Bill Weintraub

World AIDS Day 2006: HIV treatment interruptions don't work, a huge international clinical trial shows

12-1-2006

This is a very important finding, and as I noted in the testicular HIV message thread, this finding is one in a series which tells us that HAART renders HIV far LESS manageable than we'd been led to believe.

Or that doctors believed.

Note how they say in the articles: "quite unexpectedly" "a big surprise" "totally unexpected"

So, once again, the doctors and other health professionals have been too optimistic about not just the efficacy of HAART but the immense difficulties of dealing with HIV.

And this really, really matters because the message which has been going out is "get tested, get treated."

That's not bad advice, except that the difficulties of treatment have been way understated.

And again, we've looked at this in other posts, such as Living with HIV not easy.

That's the truth, and that's the first message which needs to get out there:

That living with HIV is not easy.

That if you get infected, you face at best a lifetime on TOXIC medications with NO treatment holidays.

Never a day off.

You're on these meds for the rest of your life -- 24/7/365 till death you do part.

Of course there's another message which has to go out as well -- and I'll talk about that after we've had a look at some of today's articles:

HIV drug therapy interruption doubles AIDS risk: study

Nov 30, 2006

WASHINGTON (AFP) - HIV/AIDS patients who temporarily stop taking their anti-retroviral drugs to reduce side effects are doubling the risk of getting full-blown AIDS and other diseases and of dying from them, US scientists said in a new study.

Tests on nearly 5,500 volunteers with chronic HIV infection and taking anti-retroviral drug therapy showed that those who interrupt the treatment "had a significantly increased risk of disease progression," said a summary of the report in this week's issue of the New England Journal of Medicine.

The scientists overseeing the study, at the National Institute of Allergy and Infectious Diseases, cut it off after collecting only interim data because the results were clear after comparing one group which maintained continuous drug therapy against one which interrupted it.

For every one person in the former group who still became ill despite the treatment, 2.6 patients in the latter group experienced an advance in AIDS and other life-threatening disease.

The ratio made clear the advantage to not breaking off the therapy, the report showed.

Aside from the surge in the advance of the AIDS disease itself, the group which temporarily halted HIV retroviral drug therapy saw a sharp increase in cardiovascular, kidney and liver disease.

"Quite unexpectedly, our results show that interrupting therapy increases the risk of serious non-AIDS-related events," said Harlem (New York) Hospital's Wafaa El-Sadr, one of the co-chairs of the trial, which was carried out at 318 clinical sites around the world.

He called the results a "major lesson" for any tests of HIV/AIDS treatment: the need to evaluate all illnesses and causes of death, not only those directly linked to AIDS.

The study addressed the practice of many HIV sufferers taking lifelong retroviral therapy. Some have tried to regularly stop taking the drugs to enjoy a temporary respite from the side effects and free themselves from the rigor of the treatment regime.

But the results strongly discourage such practices and endorse the uninterrupted therapy approach, the researchers said.

"The prospect of lifelong treatment is difficult for people with HIV," said David Cooper, an HIV expert at the University of New South Wales in Australia who also worked on the study.

"We are gratified that (this) study has so clearly delineated the risk and benefits of these two strategies," he said in a statement.

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Treatment timeouts dangerous in HIV care

By Gene Emery

Thu Nov 30, 2006

BOSTON (Reuters) - Doctors seeking to reduce the dangerous side effects of long-term HIV therapy have discovered that taking a breather is not better.

People infected with the HIV virus and who have treatment timeouts are more than twice as likely to die or suffer other serious consequences than those kept on a steady diet of drugs, a study published in this week's New England Journal of Medicine shows.

The study was supposed to follow patients for six years, but it was called off after about 16 months because the dangers of intermittent treatment are so high.

And while doctors expected the risk of heart, liver and kidney disease to decline with intermittent drug use, primarily because those were regarded as side effects of the newest HIV medicines, the likelihood of those problems actually increased.

"Treatment may increase the risk, but the absence of treatment appears to increase the risk even more," James Neaton of the University of Minnesota told Reuters.

Under the rules of the study, 2,720 volunteers from 33 countries were given holidays of various lengths from their drug therapy once their CD4+ counts, a measure of the health of the immune system, hit 350. Drug treatment resumed if their counts dropped below 250.

But those patients were 2-1/2 times more likely to die or be hit by an AIDS-related infection than the 2,752 volunteers who were told to keep taking their medicine, regardless of their CD4+ count.

Also, the people who received intermittent drug treatment were 70 percent more likely to develop heart, kidney or liver problems.

"This was a big surprise," Neaton said.

Fifty-five of those who had intermittent treatment died from various causes, while 30 who had continual treatment died, the study said.

AGGRESSIVE THERAPIES

Doctors had thought that kidney, liver and heart disease were caused by the aggressive therapies that have allowed HIV patients to live longer.

Among patients who received the drugs only when they seemed to be needed, "we expected the rate of cardiovascular disease to be 15 percent lower," the researchers said.

The new findings suggest that those health problems may instead be the result of long-term infection with the HIV virus, Neaton said.

Doctors involved in the Strategies for Management of Anti-Retroviral Therapies (SMART) study had hoped that patients could take a break from the treatments because the therapy is difficult and expensive.

"The prospect of lifelong treatment is difficult for people with HIV," said David Cooper of the University of New South Wales in Australia. "We are gratified that the SMART study has so clearly delineated the risk and benefits of these two strategies."

At a conference on AIDS, Dr. Anthony Fauci, head of the U.S. National Institute for Allergy and Infectious Diseases, said he did not believe any doctor should now offer patients treatment breaks, at least not breaks monitored by watching their CD4 immune cells.

"I think for practical purposes, it is the end," Fauci told reporters.

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Study: HIV 'Drug Holidays' Don't Work

Clinical Trial Says HIV Treatment Interruptions Generally Aren't Effective

Nov. 30, 2006

(AP / CBS)

(WebMD) HIV treatment interruptions don't work, a huge international clinical trial shows.

The strategy is known to scientists as "structured treatment interruptions," or STI. Patients have another name for it: drug holidays.

The idea is to put HIV treatment on pause once the powerful drug combination lets a person's CD4 T-cells -- the immune cells under attack by the AIDS virus -- return to higher levels. Treatment starts again when CD4 counts drops toward the danger zone.

It was hoped the strategy would cut back on the side effects -- and cost -- of HIV treatment. Scientists also hoped it would help the recovering immune system learn to fight the virus more effectively. The new findings dash those hopes.

In a study involving 5,472 people with HIV, those on interrupted therapy had a 2.6-fold higher risk of death from any cause or from HIV-related infection.

"The idea of a benefit of interrupted HIV treatment for long periods of time, where you allow the virus to bounce back, is not a valid strategy," Anthony Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases, said at a news conference.

The trial, which began in January 2002, enrolled 5,472 HIV patients with CD4 counts of more than 350. Half took their drugs every day without fail. The other half took their HIV drugs only when their CD4 counts dropped to less than 250, then stopped treatment whenever their CD4 counts reached more than 350.

The trial was supposed to last six years but was stopped early when it became clear patients getting treatment interruptions were doing significantly worse. Not only did they have a greater risk of death, they also had a 1.7-fold higher risk of major heart, kidney, and liver disease.

This last finding was totally unexpected, as these events were thought to be side effects of HIV drugs. Instead, the higher risks to the treatment-interruption patients were due to higher blood levels of HIV and lower CD4 T-cell counts.

"We still have much to learn regarding the detrimental effects of uncontrolled HIV infection," write UCLA researchers Judith S. Currier, M.D., and Lindsey R. Baden, M.D., in an editorial accompanying the study in the Nov. 30 issue of The New England Journal of Medicine.

The treatment-interruption strategy used in this study isn't the only one being tried. Study researchers W.M. El-Sadr, M.D., and colleagues warn that these strategies must now be considered risky.

"The lack of benefit of our interruption strategy on major adverse events associated with antiretroviral therapy suggests that such strategies should be viewed as carrying a net clinical risk unless proven otherwise," El-Sadr and colleagues conclude.

SOURCES: El-Sadr, W. The New England Journal of Medicine, Nov. 30, 2006; Vol. 355: pp. 2283-2296. Currier, J. and Baden, L. The New England Journal of Medicine, Nov. 30, 2006; Vol. 355: pp. 2359-2361. News conference, HIV Summit, Nov. 29, 2006.

By Daniel DeNoon

Reviewed by Louise Chang, M.D.

[emphases mine]

Bill Weintraub:

Six years ago, in my Founder's Message, I talked about "the failure of HAART."

Has HAART failed?

It's keeping people alive, but they're DISEASED.

They have HIV in their brain, they have HIV in their balls, they have HIV in their gut, they have HIV in their rectum and anus.

And they have HIV in their semen.

So the virus continues to spread.

The last survey I've seen puts HIV prevalence at 25% among gay men in America, and at 46% among Black gay men.

That 25% figure is FAR HIGHER than in sub-Saharan Africa.

GAY MEN IN AMERICA HAVE THE HIGHEST RATES OF HIV/AIDS IN THE WORLD.

And the rates keep rising.

Sharply.

The term used is skyrocket.

There are now, by conservative estimates, 500,000 gay and bi men infected with HIV living in the US, and facing a lifetime, without break, on these toxic meds.

And as we've seen, what's happening is that the older age groups have tended to become saturated with the virus, so that now it's YOUNG PEOPLE who have the highest rate of new infection.

That's the reality.

Here's another reality:

The gay male leadership is not doing ANYTHING to prevent every gay man in America from being infected.

The leadership continues to put the protection of ANAL -- and effeminacy -- and promiscuity -- ahead of every other consideration.

That's the truth.

ONLY WE OF THE FROT MOVEMENT HAVE DARED TO TALK OF A DIFFERENT WAY.

A WAY THAT'S PHALLIC.

A WAY THAT'S FAITHFUL.

A WAY THAT'S MASCULINE.

That WAY -- which we call, correctly, THE WAY OF THE WARRIOR -- would end this epidemic and prevent all future epidemics.

While the analist path -- the path of anal, promiscuity, and effeminacy -- leads inevitably to DEATH.

Alain Danielou:

Contempt for this sacred emblem [the phallus], as well as degradation and debasement of it, pushes man from the divine reality. It provokes the anger of the gods and leads to the decline of the species. The man who scorns the very symbol of the life principle abandons his kind to the powers of death.

Contempt for and degradation and debasement of the phallus pushes man from the divine reality, leads to the decline of the species, and abandons humankind to the powers of death.

And that's what has happened.

Yet, there's an alternative:

THE WAY OF THE WARRIOR IS THE WAY OF SALVATION.

Robert Loring:

There is an ongoing war upon manhood and natural masculinity. That war is now to the point that simply dehumanizing males is not enough so now society is trying to feminize males and turn them into pseudo-women, creatures never intended to be! Creatures which are totally stripped of any vestiges of maleness! Creatures living in both shame and denial of their innate manhood.

Males are losing the battle! The fems and the BFD are winning battle after battle. Look at the great numbers of feminized, sissified boys growing up today that know nothing about being a masculine man. They are everywhere! Weak in body, mind, and spirit! Confused about their own natural identity but isolated in their confusion for fear of talking about it. Yet, something deep within them knows that society is WRONG!

Can you imagine what boys would be like today if they were raised in a contemporary Agoge? Raised to be men who were proud and unashamed of their innate masculinity. Raised to be unashamed of their male bodies and penises. Instead they are being raised under the boot of guilt and shame and by the time they become adults there is already a great and dark cloud hanging over their heads! A cloud of guilt and shame which eats them alive from the inside out!

In most societies in ancient times masculinity and the male penis was honored and esteemed. Today it is dishonored and shamed. No longer is a male's penis a thing of pride but of guilt and embarrassment. That may be what the world teaches but that is no the way our one Creator sees it. Notice people are still being born NAKED? If the male penis was so vile and evil then surely God would make it so male's were born with clothing already on! Or surely the Creator would just remove the penis altogether prior to birth!

The return of the Agoge would make boys into men and men into Warriors! They would be natural males as divinely intended to be. They would have a clear sense of manhood and walk in pride and they would not live under a cloud of shame and guilt.

Or disease.

Bill Weintraub

World AIDS Day, 2006

© All material Copyright 2006 by Bill Weintraub. All rights reserved.

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