HONG KONG (Reuters) – How quickly an HIV patient’s immune system deteriorates may not affect the outcome of the illness, a study has found, and this could help change current guidelines for treatment of the disease.

Health

There is no cure for the human immunodeficiency virus (HIV) that causes AIDS, but combinations of drugs can keep the virus from replicating and damaging the immune system.

Doctors normally do not start treatment until there is some evidence of damage to this system, measured by counting the number of immune cells, called CD4 T-cells.

In developed countries, HIV treatment usually begins when CD4 numbers drop below 350 cells per microlitre of blood.

Some treatment guidelines also recommend that therapy be started more quickly for people whose CD4 counts decline rapidly.

But the study, involving an international team of researchers, found that the pace of decline did not result in any substantial differences to the outcome of the illness.

“What we looked at was whether it matters how a person reached his current CD4 cell count, whether the CD4 count declined very quickly, or very slowly, and we found that the CD4 cell dynamics don’t provide additional information about the patient’s prognosis on top of the current CD4 cell count,” said Marcel Wolbers of the Hospital for Tropical Diseases in Ho Chi Minh City in Vietnam.

Wolbers, a biostatistician and one of the principal investigators of the study, and his colleagues examined records of 2,820 HIV patients from Australia, Canada and Europe with varying rates of CD4 declines.

They found no significant differences in their progression to AIDS or the number of deaths.

“The current rate of CD4 cell decline is neither a strong predictor of whether a person is progressing to AIDS or dies, nor does it predict future CD4 cell decline,” he said. “Therefore, it shouldn’t guide clinical decisions, in particular the decision whether to initiate (drug) therapy or not.

“A further implication of our study is that the patient’s CD4 cell count should be monitored regularly regardless of the prior rate of CD4 decline and that should be done according to current guidelines, i.e. every three to six months.”

The study, published in the latest issue of PLoS Medicine, is available for free here%3Adoi%2F10.1371%2Fjourn

al.pmed.1000239 (Reporting by Tan Ee Lyn, Editing by Ron Popeski)

WASHINGTON (Reuters) – President Barack Obama will propose giving the government new power to block health insurance companies from attempting “excessive” rate increases when he posts his plan for how to overhaul the healthcare system, the White House said on Sunday.

Barack Obama  |  Health

Gearing up for a bipartisan meeting it hopes will help seize back control of the healthcare debate, the White House will unveil its own plan on Monday for how to overhaul the $2.5 trillion medical care system.

Obama will add a measure targeting insurance companies, a White House official said, something that had not been included in Democratic healthcare overhaul bills reached after months of debate and compromise in the House of Representatives and Senate.

The White House has been targeting health insurers with particular vehemence as it makes its case for the overhaul in recent days, seeing corporate profits as a relatively easy target for public anger in the face of flagging voter interest in the healthcare fight.

Obama’s plan will be posted on the White House’s website at 10 a.m. EST Monday to allow ample time for review before Obama and his fellow Democrats in Congress meet Republicans on Thursday for a televised conference on the proposed overhaul, one of Obama’s top domestic policy priorities.

“As bad as things are today, they’ll only get worse if we fail to act. We’ll see exploding premiums and out-of-pocket costs burn through more and more family budgets,” Obama said on Saturday.

White House officials have said little on the record about what exactly will be posted, as they wait for official word from the president, beyond saying they expect it will combine the best features of the House and Senate bills.

The bills are broadly similar. Both would extend coverage to many of the 46 million Americans who now lack health insurance and impose restrictions on insurance companies such as requiring them to cover people with pre-existing medical conditions.

Congressional Republicans, who have remained solidly united in opposition to the healthcare bills, have called on Democrats to scrap both and start over with a far less sweeping agenda.

They had not formally accepted the invitation to the summit, expressing wariness about the Democrats’ intentions, but Republican leaders have said they planned to attend.

(Editing by Philip Barbara)

WASHINGTON (Reuters) – The quest for a cream or gel to prevent AIDS infection has narrowed to using powerful HIV pills that are already on the market, scientists say.

Health

AIDS experts have long been searching for a microbicide — a cream, gel or vaginal ring that women or men could use as a chemical shield to protect themselves from sexual transmission of the deadly and incurable virus.

Several substances have been tried unsuccessfully but experiments presented this week at the Conference on Retroviruses and Opportunistic Infections, a scientific meeting of AIDS experts, suggested HIV drugs might hold the key to making such gels work.

“The next wave of compounds is all going to be based on antiretroviral drugs,” Dr. John Moore of Weill Cornell Medical College in New York told reporters.

Moore’s team tested Pfizer’s new drug maraviroc, sold under the brand name Selzentry. It is in a new class of drugs called CCR5 entry inhibitors, designed to stop the human immunodeficiency virus from getting into human cells using a type of cellular doorway or receptor named CCR5.

“The CCR5 inhibitors are compelling candidates as an alternative because these drugs are not being used for treatment in, for example, Africa,” Moore said.

That means there is less risk of resistance developing — when viruses evolve to get around the effects of drugs.

Moore’s team took a unique approach to formulating their experimental microbicide using Selzentry.

“We found a friendly physician, scrounged a tablet, ground it up,” Moore said. “I assure you it actually works very well,” he told the San Francisco meeting.

Tests in monkeys showed it would protect a female from sexual transmission for about four hours. “You couldn’t apply these gels in the morning and have protection in the evening,” Moore said.

A vaginal ring with a time-release formula may work better for longer-term protection, Moore said.

The approach is affordable, he said. “A single maraviroc tablet, about 300 mg, retailing for about $15 on the Internet, contains enough drug to fully protect around 15 macaques. That is broadly going to be applicable to women.”

Laura Guay of the Elizabeth Glaser Pediatric AIDS Foundation said the approach sounds reasonable. Her group supports the development of microbicides to protect women and by extension their children.

“The hope is by putting antiretrovirals into the microbicide, you can prevent the virus from either entering or replicating,” she said in a telephone interview.

Last year researchers found Gilead Sciences Inc.’s drug Truvada also might work as a microbicide. But a gel made by Massachusetts-based Indevus Pharmaceuticals that did not include an HIV drug failed in human trials.

The AIDS virus, which infects 33 million people globally and has killed 25 million, is mostly passed sexually. In Africa women account for more new cases than men and are often infected by their husbands.

Abstinence and condom use are not options for women trying to have children, but a microbicide would be. Microbicides using HIV drugs would represent a large new market for the companies that make the drugs, which are currently now used only to treat infection.

(Editing by Alan Elsner)

WASHINGTON (Reuters) – Confidential U.S. government reports recommend that GlaxoSmithKline Plc’s diabetes drug Avandia be pulled from the market because it can hurt the heart, The New York Times reported on Friday.

Health

The newspaper said the findings, which it said it obtained, reported that if all diabetics now taking Avandia were given Takeda’s Actos drug instead, about 500 heart attacks and 300 cases of heart failure would be averted each month because Avandia, also known as rosiglitazone, can be harmful to the heart.

“Rosiglitazone should be removed from the market,” one report, by Dr. David Graham and Dr. Kate Gelperin of the FDA concluded, according to the Times, which said both authors recommended Avandia’s withdrawal from the market.

Sales of Avandia, once Glaxo’s second biggest-selling product, plummeted two years ago after a U.S. study linked it to an increased risk of heart attack in a conclusion disputed by Glaxo.

The Times said an FDA advisory board voted, 8-7, in 2007 to accept the advice of an independent committee that while Avandia might increase the risk of heart attack, it should stay on the market.

A Canadian study last year found that Avandia was associated with an increased risk of heart failure and death among older patients compared with Actos. [nLI168328]

Glaxo contested the findings, which it said did not reflect evidence from two randomized controlled trials comparing Avandia and Actos that found no differences in heart failure.

The drugmaker is enrolling patients into a long-term clinical trial that will look at cardiovascular outcomes and compare the effect of the two drugs.

The Times said the internal FDA findings reflected a fierce debate inside the agency about Avandia. The newspaper quoted Glaxo as saying it had studied Avandia extensively and that “scientific evidence simply does not establish that Avandia increases” heart attack risk.

Dr. Janet Woodcock, director of the FDA’s drug center, wrote in a December 2009 internal memorandum that “there are multiple conflicting opinions” about Avandia and ordered officials to assemble another advisory committee to reconsider if the drug should be sold, according to the Times.

It quoted FDA Commissioner Margaret Hamburg as saying on Friday, “I await the recommendations of the advisory committee.”

A bipartisan U.S. Senate investigation said Glaxo failed to warn patients earlier that Avandia was potentially deadly, according to the Times. The newspaper reported that the results, which it said it also obtained, were expected to be released on Monday.

The Times quoted GlaxoSmithKline as saying it disagreed with the Senate investigation’s conclusions. It added that the company declined comment on internal FDA. documents but that “the official ruling from FDA is that Avandia remain on the market.”

(Writing by Peter Cooney; Editing by Bill Trott)

WASHINGTON (Reuters) – An AIDS vaccine that appears to have worked at least partly in Thailand may only temporarily protect patients, with the effects starting to wane after a year or so, researchers reported on Thursday.

Health

That may explain why results of the experimental vaccine have been so difficult to interpret, said Dr. Nelson Michael, a colonel at the Walter Reed Army Research Institute of Research in Maryland, who helped lead the trial,

Michael’s team is trying to find out how or why it might have worked. They surprised the world last September when they showed the experimental vaccine cut the risk of infection by 31 percent over three years.

“It is very likely that this vaccine only worked for a short period of time,” Michael said in a telephone interview.

“It is a weak, a modest effect but something that we can build on.”

The vaccine is a combination of Sanofi-Pasteur’s ALVAC canarypox/HIV vaccine and the HIV vaccine AIDSVAX, made by a San Francisco company called VaxGen and now owned by the nonprofit Global Solutions for Infectious Diseases.

Michael told the Conference on Retroviruses and Opportunistic Infections in San Francisco that it may be possible to design a trial that will show better whether the vaccine can really help people.

Part of the problem, he said, was that the 16,000 Thai volunteers who tested the vaccine were not at especially high risk of AIDS infection.

He said he would work with Dr. Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, to design trials in Asia or Africa.

According to the United Nations, more than 33 million people are infected with the fatal and incurable virus, with 2.7 million new infections every year.

Even a vaccine that protected for just a year would be useful, Michael said.

“Is that ideal?” No,” Michael said. “But it is true there are vaccines like the flu vaccine where you have to get them every year.”

Within the next few weeks, Michael said studies will also start to try to find clues from the blood of the vaccinated volunteers.

“Everyone wants to know why this worked and what lab measurements we could take that could predict this,” he said.

Results will take roughly a year, he said, but labs all over the world will be looking for so-called correlates — measurements such as antibody levels that will show whether a vaccine has affected the immune system in the desired way.

“It is what I call an all-hands-on-deck exercise,” he said.

The AIDS virus has killed 25 million people since it was identified in the 1980s. Cocktails of drugs can control HIV but there is no cure. In 2007, Merck & Co ended a trial of its vaccine after it was found not to work, and in 2003, AIDSVAX used alone was found to offer no protection, either.

(Editing by Eric Walsh)