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Guidelines for Care

A Brief Summary

Summer 1997

The Guidelines for use of antivirals are basically a "rule of thumb" for doctors to go by when treating individuals with HIV/AIDS. In a nut shell, they recommend triple combination therapy with at least one protease inhibitor. They emphasize the need to try to suppress HIV to undetectable levels and the need to start therapy with three drugs instead of two.

Monotherapy (taking only one antiviral) is not recommended for anyone at any stage of disease.


Prevention

If T-cells fall to 200 or below, and one is prescribed preventative therapy (prophylaxis) to avoid opportunistic infections, such as Bactrim to prevent PCP (pneumonia) and then the T-cells go back up; it is recommended that one still take preventative therapies for OI's. See "Staying Well."

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Commentary

Monotherapy is not recommended, unless of course you are pregnant. If you are pregnant the guidelines suggest that you consider stopping therapy for yourself altogether and take the 076 study regimen of AZT monotherapy to prevent transmission to the neonate. It is curious that while every scientist and every doctor is telling everyone in the whole world that they cannot miss a single dose of protease, they are suggesting that pregnant positive women interrupt therapy.


Theory

They theorize that if pregnant women stop all antivirals at once and then resume all antivirals at once that there is probably little or no risk to her health. Quote: "There are currently no data to address whether transient discontinuation of therapy in this manner would be harmful for the woman." However, the reverse is also true. There is no data to say that it would not be harmful because they have never done a study to find out.

If you are pregnant and positive and taking protease and other anit-virals for your virus, get as much information from as many sources as you can. Together with your health care provider, make an as informed decision as possible. Remember that your health is important too.


Public Comment

The Department of Health and Human Services (DHHS) requested comments from all interested parties on the Draft Guidelines for the Use of Antiretroviral Agents in HIV-infected Adults and Adolescents developed by the Panel on Clinical Practices for Treatment of HIV infection.

Women Alive faxed the following letter to all local AIDS agencies:

Dear AIDS Service Provider & Community Activist:

As you may know, the Department of Health and Human Services is requesting comments on the "Draft Guidelines for the Use of Antiretroviral Agents in HIV-Infected Adults and Adolescents". The members and Task Force of Women Alive have prepared a comment. We are asking your agency to "sign-on" to our comment as an endorser. Our comment is based on the fact that there was a 3% increase in deaths among women with HIV/AIDS in the first 6 months of 1996. AIDS deaths decreased by 15% for men. Women Alive believes that these statistics reflect the fact that there is inadequate research being done to address efficacy, dosages, and toxicity of antiretroviral therapy in women. We agree that access to care and treatments remains an issue for many women living with HIV/AIDS but, we also accept that this is only part of the problem. The other part is that the medical community has not yet discovered how to best treat HIV disease in women. This is primarily due to the lack of women in AIDS clinical trials.

The Draft Guidelines are based entirely on research done on men living with HIV/AIDS. Please review our comment and let us know if your agency will endorse it. We are also providing you with a blank form for public comment. In the event that your agency chooses not to endorse the Women Alive comment, we encourage you to submit your own.

Thank you very much for your time and effort. If you are in agreement with our comment, please fill in the information at the top of the attached form and fax it back to Women Alive.


Our Voice

On behalf of the Board of Directors, Women's Task Force, Volunteers, and Staff of Women Alive, we wish to provide public comment on subject document: It must be acknowledged that there are currently minimal data available on either the natural history of HIV infected women or the pharmacokinetics and safety of antiretroviral agents in women. The physician and the woman patient should be fully aware that the guidelines for therapy for HIV infection are based on theoretical considerations from research done almost exclusively on men.

Acknowledgments must be made of uncertainties including female-tested anti-retroviral efficacy, dosages and toxicities. In the absence of clinical trial data, drug choices will need to be individualized based on discussion with the female patient and on available data about women from pre-clinical and post drug approval clinical testing of individual drugs and/or combinations of drugs. When possible, female patients requiring and choosing antiretroviral regimens, which include any drugs that have not been studied in statistically significant numbers of women, should be referred for consideration in appropriate clinical trials.

The following agencies signed on to the Women Alive comment: Tuesday's Child, The AIDS Prevention Team of the Black Lesbian & Gay Leadership forum, Los Angeles Shanti, and WomensLink. The Women Alive Task Force and Membership appreciates your support.

A national coalition of ACT UP women and hundreds of supporters submitted public comment contesting the guidelines in regard to pregnant women and the discontinuation of therapy. For a complete copy, see "BETA" Box 426182, SF, Ca. 94142.




  
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This article was provided by Women Alive. It is a part of the publication Women Alive Newsletter.
 

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