Abbott increased the wholesale price of Norvir in December to $8.57 a day, or $257.10 a month, from $1.75 a day, or $52.50 for a 30-day supply, according to company records.

"Norvir is not like a hay fever medication that people take to lessen symptoms to be more comfortable," Madigan told the newspaper. "It is a drug they take to survive. This investigation is aimed at determining the real reason for the price increase and whether it violates Illinois law."

In New York, Attorney General Eliot Spitzer is trying to determine if the company violated antitrust law, Abbott confirmed. A spokesman for Spitzer's office would neither confirm nor deny the existence of an investigation.

Both investigations center on whether the increase was designed to make AIDS drug cocktails cost-prohibitive and steer patients to Abbott's newer drug, Kaletra, which is more expensive and has a longer patent life.

Abbott said Norvir was priced lower than its rivals for years and denies any wrongdoing.

"Many companies have known the value of Norvir to their drugs and priced their drugs at a premium despite this," said Abbott spokeswoman Melissa Brotz. "Competitors need to price their drugs based on their clinical value. Perhaps those concerned about the cost of therapy should look at the highest cost component of HIV regimens."

By Lisa Richwine and Kim Dixon

WASHINGTON/CHICAGO (Reuters) - AIDS doctors on Tuesday called for a boycott of drugs made by Abbott Laboratories Inc. to protest the company's huge price hike on an important HIV medicine.

Abbott's decision in December to raise the price of the drug Norvir, a key component of many AIDS-fighting cocktails, has generated "a never-before-seen level of outrage" among physicians, said Dr. Benjamin Young, an HIV specialist at Rose Medical Center in Denver.

"It's simply untenable and unethical for a company to raise the price of a life-saving medicine nearly 500 percent," Young said in an interview.

About 200 physicians have agreed to boycott Abbott drugs in favor of alternatives whenever medically appropriate, Young said. Norvir has no equivalent, but physicians can find substitutes for other Abbott products, Young said.

"If there's an equal alternative, we will pursue that actively," Young said.

The doctors also have agreed to ban Abbott sales representatives from their offices and to refuse to participate in any new Abbott-sponsored clinical trials, until the company rescinds the price hike.

Abbott raised the price for 100 milligrams of Norvir, the most common daily dose, to $8.57 from $1.71.

Young and others were scheduled to speak about their protest at a Tuesday afternoon press conference in San Francisco, where top experts were attending a medical meeting on AIDS and other infectious diseases.

Norvir, generically called ritonavir, helps quell the HIV virus that causes AIDS. It is unique in its drug class because it can boost effectiveness of other drugs.

Abbott, which denies wrongdoing, has argued the price increase was long overdue.

"Norvir is still the lowest price" AIDS drug in its class, said Laureen Cassidy, a spokeswoman for the company.

The doctors' protest comes as two states probe whether Abbott is unfairly pricing the medication.

Illinois Attorney General Lisa Madison and New York Attorney General Eliot Spitzer both sent subpoenas to Abbott late last week, the company confirmed.

Critics say the Norvir price hike was likely to steer patients to another Abbott product, Kaletra, because it is cheaper than combining Norvir with other AIDS medicines.

AIDS activists late last month asked federal antitrust authorities to investigate the pricing. The Federal Trade Commission would not comment.

Abbott has denied that the Norvir price hike was related to Kaletra.

Abbott shares fell 11 cents to $44.260 in midday trading on the New York Stock Exchange.

By Gina Keating

LOS ANGELES (Reuters) - The nation's largest AIDS organization has sued Abbott Laboratories Inc. in U.S. District Court in Los Angeles, claiming the pharmaceutical giant violated federal antitrust laws by hiking the price of a key "AIDS cocktail" drug by 400 percent in December.

The lawsuit, filed on Tuesday by the AIDS Healthcare Foundation, accuses Abbott of "monopolization, conspiracy to restrain trade and unfair competition" and asks a judge to roll back the price increase on the protease inhibitor Norvir.

Norvir, generically known as ritonavir, helps quell the HIV virus that causes AIDS and boosts effectiveness of other AIDS drugs.

AIDS Healthcare Foundation, which operates seven pharmacies as well as clinics in the United States, Africa and Central America, is one of the nation's largest buyers of AIDS drugs, foundation president Michael Weinstein said.

The Dec. 4 price increase raised the daily cost of Norvir from $1.71 to $8.57 per patient, and quickly prompted outrage in the AIDS community, boycotts of Abbott drugs by AIDS doctors and probes by the New York and Illinois attorneys general.

The company has argued the price hike was long overdue, and said Norvir was still the lowest priced drug in its class.

Abbott spokeswoman Laureen Cassidy on Wednesday said the company has not reviewed the lawsuit, but "has made tremendous efforts to insure no patient goes without this drug."

"We have reviewed our pricing actions and Abbott has acted lawfully," Cassidy said. "The recent pricing action for Norvir in no way limits access or choice to the full range of HIV therapies."

Cassidy said public assistance programs such as Medicaid can buy Norvir at the old price, and anyone without public aid or private insurance can get Norvir for free.

Weinstein said the company's price hike was intended to steer patients toward a cheaper Abbott AIDS drug called Kaletra in an effort to boost its market share. Cassidy denied the claim, adding that the company invests more than $1 billion annually on researching new drugs.

Weinstein called the lawsuit "the line in the sand for the AIDS community."

"Drug assistance programs for the indigent are broke," he said. "There are waiting lists in many states because prices have spiraled out of control. There is absolutely no justification for the prices that are being charged."

By DANIEL Q. HANEY, AP Medical Editor

SAN FRANCISCO - The treatment used in poor countries to prevent the spread of HIV from mothers to their babies may have a serious drawback: It can make the women resistant to the AIDS drugs they may need later on, disturbing new research shows.

In impoverished areas where the risk is greatest, researchers have settled on a simple, one-time treatment for HIV-infected pregnant women to keep them from passing the virus to their newborns. The treatment, using the drug nevirapine, is easy, inexpensive and effective, typically cutting the risk of HIV transmission in half.

However, new findings presented Monday at the 11th Annual Retrovirus Conference suggest a potentially important trade-off for the mother that could complicate her later treatment, if it is available.

Earlier studies had suggested that the single dose of the drug might make the virus impervious to later treatment, but until now there has been no clear evidence whether the theoretical risk is real.

"These are crucial data that the world has been waiting for," said Dr. Scott Hammer of Columbia University.

One study, conducted in South Africa, found that 39 percent of HIV-infected women who get nevirapine during pregnancy go on to harbor virus that is resistant to the drug. Another, done in Thailand, shows the potential consequence: The mothers who eventually need drug treatment for their infection are much less likely than usual to respond to it.

Kate Carr, president of the Elizabeth Glaser Pediatric AIDS Foundation, said the discovery is not a complete surprise, since earlier studies have hinted at that problem. And for now, there is no easy way around it.

"The sad reality is, we do not have another option in most places, either for mothers or babies," Carr said.

She said the foundation is the single largest provider of treatment to prevent mother-to-child AIDS transmission in Africa and other poor parts of the world.

The World Health Organization estimates that 40 million people are infected with the AIDS virus, 95 percent of them in developing countries. In some African countries, 40 percent of pregnant women have the virus. Last year, an estimated 700,000 children caught HIV.

In the United States and Europe, pregnant women with HIV are routinely given combinations of powerful AIDS drugs throughout their pregnancy. This reduces the risk of passing the virus on at birth to near zero and minimizes the chance of developing resistance.

In Africa and other places where this approach is not considered practical, the WHO has recommended giving a single dose of nevirapine when labor starts and then giving a second pill to the baby two days after birth.

"We've heard a lot about nevirapine resistance, but it should be remembered that it does work," said Dr. Neil Martinson of Johns Hopkins University. About 8 percent of babies catch the virus after nevirapine, compared with about 20 percent of those who get no treatment.

Doctors at the conference said several alternatives are under consideration:

_Giving pregnant women three AIDS drugs combined into a single pill.

_Giving no drug to the mother and treating only the child after birth.

_Giving the mother a month of two or three AIDS drugs after delivery.

_Experimenting with alternative single drugs that might produce less resistance.

"The solution can't be to infect the babies," said Dr. Gonzague Jourdain of Harvard School of Public Health, who was involved in the Thai study.

In that study, doctors found that women who had gotten nevirapine during pregnancy were much less likely to do well on a standard three-drug regimen if they developed AIDS. Three-quarters responded to treatment if they had never received nevirapine during pregnancy, compared with just one-third of those who had developed resistant virus because of their pregnancy treatment.

___EDITOR'S NOTE: Medical Editor Daniel Q. Haney is a special correspondent for The Associated Press.

ZURICH (Reuters) - A clinical trial has shown Roche Holding AG's Pegasys drug works better than standard therapy in helping patients infected with both hepatitis C and the HIV virus that causes AIDS, Roche said on Saturday.

A trial of nearly 900 people found Pegasys combined with Copegus, Roche's brand of standard antiviral drug ribavirin, produced a sustained virological response in 40 percent of patients, the Swiss company said.

This compares to 12 percent for co-infected patients who got conventional interferon plus ribavirin.

Results of the so-called APRICOT trial were released at the Conference on Retroviruses and Opportunistic Infections in San Francisco.

It was more good news for Roche from clinical trials about Pegasys, which has seen fast uptake as a treatment for hepatitis C and is being tested for other uses as well, including as a drug against hepatitis B.

Pegasys is a long-lasting form of the naturally occurring protein interferon that stimulates the immune system and was approved in the United States in December 2002.

Sales of Pegasys/Copegus soared to 942 million Swiss francs ($753 million) last year, making it Roche's sixth-biggest drug. It has been wresting market share from Schering-Plough Corp's rival Peg-Intron.

This week Roche maintained for now its forecast that annual sales could peak at around two billion francs. ($1=1.251 Swiss Franc)

By Karla Gale

NEW YORK (Reuters Health) - People with a genetic variation in a receptor on immune cells, called the CCR5-delta-32 mutation, are resistant to infection with HIV. The mutation is much more common in people of Northern European descent than in other populations, and it seems to have arisen some 800 years ago.

Researchers have suggested that it became so common as a result of selective pressure by the Black Death plague in the Middle Ages, meaning that people with the mutation were more likely to escape the contagion.

As plausible as the theory seems, it's apparently unfounded, researchers conclude in an article in this week's issue of the science journal Nature.

It turns out that the CCR5 mutation does not protect against Yersinia infection, the cause of the plague, and so it would not have conferred a survival advantage. Instead, it is more likely that the mutation increased in prevalence as the result of smallpox epidemics.

According to Dr. Donald E. Mosier, at the Scripps Research Institute in La Jolla, California, CCR5-delta-32 occurs in 20 percent of people in areas of Scandinavia, decreasing in more southerly regions in Europe, to as low as 3 percent in Sicily. People with the mutation are resistant to infection with HIV because the virus has to latch on to normal CCR5 to gain entry into cells.

However, "we are certain there was no HIV in Europe" 800 years ago, Mosier pointed out to Reuters Health, so HIV was very unlikely to have exerted selective genetic pressure.

To check the notion that the black plague was the reason why the mutation became relatively common, he and his associates compared the effect of Yersinia infection in normal mice and in mice bred without the CCR5 receptor. There was no difference between the two groups in the severity of the infection or the numbers that died, the researchers found.

Previous research has suggested that smallpox may have provided the selective pressure for the CCR5-delta-32 mutation.

"Smallpox emerges as a leading candidate," Mosier agreed. His team is going to test CCR5-deficient mice to see if they're resistant to mousepox, a close relative of smallpox.

If the smallpox theory holds up, drugs or antibodies that block CCR5 may be of potential benefit in the event of a bioterror attack with the smallpox virus, Mosier said. However, similar agents would not protect against an attack with Yersinia.

SOURCE: Nature, February 12, 2004.

By Ransdell Pierson

NEW YORK (Reuters) - GlaxoSmithKline Plc said on Wednesday it has begun a mid-stage trial of a promising new type of HIV pill, following positive data from a previous study of the medicine that were described earlier in the day.

Pfizer Inc. has already completed Phase II, or mid-stage, trials of a similar medicine and Schering-Plough Corp. plans to soon begin Phase II trials of its own such experimental drug meant to prevent HIV from entering human cells.

Data from the Phase I trial of Glaxo's drug, called 873140, were presented on Wednesday at the annual meeting of the Conference on Retroviruses and Opportunistic Infections in San Francisco.

Stephen LaFon, Glaxo's project leader for the medicine, said his company earlier this month began enrolling patients for the follow-up Phase II trial, whose results are expected to be announced later this year.

Like the Pfizer and Schering-Plough pills, it works by blocking receptors to the CCR5 protein found on the surface of a certain type of white blood cell that is also covered with receptors to a second protein called CD4.

HIV, the virus that causes AIDS, invades the white blood cells through a two-step process of latching onto a CD4 receptor and then grabbing hold of a CCR5 receptor.

By binding to the CCR5 receptor, and thereby blocking that doorway, the three rival drugmakers hope their drugs will effectively prevent HIV from slipping inside the white blood cells and turning them into factories for making copies of itself.

LeFon said Glaxo's Phase I trial involved 40 people who had never been infected with the virus that causes AIDS. They were given varying doses of 873140 twice daily for 7 days. Their white blood cells were then analyzed to see how well the drug bound to -- and presumably thereby blocked -- the CCR5 receptors found in great numbers on their surfaces.

"Our drug pretty much completely blocked the CCR5 receptors, by 95 to 100 percent, regardless of the dose used," LeFon said in an interview.

Moreover, he said most of the receptors remained bound more than 24 hours, providing optimism the Glaxo drug might only have to be administered once daily if it is eventually approved.

Pfizer plans within the next few months to begin Phase III trials of its medicine, called UK-427,857.

Schering-Plough Corp. on Monday said it had completed a Phase I trial of its CCR5 blocker, called SCH-D, and that it caused a 50-fold reduction in the amount of virus in HIV-infected patients.

That is similar to the efficacy seen with Pfizer's drug. It is also in line with the impressive viral reductions achieved with standard HIV treatments, all of which, by contrast, work by preventing HIV from replicating once the virus has already gotten inside CD4 white blood cells.

A high percentage of people taking HIV drugs eventually fail to benefit from the medicines as the virus mutates and becomes resistant to the treatments.

LeFon said the virus was "very slow" in test-tube studies to develop resistance to Glaxo's drug, although it remains unclear whether that favorable trend will hold up in clinical trials.

He said Glaxo aims to seek U.S. approval for its drug in mid-2007, if it succeeds in upcoming trials.

By Maggie Fox, Health and Science Correspondent

WASHINGTON (Reuters) - New classes of HIV drugs that prevent the virus from infecting cells are showing promise in early trials, researchers reported on Wednesday.

Schering-Plough Corp.'s new drug that blocks a cellular doorway called CCR5 is safe and works about as well as older classes of drugs called protease inhibitors and non-nucleotide reverse transcriptase inhibitors, researchers said.

And researchers said Bristol-Myers Squibb's new drug, an attachment inhibitor, also seems to suppress the virus in early, experimental tests in patients.

There are about 20 AIDS drugs on the market now and they can be used in various combinations called highly active antiretroviral therapy. When it works well, HAART can keep the virus at very low levels in patients, in turn keeping them healthy and able to live virtually normal lives.

But eventually the virus develops ways to resist the drugs and, after a while, patients run out of options. Some of the drugs also cause side-effects including heart disease and osteoporosis.

While new AIDS drugs do not offer a cure, they may offer a few more years of healthy life for patients with the always-fatal infection.

Dr. Mark Laughlin, a senior Schering-Plough research executive, told the annual Conference on Retroviruses and Opportunistic Infections in San Francisco tests on the company's experimental drug, called SCH-D, showed it could reduce viral load -- how much virus can be detected in a patient's blood -- by as much as older HIV drugs.

"I think that it clearly will have clinical implications," Laughlin said in a telephone interview.

Lower viral load usually translates into fewer symptoms for patients.

The drug is a CCR5 antagonist, which blocks a receptor or cellular doorway called CCR5 that HIV uses to get into cells.

Pfizer Inc. and GlaxoSmithKline Plc are also developing CCR5 inhibitors.

The drugs all have the advantage of being pills. The latest HIV drug to hit the market, Roche Holding AG's Fuzeon, must be injected.

Bristol-Myers Squibb also reported on its experimental drug called BMS-488043. It is called an attachment inhibitor and would represent yet another new class of HIV drugs.

An early trial in HIV patients given the drug for two weeks showed it was initially safe and reduced viral load by a measurable amount.

SAN FRANCISCO (Reuters Health) - For people with nerve damage that can result from HIV infection, smoking marijuana seems to relieve the pain they experience, according to the results of a small pilot study.

Diffuse nerve pain, or polyneuropathy, is a significant problem for many people with HIV infection. Pre-clinical research findings suggest that cannabis-like compounds may be effective for treating neuropathic pain, Dr. Cheryl Jay of the University of California, San Francisco and colleagues noted this week at the 11th Annual Retrovirus Conference.

In a trial, 16 HIV-infected subjects with neuropathy were given three marijuana cigarettes each day for seven days. The cigarettes were dispensed by the pharmacy at San Francisco General Hospital. All of the patients reported previous experience smoking marijuana but had not done so for 30 days prior to the trial.

Fourteen of the participants were men, and their average age was 43 years. They had had neuropathy for an average of 6 years.

Reductions in pain were assessed using a 0-to-100 visual scale. The aim was to achieve a 30 percent reduction in average daily pain, "which is a pretty typical standard used in pain studies, and is considered a clinically meaningful amount of pain relief," Jay told Reuters Health.

Average pain scores dropped from 47 at the start of the study to 20 at the end of the seven-day period. Twelve of the 16 participants reached the 30-percent goal in reduction of pain, Jay said.

A trial with participants randomized to receive marijuana or an inactive placebo has now been started, she added, and 20 out of 50 participants have been enrolled so far.