gilbert@tce.com (Gilbert Cornilliet) (02/19/91)
Hi there! This is a selection of articles (mostly medical) from the January 1991 Being Alive Newsletter. I am one of the editors of this Newsletter. Comments, suggestions, critics, submission of articles, etc are welcome. My E-mail address is gilbert@tce.com. Please share this information with your friends. Take care. Gilbert. ======== TABLE OF CONTENTS ======== BEING ALIVE STATEMENT HOW TO SUBSCRIBE TO THE BEING ALIVE NEWSLETTER ABOUT THE BEING ALIVE NEWSLETTER 1990 AIDS WRAP-UP - THE TEN MOST IMPORTANT STORIES OF THE PAST YEAR MEDICAL UPDATE: DECEMBER 10, 1990 AZT AND DDI COMBINATION THERAPY CHANGING IDEAS ON PCP PROPHYLAXIS A PROPHYLAXIS PROTOCOL AIDS REGIONAL BOARD, HOUSING FOR PWAS AN ANALYSIS OF THE MAJOR RISK MEDICAL INSURANCE PROGRAM LONG TERM SURVIVAL ============================================================================== BEING ALIVE STATEMENT Being Alive is an organization OF and FOR people with HIV/AIDS. We understand the pain and the fear; how easy it is to hide, how difficult it can be to come to terms with this disease and reach out. 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. Being Alive provides the following services to its members and the community: Advocacy HIV Fight Back! Library Medical Update Neighborhood Networks Newsletter Peer Counseling Roommate Referral Social Events Speakers Bureau Support Groups Vital Information TOGETHER, WE ARE MAKING A DIFFERENCE. ============================================================================== HOW TO SUBSCRIBE TO THE BEING ALIVE NEWSLETTER We are happy to provide the Being Alive Newsletter to people who cannot afford to purchase a subscription; however, we ask that anyone who can afford to subscribe, do so. |__| Enclosed is $12 for a six month subscription. |__| Enclosed is $20 for a one year subscription. |__| I cannot afford to pay for a subscription. Please enter my free subscription. |__| Here is an additional donation to support Being Alive. Name: Phone: Address: City: State: Zip: Please note that all names are kept confidential 4222 Santa Monica Blvd. Suite 105 - Los Angeles, California 90029 TOGETHER, WE ARE MAKING A DIFFERENCE. ============================================================================== ABOUT THE BEING ALIVE NEWSLETTER The Being Alive Newsletter is produced and published by Being Alive, People with HIV/AIDS Action Coalition, which is solely responsible for its content. If you have articles you would like to submit to the Being Alive Newsletter or if you just want to help, please contact the Being Alive office during regular hours. Please note: Information and resources included with your Newsletter are for informational purposes only and do not constitute any endorsement or recommendation of, or for, any medical treatment or product by Being Alive, People with HIV/AIDS Action Coalition. With regard to medical information, Being Alive recommends that any and all medical treatment you receive or engage in be discussed thoroughly and frankly with a competent, licensed, and fully AIDS-informed medical practitioner, preferably your personal physician. Being Alive and Being Alive Coping Skills Support Group are trademarks of Being Alive, People With HIV/AIDS Action Coalition, Los Angeles. Opinions expressed in various articles in the Being Alive Newsletter are not necessarily those of Being Alive's membership. Any individual's association with Being Alive or mention of an individual's name should not be, and is not, an indication of that person's health status. ============================================================================== 1990 AIDS WRAP-UP - THE TEN MOST IMPORTANT STORIES OF THE PAST YEAR By Mark Katz, M.D. The year's end gives movie reviewers, newscasters and other "enumerators" a chance to review the twelve months past in terms of their respective disciplines. It seems fitting to do the same for HIV/AIDS, as we turn the corner into the decade year of the epidemic. As a frequent list-maker, I found it insightful to put the year in perspective as I reflected on "The Ten Most Important Stories Involving AIDS." Please note, there is an implicit bias in this list towards issues regarding treatment; also, the cited items are more clinically-related than political. But let it now be said that without the efforts of concerned persons, from MAP (Mothers of AIDS Patients) to ACT-UP, from Bronx social workers to Bangkok demographers, all of the other reflections would indeed be dimmer. Access to treatment and increased awareness of affected demographic groups remain threads to be woven intricately but loudly and proudly into the ten items which follow: 1. PROPHYLAXIS FOR OPPORTUNISTIC INFECTIONS Aerosolized pentamidine is already yielding its throne to oral trimethoprim-sulfamethoxazole (Bactrim, Septra), as there has been an increasing, steady shift in favor of the latter for PCP prophylaxis. As reported at the December Medical Update (see page 6 of this issue), Bactrim is more clearly than ever superior in reducing the incidence of primary or secondary PCP. Plus, it's much cheaper, easier to take, and may serve as prophylaxis for toxoplasmosis as well. Data presented at the October ICAAC (an annual nationwide infectious disease conclave) was compelling, especially the Kaiser Sunset study in which 116 persons treated with Bactrim, one double-strength pill three times weekly, for a median of 18-24 months, showed zero incidence of PCP! There was also a lower incidence of frank intolerance than previously indicated. Closely related to this is the additional issue of prophylaxis of other OIs. While none have been FDA approved, nor even widely studied for that matter, medication exists which may reduce the incidence of fungal (Cryptococcus, Candida) and atypical mycobacterial (MAI) infections, and we hope a stride against CMV is not too far away. 2. STRIDES IN ANTI-RETROVIRALS DDI has been available all of this year through a novel but now household term "parallel track," a tremendous investment of money and energy on the part of sponsoring company Bristol-Myers. A study of DDI published in Lancet in September implied some superiority to AZT, but this study was not officially comparing the two, and thus the data is not formally valid scientifically. For those who believed that DDI, introduced in 1989, was a magical drug, free from side effects and effective in all subjects, 1990 taught us that, like its predecessor, it has potential toxicities (neuropathy, pancreatitis, hepatitis). Hats off, too, to Hoffman-LaRoche, who also made its nucleoside analogue, DDC, available through a similar program this fall. Persons who now have failed AZT treatment for whom the drug is no longer effective or who cannot tolerate it because of side effects can take one of these other two. Increasing numbers of optimistic voices speak of a 1991 FDA approval for both of them! 3. INCREASING EXPERIENCE WITH AZT While the FDA officially dropped the recommended dosage this year to 500 mg daily, newer studies point to the possible efficacy of 300 mg per day, one-fourth the original 1987 recommendation! (NB: This data has yet to be substantiated and most providers are not encouraging the further dosage decline at this time.) A major AZT story this year, as presented by David Ho, M.D. in San Francisco in June, was about the reality and prevalence of AZT-resistant HIV strains. This is somewhat of a setback for AZT, but until more options are developed and/or a test is made commercially available to see if one's HIV is or is not sensitive to AZT's beneficial effects in slowing disease progression, it remains the only FDA-approved drug for HIV/AIDS. A potential advantage of the lower dosages is diminished toxicity, and more newly developed drugs, such as EPO (erythropoietin) can mitigate AZT's toxicity (for some) when it does occur. 4. NEWER CLASSES OF ANTIVIRALS Most experts agree that at this point the best possible therapy would be not any one drug, but a combination of drugs which work at different points in the HIV life cycle. Many are turning to the hope of combinations (such as AZT and DDC, an experimental protocol). At least two new classes of anti-HIV drugs were announced this year, and human testing will be more widespread in 1991: TIBO derivatives (work against reverse transcriptase, but differently from AZT/DDI/DDC) and protease inhibitors (result in ineffective, non-infectious new progeny virus made by the infected T-cell) are both capable of more specifically directed anti-HIV action than other drugs previously used, by a higher so-called index of selectivity. 5. RAPID INFORMATION ACCUMULATION/NETWORKING The machinery for disseminating information about HIV/AIDS treatments has become so intricately woven and so well lubricated that when African researchers touted the success of oral alpha-interferon (OAIF) in April, American activists were in Kenya within days to see for themselves! They brought back the medicine, and studies were instituted in at least four major American cities. Initial reports do not match the excitement of the good news generated by the Kemron data... But at least we knew quickly! (This concept has led me to formulate what I call "The Six-Month Rule": If a new remedy comes out and is indeed promising in effectiveness and/or minimally toxic, we, the community-at-large, should know of its promise within half a year. Conversely, a remedy which has already been in use for several years may hold promise for some, but is probably indeed far from the would-be magic bullet!) Project Inform and our own local activists are to be commended for their important contributions to research, saving others false hope and misspent dollars. 6. FDA APPROVAL OF FLUCONAZOLE The FDA in January approved this oral, well-absorbed, extremely safe medication to be as effective as intravenous amphotericin B for maintenance therapy of cryptococcal meningitis after the initial bout has been treated. Amphotericin remains the standard of care for initial primary anti-cryptoccal therapy. However, fluconozole (Diflucan) signifies a growing shift to improved treatment of specific OIs, adding considerably to the positive quality of life which PWAs can hope to enjoy. A daily pill is certainly preferable to a weekly infusion (usually through a central catheter) of a potentially toxic drug. Fluconozole also works to treat Candida, which can cause thrush or esophagitis. 7. OFF-THE-RECORD AVAILABILITY OF CLARITHROMYCIN This erythromycin-related antibiotic, not FDA-approved at this time (but expected to be in early 1991 for other medical uses), may be the long-awaited breakthrough in treatment of disseminated Mycobacterium avium intracellulare complex (MAI/MAC). The current standard of care is for four or five drugs, with combined side effects, at least one of them usually intravenous (implying hospitalization or an indwelling catheter), and with some but limited success. Anecdotal reports (and indeed at this time they are mostly just this anecdotes, but good ones!) have proclaimed the remarkable effectiveness of this one drug in comparison to the other 4 or 5. The increasing recognition of MAI as a cause of symptoms in full-blown AIDS underlines the importance of these therapies. 8. CHINESE HERBS AS ANTIVIRALS These substances are perhaps the best studied and most scientifically representative of so-called "complementary" therapies. The Quan Yin Healing Arts Center in the Bay Area has published considerable data on the efficacy of oriental medicine in the fight against HIV, and while HIV is relatively new, Chinese medicine is admirably old. (Refer to Qingcai Zhang, MD's 1990 publication, "AIDS and Chinese medicine" for an exhaustive, but not exhausting, treatise on the subject.) Composition A, consisting of approximately 30 different herbs, is one example being widely used presently in Los Angeles. 9. INCREASED COMMUNITY-BASED RESEARCH AIDS activists are no longer waiting for the FDA to obtain potentially beneficial treatments, so physicians have banded together to facilitate research of such treatments. Aerosolized pentamidine, which did meet FDA approval two years ago, was studied largely via community-based groups. This new item rates my top ten list this year because of the formation in June of Search Alliance, a local non-profit organization which joins the ranks of San Francisco's County Community Consortium (CCC) and New York's Community Research Initiative (CRI). I feel that this degree of physician activism and commitment, along with that of affected/infected persons, is seen at governmental level as a more emphatic message, "The old rules just have to go." 10. GOOD NEWS ON HIV NATURAL HISTORY Only three years ago, it was widely believed that all HIV-positive persons would eventually/inevitably develop full-blown AIDS. By 1989 we recognized the existence of different virus strains, which might possess varying virulence levels. The San Francisco Men's Cohort Study shows that after 11 years of seropositivity, 54% of infected gay/bisexual men have a diagnosis of AIDS. (This is considered to be a worst-case scenario, as these blood samples date back to 1978, before we knew anything about AIDS, let alone risk reduction and antiviral therapy.) This year's International AIDS Conference announced that in the 46% who don't, almost half are asymptomatic, many with CD4 counts of over 500! Robert Gallo himself, dean of AIDS research (despite recent controversy regarding his scruples), said in late 1989 that he would estimate over 30% of HIV-infected persons would not develop AIDS. Perhaps HIV can level off in certain hosts. While the validation of his statement remains to be seen over the years to come, it heralds an appropriate seasonal message of HOPE! ============================================================================== MEDICAL UPDATE: DECEMBER 10, 1990 by Mark Katz, M.D. as reported by Jim Stoecker HIGHLIGHTS FROM THE ICAAC The ICAAC (Interscience Conference of Antimicrobial Agents and Chemotherapy) was held in Atlanta during October. This annual conference is second to the International Conference on AIDS in terms of information about HIV and AIDS. At this year's conference, there were some two hundred abstracts on HIV/AIDS. One abstract out of Minneapolis reported on a study of the effect of cocaine on HIV. When cocaine was added to HIV-infected cells in a test tube, researchers noted increased replication of HIV in the cells. In the past, the public health community discouraged cocaine use among those infected with HIV because such use might impair judgment and lead to possible unsafe sex. Now we are seeing that cocaine may in fact stimulate HIV growth in blood cells. There is a possibility that cocaine use is an independent cofactor in the progression of HIV disease. The ICAAC included reports on SCH39304, a new antifungal drug being developed by the Schering Company. This drug may be comparable to or better than fluconazole. We should be hearing more about SCH39304 in the year ahead. A Seattle study looked at the level of HIV excreted in semen. The twenty study subjects were at different stages of HIV disease. The semen of seven patients was consistently negative, i.e., no HIV was excreted, whereas that of three patients was consistently positive. The semen of the remainder of the study subjects varied from testing to testing. At times, HIV was excreted, but not on a consistent basis. The most interesting result of this study is that the excretion of HIV in the semen was not related to the subject's clinical status or T-cell count. In the past, researchers thought that someone later on in HIV disease was more likely to infect others. This study calls such a conclusion into question and reinforces the extremely risky nature of any exchange of semen. An NIH report pointed up the importance of the sinuses as a focus of infection in those who are HIV+. The sinuses harbor bacteria and many also hold fungal infections. Symptoms of sinusitis should be looked at seriously and treated aggressively in HIV+ patients. AZT DOSAGE Almost four years after the FDA approved AZT, we are still asking about the right dosage and the right dosing interval. We now have another study of AZT dosage reported in the New England Journal of Medicine. Sixty-seven HIV+ patients were included in the study. All had CD4 counts between 200 and 500. Some were symptomatic and all had positive p24 or plasma viremia. The study participants were divided into three dosage groups: 300, 600, or 1500 mg daily. After twelve weeks, those on 300 mg showed the greatest increase in CD4 counts. All three groups had comparable decreases in plasma viremia. The 300 and 600 mg groups had better weight gain and less fatigue than the 1500 mg group. This study is still too small a one to change the current standard of care, i.e. 500 mg daily. The investigation continues. It now appears that 300 mg of AZT on a daily basis may be efficacious, though the evidence is not conclusive. As the dosage goes lower, there may be an increasing propensity for AZT resistance. At this point, however, there is support for the use of 300 mg if one is intolerant of a higher dosage. DDI UPDATE A September Lancet article reported that 88% of the original participants in the DDI trials were still alive after 21 months. This is a much higher survival rate than that of the initial AZT study. Since the time of that study, however, we have developed PCP prophylaxis and new treatments for KS. As we get more experience with a drug, we begin to see its side effects. For DDI, the most serious so far seen is pancreatitis. Symptoms include mid-abdominal pain, nausea and vomiting. Elevated amylase levels alone, without any of the above symptoms, may not herald pancreatitis. There is increasing evidence that this side effect is more likely to be found if the patient has a previous history of pancreatitis, has low CD4 counts, exhibits poor overall health or is currently taking MAI or CMV medications. Pancreatitis generally resolves rapidly upon withdrawal from DDI. Neuropathy, a painful tingling in the extremities, is another of the observed side effects of DDI. This most often occurs when the drug dosage is above 9.6 mg/kg. Neuropathy begins to subside soon after going off the drug, though symptoms may linger. There is still a question of whether one should restart at a lower dosage after all symptoms have gone. An abstract at the recent ICAAC reported that five of the sixteen symptomatics in the study (31%) had improved CD4 function after treatment with DDI. For asymptomatics, five of the seven (71%) showed improved CD4 function. Actual CD4 counts remained stable. This points out the importance of looking at the quality, not just the quantity of T cells. We need to look at how well the T cells are working. The actual number does not tell the whole story. Unfortunately, we do not as yet have a routine qualitative T cell test available. STEROIDS AND PCP We now have the official recommendation from an expert panel that steroids be used as a treatment for moderate to severe PCP. The panel noted that such drugs shorten the duration of the infection and lessen the need for a respirator during the infection. It is true that long term steroid use is immunosuppressive. In four of the five studies cited by the panel, however, there was no worsening of other opportunistic infections. Whether steroids should be used for treatment of mild cases of PCP is still an open question. Studies of this issue are currently underway. 566C80: A NEW DRUG FOR PCP TREATMENT Burroughs-Wellcome is developing 566C80, a new anti-PCP drug that is generating much excitement in early clinical studies. This drug may kill the actual cysts which harbor the organism that brings on PCP. Studies with laboratory rats went well and human studies are just beginning. There will be Phase II and III studies to look at 566C80 both as a treatment for acute PCP and as a prophylaxis. We understand that USC is one of the few places in the U.S. involved in the study of this new drug. MAJOR STRIDE IN MAI THERAPY The price of keeping people alive longer with prophylaxis for PCP is that they develop other infections that interfere with the quality of life. Mycobacterium avium or MAI is one such infection. Before the 1980s, only fifty cases of this infection were reported in all the world's medical literature. Now, it is estimated that as many as 50% of PWAs may have MAI in the course of their HIV disease. MAI manifests with multiple symptoms which may be non-specific. Very often, this infection can be confused with other things and is difficult to diagnose. The current standard therapy for MAI is a four or five drug regimen that includes the following: INH, Rifampin, Ethambutol, Ciprofloxacin, Clofazimine, and Amikacin. We see a fairly good response rate to this regimen. There is some improvement of symptoms. The infection, however, does not get cured, and persistent, low grade symptoms may interfere with the quality of life. The four or five drug regimen, however, may be difficult to keep up, since some need to be taken intravenously. Now there is a new antibiotic, clarithromycin, which may offer a one drug anti-MAI therapy. This compound is related to erythromycin, but has a wider spectrum of activity and is more fat soluble. Clarithromycin is available in Ireland, Italy and a few other countries, but has not yet been approved by the FDA for use in the U.S. It is likely to be approved in the next year, however, as a treatment for outpatient pneumonia. We have two studies of clarithromycin as treatment for MAI. A 1989 study looked at how much clarithromycin was needed to treat MAI in the test tube. An effective dose was fairly easy to attain. The researchers also studied MAI-infected rats and found that clarithromycin was the single best drug that they tried as treatment. At the recent ICAAC, Paris researchers reported on a double blind study of clarithromycin for MAI in actual AIDS patients. The study was divided into two groups of twenty-three patients. The first group received clarithromycin alone for the first six weeks. The second group received a placebo during the same period. The clarithromycin group showed a steady decrease in MAI levels over the six weeks, whereas the placebo group showed a steady rise. During the second six weeks of the study, the first group received a placebo and four drugs from the standard regimen. MAI levels began to move up. The second group was given clarithromycin and the four drugs. Their MAI levels steadily decreased. The researchers concluded that clarithromycin either alone or in combination was a reasonably effective treatment for MAI. In Los Angeles, clarithromycin is available through the recently organized Staying Alive Buyers' Club (213.748.1295). The drug, however, is expensive. The standard regimen of four to six pills daily for a month and then two pills daily may cost as much as $400/month. If the FDA approves the drug for pneumonia, a physician can also prescribe it for MAI. The four or five drug regimen remains the current standard of care. Because these drugs are approved and thus paid for by insurance, this regimen may be cheaper for many. But for those who have failed on the standard regimen, clarithromycin offers a viable treatment option. ============================================================================== AZT AND DDI COMBINATION THERAPY Medical researchers have known for several years that chemotherapies in combination are more effective in treating cancer than any one drug by itself. There is a very strong belief in the scientific community that antivirals in combination are similarly be the most effective type of treatment against HIV. In fact,combination therapy was the strongest recommendation made at the last international AIDS conference. Specifically, combining AZT and DDI appeared to be a particularly safe and effective treatment. A report in the British medical journal, Lancet, on September 1, indicated that DDI by itself may be more effective than AZT by itself. Yet it may not be wise to take DDI alone for long periods of time because it can be toxic in moderate to high doses, and because when one antiviral is given alone, it's easier for viruses to develop resistance against it. Theoretically, AZT and DDI in combination should be a safer and more effective treatment. Yet, in spite of these recommendations, ready access to combine these antivirals is still several years away, since DDI is not a legally prescribed drug even though it has been used safely by thousands of patients. FDA regulations specifically forbid combining DDI with AZT until DDI is a prescription medication. And even then the research to see how they work in combination could take years. Many doctors experienced in AIDS care have been combining DDI and AZT in spite of the FDA prohibitions. Funded by a grant from the Theater Center Group, Search is collecting and analyzing their valuable data which might otherwise be lost. If, in fact, AZT and DDI are synergistic, this information could benefit hundreds of thousands of people with HIV. In Project Number 90-5: AZT/DDI COMBINATION THERAPY, Search will be correlating information from community physicians with patients who are already taking this combined therapy. For the purposes of this experiment, combination therapy will consist of at least three (3) AZT and one (1) packet of DDI per day. At this time, information on patients taking less medication, or those who are alternating AZT and DDI, is not being gathered. If you have information which might be pertinent to this study, have your physician contact Search at 213.930.8820. ============================================================================== End of Being Alive Newsletter (January 1991 - part 1/2)