Archive-Name: aids-faq2 Last-Modified: 10 Nov 1993 =============================================================================== Section 3. Confidentiality. Q3.1 How is blood tested in the United States? Q3.2 What if a blood-bank finds out you are HIV positive? ------------------------------------------------------------------------------- Question 3.1. How is blood tested in the United States? All blood products in the U.S. are screened by ELISA assays for several infectious agents, including: HIV 1/2, HTLV I/II, HBV, HCV, Syphillis, Hepatitis B core, and a liver enzyme ALT, indicative of hepatic infections. Some blood donations are also tested for CMV, a more common virus that has devestating effects in immunocompromised individuals, such as cancer patients and transplant recipients. In addition to these laboratories, all donors are screened through questionaires that meet or exceed FDA requirements. ------------------------------------------------------------------------------- Question 3.2. What if a blood-bank finds out you are HIV positive? The Red Cross and other blood banks routinely test blood donations for HIV antibodies. The Red Cross has specifically asked that people not use blood donation as a way of finding out if they are HIV+. If you think you might be infected, go get a blood test. Many cities offer free anonymous HIV testing. Contact your local public health service office for details. This is particularly important if you think you might have been infected within the last six months, since there's the risk that you are indeed infected, but do not yet have antibodies to HIV. Blood donation is a fine thing to do--but how will you feel if you donate, then a month later you find out through some other means that you're HIV+? We're supposed to be making a gift of life, not death. The following article discusses how blood banks use the information, if you have tested positive for HIV antibodies. In addition to your possible role in killing another person, donating blood to obtain a free HIV test also risks your anonymity. From: McCullough J. The nation's changing blood supply system. JAMA. 1993 May;269(17):2239-45. "The coded identity of potential or actual blood donors who are found to be unsuitable on the basis of medical history or laboratory testing is entered into a donor referral registry (DDR). Before each donated unit of blood is made available for use, the coded identity of the donor is checked against the DDR to ensure that the donor has not been found to be unsuitable during a previous donation. Although potentially infectious donors are so informed and asked not to give blood in the future, this DDR check is thought to improve the safety of the blood supply by serving as an additional way of identifying potentially infectious blood should these donors return. The American Red Cross operates a single DDR with information from all of its 47 reginal centers. However, other blood banks' DDRs act only locally since there is no requirement that different blood banks in the same or neighboring communities exchange this DDR information. The operation of these DDRs costs money, consumes experts' time, and has the potential for many abuses such as failure to obtain informed consent and breeches of confidentiality. The value of a DDR in improving the safety of the blood supply has not been established. An analysis of the value of thse DDRs should be conducted, and based on the results, DDRs should be either eliminated or refined into an appropriate system." See also: Grossman BJ. Springer KM. Blood donor deferral registries: highlights of a conference. Transfusion. 1992;32:868-72. =============================================================================== Section 4. Treatment options. Q4.1 General treatment information. Q4.2 AIDS and Opportunistic Infections. Q4.3 Guide to Social Security Benefits. Q4.4 What if you can't afford AZT? Q4.5 What about DNCB? (please contribute) ------------------------------------------------------------------------------- Question 4.1. General treatment information. [This article was published in AIDSFILE, 1993 Sept, Vol. 7, No. 3, p. 1-3. (Copyright 1993 The Regents of the University of California). The Regents grant permission for material in AIDSFILE to be reprinted for use by nonprofit educational institutions for scholarly or instructional purposes only, provided that (1) the author and AIDSFILE are identified; (2) proper notice of the copyright appears on each copy; (3) copies are distributed at or below cost.] Review of Clinical Guidelines - Antiretroviral Therapy Paul A. Volberding, MD Introduction A number of new observations have been made recently concerning antiretroviral therapy for HIV infection. Although new data is always welcome, lately it seems to cause as much confusion as clarification. Caregivers for patients with HIV disease continue to recognize the established benefits of antiretroviral therapy, but new uncertainties have been introduced. These uncertainties mean that we must consider the new information in order to make the best use of available treatments at the same time that we appreciate their limitations. Those who care for patients with HIV disease also anticipate the introduction of new classes of drugs, and we are beginning to determine how we might use these additional agents in our patient care. Review of Clinical Guidelines Antiretroviral therapy clearly has shown activity in delaying the progression and death of patients with HIV infection, especially when therapy has been tested in patients with more advanced disease. But even in asymptomatic HIV infection there is a general agreement of at least a transient clinical benefit from the use of nucleoside analog therapy. It is clear also that antiretroviral therapy improves various laboratory markers of the disease, including immunologic and virologic disease markers, such as CD4 cell counts and HIV p24 antigen levels. Further evidence of the clinical activity of these drugs comes from trials showing a second period of benefit when therapy is changed to a non-cross-resistant agent, for example, switching from zidovudine to ddI. In addition, we are encouraged by symptomatic improvement in patients with advanced disease who are started on antiretroviral drugs. Also, many retrospective epidemiology studies continue to show a survival advantage in patients taking these drugs. Despite continuing agreement on some of the benefits of antiretroviral therapy, we also face growing uncertainties. Recent studies have shown no survival advantage when antiretroviral drugs are used in asymptomatic HIV infection, and any benefit in slowing clinical progression seems to disappear when zidovudine monotherapy, at least, is given for a prolonged period. Questions continue as well about the degree of benefit of antiretroviral therapy for patients with advanced HIV disease. Early clinical trials of zidovudine, for example, were done before the routine used of PCP prophylaxis, which, by itself, delays progression to that common indicator of AIDS. Questions about the current status of antiretroviral therapy include: Which drug or combination is superior as initial therapy? When should this initial therapy begin? What is the duration of the benefit from initial therapy? How long should it be continued before other drugs or combinations are initiated? Finally it is important to consider: Which drugs should be used following initial therapy? What might we anticipate in the future from drugs in current clinical development? Beginning Therapy -- What and When Probably the easiest question at the moment in the field of HIV therapy is which drug to use to begin treatment. Data from ACTG 116A make it clear that zidovudine is superior to ddI as a monotherapy in previously untreated patients, and data from other studies show the superiority of zidovudine over ddC. An independent "State of the Art Panel" recently convened by the National Institute of Allergy and Infectious Diseases (NIAID) and chaired by Merle Sande, MD, UCSF chief of the medical service at San Francisco General Hospital, found an easy consensus that zidovudine monotherapy is the initial therapy of choice. Even here, however, other opinions may be heard, especially concerning the potential for initial use of combinations of nucleoside analogs. For example, the recent ACTG 155 trial in much more advanced disease tended to show a superiority of the combination of zidovudine and ddC, which was limited to patients with the highest CD4 cells (between 150 and 300). A large study, ACTG 175, is comparing initial combination with monotherapy, but the results from this trial are not anticipated before the end of 1995. In the meantime, combinations including zidovudine with ddI or zidovudine with ddC as initial therapy remain of interest. When best to initiate antiretroviral therapy is probably the most controversial question in the field of HIV management. Extended data from ACTG 019 demonstrate durable clinical progression benefit with the use of 500 mg of zidovudine daily in patients with asymptomatic HIV infection and with CD4 cell counts between 300 and 500, but these data are in apparent conflict with those from the recently completed Concorde Study. Concorde, enrolling more than 1700 patients with any level of CD4 count, compared the initial use of one gram of zidovudine daily with the same therapy deferred until after the person developed AIDS or ARC. After a median treatment duration of three years, and despite a clear and sustained CD4 improvement with the immediate use of zidovudine, there was no apparent benefit in the immediate treatment group either in clinical progression or survival. When the investigators analyzed a subset of the overall group with CD4 counts below 500 cells and after one year of therapy, a benefit similar to that seen in ACTG 019 was observed. Although Concorde was a powerful study, given the size and duration of follow-up, concerns have been raised that the dosage at one gram was excessively high and that the large number of patients allowed to begin therapy before they became symptomatic complicates the analysis. Also adding to the confusion are the recently published results of the European-Australian cooperative Group trial, which tended to find a clinical benefit with the use of zidovudine in patients with CD4 counts up to 750 cells. The State of the Art Panel recommended two broad options after considering the available data--initiating therapy in asymptomatic individuals with CD4 counts under 500 cells, or delaying this therapy until symptomatic HIV disease intervened. Another option favored by many clinicians is to follow patients, delaying therapy until evidence of more rapid disease progression becomes apparent as manifested by rapid declines in CD4 count or by a rise in p24 antigen or, especially, a rise in beta-2 microglobulin. At any rate, the clinician must discuss the various options with each patient, individualizing this decision according to the clinical and laboratory status of the patient and according to the patient's own desires. Duration of Therapy A second difficult question in the field of HIV management is how long to continue initial zidovudine. Again, the ACTG 019 experience would suggest that zidovudine monotherapy has a prolonged period of benefit, especially in patients with higher CD4 cell counts (300-500) when therapy is begun. On the other hand, ACTG 116A seemed to indicate that the initial superiority of zidovudine was lost after as little as two to four months of treatment with this drug prior to treatment with didanosine. Here again, the State of the Art panel could find little room for consensus. When therapy is begun in individuals with CD4 counts above 300, the panel suggested that it should be continued until the CD4 cell count fell below 300. When zidovudine monotherapy is begun in patients with CD4 counts under 300, the additional option of switching to ddI monotherapy after a fixed interval was raised, but again this interval was not defined. Once zidovudine monotherapy has been used, and when it is no longer felt to be effective for an individual, secondary therapy must be initiated. The choice of this therapy, however, is also uncertain. In moderate disease, with CD4 cell counts below 300, switching to ddI was superior to continuing with zidovudine in ACTG trials 116a and 116b/117, while switching to ddC was not of benefit in ACTG 155. On the other hand, from data gathered in CPCRA Trial 002, in patients with more advanced disease, ddI and ddC were equivalent in secondary treatment of patients previously treated with zidovudine who had progressed despite taking that drug or who were intolerant of zidovudine toxicity. In fact, ddC had a slight but significant superiority compared to ddI in terms of survival in this trial. It was hoped that combination therapy following zidovudine would be beneficial but questions have been raised following the results of ACTG 155. In this study, patients previously treated with zidovudine with CD4 cells below 300 were randomized to stay on zidovudine, start ddC monotherapy, or begin zidovudine and ddC combination therapy. Overall, there was no difference in clinical progression or survival among the three study arms. When the baseline CD4 counts are examined, however, it was found that combination therapy was superior in patients with higher CD4 cell counts, especially between 150 and 300. Therefore, it might seem advisable not to delay the introduction of combination therapy until patients have very advanced disease but rather to use such therapy earlier in the disease course. Whether zidovudine and ddI would be as good as zidovudine and ddC has not been investigated. Newer Classes of Drugs Along with new data on existing therapies, more information is available now on newer classes of drugs. These include nucleoside analogs, non-nucleoside reverse transcriptase inhibitors, protease inhibitors, and the tat inhibitor. Nucleoside Analogs. New nucleoside analogs in clinical investigation include d4T (stavudine) and 3TC. d4T has been much more extensively studied and appears effective in raising CD4 count and lowering HIV p24 antigen in a number of Phase 1 trials. It appears safe. Although cases of pancreatitis have been reported, they seem to be extremely rare. Neuropathy is the main toxicity but, again, it appears to be somewhat less than with ddI or ddC. d4T may not be suitable for combination with zidovudine as the two drugs have a negative interaction limiting their activation within the cell. On the other hand, d4T is a well-tolerated drug and may prove to be an alternative to one or more of the existing nucleosides. 3TC also appear safe and may be able to help restore sensitivity to zidovudine when the patient's HIV has become resistant. Reverse Transcriptase Inhibitors. The non-nucleoside reverse transcriptase inhibitors, including nevirapine and the Merck "L" drug, were recently thought to have limited value because they induce high-level drug resistance so rapidly. At the Berlin conference, however, one report showed that by increasing the dosage of nevirapine to 400 mg daily, a dose well above the level of resistance, prolonged benefit might be achieved. Also, it was shown that combining zidovudine with nevirapine delays the onset of nevirapine resistance. Thus, these drugs may still find a place in clinical medicine. At the same time, convergent therapy, using three drugs together, was disappointing because of simultaneous resistance to zidovudine, ddI and non-nucleoside reverse transcriptase inhibitors. Protease Inhibitors. Protease inhibitors seem to be gaining some ground. In Phase 1 trials, several of these compounds have evident antiretroviral activity, which was reflected in decreasing HIV p24 and increasing CD4 cell counts. Clinical benefits have not been established nor has the activity of these drugs used in combination with zidovudine been described. Because several structurally different protease inhibitors are being developed by different drug companies, it is hoped that at least one of these compounds will become more widely available soon for clinical use. Tat. While the protease inhibitors appear encouraging, tat inhibitors appear to be clinically inactive. In Phase 1 trials of the Hoffman LaRoche tat inhibitor, little or no antiretroviral activity was seen and it is probably that this class of drugs will not be developed further. Summary Given this complex and seemingly confusing information, what recommendations can be given to the clinician? Most important is to individualize the decision-making and to consider the desires of the patient even more than previously. Some patients gravitate easily to more aggressive therapy, while others prefer a more conservative therapeutic approach. With the former, initiating therapy at or even above 500 CD4 counts, perhaps even with a combination of zidovudine and ddI, may be considered. For more conservative patients, however, following the recommendations of the Concorde study may in order. In other words, defer the initiation of zidovudine monotherapy until the onset of clinical symptoms. Once the choice of initial therapy has been made, all other recommendations must also be individualized. No firm data are available to guide the decision about how long to continue a therapy or even about what to use next. Most of these options have not been compared directly in clinical trials. It would seem advisable to continue therapy longer in patients with relatively earlier disease when therapy is initiated. On the other hand, if patients have more advanced disease, for example, are symptomatic or have CD4 cell counts below 300 when therapy is begun, then a more rapid alteration of therapy to a non-cross-resistant drug or combination should be considered. The goal in each patient is to continue effective antiretroviral therapy for as long as possible, discontinuing the therapy if further benefits appear impossible. Although the results of recent clinical trials are disappointing in some respects, it nevertheless is important to have these data. Only then can we adjust our expectations and our patients' expectations of antiretroviral treatment and learn how to make the best use of the drugs that we have available. Recognizing the increasing need for the development of new classes of more effective drugs in combinations, we must still seek to maintain the optimism that enables progress in our patients' care. Dr. Volberding is a UC San Francisco professor of medicine and Director, UCSF AIDS Program at San Francisco General Hospital. References: ZDV and The AIDS Clinical Trials Group (1989-93): Aweeka FT. Gambertoglio JG. et al. Pharmacokinetics of concomitantly administered foscarnet and zidovudine for treatment of human immunodeficiency virus infection (AIDS Clinical Trials Group protocol 053). Antimicrobial Agents & Chemotherapy. 36(8):1773-8, 1992 Aug. Fischl MA. Richman DD. et al. The safety and efficacy of zidovudine (AZT) in the treatment of subjects with mildly symptomatic human immunodeficiency virus type 1 (HIV) infection. A double-blind, placebo-controlled trial. The AIDS Clinical Trials Group [see comments]. Annals of Internal Medicine. 112(10):727-37, 1990 May 15. [Editor's Note: This article reports the results of ACTG 106.] Fischl MA. Parker CB. et al. A randomized controlled trial of a reduced daily dose of zidovudine in patients with the acquired immunodeficiency syndrome. The AIDS Clinical Trials Group. New England Journal of Medicine. 323(15): 1009-14, 1990 Oct 11. Gelber RD. Lenderking WR. et al. Quality-of-life evaluation in a clinical trial of zidovudine therapy in patients with mildly symptomatic HIV infection. The AIDS Clinical Trials Group. Annals of Internal Medicine. 116(12 Pt 1):961-6, 1992 Jun 15. Hochster H. Dieterich D. et al. Toxicity of combined ganciclovir and zidovudine for cytomegalovirus disease associated with AIDS. An AIDS Clinical Trials Group Study. Annals of Internal Medicine. 113(2):111-7, 1990 Jul 15. Kahn JO. Lagakos SW. et al. A controlled trial comparing continued zidovudine with didanosine in human immunodeficiency virus infection. The NIAID AIDS Clinical Trials Group [see comments]. New England Journal of Medicine. 327(9):581-7, 1992 Aug 27. Koch MA. Volberding PA. et al. Toxic effects of zidovudine in asymptomatic human immunodeficiency virus-infected individuals with CD4+ cell counts of 0.50 x 10(9)/L or less. Detailed and updated results from protocol 019 of the AIDS Clinical Trials Group. Archives of Internal Medicine. 152(11):2286-92, 1992 Nov. Krogstad DJ. Eveland MR. et al. Drug level monitoring in a double-blind multicenter trial: false-positive zidovudine measurements in AIDS clinical trials group protocol 019. Antimicrobial Agents & Chemotherapy. 35(6): 1160-4, 1991 Jun. Meng TC. Fischl MA. Richman DD. AIDS Clinical Trials Group: phase I/II study of combination 2',3'-dideoxycytidine and zidovudine in patients with acquired immunodeficiency syndrome (AIDS) and advanced AIDS-related complex. American Journal of Medicine. 88(5B):27S-30S, 1990 May 21. Sidtis JJ. Gatsonis C. et al. Zidovudine treatment of the AIDS dementia complex: results of a placebo-controlled trial. AIDS Clinical Trials Group. Annals of Neurology. 33(4):343-9, 1993 Apr. Sperling RS. Stratton P. Treatment options for human immunodeficiency virus-infected pregnant women. Obstetric- Gynecologic Working Group of the AIDS Clinical Trials Group of the National Institute of Allergy and Infectious Diseases. Obstetrics & Gynecology. 79(3):443-8, 1992 Mar. Volberding PA. Lagakos SW. et al. Zidovudine in asymptomatic human immunodeficiency virus infection. A controlled trial in persons with fewer than 500 CD4-positive cells per cubic millimeter. The AIDS Clinical Trials Group of the National Institute of Allergy and Infectious Diseases [see comments]. New England Journal of Medicine. 322(14):941-9, 1990 Apr 5. [Editor's Note: This article reports the results of ACTG 109.] See also: Aboulker JP. Swart AM. Preliminary analysis of the Concorde trial. Concorde Coordinating Committee [letter]. Lancet. 1993 Apr 3;341(8849):889-90. Comment in: Lancet 1993 Apr 17;341(8851): 1022-3; Lancet 1993 Apr 17;341(8851):1023; Lancet 1993 May 15; 341(8855):1276; Lancet 1993 May 15;341 (8855):1276-7; and Lancet 1993 May 15;341(8855):1277. Cooper DA. Gatell M. et al. Zidovudine in persons with asymptomatic HIV infection and CD4+ cell counts greater than 400 per cubic millimeter. New England Journal of Medicine. 329(5): 297-303, 1993 Jul 29. Hamilton JD. Hartigan PM. et al. A controlled trial of early versus late treatment with zidovudine in symptomatic human immunodeficiency virus infection. Results of the Veterans Affairs Cooperative Study. New England Journal of Medicine. 326(7):437- 43, 1992 Feb 13. ------------------------------------------------------------------------------- Question 4.2. AIDS and Opportunistic Infections. AIDS and Opportunistic Infections NIAID BACKGROUNDER: Office of Communications, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland 20892 - September 1993 Opportunistic infections (OIs) cause most of the illnesses and deaths among people infected with HIV, the virus that causes AIDS. The National Institute of Allergy and Infectious Diseases (NIAID) leads the way in U.S. research on these life-threatening infections. As part of the NIAID effort, investigators are defining the optimal therapies, alone and in combination, to prevent and treat OIs. They seek ways to identify infections earlier and recognize resistance to therapies more quickly. What are OIs? The immune systems of most people with HIV gradually deteriorate, leaving them vulnerable to numerous viruses, fungi, bacteria and protozoa that are held in check in people with healthy immune systems. These microbes can become active in HIV-infected individuals, causing frequent and severe disease. NIAID uses a two-pronged approach to the prevention and treatment of OIs: basic laboratory research to learn how these microbes cause disease and clinical research to develop and evaluate promising therapies. Prevention and treatment of one such disease, Pneumocystis carinii pneumonia or PCP, has been a major thrust of the NIAID program. Other NIAID investigations include cytomegalovirus (CMV) infection, Mycobacterium avium complex (MAC) and tuberculosis (TB). Institute research focuses on these infections because, although they occur repeatedly among HIV-infected people, they are rare in the general population and few drugs are available now to prevent and treat them. PCP: The Most Common OI PCP remains the most common, life-threatening opportunistic infection in people with HIV, occurring in up to 80 percent of individuals who do not take preventive therapy. The PCP organism, a microscopic parasite, appears to infect most people during childhood. In people with healthy immune systems, the parasite normally remains dormant, but it may cause disease in those with damaged immune systems. PCP infection is characterized by a dry cough and shortness of breath. Individuals may experience other, less specific symptoms such as fever, fatigue and weight loss for weeks or even months before respiratory problems appear. As PCP infection progresses, the functioning lung tissue becomes clogged, which decreases the transport of oxygen from the inhaled air into the blood. At this point, the oxygen in the blood may be lowered to dangerous or even fatal levels. Without treatment, close to 100 percent of HIV-infected patients with PCP die. During the 1980s, the development of effective therapies led to better management of PCP. Drugs for preventing and treating PCP include aerosolized pentamidine and oral trimethoprim-sulfamethoxazole (TMP/SMX), but both can result in serious side effects that prevent some patients from taking the drugs. TMP/SMX is recommended more often than aerosolized pentamidine for treating and preventing PCP because the combination is effective, tolerated by about half of the patients who take it and may work against other disease-causing organisms as well. In 1992, an NIAID-supported trial proved that TMP/SMX is better than aerosolized pentamidine at preventing a second episode of PCP in people with AIDS who can tolerate either therapy. Although definitive research data are lacking, other agents may be considered in situations in which neither TMP/SMX nor aerosolized pentamidine can be given. The drug atovaquone is approved for patients with mild to moderate PCP who cannot tolerate TMP/SMX. One NIAID study showed that primaquine, an antimalaria drug, with clindamycin is an effective oral therapy for PCP. TMP with dapsone is an alternative treatment. The search for new, more effective, less toxic drugs and combinations of drugs to fight PCP continues. NIAID studies play an important role in this effort. One trial compares three drug regimens--TMP/dapsone, primaquine/clindamycin and TMP/SMX--for oral treatment of mild to moderate PCP. Another protocol looks at an 8-aminoquinoline, an antimalaria drug, while a third trial considers two regimens of TMP/SMX to prevent PCP. CMV: A Herpesvirus Infection with CMV, a virus in the herpes family, may occur throughout life. By age 50, about half of the general population has been exposed to this virus, yet most people do not become ill. After the original infection, the virus may lie dormant and reactivate itself if the immune system becomes suppressed. For people with HIV infection, CMV is one of the most frequent and serious OIs they face. CMV retinitis, an inflammation of the light-sensitive inner layer of the eye, is the most common CMV infection and leads to blindness if left untreated. Infections also may occur in the gastrointestinal tract, lungs, brain, heart and other organs. Both intravenous ganciclovir and foscarnet are approved to treat CMV retinitis. Lifelong maintenance on either treatment is required because the drugs do not kill CMV, they merely slow down its ability to grow. Even with therapy, the rate of relapse is high. NIAID studies of CMV and other herpesviruses have shown that intravenous foscarnet and ganciclovir are equally effective for CMV retinitis, although foscarnet was associated with increased survival for patients in the study. An ongoing trial is testing an oral form of ganciclovir to prevent CMV disease. The oral form of the drug would be much easier and safer for patients to take. MAC: A Bacterial OI Infection with MAC is diagnosed in up to 40 percent of people with AIDS in the United States, making it the most common bacterial OI. Usually, it affects people in advanced stages of HIV disease when the immune system is severely suppressed. The MAC organism is found widely in the environment and is thought to be acquired most commonly through the mouth or gastrointestinal tract. It can spread to the lungs, liver, spleen, lymph nodes, bone marrow, intestines and blood. MAC causes chronic debilitating symptoms--fever, night sweats, weight loss, fatigue, chronic diarrhea, abdominal pain, liver dysfunction and severe anemia. Rifabutin is the first drug to be approved for preventing MAC disease in people with advanced HIV infection. The Food and Drug administration based this approval on clinical studies showing that patients who received rifabutin were one-third to one-half as likely to develop MAC as were patients who received placebo. To prevent MAC disease, a U.S. Public Health Service Task Force on Prophylaxis and Therapy for MAC suggests that patients with HIV infection and fewer than 100 CD4 + T cells receive oral rifabutin for the rest of their lives unless disease develops. In the latter case, multiple drug treatment is needed. CD4+ T cells are immune system cells targeted and killed by HIV. No other drug regimen is recommended currently to prevent MAC. Azithromycin and clarithromycin are promising agents for prophylaxis, but studies of these agents have not been completed. Increasing evidence suggests that treatment can benefit patients with disseminated MAC, especially multiple-drug regimens including either clarithromycin or azithromycin. Therefore, the PHS task force suggests that all regimens, outside of a clinical trial, should consist of at least two drugs, including clarithromycin or azithromycin plus one other agent such as clofazimine, rifabutin, rifampin, ciprofloxacin and, in certain situations, amikacin. They recommend continued therapy for the patient's lifetime, as long as clinical benefit and reduction of mycobacteria are observed. NIAID has several studies under way looking at the roles of clarithromycin and azithromycin, and other drugs such as sparfloxacin, alone and in combination, to prevent and treat this serious disease. TB: An Airborne Disease TB, a chronic bacterial infection, causes more deaths worldwide than any other infectious disease. About one-third of the world's population harbors the predominant TB organism, Mycobacterium tuberculosis, and is at risk for developing the disease. The World Health Organization (WHO) estimates that 4.4 million people worldwide are coinfected with TB and HIV. WHO predicts that by the year 2000, TB will take one million lives annually among the HIV-infected. Because of their weakened immune systems, people with HIV are vulnerable to reactivation of latent TB infections, as well as to new TB infections. Transmission of this disease occurs most commonly in crowded environments such as hospitals, prisons and shelters--where HIV-infected individuals make up a growing proportion of the population. Active TB may occur early in the course of HIV infection, often months or years before other OIs. TB most often affects the lungs, but it also can cause disease in other parts of the body, particularly in people with advanced HIV disease. Of particular concern for people with AIDS is multi-drug-resistant TB (MDR-TB). MDR-TB can occur when patients fail to take their TB medicine for the prolonged periods necessary to destroy all TB organisms, which then become resistant to the drugs. These resistant organisms can be spread to other people. Even with treatment, for individuals coinfected with HIV and MDR-TB, the death rate may be as high as 80 percent, as opposed to 40 to 60 percent for people with MDR-TB alone. The time from diagnosis to death may be only months for some patients with HIV and MDR-TB, as they are sometimes left without adequate treatment options. The initial site of TB infection is in the balloon-like sacs at the ends of the small air passages in the lungs. In these sacs, white blood cells called macrophages ingest the inhaled TB organism. Some of the organisms are killed immediately, while others remain and multiply within the macrophages. If the organism breaks out of the sacs, TB can become active disease. This spreading sometimes results in life-threatening meningitis and other problems. NIAID launched the first large U.S. study to assess TB treatment strategies for people coinfected with HIV and TB. The study is aimed at finding state-of-the-art treatment. NIAID is the lead institute for TB research at the National Institutes of Health, supporting more than 50 research projects related to TB. Other OIs NIAID-supported scientists also study other OIs including fungal infections, herpes simplex virus infections, toxoplasmosis and cryptosporidium infections. ------------------------------------------------------------------------------- Question 4.3. Guide to Social Security Benefits. U.S. Department of Health and Human Services Social Security Administration SSA Publication No. 05-10020 September 1993 A Guide to Social Security and SSI Disability Benefits For People With HIV Infection About This Booklet Social Security can provide a lifeline of support to people with HIV infection. That lifeline comes in the form of monthly Social Security disability benefits and Supplemental Security Income payments, Medicare and Medicaid coverage, and a variety of other services available to people who receive disability benefits from Social Security. If you are disabled because of HIV infection, this booklet will help you understand the kinds of disability or Supplemental Security Income programs. What's Inside Part 1 -- Background Information The first section provides some brief background information about HIV infection and Social Security. Part 2 -- What Benefits Are You Eligible For? This section explains the nonmedical rules and eligibility factors for Social Security Disability Insurance benefits and Supplemental Security Income Disability payments. Part 3 -- How Does Social Security Define "Disability?" This section explains Social Security's definition of "disability" and how it relates to claimants with HIV infection. Part 4 -- How Does Social Security Evaluate Your Disability This section explains how Social Security evaluates disability claims involving HIV diseases in general. And it includes up-to- date information about the way we process claims, especially those involving women and children with HIV infection. Part 5 -- How Do You File For Disability Benefits? This section includes information about when and how to apply for disability, what steps we take to ensure that your claim is processed quickly and accurately, and most important, what things you can do to help the process along. Also included is information about situations when we can presume a person is disabled and make immediate payments. Part 6 -- Helping You Return To Work This section provides an overview of special rules designed to help you return to work. Part 7 -- What you Need To Know About Medicaid And Medicare This section includes a brief overview of the kinds of benefits available from the Medicaid and Medicare programs. For More Information ***************************************************************** PART 1 -- BACKGROUND INFORMATION Acquired immunodeficiency syndrome (AIDS) is characterized by the inability of the body's natural immunity to fight infection. It is caused by a retrovirus known as human immunodeficiency virus, or HIV. Generally speaking, people with HIV infection fall into two broad categories: 1) those with symptomatic HIV infection, including AIDS; and 2) those with HIV infection but no symptoms. Although thousands of people with HIV infection are receiving Social Security or Supplemental Security Income disability benefits, we believe there may be others who might be eligible for these benefits. Social Security is committed to helping all men, women, and children with HIV infection learn more about the disability programs we administer. And if you qualify for benefits, we are just as committed to ensuring that you receive them as soon as possible. You should also be aware that the Social Security Administrations's criteria for evaluating HIV infection are not linked to the Centers for Disease Control's (CDC) definition of AIDS. This is because the goals of the two agencies are different. CDC defines AIDS primarily for surveillance purposes, not for the evaluation of disability. PART 2 -- WHAT BENEFITS ARE YOU ELIGIBLE FOR? We pay disability benefits under two programs: Social Security Disability Insurance, sometimes referred to as SSDI, and Supplemental Security Income, often called SSI. The medical requirements are the same for both programs, and your disability is determined by the same process. However, there are major differences in the nonmedical factors, which are explained in the next two sections. Social Security Disability Insurance Benefits: The Nonmedical Rules Of Eligibility Here are examples of how people qualify for SSDI: o Most people qualify for Social Security disability by working, paying Social Security taxes, and in turn, earning "credits" toward eventual benefits. The maximum number of credits you can earn each year is 4. The number of credits you need to qualify for disability depends on your age when you become disabled. Nobody needs more than 40 credits and young people can qualify with as few as 6 credits. o Disabled widows and widowers age 50 or older could be eligible for a disability benefit on the Social Security record of a deceased spouse. o Disabled children age 18 or older could be eligible for dependent's benefits on the Social Security record of a parent who is getting retirement or disability benefits, or on the record of a parent who has died. (The disability must have started before age 22.) o Children under the age of 18 qualify for dependents benefits on the record of a parent who is getting retirement or disability benefits, or on the record of a parent who has died, merely because they are under age 18. For more information about Social Security disability benefits in general, ask Social Security for a copy of the booklet, Disability (Publication No. 05-10029). How Much Will Your Benefits Be? How much your Social Security benefit will be depends on your earnings history. Generally, higher earnings translate into higher Social Security benefits. You can find out how much you will get by contacting Social Security and asking for an estimate of your benefits. We'll give you a form you can use to send for a free statement that contains a record of your earnings and an estimate of your benefits. In addition to checking your benefit, we encourage you to use this statement to verify that your earnings have been properly recorded in our files. It's important that you do this because any missing or unreported wages could lower your Social Security benefit or even prevent you from qualifying for disability benefits. If you find a problem, contact your local Social Security office right away, show them proof of your actual wages, and the record will be corrected. This can be particularly important for people who have tested positive for HIV but have not developed symptoms, so that any potential benefits will not be delayed by wage correction efforts. Disabled widows, widowers, and children eligible for benefits as a dependent on a spouse's or parent's Social Security record receive an amount that is a percentage of the worker's Social Security benefit. Supplemental Security Income: The Nonmedical Rules Of Eligibility SSI is a program that pays monthly benefits to people with low incomes and limited assets who are 65 or older, or blind, or disabled. As its name implies, "Supplemental" Security Income "supplements" a person's income up to a certain level that can go up every year based on cost-of-living adjustments. The level varies from one state to another, so check with your local Social Security office to find out more about SSI benefit levels in your state. We don't count all the income you have when we figure out if you qualify for SSI. And if you work, there are special rules we use for counting your wages. Again, check with Social Security to find out if you can get SSI. In addition to rules about income, people on SSI must have limited assets. Generally, individuals with assets under $2000, or couples with assets under $3000, can qualify for SSI. However, when we figure your assets, we don't count such items as your home, your car (unless it's an expensive one), and most of your personal belongings. Your Social Security office can tell you more about the income and asset limits. For more general information, ask for a copy of the booklet, SSI (Publication No. 05-11000). PART 3 -- HOW DOES SOCIAL SECURITY DEFINE DISABILITY? In this section, we'll explain the criteria you must meet in order to be considered "disabled." First, we'll explain in general terms how Social Security defines and determines disability. Then we'll discuss how it applies to people with HIV infection. The General Definition Of Disability Disability under Social Security is based on your inability to work because of a medical condition. You will be considered disabled if you are unable to do any kind of "substantial" work for which you are suited. (Usually, monthly earnings of $500 or more are considered substantial.) Your ability to work must be expected to last at least a year. Or, the condition that keeps you from working must be so severe that you are not expected to live. For children, we decide how the condition affects their ability to function--to do the things and behave in the ways that other children of the same age normally would. How This Definition Of Disability Applies To People With HIV Infection A person with symptomatic HIV infection is often severely limited in his or her ability to work. In other words, if the evidence shows that you have symptomatic HIV infection that severely limits your ability to work, and if you meet the other eligibility factors, the chances are very good that you will be able to receive Social Security or SSI Benefits. On the other hand, some people with HIV infection may be less impaired and able to work, so they may not be eligible for disability. PART 4 -- HOW DOES SOCIAL SECURITY EVALUATE YOUR DISABILITY? Social Security works with an agency in each state, usually called a Disability Determination Service (DDS), to evaluate disability claims. At the DDS, a disability evaluation specialist and a doctor follow a step-by-step process that applies to all disability claims, thus assuring a consistent approach to evaluating disability. First, the DDS specialists decide whether your impairment is "severe." This simply means the evidence must show that your disability interferes with your ability to work. The next step in the process is deciding whether the disability is included in a list of impairments. This list describes, for each of the major body systems, impairments that are considered severe enough to prevent an adult from doing any substantial work or in the case of children under the age of 18, impairments that are severe enough to prevent a child from functioning in a manner similar to other children of the same age. Recently we published a list of impairments for HIV infections. In this list, we have included many conditions associated with symptomatic HIV infection, including some that specifically apply to women and children with HIV infection (See next two sections). Some of the HIV-related conditions included in the HIV list of impairments are shown below. The level of severity that an impairment must meet to be found disabling are also specified in the regulations. o Pulmonary tuberculosis resistant to treatment o Kaposi's sarcoma o Pneumocystis carinii pneumonia (PCP) o Carcinoma of the cervix o Herpes Simplex o Hodgkin's disease and all lymphomas o HIV Wasting Syndrome o Syphilis and Neurosyphilis o Candidiasis o Histoplasmosis Remember: these are just a few examples. You can see a complete list of HIV-related impairments at any Social Security office. The complete list will also include the findings necessary for listed impairments to be considered disabling by Social Security. If you have symptoms of HIV infection that are not specifically included in (or equal in severity to) the impairments on our list, then DDS disability specialists will look at how frequently these conditions occur and how they affect your ability to function. The DDS team will evaluate how well you function in three general areas: daily activities; social functioning; and the ability to complete tasks in a timely manner, which requires the ability to maintain concentration, persistence, and pace. If you have "marked limitations" in any one of these functional areas and repeated manifestations of HIV meeting the criteria in the listings, you may be found disabled. A marked limitation is one that seriously interferes with your ability to function independently, appropriately, and effectively. It does not mean that you must be confined to bed, hospitalized, or in a nursing home. If the specialists decide that you are not disabled at this point because you do not have a condition that exactly matches or is equal in severity to one on our list, then they will look to see if your condition prevents you from doing the work you normally do. If it does not, then we look to see if it prevents you from doing any other type of work you're suited for, based on your age, education, and experience. If it does, you may still be found disabled. Remember, at all steps in the process, your impairment must be documented. Documentation includes medical records from your doctors, as well as laboratory test results, X-ray reports, etc. The HIV infection itself--that is, the presence of the virus--must be documented as well as any HIV-related manifestations. At all steps in the process it is important that we have evidence of signs, symptoms, and laboratory findings associated with HIV infection, as well as information on how well you are able to function day-to-day. The signs and symptoms may include: repeated infections; fevers/night sweats; enlarged lymph nodes, liver or spleen; lower energy or generalized weakness; dyspnea on exertion; persistent cough; depression/anxiety; headache; anorexia; nausea and vomiting; and side effects of medication and/or treatment, as well as how your treatment affects your daily activities. Evaluation Of HIV Infection In Women Statistics show that there is an increasing number of women with HIV diseases. Social Security's guidelines for the immune system recognize that HIV infection can show up differently in women than in men. In addition to following the criteria outlined in the previous section, DDS disability evaluators consider specific criteria for diseases common in women. These include: vulvovaginal candidiasis (yeast infection); genital herpes; pelvic inflammatory disease (PDI); invasive cervical cancer; genital ulcerative disease; and condyloma (genital warts caused by the human papillomavirus). Again, the level of severity necessary for these impairments to be considered disabling is included in the list of impairments. Evaluation Of HIV Infection In Children We also have separate listings for children with HIV infection. These guidelines recognize the fact that the course of the disease in children can differ from adults. As with adults, some children may not appear to have the conditions specified in the guidelines, or may have listed conditions that are not as severe as the guidelines require. When this happens, a functional assessment is made using criteria contained in the lists. A child may be disabled if the HIV-related impairments substantially reduce his/her ability to grow, develop, or engage in activities similar to children of the same age. For more information about disability benefits for children, ask Social Security for a copy of the booklet, Social Security And SSI Benefits For Children With Disabilities (Publication No. 05- 10026). PART 5 -- HOW DO YOU FILE FOR DISABILITY BENEFITS You apply for Social Security and SSI disability benefits by calling or visiting any Social Security office. All Social Security files are kept strictly confidential. It would help if you have certain documents with you when you apply. But don't delay filing because you don't have all the information you need. We'll help you get the rest of it after you sign up. The information you'll need may include: o your Social Security number and birth certificate; o the Social Security numbers and birth certificates for family members signing up on your record; and o a copy of your most recent W-2 form (or your tax return if you're self-employed). If you're signing up for SSI, you will need to provide records that show that your income and assets are below the SSI limits. This might include such things as bank statements, rent receipts, care registration, etc. You'll also need to give us information about how your condition affects your daily activities, the names and addresses of your doctors and clinics where you've received treatment, and a summary of the kind of work you've done in the last 15 years. If you have medical evidence such as reports of blood tests, laboratory work, or a physical, it would be helpful if you brought them with you. In the section below (What You Can Do to Expedite the Processing of Your Claim), we give you some guidelines for providing us with medical and vocational information that will help speed up your claim. But first, we want you to know what Social Security does to make the process work as smoothly as possible. What Steps Has Social Security Taken To Ensure Prompt Processing And Payment Of Disability Benefits? All HIV infection claims are given prompt attention and priority handling. For many people applying for SSI with a medical diagnosis of symptomatic HIV infection, the law allows us to PRESUME they are disabled. This permits us to pay up to 6 months of benefits pending a final decision on the claim. You will qualify for this immediate payment if: o a medical source confirms that the HIV infection is severe enough to meet SSA's criteria; o you meet the other SSI nonmedical eligibility requirements; and o you are not doing "substantial" work (See section, "The General Definition of Disability" in Part 3). If you have symptomatic HIV infection but the local Social Security office cannot provide immediate payment, a disability evaluation specialist at the DDS may still make a "presumptive" disability decision at any point in the process where the evidence suggests a high likelihood that your claim will be approved. (If we later decide you are not disabled, you will NOT have to pay back the money you received.) Special arrangements have been made with a number of AIDS service organizations, advocacy groups, and medical facilities to help us get the evidence we need to streamline the claims process. And many DDS's have Medical/Professional Relations Officers who work directly with these organizations to make this process work smoothly. What You Can Do To Expedite The Processing Of Your Claim You can play an active and important role in ensuring that your claim is processed accurately and quickly. The best advice we can give you is to keep thorough records that document the symptoms of your illness and how it affects your daily activities, and then to provide all of this information to Social Security when you file your claim. Below are some guidelines you can follow: o Document the symptoms of your illness early and often Use a calendar to jot down brief notes about how you feel on each day. Record any of your usual activities you could not do on any given day. Be specific. And don't forget to include any psychological or mental problems. o Help your doctor help you Not all doctors may be aware of all the kinds of information we need to document your disability. Ask your doctor or other health care professional to track the course of your symptoms in detail over time and to keep a thorough record of any evidence of fatigue, depression, forgetfulness, dizziness, and other hard-to-document symptoms. o Keep records of how your illness affected you on the job If you were working, but lost your job because of your illness, make notes that describe what it is about your condition that forced you to stop working. o Give us copies of all these records when you file In addition to these records, be sure to list the names, addresses, and phone numbers of all the doctors, clinics, and hospitals you have been to since your illness began. Include your patient or treatment identification number if you know it. Also include the names, addresses, and phone numbers of any other people who have information about your illness. PART 6 -- HELPING YOU RETURN TO WORK If you return to work, Social Security has a number of special rules, called "work incentives," that provide cash benefits and continued Medicare or Medicaid coverage while you work. They are particularly important to people with HIV disease who, because of the recurrent nature of HIV-related illnesses, may be able to return to work following periods o disability. The rules are different for Social Security and SSI beneficiaries. For people getting Social Security disability benefits, they include a 9-month "trial work period" during which earnings, no matter how much, will not affect benefit payments; and a 3-year guarantee that, if benefits have stopped because a person remains employed after the trial work period, a Social Security check will be paid for any month earnings are below the "substantial" level (generally $500). In addition, Medicare coverage extends through the 3-year timeframe after the trial work period, even if your earnings are substantial. SSI work incentives include continuation of Medicaid coverage even if earnings are too high for SSI payments to be made, help with setting up a "plan to achieve self-support" (PASS), and special consideration for pay received in a sheltered workshop so that SSI benefits may continue even though the earnings might normally prevent payments. These and other work incentives are explained in detail in the publication, Working While Disabled...How Social Security Can Help (Publication No. 05-10095). For a free copy, just call or visit your nearest Social Security office. PART 7 -- WHAT YOU NEED TO KNOW ABOUT MEDICAID AND MEDICARE Medicaid and Medicare are our country's two major government-run health insurance programs. Generally, people on SSI and other people with low incomes qualify for Medicaid, while Medicare coverage is earned by working in jobs covered by Social Security, for a railroad, or for the federal government. Many people qualify for both Medicare and Medicaid. Medicaid Coverage In most states, Social Security's decision that you are eligible for SSI also makes you eligible for Medicaid coverage. (Check with your local Social Security or Medicaid office to verify the requirements in your state.) State Medicaid programs are required to cover certain services, including inpatient and outpatient hospital care and physician services. States have the option to include other services, such as intermediate care, hospice care, private duty nursing, and prescribed drugs. For more information about Medicaid, contact your local Medicaid agency. Medicare Coverage If you get Social Security disability, you will qualify for Medicare coverage 24 months after the month you became entitled to those benefits. Medicare helps pay for: o inpatient and outpatient hospital care; o doctor's services; o diagnostic tests; o skilled nursing care; o home health visits; o hospice care; and o other medical services. For more information about Medicare, call or visit your local Social Security office to ask for the booklet Medicare (Publication No. 05-10043). FOR MORE INFORMATION For more information or to apply for benefits, call or visit Social Security. It's easiest to call Social Security's toll-free telephone number. The number is 1-800-772-1213. You can speak to a representative 7 a.m. to 7 p.m. each business day. The best times to call are early in the morning, early in the evening, late in the week, and toward the end of the month. The Social Security Administration treats all calls confidentially--whether they're made to our toll-free numbers or to one of our local offices. We also want to ensure that you receive accurate and courteous service. That's why we have a second Social Security representative monitor some incoming and outgoing telephone calls. Note from the AIDS Information Center: This document reflects changes in Social Security rules that took effect on July 2, 1993 and, also, how SSA evaluates claims based on HIV/AIDS. Copies of this publication, available in English and Spanish, can be ordered through Social Security's toll-free number, 1-800-772-1213. The publication numbers are 05-10020 (English) and 05-10920 (Spanish). For bulk quantities call the Public Information Distribution Center at (410) 965-0945. The fax number for ordering publications is (410) 965-0696. ------------------------------------------------------------------------------- Question 4.4. What if you can't afford AZT? PATIENT ASSISTANCE PROGRAM AT BURROUGHS WELLCOME The Burroughs Wellcome Company has announced changes in its Patient Assistance Program (PAP) to make access to its drugs easier for disadvantaged patients. Physicians can now call a toll-free number, once they have determined that a patient is in need, to receive authorization to enroll the patient in the program. Upon authorization, the physician will give the patient a prescription benefit card from PCS Health Systems that can be used at any pharmacy. To qualify, patients must meet the following guidelines: o be a resident of the United States or its territories; o be financially disadvantaged; o have applied for and be awaiting reply from other prescription funding sources; or o not qualify for private or government assistance. The primary patient groups expected to participate are those using Burroughs Wellcome products for HIV and related infections, those with herpesvirus infections, transplant recipients, and those with cancer or congestive heart failure. Enrollment in the PAP must be initiated by a physician. To find out if an individual is eligible, patients should have their physicians call (800) 722-9294. ------------------------------------------------------------------------------- Question 4.5. What about DNCB? (please contribute) (please contribute to this FAQ)