The Bay Area Reporter - November 19, 1999
Matt Sharp, ACT UP/Golden Gate Writers Pool

While the syndrome(s) was first thought to be related to protease inhibitors, there is more evidence showing that it may be caused by other HIV drugs and possibly a combination of the disease itself and/or immune system dysfunction. Still, even though the answers to the metabolic complications are coming slowly, the need for treatment is becoming a foreboding problem.

A group of metabolic experts recently met in Washington D.C. to sort out the various issues: what the causes may be, critical research questions and a badly needed treatment discussion. The Forum for Collaborative HIV Research has met three times to strategize about the metabolic problems, previously referred to as "lipidystrophy". Sponsored by George Washington University in D.C., the forum is an independent public-private partnership facilitating meetings and collaboration between researchers, patients, and the pharmaceutical industry to help answer some of the befuddling complications seen today in HIV. Metabolic problems are only one area of focus for the forum. Last week, the important issue of how to treat some of the metabolic issues was added to the agenda at the meeting due to pressure from ACT UP/ Golden Gate. A full report of the meeting will be published in two weeks.

Metabolic issues are incredibly complex. With each year new findings only bring more questions. Many of the mechanisms behind how we process our nutrients and the way we study them are seriously problematic in HIV because there are many holes in the understanding of the cause of the syndrome. Indeed, the forum has had difficulty coming up with a clear definition because there are so many different, overlapping syndromes. Sorting out the definition and the cause has been the focus for metabolic researchers but people with HIV are begging for treatments today that they are already using.

Of more concern is that some of the complications may be life-threatening, such as cardiovascular disease and lactic acidosis, a fatal build-up of lactic acid in the body. Because of the scare, people with HIV are also deciding to stop their therapies whether the drugs are successful or not, or are even reluctant to start them at all. So, the obvious need for treatment of the complications outweighs the bantering of researchers who often have their own problems in designing trials and getting the funding needed to run expensive studies.

Treatment

Some treatments for the lowering of lipids are being used with some effect even though interactions with HIV drugs may still pose a problem. The "statin" and "fibrate" class of drugs such as provastatin, atorvastatin, and gemfibrozil are being researched with some good results in lowering elevated triglyceride and cholesterol levels. Provastatin is showing to be safer in terms of HIV drug interactions.

Metformin is being studied in reversing insulin resistance. Interestingly, studies are showing a side effect of metformin is loss of visceral fat (the fat showing up in the belly in people with HIV), and unfortunately, lactic acid build up. This is a serious problem that will have to be monitored in studies before metformin can be safely used to treat insulin resistance.

Progress is being made with human growth hormone for reducing trunk fat and buffalo hump. There is more evidence from the Kotler studies in New York that the drug will be a formidable agent in reduction of visceral fat, but mostly the studies have been small and there are inherent access problems. (Recently, Serostim, Serono's recombinant human growth hormone was added to the California AIDS Drug Assistance Program formulary for wasting syndrome.) Serono is working with community representatives and the Food and Drug Administration to begin studies for treatment of trunk obesity, but until the studies show positive results, coverage for growth hormone for reducing body fat is prohibitive.

Unfortunately, there is no progress for treatment of peripheral wasting. Treatments to increase fat lost in these areas is most problematic as the situation is not fully understood as a part of the syndrome. Researchers are still trying to figure out if the syndromes have anything to do with each other or if they are totally separate problems. There are whole sets of answers that bring forth disagreement and confusion among researchers.

Trials to ascertain which antiretroviral drugs might be causing the complications have been completed, but clearly there is disagreement over the quality of the information in those studies. Studies looking at switching drugs to determine if one drug or class of drugs is responsible for one or more of the complications have not been confirmed. No one has been able to definitively prove, for example, that stopping protease inhibitors and switching to a non-nucleoside drugs will improve lipid abnormalities or body fat redistribution. While trying to pin the abnormalities on one drug or a certain class of drugs for would be a scientific gain, doing so will be difficult and will take large, longer trials that have to be carefully designed and controlled.

Overall, the frustration over metabolic research in HIV is a continuing problem and treatments remain illusive even though some gains are being made. But, meetings such as the Forum for Collaborative HIV Research can be useful in coordinating research efforts to sort out the various questions. In bringing different disciplines together at one table, i.e. experts in metabolics, virology, immunology, and nutrition, more concentration and focus can take place. Having industry there as a part of the solution and not the problem is key. A collaboration of this kind will also enable the pooling of resources for the funding of the expensive studies. And finally, listening to the treatment needs of people affected by this complex situation we find ourselves in at this point of the HIV epidemic will be the only way to understand critical answers to a most frightening deviation to the progress being made against HIV.
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