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John
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HIV infection, antiretroviral treatment, ageing, and non-AIDS related morbidity: review by Steve Deeks and Andrew Phillips

Interesting article about health with HIV/AIDS from National AIDS Treatment & Advocacy Project in the USA.

Sets the picture for living with HIV and maybe useful to site as evidence.

You may also be interested in this post from NAM - Click here - which is further study information on the same subject.

HIV infection, antiretroviral treatment, ageing, and non-AIDS related morbidity: review by Steve Deeks and Andrew Phillips

Interesting article about health with HIV/AIDS from National AIDS Treatment & Advocacy Project in the USA.

Sets the picture for living with HIV and maybe useful to site as evidence.

You may also be interested in this post from NAM - Click here - which is further study information on the same subject.

kevin
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Joined: 09/03/2009
HIV services: caring for older patients

As people with HIV/AIDS live longer, services must adapt to meet the needs of more patients and the first generation of HIV-positive pensioners. Emma Dent reports

Who remembers the Don't Die Of Ignorance campaign? Every household in the UK was sent a leaflet as part of the huge 1987 public information campaign warning how easy it could be to contract HIV, accompanied by sombre TV adverts featuring giant tombstones.

A little over 20 years later, the numbers of people with HIV/AIDS in the developed world have not reached the horrifying figures some predicted. It has been estimated that by the end of 2008 about 60,000 people in the UK will have been diagnosed. The number of deaths from AIDS has remained stable at around 500 a year since the late 1990s.

But the number of those with HIV is growing by 10 per cent a year. The most recent estimate is that there are around 73,000 people living with HIV in the UK - a figure predicted to grow to 100,000 by 2010 - and that around a third are unaware they are infected. This presents huge public health issues, as around half of all new infections are thought to have come from people who do not know they have the condition.

Conversely, the introduction of highly active antiretroviral drug treatments in the 1990s means that those with access to them should have a significantly increased life expectancy and HIV can be treated as a long-term condition.

Just five years ago the life expectancy of someone in the UK with a diagnosis of HIV was 17 years. Now it is 30 years and expected to grow further, in a reflection of the UK's ageing population. With the average age of diagnosis being 33 or 34, the UK could soon be welcoming its generation of HIV-positive pensioners.

But this significant success has come at a cost, as NHS services for people with HIV have not grown to reflect either the success of treatments, the increased life expectancy, or the ever-growing numbers of those with the virus.

"The basic service model for HIV - involving a regular, probably three-monthly, appointment at an outpatient clinic, for blood tests and a repeat prescription - has not changed," says Paul Ward, deputy chief executive at sexual health charity the Terrence Higgins Trust.

Mr Ward argues that much HIV care should be shifted out of hospital and into the community. "Services could be nurse led or run by the third sector. When people need specialist care, they could be seeing clinicians who are currently overwhelmed but would be freed up by these moves.

"A good comparison is the care programme approach for people with mental health problems, where most are on a standard care programme and those with the most complex needs are on an enhanced care package," he adds. "No hospital-based HIV service model currently has a future-proof model of care."

But he believes a combination of HIV not being on the radar of sexual health managers (at least partly because it is not driven by the targets found elsewhere in the sector, such as on 48-hour access) and "a degree of clinical inertia" may delay change.

HIV clinicians are as one when they agree that services have changed "dramatically" from the early days when care consisted at best of advising patients to eat well and take vitamins and at worst comprised nothing more than providing a good death. "Now when people are on the ward, it is because they did not take treatment [although treatment regimes have become easier, they must be strictly adhered to] or have presented late," explains Simon Edwards, lead clinician for HIV services at Camden Provider Services.

"We are usually confident we can get them over their acute illnesses and the aim is to treat them once and not have to see them again, although they can be in hospital for up to six months."

However, keeping most of your patients well has downsides for HIV services which, run without referrals as open-door services, have become overwhelmed.

"We have made a number of changes to become more efficient," says Dr Edwards. "We see people less often - it used to be four times a year, now it's 2.5 times - we have more virtual appointments over the phone or via email and shorter appointment times. We have specialist nurses to see patients, and early morning and evening appointments."

It is a delicate balancing act. Unwilling to use primary care, patients have become accustomed to using HIV services as a one-stop health shop. And as patients can choose service by choice, rather than by referral, if they decide they do not like one service, they can switch their allegiance - and the funding that comes with it - to another one.

"Patients do tend to use us as a primary care service. We refer them on if needed, and three years ago we decided we would only prescribe HIV-related drugs," says Imperial College Healthcare trust lead clinician for HIV services John Walsh.

"We are always trying to ensure the greatest number of patients experience a good quality of care and it was unsustainable to carry on doing everything, with no increase in consultant time but an 8 per cent increase a year in patients.

"There remains an anxiety among patients: what symptoms are HIV related and what are not?" Dr Walsh continues. "And some are unhappy about the changes. But some newer patients understand this is one long chronic disease among others that they will get as they get older."

The question of moving services into the community remains a highly contentious one. "It would be stupid to suggest HIV care can be managed in the community. The healthcare needs of someone with HIV need to be separated from their other needs and HIV services should work alongside GPs and support them in their work. HIV needs specialist care and the real issue is getting an early diagnosis," says Simon Barton, clinical director of HIV and genitourinary medicine services at the Chelsea and Westminster Hospital foundation trust.

National AIDS Trust chief executive Deborah Jack points out that the condition of someone with the virus can fluctuate and that life chances of HIV patients have changed dramatically since many non-specialists did their training. "HIV specialists understand the condition very well but outside the specialty, levels of understanding are often very low," she explains.

Resistance to change

Dr Edwards says: "When we have GPs sitting in on our clinics, they say 'it's complicated, isn't it?' We frequently have to change our advice to patients, as serious side-effects emerge frequently and require intense monitoring, as do emerging health risks, such as an increased risk of developing cardiovascular disease and drug alerts. Any move into the community needs to be looked at carefully and closely monitored."

He points out that patients "have a lot to lose. They get a very good service from HIV clinics; walk-in clinics; a doctor on call until 10pm; a prescription for three or four months' worth of medication".

And patients, who often feel they are experts in a condition they have been living with for some time and want to be in charge of, are reluctant to see changes to services. "They will have to be dragged kicking and screaming," says one clinician.

Paul Decle, founding member of the Chelsea and Westminster positive patients forum, points out that HIV patients often do not have a GP or if they do they are not confident the doctor is capable of handling their needs or that confidentiality will be maintained.

"We hear time and again that a clinic tells a patient something they want help with is not an issue for them and they should go to their GP. But their GP takes one look at them and their notes and says, 'you have to go to the HIV clinic'," Mr Decle says. "What patients want is evening and weekend appointments - a service that wraps around the patient rather than it having to be the other way round. It is no good being told to 'normalise' your life with HIV, to go back to work and so on, when you have to take annual leave for a clinic appointment."

Some clinicians acknowledge that service redesign will probably close some HIV services. But it is not yet known what future demands on HIV care will be, or the effects of having the virus as an ageing person or of taking antiretroviral drugs over 20 or 30 years. Nor is it known how services routinely targeted at older adults will adapt to the needs of people with the disease.

"We are now asking our service users what they want from services long term. Are we going to have to be working with charities such as Help the Aged and Age Concern?" asks Lynda Shentall, director of services at HIV charity George House Trust.

Mr Ward agrees: "It is gradually dawning on people who never thought they would get to retirement that they now have to start thinking about it. The sort of care pathways currently in place between HIV and oncology or HIV and cardiovascular services will need to be in place with older people's services."

Testing times: the need for faster diagnosis

With around a third of people living with HIV currently undiagnosed, the need for testing for the disease remains urgent. But campaigners and clinicians are concerned NHS-based testing remains largely and unnecessarily confined to hospitals and tests are not offered often enough.

New testing guidelines produced by the British Association for Sexual Health, the British HIV Association and the British Infection Society due to be published this month aim to increase the numbers tested by enabling doctors, nurses and midwives to routinely obtain informed consent for an HIV test, as they would for any other clinically appropriate examination.

Clinicians emphasise the importance of early diagnosis.

"A significant proportion of our inpatients, with acute infections, have had a late diagnosis," says Adrian Palfreeman, a consultant physician at University Hospitals of Leicester trust, who chairs the HIV special interest group at the British Association for Sexual Health. "Often when they are first admitted it has not crossed the doctor's mind that they could be HIV positive, they are embarrassed to suggest it, or they feel the patient is not in a high-risk group." Ignorance about the condition is also causing more people from traditionally low risk groups, such as white heterosexuals and people aged over 50, to become infected.

A 2007 National AIDS Trust survey showed that more than 90 per cent of respondents did not fully understand how HIV is transmitted. "There is a lot of ignorance and a lot of fear about HIV in the heterosexual population and we are also seeing quite a few teenagers in the service," says lead clinician for HIV services at Imperial College Healthcare John Walsh. "Diagnosis is often a complete shock."

Race against time

1950s-70s

It is now thought people died of AIDS as early as the late 1950s and 1960s. AIDS-like symptoms begin to be recognised in the 1970s among Africans and people who had worked in Africa.

1980

The first case of a person dying of AIDS in the US is recognised. Four Americans are thought to have died of the disease that year.

1981

AIDS is first written about by a journalist, in a newspaper for the gay community, in an article on the number of gay men being treated in hospitals for a strange form of pneumonia. US agency Centers for Disease Control and Prevention reports clusters of the rare skin cancer Kaposi's sarcoma and Pneumocystis pneumonia among drug users and gay men in California and New York. By year end 121 people are known to have died of AIDS, including the first known UK case.

1982

Early use of the term "gay-related immune deficiency" for the disease falls aside when heterosexual immigrant Haitians begin showing symptoms. The term AIDS (for acquired immune deficiency syndrome) is proposed at a meeting in Washington DC.

First known cases are reported in Italy, Brazil, Canada and in a baby from California who received a blood transfusion; haemophiliacs and others are later found to have contracted the disease through blood transfusions.

1983

A National AIDS Helpline is set up in the US.

The US Food and Drug Administration issues guidelines that state people at high risk of contracting the disease should not donate blood or plasma products.

First reported AIDS death in Australia sparks public health campaign.

1984

US health and human services secretary Margaret Heckler announces scientists have discovered the probable cause of AIDS - a retrovirus, named as human immunodeficiency virus or HIV. She says a vaccine will be available in two years.

1985

The FDA approves AIDS antibody screening tests for use on all donated blood and plasma intended for transfusion.

Rock Hudson, the first US celebrity to publicly admit having AIDS, dies of the disease.

First cases of AIDS reported in China.

1986

First known cases of AIDS in the USSR and India.

An American immunologist, National Institute of Allergy and Infectious Diseases head Anthony Fauci, states one million Americans have been infected with HIV and predicts this will rise to two to three million in five to 10 years.

1987

The first antiretroviral drug, AZT, is available.

UK government launches Don't Die of Ignorance campaign.

Needle exchanges are piloted in the UK and HIV testing is introduced.

Pictures of Princess Diana holding the hand of a patient in an AIDS ward are broadcast around the world.

1988

First World AIDS Day.

1989

First HIV awareness materials targeted at gay men are produced by the UK Health Education Authority.

1990

EastEnders runs a storyline in which greengrocer Mark Fowler is HIV positive.

1991

24 hours after issuing a statement that he has AIDS, Queen singer Freddie Mercury dies.

US basketball star Magic Johnson publicly announces he is HIV positive.

The red ribbon becomes an international symbol of HIV.

In the US the FDA licenses a rapid HIV test.

Ten million people worldwide are HIV positive.

1992

In America AIDS becomes the leading cause of death among 24 to 44-year-old men.

The first combination drug therapies, which are more effective than a single drug regime, are introduced.

1995

Highly active antiretroviral therapy (HAART) becomes possible. Death rates from AIDS in the UK peak at more than 1,700. Within two years, the introduction of HAART drugs means death rates due to AIDS plummet in the developed world.

1998

Trials of a vaccine against HIV begin.

2001

Drug companies abandon their opposition to the generic production of antiretroviral drugs.

Department of Health publishes its first national strategy for sexual health and HIV.

2002

The Global Fund for the fight against HIV/AIDS, malaria and TB is set up.

2005

World leaders meeting at the G8 summit in Gleneagles commit to universal access to treatment for HIV/AIDS.

http://www.hsj.co.uk/hiv-services-caring-for-older-patients/1827393.article

2006

About 38.6 million people are estimated to be living with AIDS worldwide.

2008

Around 80,000 people are living with HIV in the UK. New diagnoses occur at a rate of about 10 per cent a year.

The annual number of deaths in the UK has hovered at around 500 annually since 1998. The life expectancy of someone on antiretrovirals and in good health is predicted to be around 30 years.

anonymous (not verified)
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Antibodies 'may aid HIV jab hunt'

Two powerful new antibodies to HIV have been found which could aid development of a vaccine, researchers say.

Researchers, led by the International Aids Vaccine Initiative (IAVI), say the discovery reveals a potential new Achilles heel in the virus's defences.

The antibodies are the first of their type to be identified in more than a decade, and the first to be isolated from donors in developing countries.

Details of the breakthrough feature in the journal Science.

The researchers hope it could lead to more similar antibodies being found, which in turn could aid the hunt for an effective HIV vaccine.

Identifying antibodies that act against a broad range of HIV types will be critical for the development of an effective vaccine
Keith Alcorn
NAM

Wayne Koff, of the IAVI, said: "The findings themselves are an exciting advance toward the goal of an effective Aids vaccine because now we've got a new, potentially better target on HIV to focus our efforts for vaccine design.

"And having identified this one, we're set up to find more, which should further accelerate global efforts in Aids vaccine development."

The new antibodies - broadly neutralising antibodies - are produced by a minority of people with HIV.

They are distinct from other antibodies to HIV because they neutralise a high percentage of the many types of HIV in circulation worldwide.

It is widely believed that to prevent HIV infection a vaccine would need to teach the body to produce these powerful antibodies before exposure to the virus.

Animal experiments suggest that conceptually such a vaccine would work.

Before this finding only four antibodies to HIV had been discovered that were widely agreed to be broadly neutralising.

However, all four worked by binding to a place on HIV that has proven difficult for vaccine-makers to exploit.

Accessible target

The latest duo are potentially much more useful because they bind to the virus at sites which scientists believe are more accessible.

In theory that should make it easier to produce a vaccine which could stimulate the body to start producing these key antibodies.

And because the antibodies are very powerful they would not have to be produced in very large quantities to confer protection.

The two new antibodies target one of the proteins that form a spike used by HIV to infect cells.

These proteins are highly-variable and thus difficult for the immune system to attack.

But the new antibodies target an area of one protein that does not change.

Keith Alcorn, of the HIV information service NAM, said: "Identifying antibodies that act against a broad range of HIV types will be critical for the development of an effective vaccine.

"We need to remember that this is an early stage of research.

"HIV vaccine research will be a long-term effort and we certainly shouldn't expect these findings to lead to a vaccine in a few years.

"A lot more work on antibodies and vaccine design is going to be needed to come up with vaccines that can be put into clinical trials."

The IAVI team joined forces with the Scripps Research Institute, and the biotechnology companies Theraclone Sciences and Monogram Biosciences on the project.

http://news.bbc.co.uk/1/hi/health/8233784.stm

anonymous (not verified)
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New HIV vaccine hope

03 September 2009

A team of scientists in the US has discovered two new antibodies that could lead to an HIV vaccine. Researchers from the Scripps Institute in California, the International Aids Vaccine Initiative (IAVI) and US-based biotech companies Theraclone Sciences and Monogram Biosciences discovered these two broadly neutralising antibodies using high-throughput screening of serum from patients infected with HIV.

When people are first infected with HIV, they produce antibodies that are specific to the infected strain, but a few years later some start to make antibodies active against other strains of the virus - known as broadly neutralising antibodies. 'There is a huge variability in the virus, so vaccination has to induce antibodies that are broad,' explains Dennis Burton, scientific director of the IAVI neutralising antibody centre at Scripps. 'Only four such antibodies have been isolated in the past, and none in the past decade.'

The new antibodies are important as they provide a big clue for future vaccine design. They are directed at the viral spike that HIV uses to infect cells, and which produces the glycoproteins gp120 and gp41. These are highly variable and evolved to prevent immune attack, but the antibodies target a part of gp120 that does not change. 'As well as being broadly neutralising, they are also more potent,' Burton says. 'This is good as the concentration that would have to be induced by a vaccine is lower. They bring a vaccine more within reach.'

HIV virus

Approximately 33 million people worldwide are infected with the HIV virus (above)

Serum from nearly 2000 HIV-infected donors from Thailand, Australia, the UK, US and several sub-Saharan African countries was screened for broad and potent neutralising activity, covering about 160 different forms of HIV; about three-quarters of these strains were neutralised with the newly discovered antibodies.

'We don't expect one antibody to neutralise everything, but we hope we can design vaccine candidates that will induce not just one but several of these antibodies, and that will slowly get us up to 100 per cent protection,' says Burton.

A troubled past

The search for a vaccine against HIV has been dogged by failure. Two years ago, Merck's vaccine candidate V520 failed in Phase II trials when it appeared to leave subjects more susceptible to infection, not less. Another vaccine which worked in the same way - inducing an immune response in the body's own T-cells - was also canned last summer by the US National Institutes of Health.

Burton is now optimistic about the possibility of developing an effective HIV vaccine. 'I'm more enthusiastic about this than anything that's happened for quite some time,' he says. 'I worried that we had these four antibodies, and their potency was not terrific. But given the potency of the new antibodies I think we are on much better ground. It's still a very long way to go, but it's a very positive signal.'

'It's interesting that they have identified new antibodies that are not cross-reactive with the currently known antibodies,' says Steve Patterson of Imperial College medical school's division of investigative science. 'I think the general view is that we need both T-cells and antibodies to give protection, and with the failure of the Merck trial there has been renewed interest in the antibody side. There seems to be a hierarchy of development of the immune response that strain-specific antibodies come up first, followed by broadly neutralising ones later on. The trick will be to induce immune responses that are usually seen later on in the disease.'

Sarah Houlton

 

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References

L M Walker et al, Science, 2009, DOI: 10.1126/science.1178746

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GSK and Pfizer join forces in fight against HIV

20 April 2009

Unique HIV joint venture formed by two pharma heavyweights

http://www.rsc.org/chemistryworld/News/2009/September/03090901.asp

 

anonymous (not verified)
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HIV Vaccine Combo Stops 31.2% of Infections in ‘Wow’ Result

By Simeon Bennett

Sept. 24 (Bloomberg) -- An HIV vaccine has for the first time been proven effective against the virus responsible for AIDS, according to a U.S.-funded study involving more than 16,000 volunteers in Thailand.

A combination effort that includes ALVAC, made by Paris- based Sanofi-Aventis SA, and AIDSVAX, a product of VaxGen Inc., of South San Francisco, prevented infections in 31.2 percent of people in the trial compared with those on a placebo, scientists said today in Bangkok. Neither vaccine had stopped the virus when tested independently in previous studies.

The finding represents a revival in a quarter-century long campaign that appeared to stall just two years ago when use of Merck & Co.’s experimental Ad5 vaccine boosted some people’s chances of infection in a study that was terminated. The newest result will transform future research, said Mitchell Warren, director of the New York-based AIDS Vaccine Advocacy Coalition.

“Wow,” said Warren, who was not involved in the study, in a telephone interview today. “We are in a new place in the search for an AIDS vaccine. It’s safe to say that the scientific community is caught off-guard.”

The findings don’t mean the vaccine can be delivered worldwide, because of the complexity of the process and the fact that it’s based on old technology, Warren said. Instead they will serve to spur scientists to look for better combinations in more user-friendly regimens, and higher success rates, he said.

Different Strategies

The Thailand study looked at whether different infection- fighting strategies devised by Sanofi and VaxGen could be combined into a two-pronged attack. It was conducted by Thailand’s Ministry of Public Health over six years, and led by researcher Supachai Reks-Gnarm.

Sanofi’s ALVAC uses a canarypox virus that’s been disabled so it doesn’t cause sickness in humans to smuggle three HIV genes into the body. It’s designed to coax the immune system to make so-called T-cells, immune system protectors that hunt and kill infection deep inside the body.

The AIDSVAX shot contains an HIV protein called gp120 that’s used by the virus to enter human cells. It is designed to encourage the body to produce neutralizing antibodies to destroy HIV viruses before they can infect healthy cells.

“That’s what makes it so exciting,” Warren said. “We now have proof of concept that a combination vaccine regimen stimulating both arms of the immune system can have an effect.”

The search for a vaccine to prevent HIV has eluded scientists since the early 1980s. AIDS, the syndrome linked with HIV, infects about 6,800 new people globally every day. While there are treatments for HIV that limit the virus in the body, holding AIDS at bay for years, there is no cure.

Merck Vaccine

An international test of the Ad5 vaccine made by Whitehouse Station, New Jersey-based Merck in about 3,000 people was halted in September 2007, when 49 HIV infections occurred among those who received it compared with 33 among those who got placebo shots. That suggested the product may have raised HIV risk among people exposed to blood or semen containing the virus.

In 2004, a group of U.S. AIDS researchers said in a letter to the journal Science that the combination trial would probably disappoint, and shouldn’t be allowed to proceed because of the failure of the two previous studies.

In a telephone interview from Oxford, England, before the results were reported, Marie-Paule Kieny, director of the World Health Organization’s Initiative for Vaccine Research in Geneva, said, “I don’t think there is a lot of expectation that the efficacy of this vaccine will be very high. Any hint towards identifying something which is protective in humans would be very good news,” she said.

Highest HIV Rates

The researchers enrolled volunteers in Thailand’s Chon Buri and Rayong provinces, which have the nation’s highest rates of HIV, according to the study Web site.

Subjects were given four doses of the ALVAC vaccine and two of the AIDSVAX shot over six months, then monitored for three years. They were also given advice on safe sex. There were no serious side effects, the researchers said.

Those in the study who became infected with HIV during the trial were given free access to treatment.

VaxGen, a venture spun off in 1995 from South San Francisco, California-based biotech company Genentech Inc., ceased development of AIDSVAX in 2003 after a trial showed it didn’t prevent people from getting HIV. The Global Solutions for Infectious Diseases, a South San Francisco-based non-profit organization, acquired the rights to AIDSVAX.

The trial was funded by the National Institute of Allergy and Infectious Diseases, the National Institutes of Health and the U.S. Army Medial Research and Materiel Command.

To contact the reporter on this story: Simeon Bennett in Singapore at sbennett9@bloomberg.net.

http://www.bloomberg.com/apps/news?pid=20601103&sid=aFJv0pjoEKlI

 

anonymous (not verified)
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HIV Vaccine
anonymous (not verified)
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HIV drug cuts risk of infection in tests - FT.com

Scientists on Thursday announced a major breakthrough in the search for a vaccine for HIV/Aids after a major testing programme in Thailand found that an experimental drug had cut the risk of infection by 31 per cent.

The tests on 16,000 Thai volunteers provided the first measurable effect in preventing the transmission of the HIV/Aids virus and would provide new momentum in a field which many researchers had written off as a dead end.

“It's the first evidence that we could have a safe and effective preventive vaccine," Colonel Jerome Kim of the US Army, which co-sponsored the tests with the National Institute of Allergy and Infectious Diseases, told a media conference in Bangkok.

Doctors said that an actual vaccine was still some way away but the tests provided a valuable “proof of concept”.

The regimen that was tested is based on drugs developed by Sanofi-Adventis and VaxGen, and comes in two parts: a modified canarypox virus – known as Alvac – that had been genetically manipulated to carry synthetic versions of three HIV genes to prime the immune system, followed by a booster known as AidsVAX B/E, a formulation which had previously been tested on its own without showing any benefit for the patients.

“The combination is stronger than each of the individual members,” said Col. Kim.

The use of the AidsVAX vaccine, which had been discredited in the eyes of many virologists, had made the tests controversial, with one researcher calling the drug “spectacularly unsuccessful”.

Scientists have been searching for an HIV/Aids vaccine for 25 years, but all previous large-scale tests indicated that they had no significant effect.

The blind tests were run on young Thais with average chances of infection. Of the 8,197 given the drugs, 51 became infected, compared to 74 of the 8,197 who were given placebos as a control group.

http://www.ft.com/cms/s/0/8950e4d6-a8d2-11de-b8bd-00144feabdc0.html?ncli...

 

anonymous (not verified)
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Q&A: HIV vaccine

An experimental HIV vaccine has for the first time cut the risk of infection, researchers say.

HIV researchers say the results from a large trial in Thailand offer renewed optimism that an effective HIV vaccine is possible.

What is different about this vaccine?

For more than 20 years, the field of HIV vaccine research has been dogged by disappointment.

Most notably, in 2007, Merck halted trials on a vaccine which had been regarded as one of the most promising to date, after finding no difference in rates of HIV infection between vaccinated and unvaccinated volunteers.

The latest trial combined two vaccines which on their own had been shown not to be effective.

In all 8,000 18-30 year olds in Thailand were given a primer dose with one vaccine followed by a booster dose of the other and 8,000 given a dummy vaccine.

After three years, the rate of HIV infection was a third lower in the vaccine group with 51 people infected compared with 74 unvaccinated people infected.

What do the results tell us?

The numbers of people in the trial who became infected with HIV were very small and there is always the possibility that the difference between the groups is down to chance.

But Dr Adriano Boasso, an HIV vaccine expert at Imperial College London, said the numbers were statistically significant.

"Tests will have been done to verify that the difference is unlikely to have occurred by chance and I have no trouble believing the figures."

Scientists are anxiously awaiting the publication of the full trial data so they can judge how significant the findings are.

But because this is the first time that an HIV vaccine has been shown to be effective - at least partially - the general view in the vaccine community is that the results are an important step forward.

The HIV strains used in the vaccines were B and E - the B strain predominates in North America and Europe - so the results are not immediately relevant to Africa where the main strain is C.

What do the experts think?

Some 33 million people around the world have HIV and a vaccine would have a huge impact especially in areas where the infection is endemic, such as sub-Saharan Africa.

But HIV appears to be remarkably good at fooling the immune system hence the failure to produce a vaccine that can protect against the disease.

The latest study offers renewed optimism for HIV vaccine researchers after years of depressing findings.

Scientists are cautiously hopeful that it will be possible to build on the positive results to boost the chance of eventual success.

Dr Boasso said the findings were a "breath of fresh air".

"It suggests there is a chance for a HIV vaccine and we shouldn't give up just because there have been some failures.

"Vaccine development is a long process and this is a step forward."

Lisa Power, head of policy at the Terrence Higgins Trust, said the results gives experts a good idea of where to concentrate research in the future.

And Dr Seth Berkley, president and CEO of the International AIDS Vaccine Initiative, added: "Until now, we've had evidence of feasibility for an AIDS vaccine in animal models.

"Now, we've got a vaccine candidate that appears to show a protective effect in humans, albeit partially."

So what now?

There is much work to be done before a vaccine becomes available.

It is highly unlikely that any HIV vaccine would get licensing approval with an efficacy of 30% and researchers will be aiming for a success rate in the region of 70-80%.

They will need to build on the findings and tweak the vaccine to produce a stronger response.

"The researchers will probably now look at the type of immune response they have induced to try and figure out what kind of effect they need to induce in volunteers to get a certain degree of protection," Dr Boasso said.

"That could also teach us quite a lot about other vaccines."

It is also possible that further studies could be done in high-risk volunteers, where rates of infection would be higher, although those kinds of studies are hard to do and results can be difficult to interpret.

http://news.bbc.co.uk/1/hi/health/8272532.stm

 

anonymous (not verified)
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IAVI Statement on Results of Phase III ALVAC-AIDSVAX Trial

NEW YORK, NY, SEPTEMBER 24, 2009 –The International AIDS Vaccine Initiative (IAVI) greeted with excitement today’s announcement by the U.S. Military HIV Research Program and the Thai Ministry of Public Health that, according to an initial analysis, a prime-boost combination of two AIDS vaccine candidates has shown partial efficacy in a phase III efficacy trial in Thailand. The prime-boost combination was about 31% effective at preventing infection with HIV.

 

“The outcome is very exciting news and a significant scientific achievement,” said IAVI President and CEO Seth Berkley, “It’s the first demonstration that a candidate AIDS vaccine provides benefit in humans. Until now, we’ve had evidence of feasibility for an AIDS vaccine in animal models. Now, we’ve got a vaccine candidate that appears to show a protective effect in humans, albeit partially.”

 

Said Wayne Koff, IAVI Senior Vice President for Research and Development, “At the very least, these results give researchers a platform on which to improve and to validate animal models and assays, and a way to attract new investment and creative energy to the field of AIDS vaccine R&D.”

 

Berkley added, “The outcome demonstrates the vital importance of testing AIDS vaccine candidates in human trials. Because HIV causes AIDS only in humans, we can only learn so much from animal models. We could not have learned what this study is going to teach us any way other than through clinical research, and we expect to learn a great deal.”

 

IAVI congratulates the sponsors of the trial, the partners who conducted it, and the many volunteers who selflessly devoted themselves to the study on the successful completion of the trial through this long-term international collaboration.

 

IAVI looks forward to the more detailed data analysis that is underway and the discussions that will take place among policymakers, regulators, scientists, community members, and the partners associated with the trial about next steps given these results.

Official materials on the trial results can be found on the U.S. Military HIV Research Program (MHRP) website at http://www.hivresearch.org/

http://www.iavi.org/news-center/Pages/PressRelease.aspx?pubID=3158

 

anonymous (not verified)
anonymous's picture
Growing doubts about HIV vaccine

Doubts have been raised about the reliability of a trial suggesting success for a vaccine against HIV.

In the large-scale trial in Thailand, a combination of vaccines seemed to give volunteers a protective effect of 31%.

The US military and Thai government, who co-sponsored the trial, said the effect was not caused by random chance but was statistically significant.

But new data, being published at a conference in Paris on Tuesday, is believed to question that assertion.

It was the world's largest clinical trial of a HIV vaccine - involving 16,000 people in Thailand aged between 18 and 30.

This particular study was in the awkward position of producing a result that was only just statistically significant
Gus Cairns
NAM

Among the 8,000 volunteers who had been given the combination of vaccines, 51 had gone on to become infected with the virus.

Of the group given a placebo, there were 74 positive cases.

The numbers were small, but according to Seth Berkley of the International Aids Vaccine Initiative, the results were "exciting news and a significant scientific achievement".

She said: "Now we have got a vaccine candidate that appears to show a protective effect in humans, albeit partially."

Lack of detail

But there were concerns as well. Researchers were not able to indicate just how the vaccines were working.

And, as more data was given to scientists, the claims about statistical significance began to look increasingly shaky.

Gus Cairns, who works with UK HIV information charity NAM, said: "This particular study was in the awkward position of producing a result that was only just statistically significant.

"This means there was a one in 26 chance that the results could be due to pure chance - and that this may not reflect anything at all.

"That's difficult. And there is also subset analysis of this study that if you only look at the people who strictly adhered to the protocol - ie took all their vaccine doses - then it becomes not statistically significant."

The problem is that the initial figures given for the numbers infected included all those who got HIV once the trial started, including those who got it in the course of the six-month regime of injections.

But if these were excluded, as they would be in many trials, then the numbers change - and so do the claims of a protective effect.

Study power reduced

These details have been substantiated by the US military HIV research programme.

In an update to the study, they indicated that if you looked at the data in this way, it does not reach statistical significance and the study's power is reduced.

Researchers are expected to give a more detailed breakdown at the Global HIV vaccines meeting in Paris.

Many scientists have been upset that the initial information about the trial came out via a press conference, rather than via a peer reviewed journal.

But according to Dr Aland Bernstein, executive director of the Global HIV vaccine enterprise, the issue of how the information came out does not matter.

"At the end of the day what matters to me is the long run. If that work doesn't hold up that's fine, we'll hear no more of it.

"If it holds up, and we'll only know that over the weeks and months ahead, then it is an important contribution - and whether we heard those results on 24 September or 24 October it doesn't matter in the long run."

http://news.bbc.co.uk/1/hi/health/8315002.stm

 

anonymous (not verified)
anonymous's picture
Ageing society - DWP

More of us are living longer than ever before.

Life expectancy has been growing steadily for over half a century and the UK has now reached a point where there are more people over State Pension Age than children.

An ageing society is no longer on the horizon, it is here with us today.

This is of course a cause for celebration, being a direct result of enormous progress over the past 60 years. We now need to build on this progress so that we can address the challenges and make the most of the opportunities presented by this demographic change.

Our vision for an ageing society

"Building a Society for all Ages", published in July 2009, presents the Government’s vision for a society where people should no longer be defined by their age but where their skills and experiences are harnessed for the benefit of Britain as a whole.

We have also published a summary of the responses to the discussion paper "Preparing for our ageing society".

The story so far

To help meet the challenges presented by an ageing society we published “Opportunity Age – meeting the challenges of ageing in the 21st century” in March 2005. This aimed to end the perception of older people as dependent, ensure that longer life is healthy and fulfilling, and that older people are full participants in society. We put in place a series of indicators to measure how we are succeeding. In August 2009 we publicised a summary report showing the majority of the commitments made in Opportunity Age had been delivered.

More people are choosing to work longer. DWP's Age Positive initiative promotes good practice standards to employers, for example, operating without a retirement age and the business benefits of recruiting, training and retaining older workers.

Building on “Opportunity Age”, we developed the LinkAge Plus pilots to provide older people with access to a wide range of more integrated, joined-up services.

In 2007, in consultation with older people,  we developed the Public Service Agreement 17 to “tackle poverty and promote greater independence and wellbeing in later life”. This was our first commitment of its kind specifically aimed at older people.

In May 2008 we commissioned John Elbourne to undertake an independent review to examine how Government engages with older people and how that could help to inform policy and actions at all levels. The Government’s response "Empowering Engagement: a stronger voice for older people" was published on 3 February 2009.

Angela Eagle is the Government's Minister of State for Pensions and the Ageing Society. In this cross-government role, she works closely with the Prime Minister’s Strategy Unit and the Department of Health, with a specifc remit to make the most of the opportunities created by an ageing society.

Angela is responsible for taking forward PSA 17. She will co-chair the new UK Advisory Forum on Ageing with Phil Hope, the Minister of State for Care Services. The Forum will provide a stronger, clearer and louder voice for older people at a national level.

In addition, we are undertaking a far-reaching programme of pensions reform which will significantly increase the number of people, particularly women, who can get the full State Pension.

http://www.dwp.gov.uk/policy/ageing-society/

 

anonymous (not verified)
anonymous's picture
The hidden rise of HIV in the UK

My research in the west Midlands with postgraduate student Betselot Mulugeta, talking to groups of immigrant men and women from the Ethiopian and Eritrean communities, has revealed serious misconceptions about the nature of the HIV/Aids epidemic in the UK. Lack of information tailored for different migrant groups, alongside lower awareness of HIV/Aids through media coverage as a whole, is a problem with real consequences.

Newly reported cases of HIV in the UK are higher than ever before. Between 1995 and 2006, the rate of HIV infection among black Africans in the west Midlands increased 100-fold, compared to a two-fold increase among white people, a three-fold increase among black Caribbeans and a six-fold increase among other mixed ethnic groups (according to the region's strategic health authority figures).

Taking the Ethiopian and Eritrean population as one example: they are predominantly young and single, tend to live alone and are often sexually active. Their culture and language restrict the information available to them. This group therefore represents a reservoir of HIV infection which is both a concern for the immigrant community itself and the host population. As social networks among the Ethiopian and Eritrean communities in the west Midlands do not condone or tolerate the discussion of sexual issues, external information networks are crucial in raising awareness of the HIV situation in the west Midlands and reducing stigma and discrimination of those who are HIV-positive.

The respondents in our study said they believed the UK was "civilised" and therefore they could not contract HIV/Aids, that the problem had been left behind in Africa. Some commented that they believed all migrants were screened before being allowed entry, and that drugs were available in the UK that would "cure" Aids. Perhaps most tellingly, interviewees said that Aids wasn't talked about in the UK and no information or warnings were provided, so they had assumed there wasn't a problem. Culturally, condoms are a difficult issue. It is considered unacceptable for either partner in a sexual relationship to ask for a condom to be used, because it's thought to suggest the woman is promiscuous or a prostitute, or that there is a lack of trust between them.

One of the main reasons for this lack of appreciation of the HIV risk environment in the west Midlands appears to be a lack of communication and understanding between HIV-related service providers and immigrant communities. In particular there are very few culturally sensitive outreach sexual health promotion programmes aimed at different immigrant groups from high HIV-prevalence source regions in the west Midlands, with hidden groups such as failed asylum seekers and irregular migrants often ignored.

The ruling by the UK court of appeal earlier this year that refused asylum seekers and other "not ordinary UK residents" are not entitled to free NHS treatment and care is creating a reservoir of HIV infection in the UK. It is these marginalised and often hidden groups, who are highly vulnerable to HIV infection due to their socio-economic situation, that are being denied free medical treatment. Denying unrestricted NHS HIV treatment to this group is a serious public health issue which may well fuel the epidemic in the UK.

There is a desperate need to understand the social context of the disease both in terms of the migrants' region of origin as well as in their new UK communities. The British government is yet to address the steep rise in rates of the disease among heterosexuals and a new Aids awareness campaign targeted at those most at risk of spreading it is imperative. It's a campaign they are reluctant to undertake because of the sensitivities around immigration, race and perceptions of neo-colonialism.

Sub-Saharan Africa is home to 67% of global cases of HIV/Aids, but it is dangerous to think of the disease as just an African problem now that we can travel easily between continents. Surely it is time we had another UK national campaign to bring this deadly disease to everybody's attention and to correct the misconceptions both the host and migrant communities have of the HIV/Aids epidemic in the UK.

http://www.guardian.co.uk/commentisfree/2009/dec/22/hiv-aids-black-afric...

kevin
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Universal access by 2010

By the end of 2007 an estimated 33 million people worldwide were living with HIV. That same year, some 2 million died of AIDS. Globally, less than one person in five at risk of HIV has access to basic HIV prevention services. Only 31% of people who needed HIV treatment had access to it by end-2007.

Following the commitment by G8 members and, subsequently, heads of states and governments at the 2005 UN World Summit, the UNAIDS Secretariat along with their partners, have been engaging in consultations to define the concept and a framework for universal access to HIV/AIDS prevention, treatment and care by 2010.

http://www.who.int/hiv/topics/universalaccess/en/index.html

anonymous (not verified)
anonymous's picture
Increased use of generic medicines planned to save cash

Proposals to increase the prescription of cheaper generic medicines in primary care have been set out in England.

The Department of Health is keen to use more generic medicines as they are less costly than the branded equivalent.

The suggestions include establishing a list of products for substitution, and another list of items that would be exempt.

The proposals will be put out for public consultation over the next 12 weeks.

The NHS spends about £9bn a year on branded prescription medicines in the UK.

A five-year voluntary agreement negotiated between government and the pharmaceutical industry last year, includes measures aimed at reducing NHS expenditure on branded medicines by an average of 5% a year over the lifetime of the scheme.

Generic medicines - which must contain the same active ingredient as the branded originals, and can be marketed once the originator's patent protection has expired - can save substantial costs.

Currently, around 83% of prescriptions issued by the NHS are for generic drugs, but ministers want this to rise by around 5%.

The Department of Health stressed that whichever option was implemented, health professionals would be able to stipulate on a prescription form where they do not think substitution would be appropriate.

Health Minister Mike O'Brien stressed patient safety was the top priority.

But he said: "We want to make sure that patients and taxpayers are getting the best medicines at the best price.

"Where clinically appropriate, it is only sensible to allow more expensive branded products to be substituted with the same generic medicines which are just as effective as the branded version.

"Introducing generic medicine substitution will deliver value for money and savings to the NHS which will go directly back into health services, ultimately benefitting patients and improving the care they receive."

Not always possible

Neal Patel, from the Royal Pharmaceutical Society, said a number of medicines had no generic equivalent, and substitution was not always appropriate on clinical grounds.

He added: "Medicines that are thrown away by patients offer little value to the NHS."

Richard Barker, of the Association of the British Pharmaceutical Industry, said: "It is important to ensure that patients' health and safety is not compromised in the implementation of this new policy."

Warwick Smith, director of the British Generic Manufacturers Association, said the proposals offered a "perfect balance" between the need for the NHS to gain maximum value from medicines, and unfounded concerns that patients would lose out.

"The reality is that generic medicines are approved to the same standards of safety, quality and efficacy as the equivalent brands and offer cost savings of up to 90%."

http://news.bbc.co.uk/1/hi/health/8441484.stm

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