To try to force the government's hand, leading AIDS pressure group Treatment Action Campaign (TAC) leaked the confidential study conducted earlier this year by the health and finance ministries on the viability of a state-funded drugs program.

Government officials, some of whom have in the past questioned the link between HIV and AIDS, reacted angrily on Monday, accusing the TAC of "theatrics" and saying only a first draft of the study had been leaked at the weekend.

Activists say AIDS kills some 600 people each day in South Africa, where an estimated 4.7 million people suffer from the disease.

"This report, we believe, demonstrates that there are now no justifications for delaying treatment," TAC said in a statement on Monday.

According to the report, a copy of which was obtained by Reuters, universal access to anti-retrovirals could save up to 1.7 million lives by 2010. If half the people needing drugs received them, that could still save 733,000 lives.

AIDS is expected to orphan 1.8 million children between 2003 and 2010, but that figure could fall by 860,000 if the drugs are made available nationwide.

Anti-retrovirals are available to South Africans with medical insurance, but not in state hospitals on which the bulk of the poor depends.

The report estimates 1.2 million people will need treatment by 2008 at a cost of between $1.7 billion and $2 billion. That compares with the current government allocation for HIV/AIDS of about $555 million.

Chief government spokesman Joel Netshitenzhe said TAC had leaked "a very first draft" of the study and accused the group of trying to grab attention ahead of an expected cabinet meeting on the issue.

"There is no need for theatrics in dealing with the matter of HIV and AIDS," Netshitenzhe said in a statement.

Anger at the government's stance is mounting.

The opposition Democratic Alliance accused Health Minister Manto Tshabalala-Msimang of failing to show leadership on the pandemic, while the Inkatha Freedom Party, a member of the ruling coalition, urged the government to stop denying the extent of the disease.

Ben Hirschler, European Pharmaceuticals Correspondent

PARIS (Reuters) - Two decades into the global AIDS pandemic, governments around the world are finally talking of committing tens of billions of dollars to fight the killer disease in developing countries.

But Robert Gallo, the scientist who co-discovered HIV in 1983, warned on Monday there were serious dangers from embarking on widespread treatment in sub-Saharan Africa without adequate medical infrastructure.

"Obviously it is critical to get available drugs to developing nations as quickly as possible, but not just to throw this at them," Gallo, director of the U.S.-based Institute of Human Virology, told Reuters.

"We've got to have infrastructure created at the same time because we are going to create multi-drug resistant mutants if we don't."

Gallo said AIDS patients needed extensive medical care, including testing and monitoring to ensure compliance with drug regimens, something that may simply be impractical in parts of Africa where many do not have basic healthcare.

The issue of how to get drugs to the vast majority of the world's 42 million HIV infected people is dominating discussions at the International AIDS Society conference in Paris, where Gallo was speaking.

Activists say six million face imminent death without access to affordable drugs and have urged governments to pledge more to the Global Fund to Fight AIDS, Tuberculosis and Malaria in order to speed up treatment in Africa, the center of the pandemic.

President Bush in May signed into a law pledging $15 billion to help combat the deadly disease, trebling U.S. spending over five years and sparking calls for other industrialized countries to dig deeper in their pockets.

Gallo, however, is something of a dissenting voice in the chorus of support for widespread treatment by highlighting the risk that powerful antiretrovirals, if not taken correctly, can quickly induce virus resistance.

"Nobody talks about that...the danger of failure is very real in a few years if the drugs are just dumped there," Gallo said.

"There'll be great happiness with the drugs being made available, as I would see the future, for two to five years and then we're going to start seeing problems if it is not done right."

Other speakers at the conference acknowledged the need for on-the-ground medical expertise but argued the risk of resistance should not deter the build-up of large treatment programs.

"Today we are actually ahead of where we planned we would be in terms of the amount of drug we can produce in each production batch," he told Reuters.

Roche, which developed Fuzeon with U.S. biotech firm Trimeris Inc, said it expected further improvements by removing production bottlenecks at a U.S. plant in Colorado that makes Fuzeon, one of the most complex medicines on the market.

This would let it revise up production forecasts for future years in coming months. Roche currently forecasts it will supply the drug to 39,000 people by the end of 2005.

Roche has said in the past Fuzeon could have peak annual sales of up to $729.4 million.

Fuzeon is the first in a new class of HIV/AIDS drugs that works outside the cell, offering new hope to patients who have grown resistant to conventional medicines and avoiding some of the more serious side effects of other AIDS treatments.

ENTRY INHIBITORS

Robert Gallo, the U.S. scientist who co-discovered HIV in 1983, told reporters at the International AIDS Society conference he believed such entry inhibitors would be the most attractive new approach to fighting the virus in the years ahead.

A number of other pharmaceutical and biotech companies are also working on different approaches to preventing the virus from locking on to human immune cells.

The high cost of Fuzeon -- some $20,000 per patient a year -- and the fact that it must be injected twice a day, leading to injection site reactions, has caused some skepticism about the product's uptake.

But Reddy said he was pleased with early take-up of the drug, which is now on sale in the United States and some European markets, adding it was being widely reimbursed by health insurers, despite its high cost.

Roche and Trimeris also released new clinical trial data showing Fuzeon continued to offer significant benefits to patients who had been taking it for 48 weeks. Previous data released on the drug last year had only tracked users up to 24 weeks.

Professor David Cooper of the University of New South Wales, Australia, said 30.4 percent of patients given Fuzeon plus other anti-HIV drugs had undetectable levels of virus in their bodies after 48 weeks against 12 percent given conventional drugs alone.

That was only marginally less than the 32.7 percent of patients who had virtually no virus at the 24-week stage of the clinical trials, which involved 1,000 patients and are known as TORO 1 and 2.

Cooper added the benefit from the Fuzeon-based drug regimen was greatest when used earlier, when there were a greater number of drugs available that were still active and could be combined with Fuzeon.

PARIS (AFP) - The fight against the global AIDS pandemic received grim news with the release of a new study showing that 10 percent of newly infected patients in Europe have developed drug-resistant strains of the disease.

The "Catch" study involved 1,633 patients across 17 European countries who had just been diagnosed as carrying the HIV virus and had not yet received any kind of treatment.

While researchers said that resistance could be expected to occur, what was worrying about the finding was that it showed that infected people continued to engage in high-risk behavior, such as sex without condoms and needle-sharing.

Results showed that 9.6 percent of patients showed resistance to at least one of the three types of anti-retroviral drugs commonly used to fight the human immunodeficiency virus (HIV) and AIDS, including the powerful protease inhibitors.

The study, conducted between 1996 and 2002, was released by its researchers at four-day scientific conference on AIDS hosted in Paris by the International AIDS Society.

Results indicated that people infected with the HIV virus and undergoing treatment continued to have high-risk sex or share needles, said the Dutch researcher David van de Vijver from the Utrecht University Medial Centre.

They thereby passed on a disease that had already encountered anti-retroviral drugs, allowing the virus to mutate into a drug-resistant strain.

A Canadian study also showed drug-resistant strains in eight to nine percent of newly infected patients, while tests in Switzerland, France and the United States have revealed similar ranges, Van De Vijver said.

While the high-risk behaviour of HIV-positive patients added a discouraging note to the fight against AIDS, which has already killed over 20 million people, scientists were not surprised by the virus's capacity to mutate.

"It happens with other diseases. It happens with tuberculosis, it happens with antibiotics," said Dutch researcher and President of the International AIDS Society, Joep Lange.

Francoise Barre-Sinoussi, professor at France's Pasteur Institute, said the studies underligned "the importance of close, careful treatment with the help of health workers to reduce the risk of resistance."

As we cannot get rid of the virus, we must prevent a particular strain from taking over, Barre-Sinoussi said, adding that the "cocktail" of anti-retroviral drugs should be modified if there were signs of resistance to the treatment.

The results should be a warning to infected patients and anyone with high-risk behaviour, researchers said, stressing that there was still no cure nor vaccine for the disease.

A third generation of drugs, called fusion inhibitors, have produced promising results but they are still in the clinical trial stage and prohibitively expensive, at about 20,000 dollars per year.

HIV is a virus that is transmitted through sexual contact, shared use of drug needles or contaminated blood transfusions, which infects cells in the immune system, then replicates and destroys their host.

It then develops into the Acquired Immune Deficiency Syndrome or AIDS.

Today, HIV has infected more than 60 million people. Every day, the number of infected people rises by 14,000.

The International AIDS Society in Stockholm hosts a conference on the virus every two years. The meeting in Paris meeting is due to end on Wednesday.

By Emelia Sithole

PARIS (Reuters) - Treating infants of HIV-infected mothers with antiretroviral drugs during breast-feeding sharply reduces their risk of contracting the AIDS virus, according to the results of a new study released on Tuesday.

The authors of the study said the results might provide an effective and affordable new way to prevent infection of babies through breastfeeding, particularly in developing countries where there were little or no alternative to breast milk.

Social pressures in some African countries also forced some women to breastfeed even when they could afford to bottlefeed.

Under the SIMBA (Stopping Infection from Mother to Child via Breastfeeding in Africa) study, the rate of infection in babies born to HIV-infected women fell sharply to one percent from 15 percent in the first six months of their lives.

The children were given either GlaxoSmithKline Plc's Epivir or Boehringer Ingelheim's Viramune while breastfeeding for up to six months. The mothers were put on a short course of GSK's AZT and Bristol-Myers Squibb's Videx while pregnant and were counselled on how best to breastfeed.

"The combination of antiretroviral prophylaxis and counselling on breastfeeding practices in infants receiving breastfeeding from HIV-1 infected mothers is extremely effective in preventing mother to infant transmission," the authors said.

Short courses of antiretroviral therapy have been shown to reduce mother to child transmission of HIV after birth but the benefits are short-lived in countries where breastfeeding is the norm as the virus is passed on through breast milk.

About 2.5 million of the estimated 200 million women who become pregnant around the world each year have HIV, according to the latest UNAIDS report.

In 2001 alone, about 800,000 children were infected with the virus, almost all through mother to child transmission and the United Nations has pledged to reduce the proportion of infants infected with HIV by 20 percent by 2005.

Joep Lange, President of the International Aids Society (IAS), said he would recommend the immediate implementation of the SIMBA study's findings.

"It would be best to start providing universal access to treatment for people in developing countries but in the absence of that this intervention should be recommended immediately."

But Francois Dabis, a senior AIDS researcher with France's National AIDS Research Institute, was more cautious, saying he was wary about using the strategy on a large-scale basis.

"We should view the use of these drugs in infants as a model where further studies will be conducted using the same principle rather than a very effective strategy that can immediately be used in practice," he said.

NEW YORK (Reuters Health) - When HIV-infected patients alternated their drug regimen every three months, their virus levels stayed down longer than when one regimen was administered continuously.

That news comes from the SWATCH (SWitching Antiviral Therapy Combination against HIV-1) study. Dr. Javier Martinez-Picado, of Hospital Germans Trias I Pujol in Badalona, Spain, and others examined this alternating strategy among HIV patients who were randomized to one of three regimens.

Regimen A consisted of continuous treatment with didanosine, stavudine, and efavirenz. For regimen B, patients were administered zidovudine, lamivudine and nelfinavir. In regimen C, the patients alternated between the other two regimens every 3 months. The results are reported in the Annals of Internal Medicine

Response to treatment was similar in patients receiving regimen A or regimen B, so the researchers pooled these two groups when evaluating the results.

The rate of virologic failure -- that is, a rise in the amount of virus in the blood above a defined level -- was 3.5 higher during the following year in the pooled group than in the alternating therapy group.

Dr. Martinez-Picado's group concludes, "Proactive switching and alternation of antiretroviral regimens with drugs that have different resistance profiles might extend the overall long-term effectiveness of first- and second-line treatment options."

In an editorial, Dr. Michael Saag, of the University of Alabama at Birmingham, points out that current drug regimens are more efficacious than the ones used in the SWATCH study.

However, he agrees with Dr. Martinez-Picado's group that further study of proactive switching seems warranted, but that the strategy should not be routine at this time.

SOURCE: Annals of Internal Medicine, July 14, 2003.

By Ben Hirschler

PARIS (Reuters) - One in 10 HIV patients in Europe newly infected with the virus that causes AIDS is infected with drug- resistant strains, researchers said on Wednesday.

Experts said the biggest study of its kind, presented at an international conference in Paris, showed the need for patients to adhere strictly to drug regimens and for companies to develop a constant stream of new medicines to keep AIDS at bay.

Resistance has long been viewed as a serious problem in AIDS hot spots such as San Francisco, where more than a quarter of patients are drug resistant, but the scale of the problem has not, until now, been monitored across such a large area.

David van de Vijver of University Medical Center Utrecht, Netherlands, said the scale of the problem in Europe was a concern.

"The conclusion of our study is that 10 percent of newly diagnosed patients in Europe are infected with a virus that contains resistance to at least one antiretroviral drug," he told reporters.

The study, conducted by Van de Vijver and colleagues and covering 1,633 patients from 17 European countries, also found that 1.7 percent of new patients were resistant to two or more antiretrovirals.

Non-adherence to drug treatment regimens is the main reason for the emergence of drug resistance.

But Van de Vijver said its worrying spread in Europe also suggested many people on treatment were returning to high-risk behavior, such as engaging in unprotected sex and sharing hypodermic needles.

VIRUS MUTATES

Joep Lange, president of the International AIDS Society, said drug resistance would never be eradicated because of the ability of HIV to mutate swiftly.

"That means we need to develop new drugs all the time and that also means that we need to keep research-based (pharmaceuticals companies) interested in HIV because if they are not interested any longer there will be a point of time when we are in a desperate situation," he said.

Lange rejected as "totally ridiculous" suggestions that the risk of resistance was a reason not to supply antiretrovirals to the developing world, where drug supplies and medical care may be less reliable.

Kevin Frost, director of the Treat Asia network working to roll out treatment in Asia, said the European study showed the need to get proper "triple therapy" treatments into poor countries.

"If we don't get it right we could be in for serious long-term problems in developing countries," he said.

There are currently 19 separate anti-HIV drugs on the market, falling into three main classes: nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors and protease inhibitors.

Van de Vijver said resistance was found to the first class in 6.9 percent of the European patient group, resistance to the second class in 2.6 percent and resistance to protease inhibitors in 2.2 percent.

Researchers and pharmaceutical companies are working to develop a range of new medicines to attack the virus in novel ways.

These include several drugs designed to block HIV's entry into healthy cells. The first of these, a so-called fusion inhibitor called Fuzeon from Switzerland's Roche Holding AG and U.S. biotech Trimeris Inc., was recently launched in Europe and the United States.

Other companies are also working on so-called integrase inhibitors, designed to block another step in the life cycle of HIV, although these are only at an early stage of development.

By Megan Rauscher

NEW YORK (Reuters Health) - In Russia, the number of new HIV cases is rapidly increasing, not only in large urban areas but also in rural areas as well, the U.S. Centers for Disease Control and Prevention reports.

According to a report in the CDC's Morbidity and Mortality Weekly Report for July 18th, Orel Oblast, a predominantly agricultural province in central European Russia, has seen a 40-fold increase in HIV during the period 1998-2001. The annual rate of new positive HIV tests increased from 5 per 100,000 tests in 1998 to 202 per 100,000 in 2001. HIV testing patterns during this time remained stable.

The "overwhelming majority" of new HIV cases have occurred among young, male injection drug users (IDUs), officials with the CDC in Atlanta and the Orel Oblast AIDS Center have learned.

However, recent data also point to a shift in the HIV epidemic in Orel Oblast from IDUs to their heterosexual partners and to the general heterosexual population. For example, in 2001, nearly half of the HIV-infected women and more than 10 percent of HIV-infected men in Orel Oblast were exposed to HIV through heterosexual contact and half of those infected heterosexually had sex partners who were IDUs.

"I must say this is what we have seen in other places of a really rapid initial increase in HIV," CDC epidemiologist Dr. Shannon L. Hader told Reuters Health. "Because Orel was doing good monitoring and good surveillance for HIV they were able to identify this initial rapid increase in cases, and perhaps with good prevention activities catastrophe can be avoided."

In addition to general prevention activities, she said specific efforts designed to encourage and help IDUs to kick the habit or build skills for safer injecting and sexual practices are needed to curb the HIV epidemic among IDUs and their partners in Russia.

SOURCE: Morbidity and Mortality Weekly Report 2003.