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What's New in Treatment Information?

Excerpts From Hotline Memos of May 2001
from the Information Department of Project Inform

June 2001

Human Retrovirus Conference Selected Highlights

Complementary and Alternative Medicine

There has been increasing interest and attention being given to issues regarding complementary and alternative medicines (CAMs). A study conducted at the University Hospitals of Cleveland sought to identify factors associated with CAMs and characterize the type of CAMs people living with HIV are commonly using.

A total of 324 people with HIV visiting an inner-city care clinic were interviewed with regard to their CAMs. Overall 82% reported using CAM at some point; about 54% reported using CAMs at the time of interview. Of note, nearly 60% of people told their doctors of their complementary therapies but this information was only present in their medical charts about 13% of the time.

This represents a major breakdown in communication between people living with HIV and their doctors. Many CAMs can cause side effects or have potentially serious interactions with medications used to treat HIV and related infections. Unless information about CAMs are recorded in medical charts, serious interactions may be missed. It is critical for people to tell their doctors about alternative therapies they use and it's equally important for doctors to record this information in medical records.

Men were more likely than women to use complementary and alternative medicine (56% vs. 43%). White people were more likely than African Americans to use CAMs (62% vs. 44%). The most commonly used CAMs included non-medicinal therapies (massage, reiki and acupuncture), which are all unlikely to interact negatively with HIV treatments, herbs, vitamins, supplements, and teas.

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The most commonly used herbs included Echinacea, ginseng, gingko, St. John's Wort, goldenseal, garlic, saw palmetto, Chinese herbs, milk thistle, and yohimbe. Of these, some have interactions with HIV drugs, specifically St. John's Wort and garlic. For more information on decision-making and using herb and vitamins, call Project Inform's Hotline.


Immune-Based Therapies


Thalidomide

Thalidomide is a controversial therapy currently approved for treating a condition associated with leprosy called ENL. Thalidomide has been researched for treating HIV infection and other HIV-related conditions such as tuberculosis, skin ailments, wasting syndrome, and mouth ulcers. The most compelling data showing benefit to date are for treating mouth ulcers.

Thalidomide is famous for causing birth defects if used during the first trimester of pregnancy. Until recently it was never approved for use in the U.S., but was used regularly and routinely many years ago in other countries. It was even prescribed to pregnant women to manage morning sickness and at one time could be found in many over-the-counter products including cold medicines. The tragic result of this product being so widely used without proper testing is a generation of children born with severe disfigurements. Most babies exposed to thalidomide during their mother's first trimester died in early childhood. Those who survived into adulthood suffer numerous health challenges due to social stigma and disfigured and malformed arms and legs.

Several products are on the market today that can cause equal and greater complications if used during the first trimester. Not the least of these products is an acne medication called Accutane. The difference between the current products and thalidomide is that thalidomide was available over-the-counter and information about its possible effects on a developing child did not accompany its use.

While the history of this drug is not one to be overlooked, many studies have shown that thalidomide may provide some benefits for select indications. One test tube study presented at the recent Chicago conference suggests that thalidomide might boost anti-HIV and anti-CMV specific CD8+ cell responses. CD8+ cells from people infected with both HIV and CMV were looked at before and after exposure to thalidomide. Adding thalidomide to the cultures appeared to enhance the ability of the cells to function.

Two volunteers who gave blood for the study were given thalidomide and their cells were looked at before and after therapy. After 21 days of therapy, their HIV- and CMV-specific CD8+ cell numbers appeared to be significantly increased.

It must be noted that this was a very small study and the majority of the work was done only in test tubes. Only two volunteers were actually given treatment. A large study of thalidomide was previously conducted by the AIDS Clinical Trials Group. This study showed no measurable impact of thalidomide on HIV levels.

It's possible, however, that new versions of thalidomide might selectively enhance HIV-specific immune responses to a greater and more measurable degree than the version used in larger studies. Companies developing thalidomide derivatives are developing versions of the drug that do not cause birth defects. As it turns out these new versions might also more potently enhance specific immune responses. One of these new compounds was evaluated in the test tube study and showed some promise. Re-evaluation of thalidomide and perhaps more importantly suitable thalidomide-like drugs that don't cause birth defects would be warranted based on findings from this study.

A larger thalidomide study was also presented at the Chicago conference, which included 36 people with CD4+ cell counts of 200-500, on stable anti-HIV therapy who took various doses of thalidomide or placebo for eight weeks. Doses of thalidomide ranged from 50mg to 150mg, once daily. In this study thalidomide did not appear to have effects on either viral load or CD4+ cell counts. In a large AIDS Clinical Trials Group study (ACTG 251), thalidomide was associated with slight increases in viral load. This was not seen in this smaller study, perhaps due to the generally better health of the volunteers and the fact that they were very well controlled on anti-HIV therapy. HIV-specific immune responses were not measured in this study so it remains unknown if thalidomide enhances these responses as suggested by the test tube studies described earlier.


Mycophenolate Mofetil (MMF, CellCept)

MMF is an immune suppressive therapy commonly used to prevent the body from rejecting organ transplants. The success of the immune system is largely due to its ability to recognize the difference between self and other. For example, your immune system recognizes your liver as self, and therefore doesn't try to destroy it. In organ transplantation, however, there are two concerns. One is that a person's immune system will reject the organ -- turn against it and destroy it. The other concern is that immune cells in the transplanted organ will attack the person who received the new organ (called graft vs. host disease or GVHD). In order to prevent rejection of a newly transplanted organ and GVHD, life-long immune suppressive therapies are typically given to transplant recipients.

Interest in MMF as a therapy for HIV arose when it was discovered that MMF suppresses chemicals inside cells that HIV needs in order to reproduce. MMF is believed to have some anti-HIV affect in the same way that hydroxyurea (Hydrea, HU) works, by suppressing cellular factors. Also, like hydroxyurea, MMF is believed to work better in partnership with an anti-HIV drug. In the case of hydroxyurea, that partner is ddI; in the case of MMF that partner is abacavir (Ziagen).

It has been speculated that while these types of therapies may be useful because they inhibit these cellular factors, they may also have benefits because of the way they modulate the immune system. By suppressing the immune system, MMF might reduce activation and cell death associated with HIV replication and disease progression. One group examined the impact of MMF on activation and cell death rates in people previously treated with anti-HIV therapy who were highly resistant to therapies and had persistent viral load.

Seven volunteers used 250mg of MMF, twice daily, in addition to an anti-HIV regimen of abacavir, ddI, amprenavir and ritonavir over 16 weeks. Also, those participants not shown to be resistant to efavirenz were also given this anti-HIV drug. At study entry the group had a median CD4+ cell count of about 28, and folks had experienced viral failure while taking ten or more anti-HIV therapies. Four of the seven volunteers demonstrated decreased rates of cell death (apoptosis) and cell activation despite increases in HIV levels. Among those experiencing decreases in cell death and activation there was a doubling of CD4+ cell counts, despite failure of anti-HIV therapies to control viral load. Increases in CD4+ cell counts were not seen in people who did not experience decreases in cell death rates, and these individuals were least likely to be adherent to the MMF-containing third line therapy. These early findings from this very small study suggest that MMF warrants further study not only for its direct anti-HIV affect but also for its potential benefits as an immune modulator.





  
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This article was provided by Project Inform. It is a part of the publication What's New. Visit Project Inform's website to find out more about their activities, publications and services.
 

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