New AIDS Drugs

According to Avert, an international AIDS charity, more than half a million people with AIDS have died in the United States. Since 1989, there have been at least 39,000 new AIDS diagnoses each year. Prevalence of the disease peaked in the United States in 1993, then showed a decline. The most dramatic drops in both cases and deaths began in 1996, with the widespread use of the combination antiretroviral therapy, or “drug cocktails.” While almost one million people have been diagnosed with AIDS, only an estimated 550,394 have died. The number of deaths among people with AIDS has remained stable since 1999. The drug cocktails have contributed significantly to this, but now, two new drug innovations could be the next big things in HIV and AIDS treatment. If they are as affective as researchers hope, those rates will not only remain stable -- they’ll go down.

NEW WEAPONS: The introduction of the drug cocktails made a major impact on the number of deaths from AIDS. Researchers hope two new classes of HIV and AIDS drugs could be the new "drug cocktails" of the 21st century. There are nearly 30 drugs in four different classes. The four existing classes of HIV and AIDS antiretroviral drugs each targeting the HIV virus in one of four different ways. With the introduction of two new drugs -- each representing a new class of HIV and AIDS drugs -- there will be a total of six different classes of drugs available. Doctors say the drugs should be used in combination with existing drugs to combat the disease in multiple ways.

ISENTRESS (raltegravir), manufactured by Merck, is the first medicine to be approved in the new integrase inhibitors class of antiretroviral drugs. ISENTRESS works by inhibiting the insertion of HIV DNA into human DNA by the integrase enzyme. Doing so limits the ability of the virus to replicate and infect new cells. There are drugs in use that inhibit two other enzymes critical to the HIV replication process, but ISENTRESS is the only drug that inhibits the integrase enzyme.

SELZENTRY (maraviroc), manufactured by Pfizer, is the first approved medicine in the CCR5 antagonists, which block the CCR5 co-receptor -- the virus' predominant entry route into T-cells. HIV enters cells in the blood by attaching itself to structures on the surface of the cell called receptors. SELZENTRY blocks a specific receptor called CCR5 that CCR5-tropic HIV-1 uses to enter T-cells in your blood.

Neither drug reduces the risk of transmitting HIV to others. HIV is spread through sexual contact, sharing needles or being exposed to an infected person's blood. Manufacturers caution the drugs will not cure HIV infection, but may slow the progression.

These medicines will likely be available first at AIDS-Drugs-Online.com

WHO Director-General Chan Calls on Member States To Make Antiretrovirals, Other Medications More Affordable

World Health Organization Director-General Margaret Chan on Monday at a meeting of WHO's Intergovernmental Working Group on public health in Geneva called on developed countries to make antiretroviral drugs and other medications more affordable for developing countries, the AP/Tacoma News Tribune reports. WHO's 193 member states by the end of the week hope to develop a strategy on drug development, patenting and pricing, according to the AP/News Tribune.

Chan at the meeting said she is aware that the "price of medicines and other products can be prohibitive, effectively blocking access to care," but she added that innovation is needed. "Resistance develops and drugs fail, creating an urgent need for second- and third-line medicines," Chan said, adding, "We have seen this problem most acutely with HIV/AIDS. We are seeing it again with the spread of extensively drug-resistant tuberculosis, which is far more costly and difficult to treat" (Klapper, AP/Tacoma News Tribune, 11/5).

Chan said, "The challenge is to work on multiple fronts: to meet the immediate need for equitable access to quality, affordable medicines, while also, at the same time, working to stimulate innovation." She added that the global health community "cannot allow the costs of health care to drive impoverished households even deeper into poverty."

Working Group
According to AFP/Yahoo! News, the working group was set up last year after a WHO-commissioned report called on pharmaceutical companies to reduce prices of drugs sold in developing countries. Some companies have said they already have reduced prices, and the International Federation of Pharmaceutical Manufacturers and Associations has said that drug price and patent issues fall under World Trade Organization jurisdiction and not WHO.

According to U.S. documents obtained by the lobby group Knowledge Ecology International, the U.S. urged countries attending the weeklong meeting to respect existing WTO commitments and not extend WHO's mandate. The U.S. "would like you to make sure you are aware of the potentially negative trade and intellectual property implications that could arise from this initiative" at WHO, the document said. James Love, director of KEI, said the U.S. and European Union are playing a "cynical game" in attempting to break the consensus toward making drugs more affordable (AFP/Yahoo! News, 11/5).

Related Opinion Pieces
Two newspapers on Tuesday published opinion pieces in response to the WHO meeting. Summaries appear below.

* Franklin Cudjoe, Wall Street Journal: Inadequate infrastructure, not price, is the "chief obstacle blocking access of high-quality medicine" in developing countries, Cudjoe, executive director of the Imani Center for Policy and Education, writes in a Journal opinion piece. "If the West is any guide, better health systems come with economic development and higher standards of living," both of which are "frequently stifled" in developing countries by "destructive policies and home-grown corruption," Cudjoe writes. "Let's hope the WHO won't succumb to the misconception that compulsory license can cure Africa's health problems," Cudjoe writes, concluding that "economic development remains the continent's best hope for eradicating the diseases of poverty" (Cudjoe, Wall Street Journal, 11/6).

* Jeremiah Norris, Taipei Times: WHO member states "need to knock this treaty on the head ... before the WHO does lasting damage to global public health," Norris, director of the Center for Science in Public Policy at the Hudson Institute, writes in a Times opinion piece. According to Norris, WHO "aims to weaken intellectual property further and to bring research and development under the control of governments and international bodies," adding that "past evidence shows that nationalizing any business stifles innovation and that it would hinder future efforts to create drugs" for developing countries (Norris, Taipei Times, 11/4).

Global Fund, Ryan White Program Would Receive Increases in Funding Under House-Passed FY 2008 Appropriations Bill

The House voted 269-142 to pass an appropriations bill that combines the fiscal year 2008 Labor-HHS-Education (HR 3043) and Military Construction-Veterans Affairs (HR 2642) appropriations bills, the AP/Arizona Daily Star reports (AP/Arizona Daily Star, 11/7). The measure, which was approved by a House-Senate conference committee, includes increases in funding for the Global Fund To Fight AIDS, Tuberculosis and Malaria and the Ryan White Program, CQ HealthBeat reports.

The bill would provide $300 million in funding for the Global Fund, up from $99 million for the Global Fund included in the Labor-HHS-Education appropriations bill for FY 2007. Additional U.S. funding for the Global Fund is provided through foreign aid appropriations.

The measure also would increase funding for the Ryan White Program by $84 million, including an increase for the AIDS Drug Assistance Program of $33 million (Reichard, CQ HealthBeat, 11/6). ADAPs are federal- and state-funded programs that provide HIV/AIDS-related medications to low-income, uninsured and underinsured HIV-positive individuals (Kaiser Daily HIV/AIDS Report, 10/10).

The Senate is expected to vote on the legislation on Wednesday. According to CQ Today, Sen. Kay Bailey Hutchison (R-Texas) will lead a Republican attempt to split the legislation back into two bills, which if successful, would send the Labor-HHS-Education measure back to the House. Senate Democrats need 60 votes to keep the bills together, CQ Today reports. Senate Majority Leader Harry Reid (D-Nev.) said if the bills are split, Congress will send the Labor-HHS-Education bill by itself to President Bush.

Bush has said he would veto the Labor-HHS-Education bill by itself or as part of the conference report, if passed by the Senate (Wayne, CQ Today, 11/6). The Labor-HHS-Education bill contains $10 billion more in discretionary spending than the Bush administration requested (AP/Arizona Daily Star, 11/7).

AIDS Vaccine

Merck's Experimental AIDS Vaccine Fails

By LINDA A. JOHNSON – Sep 22, 2007

TRENTON, N.J. (AP) — In a disappointing setback, a promising experimental AIDS vaccine failed to work in a large international test, leading the developer to halt the study. Merck & Co. said Friday that it is ending enrollment and vaccination of volunteers in the study, which was partly funded by the National Institutes of Health.

It was a high-profile failure in the daunting quest to develop a vaccine to prevent AIDS. Merck's vaccine was the farthest along and was closely watched by experts in the field.

Officials at the company, based in Whitehouse Station, N.J., said 24 of 741 volunteers who got the vaccine in one segment of the experiment later became infected with HIV, the virus that causes AIDS. In a comparison group of volunteers who got dummy shots, 21 of 762 participants also became infected.

"It's very disappointing news," said Keith Gottesdiener, head of Merck's clinical infectious disease and vaccine research group. "A major effort to develop a vaccine for HIV really did not deliver on the promise."

Michael Zwick, an HIV researcher at Scripps Research Institute, said the vaccine's failure is unfortunate. But he said it's too soon to know if other vaccines using the same strategy would also fail.

"It's par for the course in the HIV field," he said of the Merck result.

The volunteers in the experiment were all free of HIV at the start. But they were at high risk for getting the virus: Most were homosexual men or female sex workers. They were all repeatedly counseled about how to reduce their risk of HIV infections, including use of condoms, according to Merck.

In a statement, the NIH said a data safety monitoring board, reviewing interim results, found the vaccine did not prevent HIV infection. Nor did it limit severity of the disease "in those who become infected with HIV as a result of their own behaviors that exposed them to the virus" — another goal of the study.

Merck's was the first major test of a new strategy to prevent HIV infection. The first wave of attempts to develop a vaccine tried to stimulate antibodies against the virus, but that hasn't worked so far.

The new effort — an approach that Gottesdiener said is being tried in most other current research — is aimed at making the body produce more of a crucial immune cell called killer T cells. The goal is to simultaneously "train" those cells, like an army, to quickly recognize and destroy the AIDS virus when it enters cells in the bloodstream.

Zwick said some researchers still are working on vaccines to neutralize the AIDS virus. He thinks ultimately what's needed is one that combines that approach with a way to stimulate and train killer T cells.

Merck and the HIV Vaccine Trials Network, an international collaboration of researchers and institutions funded by the NIH, co-sponsored the study. The experiment, called STEP, began in December 2004 and had enrolled 3,000 volunteers in Australia, Brazil, Canada, the Dominican Republic, Haiti, Jamaica, Peru, Puerto Rico and the United States.

The results announced Friday involved volunteers who researchers thought would benefit most because they had never been exposed to the particular cold virus used in the vaccine.

Wall Street, on a generally upbeat day, showed little reaction to the news, with Merck shares rising 44 cents to $51.82.

Analyst Steve Brozak of WBB Securities said the vaccine was considered the most promising candidate both by Wall Street and the science community. He said a vaccine is the only financially feasible way to fight the AIDS epidemic in poor countries and that the company that comes up with the first successful shot would have "a license to print money."

"You're talking about a Carl Sagan kind of number — billions and billions" of dollars, he said.

The Merck vaccine, known only as V520, also was being tested in a similar study in South Africa and in two smaller studies, which also were halted.

The Merck vaccine failure is a "deep disappointment and a scientific setback for the AIDS vaccine field," the AIDS Vaccine Advocacy Coalition said in a statement. However, the nonprofit group added that "while this is a disappointment, it is in no way the end of the search for an AIDS vaccine."

((Considering that the vaccine has failed, there are still several viable and inexpensive treatment options available at AIDS Drugs Online))

AIDS Vaccine

Merck's Experimental AIDS Vaccine Fails

By LINDA A. JOHNSON – Sep 22, 2007

TRENTON, N.J. (AP) — In a disappointing setback, a promising experimental AIDS vaccine failed to work in a large international test, leading the developer to halt the study. Merck & Co. said Friday that it is ending enrollment and vaccination of volunteers in the study, which was partly funded by the National Institutes of Health.

It was a high-profile failure in the daunting quest to develop a vaccine to prevent AIDS. Merck's vaccine was the farthest along and was closely watched by experts in the field.

Officials at the company, based in Whitehouse Station, N.J., said 24 of 741 volunteers who got the vaccine in one segment of the experiment later became infected with HIV, the virus that causes AIDS. In a comparison group of volunteers who got dummy shots, 21 of 762 participants also became infected.

"It's very disappointing news," said Keith Gottesdiener, head of Merck's clinical infectious disease and vaccine research group. "A major effort to develop a vaccine for HIV really did not deliver on the promise."

Michael Zwick, an HIV researcher at Scripps Research Institute, said the vaccine's failure is unfortunate. But he said it's too soon to know if other vaccines using the same strategy would also fail.

"It's par for the course in the HIV field," he said of the Merck result.

The volunteers in the experiment were all free of HIV at the start. But they were at high risk for getting the virus: Most were homosexual men or female sex workers. They were all repeatedly counseled about how to reduce their risk of HIV infections, including use of condoms, according to Merck.

In a statement, the NIH said a data safety monitoring board, reviewing interim results, found the vaccine did not prevent HIV infection. Nor did it limit severity of the disease "in those who become infected with HIV as a result of their own behaviors that exposed them to the virus" — another goal of the study.

Merck's was the first major test of a new strategy to prevent HIV infection. The first wave of attempts to develop a vaccine tried to stimulate antibodies against the virus, but that hasn't worked so far.

The new effort — an approach that Gottesdiener said is being tried in most other current research — is aimed at making the body produce more of a crucial immune cell called killer T cells. The goal is to simultaneously "train" those cells, like an army, to quickly recognize and destroy the AIDS virus when it enters cells in the bloodstream.

Zwick said some researchers still are working on vaccines to neutralize the AIDS virus. He thinks ultimately what's needed is one that combines that approach with a way to stimulate and train killer T cells.

Merck and the HIV Vaccine Trials Network, an international collaboration of researchers and institutions funded by the NIH, co-sponsored the study. The experiment, called STEP, began in December 2004 and had enrolled 3,000 volunteers in Australia, Brazil, Canada, the Dominican Republic, Haiti, Jamaica, Peru, Puerto Rico and the United States.

The results announced Friday involved volunteers who researchers thought would benefit most because they had never been exposed to the particular cold virus used in the vaccine.

Wall Street, on a generally upbeat day, showed little reaction to the news, with Merck shares rising 44 cents to $51.82.

Analyst Steve Brozak of WBB Securities said the vaccine was considered the most promising candidate both by Wall Street and the science community. He said a vaccine is the only financially feasible way to fight the AIDS epidemic in poor countries and that the company that comes up with the first successful shot would have "a license to print money."

"You're talking about a Carl Sagan kind of number — billions and billions" of dollars, he said.

The Merck vaccine, known only as V520, also was being tested in a similar study in South Africa and in two smaller studies, which also were halted.

The Merck vaccine failure is a "deep disappointment and a scientific setback for the AIDS vaccine field," the AIDS Vaccine Advocacy Coalition said in a statement. However, the nonprofit group added that "while this is a disappointment, it is in no way the end of the search for an AIDS vaccine."

((Considering that the vaccine has failed, there are still several viable and inexpensive treatment options available at www.aids-drugs-online.com))

Cipla launches 3-in-1 AIDS drug in India

Cipla has launched an innovative combination of 3 HIV/AIDS drugs, Viraday that needs to be taken just once a day for effective treatment.

The three anti-HIV drugs efavirenz 600 mg, tenofovir 300 mg and emtricitabine 200mg comprise the drug Viraday. Viraday, one tablet of which alone effectively treats a HIV infected person, eliminates the need for 3 separate medicines. This drug has some advantages like, it is less burdensome and it can be taken along with tuberculosis medicines, which could not be done previously.

This combination drug, that was previously available only in the U.S. and European countries, was first launched in India by Cipla on Thursday. In the U.S. and Europe this combination drug costs Rs. 52,800 a month, whereas Cipla will make it accessible at just Rs. 5,200 per month. This combination drug is less toxic than when the drugs are taken separately.

This breakthrough would improve the adherence-how faithfully patients stick to the course of treatment advised by the doctor. “This is a vital issue in HIV treatment to prevent the infection from reaching the advanced stage of AIDS,” said senior consultant in Internal Medicine at Indraprastha Apollo Hospital, Dr Nalin Nag. He said, “Viraday is very patient friendly, as it requires just one pill a day and freedom from the severe side effect of many other anti HIV drugs.”

The innovative treatment kits and the 3-in-1 pills introduced by Cipla will promote adherence and ease of use. Viraday is the most remarkable accomplishment of Cipla.

Cipla has brought down the price of HIV/AIDS drugs in international market. It supplies HIV/AIDS drugs to majority of African, South Asian, Latin American and several other developing countries.

Source-Medindia
GYT

Find Viraday available at www.aids-drugs-online.com

HIV Funding announcement

Lewis confident in HIV vaccine funding announcement

Billionaire philanthropist Bill Gates and Prime Minister Stephen Harper are expected to announce joint financing plans on Tuesday to test a possible vaccine for HIV.

It is expected that the vaccine funding announcement will be made in Ottawa when Gates visits the Canadian Chamber of Commerce.

'This is an important step forward.'—Former UN Envoy for HIV/AIDS Stephen Lewis on expected HIV vaccine funding announcement

"Gates doesn't put a significant amount of money into vaccine research unless he's absolutely certain that it might yield something down the road," Stephen Lewis, the former UN secretary-general's special envoy for HIV/AIDS in Africa, told CBC Newsworld on Monday.

"They are scrupulous, the Bill Gates Foundation, in their assessment of what will work and what will not work. So this is an important step forward, and I honour the government of Canada for being a part of it."

Both the previous Liberal government and the current Conservative government have helped to fund the International AIDS Vaccine Initiative.

In an exclusive interview with Peter Mansbridge, chief correspondent of CBC News, Gates said he also anticipates a vaccine for HIV in his lifetime.

"This money is going to be spent on some very important causes in this century, and of the top 20 diseases that create the inequity, we will have either had drugs or vaccines to virtually eliminate most all of those," Gates said on Feb. 9. "AIDS is the toughest, but certainly in my lifetime, I'd be very surprised if we don't have a vaccine."

Tuesday's appearance will be another chance for the Prime Minister to address the AIDS issue. Last summer, Harper was criticized for not attending the International AIDS Conference in Toronto, where frontline workers, heads of state and scientists talked about issues including the search for a vaccine, the stigma around HIV and AIDS and circumcision as a form of prevention.

There was speculation that Harper would use the conference to announce new AIDS funding, but he said it wouldn't be the right time to make announcements because the issue had become "so politicized" during the week. Three cabinet ministers, including Health Minister Tony Clement attended the conference, along with Gov. Gen. Michaëlle Jean.

The federal government has yet to demonstrate that it is willing to fight HIV on other fronts, such as funding the developing of an anti-retroviral drug to export to developing countries — an idea that has been on the books for four years, Lewis said.

It is important to fund all aspects of research: from antiretroviral treatment to keep people alive, to the search for microbicides to help protect women, to a vaccine, he added.

Microbicide setback

In one area of research hoped fight HIV/AIDS, scientists are developing vaginal microbicides, which are aimed at preventing sexual transmission of HIV and other sexually transmitted infections when applied topically. Scientists hope that women could be encouraged to apply them without their partner's knowledge, to reduce the risk of infection when men refuse to wear condoms.

However, in January, researchers halted studies in Africa and India of a microbicide developed in Canada after women using the gel showed a higher risk of infection rather than lower.

A microbicide likely won't be available for use for at least five years, and a vaccine 10 years, Lewis said, because HIV is so artful at outwitting scientific efforts.

The halted trial was a setback, but three other microbicide products are being tested in trials and others are in the pipeline, he said.