STEP PERSPECTIVE, Volume 8, No. 3 - Winter/1996; A Publication of the Seattle Treatment Exchange Project e-mail: step@eskimo.com
Jeffrey Shouten, MD, Jon Hubert, DDS & Brian Coppedge

Be As Informed As Possible

Now, more than ever, it is essential to have as much knowledge as possible about HIV treatment options. Even expert panels of researchers have difficulty in making recommendations in today's environment of multiple treatment regiment and rapidly evolving research data. A recent review of AIDS information newsletters demonstrates the range of opinions to be found regarding treatment choices. For a person newly infected with HIV, one doctor recommended no treatment, while another recommended a six drug combination. How can a reader make sense of such a wide disparity in recommendations? How could one person, perhaps consulting these two doctors for recommendations, make a decision? The tremendous value of newsletters lies in the explanation and discussion of the background issues and the context of each approach. The six drug combination was used in a research setting, testing a very aggressive approach for people newly infected with HIV. The " no treatment" approach was discussed by a conservative doctor working in a urban clinic who wanted more research done and was concerned about compliance and medical coverage issues.

When treatment strategies are reported on television, in newspapers, or discussed by friends, often the background information is left out. Reliable treatment newsletters provide information based on interviews and surveys of leading researchers, reports from scientific journal articles and analysis by authors experienced in HIV/AIDS treatment issues. The information in these newsletter is reviewed and cross checked by a number of different people to insure accuracy and reduce bias.

Treatment journals (see end of this article) are an extremely valuable source of state of the art information covering various options as well as putting these options in perspective. They can provide a lifeline for people living in small communities or who otherwise have limited access to up to the date treatment. They also provide information which can be taken to a doctor to help with treatment discussions.

Finding the Right Health Care Provider (HCP)

In today's world of PPO's, HMO's, provider lists and other manifestations of managed care, finding a HCP can be a challenge. In some managed care situations HCP choice is restricted, change is difficult and cost constraints limit treatment choices. However, the single most important factor in choosing a HCP is his or her level of clinical experience in treating people with HIV and AIDS. A recently published study conducted at a health care maintenance organization in Seattle found that the level of experience of primary care physicians in the treatment of HIV/AIDS was significantly associated with the survival of their patients. The study was conducted by Kitahata et al, and was report in the New England Journal of Medicine, March, 14, 1996. The study looked at 403 adult males diagnosed between 1984 and 1994 and cared for by 125 primary care physicians. The researchers rated the physicians based on their experience caring for people living with HIV/AIDS during their medical training and the cumulative number of patients with AIDS they had cared for in their individual practices. The median survival of people who had physicians with the least experience was 14 months, as compared to 26 months for patients who had physicians with the most experience. The authors controlled for CD4 count, severity of illness and year of diagnosis. For physicians who saw 5 or more AIDS patients the survival rate improved significantly

The bottom line in insuring the best treatment possible is the combination of an educated client and a knowledgeable and experienced health care provider. It is essential that a HCP has a good understanding of current treatment guidelines as well as a reasonable amount of clinical experience with HIV/AIDS clients. AIDS/HIV Care Access Project (ACAP) is a non-profit organization in Seattle that can provide physicians referrals for people living with HIV/AIDS. They can be reached at: 190 Queen Anne Ave. N (Third Floor), Seattle, WA 98109 206/284-9277

Treatment Guidelines

The table below outlines basic treatment guidelines as recommended by health care professionals who treat a large number of HIV-positive people, recommendations published by the International AIDS Society, and recommendations made by local and national university-based AIDS experts. As with any general guidelines, each person's unique situation must be factored into any treatment plan. Considerations include drug tolerance, drug interactions, and the person's overall health, including energy level, weight loss, or other symptoms. Another very important consideration is the rate of change of CD4 cells and viral load. Any treatment plan should take into consideration future therapy as well.

Two measurements of viral load a couple of weeks apart are recommended for a baseline for all HIV-positive persons. Subsequently, viral load should be measured about 4 times per year. Additionally, viral load measurements should be obtained 4-8 weeks after initiating a new therapy to assess its efficacy.

Therapy Recommendations

Viral Load Non-detectable, CD4 greater than 500 - OBSERVATION

Viral Load Non-detectable, CD4 200-500 - DOUBLE THERAPY

Viral Load Non-detectable, CD4 less than 200 - TRIPLE THERAPY

Viral Load up to 5-10,000 , OBSERVATION OR DOUBLE/TRIPLE THERAPY

Viral Load up to 5-10,000, CD4 200-500, TRIPLE THERAPY

Viral Load up to 5-10,000, CD4 less than 200, TRIPLE THERAPY

Viral Load greater than 5-10,000, CD4 greater than 500, DOUBLE OR TRIPLE THERAPY

Viral Load greater than 5-10,000, CD4 200-500, TRIPLE THERAPY

Viral Load greater than 5-10,000, CD4 less than 200, TRIPLE THERAPY

Note: Double therapy means a combination of 2 drugs, usually two nucleoside reverse transcriptase inhibitors (AZT, 3TC, ddI, ddC, and d4T). Triple therapy means a combination of 2 nucleoside reverse transcriptase inhibitors and a protease inhibitor (saquinavir, ritonavir, or indinavir) or a non-nucleoside reverse transcriptase inhibitor ( delavirdine or nevirapine). Alternatively, an effective combination of 2 drugs may be 2 protease inhibitors, such as saquinavir and ritonavir. (See STEP Perspective, Summer 1996; Vol. 8, No. 2 for a complete discussion of combination therapy.)

Guidelines for Prevention of Opportunistic Infections

Following is a list of common Opportunistic Infections (OI's) and whether or not preventative therapy is recommended:

Pneumocystis pneumonia (PCP), DEFINITELY BENEFICIAL IF CD4 less than 200

Toxoplasmosis, MAY BE BENEFICIAL IF CD4 less than 100 AND Toxo Antibody Positive

CMV, DEFINITELY BENEFICIAL IF CD4 less than 50

Cryptococcus, MAY BE BENEFICIAL IF CD4 less than 100

Mycobacterium Avium Complex, DEFINITELY BENEFICIAL IF CD4 less than 100

Note: Preventative therapy (prophylaxis) for PCP is definitely of benefit to all HIV-positive persons with CD4 values below 200, and some health care providers recommend preventative therapy even in some people with slightly higher CD4 counts. While some studies have shown a benefit for preventative therapy for the other infections in the table above, problems with side-effects, drug interactions, and resistance have resulted in selective use of drugs to prevent these infections. An HIV-infected person with low CD4 counts, (less than 100), should discuss the use of drug therapy to prevent these infections with their health care provider on an individual basis. CMV infection in the eye can cause permanent, irreversible vision loss, even when treated. Therefore, many health care providers recommend that all HIV-infected persons with CD4 counts below 100 be examined regularly for evidence of early CMV infection in the eye (retinitis). Early treatment may prevent vision loss. Screening cannot be done by a quick look into the eye, but requires drops to dilate the eye and a careful examination by a trained professional (fundoscopy). Prophylactic therapy for opportunistic infections should not be discontinued if low CD4 counts increase significantly on antiretroviral therapy. Apparently, the risk of an OI is not significantly decreased when CD4 cell counts increase on antiretroviral therapy.

Self-Advocacy

In a perfect world, all health care providers would be well-informed and the best and most effective treatment would be offered to all persons who are HIV-positive. However, this is not always the case, and clients must take action and insist that their health care provider and health plan provide them with the opportunity to receive the best possible care. Survival may depend upon it! Sometimes, health care providers are not well-informed about the latest developments concerning protease inhibitors or viral load testing. Other times, the health care plan or health maintenance organization (HMO) may not allow health care providers access to the newest, or best drug, or laboratory tests that he or she wants to prescribe. In either case, each person must become an activist and a treatment advocate on their own behalf.

The first option for a client is to discuss their care with their health care provider and provide him or her with literature supporting any requests, such as the treatment guidelines outlined above. If this approach does not resolve the problem, then the next option is to request to talk to a patient care representative. Most HMO's and clinics have an ombudsman or patient care representative with whom concerns can be addressed, within the group or clinic, if a health care provider has not been responsive.

If the client is still not able to access the care they feel is in their best interest, then a few other options are still available. HMO and some clinics have a restricted formulary, which means that they control the drugs they provide to their members. However, often times these organizations have a mechanism whereby an individual health care provider can prescribe a non-formulary drug. So if a health care provider refuses to administer a drug that has been requested because it is not on the formulary, they should be asked if there is any mechanism whereby approval may be obtained for him or her to prescribe a non-formulary drug.

HMOs and managed care plans often erect "gate-keepers" to limit access to test or drugs, but there are usually appeals or approval processes built in to allow for individual exceptions. Ask your health care provider what mechanisms are available in your HMO or health care plan to make an exception to these rules. Also, most HMOs allow members to switch health care providers if they are not satisfied with their current HCP, although this will not resolve institutional problems.

Lastly, some people have found that the only way to advocate for change within an HMO or managed care group is to form an advocacy group of members within that particular HMO or managed care plan. The most successful of these group have lobbied for changes with the Kaiser-Permanente HMO in California. One person cannot advocate for change as effectively as a group. STEP can assist in forming an advocacy group within health care plans or clinics. If, the above recommendations have been followed, and still not achieved the desired outcome, call STEP and they will attempt to coordinate and facilitate the formation of a consumer advocacy group within a particular health care plan or clinic.

What To Expect When You Are Involved In a Drug Trial Or Research Project

Drug trials provide the opportunity to start on new or unapproved drugs well before they are available to the general public. Remember: trials are developed and designed to evaluate the effectiveness of a particular treatment and its potential toxicity. Before deciding to take part in a trial special consideration to the possible pro's and con's of each trial should be considered.

In most trials, one arm (group of people who receive identical treatment) includes the unapproved drug and the other arm is a drug or drugs previously shown to have some benefit. Trials may contain several arms which study drugs at different dosage levels. This allows the researchers to compare the results of the new treatment to treatments which have already been approved for use by the Food and Drug Administration (FDA). Currently, many trials compare combinations that include protease inhibitors to combinations of non-protease inhibiting drugs that have already been shown to inhibit HIV replication. People have to decide if they are willing to risk being assigned to an arm that may contain drugs that are not as effective as the ones currently available through their health care provider.

Many health care plans have been slow to offer the viral HIV RNA test. These tests are generally agreed to be the most important test to track the progression of HIV. One way to get a free viral load test is to join a drug trial. Most trails will run these tests because they are the best tool to evaluate the efficacy of the new drugs. Before joining a trial, find out if the researchers will release viral RNA results to clients; also see if the tests will be released in a timely manner, or whether they wait until the end of the trial to release the HIV RNA results. If trials don't provide access to a viral load test, or if the trial is not going to release the results frequently, it may be better not to join the trial.

Some trials may ask participants to stop taking particular medication or may ask them not to start taking other medication. Always find out before starting a trial what restrictions will be place on participants. People who are even slightly uncomfortable with the requirements of the trial, should consult their health care provider before joining. Once in a trial, people should try to be as compliant with trial protocols as possible. If severe side effects appear, the investigators should be notified, and the option to withdraw from the trial should be considered. Trials can provide excellent opportunities for people to access drugs and tests that they would not otherwise have access to. Careful examination of the trial protocols and consultation with a health care provider are crucial when considering new drug trails.

The trial investigators can be contacted directly at:

University of Washington AIDS Clinical Trials Unit (206) 731-3184 1001 Broadway, Suite 218 Seattle WA 98122

Novum Inc. (206) 223-0086 1229 Madison, Suite 1010 Seattle WA 98104

Advanced Research Management In Seattle 726-TEST (726-8378) Outside Seattle 1-800-726-9465 600 Broadway Suite 100 Seattle, WA 98122

Bastyr University AIDS Research Center 1-800-475-0135

Some Recommended Journals:

Gay Men's Health Crisis Treatment Issues - available here at The Body 129 W 20th St New York, NY 10011 212-337-3656

AIDS Treatment News - available here at The Body John James PO Box 411256 San Francisco, CA 94141 415-255-0588

BETA San Francisco AIDS Foundation PO Box 426182 San Francisco, CA 1-800-959-1059

Positive Living AIDS Project Los Angeles 1313 N Vine St Los Angeles, CA 90028 213-993-1362

Perspective Project Inform 1965 Market St. Suite 220 San Francisco, CA 94103 415-558-8669

STEP Perspective - available here at The Body 127 Broadway E #200 Seattle, WA 98102 206-329-4857

About the Authors

Jeffrey Schouten is a general surgeon and co-chair of STEP's Scientific Review Committee.

Brian Coppedge is the Treatment Information Specialist at STEP.

Jon Hubert is a member of STEP's Scientific Review Committee and is a member of the Board of Directors.

These articles were provided by the Seattle Treatment Education Project - Copyright (c) 1997 - Seattle Treatment Education Project. Noncommercial reproduction encouraged. Distributed by AEGIS - http://www.aegis.com
961201
STEP8301

Copyright © 1996 - Seattle Treatment Education Project (STEP) - All rights reserved. Noncommercial reproduction is encouraged. STEP is published four times a year by the Seattle Treatment Education Project, 127 Broadway East, 3rd Floor, Seattle, WA 98102.    Email: step100@aol.com  STEP web page