INSITE

1. Health Crisis Brewing in Vancouver before Safe Injection Site Opened: Lawyer

April 29, 2008

Vancouver - A lawyer for a group that wants the federal government to keep a safe-injection site open in Vancouver's Downtown Eastside says a public health crisis was brewing in the area for more than a decade before the facility opened.

Monique Pongracic-Speier told B.C. Supreme Court on Tuesday that injection drug use had become an epidemic in Canada's poorest postal code and the site now provides an important health service.

"I think it would be fair to say that the Downtown Eastside has the largest open drug scene in Canada, if not North America," she said.

Pongracic-Speier represents the Portland Hotel Society, which co-manages the site. She said the facility is part of the city's overall harm-reduction strategy.

"It has been normalized to be a necessary part of the health-care services in the area," she said of the site, called INSITE.

North America's only such facility opened in 2003 and allows people to inject their own illegal drugs, including heroin and cocaine, under the supervision of a nurse.

But INSITE needs an exemption from Canada's drug laws to operate.

The exemption runs out at the end of June and the Portland Hotel Society and a group representing Vancouver drug addicts are in court to argue that the federal government has no jurisdiction over the site.

They say that because INSITE provides a health service, it is under the jurisdiction of the provincial government, which pays for it and has already said the site should not close.

Pongracic-Speier said a 1995 report by Vancouver's chief coroner said 331 British Columbia injection drug users died from overdosing in 1993, mostly in the Downtown Eastside, compared to 39 deaths in 1988.

In 1996, a report by Vancouver's medical health officer said injection drug use was responsible for a steep rise in HIV rates, skin and blood-borne infections such as HIV and hepatitis and that health-care resources were stretched as a result.

By the following year, Pongracic-Speier said, 27 per cent of Downtown Eastside residents had HIV, with researchers calling that an epidemic. It prompted the province to spend $3 million on a program to combat the infection.

She said many of the drug addicts in the Downtown Eastside are First Nations who are vulnerable to the dealers who frequent the area.

Many addicts also lack adequate housing and are infected with HIV, hepatitis C and tuberculosis and may also have a mental illness, Pongracic-Speier said.

An affidavit by Heather Hay, director of Addictions, HIV-AIDS and Aboriginal Services for the Vancouver Coastal Health Authority, said people who don't live in the Downtown Eastside are also vulnerable to infectious diseases such as hepatitis A and B as a result of inadequate access to washrooms.

Hay said in the affidavit that it's not uncommon for 80 to 90 people in some of the Downtown Eastside hotels to share one washroom.

Pongracic-Speier said that in response to the crisis in the area, more needle exchange programs have been set up, new health clinics have opened and an existing clinic has expanded its hours to accommodate up to 11,000 people a month.

She said the role of INSITE is not just to save lives by reducing overdose deaths but to also refer clients to addiction treatment facilities.

Since last year, the facility has added a detox-on-demand centre upstairs so people who want to get off drugs can enter the program immediately instead of having to wait.

The second floor of the INSITE building also includes alcohol and drug-free housing, which people can use after detoxing and while they're waiting for long-term housing.

Along with the B.C. government, Vancouver Mayor Sam Sullivan and the Vancouver Police Department also endorse INSITE.

The Canadian Press


2. Federal Stand on INSITE One of Duplicity and Intransigence

May 2, 2008

Although medical waiting times get a lot more attention, the public should be aware of another health care scandal, and it involves government attempts to suppress medical research.

The research, published in top-flight academic journals, has found that a new medical intervention effectively reduces some of the harms associated with a chronic disease, while not creating any new harms.

Instead of acknowledging this evidence and seeking to ensure that the intervention is available to all of those afflicted by the disease, the federal government has been doing the opposite. Specifically, it has attempted to create the impression that the new intervention is not effective, and has decreed that it will not make the intervention available to vulnerable people who need it.

If this story involved any ordinary intervention, the scandal would be the lead story in newspapers and newscasts across Canada. And the government would not last long if it insisted on continuing its record of duplicity and intransigence.

Alas, this is no ordinary intervention. Rather, the story concerns INSITE, Vancouver's supervised injection facility.

For the past few years, researchers at the B.C. Centre for Excellence in HIV/AIDS, who act as independent evaluators of INSITE, have been monitoring the site and publishing their findings in peer-reviewed journals.

Some two dozen studies have been published and have found, among other things, that the site is associated with a reduction in public injecting and HIV risk behaviour, and even with increased uptake of addiction treatment. The success of the site has led officials in other cities to express interest in starting their own supervised injection facilities.

Yet, as the researchers detail in a new paper published today in the International Journal of Drug Policy, the federal government has been doing everything possible to suppress the research and create the impression that INSITE has not been effective.

The government's efforts to interfere with the research became abundantly clear after Health Minister Tony Clement refused, in 2006, to extend the life of the site for another 31/2 years, instead allowing only a six-month extension. The feds also refused to allow supervised injection facility research in other cities.

In an effort to explain this decision, Clement issued a press release stating that the research raised "new questions," and implied that further research was necessary. Yet how are researchers supposed to answer these new questions -- and the government never detailed what the new questions were -- when it refuses to allow research to be conducted?

It appears the government wished to suppress further research out of fear that the research would indicate that INSITE is a beneficial intervention. After all, the research to date has attested to INSITE's beneficial effects, and the feds have done their best to spin this research in their favour.

Notably, Clement has stated that there is an academic debate about the success of INSITE. Nothing could be further from the truth: The research has resulted in an impressive academic consensus that the site is a worthwhile medical intervention.

Evidence of this consensus becomes clear as more and more scientific and medical researchers go on record opposing the government's attempts to spin the research.

Last year, for example, St. Michael's Hospital researcher Stephen Hwang wrote a commentary in the online journal Open Medicine, accusing the feds of allowing ideology to trump science. The commentary was signed by more than 130 physicians and scientists.

And in an interview on Thursday, Graydon Meneilly, head of the department of medicine at the University of British Columbia, called the government's actions "reprehensible."

They are. Certainly, the government has the authority to oppose supervised injection sites, even though they benefit some of Canada's most vulnerable people.

But if it is going to do so, it ought to be honest about its reasons, instead of trying to hoodwink the public by spinning evidence and disallowing future research whose results might conflict with its agenda.

The Vancouver Sun


3. Scientists Accuse Tories of 'Despicable' Interference
Ideological opposition to a Vancouver safe-injection site caused muzzling and misrepresentation of findings, researchers say

May 2, 2008

The federal government committed a "serious breach of international scientific standards" in its handling of Vancouver's safe injection site, according to a new study.

An article published in the International Journal of Drug Policy charges that the Conservative government interfered in the work of independent scientific bodies, attempted to muzzle scientists and deliberately misrepresented research findings because it is ideologically opposed to harm-reduction programs.

"From a scientific perspective, it's despicable," said Evan Wood, a research scientist at the B.C. Centre for Excellence in HIV/AIDS and lead author of the study. "Governments should not hand-pick grants based on ideology."

In 2003, the Liberal federal government approved North America's first safe injection facility, allowing public health officials to provide sterile needles and emergency medical care to intravenous drug users.

The facility, called INSITE, was granted an exemption from Canada's drug laws on the condition that the pilot project be subjected to rigorous scientific evaluation.

Since then, Dr. Wood said, there have been 22 peer-reviewed papers published on the program and they have all shown a positive benefit to users, such as reduced rates of transmission of HIV-AIDS and greater use of rehabilitation services.

An independent scientific review led Health Canada in the spring of 2006 to recommend that funding for the project be extended and that similar programs be tried in other cities.

But federal Health Minister Tony Clement intervened, saying there were too many unanswered questions and placed a moratorium on this type of research. The journal article says that was done at the behest of police organizations and based on political concerns, not sound public health policy.

Rita Smith, a spokeswoman for Mr. Clement, told The Globe and Mail yesterday this claim is "completely inaccurate."

"Minister Clement put no moratorium on research - he actually commissioned more research," she said, adding Mr. Clement had Health Canada form an independent committee to produce a report on all domestic and international research surrounding supervised injection sites.

The Vancouver project continues because it was funded by the Canadian Institutes of Health Research, which operates at arm's length from government.

Ottawa subsequently offered money for additional research, but with the proviso that investigators refrain from disseminating their findings until after the exemption for the safe injection site expires.

Dr. Wood said this amounts to "muzzling researchers." The University of British Columbia deemed that condition ethically unacceptable and so its researchers did not apply for the grants.

The legal exemption for INSITE expires at the end of June and operators of the facility are currently in B.C. Supreme Court trying to force the government to extend it.

Perry Kendall, B.C.'s Provincial Health Officer, said the safe injection site has proven its worth and he agrees with much of the criticism in the journal article.

"I'm a realist enough to know that public policy is not based solely on science, but you would hope that policy would be strongly swayed by science, particularly in health care," he said in an interview.

Dr. Kendall said the fact that the public health program involves intravenous drug users clouds the issue and has allowed government to intervene as it would never do in other areas.

"If there was a validated intervention for hernia repair would we accept that the government step in and say: 'We don't like hernia repair'? I don't think so," he said.

In a commentary also published in the International Journal of Drug Policy, Robert MacCoun of the Goldman School of Public Policy at the University of California, Berkeley described the INSITE saga as a "policy horror story."

He said that the evidence demonstrates that a "well-executed piece of policy research on a promising innovation was discontinued for unstated but blatant political reasons."

Dr. MacCoun said that Mr. Clement's critique of INSITE - "Do safe injection sites contribute to lowering drug use and fighting addiction?" - misses the point of harm reduction.

He said the project is designed to minimize the harm IV drugs users do to themselves and others, something a law-and-order approach cannot achieve.

By Andre Picard, Globe and Mail


4. INSITE Backers Step up Fight to Save It
Advocates of safe injection site launch campaign pressing Ottawa to let it stay open

May 3, 2008

Vancouver - The last-ditch political battle to keep open Canada's only supervised injection site is about to begin.

Friday, the International Journal of Drug Policy published articles by scientists from around the world condemning the federal government for interfering politically with the site's research.

On Monday, well-known West Coast criminologist Neil Boyd will hold a media conference in Ottawa to tell national reporters about his research into the benefits of the Vancouver site, which will see its federal narcotics law exemption expire on June 30.

Injection-site advocates will hold a rally Tuesday in a Downtown Eastside park featuring 1,000 white crosses to represent the people whose overdoses never ran the risk of becoming fatal because they were injecting at INSITE instead of on the street.

On Wednesday, Vancouver street nurses will stage an "information picket" at the office of the Vancouver Police Union, whose president has become a vocal critic of the site.

And on Friday, B.C. Nurses Union president Debra MacPherson will hold a media conference in front of the site to talk about its health benefits.

Along the way, people from all three of Vancouver's civic parties will gather to make a statement of support. A B.C. Supreme Court case over the injection site, instigated by the site's operators, the Portland Hotel Society, will continue to play out. And there's likely to be more.

"I'm feeling this is the do-or-die time," says Nathan Allen, the face of the campaign called INSITE for Community Safety. "We're definitely going to ramp up the pressure this month."

Allen and the Portland Hotel Society, along with B.C. scientists, politicians and health-care groups, are working on events, statements, reports and whatever else it takes to convince the federal government it will be a political disaster to shut down a site so supported by the local establishment.

"As we get closer to the deadline, there will be heightened level of activity," said David Hurford, a spokesman in Mayor Sam Sullivan's office.

The site opened in 2003 with a three-year exemption from federal narcotics laws. It has since been extended twice, for 18 months each, by a Conservative government that has clearly indicated its ideological discomfort with the site, which critics see as enabling drug use.

The sense now is that the federal government has to choose to either shut it down, give it a long-term exemption, or find some way of getting itself out of a mess by turning it over to the provincial government's jurisdiction. That last option would allow the Vancouver site to remain without opening the door to injection sites in other provinces.

Hurford said the mayor's office is trying to make sure that the political activism is smart and strategic.

"We need to be cautious about the rhetoric and recognize that the federal government is doing some good things with the national drug strategy, with treatment money," said Hurford. "And then they need to see that with this issue, there may be a danger if this decision goes the wrong way that we may lose some of that momentum."

But that coordinated campaign doesn't sit well with opponents.

Vancouver Police Union president Tom Stamatakis, who has emerged as the site's most high-profile local opponent, said the public is being misled by the "well-funded and well-organized" lobby from the pro-site advocates.

"It seems like the proponents have the momentum and they're ruthless in getting their message out."

That's not something the advocates are so sure of.

The Portland Hotel Society's Mark Townsend said his group is engaging in the strategic events it is because they're the only mechanisms it has to get its message across.

"The prime minister and the police are gigantic organizations. All we are is a tiny non-profit. We've tried to get meetings in Ottawa but we hear nothing. This is the only way we have to communicate with Stephen Harper and his people so they get what people really think."

Frances Bula, The Vancouver Sun

eHealth Bill A Threat To Privacy, Say Health and Rights Groups

Groups want bill redrafted with right of patient consent enshrined

April 28, 2008

A number of BC health and civil liberties organizations say the province's eHealth bill is a threat to personal freedoms and health information privacy.

Bill 24 would allow the provincial government to create massive electronic databanks of citizens' personal health information.

And those databanks will be talking electronically to other
government databanks, says the BC Persons With AIDS Society chair Glyn Townson.

That means, for example, your health data could be shared with officials looking at your EI data. Bill 24 is due to receive its second reading in the Legislature in the next two weeks.

Townson says without any privacy protections, interlinked government databases will allow unsecured access to medical information.

He says this should concern everyone, but he singles out people with HIV/AIDS, people using birth control and women getting abortions.

The bill's critics say public consultations on the bill have not
produced meaningful results.

They say the government's failure to enshrine meaningful citizen control over medical information makes the government's assurances of privacy meaningless.

Townson says he's been working with committees on the legislation but says the government's lack of consideration for people's privacy has "sideswiped" those groups.

"I am dismayed, disappointed and somewhat angry," says Townson, who estimates he's spent 40 per cent of his recent time working with BCPWA working on the law.

Darrell Evans of the BC Freedom of Information and Privacy Association says Bill 24 opens the door to massive security breaches.

"They are happening all the time," he says. "We're talking drug histories, genetic information, medical test results, you name it.

"And once your personal information gets out or on the internet, it's there forever, beyond anyone's control."

The groups want Bill 24 to be redrafted with the right of patient consent and control enshrined, with only strictly limited exceptions for emergencies and audits.

Further, they say, that sensitive health information should never leave Canada without express consent.

By Jeremy Hainsworth, Xtra West

Major Global Health Conference Set for Late May at Simon Fraser University

May 1, 2008

Vancouver - An international conference focusing on global health threats - held in Canada for the first time - will hear how gender inequality, disease, war and poverty are increasingly affecting global security and explore what might be done about it.

"We are seeing more and more of the main global health issues in the news and people feel increasingly unable to deal with situations," said Jocelyn Tomkinson, one of the international conference's organizers.

The conference, partially funded by the Bill and Melinda Gates Foundation, is set for May 23-25 at Simon Fraser University.

Tomkinson, who is working towards a master's degree in science at the university's health program, said the Western Regional International Health Conference brings well-known people in social and health fields "to try to identify the areas in which we should act first or where we need intervention the most."

"Global health issues are increasingly affecting global security," she said.

Dr. Julio Montaner, a world-renowned researcher on HIV/AIDS and the clinical director at the B.C. Centre for Excellence in HIV/AIDS, is one of the main speakers.

"HIV and AIDS on a global level represents one of the greatest threats to human development," said Montaner.

"The epidemic continues to grow at a rapid pace."

Montaner will speak about the challenges and rewards of combatting the human immunodeficiency virus.

The number of cases continues to expand rapidly while researchers appear to have reached an impasse on new technologies, he said.

"If we were truly commit to rolling out HIV treatment to the people we would see a dramatic change in the course of the epidemic," said Montaner.

Dr. Samantha Nutt, voted by Time magazine as one of Canada's top five activists and the founder of War Child Canada, will also be at the conference.

"The theme of my talk is how we might achieve more support for people living with war and displacement," said Nutt.

Nutt is convinced that conferences like this one can make a difference worldwide because they establish relationships . . . where people share their experiences and what they know works on the ground."

"We have found over the years that the best way often to affect people is that personal connection, when they see you and speak to you and they ask questions."

Colleen Phung, a researcher at Simon Fraser working on population and public health in the faculty of Health Sciences, will deliver findings on gender inequality and the effect on women's reproductive health.

Each year, she said, the World Bank produces a global gender gap index that measures differences between men and women in a number of factors, including politics, degree of participation in the economy and income.

She and others took the index and measured it against indicators that are related to reproductive health, such as maternal mortality rate, skilled attendance at delivery, fertility rates, contraceptive prevalence and HIV prevalence.

"They are all indicators of reproductive health - a woman's ability to control her reproduction," said Phung.

"We found that the higher the gender gap difference, the least likely a woman is able to control her reproductive health."

She said those findings are important because, since about half the population is female, "it comes down to the issue of empowerment, women not having control over their lives."

Improving the health of women can, in turn, improve the health of their children, said Phung.

"To change policy it takes attention and a cry from the public."

Tomkinson said many people living in wealthy countries want to alleviate others' suffering and "conferences like this allow us to advise major donors such as countries and non-profit organizations where the money could be put."

The Canadian Press

The Price of HIV Meds

1. Activists Call for Cheaper HIV Meds across the Globe

April 24, 2008

Health advocates from 15 different countries met earlier this week in New Delhi to discuss ways to make HIV medications cheaper across the globe, the Hindustan Times reports (hindustantimes.com, 4/22).

The meeting—which united civil society leaders from Brazil, South Africa, Malaysia, Thailand, China, Kenya and other countries—addressed ways in which countries can bypass enforcement of intellectual property rights to ensure that otherwise-patented drugs get into the hands of those who need them most.

The article notes that governments in countries such as Thailand have lowered drug costs by issuing compulsory licenses on drugs treating chronic, life-threatening conditions such as HIV/AIDS and heart disease, a measure permitted under World Trade Organization regulations. The licenses allow countries to override patent restrictions to produce cheaper generic medications.

http://www.poz.com


2. Deal Lowers Price Of Second-Line Therapy and Makes New Paediatric Formulations Available to Poorer Countries

April 29, 2008

Further reductions in the prices of generic versions of key second-line antiretroviral drugs were announced yesterday, thanks to an agreement negotiated by the international drug purchase fund UNITAID and the Clinton HIV/AIDS Initiative with Indian and Chinese generic drug manufacturers.

Under the deal the cost of tenofovir, 3TC (lamivudine) and lopinavir/ritonavir will fall by almost a fifth compared to prices a year ago.

Six new, easy to take child-friendly antiretroviral formulations will also be made available by the deal, and a paediatric fixed-dose combination of AZT, 3TC and nevirapine will cost no more than $66 per year.

The cost cutting will mean that tenofovir, 3TC and lopinavir/ritonavir, the most widely used second-line generic combination, will be available to low income countries at an average of 16% less than the current average market price and to middle-income countries at prices that are 46% lower.

A year of treatment with a generic version of lopinavir/ritonavir will now cost between $613 – $550, with fixed-dose tenofovir and 3TC costing $159 a year. It is estimated that 500,000 patients in low-income countries will require second-line therapy by 2010. Abbott, the originator of lopinavir/ritonavir, charges $500 for its heat-stable version, Aluvia, in least-developed countries and $1000 in lower middle-income countries.

The deal will also reduce the price of generic versions of tenofovir/FTC, tenofovir/3TC and tenofovir/3TC/efavirenz fixed dose combinations; the tenofovir/3TC/efavirenz product manufactured by Matrix Laboratories will cost $299 a year, compared to $100 a year for d4T/3TC/nevirapine and $159 for AZT/3TC/nevirapine. Some countries, such as Zambia, have already switched from d4T to tenofovir-based regimens for first-line treatment because they are less toxic, but others have opted to stick with d4T or AZT-based regimens in order to treat more people.

"Today’s announcement is an important step in helping to save the millions of children and adults infected with HIV in the developing world who still lack access to life-saving drugs", said former US President Bill Clinton.

Due to an agreement with the generic manufacturer, Matrix Laboratories, a paediatric fixed-dose formulation of AZT, 3TC and nevirapine will be available at a cost of no more than $66 per year. AZT-based therapy involves significantly fewer side-effects than treatment that includes d4T.

Other generic manufacturers involved in the deal are Aurobindo Pharma and Cipla.

The prices of over 40 antiretrovirals are affected by the latest deal. Compared to the latest figures from Medecins Sans Frontieres, the UNITAID/Clinton Foundation prices are an average of 21% lower.

Over 200,000 HIV-positive adults and children in poorer countries are receiving antiretrovirals with UNITAID support, and globally the partnership between UNITAID and the Clinton Foundation is supporting two-thirds of children in receipt of antiretroviral therapy. According to the Clinton HIV/AIDS Initiative, around 1.4 million adults and children are now benefiting from antiretroviral drugs purchased at prices negotiated by the CHAI Procurement Consortium.

"This achievement represents a major step in our partnership to provide more treatments to hundreds of thousands of children through 2010 and to continue to lower the price of second-line treatment", said Philippe Douste-Blazy of UNITAID.

By Michael Carter, www.aidsmap.com

Egyptian Actors Address HIV/AIDS, Recent Imprisonment of Men Living With Disease

April 29, 2008

Egyptian actors Amr Waked and Khaled Abul Naga are speaking out against HIV/AIDS-related stigma in the country after several people who are allegedly living with the disease have been jailed in recent months, AFP/Yahoo! News reports.

"These convictions will only further reinforce prejudices while making the fight against AIDS all the more difficult," Waked said, adding, "The deliberate confusion (around the issue) must stop -- stigmatization does not help the fight against AIDS" (Navarro, AFP/Yahoo! News, 4/26).

An Egyptian court earlier in the month sentenced five men to three years in prison on charges of "habitual practice of debauchery," which some human rights groups said is evidence of an "escalating crackdown" on HIV-positive Egyptians. According to Human Rights Watch, the five men -- four of whom are allegedly living with HIV/AIDS -- are among 12 people arrested since October 2007 in a "spreading hunt for people suspected of being HIV-positive."

Adel Ramadan, an attorney for the Egyptian Initiative for Personal Rights, said the five men were abused and tortured over the past several months to "extract confessions." HRW and 117 other organizations sent a letter to the Egyptian Ministry of Health and Population condemning the prosecutions. According to the letter, physicians employed by the ministry "subjected the men to HIV tests without their consent." In addition, doctors from Egypt's Forensic Medical Authority "forcibly subjected the men to intrusive, medically valueless and abusive forensic anal examinations to 'prove' they had engaged in homosexual conduct," the letter said. HRW and the other organizations also allege that the men who tested HIV-positive were chained to their beds at Cairo hospitals until Feb. 25.

According to court sources, the five men also were ordered to pay a fine of 300 Egyptian pounds, or about $55 (US). Ramadan said the sentence includes three years police supervision after the prison sentence ends. Ramadan said he appealed the ruling to Egypt's Court of Cassation, the country's highest appellate court (Kaiser Daily HIV/AIDS Report, 4/11).

EIPR Director Hossam Bahgat said, "Unlike incidents in the past, this is not a renewed homophobic attack, but it's an offensive against AIDS via security measures."

Abul Naga, who was recently appointed a UNICEF goodwill ambassador, called the convictions "worrying," adding that they fuel "the idea that AIDS is not a disease to treat but a crime to punish. People will be too scared to take an HIV test voluntarily." Sheikh Mohammed Saleh from Al-Azhar, Sunni Islam's highest seat of learning, said that HIV/AIDS is a "disease sent by God to punish sexual deviants." According to AFP/Yahoo! News, authorities have denied or sought to minimize the existence of HIV/AIDS in Egypt for years.

There are no official figures about HIV/AIDS cases in Egypt, according to AFP/Yahoo! News. However, Wessam al-Beih, country director of UNAIDS, said that "Egypt is one of the countries with the highest rate of increase" in HIV/AIDS cases, with the number of cases ranging from 2,000 to 17,000. About 80% of women living with the disease contracted the disease from their husbands, Beih said. Waked said he is hopeful that Egyptian society is changing. "Egypt is starting to move forward," he said, adding that a "whole generation is waiting for it" (AFP/Yahoo! News, 4/26).

http://www.kaisernetwork.org

South Africa

1. Beating Beetroot: South African AIDS Plan Boosts Treatment

May 2, 2008

Winterton, South Africa -The waiting room at the anti-retroviral clinic in rural Kwazulu-Natal, South Africa, is bustling, as patients clutch their files patiently awaiting their life-saving medication.

Smiling shyly, a 51-year old woman clasping a brown paper bag upends her medicines in front of Nokubonga Potelwa, who explains how to take the drugs that were long snubbed as toxic by the South African government.

Potelwa hands the woman a photocopied calendar, with a picture of a sun and a moon drawn in each day where she has to mark off that her medicines were taken, and uses a red crayon to indicate with an X, the day she should return.

Emmaus hospital, nestled among the majestic Drakensberg mountains in the AIDS-stricken province is one of several rural hospitals recording astonishing successes in ARV-treatment, having already hit ambitious targets set for 2011.

After the cabinet adopted on May 4 2007 a five-year AIDS plan which aimed to halve new infections by 2011 and have 80 percent of patients on treatment, South Africa's once sluggish and embarrassing AIDS response has taken new shape.

"I am happy, because I am going to live a healthy life," the woman says quietly in Zulu.

With five and a half million HIV infections, in a population of 48 million, South Africa has the world's worst AIDS rate.

From President Thabo Mbeki's questioning of the link between HIV and AIDS, and a long battle by activists to see the provision of anti-retroviral treatment, government was reluctantly prodded into rolling out ARVs in 2004.

The slow rollout, and constant conflict between activists and health minister Manto Tshabalala-Msimang reached its zenith in 2006 when the minister's promotion of vegetables over ARVs saw her displaying beetroot, garlic and lemons at the world AIDS conference in Toronto, Canada.

The international backlash spurred the development of a new National Strategic Plan driven by a restructured AIDS council that has seen civil society relentlessly driving the fight against AIDS.

"More people are coming in and testing, there are many more on ARVs. Ay its a big difference," says Potelwa who has seen the hospitals' ARV rollout go from zero to on-target in her three years as an AIDS counsellor.

To Dr Bernhard Gaede, who heads up the AIDS clinic at Emmaus, the trick to wading through the pitfalls of rural healthcare, such as doctor shortages and long distances is decentralising, empowering nurses to perform more functions.

The initial guidelines for implementing ARV treatment from initiation to adherence at central hospitals resulted in chaos, with long waiting lists around the country.

"Very quickly, with a small amount of space and small number of staff we became very congested. We could only put five people a week on ARVs," said Gaede.

By training nurses at the five Primary Health Care clinics around Emmaus to do testing and adherence, and sending doctors there to initiate patients, 80 percent of the HIV positive community -- 20,000 people of a population of about 150,000 -- is now on treatment.

Government figures at the end of February showed that 420,000 people were now receiving ARVs nationwide, a sharp rise on the figure of 273,000 at the end of 2006.

"We improved transport to clinics, and by having doctors there the goal (in the NSP) of strengthening the health care system actually began to happen."

Denise Hunt, executive director of the AIDS consortium networking organisation, who is on the plenary of SANAC, said while there was not yet statistical evidence to measure the targets that had been set, the signs were positive.

"There is a lot of anecdotal evidence that we have come quite far in the journey. I think we have made a lot of progress, it is very exciting to see there are the success stories."

She said rural hospitals like Emmaus showed that with "creative thinking, when it is applied, the targets are ambitious but they are reachable."

Both Gaede and Hunt agree the civil society component of SANAC made a huge difference in the progress that had been made, even when the renewed goodwill between government and activists faltered.

Hiccups at the end of 2007, such as when deputy health minister Nozizwe Madlala-Routledge -- who played a big role in the development of the NSP -- was fired, sparked fears that politics could see the AIDS plan backslide.

"We all had a space last year around the deputy minister of health being fired. We all became very anxious and probably quite depressed," said Hunt.

"If government starts losing momentum civil society has to keep up the pressure."

One of the other successes has been the recent release, after many delays, of new guidelines allowing for the use of dual therapy to treat pregnant women before going into labour and their newborn babies, shown to drastically decrease chances of the HI virus being passed from mother to child.

There was an outcry when government in February charged a rural doctor, Colin Pfaff, for misconduct, when he raised donations to provide dual therapy before the protocols were officially implemented.

Gaede said it was "absurd", and added that comments by a local government minister that antiretroviral drug AZT, used in dual therapy, was toxic showed "lots of people are still completely in the way."

While many areas of the NSP still had a way to go, such as getting more people to test and improving prevention messages, Hunt said the work that had been done was inspiring.

"Although sometimes it's shaky, it's inspiring to see the plans that are been made. We are still speaking the same message.

AFP


2. New Stats Show Millions More HIV Positive

May 4, 2008

Shocking new AIDS statistics reveal that 2 million more South Africans are infected with HIV than the most recent government estimates show.

According to statistics released by the Development Bank of South Africa (DBSA), more than 7,6 million South Africans are HIV-positive - 2,2 million more than the department of health's figures for 2007 state.

Of these, about 6,1 million are the economically active people between the ages of 20 and 64, who could contribute to the country's economy.

What makes these statistics more alarming is the fact that the data on which they are based are probably more reliable than the department of health's because they were collected at grassroots level and not based on estimates.

The DBSA's 2007/2008 statistics state that:

• 7,6 million South Africans are HIV-positive;

• more than 27 percent of men and women aged between 20 and 64 are HIV positive;

• more than 92 000 babies have been infected, either perinatally or through mother's milk, in the past year;

• the total number of AIDS sick by mid-2007 was 1 287 844;

• nearly 722 000 people have died of AIDS-related diseases in the past year, bringing the total number of such deaths since 2003 to more than 3,7 million;

• In 2003, the accumulated total AIDS-related deaths stood at just under 1 million; and

• 1,2 million of the country's 1,49 million orphans have lost their parents to AIDS and this number is expected to increase by more than 336 000 this year alone.

Shanghai, China, To Establish Four New Methadone Clinics to Curb Spread of HIV, Health Officials Say

May 2, 2008

Health officials in Shanghai, China, on Wednesday at a public health conference said the city will establish four new methadone clinics in an effort to control the spread of HIV/AIDS, the Shanghai Daily reports. The new clinics -- which will be located in the city's Minhang, Nanhui, Pudong New Area and Xuhui districts -- will bring the total number of methadone facilities in Shanghai to 12.

Officials at the conference also said that the city's 42 HIV testing and counseling centers, as well as maternity and child health hospitals, provided 14,771 counseling sessions and 13,279 HIV tests last year. Officials added that the city's public health priorities for this year include controlling the spread of infectious diseases, such as HIV, and reducing deaths among pregnant women and infants (Cai, Shanghai Daily, 5/1)

http://www.kaisernetwork.org

Suppression of Human Protein Reduces HIV's Ability To Enter T Cells, Replicate, Study Finds

April 30, 2008

Researchers have found that suppressing the human protein ITK in CD4+ T cells reduces HIV's ability to enter the cells and replicate, according to an NIH study published Monday in the Proceedings of the National Academy of Sciences, Reuters reports.

For the study, Pamela Schwartzberg of Boston University and colleagues used human cells in a laboratory to test two methods of inactivating ITK. One method stopped ITK from functioning. In the other method, the researchers used a drug to chemically interfere with the protein (Dunham, Reuters, 4/28). "Suppression of the ITK protein caused many of the pathways that HIV uses to be less active, thereby inhibiting or slowing HIV replication," the researchers said (AFP/Google.com, 4/28). Schwartzberg added that the researchers did not "completely block (infection), but we certainly severely impaired it. It has minor effects at multiple stages of HIV life cycle, and together that all adds up to a more profound effect" (Reuters, 4/28).

The researchers said that they were concerned that ITK suppression "might kill or otherwise impair the normal functions of T cells." However, both suppression methods slowed HIV replication but did not interfere "significantly" with T cell survival, according to the study. In addition, the researchers said that mice with ITK deficiencies were able to fight other viral infections (AFP/Google.com, 4/28).

According to the PA/Google.com, ITK suppression could help address the emergence of drug-resistant strains of HIV because it targets a human protein rather than the virus (PA/Google.com, 4/28). Study researcher Andrew Henderson of Boston University added that treatments based on ITK suppression could complement existing antiretroviral drugs. Schwartzberg said that it likely would be several years before a drug that suppresses ITK could enter human clinical trials. She added that more lab experiments are needed to assess other ways of suppressing the protein.

NIH and the researchers have filed for a patent on suppressing ITK to treat HIV with the U.S. Patent and Trademark Office. The protein also is being examined as a possible target to treat asthma and other illnesses involving the immune system, Reuters reports (Reuters, 4/28).

http://www.kaisernetwork.org

Treatment Failure: Symptoms Matter Too

April 25, 2008

Symptoms of failing health are nearly as effective as viral loads or CD4 counts in determining if an antiretroviral (ARV) treatment regimen has stopped working and needs to be switched, according to new research published in The Lancet and reported by AIDSmap. These findings have important implications in developing countries, where shortages of viral load and CD4 tests are delaying the rollout of much needed ARV therapy.

Using data from a number of cohort studies, Andrew Phillips, MD, of the Royal Free and University College Medical School in London, and his colleagues designed a computerized system to predict short- and long-term survival in people switching from a first to a second ARV regimen. They asked the system to predict survival if people switched following a viral load result above 500 copies, a CD4 drop of at least 50 percent from the highest measure after starting treatment, or based on a set of HIV-related symptoms maintained by the World Health Organization (WHO). Survival five years after a switch was 82 to 83 percent for each of the three models. It was only after 20 years where switching due to symptoms performed significantly less well than CD4 count or viral load.

The authors concede that computer simulations are not equal to clinical studies, and that their results stand in contrast to a clinical study conducted in Uganda in 2003 and 2004. However, they still conclude that these data support arguments favoring the distribution of ARV therapy in countries that do not have access to the viral load or CD4 tests that are typically used as a component of follow-up care in industrialized nations.

http://www.poz.com

Peace Corps Fires Man with HIV

April 22, 2008

New York City - The American Civil Liberties Union has sent a letter to the Peace Corps demanding that it change its policy of barring people with HIV from serving as volunteers.

The letter was sent on behalf of a Denver, Colorado volunteer who was sent home from his post in the Ukraine and terminated after he tested positive.

"I joined the Peace Corps because I wanted to learn more about the world and help people," said Jeremiah Johnson.

"It was hard enough to learn that I had contracted HIV, but to then be shipped home and told I was unworthy of finishing my service was incredibly humiliating."

Johnson, now 25, began his tour as a Peace Corps volunteer in December 2006.  He tested negative for HIV prior to beginning his service.  

For nearly thirteen months, he was the sole volunteer in Rozdilna, Ukraine, where he taught English to middle and high school students.

In January 2008, Johnson, who was in Kiev to attend a Russian language program with other volunteers, received a midservice medical examination and opted to take an HIV test.  

After the results confirmed that he was positive for the disease, he was immediately told that he could no longer work in the country because of a Ukrainian law barring people with HIV from working in the country.  He was also told he would not be able to finish his service elsewhere.  

Although he had no health problems, he was only allowed to return to Rozdilna for two days to pack his bags and say goodbye to the people he had met during his tour, the ACLU said in a statement.

He was forced to abandon projects that he had been developing to help the community.  Johnson was then sent to Washington, D.C., for an end-of-service medical exam.  

The ACLU said that while in DC, he again asked Peace Corps officials to explain why he was being terminated and asked if he could continue his service elsewhere, but these requests were denied.  Instead, he was given an automatic medical termination, stating HIV as the reason for his termination.

The ACLU’s demand letter charges that it is illegal under the Rehabilitation Act for the Peace Corps to discriminate against Johnson because he has HIV.  

The letter cites a recent federal appeals court decision finding that it is illegal for the Foreign Service to bar people with HIV from serving.  In that case, the Foreign Service, which also sends workers around the globe, had argued that it was justified in barring people with HIV from service in order to protect the health of people with HIV who would be stationed in areas with limited access to medical treatment.  The court rejected that rationale.

"There is not a single justifiable reason for the Peace Corp to bar people with HIV from serving as volunteers," said Rebecca Shore, an attorney with the ACLU’s AIDS Project.

"Jeremiah was, and continues to be, in good health, fully capable of performing his responsibilities.  It is especially disappointing that an agent of our government would have an illegal and discriminatory policy barring people with HIV from trying to make the world better."

The ACLU’s letter demands that the Peace Corps change its policy or confirm that it does not have a policy of automatically excluding all people with HIV. According to the ACLU, the Peace Corps must consider on an individualized basis whether an applicant with HIV can volunteer, including making every effort to place those who are able to serve in a country that doesn’t bar people with HIV from working in the country.  

"It was hard being sent home the way I was." Johnson said.  "I had no time to plan for my return."

"I was forced to have a lot of conversations I wasn’t really ready to have.  I had no money, no job and no place to live.  Fortunately, my family welcomed me back with open arms and helped me get back on my feet," said Johnson.  "But one thing I’ve come to realize is that having HIV won’t stop me from realizing my dreams of helping others.  I hope by bringing attention to what happened to me, the Peace Corp will realize that too."

http://www.365gay.com

Better Antibiotics for Second-Line PCP Treatment

April 28, 2008

A combination of two oral antibiotics is more effective than the commonly used, yet side effect-prone, intravenous pentamidine for people who’ve failed their first AIDS-related pneumonia regimen, according to the authors of a new study published in the May 1 issue of the Journal of Acquired Immune Deficiency Syndromes (JAIDS). Data supporting the use of clindamycin and primaquine is promising news for the roughly 10 percent of patients whose first course of treatment for Pneumcystis jirovecii pneumonia (PCP) doesn’t work.

Intravenous pentamidine is known for a range of serious side effects, including kidney toxicity, low blood pressure and low white blood cell count, and has been shown less effective as treatment for PCP than the antibiotic trimethoprim-sulfamethoxazole (TMP-SMX), commonly known as Bactrim or Septra. For this reason, pentamidine is typically recommended only as second-line therapy for those who don’t respond effectively to their initial treatment choice, or as first-line treatment for people who cannot tolerate TMP-SMX. There are alternatives to pentamidine, but there has been little research to show how effective they may be in treating people who fail their first PCP regimen.

Thomas Benfield, MD, DMSci, from the Department of Infectious Diseases at Hvidovre University Hospital in Copenhagen, Denmark, and his colleagues conducted an analysis of 29 published studies, plus an additional 82 case reports from three European cities. In all, they were able to study the outcomes of 468 second-line PCP treatment episodes.

Benfield’s team found intravenous pentamidine was effective 44 percent of the time in curing cases of PCP in people who’d failed their first treatment. However, the cure rate was far higher (73 percent) in people who took clindamycin and primaquine, which are also less likely to cause serious side effects than pentamidine.

Benfield’s group recommends that clindamycin-primaquine now be used as second-line treatment in people with PCP who fail on TMP-SMX, or who cannot tolerate TMP-SMX.

http://www.AIDSmeds.com

Scientists Test Device to Track Medication Adherence in Patients with HIV/AIDS

April 21, 2008

Gainesville, Florida - Most of us have missed a dose of antibiotic or forgotten to take a daily vitamin. But when the stakes are higher — as they are for people with HIV/AIDS — a skipped pill could mean the difference between health and hazard for the entire population.

Now, a breath monitoring device developed by scientists at the University of Florida and Xhale Inc. could help prevent the emergence of drug-resistant strains of HIV by monitoring medication adherence in high-risk individuals.

"For HIV, it’s been shown that if you don’t take a very high percentage of your medication, you may as well not take medication at all," said Richard Melker, M.D., a professor of anesthesiology at the UF College of Medicine and chief technology officer for Xhale.

Patients who take some but not all of their medication increase the likelihood the virus will mutate into a deadlier, drug-resistant form. Experts have tried literally hundreds, if not thousands, of ways to monitor drug adherence, ranging from daily log books to blister packs that record the time each pill is dispensed. Despite the money, time and effort devoted to these methods, Melker said only one works well: directly observed therapy, or DOT.

"If you have a disease that is deemed to be a public health risk, authorities can put you into a program where you have to come to the clinic every day and be observed putting the pill into your mouth and swallowing it," Melker said.

But that process is inconvenient for patients, as well as for clinic personnel who have to track them down when they fail to show up. A breath-monitoring device developed by UF scientists and Xhale could change that, allowing patients to participate in a type of virtual DOT from home.

"The machine sits in your home and when it’s time for you to take your medication, it makes a beeping noise. If you don’t hit a button after about five minutes, it’s going to beep louder and louder until you come," Melker said. "If you don’t come after a certain amount of time, the machine can call the clinical trial coordinator and indicate that subject or patient didn’t take the medication as prescribed."

The device, which is slightly smaller than a shoebox, records the results of each breath test, allowing patients to bring a memory card or USB key to the clinic once a month and receive a printout of their results. Eventually, the researchers hope to reduce the size of their detection device to fit inside a cell phone. But for now, they’re satisfied that the technology works.

"The doctor can see how often you took it and exactly what time. If it made the patient really sick or dizzy and they didn’t take it, they can find out why," Melker said. "It’s not just a question of did I or didn’t I take it, but when you took it or why you didn’t take it."

The researchers developed the adherence monitor by incorporating minute amounts of an alcohol into a gel capsule. The additive, called 2-butanol, is one of many GRAS — Generally Recognized as Safe — compounds approved by the Food and Drug Administration for use in foods.

"We wanted (patients) to swallow a chemical and have it transform into something else that’s easy to monitor," said Matthew Booth, Ph.D., an assistant professor of anesthesiology at the UF College of Medicine and an investigator in the study. "When it hits the stomach lining and liver, an enzyme converts the alcohol to a gas that can be measured in the breath."

To determine how well the byproduct could be detected, six healthy volunteers swallowed empty pills in which the capsules contained trace amounts of 2-butanol. After five to 10 minutes, the scientists could measure the volatile byproduct in the volunteers’ breath using a small detector. The scientists say their device could also be used to monitor medication adherence in patients with other communicable diseases, such as tuberculosis.

"It is encouraging that the biological and chemical elements of the adherence system work as predicted. We were able to conclusively show who swallowed the capsules containing the 2-butanol. With further optimization, we are optimistic the device will perform very well," said Donn Dennis, M.D., the Joachim S. Gravenstein professor of anesthesiology at the UF College of Medicine and an investigator in the study.

The researchers say the device may prove equally helpful for monitoring adherence in clinical trials.

"If you enroll HIV/AIDS patients in a clinical trial and they don’t take the medication, then you may not get adequate proof that the drug is effective," Melker said. "It might be effective, but some of the patients aren’t taking it."

Phase 2 trials are often conducted in the community, rather than at research institutions, making it difficult for researchers to monitor adherence. As a result, many trials enroll a larger group of subjects than needed, in hopes they’ll obtain enough data to determine the safety and efficacy of the medication.

"If we had a good way of doing DOT that’s realistic, instead of having someone come to your house or you going to clinic every day of your life, then we would know whether these people stopped taking their medication and why. Right now, nobody knows any of that." Melker said. "The implications of being able to understand what normal human behavior is in a clinical trial and, of course, in the real world, are huge."

By Ann Griswold, http://www.eurekalert.org

Stanford Researchers Synthesize Compound to Flush HIV Out Of Hiding and Into Crosshairs

May 1, 2008

Any hunter will tell you that when your quarry goes into hiding, you have to flush it out to get a good shot at it. Such is the case with HIV, the virus that causes AIDS.

Though antiretroviral "cocktails" can target an active infection, they cannot get at the virus when it retreats inside the host's T cells, where it may lie dormant for decades, waiting for an opportunity to burst forth in a fresh round of infection. What HIV hunters need is a good bird dog.

Now, Stanford chemist Paul Wender and his coworkers have found a way to synthesize better bird dogs, agents that can be tailored to flush HIV out into the open where the immune system and antiretroviral therapies can destroy it. Wender is senior author of a paper about the research in the May 2 issue of Science.

"We're not sure how far this will go, but certainly, from a theoretical point of view, it has promise of taking therapy to the next level—that is, addressing issues related to eradication of the disease, of the virus, at least," said Wender, the Francis W. Bergstrom Professor.

Wender and his co-workers Jung-Min Kee and Jeff Warrington have developed a way to synthesize prostratin and DPP, two compounds that occur naturally in plants, in the laboratory. Prostratin, found in the Mamala plant (Homalanthus nutans) that grows in the Samoan rainforest, has shown promise in previous studies as an activator of dormant HIV. DPP, a molecular relative of prostratin found in resin spurge (Euphorbia resinifera), which grows in arid regions, also has shown potential.

Research has been hampered, though, because the compounds are difficult to obtain, particularly in the quantities needed for practical lab work on their mode of action and therapeutic potential. The yield from both plants is low and highly variable; the availability of the plants is limited; and isolating the compound is difficult. Heavy harvesting of the wild plants, especially in Samoa, also could cause ecological damage.

But synthetic prostratin and DPP, which now can be readily made in the lab, changes that equation.

"We have now minimized, if not eliminated, the issue of availability of prostratin and DPP," Wender said. "But equally, if not more importantly, we have opened access to other compounds that might be similar in structure but superior in function."

Previous work done in mice by researchers at the University of California-Los Angeles indicates that prostratin, used in combination with interleukin-7, an immune system stimulator made in bone marrow, managed to flush out and eliminate approximately 80 percent of the dormant virus. But with HIV, 80-percent efficiency is not enough. Anything less than 100 percent means the virus is still lurking in the T-cells and will spring back to action as soon as an opportunity presents itself.

"Nature has produced these compounds for various reasons in the plants from which they're derived, but certainly not to treat human maladies," Wender said. "They're not optimized for human therapy."

But with synthetic prostratin and DPP available, researchers can take the basic compounds and tinker with the structure and related function. "We could find out how to improve them by reverse engineering: figuring out what is important and what isn't important," Wender said. "We could begin to design and synthesize molecules that would never be found in nature but might actually be therapeutically more beneficial than what has been found thus far."

In the Science paper, Wender and his team detail how both compounds can be synthesized, but also show the initial phase of designing and making new derivative compounds.

Although prostratin has long been used by traditional Samoan healers without their patients experiencing acute side effects, it is possible that undesirable effects could show up in an immune-impaired patient taking prostratin or DPP. But Wender noted that engineering the compounds in a lab would permit scientists to circumvent these problems. "Usually these kinds of side effects are a result of a drug hitting multiple targets. So it hits one target, which is beneficial, but then it hits some other target, too," he said. "But by modifying the structures, you could select for the beneficial activity over the non-beneficial activity."

"It's a little bit like draw poker," Wender said. "The important point is that we're not forced to use the hand we get. We'll get a hand and we'll return a few cards if we don't like it, because we can keep on tuning this until we get it right, so that a royal flush, hopefully, can be realized."

Wender's team developed their method of synthesizing prostratin and DPP by using a renewable resource, croton oil, made from the seeds of a small tree (Croton tiglium) cultivated in Asia. They derived phorbol from the croton oil and then converted it into the structure of prostratin.

The conversion process required some engineering finesse; they had to overcome a hurdle when, by removing an oxygen atom, they triggered a series of anticipated but seemingly undesired changes.

"To the credit of my coworkers, Jung-Min Kee and Jeff Warrington, they employed a strategy that sometimes is missed," Wender said. "Rather than fighting the flow, they went with it." They found a way to redirect the chemical complications into a solution to the problem that proved even better than the route they had initially sought to follow.

"Eventually they produced a shorter, more economical way of connecting our starting material, phorbol, to our target, prostratin," Wender said. The process Kee and Warrington came up with requires only five steps, which is of tremendous importance in making it economically feasible. As Wender pointed out, "steps cost money and human time."

Wender emphasized that the work of his team is the most recent chapter in efforts of a truly global community, starting with the Samoan healers, who willingly shared their knowledge with Paul Cox, an ethnobotanist who saw them prescribing a tea made from Mamala bark for patients with hepatitis-like symptoms. Cox, in turn, sent samples to the National Institutes of Health, in hopes that the bark might have antiviral properties useful in fighting some cancers. Researchers at NIH then analyzed the bark and isolated prostratin.

Prostratin belongs to a class of compounds called tiglianes, many of which promote tumor growth, so it had no initially perceived use in fighting cancer. But NIH researchers found that prostratin was not a tumor promoter and checked to see if perhaps it could help combat HIV, which is when its remarkable ability to flush out the dormant virus was discovered. Significantly, prostratin has also been found to block uptake of the purged virus, offering yet another potentially therapeutic benefit.

"The whole effort is a testimonial to a global community working to deal with what I think is a global, and top priority, problem," Wender said.

The research was funded by the National Institutes of Health. At the time of the study, Kee was a doctoral candidate in chemistry and Warrington was a postdoctoral scholar at Stanford. Kee is now a postdoctoral scholar at Rockefeller University, and Warrington is working in the biotech industry.

The Joint United Nations Programme on HIV/AIDS estimates that 33.2 million people were living with HIV and 2.1 million people lost their lives to AIDS in 2007. Current antiviral therapies require lifelong treatment, and patients must consistently take doses of medication on a precise schedule, which creates compliance challenges for many of them. The antiviral drugs often become ineffective as the virus develops resistance and are exceptionally costly, the last a major problem in less-developed regions of the globe.

By Louis Bergeron, http://news-service.stanford.edu

mtvU, Kaiser Family Foundation, POZ Magazine Launch Online Game To Confront HIV/AIDS-Related Stereotypes

May 2, 2008

mtvU, MTV's college network, and the Kaiser Family Foundation, in partnership with POZ Magazine, on Wednesday unveiled "Pos or Not (http://posornot.com)," an online game that aims to confront HIV/AIDS stereotypes and overcome obstacles that prevent people from talking openly about the disease, Reuters reports (Reuters, 4/30). In the game, which also seeks to break down barriers that keep people from getting tested for HIV and using protection, players must decide whether a profiled participant is HIV-positive or negative based on a photo and a few personal details. HIV-positive participants share when they first learned their HIV status, and HIV-negative participants talk about how they have been affected by the disease. The game also provides information about HIV prevention, as well as local HIV and sexually transmitted infection resources from CDC (Kaiser Family Foundation release, 4/30).

The "Pos or Not" campaign, which was inspired by a nationwide competition asking college students to create a web-based game on the topic, is supported by several celebrities, including Wyclef Jean, Fall Out Boy, Will.i.am, Alyssa Milano, Say Anything, Perez Hilton, Angels & Airwaves, Atmosphere, The Spill Canvas, 30 Seconds to Mars, Aesop Rock, Motion City Soundtrack, All Time Low and Rise Against (Reuters, 4/30). Representatives from mtvU and the Kaiser Family Foundation will be presenting "Pos or Not" at the fourth annual Games for Health Conference on May 8-9 in Baltimore (Kaiser Family Foundation release, 4/30).

Advisory Board Company and Kaiser Family Foundation, http://www.medicalnewstoday.com

Cognitive Therapy Can Reduce Risky Sex Amongst Gay Men With Compulsive Sexual Behaviour

May 2, 2008

A single session of focused cognitive counselling may be able to reduce rates of unprotected sex amongst gay men with compulsive sexual behaviour, according to a study published in the May 1st edition of the Journal of Acquired Immune Deficiency Syndromes.

Sexually compulsive behaviour is a term used to describe out of control sexual behaviour which has become preoccupying and interferes with relationships or work. Compulsive sexual behaviour has been associated with a high risk of infection with HIV.

Treatment for gay men with compulsive sexual behaviour consists of group psychotherapy or the use of SSRI antidepressants.

In a study involving 336 individuals, investigators in San Francisco recently demonstrated that a single session of cognitive therapy can produce a swift and sustained reduction in HIV risk behaviour amongst gay men who have multiple HIV tests. They wished to see if this therapy helped rates of unprotected sex with casual partners that potentially involved a risk of HIV transmission amongst men with compulsive sexual behaviour.

The therapy involves an individual providing a detailed account of a recent episode of unprotected anal sex with a casual partner who was either HIV-positive or of unknown HIV infection status. During this they examined the thoughts, attitudes and beliefs involved in the decision to engage in unprotected sex.

Sex compulsion was assessed using the Kalichman Sexual Compulsivity Scale. This has ten items and is on a four-point scale. Individuals’ sexual compulsivity is classified from low to high in quartiles. A score above 2.2 is in the highest quartile and is classified as highly sexually compulsive. The men were followed up twelve months later.

Men with the least compulsive sexual behaviour has a 16% (p = 0.06) reduction in their risky sexual behaviour after the single cognitive counselling session. But men in the next two quartiles showed a 20% and 6% increase (both p = 0.06) increase in reported unprotected anal sex with men who were HIV-positive or of unknown infection status. The authors do not comment on this trend.

Men with the most compulsive behaviour, however, had a 48% (p = 0.06) reduction in the rate of reported unprotected sex with men who were HIV-positive or of unknown HIV status.

The investigators write, "this decrease in unprotected anal intercourse, although not at the traditional level of statistical significance, still raises the possibility that this cognitively based counseling approach may have been of use to the men rated as the most sexually compulsive in gaining some control over their sexual impulses…this preliminary finding suggests that further research in this area is warranted."

Reference
Dilley JW et al. Sexual compulsiveness and change in unprotected anal intercourse. Unexpected results from a randomized controlled HIV counseling intervention study. J Acquir Immune Defic Syndr 48: 113 – 114, 2008.

By Michael Carter, www.aidsmap.com

BHIVA: British HIV Association Conference

1. Current Tests May Miss a Third of HIV Resistance in Treatment-Naive

April 29, 2008

Standard HIV drug resistance tests may fail to detect HIV drug resistance in more than one-third of newly diagnosed patients, the 14th British HIV Association Conference heard last week. This is important clinically because if no more 0.4% of a person’s viral population is drug-resistant, this can triple the risk of treatment failure, the conference was told. Standard resistance tests can only detect resistance if 10-20% of a person’s viral population is drug-resistant.

Dr Jeffrey Johnson of the US Centers for Disease Control retested 205 samples of what was thought to be wild-type, non-resistant HIV from a group of people newly diagnosed with HIV between 2003 and 2005 in Los Angeles and Chicago, using hypersensitive resistance tests that could pick up resistant virus that comprised as little as 0.1% of the viral population.

The group was a very mixed population of newly-diagnosed people, with roughly a third each being white, Latino and black. Two-thirds were gay men, one in five were injecting drug users, and in the other 15% the HIV exposure risk was heterosexual sex.

The hypersensitive test found that 34 out of the 205 (17%) actually had resistance mutations. This would increase the proportion of people with transmitted drug resistance amongst the cohort from which the samples were drawn from the 20% picked up by standard tests to 33%.

In a similar retesting of 303 samples from people diagnosed between 1998 and 2005 who were already known to have at least one drug resistance mutation, hypersensitivity testing similarly increased the number of resistance mutations found by 60%.

The proportions of people with certain individual mutations were considerably elevated by hypersensitive resistance testing. This is because some mutations affect viral replication capacity more than others, so that resistance mutations that result in very unfit virus may exist at very low levels in people with them – until selective drug pressure brings them out.

For instance, while hypersensitive testing only found an additional 5% of people with the K103N NNRTI resistance mutation (which is known not to affect viral fitness), it doubled the number found to have the Y181C NNRTI mutation and more than quadrupled the number found to have the T215F thymidine analogue NRTI resistance mutation that (in conjunction with other mutations) confers resistance to AZT and d4T and to a lesser extent to most other nucleoside drugs.

It also picked up 20% more of the similar T215Y mutation, 23% more of the 3TC/FTC M184V mutation, 25% more of the L90M protease inhibitor resistance mutation, and 60% and 70% more of the other thymidine analogue resistance mutations M41L and K70R.

Using hypersensitive tests meant that 21 people out of the 303 (7%) were classified as resistant to a whole new class of drugs. Johnson commented that hypersensitive testing showed that in this population, 20-27% of patients with primary HIV resistance had multi-drug-resistant virus.

Did this matter clinically? Johnson asked. The answer was yes, most certainly; low-frequency resistance might be responsible for a high proportion of unexplained drug failures.

Johnson’s team re-tested patients participating in GSK-sponsored clinical trials of efavirenz, 3TC, abacavir and AZT. Samples were re-tested for low-frequency resistance to NNRTIs (K103N and Y181C) and to 3TC (M184V). Nine people out of 221 trial participants previously thought to have wild-type virus were found to have drug resistance. Of these, seven (78%) had experienced virological failure.

In another analysis of a sample of patients who had virologically failed treatment in drug trials with what appeared to be wild-type virus, ten per cent turned out to have the K103N NNRTI mutation at low frequency.

These studies allowed Johnson to calculate that all people with low-frequency mutations had eleven times the risk of virological failure compared with people with genuine wild-type virus. In people with K103N, if more than 0.9% of the viral population had the mutation, the risk of treatment failure was multiplied more than eight times; people with more than 0.4% resistant virus had three times the risk of failure; while people with more than 0.1% resistant virus had a 50% greater risk of failure.

Johnson pointed out that his were not the first studies to find that minority resistance was associated with failure. A previous study his team had conducted in 2005 had revealed that an additional 20% of women who had received single-dose nevirapine for the prevention of mother-to-child transmission turned out have resistance to the drug, in addition to the 40% picked up by standard resistance tests.

Similarly, Prof. John Mellors of Pittsburgh University had found, on retesting patients who had failed on efavirenz with apparently wild-type virus, that eight out of 12 patients in fact had minority resistance mutations, while Simen and Kozal, using a so called "ultra-deep-sequencing" technique, had found in a similar group of naïve patients that detecting patients with one to five per cent minority resistance variants doubled the total number with resistance to 25%, and that all patients with NNRTI resistance, whether majority or minority, experienced failure to this class of drugs.

A related question is whether standard tests can pick up resistance at lower viral loads than the ones they are designed for. If they could, this would be of considerable benefit, as one of the reasons doctors fail to order resistance tests for patients before switching them to other regimens is because of the time-lag necessary in waiting for a failing patient’s viral load to reach levels that can be resistance-tested (usually 1,000-2,000 copies/ml).

A survey of eight laboratories in the UK that do resistance testing found that seven regularly accepted requests for testing on samples with viral loads lower than 1,000 copies/ml, while two labs said they accepted requests for tests on ‘undetectable’ samples (viral load under 50 copies/ml).

Results at lower viral loads were highly variable. While labs were able to sequence (achieve a valid result) for 60-100% of samples with viral loads between 1,000 and 2,000 copies/ml, the success rate for viral loads between 50 and 100 copies/ml varied between zero and two-thirds.

Labs varied in the sensitivity and specificity of their techniques in a consistent way; the lab that was least sensitive at viral loads of over 1,000 copies/ml, with a 60% success rate where others claimed success in sequencing in between 80% and 100% of cases, was also the one that scored zero on attempts to sequence samples with viral loads between 50 and 100 copies/ml.

Conversely, the lab that scored 100% for samples with viral loads between 1,000 and 2,000 copies/ml also managed to sequence two-thirds of samples with viral loads between 50 and 100 copies/ml and even managed to sequence 38% of samples with viral loads under 50 copies/ml.

However the more sensitive techniques it was using paid the price with a lack of specificity, and this lab commented that the gene sequences it did obtain could have been picking up proviral DNA released from the nuclei of quiescent cells – which might give an inaccurate result as this may not represent the variant of HIV that is currently responsible for producing active virus.

This is the reason hypersensitive resistance tests are not carried out routinely; there is too much risk of contamination and false-positive results unless extraordinary care and therefore expense is taken to avoid it.

The researchers comment: "In conclusion, it is technically possible to carry out resistance testing at a viral load lower than currently recommended, though such tests require the most stringent quality control."

References
Johnson J. The impact of Low-frequency drug-resistant variants on antiretroviral treatment responses. Plenary session, 14th BHIVA Conference, Belfast. 2008.

Johnson J et al. Resistance emerges in the majority of women provided intrapartum single-dose nevirapine. Twelfth Conference on Retroviruses and Opportunistic Infections, Boston, abstract 100, 2005.

Mellors J et al. Low frequency NNRTI-resistant variants contribute to failure of efavirenz-containing regimens. Eleventh CROI, San Francisco, abstract 36. 2004.

Simen BB et al. Prevalence of low abundance drug-resistant variants by ultra-deep sequencing in chronically HIV-infected antiretroviral (ARV)-naive patients and the impact on virologic outcome. 16th Intl HIV Drug Resistance Workshop, Barbados. Abstract 134. 2007

Cane P et al. Genotypic antiretroviral drug resistance testing at low plasma HIV-1 RNA loads in the UK. Fourteenth BHIVA Conference, Belfast. Abstract P96. 2008.

By Gus Cairns, www.aidsmap.com


2. No Evidence of a Hepatitis C Epidemic in HIV Negative Gay Men

April 28, 2008

Data from attendees at a London GUM clinic presented at the 14th BHIVA Conference on Friday suggest that there is no increase in hepatitis C infections amongst HIV negative gay men. The study found that the likelihood of being newly diagnosed with hepatitis C was not significantly greater in gay men than it was in heterosexual men, and hepatitis C infection was much more strongly associated with having HIV than it was with sexual orientation.

Dr Jo Turner told the conference that the University College Hospital (UCH) Centre for Sexual Health, wishing to establish if the apparent rise in hepatitis C infections in positive gay men was matched by a similar rise in HIV negative men, had decided to offer hepatitis C tests to all men attending the GUM clinic for STI checkups between March 2007 and March 2008.

Over the year 10,204 men attended the GUM clinic and 4,554 (44%) accepted the offer of a hepatitis C test. Dr Turner was reporting on 4,472 valid results. The men who accepted the offer of a hepatitis C test were more likely to be gay (58% of those accepting a test, 48% of those turning one down), less likely to be African or Caribbean (8.7% of those accepting, 13.3% of those not accepting) and more likely to be injecting drug users (2.4% of those accepting, 1.0% of those refusing).

The average age of all the men was 34. Seventy-one per cent were of white ethnicity, about 8% black, 6% Asian and the rest other/mixed. Nearly a quarter (1032 or 23%) were HIV positive, 3122 HIV negative at their last test, and 318 did not know their HIV status at the time they were tested for hepatitis C. One hundred and eight (2.5%) were or had been injecting drug users and another 77 (1.7%) were both gay and injecting drug users. Acute STIs were diagnosed in 775 men (17.3%).

Hepatitis C testing was conducted by antibody-testing pools of twelve blood samples. If the pool tested positive, sub-pools of four were tested and these tested individually if the sub-pool tested positive. Individual samples that tested HCV antibody positive were also tested for hepatitis C RNA (viral load).

So far one hundred and fourteen hepatitis C infections (2.55%) have been confirmed in the group. Of these 97 were already known and 17 were newly diagnosed infections.

The hepatitis C rate in HIV positive men was 9.3% (82 infections), and was no different in gay men (9.25%) than in all men. Similarly the rate in HIV negative men, 0.51% (16 infections), was no different in HIV negative gay men (0.49%). There was one infection in a heterosexual man of unknown HIV status.

The 17 newly diagnosed infections comprised ten infections that appeared to be chronic, three where people tested antibody positive but had cleared the HCV virus, and four that appeared to be incident (recent). Of the ten new diagnoses of chronic infections, six were in HIV positive men, three of whom were injecting drug users. Two were in HIV negative gay men, one in an HIV negative drug user, and one in a man without any hepatitis C or HIV risk factors.

Three of the four incident infections were in HIV positive men. The one in an HIV negative man was interesting; he was a gay man with an HIV positive partner and his sexual risk behaviour commented Dr Turner, suggested that he was at high risk of both HIV and hepatitis C. However he had told the staff he was taking anti-HIV drugs as pre-exposure prophylaxis to prevent infection by his partner. Dr Turner told the conference that, independently of the study, liver function testing had revealed another five incident hepatitis C infections in untested male clinic attendees during the same period.

If injecting drug users were excluded, the hepatitis C rate was 2.9% in gay men and 0.4% in heterosexuals, but the difference was solely due to the fact that more of the gay men had HIV. The hepatitis C rate was 7.5% and 6.5% respectively in HIV positive gay and heterosexual men, and 0.4% and 0.2% in HIV negative gay and heterosexual men; neither of these differences was statistically significant.

Dr Turner concluded that there was no evidence of an increased risk of hepatitis C infection in HIV negative gay men.

Asked to comment on the source of hepatitis C infections in HIV positive men, given that rates in non-drug using men were the same regardless of sexual orientation, Dr Turner said analysis of behavioural risks were ongoing but speculated that infections might be due to non-sexual exposures such as undisclosed needle use.

Reference
Turner J et al. Is there an unrecognised epidemic of hepatitis C infection in men who have sex with men? Fourteenth British HIV Association Conference, Belfast. Abstract O22. 2008.

By Gus Cairns, www.aidsmap.com


3. Most Older People with HIV in UK Diagnosed Recently

April 30, 2008

The majority of people over 50 living with HIV in the UK have been diagnosed in the last decade, a study finds, rather than being long-term survivors.

However the study also found that people over 50 had, on average, considerably lower CD4 counts when they were diagnosed. While CD4 counts can decline with age, this finding suggests that a higher proportion of the older diagnosed could be late presenters who have lived with HIV unaware for years.

The study was conducted by Professor Jonathan Elford and his team from City University in London. They conducted a questionnaire study between June 2004 and June 2005 examining the clinical, social and behavioural characteristics of patients attending six HIV outpatient clinics in east London ranging from Bart’s Hospital in the City of London out to Barking.

Nearly 2,300 patients were eligible to complete the questionnaire, of whom just under 1,700 agreed to participate, resulting in a response rate of 73% of eligible patients or 63% of all patients attending the clinic. Of responders 1,462 (87%) were either gay/bisexual men (758 in total, of whom 15% were of ethnic minority origin) or heterosexuals of African origin (704, of whom 68% were women), and the figures for the rest of the survey concentrate on these groups.

Overall, 10.9% of the group were 50 years old or more (184 respondents) and a quarter of these (2.6% of the whole group) were over sixty. Another 40 per cent were over 40.

There were significant differences in age distribution between the gay men and the Africans, as might perhaps be expected. Fourteen per cent of the gay men were over 50 compared with about 7.5% of the Africans, with the African men and women having more or less the same average age. However the ethnic minority gay men were younger, with only 6% of this group over 50.

At least three-quarters of people over 50 had been diagnosed with HIV in the last decade. The researchers did not ask each participant how long they’d been diagnosed but instead how old they were when they were diagnosed. Forty per cent were already over 50 at the age of diagnosis and another 44% were over 40. A few of these would be people now in their 60s and 70s who had lived a long time with HIV but a quick calculation shows that between 74% and 84% of the over-50s have been diagnosed since combination therapy became available.

Were they also infected recently? The group would include both people who had acquired HIV in their 50s and late presenters, pointed out Elford, and there was some evidence of late presentation. People diagnosed when they were over 50 had had a baseline CD4 count of 170 cells/mm3 at diagnosis compared with 200 cells/mm3 for people diagnosed in their 40s, 231 for people in their 30s and 374 for people in their 20s. This could be due to the immunological effects of age but is more likely to be explained by a higher likelihood of late diagnosis in the over-50s.

However a large proportion of the group will be people who lived until late middle age before acquiring HIV.

"These are people who managed to avoid HIV for years and then acquired it," commented Elford. "Did something in their behaviour change? If so, it suggests that HIV testing among those at risk of HIV in the UK should target people in their 40s and 50s as well as younger people.

"The diversity of older people living with HIV will present a continuing challenge for HIV treatment and care among this group in the UK," he concluded.

Reference
Elford J et al. HIV and aging. Fourteenth BHIVA Conference, Belfast: abstract O19. 2008.

By Gus Cairns, www.aidsmap.com


4. Concerns over Confidentiality, Drug Interactions, Communication, Barriers to Integrating GPs into HIV Care

May 2, 2008

Patients' and GPs' worries about confidentiality, drug-drug interactions, and poor communication between primary and secondary care continue to be barriers to the integration of general practices into the care and management of HIV-positive individuals, the 14th Annual Conference of the British HIV Association (BHIVA) heard last week.

Of concern is that this study – based on two surveys of more than 220 patients and 174 GPs in Brighton – comes from the UK city that is a shining example of best practice when it comes to HIV education for GPs and extra funding. Since 2005, Brighton’s HIV clinic has been running an interactive two-day HIV-ED course for interested GPs and their practice nurses. In addition, the local Primary Care Trust funds locally enhanced services for HIV. Both are a rarity in the UK.

Historical Barriers to Integration

Standards of care documents from MedFASH and BHIVA both recommend that some aspects of HIV management should take place within primary care. However, for a variety of reasons, historically there has been reluctance from both GPs and patients, noted Michelle Kennedy of Brighton and Sussex Medical School, presenting.

In order to better understand barriers to the integration of GPs into HIV-positive patient care, investigators at Brighton’s HIV clinic developed two questionnaire-based studies – one for GPs and one for patients – utilising a series of statements exploring various concerns.

The questionnaire was offered to all patients attending Brighton’s HIV outpatient clinic between March and May 2007, and posted to all GPs in the city of Brighton & Hove during the same period.

Of 475 HIV-positive individuals invited to take part, 222 filled in a questionnaire (resulting in a 47% response rate). The majority were white gay men, consistent with Brighton’s demographics.

Plurality of Concerns

The investigators were surprised to find that 207 (93%) had, in fact, registered with a GP and of those, 174 (84%) had disclosed their HIV status to their GP, somewhat higher than in pre-HAART UK studies.

Of 174 GPs in Brighton & Hove, 124 (71%) completed a questionnaire. Of those 109 (88%) had treated five or more HIV-positive patients and 76 (61%) had attended the HIV-ED course.

More than a third of patients felt that their GP lacked sufficient HIV knowledge (38%) and experience (36%) and a sizeable proportion of GPs agreed that they did not have enough experience (44%), although fewer had concerns over their knowledge of HIV (27%).

The investigators were surprised that 50% of patients were not worried about the confidentiality of GP practices, even though 94% of GPs felt that they could maintain the confidentiality of the HIV-positive patients in their practice. However, they noted, "this still leaves half the patients in our study who, for some reason or another, had still not received this message and still see confidentiality as an important barrier."

Despite a recent study from London finding HIV-associated discrimination amongst GPs, a negative attitude from the GP (in terms of judging a patient’s lifestyle) was neither perceived (18%) nor expressed (4%) by a majority of patients or GPs in both studies.

GPs Worried About Cost, Drugs, Interactions and Poor Communication

However, there were an additional three areas of concern for GPs (these questions were not asked of patients).

Despite locally enhanced services being available in Brighton & Hove (which pay GPs extra money for looking after HIV-positive patients), 59% of GPs cited cost as an important barrier.

In addition, 79% of GPs felt unsure about current antiretrovirals, including interactions and side-effects. "We felt this was a little worrying," said the investigators, "as a third of GPs also felt that communication with secondary care was currently inadequate."

In fact, another study presented to the conference as a poster, from London’s Royal Free Hospital, highlights the issue of poor communication and drug interactions when HIV-positive patients on protease inhibitor-based therapy are prescribed statins via their GP.

A retrospective case notes review enhanced by patient interview in the first half of 2007 found that, of the 95 patients receiving a statin during this period, 26 (16 on atorvastatin; 10 on pravastatin; 14 on PI-based ART) had their lipid-lowering prescriptions transferred to a GP, primarily via a letter. However, only 5% of letters highlighted that co-administration of simvastatin and PIs is contraindicated.

Following this transfer of care, only 14 of the 26 patients (52%) continued on the same statin; a quarter discontinued the statin due to non-attendance at primary care; one patient refused to pay NHS prescription charges and returned to the HIV clinic; and in 19%, the GP initiated simvastatin, including in two patients who were taking PI-based ART.

The investigators recommend that communication with GPs must specifically state relevant contraindications and stress that close follow-up is essential. Alternatively, they suggest that ongoing statin prescribing should remain a responsibility of HIV practitioners.

Disclosure and GP Training Reap Rewards

When the Brighton investigators compared the patients who had not disclosed their HIV status to their GPs with patients who had, they found that every barrier listed (GP knowledge, GP experience, confidentiality concerns, GP attitude, and patient preference) was perceived by the majority of patients who had not disclosed their HIV status.

Unsurprisingly, all of these barriers were significantly less likely to be perceived if the patient had disclosed their HIV status compared to patients who had not.

The investigators also compared GPs who had attended HIV-ED training courses with those who had not and found that trained GPs were significantly more comfortable with their HIV knowledge and experience and felt up to date with current ART (around 70% of those trained versus half of those not trained).

Similar results were found when GPs who had treated ten or more HIV-positive patients were compared to GPs who had treated fewer than ten HIV-positive patients.

Better communication, training and experience are key
"From the patient’s perspective," noted Michelle Kennedy, "it seems that contact with primary care practice has lessened many of the historically-conceived barriers, and this may be due to changed policies within practices."

From the GP perspective, she stressed that "the key is training and experience." Although the investigators identified drug knowledge and cost as important barriers, they think that this may be due to GPs’ erroneous concerns about prescribing anti-HIV treatment through primary care in the future, which is not being recommended by either MedFASH or BHIVA.

She concluded with several recommendations.

• HIV-positive patients should be encouraged to register and disclose to GPs.

• HIV specialists should reassure patients and dispel myths that are preventing them from accessing primary healthcare services.

• More prominent and visible confidentiality agreements should be displayed in GP's practices.

• Improvement in communication between primary and secondary care is needed, and this may be through improved correspondence from specialists to GPs.

• Rather than expect all GPs to have HIV-positive patients, "perhaps a better approach might be to encourage interested GPs to have regular training".