Canadian-made HIV vaccine close to human trial

From the National Post:
It has been 20 years in the making but researchers at the University of Western Ontario say they're confident their HIV vaccine is only months away from being approved for human trials.

Lead researcher Dr. Chil-Yong Kang said Thursday the approval from the U.S. Food and Drug Administration can come as soon as two or three months.

"We've been working on the HIV virus since 1987. This is a very important day for us," Dr. Kang said while attending a conference in South Korea. "It is a very important milestone for us, this vaccine."

The SAV001-H vaccine has already been tested on monkeys and rats with no side effects. ...more

Taming a deadly disease

From the Globe and Mail:
Twenty-five years after the discovery of the AIDS virus, the deadly disease has been halted in its tracks – so much so that sufferers are now dying at a ripe old age.

Nearly 85 per cent of patients being treated for HIV-AIDS with drug cocktails have undetectable levels of virus in their bloodstream, according to new data from the B.C. Centre for Excellence in HIV-AIDS in Vancouver.

“People with HIV are not exempt from destiny,” Dr. Julio Montaner, the centre's director, said in an interview, “but they are no longer dying from AIDS.” That fact, he said, “really tells the story of how far we've come with treatment.”

When Margaret Heckler, then secretary-general of the U.S. Health and Human Services Department, announced at a Washington news conference on April 23, 1984, that the “probable cause” of AIDS had been found, she boldly predicted a vaccine within two years and eradication of the disease by 1990.

If only it were so.

There is still no vaccine, no cure, and HIV-AIDS continues to spread relentlessly, with 2.7 million new infections worldwide last year and 33 million people living with the virus. ...more

HIV deal shows need for new pharmaceutical models

From Reuters:
The pharmaceutical industry is going back to the lab for its business models as it faces historic challenges.

Large drugmakers are experimenting with various collaborations as their major products face revenue declines, research productivity stalls, and governments and health insurers crack down on drug prices and healthcare costs.

The new ventures -- from deals on products to mega mergers -- seek to meet these challenges by cutting costs and mitigating the risks of research into new treatments.

Look no further than Thursday's deal between GlaxoSmithKline Plc and Pfizer Inc. The world's two biggest drug companies announced plans to merge their HIV operations into a new company.

"Pharma is feeling its way," said Erik Gordon, a professor at the Ross School of Business at the University of Michigan. "They know that the present business model isn't going to work in the future ... What they're not sure of is what will work." ...more

Better drugs encouraging AIDS complacency: Nobel doctor

From AFP:
People are forgetting to practise safe sex because they no longer fear dying from HIV/AIDS, says the doctor who won the Nobel prize for helping to discover the virus.

Treatment advances mean "some people in my country, France, and other Western countries have become complacent -- they see HIV/AIDS as a chronic disease -- not as one that can kill," virologist Francoise Barre-Sinoussi said.

The doctor shared the Nobel Prize last year with fellow French virologist Dr Luc Montagnier for their discovery in 1981 of the human immunodeficiency virus (HIV) that causes AIDS.

Barre-Sinoussi noted there has been a huge leap forward in treatments for HIV/AIDS with a cocktail of drugs that reduces the level of virus in the body and likewise lowers the risk of passing on the pathogen to others.

But she told AFP she worried that people's confidence in retroviral drugs had created a false sense of security, leading to an increase in unprotected sex. ...more

HIV rates 'surprisingly high' in those over 50

From CTV News:
Rates of HIV infection among people over 50 appear to be on the rise - perhaps in part to the increased use of erectile-dysfunction drugs, global experts are warning.

In an article published in the World Health Organization's Bulletin on Tuesday, WHO experts warn that HIV is still rarely considered a risk for older individuals, even though seniors are considered more likely than younger people to risk unprotected sex.

"HIV prevalence and incidence in the over-50-year-olds seem surprisingly high and the risk factors are totally unexplored," the authors from the WHO and Minnesota's St. Olaf College write.

Patients over the age of 50 make up roughly eight per cent of new HIV diagnoses in Europe and 11 per cent in the United States, the report finds. And in Brazil, HIV infection among those aged over 50 years doubled between 1996 and 2006, jumping from 7.5 to 15.7 cases per 100 000 inhabitants. ...more

HIV drug could raise heart attack risk

From the Irish Times:
A widely used anti-HIV drug could raise heart attack risk by encouraging blood clots to form, according to a new study by Irish scientists that was unveiled at a major international conference in Canada last week.

The Dublin-based researchers showed that patients on the anti-viral drug Abacavir have stickier blood platelets – which can clump to form clots – than patients who are not taking that drug as part of their therapy.

HIV infection itself is thought to increase heart attack risk, but last year a Danish-led study of more than 30,000 HIV-infected patients found that Abacavir appeared to almost double that risk, said Dr Paddy Mallon, consultant in infectious diseases at the Mater Misericordiae Hospital and a lecturer in medicine at University College Dublin. ...more

Indonesia scraps plans to tag HIV patients

From the International Herald Tribune:
An Indonesian province beleaguered by a spiraling HIV infection rate scrapped plans to implant microchips in those with full-blown AIDS on Tuesday, following strong opposition from government officials, health workers and rights activists.

Papua's parliament agreed to drop a section of the health development bill that supported the tagging of some HIV patients with small computer chips inserted beneath the skin — part of extreme efforts to monitor the disease, lawmaker Weinard Watori said. ...more

Expect vaccine to inhibit HIV within 5 years: Nobel winner

From CBC News:
A therapeutic vaccine to inhibit the spread of HIV will be available within five years, according to a Nobel Prize-winning scientist who helped discover the virus.

Luc Montagnier, director of the World Foundation for AIDS Research and Prevention, said he thinks it is "a matter of four to five years" before such a vaccine is developed. Restricting the transmission of HIV, he said, would change how the disease is managed and controlled.

Montagnier, 76, said a therapeutic vaccine, to be given to those who are already infected in order to inhibit the likelihood of transmission, would be a key step in fighting the virus. By comparison, a preventative vaccine would protect people from contracting HIV in the first place. ...more

Indonesian AIDS patients face microchip monitoring

I realize this isn't really a pharmacy story, but it it heath/medical related and extremely troublesome so I thought I'd include it here.

From the Associated Press:
Lawmakers in Indonesia's remote province of Papua have thrown their support behind a controversial bill requiring some HIV/AIDS patients to be implanted with microchips — part of extreme efforts to monitor the disease.

Health workers and rights activists sharply criticized the plan Monday.

But legislator John Manangsang said by implanting small computer chips beneath the skin of "sexually aggressive" patients, authorities would be in a better position to identify, track and ultimately punish those who deliberately infect others with up to six months in jail or a $5,000 fine.

The technical and practical details still need to be hammered out, but the proposed legislation has received full backing from the provincial parliament and, if it gets a majority vote as expected, will be enacted next month, he and others said.

Indonesia is the world's fourth most populous country and has one of Asia's fastest growing HIV rates, with up to 290,000 infections out of 235 million people, fueled mainly by intravenous drug users and prostitution. ...more

Rare Treatment Is Reported to Cure AIDS Patient

From the New York Times:
Doctors in Berlin are reporting that they cured a man of AIDS by giving him transplanted blood stem cells from a person naturally resistant to the virus.

But while the case has novel medical implications, experts say it will be of little immediate use in treating AIDS. Top American researchers called the treatment unthinkable for the millions infected in Africa and impractical even for insured patients in top research hospitals.

“It’s very nice, and it’s not even surprising,” said Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases. “But it’s just off the table of practicality.”

The patient, a 42-year-old American resident in Germany, also has leukemia, which justified the high risk of a stem-cell transplant. Such transplants require wiping out a patient’s immune system, including bone marrow, with radiation and drugs; 10 to 30 percent of those getting them die.

“Frankly, I’d rather take the medicine,” said Dr. Robert C. Gallo, director of the Institute of Human Virology at the University of Maryland School of Medicine, referring to antiretroviral drugs. ..more

AIDS vaccine developed in Ont. nears human trials

From Canada.com:
An experimental vaccine aimed at combating the HIV/AIDS virus has been developed by a researcher at the University of Western Ontario in London and is ready to be put through a key testing phase, the university announced Wednesday.

The vaccine, developed by virologist Dr. Chil-Yong Kang, will now go through toxicology tests to ensure it can safely be injected into humans.

Toxicology trials using animals will begin in a matter of days at a research facility in the United States with results expected in approximately three months, Kang said.

Phase 1 human clinical trials could begin in early spring.

Unlike other vaccines, which have used only a small amount of HIV's genetic material, Kang said his vaccine uses a whole dead HIV-1 virus, a technique Jonas Salk used in the polio vaccine.

"We have engineered a virus in such a way that it can be produced in larger quantities in shorter periods of time and it is also non-pathogenic. In other words, it doesn't cause the disease," Kang said. "We have tested animals and they do respond to the vaccine and we now have to try it in humans."

The vaccine will be tested in individuals who are HIV-positive, but don't yet have AIDS symptoms, Kang said....more

Downtown Walgreens to focus on HIV/AIDS

I think it's pretty interesting that some of the bigger pharmacy chains are starting to develop niche markets. Typically this has been the domain of independent pharmacies.

From the Indianapolis Star:
Walgreens is reaching out to people with HIV and AIDS by creating a hub store in Downtown Indianapolis to meet their needs.

Staffed with a pharmacist trained to help HIV patients, the store reflects the nationwide drugstore chain's new strategy of providing customized services to those with certain diseases.

"The company is changing from most people's image of Walgreens, where you have four brick walls, Snickers bars and greeting cards and school supplies," said Bruce Hinshaw, health-care market leader for Walgreen Co. for the Indianapolis/ Central Indiana market. "It's always been a health-care company, and I think Walgreens is saying, 'That's our strength. Let's go back to our core strength.' "

In New Castle, this approach has translated into a pharmacy that offers compounding services. Later, Indianapolis could see a store with a specialty in diabetes care, Hinshaw said. Other Walgreens stores around the country specialize in services for those with respiratory problems, tumors or cancer, or rheumatoid arthritis. ...more

Canadian to ship AIDS drugs to Rwanda for first, perhaps last time

From the Vancouver Sun:
Seven million pills will leave Toronto Wednesday bound for Rwanda, the first and perhaps the last shipment of generic, low-cost drugs to treat HIV-AIDS produced under Canada's Access to Medicine Regime (CAMR).

This is the first time any manufacturer in any country has used such a licensing framework to get essential medicine to people in the developing world.

But Apotex, the drug manufacturer that produced the pills, says the Canadian legislation - and the World Trade Organization regulations it's based on - has created such a complicated, costly system, the company won't be doing it again unless the regulations are changed.

"It took us more than four years just to get to this point," says Elie Betito, director of public affairs for Apotex, the generic-drug manufacturer supplying the pills. "It's a huge process, with huge costs involved.

"We will not be doing this again."

The process began when humanitarian organization Medecins Sans Frontieres asked Apotex to produce a generic version of several costly, brand-name antiretroviral medications - treatments easily accessible to patients in the developed world and proven to prolong the life of most AIDS patients for years. ...more

First batch of AIDS meds leaves for Africa

From the Winnipeg Sun:
The first batch of Canadian-made AIDS drugs will leave for Africa this week, four years after the federal government established a program to get cheaper medications into the hands of patients in poor countries.

The shipment from generic drug giant Apotex Inc., will likely start its journey to Rwanda on Wednesday.

Apotex says it plans to send another batch of medication to Africa next year, but says the company won’t participate in the program any more until the government fixes laws that have left the initiative bogged down in red tape.

Canada’s Access to Medicines Regime was passed in 2004 with much fanfare and heralded internationally as an opportunity for Canada to be a major player in the global fight against disease in poor countries.

The government promised access to first-world therapies at reduced prices by getting brand-name pharmaceutical firms to negotiate with generic drug makers and allow the generics to manufacture cheaper AIDS drugs. ...more

Drugs increase life expectancy of HIV patients by 13 years: study

From CBC News:
B.C. researcher Robert Hogg knew that a frequently used cocktail of drugs was helping people with HIV live longer than expected. He was also well aware of studies, regional in focus, that showed drugs taken in combination were keeping AIDS at bay.

Although treatment had to be for life, evidence was growing that people with HIV could live many years with the right mix of medication. Prospects for a longer life were improving.

But Hogg did not know how much better. So in the late 1990s, he undertook, along with researchers from Western Europe, the U.S. and Canada, to find out the impact of AIDS drugs on life expectancy.

Hogg and others published their findings in the July 26 issue of the medical journal Lancet. Their study found that a combination of antiretroviral drugs increases the life expectancy of HIV patients in high income countries by more than 13 years.

That means a patient who began drug treatment at age 20 could expect, on average, to live about 49 years longer to reach 69. ...more

Coverage could soar under new guidelines

From the Globe and Mail:
The number of people with HIV-AIDS eligible for treatment with powerful drug cocktails could more than double under new guidelines being published today.

In wealthy countries such as Canada, that means virtually everyone who is infected with the AIDS virus could soon be on a drug regimen.

But the number of people in the developing world getting optimal treatment is unlikely to grow because of the cost, creating an ever-widening care gap.

"Our coverage is sub-optimal everywhere," Julio Montaner, president of the International AIDS Society, said yesterday. "We want these guidelines to be a motivation for the expansion of treatment."

Currently, people with HIV-AIDS are deemed to be eligible for treatment with antiretroviral drugs (ARVs) when their CD4 count falls below 200. (CD4 cells control the body's immune response against infections and are a key measure of how the disease is progressing.) Under the new guidelines, published in the Journal of the American Medical Association, it is recommended that anyone with a CD4 count of 350 or lower begin treatment with ARVs. ...more

Roche to suspend HIV research, seeing no advances

From the National Post:
Swiss pharmaceutical company Roche Holding AG will suspend its HIV research because none of its pending medicines represent significant improvement over existing drugs, a company spokeswoman said on Friday.

"Research scientists currently working in HIV will be reassigned to other activities," Linda Dyson, a spokeswoman in Roche's U.S. office in New Jersey, said in an e-mail.

Dyson confirmed an e-mail sent on Wednesday to some activists informing them of the decision. In that e-mail, the company said it "decided to refocus our resources within virology on diseases in which we can deliver substantial improvements over existing medications." ...more

Drug for treating HIV may raise heart attack risk, manufacturer warns

From the Canadian Press:
A drug used in combination with other antiretrovirals to treat HIV infection has been linked with an increased risk of heart attack, the medication's manufacturer warned Monday.

GlaxoSmithKline, in conjunction with Health Canada, is advising patients taking abacavir-containing products - sold under the brand names Ziagen, Kivexa and Trizivir - of concerns raised by a recent study in The Lancet about the possible elevated heart attack risk.

Patients should not stop taking any of the abacavir-containing medications without first consulting their doctor, the company said in a release. Patients should also discuss any serious, pre-existing cardiovascular disease with their physician.

"Health-care professionals thoroughly consider the overall benefit versus the risk of a medication for each individual patient before prescribing," the company said. "If patients have questions regarding their current prescription, they are asked to contact their doctor." ...more

HIV drug linked to serious liver side-effects, Health Canada warns

From the Canadian Press:
Health Canada and pharmaceutical company Janssen-Ortho are warning people taking the HIV drug Prezista that the drug can cause serious liver side-effects.

Prezista, which is used in combination with another antiretroviral medication known as ritonavir, is used to treat adult patients in whom other HIV therapy has failed.

The warning says that in clinical trials, 0.5 per cent of people who took the drug developed hepatitis or inflammation of the liver.

And since the drug has been brought to market, there have been 13 reports of patients who developed hepatitis, including two who died.

The warnings says that between mid-2006 and the end of 2007 there were also 25 reports of patients who developed other liver problems; 14 of those patients died. ...more

Association of Prezista (darunavir) with hepatotoxicity

From Health Canada:
Tibotec, a division of Janssen-Ortho Inc. ("Tibotec"), in cooperation with Health Canada, would like to inform you of important new safety information regarding hepatotoxicity in association with the use of PREZISTA (darunavir). PREZISTA, co-administered with ritonavir (rtv) and other antiretroviral agents, is indicated for treatment of human immunodeficiency virus (HIV) infection in adult patients who have failed prior antiretroviral therapy.
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