ALDA Provides Update on Ottawa HIV Conference

February 12, 2008

Vancouver -- Representatives of ALDA Pharmaceuticals Corp. (TSX VENTURE:APH) ("ALDA") attended the 4th Canadian Microbicides Symposium held in Ottawa on January 28, 2008. A round table discussion on the current status of microbicide research revealed that no microbicidal products available to date have proven to be effective against the spread of HIV and AIDS, a conclusion that is supported by statements from the World Health Organization.

After participating in the symposium, the ALDA team met with Senator Celine Hervieux-Payette and the Hon. Robert Thibault, Member of Parliament. In these meetings, discussions took place about Canada's position domestically and on the global stage of HIV and AIDS prevention and how ALDA might contribute to this effort. A meeting was also held with Health Canada to determine the best path to follow to obtain regulatory approval of T³6® Microbicide.

By attending and participating in the symposium and the subsequent meetings, ALDA was provided an opportunity to introduce T³6® Microbicide to individuals and agencies in the federal government and the private sector that are active in the area of combating HIV and AIDS.

Dr. Terrance Owen, President & CEO, states, "Other organizations working in the field of HIV and AIDS prevention have discovered that the development of a successful microbicide is fraught with difficulties. Having knowledge of these complex issues, we have been cautious about straying from our focus on infection-control treatments to pursue the more complicated field of preventative microbicides. However, our attendance at the recent symposium in January and the personal meetings thereafter has convinced us that T³6® Microbicide is a promising candidate for further study in preventing the spread of HIV and AIDS. Dr. Brian Conway, who is a member of ALDA's Scientific Advisory Board and is also Co-Chair of The Ministerial Advisory Council on the Federal Initiative to Address HIV/AIDS in Canada has agreed to assist us with the design and completion of preliminary clinical trials."

About T³6® Microbicide Gel

T³6® Microbicide Gel is a personal lubricant that is designed to prevent the spread of HIV and other Sexually Transmitted Infections ("STI's"). It contains infection-control ingredients in relatively low concentrations that act synergistically to disrupt the physical structure of microbes rather than interfering with their metabolic pathways. The competitive advantage is its ability to kill STI-causing organisms while preventing microbial resistance, side effects or toxicity.

About ALDA Pharmaceuticals Corp.

ALDA is focused on the development of infection control therapeutics derived from its patent-pending T³6® technology. The company trades on the TSX Venture Exchange under the symbol APH.

ALDA Pharmaceuticals Corp., http://www.aldacorp.com/

‘Kenya Project’ Aims To Spread Awareness About HIV/AIDS In Western Kenya

February 12th, 2008

Vancouver - Looking for an African adventure this summer? That was what fifth-year UBC global resource systems major Jackie Siegel was looking for when he volunteered for the Kenya Project last year. Siegel traveled with other UBC students to Kanyawegi, a small village in Western Kenya, for eight weeks in the summer of 2007.

According to the Kenya Project’s website, “their main mandate was to bring HIV/AIDS education to areas of Kenya with a high prevalence rate of HIV infection, the belief being that knowledge was the first step to combating this pandemic.”

Siegel, who is also one of the project’s team leaders, recounted his reasons for getting involved in the ambitious endeavour. “The fact that it [the Kenya Project] was student-ran. It provided the opportunity to be involved in the decision making of the group.”

The Kenya Project was started in 2005 by a group of UBC students, who called themselves Global Students Initiative (GSI). In the summer of 2006 the first group of UBC student volunteers traveled to Kenya and were well received. The project’s early success led to the 2007 volunteers returning to the same village and taking on additional responsibilities such as ‘creating a community bank,’ and helping the villagers locate a ‘clean water source.’

Kanyawegi was chosen as the group’s destination because of the personal connection of former UBC master’s student and Kenya native John Agak. Agak teamed up with the GSI at the 2006 African Awareness Week. “I grew up in Kenya and moved to Canada. I lived the experience of the poverty, and the suffering, and the needs that people had there. I introduced the GSI to a number of ideas. It has been a very successful project so far,” he said.

One of the benefits of the project is the strong emphasis on accountability to donors. “People give money to causes and never see any feedback. We want to show them [our donors] positive feedback. We were able to come back from each of our trips with results to show our donors,” Agak added.

The Kenya Project’s current membership stands at twenty UBC students and alumni. “In 2005 everything just fell into place. We developed a curriculum for the project. It was just one of those things that happened. I have developed a passion for Kenya, and to try and help people,” Kenya Project chairperson and first-year UBC medical student Matthew Sibley told the Ubyssey. “I have grown up with a generation of people who have suffered no world wars, no famines, no depressions. Our generation is spoiled. I have this fortunate life, and others are on the other end of the spectrum,” he added.

With the recent upsurge of violence in Kenya, one has to wonder if the project will go ahead as planned. Siegel voiced his disappointment with the current state of affairs in Kenya. “Kenya had been doing so well as a country. It—the recent violence—is really sad news. It definitely has the potential to change the plans of the trip for this summer.”

Agak, however, voiced a different point of view. “The violence has been confined to the cities and towns. The violence has not spread to the villages yet, so the project is not really affected. Travel inside of Kenya could become a problem though.”

The group is hosting a fundraiser for the project on Thursday March 6th at Darby’s Pub with 100 per cent of proceeds going towards the initiative.

More information can be found at www.thekenyaproject.com

By Freeman Poritz, http://www.ubyssey.ca

B.C. To Enshrine Sustainability Clause in Provincial Health Law

February 13, 2007

The British Columbia government will make it mandatory for health care spending to remain sustainable with an amendment this year to provincial laws.

In what is believed to be a first in Canada, the changes to the province's Medicare Protection Act will define sustainability, as well as protect public funding of health care by enshrining the five principles of the federal Canada Health Act.

'Sustainability is about prevention … efficiency in the provision of health-care services.'— B.C. Health Minister George Abbott

Health Minister George Abbott said Wednesday the Liberal government will introduce the amendments as a means to ensure the future of B.C.'s health-care system.

"There will be some legislation [coming] forward and one of the pieces will be a definition of sustainability and the other five principles of the Canada Health Act," he said.

The five principles of the Canada Health Act are universality, comprehensiveness, accessibility, portability and public administration.

A health ministry official said the proposed amendments are bold steps and the addition of a sustainability clause is likely a first in Canada.

Abbott said the government signalled two years ago it wanted to include a sustainability clause in provincial health law.

The government's throne speech Tuesday, which highlights the government's political agenda for the coming months, mentioned amending the Medicare Protection Act to include sustainability.

Abbott said the sustainability clause is not an attempt by the government to get around the Canada Health Act or a way to increase private care in British Columbia.

'What that means is higher health-care premiums for people and less service.'— Opposition health critic Adrian Dix

"No, I don't think it's on anyone's mind, except possibly the NDP, that sustainability is about private care," he said.

"Sustainability is about prevention. It's about efficiency in the provision of health-care services. It's about extracting the maximum value from every taxpayer dollar we have.

"Most importantly, it's about ensuring that we have a system that will be there for our children and grandchildren," said Abbott.

Sustainability Means Rise In MSP Premiums: NDP

Opposition New Democrats health critic Adrian Dix said that when the Liberals mention sustainability, they're talking about increases in medical plan premiums and reducing the coverage of the Medical Services Plan system.

NDP health critic Adrian Dix said that when the Liberals mention sustainability, they're talking about increases in medical plan premiums and reducing the coverage of the Medical Services Plan system.

"What that means is higher health-care premiums for people and less service," he said. "That's what they mean when they say sustainability."

The Hospital Employees' Union said it sees British Columbia moving towards a market-based approach to health care.

British Columbians told the Liberal government during a year-long public consultation process that they wanted investment in public health programs that improve services and access for everybody, said union spokeswoman Judy Darcy.

"But instead, this government is essentially stamping a dollar sign on the head of every patient who walks into an ER and forcing hospitals into a wasteful competition with each other," Darcy said in a statement.

The Canadian Press, www.CBC.ca

Man Who Spread HIV Was In 'Extreme Denial,' Court Hears

February 13, 2008

A psychiatrist testified Wednesday that an Ontario man who knowingly spread HIV to women was in "extreme denial" about his illness until his trial last year, believing his diagnosis a decade earlier was a mistake.

The testimony came on the second day of a hearing to determine whether Carl Leone should be classified a dangerous offender, a status that would keep him behind bars indefinitely.

Leone, 31, of Windsor, Ont., pleaded guilty last April to aggravated assault after failing to notify 15 women that he had HIV, the virus that causes AIDS. Five of his victims contracted the virus as a result.

Dr. Paul Federoff, who was called as a defence witness, told the Windsor court that based on two meetings with Leone last month he found "evidence of extreme denial of the seriousness of the disease he had been diagnosed with."

"Mr. Leone's problem is not an overly high sex drive," said Fedoroff, who was called as a defence witness.

"His problem is one of not being aware of the nature of his [condition] and engaging in unsafe sexual activity."

Windsor Essex County Health Unit workers told Leone in 1997 that he was HIV-positive. He was arrested seven years later on June 6, 2004, for knowingly spreading the virus.

But Federoff testified that Leone came to the conclusion the test was a so-called false positive, or a mistake.

"He tells me that he has changed his opinion, he now believes he is HIV-positive and requires treatment," said Federoff, a psychiatrist at the Royal Ottawa Hospital.

He said that realization came to Leone during his trial, which ended abruptly last April when he pleaded guilty after the court heard several weeks of testimony.

But Crown prosecutors argued Wednesday that the guilty plea was a clear admission by Leone that he knowingly spread HIV.

"What lies at the foundation of all this was the fact that there was dishonesty, there was deceit," said prosecutor Frank Schwalm.

Schwalm cited an HIV pre-test counselling form dated March 3, 1997, as evidence that Leone suspected "something was wrong" back then.

"He suspected that he contracted, or was exposed to, some sort of sexually transmitted disease," said Schwalm.

But despite the diagnosis, Federoff testified that Leone didn't develop any symptoms and concluded the test must be wrong. To this day, Leone still doesn't show any symptoms of full-blown AIDS.

Federoff said his denial argument is bolstered by Leone's low scores on a psychopathy test, suggesting that perhaps he was not purposely out to harm others.

The Crown is seeking to have Leone declared a dangerous offender. As such, he could be jailed indefinitely with his detention subject to review after seven years and every two years following.

The judge could also sentence Leone as a long-term offender, which would see him placed under community supervision for up to 10 years after release from prison. He could also be handed a straight prison sentence.

On Monday, a court-ordered psychiatric assessment by forensic psychiatrist Dr. Paul Klassen portrayed Leone as exhibiting a "shocking lack of empathy" for the women.

But both psychiatrists came to the same conclusion that Leone should not be considered a dangerous offender since he presents a low to moderate risk of re-offending.

On Tuesday, the court heard victim impact statements from 13 of Leone's victims. The women detailed the severe depression, shame and suicidal thoughts they had after learning of Leone's actions.

Two other victims are scheduled to present their statements in person on Friday when the week-long hearing is expected to wrap up.

With files from Canadian Press, www.CBC.ca

A Different Kind Of Valentine's 'Call To Love'

Jamaican gay activist seeking refugee status in Canada urges leaders to renounce hate crimes

February 15, 2008

There are certainly more inviting places to spend Valentine's Day than in an old church in east-end Toronto.

Still, Metropolitan Community Church was a damn sight safer for Gareth Henry yesterday than where he spent the previous Feb. 14 - inside a drugstore in Kingston, Jamaica, as 250 people stood outside shouting anti-gay slurs and calling for him and three other men to be beaten.

Instead, Mr. Henry said, the police who were called to break up the mob wound up doing its dirty work.

"I was physically abused by four police officers," Mr. Henry, a 30-year-old Jamaican gay activist now seeking refugee status in Canada, said yesterday. "I was slapped in the face, beaten with guns and left on the floor of the pharmacy while they escorted the three guys out. Their thing was that I talked too much."

In Jamaica, where anal sex is still punishable by 10 years of hard labour, and some dancehall singers win fans by advocating violence against homosexuals, Mr. Henry was among a handful of souls audacious enough to demand the right to live in peace.

His own treatment, along with a string of gruesome killings and assaults on others, have since pushed him to the reluctant conclusion that a life in exile offers the best chance to make change - and to stay alive.

"It was a hard decision," Mr. Henry said of his move to Toronto late last month, where he promptly filed a refugee claim. But it was a choice between "a different environment that would allow some level of comfort and security, or staying there and constantly living in fear. At some point in time, you're going to get exhausted, because you're fighting a battle that seems impossible to win."

Mr. Henry opened a new front on the battle yesterday, with the high-profile help of Rev. Brent Hawkes, the Metropolitan Community Church pastor who was instrumental in winning key rights, including marriage, for gays and lesbians, and Helen Kennedy, long-time activist and head of Egale Canada, a gay-rights group.

Dubbing their Valentine's Day effort the "Call for Love," they held a news conference to urge political and religious leaders in and outside Jamaica to renounce hate crimes against homosexuals, which they said are too often exacerbated by an apathetic, and in some cases complicit, police force.

Later, they delivered a letter to the Jamaican consulate-general in Toronto, asking the Caribbean country's government to ensure police "uphold their sworn duty to equally protect and serve all Jamaican citizens." The consulate did not respond yesterday to a request for comment.

Mr. Henry said he'd wished for that kind of protection many times, as he saw friends and acquaintances attacked just for being themselves. As co-chair of J-FLAG, a gay-rights group, he offered support to the victims' friends and partners, and for his trouble, began to attract police attention himself.

In 2005, when a friend and HIV/AIDS activist named Steve Harvey was abducted and shot in the head, Mr. Henry went to identify the body.

"The police officers said, 'Why are you crying? You're gay, a man crying over another man,' " he recalled. "For my own safety, I had to leave the scene of the crime, and the next morning, there were police officers outside my apartment. I said, 'What crime have I committed?' "

In another case, in the north-coast resort city of Montego Bay in June of 2004, Mr. Henry and a few friends watched helplessly as three police officers roughed up Victor Jarrett, a man in his early 20s whom the officers had accused of looking at a teenage boy on the beach. When the officers were finished, a crowd that had formed chased Mr. Jarrett into the city.

"The five of us were standing there, hoping that he may be safe; that he would find somewhere to run to and somewhere to hide," Mr. Henry said. But, the next morning, the Western Mirror newspaper carried a front-page headline: "Alleged Gay Man Chopped To Death In MoBay."

"In the time that he needed us the most, it was the time we were actually turning our backs on him," Mr. Henry said, describing how he and his friends feared they would have met a similar fate had they intervened.

The case, documented by Human Rights Watch in a damning 2004 report titled "Hated to Death: Homophobia, Violence, and Jamaica's HIV/AIDS Epidemic," weighed heavily on Mr. Henry in the drugstore a year ago, as he watched a similar situation shaping up - with himself in Mr. Jarrett's place.

"What went through my head was, what happened to Victor 21/2 years ago, this is what is going to happen to me."

The police took Mr. Henry to a station away from the waiting mob and released him. He went into hiding shortly thereafter, moving from place to place in an effort to keep up his work with J-FLAG. But police, along with threats, continued to find their way to him.

"At this point in time, I need to take this break," Mr. Henry said, adding that his growing preoccupation with safety had overtaken his ability to do his work.

"I will not be there physically," he said, "but I will do what I can."

By Anthony Reinhart, Globe and Mail

Businesses 'Need to Act Now' To Prevent Spread of HIV/AIDS in Russian Workplaces, Opinion Piece Says

February 12, 2008

The "potential threat" that HIV/AIDS "poses to the strength of the private sector" in Russia is "not as high on the corporate agenda" as it "should be," Daniel Kashnitsky -- an associate at Transatlantic Partners Against AIDS and the Global Business Coalition on HIV/AIDS, Tuberculosis and Malaria -- writes in a Moscow Times opinion piece. Ignoring the spread of HIV/AIDS in Russia could "significantly hamper the ability of companies to effectively" compete in the global market, Kashnitsky writes, adding that corporations can "protect themselves" by incorporating HIV/AIDS education and prevention into workplace health care programs.

According to Kashnitsky, the number of Russian businesses with HIV/AIDS-related policies has nearly tripled since 2006. However, only 15% have launched HIV/AIDS prevention programs, and only 10% have implemented policies to protect the rights of HIV-positive employees, Kashnitsky notes. Many business executives in Russia have not yet experienced the "direct impact" of HIV/AIDS because most employees living with the virus have not developed AIDS-related illnesses, Kashnitsky writes. He adds that a survey by TPAA and the Russian Managers Association found that 12% of respondents said HIV/AIDS has had a negative impact on their companies' competitiveness.

HIV/AIDS in Russia is a "ticking time bomb that, if left ignored, will explode in the next few years," Kashnitsky writes, adding that business executives "need to act now to help our employees remain healthy and disease free" (Kashnitsky, Moscow Times, 2/11).

http://www.kaisernetwork.org

Australia To Provide Indonesia With $40M Million To Fight HIV/AIDS

February 11, 2008

Australia will allocate $40 million in 2008 to help fight the spread of HIV/AIDS in Indonesia, Australian Foreign Minister Stephen Smith announced on Thursday, the AAP/Australian reports. "I am pleased to announce today that in 2008, Australia will commence a new program with Indonesia to give people with HIV, or at risk of contracting HIV, better access to essential treatment and prevention," Smith said. Smith made the announcement after meeting with Indonesian Foreign Minister Hassan Wirajuda in Perth, Australia (AAP/Australian, 2/7).

The funding will go toward an HIV/AIDS program that aims to increase access to medicines and treatment among marginalized groups living with HIV/AIDS, AHN Media reports. According to the Indonesian Ministry of Health, the HIV situation in Indonesia is one of the fastest spreading in Asia. About 170,000 people are living with HIV/AIDS out of the country's 231.6 million residents. About 29,000 of those living with the disease are women. Most HIV cases occur among injection drugs users and commercial sex workers, followed by men who have sex with men, AHN Media reports. A 2005 survey found that 40% of IDUs in Jakarta tested positive for HIV. The survey also found that about 25% of IDUs in Bandung, Jakarta and Medan said they had had unprotected sex during the past year (Morales, AHN Media, 2/7).


Also: U.N. Envoy Calls for Increased Efforts on HIV/AIDS in Indonesia

In related news, Nafis Sadik, United Nations Special Envoy for HIV/AIDS in Asia and the Pacific, on Friday called on Indonesia to scale up its HIV/AIDS prevention efforts while rates of the disease are still low among the general population, Reuters reports. "The window of opportunity is now open to keep the epidemic at low levels," Sadik said during a five-day visit to the country. "I am happy with the progress, but Indonesia needs to do more," Sadik said, adding, "Prevention has to be equal priority if not more priority in the program. Unless you prevent it, you are not going to get rid of HIV." Indonesia's National AIDS Commission estimates that the country will have one million cases by 2015 if efforts are not strengthened. Sadik said the country should bolster its existing programs to promote behavior change and condom use. However, religious groups have strongly criticized the campaigns, saying they promote promiscuity, according to the commission (Reuters, 2/8).

http://kaisernetwork.org

HIV/AIDS Devastates Black America

February 13, 2008

As we commemorated World AIDS Day, no one should overlook the devastating toll the deadly disease has taken on the African-American community. Consider the following:

• Although African-Americans represent only 12.7 percent of the U.S. population, they were half of all AIDS cases detected in 2005;

• The rate of Blacks contracting AIDS is 10 times that of Whites and Black women have contracted AIDS at a rate 23 times higher than that of White women;

• Although African-Americans constitute only 16 percent of U.S. teenagers, they represent 69 percent of all new AIDS cases reported among teens;

• Black women account for 66 percent of all new AIDS cases among women and

• HIV- and AIDS-related death rates are highest among African-Americans, with Blacks accounting for 55 percent of such deaths.

There are some interesting facts among the numbers.

Both Black and White women were most likely to be infected through heterosexual activities. White women were more likely than Black women to have been infected as a result of drug use. And among men having sex with men, one study conducted in five cities found that 46 percent of such Black men were HIV infected compared to 21 percent of White men in that category.

There were some geographical variances as well. AIDS cases were highest in the eastern section of the country, with the District of Columbia leading the way with the highest rate. However, 51 percent of Blacks living with AIDS and 56 percent of all newly-reported cases among Blacks were in the South, where African-Americans make up only 19 percent of the region’s population.

Just nine states and Washington, D.C. account for 72 percent of all Blacks living with AIDS. In order, they are: New York (33,924), Florida (22,232), Texas (11,307), Georgia (11,255), Maryland (11,113), California (10,947), New Jersey (9,511), Pennsylvania (8,488), Illinois (8,042) and the District of Columbia (7,925).

Compounding matters, according to data assembled by the Kaiser Family Foundation, "Blacks with HIV/AIDS were more likely to be publicly insured or uninsured than their white counterparts, with over half (59 percent) relying on Medicaid compared to 32 percent of whites. One fifth of Blacks with HIV/AIDS (22 percent) were uninsured compared to 17 percent of whites. Blacks were also much less likely to be privately insured than whites (14 percent compared to 44 percent)."

What can be done?

On an individual level, African-Americans should eliminate risky sexual behavior. And even if one contracts HIV, they can live healthier lives by being tested and treated early. Unfortunately, HIV and AIDS are detected in more advanced stages among African-Americans.

From a public policy perspective, the Open Society Institute published a report earlier this year titled, "Improving Outcomes: Blueprint for a National AIDS Plan for the United States." Chris Collins, the author of the study, observed, "It is time the United States develops what it asks of other nations that it supports in combating AIDS: a national plan that provides a roadmap for concrete and equitable results."

According to the report, such a plan should:

1) Focus increased attention on concrete outcomes through reliance on evidence-based and cost-effective programming.

2) Set ambitious, visible and credible targets for improvement in a limited number of areas.

3) Identify clear priorities for action on the selected targets.

4) Set out specific objectives for multiple sectors, including government, civil society, community organizations, and business.

5) Make the prevention and treatment needs of African Americans a primary focus.

6) Promote and test innovative ideas about how to overcome structural barriers to more effective prevention and treatment.

7) Improve methods of measuring progress.

8) Make federal agencies responsible for coordinating the collaborative efforts of government, business, and civil society.

9) Require the Secretary of Health and Human Services to report regularly on the status of progress toward targets in the national plan.

In calling for a national plan to combat AIDS, the Open Society report does not ignore numerous panels and studies that have predated the report. Ronald Reagan’s Presidential Commission on the HIV epidemic, for example, issued 600 recommendations, most of them ignored. The Clinton administration issued its own National AIDS Strategy report in 1997. Most of its proposals were similarly ignored.

"Over 1.5 million infections and over a half million deaths into its 26-year-old HIV/AIDS epidemic, the United States still does not have a comprehensive strategic national plan to tackle AIDS within its own borders," the Open Society report states. "The United States will spend over $16 billion on the domestic epidemic in fiscal year 2007…But no comprehensive plan will guide strategic use of AIDS-related dollars or hold government agencies accountable for steadily improved outcomes for people living with HIV/AIDS or at risk of infection."

By George Curry, http://www.hvpress.net

Brazil: HIV-Positive Need to Seek Earlier Treatment

February 15, 2008

Brazil plans to set up diagnostic centers in remote areas and increase advertising campaigns to get people with HIV/AIDS to seek treatment sooner, health authorities said Thursday.

Mariângela Simão, the head of the Health Ministry's National Program of Sexually Transmitted Diseases and AIDS, said many Brazilians with HIV are waiting too long to seek treatment. She cited a recent survey of 115,441 AIDS patients that showed that 44% only sought treatment when they already had severe immunological deficiencies. ''These figures are unacceptably high for a country like Brazil,'' she said.

Simão noted that those who sought treatment at an early stage lived longer and ''remained active on the job market, while those who didn't either became too weak to work or died.'' Speaking at a news conference, she blamed delays in seeking treatment on problems reaching diagnostic centers and some people's refusal to admit that they are at risk and be tested. To deal with this problem, she said the government plans to set up diagnostic centers in remote areas and increase advertising to convince people to seek treatment.

Some 600,000 Brazilians are HIV positive. The Brazilian government's anti-AIDS program, which provides free antiretroviral treatment to anyone who needs it, is considered by international organizations as a model for the developing world.

The government also distributes tens of millions of condoms each year in an effort to stem the spread of HIV, the virus that causes AIDS. (AP)

Associated Press.

Watchdogs: Egypt Ups Arrests Of HIV-Positive Suspects Violating Human Rights

February 15, 2008

Cairo, Egypt - Egyptian police have stepped up arrests of HIV-positive suspects, detaining four more men this month in a crackdown that violates basic human rights, two leading international rights groups said Friday.

The New York-based Human Rights Watch and the London-based Amnesty International warned in a joint statement that the arrests could also undermine HIV/AIDS prevention efforts, as people in Egypt become increasingly afraid to seek information about HIV prevention and treatment.

The latest arrests brought to eight the number of HIV suspects in detention.

Four other men, arrested earlier, were convicted in mid-January for "habitual practice of debauchery" - a term used in the Egyptian legal system for consensual homosexual acts - and sentenced to one-year prison terms. The sentence was upheld Feb. 2 by an appeals court, HRW said.

Homosexuality is not explicitly referred to in the legal code here, but a wide range of laws covering obscenity, prostitution and debauchery are applied to homosexuals in this conservative country.

"In their misguided attempt to apply Egypt's unjust law on homosexual conduct, authorities are carrying on a crackdown against people living with HIV/AIDS," said Rebecca Schleifer of the HRW. "This not only violates the most basic rights of people living with HIV. It also threatens public health, by making it dangerous for anyone to seek information about HIV prevention or treatment."

Police deny any HIV-related arrests, but a police official, speaking on condition of anonymity because he was not authorized to talk to media, said there is a campaign to get persons who are registered in hospital records as HIV-positive to treatment in "special clinics."

The official told The Associated Press that police recently rounded up four men and sent them to "precautionary hospital detention" for treatment. He declined to elaborate.

The two watchdog groups called on Cairo to release all the 12 men, both the four convicted and the eight in detention.

The latest arrests came after police followed up on information coerced from those already in custody, HRW and Amnesty said.

The arrested were forced to undergo HIV tests and two tested positive, the groups added. One appeared in court Feb. 12 and had his detention extended for 15 days after the judge and prosecutor declared him a danger to public health. The second is to appear in court Feb. 23.

HRW and Amnesty say that those in custody who tested positive are being held chained to their hospital beds.

"Arbitrary arrests, forcible HIV tests, and physical abuse only add to the disgraceful record of Egypt's criminal justice system, where torture and ill-treatment are greeted with impunity," said Hassiba Hadj-Sahraoui, deputy chief of Amnesty's Mideast and North Africa branch.

The rights groups also urged Egypt to undertake training for all criminal-justice officials on medical facts and international human rights standards in relation to HIV, and to immediately discontinue all testing of detainees that is not consensual.

In an earlier statement last week, HRW said the arrests and trials of HIV-positive suspects reflect the Egyptian government's criminalization of AIDS.

The wave of arrests began last October, when one man admitted he was HIV-positive after he and another man were detained after an altercation on a downtown Cairo street. Two other men, whose telephone numbers were among the belongings of the first two, were later also arrested and all four were forced to take HIV tests. The four convicted in January were arrested last November.

In the largest case to date here, state security arrested 52 homosexuals on a floating restaurant on the Nile River in 2001. Twenty-three were sentenced to two years in prison, two got three and five years while the rest were acquitted.

The Canadian Press

Bacteria Boost Human Health

Probacteria fight AIDS and gas

February 12, 2008

Your gut is loaded with approximately 100 trillion bacteria, outnumbering your own cells by around a factor of ten. Linked end-to-end, the micro-organisms we carry around could circle the globe two and a half times, and without them, none of us could digest any food. Knowing this, it’s no surprise that we owe much of our health to the “good” bacteria that inhabit the dark, dank labyrinth of our bowels.

A healthy body depends on a healthy gut, and a healthy gut cannot exist without bacteria. We have all heard of antibiotics, drugs that save countless lives by eliminating disease-causing bacteria. Few of us are familiar with probiotics, the friendly bacteria which, when taken in sufficient amounts, can make people healthier. The very term probiotic means “for life,” and current research suggests that beneficial bacteria, much like other nutrients and vitamins, should be consumed regularly to promote general health. Dr. Gregor Reid, director of the Canadian R&D Centre for Probiotics, explained that we need probiotics in our diet because they don’t always stick around in the body.

Ninety per cent of our stool is bacteria, so how do we naturally replenish them if our food is sterile?” he said.

We can renew good bacteria by consuming supplements, like probiotic yogurt or other fermented milk products packed with live bacterial cultures. Such foods establish a healthy balance between good and bad bacteria in our bodies.

Reid’s colleague Dr. Shari Hekmat, Professor of Food and Nutrition at the University of Western Ontario, explains that probiotics impact many aspects of health.

Depending upon the strain, probiotic bacteria have been shown to provide several therapeutic benefits such as modification of the immune system, reduction in cholesterol, alleviation from lactose intolerance, maintained remission of Crohn’s disease, faster relief from diarrhea, and prevention of urogenital infections,” he said.

For the average university student, consuming regular doses of probiotics is especially important. The stress that goes along with midterms and finals can suppress the immune system and destroy good bacteria, making room for bad bacteria to invade and cause sickness. As a result, come April many of us will be battling diarrhea, bloating, and gas – a deadly library combo. In the long term, these seemingly minor inconveniences can escalate into severe gastrointestinal disorders.

Poor nutrition can also throw the bacterial balance out of whack. Bad bacteria thrive on processed foods high in animal proteins and sugar – staples of the dorm-room diet. By eating fiber-rich foods combined with a regular intake of probiotics, we can encourage good bacteria to destroy their harmful counterparts.

Our growing understanding of probiotic benefits also has more far-reaching implications. The research of both Reid and Hekmat forms the basis of a unique internship project called Western Heads East. The project sends Western students to rural Tanzania where they have established a community kitchen. There, local mothers (“yogurt mamas”) are trained to produce probiotic yogurt and distribute it to their families and to HIV/AIDS sufferers in the community. Up to 90 per cent of HIV/AIDS patients in Sub-saharan Africa suffer from diarrhea, and in an upcoming article for the Journal of Clinical Gastrology, Reid writes that probiotics could save these patients’ lives.

“The fact that a food easily produced in developing countries…can alleviate diarrhea, represents a significant potential means of reducing some deaths amongst HIV/AIDS patients,” Reid comments.

Furthermore, a probiotic diet may reduce HIV transmission by maintaining the high level of acidity needed in a woman’s vagina to prevent contraction of the disease. This year, Western Heads East is expanding to Kenya and aims to eventually increase the quality of life in developing countries worldwide.

Unfortunately for the average consumer, Hekmat explained that many products marketed as probiotics are not in fact probiotic.

“A product can only be considered probiotic if it contains at least one million active probiotic bacteria per gram of the product. If the probiotic bacteria are not present in sufficient number over the storage period, then the product cannot be claimed as probiotic,” he said.

A true probiotic must also confer a health benefit proven in human trials. Yet, to date, there is no legal definition for the term “probiotic,” as Health Canada and the USFDA struggle with how best to legislate these products. Nonetheless, Reid mentions some marketed products with proven efficacy: “Florastor for diarrhea, Activia for regularity, DanActive for immune health, and VSL#3 for IBD.”

By Ashley Minuk, http://www.mcgilldaily.com

Immune System Protein Starves 'Staph' Bacteria, Could Lead To New Treatments

February 14, 2008

One of the ways we defend ourselves against bacterial foes is to "hide" their food, particularly the metals they crave. A multi-disciplinary team led by Vanderbilt University investigators has now discovered that a protein inside certain immune system cells blocks the growth of "staph" bacteria by sopping up manganese and zinc.

The findings, reported Feb. 15 in Science, support the notion that binding metals -- to starve bacteria -- is a viable therapeutic option for treating localized bacterial infections. New treatment strategies are urgently needed to combat the surging number of infections and deaths caused by antibiotic-resistant forms of Staphylococcus aureus (staph), such as MRSA.

If recent estimates are accurate, the number of deaths caused by MRSA exceeds the number of deaths attributable to HIV/AIDS in the United States. "Staph is arguably the most important bacterial pathogen impacting the public health of Americans," said Eric Skaar, Ph.D., assistant professor of Microbiology and Immunology and senior author of the study.

Staph is the leading cause of pus-forming skin and soft tissue infections, the leading cause of infectious heart disease, the number one hospital-acquired infection, and one of four leading causes of food-borne illness. "And it seems as if complete and total antibiotic resistance of the organism is inevitable at this point," Skaar said.

The dire outlook motivates Skaar and his colleagues in their search for new antibiotic targets.

Skaar and Brian Corbin, Ph.D., postdoctoral fellow and lead author of the report in Science, reasoned that proteins present at the site of a staph infection might be important to the battle between the bug and the immune system, and might therefore make good targets for therapeutics. They took advantage of the fact that staph forms abscesses -- pimple-like infected areas -- in internal organs like the liver.

"Because we can tell exactly where the infection is, we can look for proteins that are present only at the site of infection," Skaar said.

Using sophisticated technology called "imaging mass spectrometry," the investigators identified dozens of proteins specifically expressed in staph abscesses in mice. They decided to focus on one that was particularly abundant.

The protein turned out to be calprotectin, which was discovered as a calcium-binding protein about 20 years ago and is known to inhibit bacterial and fungal growth in test tubes. But how it kills bugs was unclear.

The team demonstrated in a series of in vitro and in vivo experiments that calprotectin inhibits staph growth and that it does this by binding -- chelating -- nutrient metals, specifically manganese and zinc.

"It basically starves the bacteria by stealing its food," Skaar said.

Calprotectin makes up about half of the internal content of neutrophils, the primary immune cells that respond to a staph infection. The investigators propose that calprotectin is a second weapon neutrophils employ as they wage battle in the abscess. First, neutrophils try to "gobble up" the bacteria. If they fail and die (staph is expert at secreting toxins that kill neutrophils), then they spill their guts, which are filled with metal-binding calprotectin sponges that soak up the metals.

"The neutrophil gets the last laugh," Skaar quipped.

"The work is a phenomenal merger of several cutting edge technologies, which collectively allow an unprecedented view of the host-pathogen interface," said Paul Dunman, Ph.D., assistant professor of Pathology and Microbiology at the University of Nebraska Medical Center, and a co-author of the Science paper. "This discovery could lead to a new way to treat staph infections."

The findings suggest that drugs that bind metals -- like calprotectin does -- would make good antibiotics.

"If we can figure out how to make a molecule that transiently binds metals, and that can be targeted to abscesses, I think that would be a great drug," Skaar said.

Walter Chazin, Ph.D., Richard Caprioli, Ph.D., and members of their teams at Vanderbilt were key to the studies, as were collaborators at the University of Aberdeen, Scotland, the University of Nebraska Medical Center, the University of Muenster, Germany, and Applied Speciation and Consulting in Washington. The research was supported by the Searle Scholars Program, the Burroughs Wellcome Fund, the National Institutes of Health, and the Department of Defense.

Adapted from materials provided by Vanderbilt University Medical Center, via EurekAlert!, a service of AAAS.

http://www.sciencedaily.com

HIV Vaccine Research Hits Impasse

February 15, 2008

Scientists are no further forward in developing a vaccine against HIV after more than 20 years of research, a Nobel Prize-winning biologist has said.

Anti-HIV medication fails test in Africa

Gates Foundation Helped Fund Study

February 18, 2008

A highly anticipated international study of an anti-HIV microbicide, involving more than 6,200 women in South Africa and funded in part by $20 million from the Bill & Melinda Gates Foundation, has failed to demonstrate it can protect women from the AIDS virus.

"Carraguard was shown to be safe but not effective at preventing HIV transmission," said Dr. Khatija Ahmed, the lead scientist on the three-year clinical trial conducted by the Population Council, an international research organization focused on reproductive health.

Carraguard, a seaweed-based gel that blocks HIV infection of cells in lab tests, had been considered the most promising of several experimental microbicidal vaginal gels or creams intended to reduce a woman's risk of HIV.

The study, which lasted three years and was the only one so far to get to the final phase of testing, ended with 134 new HIV infections among women who used the microbicide and 151 infections among women given placebo gel. Statistically, considered within the 4,244 women who completed the study, this was regarded as no difference.

"We're all disappointed, but we're going to learn from this," said Lori Heise, director of the Global Campaign for Microbicides, based in Washington, D.C., and operated by Seattle-based PATH, the Program for Appropriate Technology in Health.

More than 15 years ago, Heise and Dr. Chris Elias, now president at PATH, worked at the Population Council and actually coined the term "microbicide." The goal was to promote the concept of a South African epidemiologist, Zena Stein, of finding a simple, inexpensive anti-HIV vaginal cream that could be used by women to protect against infection.

Worldwide, by far most new HIV infections today are in women. UNAIDS, the United Nations Joint Program on HIV/AIDS, has estimated that women in sub-Saharan Africa are anywhere from three to six times more likely to become infected by HIV than men due to a greater inability to adequately protect against infection during sexual intercourse.

Carraguard, developed by the Population Council from a seaweed derivative known as carrageenan used in ice cream and cosmetics, had been considered a top contender. Studies of two other experimental anti-HIV microbicides, (a spermicide called nonoxynol-9 and another one using the chemical cellulose sulfate), had to be halted due to safety concerns when it appeared test subjects had higher rates of HIV infection.

Some wonder if further analysis of the trial data may even show it wasn't so much Carraguard that failed to protect against HIV as it was the inability of study participants to use it consistently.

The Population Council said the Carraguard study participants "self-reported" using the gel in 44.1 percent of their sex acts. Only 10 percent of the women said they used the gels 100 percent of the time and only 20 percent used the gels three-quarters of the time.

"It could still turn out, upon further analysis among those who used it more consistently, that there was a protective effect," said Dr. Henry Gabelnick, executive director of CONRAD, a reproductive health and HIV research organization based in Arlington, Va., that led the cellulose sulfate microbicide study.

Heise, however, said that to get an anti-HIV microbicide approved by regulators and put into wide distribution, they would likely need much more than that kind of parsed evidence anyway.

"This is an entirely new class of (medical) product," she said. A more important lesson to take away from this trial is to conduct future microbicide trials with much greater attention to and emphasis on maximizing subject participation, she said.

"What we haven't done well is really focus on the behavioral side of this equation," she said.

Barbara Friedland, behavioral coordinator on this study and an AIDS expert with the Population Council, agreed with Heise and Gabelnick. Friedland said it is possible they could have seen different results had the rate of consistent use of Carraguard been higher. "But it's tricky. Everyone struggles with adherence (to consistent use) on these kind of trials. Everybody tries to improve both adherence and our ability to measure it."

The Population Council plans to continue testing Carraguard, next time in combination with an experimental anti-HIV drug known as MIV-150. This drug, initially abandoned by a drug maker because it is not absorbed when taken internally, nevertheless fights the AIDS virus on contact in lab cultures.

By Tom Paulson, http://seattlepi.nwsource.com

More News from CROI

A. Tetherin: A Newly Discovered Host Cell Protein That Inhibits HIV Replication

B. Region of Origin And Gender Significant In Long-Term Changes In CD4 Cell Count During Effective HIV Therapy

C. Boehringer-Ingelheim Begins Trial of Once-Daily Extended Release Nevirapine

D. Kivexa and Truvada Have Similar Efficacy And Safety


A. Tetherin: A Newly Discovered Host Cell Protein That Inhibits HIV Replication

February 11, 2008

In a Wednesday morning plenary session at the 15th Conference on Retroviruses and Opportunistic Infections, Paul Bieniasz of the Aaron Diamond AIDS Research Center gave an overview of research findings in the area of retrovirus/host cell interactions. Notably, a human cellular protein has recently been identified which prevents newly formed viral particles from being fully released from infected cells.

In the context of viral infections, infected cells are known as host cells due to the host role they play to the infectious agents. The research field of viral/host cell interactions investigates the ways in which host cells' innate defensive mechanisms interact with viral infectious processes.

Host cells in humans and other primates have evolved a number of proteins that inhibit retroviral infection and replication. Genetic evidence indicates that these defensive proteins are produced by genes that have evolved over a very long time, and were shaped by ancient retrovirus epidemics. Since retroviruses evolve much more quickly than primates, these genetic defenses may be only partly or poorly effective against modern-day retroviruses such as HIV.

Several antiviral host cell proteins are currently the subjects of research. One such protein, TRIM5, is able to recognize retroviral capsid proteins in infected cells and inactivate the retrovirus by an as yet unknown process. Another, APOBEC3, infiltrates newly produced viruses and degrades their genetic material.

HIV, however, has evolved ways to counter the actions of these proteins. These viral countermeasures are often driven by so-called viral accessory genes such as vif and vpu. These genes – unlike those that code directly for reverse transcriptase and other essential parts of the replication cycle – are not directly involved in viral replication, and their purpose was at first not clearly understood. It is now becoming clear that they play a key role in evading cellular defenses.

HIV can resist the effects of TRIM5 by varying the sequence of its capsid proteins, or by binding a host cell protein called cypA to TRIM5. The viral vif gene produces a protein which prevents APOBEC from being incorporated into new viruses.

Tetherin and the Vpu Gene

The remainder of the plenary focused on a third antiviral process in host cells that is only now being more clearly defined, after a long period of research into the function of the viral vpu gene which produces the Vpu protein.

Certain host cells are known to have a means of inhibiting the release of newly formed retrovirus particles. Not all host cells show this activity. In those that do, HIV that has had Vpu removed cannot replicate – indicating that Vpu plays a part in the release of new viral particles.

Several lines of evidence have shown that cells which can inhibit the release of new virions do so by using cell proteins which bind newly formed retroviruses to the cell surface. In cells which are actively expressing these proteins (dubbed "tetherins"), newly budded virions can be seen to cluster densely just outside the cell membrane and remain there, rather than being released into the body to serve as new infectious particles.

This "tethering" action is opposed by the HIV accessory protein, Vpu. Vpu is otherwise not strictly needed for viral replication, and its function was originally poorly understood; it is now recognized as a viral countermeasure against cells which produce tetherin.

In the last several months, independent studies at Bienasz's lab and that of John Guatelli of the University of California, San Diego have both identified a specific protein (cellular transmembrane protein BST-2/CD317) that appears to play this tethering role. Cells that express this protein – dubbed tetherin – are able to inhibit HIV viral release. These same cells become permissive of viral release when this protein is removed. HIV lacking the vpu gene is not able to successfully bud from these cells when they are actively producing this protein, but can do so when its production is shut down.

Tetherin has been observed to block the release of retroviruses other than HIV, and is triggered by the presence of the inflammatory cytokine interferon-alpha which is released by the immune system during viral infections.

While there are no immediate therapeutic implications, Bieniasz concluded by noting that future work will continue to explore the spectrum of viruses against which tetherin is active, the precise mechanisms by which tetherin inhibits viral replication, and the mechanisms by which the HIV Vpu protein opposes tetherin. The complexity of this area of HIV/host cell interaction could ultimately provide new avenues for therapeutic interventions; conceivably, for example, small drug molecules might be designed which could inhibit the action of viral Vpu.

References:
Bieniasz P. New insights into retrovirus-host-cell interactions. Fifteenth Conference on Retroviruses and Opportunistic Infections, Boston, abstract 114, 2008

Guatelli J, Goff D and Van Damme N. Modulation of viral assembly and virion release by Vpu. Fifteenth Conference on Retroviruses and Opportunistic Infections, Boston, abstract 104a, 2008.

By Derek Thaczuk, www.aidsmap.com


B. Region of Origin And Gender Significant In Long-Term Changes In CD4 Cell Count During Effective HIV Therapy

February 13, 2008

Long-term, virologically effective antiretroviral therapy yields smaller increases in the CD4 cell counts of patients originating in sub-Saharan Africa than in patients originating from Western Europe and North America, according to Dutch research presented to the recent 15th Conference on Retroviruses and Opportunistic Infections in Boston.

The research also showed that gains in CD4 cell were lower in men than women and that patients taking anti-HIV treatment that included a boosted protease inhibitor had greater increases in their CD4 cell counts than patients who were taking therapy based on a non-nucleoside reverse transcriptase inhibitor (NNRTI).

The role of ethnicity and gender on long-term changes in CD4 cell count during anti-HIV therapy have not been well studied.

Investigators from the Netherlands’s ATHENA cohort therefore looked at the records of patients starting anti-HIV treatment for the first time between 1996 and 2005. Patients in this cohort are receiving their HIV treatment and care in the Netherlands. They restricted their analysis to individuals whose viral load was suppressed to undetectable levels nine months after starting anti-HIV drugs and who then maintained a viral load below 400 copies/ml. They then looked at increases in the CD4 cell counts of these patients over five years and looked at the effect of region of geographical origin and gender on such changes.

A total of 4,348 patients were included in the study, the majority of whom (80%) were male and from Western Europe and North America (68%). Sub-Saharan Africa was the region of origin for 17% of patients, 4% originated in South-East Asia, and 11% from Latin America and the Caribbean.

When HIV therapy was started, patients from Western Europe and North America had median CD4 cell counts of 210 cells/mm3, significantly higher than patients originating in any other region (sub-Saharan Africa, median 160 cells/mm3; South-East Asia, median 140 cells/mm3; Latin America and the Caribbean, median 170 cells/mm3, p < 0.0001).

Five years of antiretroviral therapy yielded a median CD4 cell increase of 360 cells/mm3 in patients from Western Europe and North America. Comparable increases were seen in patients from South-East Asia and Latin America and the Caribbean. In patients from sub-Saharan Africa however, the median five-year increase in CD4 cell count was significantly lower at 320 cells/mm3 (p = 0.004).

Analysis also showed that differences in CD4 cell gains between patients from sub-Saharan Africa and other geographical regions were apparent as early as six months after starting antiretroviral therapy, with African patients gaining a mean of 93 cells/mm3 fewer at this time point than patients from Western Europe and North America (p = 0.008). During the next four and a half years of follow-up, sub-Saharan Africans gained a mean of 11 cells/mm3 fewer per year than patients from other regions (p = 0.008).

Gender also played a role in CD4 cell gain. During the first six months of therapy women gained a mean of 27 cells/mm3 more than men (p = 0.04), and this difference was maintained during subsequent follow-up with women gaining an additional 11 cells/mm3 per year compared to men.

Greater increases in CD4 cell counts were seen in patients who took a ritonavir-boosted protease inhibitor (mean gain, 58 cells/mm3 per year) than in patients who took an NNRTI (mean gain, 36 cells/mm3, p < 0.001).

“In patients achieving and maintaining viral suppression, changes in CD4 cell count during five years of combination antiretroviral therapy were significantly lower in male patients and in patients from sub-Saharan Africa compared with [patients from] western Europe and north America,” conclude the investigators. They add, “this effect was independent of differences in baseline CD4 count and viral load and AIDS diagnosis prior or after starting combination antiretroviral therapy.”

Reference:
Kesselring A et al. Maximum capacity of restoration of CD4 counts is lower in HIV-1-infected patients from Sub-Saharan Africa during the first months of cART: the Athena cohort. Fifteenth Conference on Retroviruses and Opportunistic Infections, Boston, abstract 817, 2008.

By Michael Carter, www.aidsmap.com


C. Boehringer-Ingelheim Begins Trial of Once-Daily Extended Release Nevirapine

February 13, 2008

Anxious not to be left behind in the move towards once-daily HIV treatment, Boehringer-Ingelheim announced yesterday that it is beginning recruitment to an international study of an extended-release, once-daily formulation of its antiretroviral drug nevirapine (Viramune).

Once-daily use of nevirapine has been in doubt since the 2003 results of the 2NN study, which showed a higher risk of liver toxicity in those who received the once-daily dose when compared with those who received the drug twice daily, the current license recommendation.

Subsequent studies have not clarified matters:

* A literature review published in 2007 showed a trend towards higher rates of rash across studies in patients taking the drug once-daily.

* A randomised study in France found no adherence advantage to once-daily treatment with nevirapine.

* A large (n=289) randomised study in Spain found no significant difference in the rate of grade 3 or 4 liver toxicity over 72 weeks of follow-up between those who switched to nevirapine once-daily and those who remained on twice-daily dosing (Podzamczer).

The disadvantages of once-daily nevirapine dosing are due in part to the very high drug levels that result from once daily dosing, and an extended release formulation is intended to smooth out the peak level of the drug by releasing the drug more slowly than two 200mg standard tablets taken together.

The VERXVE study will compare twice daily dosing with once-daily dosing of a new, extended release formulation comprising one nevirapine tablet. All participants will receive Truvada alongside nevirapine.

VERXVE is a 48-week study that will recruit around 1000 treatment-naive patients in North and South America, Europe, Australia and South Africa, and results are expected in 2010.

The study will also need to put to rest concerns regarding the efficacy of combinations which combine nevirapine and tenofovir. The DAUFIN study, reported in 2007, found a high risk of failure using the combination of tenofovir, 3TC and nevirapine, while an Italian study found a high failure rate in recipients of Truvada (tenofovir and FTC) plus twice daily nevirapine who had high viral load.

The potential licensing of a new once-daily formulation will have an additional commercial advantage for Boehringer-Ingelheim: its patent exclusivity on the current formulation of nevirapine expires in Europe in 2010 and the United States in 2011, at which point generic manufacturers could begin to sell cheaper versions of the drug. A new extended release formulation of the drug would be patented as a new product, and so would be protected from generic competition.

Reference:
Podzamczer D et al. Low hepatotoxicity in patients randomized to switching to nevirapine QD vs continuing with nevirapine BID. Fifteenth Conference on Retroviruses and Opportunistic Infections, Boston, abstract 960, 2008.

By Keith Alcorn, www.aidsmap.com


D. Kivexa and Truvada Have Similar Efficacy and Safety

February 14, 2008

A nucleoside reverse transcriptase inhibitor (NRTI) backbone of abacavir and 3TC (Kivexa) is just as effective and safe as a backbone of tenofovir and FTC (Truvada) when combined with Kaletra, according to a study presented to the recent Fifteenth Conference on Retroviruses and Opportunistic Infections in Boston.

Patients taking abacavir and 3TC (available in a combination pill, Kivexa) were just as likely to have a viral load below 50 copies/ml after a year of treatment as patients taking tenofovir and FTC (which are combined in Truvada). Both backbones were well-tolerated, with few patients taking either treatment stopping their therapy because of side-effects. But patients taking Kivexa had significantly greater increases in CD4 cell counts.

In HIV treatment guidelines (including those of the British HIV Association) two nucleoside/nucleotide backbones are recommended: Kivexa or Truvada. But there are few data comparing these fixed-dose combination pills.

Investigators therefore designed a study comparing the efficacy and safety of the two products. Called the HEAT study, its objectives were to establish the virologic non-inferiority of Kivexa to Truvada over 48 weeks when the products were combined with the protease inhibitor Kaletra (lopinavir/ritonavir); and to compare the side-effects over three years of treatment.

The double-blind, randomised study involved 688 patients at 72 sites in the US and Puerto Rico.

Patients were defined as having experienced virologic failure if their viral load was not suppressed to below 200 copies/ml in the first six months of treatment, or if their viral load, after being suppressed to below 50 copies/ml then increased to over 200 copies/ml in two consecutive tests.

After 48 weeks of treatment, equal numbers of patients treated with Kivexa (68%) and Truvada (67%) had a viral load below 50 copies/ml. This demonstrated the virologic non-inferiority of Kivexa to Truvada.

When the investigators looked at viral suppression in patients with high baseline viral loads - above 100,000 copies/ml, they once again found that the two products had equal efficacy, with 63% of Kivexa-treated patients with a viral load above this level having an undetectable viral load at week 48 compared to 65% of those taking Truvada.

Comparable proportions of patients taking each product (Kivexa, 12%; Truvada, 11%) experienced virologic failure. This failure was more likely to involve the NRTI-associated M184V mutation in the Truvada-treated patients than in the Kivexa-treated patients.

Median CD4 cell counts after 48 weeks of treatment were 429 cells/mm3 in the Kivexa-treated patients and 370 cells/mm3 in the patients taking Truvada.

Treatment was stopped before 48 weeks by 4% of patients taking Kivexa and 6% of those taking Truvada due to side-effects.

Patients were not screened for allergy to abacavir with an HLA-B*5701 test, and 4% of patients taking Kivexa were diagnosed with a suspected abacavir hypersensitivity reaction as were 1% of patients taking Truvada in the double-blind study (neither patients nor investigators knew which drugs they were taking).

Cholesterol and triglyceride levels increased in both groups of patients, but were marginally higher in patients taking Kivexa.

“Abacavir/3TC is comparable to tenofovir/FTC in virologic efficacy when combined with lopinavir/ritonavir through 48 weeks,” conclude the investigators. They add, “both treatment regimens were well tolerated with few discontinuations due to adverse events in either arm.”

Reference:
Smith KY et al. Efficacy and safety of abacavir/lamivudine combined to tenofovir/emtricitabine in combination with once-daily lopinavir/ritonavir through 48 weeks in the HEAT study. Fifteenth Conference on Retroviruses and Opportunistic Infections, Boston, abstract 774, 2008.

By Michael Carter, www.aidsmap.com

Growing Old Gracefully

Recent advances in treatment mean people with HIV are not only living better, they’re living longer. Here’s how to cope with the new reality.

by Laurette Lévy, http://www.positiveside.ca/e/V9I1/Growingold_e.htm

Cultivating Compassion

Operating in a legal no-man’s-land and facing criminal action at any time, dedicated activists at compassion clubs across Canada are working to make medicinal marijuana available to any PHA who needs it.

Derek Thaczuk explores how they work and why they are so important.

http://www.positiveside.ca/e/V9I1/Compassion_e.htm