Step To HIV Patent Pool

posted: 11/02/2011

The determined people campaigning for a patent pool to make HIV drugs available cheaply in developing countries are slowly getting results.
 

Unitaid works to improve access to medicines in developing countries and has set up the Geneva-based Medicines Patent Pool .

Sharing the patents of HIV drugs provides people in the developing world with cheap copies (‘generic’ versions of the drugs, rather than expensive brand name originals). Generic drug manufacturers in countries like India and China can then make legal cheap combinations of some of today's advanced HIV medicines.
 

2nd line generic treatments needed now

The world needs cheap combinations of new generic drugs to keep healthy and well the millions of people already talking treatments in the developing world, as HIV inevitably develops resistance to the basic drugs already being used.
 

Even GSK are now negotiating
But today, two months after sending out letters inviting the major makers of HIV drugs to add their patents on HIV drugs to the patent pool, it was announced that F. Hoffman-La Roche, Gilead Sciences, Sequoia Pharmaceuticals, and ViiV Healthcare (a joint venture of GlaxoSmithKline and Pfizer) are about to start talking business.
 

The big surprise is Viiv Healthcare. GSK has always said it wasn't uninterested in pooling HIV patents. Its chief executive Andrew Witty, said they would do something else instead.
 

Viiv Healthcare has however now taken the first step by saying it is interested in joining the negotiations.

The Medicines Patent Pool has published the responses to the HIV drug patent pool invitation from all the companies, naming and shaming the less than enthusiastic companies with their own letters. They’ll update this every quarter. It will be worth watching to keep drug companies accountable to people with HIV.
 

Source

Gene Testing Cuts Side Effects

posted: 12/01/2011

Testing people before they start HIV treatment for specific genes could stop many people suffering treatment side effects and avoid the need to change HIV treatment, new research suggests.

Like any medicine, HIV treatment drugs can cause side-effects. There are 23 genetic variations HIV doctors can now use to predict bad reactions, before patient and doctor decide what treatment drugs would be best.

Gene variation says no to Abacavir
We know well that people who have an allergic reaction to the drug abacavir (Ziagen, also in the combination pills Kivexa and Trizivir) have a gene variation that can be easily found.

People should always be tested for this gene before they start treatment with this drug. If you are tested and your result is positive, you shouldn’t take abacavir.

Other genes for other drugs
Now researchers have found that some genes increase the risk of side-effects caused by several other anti-HIV drugs.

They tested 577 patients starting HIV treatment for the first time to see if they had variations in genes associated with certain side-effects.

These were mood and sleep problems caused by efavirenz (Sustiva, also in the combination pill Atripla), and a non-dangerous yellowing of the skin and eyes caused by atazanavir (Reyataz).

Genes – side effects up to 9 times worse

People taking efavirenz who have the warning gene have much higher rates of mood and sleep problems – these are three times worse if you have this ‘warning’ gene.

The risk of atazanavir-related side-effects was increased nine-fold among people with the ‘warning’ gene for that.

We need more research into drug side effects linked to genes, the researchers say.

More side effects information

For more information on the side-effects of HIV treatment, NAM and i-Base both produce good side-effects booklets
 

Nam booklet – Side Effects

i-Base booklet - HIV and your quality of life: a guide to side effects and other complications
 

HIV, treatments and genes website
There is a useful new website on HIV, drug treatments and genes – HIV pharmacogenomics

More information on genetics and HIV treatment

Source, with reference 

Image

Gene Hope from HIV Controllers

posted: 05/11/2010

Scientists are closer to understanding why a tiny proportion of people with HIV can live for many years without treatment and without developing AIDS. New scientific insights could boost HIV vaccine and treatment prospects by exploiting natural immunity to the virus. But a UK HIV expert said there is still a "long way" to go before a vaccine or any new drug for HIV can be developed.

Natural immunity

About one in 300 people with HIV do not develop AIDS because of natural immunity. Their immune systems keep the virus in check, preventing HIV from overwhelming the body's immune system defences, and reducing the risk of passing on HIV.
 

People who stay healthy are described as "HIV controllers". Their bodies are able to control HIV by suppressing it so far that the viral load can be undetectable.
 

Genes of 1000 compared with 2,600

The latest study involved an exhaustive genome-wide genetic scan involving a million measurements of the DNA of 1000 HIV controllers from around the world. These were compared with the genomes of 2,600 other people with HIV. The comparison revealed significant differences in the DNA responsible for one of the immune system's vital proteins, called HLA-B. This is already known for defending the body against viruses.
 

Small differences
The study found that the ‘Controllers’ version of this protein has differences in only five of the amino acids – the building blocks of proteins. These differences are at the "binding pocket," which locks on to invading viruses, before warning the immune system that it is under attack.
 

HLA-B is part of the process by which the immune system recognises and destroys virus-infected cells. Part of the protein called a binding pocket "drags and drops" peptides from inside the virus onto the cell membrane. These then mark out the cell for destruction by CD8 "killer" T cells of the immune system.
 

"We found that, of the three billion nucleotides in the human genome, just a handful make the difference between those who can stay healthy in spite of HIV infection and those who, without treatment, will develop AIDS," said Bruce Walker, director of the Ragon Institute at the Massachusetts General Hospital in Boston.
 

Paul de Bakker of the Broad Institute in Cambridge, Massachusetts, said: "Earlier studies showed that certain genes involved with the HLA system were important for HIV control. But they couldn't tell us exactly which genes were involved and how they produced this difference. Our findings take us not only to specific protein, but to a part of that protein essential to its function."
 

One step closer

Dr Walker emphasised that the discovery just one of the major differences that increase people’s chance of living healthily with HIV.
"We've not identified the precise mechanism to explain HIV controllers, but we know that of all the genetic influences involved, this is by far the most important," Dr Walker said.
 

Doug tells us why he's involved
Doug Robinson, 46, from Truro, Massachusetts, is one of hundreds enrolled in the study of "HIV controllers". He was diagnosed in November 2003 but is still healthy and well. Normally by this stage of HIV infection, and without anti-HIV drugs, Mr Robinson would be expected to have a high level of HIV in his bloodstream – a "viral load" of about 50,000 copies of HIV. Instead, Mr Robinson has under 50 copies, which is undetectable.
 

"After my diagnosis, a friend told me that I am here for a purpose, that I could be a link to something that could be beneficial, and I felt like I had a responsibility to put myself out there," Mr Robinson said. "I feel it's my responsibility, no matter what I do, to put that to use. When I'm long gone, and the dust has blown over me, I hope to leave something, a positive contribution."

Hope but a long road
Gus Cairns, editor of HIV Treatment Update of the UK's National Aids Manual, said: "This research opens the door to the development of a vaccine that could encourage the body to mimic the most effective kind of immune response, or to drugs that could interfere with HIV's ability to infect cells and derange the immune system.
"Nonetheless there is still a lot we don't know about why some genetic variants provide a much less welcoming environment for HIV than others and, although we are becoming clearer about what kinds of specific immune response are effective against HIV, we are a long way from being able to make them happen, or even knowing what we must do to make them happen."
 

Sources and reference
Independent
BBC
HIV Controllers study

Science article (pay to view)

EU Blocking Cheap HIV Drugs

posted: 08/10/2010

The EC is pushing for a trade agreement with India which will restrict companies from making cheap copycat drugs for poor countries, says MSF. In 2001, when the Doha declaration was signed, it was widely thought that the battle for cheap drugs for developing countries had been won.

The declaration created a helpful loophole in the medicine patent rules. Indian companies and those in other countries would be licensed to make cheap copies of patented HIV and other drugs for poor countries.
 

Fight-back against drug company and EU
Now Médecins Sans Frontières, is accusing the European Commission of aggressively pushing policies - including a trade agreement with India - that will dry up the flow of cheap drugs to those who badly need them in poor countries.
 

Europe! HANDS OFF our medicine
A three-month campaign, called "Europe! HANDS OFF our medicine", launched today, invites people to let the EC know they object by an easy email system. The emails go to the Trade Commissioner, Karel De Gucht. "If you continue to pursue your actions, people who rely on these medicines to stay alive will be left without a lifeline and many are likely to die," it says.
 

Send an email today

Tough language, but MSF believes the stakes are high and argues that the EC has been doing the bidding of the multinational drug companies (who want to protect their drug monopolies) for some time and in a number of ways. This is what Dr Unni Karunakara, president of MSF's international council says:
'We depend on access to affordable medicines like those produced in India to treat all kinds of diseases. We buy 80% of our AIDS medicines from India - medicines that keep 160,000 people alive today. On their behalf, we cannot remain silent as Europe works to close the door on every aspect of drug supply - the production of a generic medicine, its registration, and its transportation to patients in other parts of the world. So today we are launching a campaign demanding 'Europe! HANDS OFF our medicine.'

Tougher patent rules
There are several issues. The free trade agreement is seeking tougher patent rules than the existing World Trade Organisation agreement requires, says MSF. The EC wants to introduce "data exclusivity", which would stop a generic company registering a copy of a drug without running its own expensive and lengthy clinical trials. This would seriously delay the supply of generic versions.
One example is nevirapine syrup for children with HIV. It does not have a patent from the Indian patent office, which means generics companies could copy it. If there was data exclusivity, children in Africa would have had to wait for years.
 

Generic HIV drugs seized at ports
But the campaigners also take issue with the EC over a number of seizures of generic drugs that have taken place in European ports since 2008. AIDS drugs intended for Nigeria, bought by the European-funded access to medicines organisation UNITAID, were seized in the Netherlands.

EU pawn of drug companies
Michelle Childs, policy advisor for MSF's access campaign, says the EC is doing the pharmaceutical's industry bidding. "The IFPMA [the trade body] has said they want data exclusivity. They have repeatedly asked for this. It's been a long-standing aim of the pharmaceutical companies to introduce this because it gives them the extra period of time."
The Office of the EU Trade Commissioner denied it was impeding access to medicines for the poor. This was what its spokesman told the BBC:
‘The EU has never and will never stand in the way of the production of legitimate generic medicines. The EU is in favour of providing access to medicines to people in need and these negotiations with India do not stand in the way of this. Patents are important, they need to be protected. The European pharmaceutical companies say that the patents need to be protected otherwise the production of new drugs will be seriously in peril.’
MSF simply points out that the issue is not about patents.

Europe! HANDS OFF our medicine

Source
 

End to Cheap HIV Drugs?

posted: 15/09/2010

A new report shows that the vast majority of HIV drugs keeping people alive in developing countries are made by Indian generics companies, but new trade rules may prevent them making cheap copies in the future.
Several million people are alive today - and fit and active and looking after their children - who would be dead, had it not been for the roll-out of antiretroviral drugs to treat people with HIV. This is a spectacular success story - even though less than half (4 million out of 9.5 million) people who need HIV drugs are so far on treatment.
 

But will the cheap generic drugs continue to be provided? Much may depend on the cost of the drugs.
 

Cheap generics

The three-drug antiretroviral combinations now in use in the developing world are cheap - really cheap. The prices came down from over $10,000 a year per person to under $100, because Indian generic drug manufacturers make cheap but effective versions, which are approved for quality by the World Health Organisation.
 

Just how much that price plunge mattered is made clear in a report from Brenda Waning and colleagues, available free online, published in the Journal of the International Aids Society today.  Their research shows that the vast bulk of these HIV drugs - up to 87% by 2008 - were supplied by the Indian generics companies.
 

Almost all the rest that are used in poor countries are not first-line combinations, but second or even third-line treatments, for use when the first combination won’t work. HIV is adept at developing resistance to the drugs used against it - it also happens across Europe and the USA.
 

Few 2nd and 3rd line generics

Generic versions of the newer, second and third combination drugs needed to deal with this resistance are not widely available.

Alarm bells TRIP for cheap new generics

Today's report raises the alarming possibility that they may not be made widely available.
Generic companies in India were able to make the basic HIV drugs because India did not recognise the patents on those drugs. But now everything is changing. Since 2005, a global trade agreement called TRIPS (trade-related aspects of intellectual property), has begun to have an impact, restricting the copying of new drugs. Negotiations on further trade agreements are ongoing.
 

The report’s author Waning works for UNITAID, an organisation dedicated to obtaining greater access to HIV medicines for poor countries. This is what UNITAID's executive secretary Jorge Bermudez had to say about the report:
“The findings of this study raise grave concerns for us because UNITAID relies heavily on Indian generic manufacturers to supply quality-assured, patient-friendly, low cost AIDS medicines in over 50 countries. What we need today is a more flexible approach to scale up treatment and not the opposite.”

If Indian manufacturers cannot meet these demands, a lot of the progress we have made in the last seven years against HIV in the developing world will be reversed.
 

Source The Guardian