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.
For the public
For health professionals

Canadian AIDS meds may soon head to Rwanda

From CBC News:
Four years after it was passed unanimously by Parliament, a bill drafted to allow low-cost Canadian-made AIDS drugs to be exported to developing countries may finally be on the verge of producing results.

Generic drug maker Apotex Inc. announced Wednesday that it has been awarded a contract by the government of Rwanda to sell its three-in-one AIDS pill Apo Triavir to the African country. Securing that contract was the final legal hurdle that Apotex had to manoeuvre in the onerous process of making Canada's Access to Medicines Regime work.

"We're almost there," Elie Betito, the company's director of public and government affairs, said in an interview.

"By October sometime we're hoping that the product will be on a plane on delivery to Rwanda."

He noted, though, that nothing will be final until that actually happens. The companies that hold the patents on the drugs in the Apotex combined medication can still withdraw permission for the sale to take place "even on the day we are shipping." ...more

New HIV finding could prevent drug resistance, toxic side-effects

From CBC News:
Researchers have discovered a new method of attacking the HIV virus which may offer a solution to drug resistance.

Their method involves targeting the proteins of human cells, which bind with the virus. Many of the antiretroviral drugs that are used to fight HIV, the virus that causes AIDS, attack the proteins that exist on the surface of the virus, rendering it incapable of infecting healthy cells.

But as the virus can mutate, these targets can change and render these medications useless, even when physicians prescribe multi-drug "cocktails" that attack the virus on different fronts. ...more

FDA reviews safety of HIV drugs from Glaxo, Bristol-Myers after heart attack risks

From the Canadian Press:
The Food and Drug Administration said Thursday recent data show patients taking HIV drugs from GlaxoSmithKline and Bristol-Myers Squibb may have increased risk of heart attack.

FDA said data pooled from a 33,000-patient study of HIV patients showed those taking Glaxo's Ziagen and Bristol-Myers' Videx had a greater chance of heart attack than patients on other medications.

Labelling changes could be needed for the drugs, FDA said, though it stressed it is still working with incomplete data. The agency does not have information on heart attack risks of two other drugs in the class of virus-fighting medications. ...more

Hundreds dying of AIDS never accessed drug cocktails: report

From the Vancouver Province:
Hundreds of people with HIV are dying without ever taking the drug cocktails that can prolong their lives for decades and the biggest at-risk group is poor, homeless, mentally ill or drug-addicted.

A new study by the B.C. Centre for Excellence in HIV/AIDS found 40 per cent of the 1,436 people who died of HIV-related causes between 1997 and 2005 hadn't accessed the antiretroviral drugs.

It found 567 persons, or about 63 a year or more than one every week, who had tested positive died without treatment.

The antiretrovirals have improved in the past 10 years from a "burdensome quantity of therapy" requiring "many doses, many side effects" to a once-a-day dose that can prolong a person's life for decades, said Dr. Julio Montaner, director of the centre.

They also prevent those infected from spreading the disease.

"The treatment is free and effective but in reality is not accessible to those who need it most," he said.

He said the problems of mental illness, homelessness, drug addiction and food security have to be tackled first because those infected may not be pursuing treatment of a long-term illness while they're faced with more immediate concerns. ...more

Canadian researchers find gene that may block HIV

From CTV News:
Researchers at the University of Alberta have made a breakthrough with the discovery of a gene that might block the spread of HIV and the onset of AIDS.

The hope is that the discovery could lead to a vaccine that would combat the deadly virus.

Lead researcher Steven Barr said the gene, known as TRIM22, has a natural anti-viral defence function and has the ability to block HIV.

Though the research is admittedly in its infancy, Barr said the goal now is to study how the gene works in hopes to mimic its ability to combat the virus.

"It's exciting because it's a natural defence against HIV. So if we can harness this without the toxic effect of drugs it's going to be beneficial for HIV patients in the future," Barr told CTV's Canada AM on Friday. ...more

Front-line AIDS drugs show staying power: study

From AFP:
Standard triple-drug treatment for HIV provides long-term protection against the development of full-blown AIDS, according to a study released Friday.

But when this front-line therapy fails, HIV-infected people in poorer nations could find themselves nearly defenceless against AIDS-related disease, it warned.

Data on 7,916 HIV-infected individuals in Britain who began standard triple-drug therapy showed that only 167 developed extensive resistance to all three types of medication, the researchers found.

The risk of such "triple-class" failure at the end of 10 years was estimated at 9.2 percent, according the study, published in the British medical journal The Lancet. ...more

Life-saving meds wrapped in red tape

From the McGill (Que.) Daily:
Six months after Industry Canada finished its review of legislation that allows Canadian drug manufacturers to produce and export generic medicines, a report of the findings has yet to be completed.

The legislation, known as the Canada Access to Medicines Regime (CAMR), was passed in 2004 to facilitate access to affordable essential medicines in developing countries. But the legislation is widely recognized as flawed – so far, not a single pill has left the country. ...more

Promising new HIV-AIDS drug, 1st in new class, approved for Canadian market

From Canada East:
Health Canada has granted licence approval for a new HIV-AIDS drug, the first in a promising new class of medications.

Drug maker Merck Frosst says it has been given permission to bring Isentress to the Canadian market for treatment of HIV-positive people whose viruses are resistant to multiple other HIV drugs. AIDS expert Dr. Mark Wainberg says there is tremendous optimism about the drug in the community of HIV patients, doctors and researchers.

The drug's generic name is raltegravir.

It is the first in a new class of drugs known as integrase inhibitors to hit the global AIDS drug market; another drug, eltegravir, is in development by Gilead Sciences Inc. of Foster City, CA. ...more

HIV infections rise in Canada, fall globally

From the London (Ont.) Free Press:
James Armstrong can't walk. He is blind in his left eye. He has survived cancer, kidney failure and numerous blood and lung infections, but he is happy to be alive.

The 45-year-old Toronto man has been on the verge of dying a dozen times since he began living with HIV in 1986.

In May, he agreed to be pulled off life support in the hospital while suffering from his third bout of pulmonary edema. Armstrong's doctor told him he would have 20 minutes left to live, yet he managed to survive.

"The doctor told my mom at my bedside before he left that it was an honour being my doctor for 12 years and to be sure to let him know when my funeral was -- but somehow I miraculously survived again," Armstrong, who lives at Casey House, said. ...more

Entre Nous with Mark Wainberg

This is not exactly a pharmacy article, but I had to include it as it's related to HIV/AIDS and it features Mark Wainberg. His group's research in the 80's led to the discovery of 3TC, one of the most important antivirals on the market. Very few people seem to be aware that Canadians discovered this medication.

I've had the opportunity to hear him speak and meet with him. If you ever get the chance to do the same, I'd highly recommend it.

From the McGill (QC) Reporter:
Fresh off the red-eye from L.A. where he was visiting his grandchildren, Mark Wainberg poked fun at our photographer when it was suggested that he change his shirt for the photo shoot. "The New York Times never asked me to change my shirt," laughed the Director of the McGill AIDS Centre, over his shoulder as he hustled to his car to get a change of wardrobe. A leading HIV/AIDS researcher and activist, Wainberg is tireless; meeting with scientists, world leaders, industrialists and Hollywood celebrities in his ongoing quest to raise awareness and shape policies geared toward slowing the spread and, ultimately, eradicating the dreaded disease. Having donned a fresh shirt, Wainberg sat down with the Reporter to talk about where the world stands on the eve of World AIDS Day. ...more

Living longer with HIV

From the Toronto Star:
"You can't live your life with a gun to your head," says 52-year-old Gary, who tested positive for HIV in 1985. "At some point, you have to look away and get on with things."

While Gary is rigorous about his drug routines and follows his doctor's orders, he no longer wastes time speculating about when he'll die.

"I stopped asking my doctors how long I had to live 20 years ago," says the Toronto house painter. (Gary asked us not to use his last name.) "And I stopped paying attention to survival time statistics because, especially in the beginning, it was a pretty safe assumption that I wasn't going to live very long."

A lot has changed since then. Not only are people living longer with HIV, in the final analysis most of them will not die of AIDS at all. ...more

HIV-blocking drug offers hope – doctors

From the Halifax Chronicle Herald:
The Canadian launch this week of a new medication that prevents HIV from entering fresh cells will help many people living with the virus, says a Halifax infectious diseases specialist.

Dr. David Haase said Tuesday that maraviroc, brand-named Celsentri, is a new class of drug that’s taken in tablet form. It’s been approved by Health Canada and was introduced into the marketplace Monday.

Maraviroc prevents entry of HIV "into the cells that usually infect the white blood cells," said Dr. Haase of the Queen Elizabeth II Health Sciences Centre. ...more

Gilead's Atripla approved in Canada

From the San Francisco Business Times:
Gilead Sciences Inc. said Atripla -- the three-in-one HIV treatment developed in concert with Bristol-Myers Squibb Co. -- was approved by Canadian drug regulators for use by adults with HIV-1 infection.

Atripla combines Gilead's (NASDAQ: GILD) HIV drug Truvada -- itself a combination of the Foster City-based company's Viread and Emtriva -- with Bristol-Myers Squibb's (NYSE: BMY) Sustiva. ...more

New drug approved in Canada to treat HIV, first in 10 years

From the Canadian Press:
Health Canada has approved the first drug in the first new class of HIV medications to be brought to market in Canada in a decade.

Celsentri - the brand name for the drug maraviroc - is the first of a class of drugs called CCR5 antagonists to gain regulatory approval.

The drug, made by Pfizer Canada Inc., blocks entry of HIV into the immune system's T cells, reducing the level of the virus in the body. It is approved for use only in people who have already been on other HIV medications; it is not licensed for people who are just starting anti-retroviral drug therapy. ...more

Pfizer wins U.S. approval for new HIV drug

My understanding is that Selzentry will likely be approved in Canada later this year.

From the Financial Post:
Pfizer Inc said on Monday that U.S. regulators approved its AIDS drug, Selzentry, the first in a new class of oral HIV medicines.

Selzentry is the first drug designed to keep the HIV virus that causes AIDS from entering healthy immune cells. Older AIDS medicines attack the virus itself.

The drug, also known as maraviroc, blocks the CCR5 co-receptor that serves as a main doorway for the HIV virus into immune cells.

The U.S. Food and Drug Administration approved Selzentry for use in patients who have tried other medicines and for those for whom a diagnostic test has confirmed their HIV strain is linked to the CCR5 receptor. About 50 percent to 60 percent of patients who have been treated with other AIDS drugs meet that definition, the FDA said.

Selzentry will come with a "black box" warning, the strongest for prescription drugs, about the risk of liver toxicity, the FDA said. ...more

Canadian companies agree to share generic AIDS drugs with Rwanda

From the Globe and Mail:
AIDS drugs could be heading for Rwanda as soon as November under a Canadian program that allows generic-drug companies to send copies of brand-name medicines to poor countries.

GlaxoSmithKline Inc. said yesterday it had given consent to Apotex Inc. to manufacture an antiretroviral medication for the treatment of HIV/AIDS patients in Rwanda. Consent, through Canada's Access to Medicines Regime, was needed as GSK has patent rights for two of the three molecules in the medication.

"We have made a commitment, we have the drug and if we can get the green light, we will move quickly on it," said Elie Betito, director of public and government affairs for Apotex Inc. ...more

Merck's Drug for AIDS Virus Faces Review in September

It should be interesting to see how the FDA handles the application of this fantastic new antiviral drug. Some of the reports regarding this drug have been extremely promising.

It's my understanding that Health Canada is trying to speed up the review on this product as well.

From Bloomberg:
Merck & Co.'s experimental HIV/AIDS treatment will be scrutinized by a panel of U.S. regulatory advisers on Sept. 5.

A Food and Drug Administration advisory committee meeting in Silver Spring, Maryland, will review Merck's application to sell the drug, called Isentress, according to a notice posted today on the agency's Web site. The twice-a-day tablets are intended for patients with the human immunodeficiency virus who don't respond to existing antiretroviral therapy.

Merck, based in Whitehouse Station, New Jersey, is competing with Pfizer Inc. to develop the first new type of medicine in a decade to treat HIV, the virus that causes AIDS. Thousands of Americans have drug-resistant forms of the infection and could benefit from new therapies, according to doctors. ...more