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What's New in Treatment Information, Development, and Policy?

Excerpts From Hotline Memos of December 1999
From the Information Department of Project Inform

January, 2000

Table of Contents:


What's New in Treatment Information?

Structured Treatment Interruption Study

The National Institutes of Health (NIH) is starting a new Structured Treatment Interruption study. Half of the participants will be assigned to continue their existing anti-HIV regimens for 22 months. The other half will be assigned to cycled treatment interruptions. A treatment interruption cycle will include one month off all anti-HIV drugs followed by two months on therapy. These cycles will repeat for 22 months.

To qualify for the study you must:

  • Have a CD4+ cell count over 300;

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  • Have received HAART (two nucleoside analogues and a protease inhibitor or a non-nucleoside reverse transcriptase inhibitor -- but must not be receiving nevirapine [Viramune®]).

  • Have a viral load of less than 500 copies HIV RNA for the past three months and less than 50 copies HIV RNA within 30 days prior to starting the study.

  • Not be on third line (salvage) anti-HIV therapy.

  • Not have used experimental anti-HIV therapies within the past six months.

  • Not have ever used interleukin-2 (IL-2).

  • Not have chronic hepatitis B infection.

  • Not have any symptomatic illnesses.

This study requires that you go to the NIH, located just outside Washington DC in Bethesda, Maryland. You must visit once a month for the first year with fewer visits expected during the second year. However, people assigned to receive the treatment interruption cycles may have to go to the NIH every week during the period when they are off all anti-HIV therapy. The NIH does have a travel budget for people living outside the Washington DC area. However, people have to pay their own way to the NIH for the first visit.

For more information on this study, contact Christian Yoder at the NIH at 1-800-772-5464 ext. 57745 or 301-435-7745.

Mitochondrial Toxicity: The Newest Hot Research in Lipodystrophy

by Tim Horn, reprinted from Community Prescription Service's InfoPack, Vol. 9, No. 3, 1999.

Mitochondria (my-toe-con'-dree-a) are small "organs" in our cells. They are the cell's power plant, using oxygen, fat and sugar to produce adenosine triphosphate (ATP). This process is called "cellular respiration." When the cell needs energy, it breaks down some molecules of ATP to release the stored energy. The more energy the cell needs, the more mitochondria it will contain, anywhere from just a few up to thousands in a single cell. The highest numbers of mitochondria are found in nerve, muscle, and liver cells.

Mitochondria have their own genetic code (DNA). Certain changes (mutations) in this code can cause problems, especially in the brain, muscles, nerves, liver, and kidneys. Some people are born with mutations in their mitochondrial DNA or they can occur naturally. Drugs or chemicals can also cause mutations. Some scientists believe that this is the key to aging. Over our lifetime, the mitochondria accumulate more and more mutations. Eventually these reduce the amount of energy available to the cells. When the energy drops low enough, the cell can experience a "brown-out" and start to malfunction. If the energy drops even further, the cell will have a "blackout" and will stop working.

One of the most common signs of mitochondrial toxicity is muscle weakness (myopathy). If muscle cells can't get enough energy through normal "cell respiration," they have to get their energy without oxygen (anaerobic). This type of energy production gives off lactic acid as a waste product. The soreness that people feel after extreme exercise (like running a marathon) is caused by a buildup of lactic acid. Some people with mitochondrial damage have unusually high levels of lactic acid in their blood.


  • How Do HIV Medications Cause Mitochondrial Toxicity?
    Along with their own DNA, mitochondria have their own enzyme (polymerase gamma) that helps them multiply. This enzyme, also called "pol gamma," is very similar to HIV's reverse transcriptase. Unfortunately, this means that the drugs we use to inhibit HIV can also interfere with the production of new mitochondria. Specifically, the "nukes" (nucleoside analogue reverse transcriptase inhibitors) can inhibit pol gamma.

    All of the nukes (AZT, 3TC, ddI, ddC, d4T, and abacavir) inhibit pol gamma, and the production of new mitochondria, to some degree. One published study compares the inhibition of pol gamma caused by the different nukes. The drug ddC is the strongest inhibitor of pol gamma. But that doesn't make ddC the most dangerous drug to take, because ddC inhibits HIV at lower doses than the other nukes. Unfortunately, there are no studies of the inhibition of pol gamma by a combination of two nukes -- which is what most people with HIV are taking!

    The nukes might also cause harmful mutations in mitochondrial DNA. However, most of the damage is probably due to a reduced number of mitochondria. We know that the results of mitochondrial damage caused by AZT are reversible when the drug is discontinued. If the damage were due to mutations in mitochondrial DNA, it would continue after the drug is stopped. But if the damage is caused by a reduction in the total number of mitochondria (due to inhibition of pol gamma), then we would expect the number of mitochondria to recover when we stop taking the inhibiting drug.

    Mitochondrial damage is also the most likely cause of "fatty liver" (hepatic steatosis) and high levels of lactic acid that can be caused by all of the nukes. Studies have also shown that mitochondrial toxicity can cause nerve damage in the test tube, and in rabbits exposed to ddC. Researchers have linked mitochondrial toxicity and heart muscle damage, kidney damage, and hearing loss. And, at a recent conference in San Diego, the finger of blame for lipodystrophy was pointed for the first time at the nukes Cd4T in particular. This was based on a theory -- but no data yet -- regarding mitochondrial damage.

  • What's Next?
    Unfortunately, there is very little research on mitochondrial toxicity caused by nukes. We have been using nukes for twelve years. We have laboratory and animal data showing that mitochondrial toxicity can cause nerve damage. We don't have human studies. We don't have studies of the combined effects of two nukes.

    Maybe this is because people with AIDS didn't live long enough for drug side effects to become a serious problem. Maybe it's because there weren't any approved drugs besides the nukes. But now we have lots of drug options. We ARE living longer, and we're demanding more information on the long-term side effects of the drugs we take.

Mitochondrial toxicity is a "hot" research topic. You'll be reading a lot on this topic in the near future.


What's New in Development?

Academy of Friends Supports Project Inform

Your generosity could put you behind the wheel of a brand new dream car! Don't miss this opportunity! BMW of San Francisco and Academy of Friends present an opportunity to win this special car -- a new 2000 Z3 Roadster Convertible. Courtesy of BMW of San Francisco, this fabulous raffle will benefit Academy of Friends and selected San Francisco Bay Area HIV/AIDS service organizations, including Project Inform.


  • Purchase Your Certificates Today!
    Each raffle certificate sells for $50 each. Only 1,000 opportunities for this raffle are available, and the BMW drawing sells out early each year! You can order your BMW Super Drawing Certificates online at www.academyoffriends.org, or simply call Julie Doherty at Project Inform for an order form: (415) 558-8669 x223. The drawing will take place on Thursday, March 23, 2000, at BMW of San Francisco at a private reception for Academy of Friends underwriters. You need not be present to win.


Ron Wilmot Bike Ride for Project Inform

Saturday, May 13, 2000
Golden Gate Park
Gather/registration at 9:00; ride begins at 10:00


  • About the Ron Wilmot Bike Ride
    Please join Project Inform and Ride For a Reason in the sixth annual Ron Wilmot Bike Ride for Project Inform. This fun-filled seven-mile ride will raise money for Project Inform's HIV/AIDS treatment information and education programs.

    The Bike Ride was started in 1995 by real estate entrepreneur, HIV/ AIDS activist, avid cyclist and long-time Project Inform volunteer and supporter, Ron Wilmot. Since then, the Ride has raised for Project Inform more than $300,000 from hundreds of donors.

    Before he died of AIDS in 1997, Ron challenged family, friends and the community -- and Project Inform -- to continue organizing a local ride for people of all abilities, with a particular emphasis on encouraging individuals with HIV/AIDS to participate. Ron also wanted the ride to continue to be unique in its low overhead costs -- less than 5%, and high average funds raised by each rider -- more than $500 each.

  • Why the Bike Ride Is Important
    Your participation in the 2000 Ron Wilmot Bike Ride will help Project Inform continue to provide the most complete and up-to-date HIV/ AIDS treatment information to everyone who needs it, free of charge.

    In 1999, riders raised over $78,000. Generous donations made by many local businesses enabled us to cover the administrative costs of the event so that more than 95% of the money raised through the Bike Ride went directly to providing vital HIV/AIDS treatment information.

  • How You Can Join In the Fun
    Register as a Rider from our web site at www.projectinform.org. Or e-mail us at: SUPPORT@projectinform.org. We will promptly send you materials so that you may begin to ask for donations to support your ride.

  • Make a Donation.
    Become a Corporate Sponsor. There are many opportunities for corporate involvement from underwriting for a Challenge Grant to serve as an incentive to riders, to supplying needed materials and gifts, to making a donation of $500 or more. Your company will enjoy prominent recognition on all promotional pieces and on our web site. For more information, please contact Julie Doherty at (415) 558-8669 ext. 223.

    Regardless of the level of participation you choose, The Ron Wilmot Bike Ride for Project Inform on May 13 is a terrific way to show your support for persons living with AIDS, and to increase the outreach of Project Inform.


What's New in Policy?

Work Incentives Improvement Act

Disability advocates won a major victory when President Clinton signed the Work Incentives Improvement Act into law on December 17th. His signature was the result of a strong bipartisan effort to craft a bill that would pass the House and Senate, and a major grassroots response by those who would benefit from the bill.

The Work Incentives Improvement Act will provide opportunities for individuals with disabilities, including AIDS, to enter, return to, or stay in the workforce without losing health care benefits. Effective immediately, the bill will extend Medicare Part A premium coverage for 4-1/2 years beyond the current limit for Social Security disability beneficiaries who return to work.

In addition, the legislation gives states the option to allow more working individuals to buy in to the Medicaid program by removing the current income limit of 250 percent of the federal poverty level (about $21,000). This will allow disabled individuals who take jobs at higher wages to maintain their health care coverage. The bill also creates a new state demonstration project that will attempt to provide Medicaid coverage to people whose health does not yet prohibit them from working, but who rely on health care to prevent their condition from worsening. This could help provide Medicaid coverage for working individuals living with HIV, but have not yet progressed to an AIDS diagnosis.

There are other components to this bill, and details are not yet entirely available. There is a fact sheet on this bill on the Social Security Administration's website at www.ssa.gov/work. In addition, Project Inform will soon provide a more comprehensive analysis of the bill and tips on how to ensure that your state implements the various options available. If you would like a copy of this discussion paper, you can e-mail Ryan Clary at tan@projectinform.org or call (415) 558-8669 x224.




  
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This article was provided by Project Inform. Visit Project Inform's website to find out more about their activities, publications and services.
 

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