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To: Joe E. who wrote (3751)	2/6/1998 7:44:00 AM
From: Henry Niman	Respond to of 6136

The Reuter's story suggests that the Buffalo Humps are associated with protease inhibitors. Although one small (n=10) study did mention Crix, the problem seems to be rather widespread and I did not get the impression that it was solely due to Crix: C H I C A G O, Feb. 4 - Scientists said today they are intrigued by a series of studies on unusual fat deposits-given nicknames like the "buffalo hump" and "protease paunch"-developing in some people taking drug cocktails to fight HIV infection. Ranging from "buffalo humps" on the upper back under the neck to pot bellies dubbed the "protease paunch," researchers say they are finding that people given strong new HIV drugs called protease inhibitors are developing strange side-effects in the form of fat. "We report 10 patients who developed a similar pattern of abdominal complaints three or more months after starting indinavir (Merck's protease inhibitor sold under the name Crixivan)," Kirk Miller and colleagues at the National Institute of Allergies and Infectious Diseases (NIAID) in Bethesda, Maryland, reported. "CT scans showed excess visceral fat," they added-extra fat inside the abdomen. May Not Be That Rare Most researchers say it is rare but a team at St. Vincent's Hospital in Sydney, Australia, found 64 percent of their patients taking protease inhibitors showed the strange effect-a wasting of their arms and legs and a buildup of dense fat around their middles. They showed pictures-and it is clearly not just weight gain. The fat deposits look unusual. One team described a "fat neck-like a football player" on an otherwise thin 55-year-old male. "Having seen several of these myself, they can be very subtle," said John Mellors of the University of Pittsburgh. But the patients are noticing. "Patients are coming to their physicians and saying 'I don't look right-what is going on?"' Often, doctors are downright unsympathetic. "I won't speak to more cosmetically sensitive areas ... but in Pittsburgh there is no quiche or fluff and if viral levels are down it's good enough," Mellors told a news conference. But he added later, "As patients' lives change, as they go from wrestling with having a fatal disease to having a future, other issues become prominent." Bad for Metabolism? And the side-effect could point to something serious, such as a metabolic defect. Long use of protease inhibitors is also being linked with diabetes and related conditions such as high blood sugar and high blood cholesterol. "When associated with insulin resistance and hyperglycemia (high blood sugar) and diabetes, it is obviously a first warning," Scott Hammer of Beth Deaconess Medical Center and Harvard University said. Some researchers pointed to other worries, too. "None of this has been fatal but it is unfortunate," said Charles Farthing, director of the AIDS Healthcare Foundation in Los Angeles. Some May Drop Drugs He fears some patients may not stick to the already difficult drug regimens. "The biggest problem with people not taking drugs is depression," he said in an interview. "If they don't care whether they live or die, they won't put up with the side-effects." He added, only half-joking, "I am very aggressive with the Prozac." The doctors predicted the issue would grow in importance. "The prevalence of this disorder will increase because individuals will start paying attention to their own bodies and physicians will start asking questions," Mellors predicted. "I'm going to start looking for it in my patients," said Farthing.

To: Joe E. who wrote (3751)	2/6/1998 9:39:00 PM
From: Henry Niman	Respond to of 6136

A subsequent Reuter's story indicates that many if not all PI's are associated with the fat deposits: HIV Drugs Linked To Unusual Fat Build-Up NEW YORK (Reuters) -- Researchers around the world are noticing an unusual side effect in HIV-infected patients taking certain medications -- an accumulation of fat on the back of the neck, shoulders, abdomen or other areas not usually associated with weight gain. That finding was reported by researchers from Georgia, Maryland, and California in the US, as well as by researchers in Canada and Australia, who presented their findings at the 5th Conference on Retroviruses and Opportunistic Infections in Chicago, Illinois this week. Often the symptoms occur in patients taking protease inhibitors, the new class of potent anti-HIV drugs, and researchers say they may be due to metabolic changes caused by the drugs. In one study of 148 HIV-infected patients, 64% of patients taking protease inhibitors developed lipodystrophy, a condition in which subcutaneous fat deposits are reduced in the face and limbs, but fat accumulates on the abdomen. The condition developed earlier in patients taking a combination of ritonavir and saquinavir, appearing after 8 months of drug treatment compared with 12 months for those taking indinavir, according to Dr. David A. Cooper and colleagues at the St. Vincent's Hospital, Garvan Institute of Medical Research and the National Center in HIV Epidemiology and Clinical Research in Sydney, Australia. The patients with lipodystrophy tended to have higher triglycerides, cholesterol, insulin and signs of insulin resistance, a precursor to diabetes. Three patients had a worsening of diabetes mellitus. In Atlanta, Georgia, four cases were identified in which HIV-infected patients developed lipomatosis, "an uncommon condition observed primarily in men who abuse alcohol," according to the researchers from Emory University. "It is characterized by the abnormal deposition of unencapsulated fat in the neck and shoulder areas in a 'horse collar' distribution." All patients were taking indinavir, some in combination with other drugs including idovudine, lamivudine or stavudine. Similar "buffalo hump" symptoms were seen in 7 out of 800 HIV-infected patients at an HIV clinic in Canada, and all were taking at least one of saquinavir, ritonavir, indinavir or nelfinavir. "This finding was not specific to the use of a particular protease inhibitor and it is not yet known whether changing or discontinuing therapy would result in regression of this mass," reported Dr. Virginia R. Roth and colleagues from Ottawa General Hospital. "Until more is known about the significance of this unique finding, decisions regarding an adjustment in antiretroviral therapy should be made on an individual basis."