particles. Integrase inhibitors have only one chance to inhibit the enzyme and once this opportunity is lost the inhibitor becomes ineffective for that cell. Another potential pitfall of integrase inhibitors, which is shared by the present group of protease and reverse transcriptase inhibitors, is that resistant mutants are likely to arise. There is no reason to believe that inhibition of integrase will not force the emergence of "escape mutants" that will expand and colonize a person's infected cells. It is, however, possible that in order to escape inhibition, the resistant virus would have to mutate to such an extent that the resultant mutant virus would not be wholly viable, allowing the immune system to keep the infection under control, as some scientists have proposed. A recent conference sponsored by the National Institutes of Health (NIH) focused exclusively on HIV integrase. The meeting, the first of its kind, brought together a variety of scientists studying every aspect of the integrase enzyme. Much of the research presented focused on how the enzyme achieves its vital task, and possible approaches toward blocking integration of the HIV genome. Scientists from the NIH reported the three-dimensional structure of the active site of HIV integrase and thereby provided a framework from which chemists can design possible integrase inhibitors. Similar studies of the HIV protease provided the means to rapidly produce several of the protease inhibitors that are currently in clinical trials at sites around the world. Several companies presented compounds derived from laboratory integrase assays. Several of the identified compounds have high activity and exhibit encouraging in vitro anti-HIV activity. At the present time, however, these compounds can only be considered test compounds and not true drugs, given their toxicological and absorption profiles. These compounds, however, could rapidly be turned into viable pharmacologic entities by chemical alterations and modeling-and such studies are under way. One of the most encouraging aspects of the meeting was the wide interest that pharmaceutical companies and scientists have demonstrated in exploring the HIV integrase enzyme as a possible therapeutic target. Most of the large companies-and a sizable number of smaller bio-tech and mid-size firms-were represented at the meeting. It is plausible that the successful control of HIV infection may arise from the combination of several, less-than-optimal drugs that have different modes of action. As integrase represents the third and final HIV "native" enzyme, exploring it as a therapeutic target should be-and has become-a major research priority. (Adapted from the April 1995 TAGline. For subscription information, write: Treatment Action Group, 200 East 10th Street, New York, NY 10003.) ================================================= Novedades en El Tratamiento del Sarcoma de Kaposi Por Steven Miles, M.D Escrito por Jim Stoecker, Traducci¢n y adaptaci¢n: Rubén Gamundi La incidencia de diferentes tipos de cánceres en personas con SIDA está aumentando. En un estudio llamado ACTG 019, el 27% de los participantes desarroll¢ algún tipo de cáncer durante los tres años que dur¢ dicho estudio. El estudio Concord, por su parte, report¢ que un 26% de los participantes desarrollaron cáncer. También se vio una incidencia de cáncer del 23% en participantes del estudio de profilaxis para MAC llamado ACTG 196. La raz¢n por la cual el cáncer se está transformando en un problema en personas con SIDA no es por los químicos ni por el AZT que dichas personas usan. Este fen¢meno sucede debido a que las personas con SIDA no tienen un sistema inmune intacto. La mayoría de los cánceres son exacerbados por la presencia del VIH y como el sistema inmune no funciona bien, es muy difícil que el organismo los combata. Hoy en día se ve mas cáncer en pacientes con SIDA debido al hecho de que las personas con SIDA viven mas que antes y eso las hace mas propensas a desarrollar algún tipo de enfermedad maligna. El Sarcoma de Kaposi (KS) es todavía el cáncer que se ve con mas frecuencia en personas VIH positiva. Es hoy un mayor problema que en el pasado debido a que las personas viven mas tiempo y tienen por lo tanto mayores posibilidades de desarrollar cánceres como ya hemos dicho mas arriba. Debemos tener en cuenta que hoy en día, las personas con KS viven mas tiempo que las personas que lo padecían diez años atrás. Se calcula que hay una disminuci¢n del 62% en el número de muertes por KS comparado con lo que pasaba en los comienzos de la década de los '80. La sobrevida de los pacientes con KS ha mejorado mucho desde 1985. No hay que ser pesimista cuando se trata de KS. Hoy, tenemos un mejor entendimiento de la forma en que el KS se forma y desarrolla. Este entendimiento nos ha llevado a tener mas y mejores opciones de tratamiento. Con suerte, dentro de poco quizás podamos tener disponible alguna forma de profilaxis para aquellas personas que están a riesgo de contraerlo. Como se desarrolla el KS En la UCLA (Universidad de California, Los Angeles) hemos desarrollado un modelo de como se desarrolla y disemina el KS. Nosotros creemos que en un estadio inicial, algunas células son, de alguna manera, transformadas. Esta transformaci¢n cambia la forma en que las células responden a las citoquinas (proteínas producidas por el sistema inmune) y al tat (una de las proteínas del VIH). Dichas citoquinas y el tat, actúan como un agente de crecimiento en células con KS. Para que esto suceda debe existir inmunodepresi¢n. El concepto de transformaci¢n celular es controversial. Barbara Ensolu, quien trabaja en el laboratorio de Robert Gallo, postula un modelo diferente al nuestro. Ella sostiene que células normales son expuestas a citoquinas y como consecuencia de dicha exposici¢n, se transforman. Dicho cambio hace que las células puedan responder al tat y una vez que tat se une a las células, actúa como un factor de crecimiento para células KS. Debe notarse que en ambos modelos, las citoquinas y el tat viral son necesarios para el desarrollo de KS. A diferencia que otros cánceres, KS no puede crecer por si solo. Esto es importante cuando se consideran opciones de tratamiento. ------------------- El papel de la IL-6 La Interleuquina 6 (IL-6) es una proteína fabricada por células y que se ha identificado como un factor de crecimiento para KS. Se ha visto en el tubo de ensayo que si se inhibe IL-6, también se puede inhibir el crecimiento de células KS. Investigadores han observado los niveles de IL-6 en la sangre de los hombres que participaron el estudio MACS (Multicenter AIDS Cohort Study) (Estudio SIDA Multicéntrico). Ellos encontraron que la sangre de hombres VIH positivos tenía niveles mas altos de IL-6 que la sangre de VIH negativos. También se vio que los niveles de IL-6 eran mayores en aquellos con KS. Los investigadores también hicieron un estudio retrospectivo de las sangre almacenada y encontraron que los niveles de IL-6 fue mayor justo antes de que dichos individuos desarrollaran KS. Este descubrimiento sería importante para detectar quienes son las personas VIH positivas que están a riesgo de desarrollar KS. ---------------------------------- Descubrimiento del Herpes Virus KS Por largo tiempo se crey¢ que algún tipo de virus de la familia Herpes tendría lago que ver en el desarrollo de KS. Algunos investigadores han demostrado una fuerte asociaci¢n entre el desarrollo de KS y CMV (Citomegalovirus). Data de un estudio de San Francisco muestra que a medida que la incidencia de CMV ha disminuido, también lo ha hecho la incidencia de KS. También se ha visto que pacientes VIH negativos con transplante de coraz¢n y/o riñ¢n y que han sido expuestos a CMV, tienen mas posibilidades de desarrollar KS después de la cirugía, cuando el sistema inmune está deprimido. Actualmente, investigadores han descubierto el virus Herpes KS, al que se llamará HHV8 (Virus Herpes Humano 8). Hasta hoy nadie ha podido aislar al mismo pero se ha podido localizar el gen TK. Dicho gen activa al acyclovir y a otras drogas similares lo que es una esperanza prometedora en el tratamiento futuro de KS. Recientemente un grupo de investigadores de la Universidad de Columbia han detectado la presencia de secuencias genéticas del virus KS en 27 de 39 biopsias de individuos con KS, de los cuales algunos eran VIH positivos y otros no. Es importante recalcar que dichas secuencias fueron encontradas en células KS y no en la sangre. Esto indicaría el porque no se ve KS en aquellas personas infectadas con VIH vía sangre-sangre pero si se encuentra en hombres a riesgo yVIH negativos. Por lo tanto el herpes virus KS es un agente de transmisi¢n sexual. El descubrimiento dicho virus es muy importante. Ya que nos permite mejor comprender la enfermedad y poder así encontrar mejores tratamientos y probablemente alguna forma de prevenirlo en aquellos que están a riesgo. Una cosa que todo paciente con KS debe tener en cuenta es que: "la observaci¢n de las lesiones no es un tratamiento apropiado". Si usted tiene KS y va a un médico que le dice: "por ahora vamos a observar las lesiones y ver como progresan", yo le sugeriría que deje de ver a ese doctor. Con todas las opciones de tratamiento no hay ninguna raz¢n para que alguien no haga algo al respecto. Hay varias formas disponibles de tratamiento. Una de ellas, es modular a las citoquinas que provocan que el KS crezca. También se pueden usar inhibidores del tat. También hay tratamientos t¢picos (en la lesi¢n) y sistémicos (en todo el organismo) al igual que agentes quimoterapéuticos. Inhibidores del Tat En UCLA y Boston, 23 pacientes con SIDA están siendo tratados con altas dosis de inhibidores del tat (desarrollado por Roche). Los resultados no fueron muy buenos. No se vio ningún efecto en las células T4 ni en el antígeno P24 y además se vieron problemas a nivel del sistema nervioso centra. ¿Significa esto que los inhibidores de tat no deberían investigarse mas? NO, ya que la droga desarrollada por Roche no es un verdadero inhibidor del tat. Esta droga se acopla con una proteína que interactúa con el tat. Yo creo que cuando tengamos un verdadero inhibidor de tat, encontraremos a un efectivo inhibidor del VIH y del KS. -------------------------------------- Estudios con Moduladores de Citoquinas Una de las cosas que se está estudiando es inhibir al Tumor Necrosis Factor (TNF), una de las citoquinas que incitaría el crecimiento de KS. La UCLA está preparando un estudio en fase II con receptores solubles de TNF, los que serían administrados dos veces a la semana. Los 40 participantes van a recibir la droga. Al menos 50 % de los pacientes deben tener 200 células t4 o mas. Los receptores solubles de TNF harán que no haya TNF circulante. De esta manera sabremos que tan importante es el papel que TNF desempeña en el desarrollo de KS. Otro estudio, analiza Vesnarosine, una droga que tiene efecto modulador de citoquinas en el tubo de ensayo. Veintiocho pacientes van a ser enrolados en este estudio que durará 16 semanas. Los pacientes recibirán vesnarosine en forma oral. El estudio se alargará en aquellos pacientes que permanezcan estables o que muestren algún tipo de mejoría. Se aceptan participantes en todos los niveles de KS y con cualquier conteo de células T4. No puede estar usando antivirales. -------------------------------- Nuevos Agentes Quimoterapéuticos El gran adelanto ha sido el descubrimiento de agentes liposomales, drogas que hacen "blanco" mas efectivamente en las células KS. Las dos drogas que están disponibles son doxorubicin y daunorubicin. La dos son efectivas pero se ha visto que doxorubicin (DOX-SL) tiene mas actividad y menos efectos indeseables sobre la médula ¢sea. Estas drogas pueden causar neutropenia severa (disminuci¢n de las células de la sangre) lo que puede ser corregido con GCSF. En estudios recientes se ha visto una respuesta parcial en el 70% de los pacientes y una respuesta total en el 7 a 9% de los mismos. Se cree que doxorubicin será aprobado rápidamente. ---------------------- Taxol para KS avanzado Taxol es una droga que ha sido usada en pequeños estudios en el Instituto Nacional de Cáncer (NCI). Investigadores de NCI reportan una respuesta favorable en el 55% de los participantes. Nosotros hemos usado Taxol en UCLA y hemos visto respuestas dramáticas, como por ej. resoluci¢n de edema o hinchaz¢n. Esta droga tiene sin embargo muchos efectos indeseables y es muy cara. Actualmente se está diseñando un estudio con taxol en UCLA y otro en USC de taxol en combinaci¢n con bleomycin para pacientes con KS avanzado. ----------------------------------- Tratamiento temprano con Retinoides Los retinoides se aplican en forma t¢pica (en la lesi¢n). El mas conocido se llama Retin-A. Hoy en día hay varios en desarrollo. Están son drogas muy selectivas y por lo tanto tienen menos problemas de resistencia e intolerancia. La UCLA y Shared Medical Research están conduciendo una serie de estudios en pacientes con algunas pocas lesiones. Cada persona actuará como su propio grupo control. Durante las primeras ocho semanas, algunas lesiones serán tratadas y otras no. Si las lesiones tratadas mejoran, le permitirá utilizar el medicamento en todas ellas. En el futuro: Profilaxis contra KS Ahora que hemos identificado la causa de KS es posible que podamos prevenir la enfermedad. Hay varios pasos que necesitamos para llegar a ello. Primero debemos mejor identificar al Herpes Virus KS, y así poder desarrollar un test que verifique su presencia. Esto nos permitirá determinar quien estará a riesgo de contraer KS. Antes de desarrollar KS, aquellos a riesgo podrían usar inhibidores TK que disminuirían las chances de desarrollar KS. También podríamos usar antivirales en contra del HVKS. Debemos también tener un mejor entendimiento del mecanismo de transformaci¢n. Cuando sepamos todo esto, mejores drogas van a poder ser formuladas. ---------- Conclusi¢n El KS es una enfermedad devastadora. Con todas las opciones de tratamiento disponibles nadie debería quedarse de brazos cruzados mirando como las lesiones aumentan. Recuerde que observar las lesiones no es una opci¢n de tratamiento. Yo le recomendaría a aquellos con KS que participen de algún ensayo clínico. Para informaci¢n sobre ensayos clínicos en el área de Los Angeles llame a Rubén Gamundi al 213.993.1483. Para informaci¢n acerca de pruebas experimentales en el resto de los Estados Unidos, llame al 1-800-TRIALS A. Trate de encontrar una soluci¢n. Algunos tratamientos puede que no funcionen para usted. No se de por vencido. Averigüe sus opciones y busque tratamiento en una forma agresiva. ======================================== Leucoencefalopatia Multifocal Progresiva Por Sarah Huffbauer, MD. Traducci¢n y Adaptaci¢n: Rubén Gamundi La Leucoencefalopatía multifocal Progresiva (PML) es un síndrome neurol¢gico parecido a la Esclerosis Múltiple que se ve en un 4% de las personas con SIDA que tienen menos de 100 células T4. A pesar de que PML es relativamente raro, un 60% de personas con HIV experimenta algún tipo de problema neurol¢gico que debe ser diferenciado de PML para poder otorgar a dichas personas un tratamiento adecuado. Podemos dividir a los síndrome neurol¢gicos que ocurren en pacientes con HIV en tres categorías: a) Demencia relacionada al SIDA, que sería causado por el HIV mismo. b) Neoplasias (cánceres). c) Infecciones oportunistas. En orden de frecuencia con que se ven tenemos en este grupo a las siguientes infecciones: toxoplasmosis, criptococosis y por otros hongos, infecciones causadas por virus como CMV, herpes y PML que es causada por un virus de la familia papovavirus llamado J.C. (Jacob-Crutchfeld). La mayoría de los adultos (70-90%) tienen anticuerpos para este virus y por lo tanto lo que sucede en personas inmunosuprimidas es una reactivaci¢n del mismo en lugar de una infecci¢n reciente. Este papovavirus fue identificado como la causa de PML en 1958. Dicha enfermedad era muy rara y solo se veía en pacientes con leucemia o linfoma. En la última década ha aumentado la incidencia de PML debido a la epidemia de HIV y por lo tanto se están haciendo mas investigaciones sobre el mismo. Como se mencion¢ al principio, PML, es similar a la Esclerosis Múltiple. Es una enfermedad desmielinizante del cerebro. Desmielinizante quiere decir que se destruye la capa de células (oligodendrocitos) que recubre y protege a las fibras nerviosas. La gente con PML con frecuencia muestran problemas de coordinaci¢n de un miembro o debilidad en el mismo. Esto también se puede ver en la Esclerosis Múltiple (EM). Síntomas que solo se ven en PML y no en EM son: dificultad para hablar o pensar. A estos síntomas a veces le siguen disturbios visuales, convulsiones, pérdida de memoria y dolores de cabeza. Generalmente PML es muy grave y progresa rápidamente los individuos que la padecen sobreviven un promedio de 2 a 4 meses después de que aparecen síntomas con un rango que va de 2 semanas a 18 meses. En los estudios de tomografía computada (CT) y de Resonancia magnética por imágenes (MRI), se ven lesiones multifocales en el cerebro. Estas lesiones se ven mejor en el MRI. Se debe hacer diagn¢stico diferencial con otras lesiones que pueden ser provocadas por linfoma o toxoplasmosis. Otras formas de diagn¢stico son punci¢n lumbar y biopsia cerebral. Se está desarrollando un nuevo test para el líquido cefalorraquídeo que tendría una sensitividad de hasta 80%. Este test y el MRI permitirían hacer un diagnostico de PML sin tener que recurrir a un procedimiento tan invasivo como la biopsia de cerebro. Hasta ahora, la biopsia es la única técnica que puede dar diagn¢stico definitivo. Las biopsias no tienen gran riesgo (solo el 3% tienen complicaciones y se pueden hacer con anestesia local y son guiadas a través de una tomografía computada). A pesar de que hay tratamiento efectivo para el PML, se han usado varios antivirales en contra del mismo. Han habido reportes de que el AZT puede ser muy beneficioso, pero no se sabe con seguridad ya que un 10% de los casos se resuelven espontáneamente. Se está haciendo un estudio (ACTG243) en el que se compara el mejor antiviral que la persona puede tolerar solo versus el mejor antiviral mas un antiviral llamada Ara-C. Dicho antiviral se administra a través de inyecciones en el líquido cefalorraquídeo. La gente que recibe dicho tratamiento debe ser monitoreada de cerca ya que dicho agente puede provocar varios efectos indeseables. A pesar de que nos es muy grato recibir un diagn¢stico de PML, cuanto mas sepamos de la enfermedad, mejor la podremos diferenciar de aquellas patologías que se le parecen y para las que hay tratamientos efectivos. Se espera que nuevos estudios puedan llegar a identificar tratamientos efectivos en contra de PML. =============================== People with PacifiCare - Update by Leonard E. Wojtyna The efforts of People with PacifiCare (PWPC) culminated in several new and exciting developments in May. The first to occur was the inaugural meeting of PacifiCare's new HIV Committee held on May 19 at their offices in Cypress. Electronic message boards throughout their offices greeted participants with a hearty "Welcome to People with PacifiCare." More significant was the interest in participation by PacifiCare employees of various levels and departments. Including medical group and LifeLink providers and representatives from APLA, Being Alive, and PWPC, attendance on this committee totaled thirteen people. Of most interest to insured members was the revelation by Neil Toyota of PacifiCare's Marketing Department of recent California legislation (SB1832) which prohibits health plans from releasing any information to employers concerning an employee's health status or medical treatment. This legislation should ease the fears of many HIV+ insured members who have called PWPC stating that they have not used their employer's health plan for HIV treatment for fear of disclosure of HIV status. For more information call PWPC at the number listed below. Several proposals were raised at this first meeting, including the development of a Case Management Task Force, part of whose purpose would be to increase PacifiCare's outreach to HIV+ insured members. Other ideas discussed included conducting an HIV "Healthcare Economics" seminar for employers, providers and members, suggestions to conduct symposiums to educate providers regarding early diagnosis and treatment of HIV disease, and developing a strategy for obtaining employer support of HIV issues and treatment. We are also seeking to define our vision for this new committee; however, we believe our focus should be on global or policy issues within PacifiCare and its providers that affect the HIV+ insured member. Dr. Mark Katz has agreed to conduct an HMO symposium as part of his regular monthly Medical Update forum on Monday, September 25, 1995, at Plummer Park. While still in the initial planning stages, it is expected that this symposium will be directed toward potential and current HIV+ consumers of HMOs. More information about format and content will be made available as we approach the target date. A representative from Secure Horizons will be attending our regular June meeting of PWPC in Silverlake. Secure Horizons, a wholly owned subsidiary of PacifiCare, offers replacement coverage for Medicare and is generally available for anyone eligible for Part A and Part B benefits at no additional cost, regardless of HIV status or prior health care provider. If you are or will be eligible for Medicare, this is an opportunity for you to hear and ask questions about how the Secure Horizons plan works and learn the pros and cons of both alternatives. People With PacifiCare (PWPC) meets on the third Saturday of each month at the offices of Being Alive, 3626 Sunset Blvd. in Los Angeles from 12 to 2 pm. Call 1.800.990.8990 for information. =============== Bits and Pieces by Fran McDonald All about Public Benefits On Tuesday, June 20, at 7 pm at the Being Alive office in Silverlake there will be a presentation of what's available in public benefits-Social Security, state disability, food stamps, MediCal, general relief, as well as information about related resources such as legal and rental assistance and reduced rates for utilities and bus passes. If you are contemplating leaving the work place, this would be a good chance to clear up the mystery that this subject is to so many people, also to soothe nerves by getting to know the unknown. I'll be there-I hope you will be, too. ------------- Money Matters The current issue of Consumer Action News reviews several new publications that could probably make better the day-to-day lives of many of our readers. The first, "66 Ways to Save Money," tells how to stretch your money on car repairs, auto insurance, groceries, among many others, in advice offered by authorities from consumer, government, education, and business groups. Single copies are available for 50¢ each from: Save Money, Pueblo, CO 81009. If you are trying to reorganize your finances to get out of debt and to avoid filing for bankruptcy, Consumer Federation of America and Visa USA have put out a brochure, "Managing Your Debts: How to Regain Financial Health," that can help you turn over a new leaf financially. For a copy, send a self-addressed, stamped envelope to: Managing Your Debts, P.O. Box 12099, Washington, D.C. 20005-0999. If you have a credit card and want the best deal available, the Federal Reserve has a new brochure listing over 150 cards with annual rates from 8.5% to 20.4%. For a copy request the "Credit Card Brochure" from: Publications Services, Board of Governors of Federal Reserve System, Mail Stop 127, Washington, D.C. 20551. ----------------- Rental Assistance This program, which is different from the renter's credit that used to appear on the California tax return, gives a once-a-year rebate to certain individuals who meet the following criteria: 1) lived in a rental unit for which the landlord paid property taxes in 1994; 2) had monthly rent of at least $50; 3) had total household income of $13,200 or less in 1994; 4) were 62 or older or blind or disabled on December 31, 1994. Depending on a qualifying individual's income, rebates can range from $240 to $10. I have the application form, so if you'd like one please call me. And note that the deadline for filing is August 31, 1995. -------------------------- Check Your Social Security Did you know that between 1978 and 1988 almost $70 billion of wages were not credited to the accounts of almost nine million workers' Social Security withholding? So concluded a report by the General Accounting Office prepared as a result of a lawsuit filed by the National Committee to Preserve Social Security and Medicare. Since such inaccurate records will result in a smaller monthly benefit, it's vitally important to keep an eye on your Social Security account so that should the time come to collect you will get every cent that you should. This becomes especially important because Social Security will not correct errors over 39 months old (not to mention the difficulty of paperwork and the gathering ofrecords that may be impossible to obtain after such a period of time). Therefore, while you are still working you should request a Personal Earnings and Benefit Estimate Statement at least every three years. You can get a request form to fill out so this information will be supplied by calling Social Security at 800.772.1213. Social Security workers commonly call this form a "PEBS." And while you're at it, hang onto your paystubs. An empty shoebox at the back of your closet is the perfect place to put your stubs as you receive them so that you can prove your point should the need arise. ----------------------- HMO Consumer Protection The most recent issue of The Medicare Advocate has an informative article about California's new HMO consumer protection that became effective January 1, 1995, amending the state's Health and Safety Code and the Insurance Code. Among the changes is one welcome to anyone who has been denied a particular referral or procedure. Henceforth, all HMOs must, upon request, reveal to the Department of Corporations, the HMO's contracting providers, and the HMO's enrollees the process whereby the HMO decides to authorize or deny services. Further, the HMO must use criteria developed with health care providers and that criteria must be reviewed annually. Changes also affect emergency services and prior authorization of such services. HMOs cannot require a provider to obtain authorization prior to rendering emergency services and care; non-contracting providers must be reimbursed until the patient has stabilized. From that point onward, if prior authorization is called for, the new law requires that HMOs have available 24 hours daily a physician and surgeon to provide such authorization. In the matter of complaints, the law now requires the Department of Corporations to release publicly information about the HMO complaints it receives, something that was not previously done. Also new is the requirement that HMOs and insurers cannot release patient information without the approval of the individual enrollee. These are just the highlights of the changes. If you'd like a copy of the article, please call me. (Fran McDonald has been in Social Services for 24 years and welcomes your calls at 213. 664.4772.) ========================== -------------------------------------------------- State Pays Private Insurance for Medi-Cal Patients If you qualify for Medi-Cal and also have private health insurance, don't cancel your private policy, even if you are having trouble paying for it. Medi-Cal may pay the premiums. Medi-Cal's Health Insurance Premium Payment (HIPP) and Employer Group Health Plan (EGHP) programs are able to pay private health insurance premiums for Medi-Cal patients who have high monthly medical costs. If your monthly medical costs are at least twice as much as your monthly premiums and if your insurance is not through another government-subsidized program, then you may qualify to have Medi-Cal pay your premiums. If you think you may qualify or know someone who may, please talk to your Medi-Cal eligibility worker or call 1.800.952.5294 and push 111 to ask about the HIPP and EGHP programs. ================================================ Upcoming Activities at Being Alive & Women Alive Silverlake 3626 Sunset Boulevard 213.667.3262 Sunday Socials Every Sunday 6:00 - 9:00 pm The big weekly event for our community. Lots of fun, food and good company. All socials are now non-alcoholic. The June 25 social will celebrate Gay Pride Day. The July 2 social will celebrate the Fourth of July. Free Legal Clinic By Appointment Wednesday, June 21 7:00 - 9:00 pm Get professional advice on legal issues in your life. Call for an appointment. All About Benefits Tuesday, June 20 7:00 - 9:00 pm Everything you always wanted to know about: SSI, SSDI, General Relief and State Disability. Brunch for Women with HIV/AIDS Sunday, July 9 11:30 - 3:00 pm Come meet other women with HIV/AIDS who share your concerns, fears and hopes in a safe and caring environment. Children are welcome. Massage Therapy By Appointment Ongoing Invigorating for the body and satisfying to the soul. Available several days duringthe week. Call for an appointment. Yoga Starting Tuesday, June 27 & Friday, June 30, 6:00 - 7:00 pm Ongoing Your instructor, Japa, will guide you through yoga postures, stretching, breathing techniques and meditations. Wear loose clothing and bring a mat. Support Groups Ongoing Twenty different support groups are offered, listed in this newsletter separately. Drop-ins are welcome. HIV Information Library Open Monday - Friday 11:00 am - 6:00 pm West Hollywood at The Ron Stone HIV Center 621 San Vicente Boulevard (across from Pacific Design Center) 310.358.2281 Literary Supplements Ongoing, First and Third Friday of every month 2:00 - 4:00 pm Join us twice a month to discuss and share reactions to agreed-upon work Conscious Breathing: The Healing Power of Your Breath Ongoing Mondays, 7:00 - 9:00 pm Conscious breathing is a powerful way to get in touch with your body and your emotions. Led by Peter Hulit and others. Chiropractic Services by Appointment Mondays, 7:30 - 11:30 am Back and body adjustments. Massage Therapy Ongoing Convenient for Westsiders. Openings available throughout the week. Call for an appointment. Acupuncture Clinic for Women Ongoing Thursdays, 1:00 - 4:00 pm Let your body benefit from the wisdom of ancient chinese medicine. Provided by Karen Raub, N.D. L.Ac. Women Alive 4410 Sepulveda Boulevard Culver City 310.313.5139 That Treatment Stuff Ongoing Tuesdays, 1:00 - 2:30 pm Drop In! Make informed choices about HIV and AIDS treatments. Become an active partner in your health care. Peer Support Group for Women Ongoing, Tuesdays, 6:00 - 8:00 pm Here's a support group facilitated by women living with HIV. Talk to other women who really understand. "Old-Timers" Group Ongoing, First & Third Friday of every month, 7:00 pm A support group specifically for women who have been living and coping with HIV for several years. A safe and supportive place to discuss issues that come with being a Long Term Survivor. Gay Pride Week-End at the Christopher Street West Festival (same location as Being Alive's West Hollywood center) Being Alive Booth Saturday, June 24 12:00 pm - 12:00 Am Sunday, June 25 11:00 am - 11:00 pm If you volunteer to staff our booth for a four hour shift, you'll get free admission to the festival. Gay Pride March Sunday, June 25 March in the parade with Being Alive's festive contingent. Call 213.667.3262 for information on gathering time. Copyright (c) 1995 - Being Alive. Noncommercial reproduction encouraged. Distributed by AEGIS, your online gateway to a world of people, information, and resources. 714.2486 * 8N1/Full Duplex * v.34