Glaxo inks AIDS vaccine deal with non-profit group

Tue Jun 21, 2005 01:59 PM ET

LONDON (Reuters) - GlaxoSmithKline Plc is to develop an experimental AIDS vaccine in collaboration with a non-profit group, in the first such public-private HIV vaccine partnership involving a major company.

Jean Stephenne, head of GSK Biologicals, the vaccines arm of Europe's biggest drugmaker, said on Tuesday the deal with the International AIDS Vaccine Initiative (IAVI), would speed research into a novel way of stopping the deadly virus.

IAVI will provide expertise and funding for the research and the two organizations will form a joint R&D team, with GSK committed to making any successful vaccine available in developing countries at affordable prices.

Such public-private partnerships are being used increasingly to tackle diseases, including malaria and tuberculosis, which occur primarily in poor countries where Western pharmaceutical companies stand little chance of making money.

Around 39.4 million people worldwide were infected with HIV at the end of 2004, almost two-thirds of them in sub-Saharan Africa, according to the World Health Organization.

The disease has already claimed almost 30 million lives and around 5 million people are infected every year.

GSK's new vaccine approach uses a chimpanzee virus, known as an adenovirus, which has been engineered to be non-infectious, to carry HIV proteins into cells and trigger an immune response.

The company believes this primate virus, using technology derived from the University of Pennsylvania, should be more effective than a human one, since people will not have pre-existing resistance to it which could stop human viruses from acting as transporters of the vaccine.

But it will be a long time before the fruits of the collaboration are seen, since the first clinical trials of the technology are a few years away.

Industry analysts said this suggested a commercially available vaccine was unlikely for at least a decade, even if everything went according to plan.

G8 MEETING

Stephenne said GSK was pursuing a number of other AIDS vaccines technologies, with its most advanced candidate currently in Phase I clinical tests.

Ultimately, an effective AIDS vaccine might combine more than one approach, he said.

GSK lags some other companies in the hunt for a vaccine that could prevent HIV infection and possibly treat patients who are already infected.

U.S. rival Merck & Co Inc. earlier this year started a mid-stage Phase II trial on vaccine based on a weakened human adenovirus, similar to one that causes the common cold.

Other companies developing AIDS vaccines include Sanofi-Aventis and Chiron Corp .

All told, more than 30 vaccine candidates are now in clinical trials around the world but scientists are not confident that any of them will be really effective at defeating HIV.

The virus is a particularly difficult to tackle because it attacks the immune system and mutates so frequently.

The GSK-IAVI collaboration comes ahead of a meeting of Group of Eight rich nations in Scotland in July, where world leaders are expected to build on previous commitments to expand support for research of vaccines against AIDS and other diseases.

The UK government has proposed a series of financing tools, including an International Finance Facility for Immunization and advance-purchase commitments to spur investment in vaccines against diseases of the developing world.

"This agreement demonstrates the kind of collaboration between the public and private sectors that is critical for enhancing the research and development of new vaccines against the world's most devastating infectious diseases," Hilary Benn, UK Secretary of State for International Development said in a statement. (additional reporting by Mark Potter)

US approves Boehringer drug for resistant HIV

Wed Jun 22, 2005 07:43 PM ET

WASHINGTON (Reuters) - Boehringer Ingelheim won U.S. approval on Wednesday to sell its AIDS medicine Aptivus for treating adults with drug-resistant HIV infections in combination with Abbott Laboratories Inc.'s Norvir.

Germany's Boehringer, the world's largest privately held drug company, said Aptivus would begin to be available in pharmacies nationwide within two weeks.

A U.S. Food and Drug Administration spokeswoman confirmed the agency had approved Aptivus, a protease inhibitor.

Protease inhibitors help suppress the HIV virus that causes AIDS. Although there are eight protease inhibitors approved in the United States, most patients develop resistance.

Health experts say new drugs that are different enough from the old ones are needed to give patients more options.

Andreas Barner, Boehringer's head of research, hopes for approval from European regulators in the second half of 2005.

"We would then be able to introduce the drug in the first European markets in winter. Germany and the UK will be among the first markets," Barner said in an e-mail.

Two major clinical trials funded by Boehringer showed Aptivus, also known by its chemical name tipranavir, was more effective than other HIV drugs when used in combination with Abbott's Norvir.

Nearly 40 percent of Aptivir/Norvir patients responded well, compared with about 21 percent of those taking Norvir with another Abbott drug, Kaletra, Boehringer has said.

In May, an FDA advisory panel cautiously supported approval of Aptivus but said more safety studies were needed on its long-term effects on the liver and cholesterol levels.

One early study showed initial liver toxicity in healthy people taking Aptivus, and later data showed 10 percent of patients taking it had liver problems compared with 3 percent on similar drugs. It also caused rashes in some women.

Boehringer said in a statement that all patients taking Aptivus should be followed closely by clinical and laboratory monitoring.

The safety and effectiveness of Aptivus is still being studied in adults who are not drug-tolerant as well as children.

Aptivus would compete with other protease inhibitors such as Roche's Invirase, GlaxoSmithKline's Lexiva, Pfizer's Viracept and Merck & Co's Crixivan.

Boehringer plans to market Aptivus on its own, Barner said. The company had more anti-AIDS drugs in development and is open to licensing drugs from other companies. (Additional reporting by Sitaraman Shankar in Frankfurt)

U.S. clears two generic AIDS drugs for global plan

Mon Jun 20, 2005 11:38 PM ET

WASHINGTON (Reuters) - U.S. regulators gave tentative approval on Monday to two generic versions of Boehringer Ingelheim's HIV drug nevirapine, which allows the medicines to be used as part of President Bush's plan to fight AIDS around the world.

The generic medicines will be sold by Indian firms Ranbaxy Laboratories and Aurobindo Pharma, the Food and Drug Administration said in a statement.

While still patent-protected in the United States, the drugs "meet all of the FDA's quality, safety and efficacy standards" and therefore are eligible for purchase and use in other countries under Bush's Emergency Plan for AIDS Relief, the FDA said.

The five-year, $15 billion program launched in 2003 aims to pay for treatment for 2 million AIDS sufferers and provide care for 10 million others in 15 countries, mostly in Africa.

Nevirapine is part of a class of drugs called non-nucleoside reverse transcriptase inhibitors that help keep the AIDS virus from multiplying. Sold by Boehringer under the name Viramune, the drug often is used to prevent pregnant women from passing HIV to their babies.

Nevirapine was the subject of controversy earlier this year when a researcher charged a study of the drug in Uganda was sloppily run and did not adequately warn about possible side effects. U.S. officials said the charges were unfounded.

Authorities in the United States and at the World Health Organization say nevirapine's benefits outweigh its risks of side effects such as liver damage.

Internet fuels risky sex in gay, bisexual men-study

Thu Jun 16, 2005 01:40 PM ET

By Paul Simao

ATLANTA (Reuters) - Gay and bisexual men who meet partners over the Internet are more likely to engage in risky sex but have a greater tendency to do so with people who have the same HIV status, a U.S. study said on Wednesday.

Forty-one percent of men who arranged to have sex with other men through the Internet reported having unprotected anal intercourse with their last partner, according to the Denver Public Health Department.

That compared with 31 percent of men who met partners in gay bathhouses, 29 percent who used other public sex venues and 25 percent of those who met in bars or at parties, according to data collected from a sexually transmitted disease clinic in Denver in 2003 and 2004.

The Colorado study also found that 51 percent of the men who used the Internet to meet had chosen a sex partner with the same HIV status as themselves, compared to 20 percent of bathhouse patrons.

Coupled with two other studies suggesting many HIV-positive gay and bisexual men are deciding to have sex based on viral load counts - the amount of HIV detectable in a person's blood - the findings prompted warnings from health officials.

The studies were presented at the 2005 National HIV Prevention Conference in Atlanta on Wednesday.

"Many men who have sex with men may falsely believe that these strategies will protect them from HIV infection," said Dr. Ronald Valdiserri, deputy director of HIV, STD and TB prevention programs at the Centers for Disease Control and Prevention.

Although choosing partners based on their HIV status or the amount of virus in blood can reduce the risk of acquiring or transmitting HIV, there are also dangers to doing so.

Many gay and bisexual men do not know they have HIV. And viral load results can become outdated and, even when accurate, are no guarantee that HIV is not present in some body fluids.

The practices can also expose people to other sexually transmitted diseases or put those who are HIV-positive at risk of becoming infected with another strain of the virus, otherwise known as a super-infection.

In the Denver study, the Internet users were more likely to have been diagnosed with gonorrhea.

The warnings came just two days after the CDC reported that more than 1 million Americans were living with HIV at the end of 2003.

Gay and bisexual men made up 45 percent of the estimated 1,039,000 to 1,185,000 people who are HIV-positive, making them the largest single infected risk group, said the Atlanta-based CDC.

AIDS, which destroys the immune system and leaves people vulnerable to opportunistic infections and cancers, has killed about a half million Americans and at least 22 million people worldwide since 1981.

Health experts have been warning of a possible resurgence of the epidemic, which eased in the early 1990s following the development of antiretroviral drugs. One of the factors fueling such concerns is the increased use of crystal methamphetamine, a powerful stimulant that can lower inhibitions and lead people to engage in risky behavior.

The number of gay and bisexual men who had used the illicit drug doubled between 2001 and 2004, according to a survey of more than 19,000 such men by the Los Angeles Gay and Lesbian Center. The jump was greater in those who were HIV-positive.

Racial gap seen in gay sex HIV rates

And almost half of HIV-positive MSM are unaware of their infection, reinforcing the recommendation from the Centers for Disease Control and Prevention that MSM be tested for HIV at least annually, according to an article in the CDC's Morbidity and Mortality Weekly Report.

One way to achieve this goal is with peer outreach through social networks, which appears to be an effective means of persuading people at high risk for HIV infection to get tested, according to authors of a second paper in the publication.

Dr. F. Sifakis, from Johns Hopkins Bloomberg School of Public Health in Baltimore, and colleagues with the National HIV Behavioral Surveillance system tested 1767 MSMs at venues where they normally congregated, such as bars, clubs and social organizations, in five different cities.

Overall, 25 percent tested positive for HIV.

However, the infection rate differed by race -- 46 percent among blacks, 21 percent among whites, and 17 percent among Hispanics.

Nearly half of those who tested positive were unaware of their HIV infection. Of those with unrecognized HIV infections, 64 percent were black, 18 percent were Hispanic, and 11 percent were white. Although most had undergone testing in the past, the researchers found that 58 percent with unrecognized infections had not been tested during the previous year.

"We know that persons who are aware of their HIV status take measures to seek treatment and reduce risk behaviors, which underscores the importance of annual testing, particularly among African-American MSM," Dr. Stephanie Behel, from the CDC in Atlanta, told Reuters Health.

Compared with MSM who were HIV-negative, those with unrecognized infections avoided testing because they were more afraid of learning they had HIV and were worried that others would find out about the test results.

One important way to overcome such barriers is to let people know about advances in testing that allow individuals to learn their test results in 20 minutes instead of waiting for 2 weeks, Behel noted.

Also, "We have to increase our prevention messages to help people understand about the benefits of treatment and that people are living longer and healthier lives even with HIV infection," she added.

In the second article, Dr. C. Emerson of the Tenderloin AIDS Resource Center in San Francisco, and associates report on a social network strategy to identify persons at risk of HIV infection and to direct them to counseling, testing and referral. The data came from nine community-based organizations involved in a 2-year demonstration project in seven cities.

The networking approach was to enlist HIV-positive recruiters who would contact high-risk individuals in their social, sexual, or drug-using network and accompany them or refer them to sites where counseling, testing and referral are conducted.

During October 2003 to September 2004, a total of 133 recruiters were enlisted, and their efforts led to testing of 814 network associates. The results showed that 46 of these contacts were newly diagnosed with HIV, and 669 were HIV negative but at high risk.

"This strategy appears to make efficient use of community-based organization staff members," the authors write, "enabling them to focus on in-depth network interviews with recruiters, establishing rapport and trust, and coaching recruiters on how to effectively refer network associates for counseling, testing and referral."

According to the CDC's Dr. Lisa Kimbrough, organizations best suited for this type of program are those that provide comprehensive services for HIV-positive individuals so they will have a base from which to enlist recruiters, and to whom the recruiters can refer their network associates.

Recruiters "go through an orientation process that includes information about the project and about what their role would be as a recruiter," Kimbrough told Reuters Health, as well as "specific information on the persons they should identify to be referred for counseling and testing."

Ideally, the recruiter would be someone with access to a network of individuals at high risk and who has some prominence in that network, she added.

"This strategy works well because about 82 percent of the people who were identified for testing were at high risk," Kimbrough commented, "as opposed to the 'worried well' people who just walk in off the street."

SOURCE: Morbidity and Mortality Weekly Report, June 24, 2005.

AIDS: Risk behaviour rising among French gays PARIS (AFP) - French health watchdogs sounded the alarm after research found that unprotected sexual intercourse is rising fast among French homosexuals. Gilles Bruecker, director of the Institute for Health Monitoring (InVS) described the results as "catastrophic... devastating," while the president of the AIDS lobby group Act Up, Jerome Martin, said it was time for gays to be vigilant about safe sex. A questionnaire answered by 6,184 homosexual or bisexual men found that 77 percent of them had had at least one episode of casual sex in the previous year, and 50 percent had had at least 10 partners for casual sex during this period. More than a third of respondents who practised anal sex with a casual partner said they had had unprotected sex at least once during the past year. Among HIV-infected men who replied, 56 percent said they had had unprotected anal intercourse with a casual partner in the previous year, a rate twice as high as for men who had tested negative for the AIDS virus. Britain and the United States are among other countries that have recently expressed concern about a rising tendency, especially among young gays, to practice anal sex without a condom. Health experts fear the complacency is bred by the success of antiretrovirals drugs that can control HIV, but not eliminate it, thus creating the impression that the AIDS is a manageable disease.

Brazil Threatens to Break AIDS Drug Patent

Brazil threatened Friday to break the patent on an anti-AIDS drug produced by Abbott Laboratories Inc. if the company refuses to allow Latin America's largest country to produce a generic equivalent or buy it at a discount.

Although Brazil has frequently made similar threats against large pharmaceutical companies, the Health Ministry took an unprecedented step by declaring the drug's price is so high it creates a public health threat. Brazil has repeatedly won price reductions from companies by threatening to break patents.

Brazilian President Luiz Inacio Lula da Silva was present for the signing of a document that would give Brazil the power to issue a compulsory license allowing a state-owned laboratory to produce a copied version of Abbott's combination Lopinavir and Ritonavir pill.

Abbott said the Brazilian government does not have a legal basis to issue a compulsory license for the drug on the grounds of public interest or national emergency.

"A compulsory license is not in the best interest of Brazilian patients because it puts the government's desire to cut health care spending ahead of patients' need for new and better treatments," the company said in a statement.

It also said that it remained "willing to work with the government to find a mutually agreeable solution."

A new Brazilian intellectual property law allows the government to break drug patents in cases of a health emergency or if it rules the pharmaceutical industry is engaged in abusive pricing.

U.S.-based Abbott has 10 days to respond to Brazil's demand for a lower price. If Abbott does not make an adequate offer or allow the country to produce a generic version, Brazil will start producing the drug at a state-owned laboratory in Rio de Janeiro, Health Minister Humberto Costa said.

It would be "the first time that Brazil breaks a patent," Costa said after Silva signed the document. Silva did not make public comments at the ceremony.

Brazil says it cannot afford to pay the cost of buying the drug in 2005, estimated at $107 million while maintaining its world-renowned AIDS prevention and treatment program. The health ministry estimates 215,000 Brazilians will need the drug by 2008.

By breaking the patent, Brazil would save $54 million annually, Costa said.

The country provides free anti-HIV and AIDS drugs to anyone who needs them. But the government says the cost of newer drugs is driving up expenses and endangering its program, praised internationally as a model for the developing world.

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