India may begin AIDS vaccine trials in mid-2004

NEW DELHI (Reuters) - India is likely to begin the first phase of clinical trials of an indigenously developed AIDS vaccine by the middle of next year, the president of the International AIDS Vaccine Initiative (IAVI) said on Wednesday.

India has 4.58 million people infected with the HIV/AIDS virus and experts say the disease is spreading at a rate that will push India past South Africa in absolute numbers in the next few years.

"Globally, vaccines are on trial in many countries including the U.S. and South Africa. Soon they should start in Rwanda and thereafter in India and eventually China," Seth Berkley told reporters.

"The real challenge after phase one trials begin in the middle of next year is to move into efficacy trials quickly."

The Indian government has been working with the New York-based IAVI on developing an AIDS vaccine for HIV strain C, the sub-type of the virus most common in India.

South Africa has more than five million people infected with the virus, the highest of any country in the world.

India faces an uphill battle in tackling AIDS because of the huge social and cultural stigma attached to the illness, which has spread beyond traditionally high-risk groups such as prostitutes, drug users and homosexuals.

Scientists have been stumped by the virus that causes AIDS. Unlike most illnesses, it leaves no survivors, giving researchers no antibodies to examine. It also varies from region to region, presenting a problem for companies wanting to run tests.

Friday, December 19, 2003 · Last updated 4:07 p.m. PT

Abbott raises AIDS drug price

THE ASSOCIATED PRESS

NORTH CHICAGO, Ill. -- Abbott Laboratories Inc. is hiking the U.S. price of an important AIDS drug more than fourfold, citing its sharp increase in treatment value and the costs of improving its formulation.

The company informed doctors, AIDS groups and pharmacies of the change in price in Norvir earlier this month, company spokeswoman Melissa Brotz said Friday. The wholesale price for a month's treatment of the protease inhibitor is being raised to $265 from $54, she said.

The dramatic price hike was reported by The Wall Street Journal, which said the increase has created a furor among AIDS groups and other critics of the move.

Norvir is not a top seller for Abbott but is used extensively in small doses to boost the potency of some AIDS combination-drug therapies.

"The value of Norvir in HIV treatment has increased dramatically since it launched several years ago," Brotz said. "The new price of Norvir continues to represent a small fraction of the cost of an HIV treatment regimen."

Critics of the price hike cited by the Journal say Abbott's intention is to push patients away from using Norvir in drug cocktails and switch to its newer AIDS treatment, Kaletra - something Abbott denies. They also say the company's decision involving the 7-year-old drug raises questions about the industry's traditional contention that drug prices are high because of the need to recoup research and development costs.

"This really puts a lie to the idea that companies set drug prices to fund their R&D," Michael Weinstein, president of the AIDS Healthcare Foundation, told the newspaper. His group operates clinics in the United States, Africa and Central America.

Responding to the criticism, Brotz said the North Chicago-based company did not take the decision lightly. "One of our priorities was ensuring that the impact was minimal for patients," she said.

The company expanded its patient assistance program so patients without prescription drug coverage or public assistance could receive the drug for free, she said. Abbott also froze the price of Norvir to AIDS drug assistance programs.

Abbott shares fell 17 cents to close at $46.40 on the New York Stock Exchange.

By David Douglas

NEW YORK (Reuters Health) - Severe and life-threatening events that are not AIDS-related are as important as AIDS as an underlying cause of illness and death in patients receiving highly active antiretroviral therapy (HAART), researchers report in the Journal of Acquired Immunodeficiency Syndromes.

In fact, as lead investigator Dr. Ronald B. Reisler told Reuters Health, the rates of classic opportunistic infections related to AIDS do not account for most of the causes of illness and death in patients on antiretroviral therapy.

Reisler of the University of Maryland Medical Center, Baltimore, and colleagues, examined data for nearly 3,000 AIDS patients treated with HAART and enrolled in five clinical trials over a 5-year period.

During follow-up, a severe life-threatening event developed in 675 patients, 336 experienced an AIDS-defining event, and, overall, 272 died.

Liver-associated problems were the most common serious events, which occurred in 148 patients. Cardiovascular events carried the greatest risk of death.

Overall, the risk of death from a first serious event was similar to that from a first AIDS-defining event. In total, 117 patients experienced an AIDS event before death and 153 had another type of serious event.

"Because we have achieved a high level of treatment success in our short-term antiviral...studies," Dr. Reisler continued, "we need to begin addressing how best to assess what the long-term impact of these medications is on our patients."

"It is critical for the both the medical community and the lay community to begin viewing HIV infection as a chronic illness much like diabetes, hypertension, or coronary artery disease," he concluded.

SOURCE: Journal of Acquired Immune Deficiency Syndromes, December 1, 2003.

 

Lengthy AIDS Treatment Ups Heart Attack Risk

Thu Dec 18, 3:31 PM ET

NEW YORK (Reuters Health) - The longer men infected with HIV are treated with anti-AIDS drugs, the more likely they are to have a heart attack, according to an analysis of French hospital database records.

The risk appears to relate specifically to protease inhibitor drugs, such as Crixivan or Viracept. Thus, the study's investigators suggest in the medical journal AIDS that clinicians may want to consider patients' cardiovascular disease risk factors when making decisions about treatment with protease inhibitors.

Dr. Murielle Mary-Krause and her team in Paris looked at data collected on nearly 35,000 men with HIV infection. Sixty subjects had a heart attack between 1996 and 1999, including 49 that occurred in patients treated with protease inhibitors.

The estimated rate of heart attacks was 8.2 occurrences per 10,000 persons annually for those treated with a protease inhibitor for less than 18 months. The rate nearly doubled to 15.9 for those treated for 18 to 29 months, and doubled again to 33.8 among those treated for 30 months or more.

By comparison, the expected heart attack rate in the general male population of similar ages is 10.8 per 10,000 person-years.

The researchers caution that the increased life expectancy gained with potent anti-HIV therapy far outweighs the risk of having a heart attack. Nonetheless, they advise that treatment decisions should take into account risk factors for heart disease, which should be determined prior to and throughout treatment.

"It seems prudent to at least consider individually managing patients with respect to their risk of developing coronary artery disease," Dr. Peter Reiss, of the University of Amsterdam, suggests in an accompanying editorial. He recommends that physicians encourage HIV patients to quit smoking and to modify their diet and exercise habits appropriately.

AIDS 2003;17:2479-2486,2529-2531.