University of Michigan scientists have discovered that bone marrow, previously thought to be resistant to the HIV, can contain latent forms of the virus. Their findings, which appear online in Nature Medicine, indicate a new target for curing the disease.

Using tissue samples, U-M researchers detected HIV genomes in bone marrow isolated from people treated with antiviral drugs for more than six months. Further studies are needed to demonstrate that stem cells can harbor the HIV virus; however, the study results confirm that HIV targets some young cells that have not fully developed but mature into cells with special immune functions. When active infection occurs, the toxic effects of the virus kill the cell even as the newly made viral particles spread the infection to new target cells.

“Antiviral drugs have been effective at keeping the virus at bay. However once the drug therapy is stopped, the virus comes back,” says senior author of the study Kathleen Collins, professor of both internal medicine and microbiology and immunology at the U-M Medical School. “Ultimately to cure this disease, we’re going to have to develop specific strategies aimed at targeting these latently infected cells,” she adds.

The researchers earlier found the HIV virus hiding in the macrophages, which are the white blood cells within the tissues, and in the disease fighting cells called memory T-cells–but they were surprised to find it in the marrow, according to The Money Times. Globally, more than 30 million people are infected with HIV, including millions of children. Improvements have been made since the 1990s in the way the disease is treated that has led to an 85 percent to 90 percent reduction in mortality.

Source: FierceBiotech

Popularity: 1% [?]

Mother-to-child transmission of HIV could be eliminated in five years if the current rate of health investments are at least maintained, officials said Monday.

Mother-to-child transmission of HIV could be eliminated in five years if the current rate of health investments are at least maintained, officials said Monday.

The Global Fund to fight HIV, malaria and tuberculosis released its annual report ahead of a funding meeting in The Hague on March 24.

“A world where no children are born with HIV is truly possible by 2015,” said Michel Kazatchkine, head of the Global Fund.

“It is also possible now to imagine a world with no more malaria deaths, since already an increasing number of countries have been reporting a reduction in malaria deaths of more than 50 per cent over the past couple of years,” he said.

“No other area of development has seen such a direct and rapid correlation between donor investments and live-saving impact as these investments in fighting AIDS, TB and malaria.”

According to the report, programs supported by the fund saved at least 3,600 lives per day in 2009 and an estimated total of 4.9 million since the fund was created in 2002.

UNAIDS executive director Michel Sidibe and South African Health Minister Aaron Motsoaledi joined Kazatchkine in appealing to governments and private donors to continue investing in the fund.

“Without a fully funded Global Fund, our shared dream of universal access to HIV prevention, treatment care and support could become our worst nightmare – putting the lives of millions of people currently on treatment in jeopardy and millions of pregnant women in a position not able to protect their babies from becoming infected,” Sidibe said in a statement on the UNAIDS website.

By the end of 2009, these funded programs provided antiretroviral treatment to 2.5 million people, including 790,000 pregnant women with HIV, which reduces the chances that babies will be born with the virus.

Treatment was also given to six million people who had active TB, and 104 million insecticide-treated nets were provided to prevent malaria.

The group estimated that between $13 billion to $20 billion US will be needed from 2011 to 2013 to meet its goals of eliminating mother-to-child HIV transmission, eliminating malaria as a public health problem within a decade in most countries where it is endemic, and halving the prevalence of TB by 2015.

Source: CBC News

Popularity: 1% [?]

HIV has become the leading cause of death and disease among women of reproductive age worldwide, the UN programme on HIV/Aids says.

At the start of a 10-day conference in New York, UNAids launched a five-year action plan addressing the gender issues which put women at risk.

One of the key issues, it says, is that up to 70% of women worldwide have been forced to have unprotected sex.

UNAids says such violence against women must not be tolerated.

“By robbing them of their dignity, we are losing the opportunity to tap half the potential of mankind to achieve the Millennium Development Goals,” said Executive Director Michel Sidibe.

“Women and girls are not victims, they are the driving force that brings about social transformation,” he said.

The agency says that experiencing violence hampers women’s ability to negotiate safe sex.

It warns that, nearly 30 years from the beginning of the epidemic, HIV services do not respond to the specific needs of women and girls.

Women, it says, continue to be disproportionately affected by HIV/Aids.

In sub-Saharan Africa, 60% of those living with HIV are women and in Southern Africa, for example, young women are about three times as likely to be infected with HIV than young men of the same age.

The programme – which will include improving data collection and analysis of how the epidemic affects women, and ensuring the issue of violence against women is integrated into HIV prevention programmes – will be rolled out in countries including Liberia.

Source: BBC NEWS

Popularity: 1% [?]

Scientists at the Gladstone Institute of Virology and Immunology say they’ve made a key discovery that should help accelerate work on an effective topical microbicide to stop the sexual transmission of AIDS. The team says that the molecule surfen has demonstrated its effectiveness as an inhibitor of “semen-derived enhancer of viral infection,” or SEVI, which amps up the infectiousness of HIV. In some cases, SEVI can increase the likelihood of infection by a factor of 100,000.

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“Surprisingly, although HIV readily replicates once inside the body, the virus struggles to establish a beachhead of infection during sexual transmission,” Dr. Warner Greene, senior author of the new study, explained in a news release from the Gladstone Institutes. “We have been studying SEVI, a naturally occurring factor present in semen that can make HIV thousands of times more infectious.

“Because SEVI can markedly influence HIV infectivity, it forms a rather attractive target for future therapies,” said Greene. “For example, we might be able to create combination microbicides that include agents targeting both the virus and host factors promoting infection. Such combinations might greatly diminish the spread of HIV; it is a target we are energetically pursuing.”

Source: FierceBiotech

Popularity: 1% [?]

The US has lifted a 22-year immigration ban which has stopped anyone with HIV/Aids from entering the country.

President Obama said the ban was not compatible with US plans to be a leader in the fight against the disease.

The new rules come into force on Monday and the US plans to host a global HIV/Aids summit for the first time in 2012.

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The ban was imposed at the height of a global panic about the disease at the end of the 1980s.

It put the US in a group of just 12 countries, also including Libya and Saudi Arabia, that excluded anyone suffering from HIV/Aids.

The BBC’s Charles Scanlon, in Miami, says that improving treatments and evolving public perceptions have helped to bring about the change.

Rachel Tiven, head of the campaign group Immigration Equality, told the BBC that the step was long overdue.

“The 2012 World Aids Conference, due to be held in the United States, was in jeopardy as a result of the restrictions. It’s now likely to go ahead as planned,” she said.

In October, President Obama said the entry ban had been “rooted in fear rather than fact”.

He said: “We lead the world when it comes to helping stem the Aids pandemic – yet we are one of only a dozen countries that still bar people with HIV from entering our own country.”

Source: BBC NEWS

Popularity: 2% [?]

Countries should phase out the use of Stavudine, the most widespread antiretroviral, because of “long-term, irreversible” side-effects in HIV patients including wasting and a nerve disorder, the World Health Organization said on Monday.

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In sweeping changes to its guidelines, the WHO also recommended that people with HIV, including pregnant women, should start taking antiretroviral drugs earlier to live a longer and healthier life.

For the first time it advised HIV-positive women and their babies to take the drugs while breastfeeding to prevent mother-to-child transmission of the virus that causes AIDS.

Stavudine, also known as d4T, is marketed as Zerit by U.S. drugmaker Bristol-Myers Squibb Co. Generic versions are made by Cipla Ltd, Aurobindo Pharma Ltd and Strides Arcolab Ltd, all of India.

Stavudine, widely available in developing countries as a first-line therapy, is relatively cheap and easy to use, according to the United Nations agency.

But it causes a nerve disorder leading to numbness and burning pain in the hands and feet, and loss of body fat known as lipoatrophy or wasting, it said, conditions that are “disabling and disfiguring.”

LESS TOXIC ALTERNATIVES

The WHO recommended “that countries progressively phase out the use of Stavudine as a preferred first-line therapy option and move to less toxic alternatives such as Zidovudine (AZT) or Tenofovir (TDF).” These are “equally effective alternatives.”

Zidovudine was first manufactured by GlaxoSmithKline Plc whose patent expired in 2005. Aurobindo and Ranbaxy Laboratories, also of India, are among makers of the generic version. Tenofovir is marketed by Gilead Sciences under the name of Viread.

Of over 4 million people globally who take antiretrovirals, about half are on a regimen containing stavudine, down from 80 percent in 2006 when the WHO first said countries should envisage moving away from it because of its long-term effects, according to Dr. Siobhan Crowley of WHO’s HIV/AIDS Department.

“It is the most widely used. There is a trend moving away from it. We think it will take some time,” she told Reuters.

An earlier start to treatment of HIV-infected adults and adolescents with antiretrovirals reduces their viral load much sooner and therefore also lowers the risk of them spreading the virus, according to the WHO.

“The new recommendations are based on a solid body of evidence indicating that rates of death, morbidity and HIV and tuberculosis transmissions are all reduced by starting treatment earlier. This prolongs and improves quality of life,” it said.

An estimated 33.4 million people worldwide, two thirds of them in sub-Saharan Africa, are infected with the AIDS virus, an annual United Nations report said last week.

Source: Reuters

Popularity: 3% [?]

Early results from the first experimental vaccine to prevent HIV infections have been validated, researchers reported on Tuesday at an international conference.

“We believe this is the first milestone that will lead us ultimately to be able to develop a globally effective vaccine for HIV,” said study author Dr. Nelson Michael, a colonel at the Walter Reed Army Institute of Research in Rockville, Md.

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“We’ve likened this to a baby’s first steps. But we need to generate a daughter who can be a marathon runner and she’s not there yet.”

Michael and his Thai research partners stressed it will be years before a vaccine is widely available. But their results prove that a vaccine will one day be possible — the first results to show a modest ability to protect people from HIV infection.

Vaccine combo

Last month, the team announced that a two-vaccine combination cut the risk of becoming infected with HIV by 31 per cent in a trial of more than 16,000 volunteers in Thailand.

The full results were published online Tuesday in the New England Journal of Medicine, and presented at a scientific conference in Paris. The latest research includes more analysis suggesting the vaccine is beneficial.

There is no definitive proof, since only 125 study participants became infected, said Dr. Anthony Fauci, director the National Institute of Allergy and Infectious Diseases, the study’s main sponsor.

The vaccine combination was tested in HIV-negative Thai men and women ages 18 to 30 at average risk of becoming infected.

Half received four doses of Sanofi-Pasteur’s ALVAC canary pox/HIV vaccine and the failed HIV vaccine AIDSVAX, made by a San Francisco company called VaxGen, and now owned by the nonprofit Global Solutions for Infectious Diseases.

‘Phenomenal moment’

The vaccine combo reduced the risk of infection by 31.2 per cent over three years, according to one analysis of the data, which excluded seven subjects who were later found to be infected with HIV before they were vaccinated.

The researchers also did two other types of analysis of the data. One approach, called intention-to-treat, showed vaccine effectiveness of 26.4 per cent. The other, called a pro-protocol analysis, showed the vaccine combination was 26.2 per cent effective.

“This is a phenomenal moment, a landmark moment for all of us,” said Canadian physician Alan Bernstein, who heads the Global HIV Vaccine Enterprise, which includes governments, HIV scientists, the World Health Organization and funders such as the Bill & Melinda Gates Foundation.

Now, four working groups as well as the wider research community will begin the next phase of work toward a vaccine, to understand how the combination worked and to see whether it can be improved, said Dr. Catherine Hankins, a Canadian who is chief scientific adviser to UNAIDS in Geneva.

“What would we need to do to enhance the effects we saw,” Hankins said.

Unanswered questions

The vaccine appeared nearly twice as effective among those at low or moderate risk of becoming infected, compared with people at high risk because they share needles, have contact with prostitutes or engage in other risky behaviours, though the finding was not statistically significant.

“Perhaps the requirements for protection against transmission in low-risk heterosexual persons are considerably different or less stringent,” Dr. Raphael Dolin, of Beth Israel Deaconess Medical Center in Boston, wrote in an editorial published by the medical journal.

Other questions that still need to be answered include how long the vaccine’s effects last and the relative contribution of each of the vaccine’s components, the editorial said.

The trial was sponsored by the U.S. government and the Thai Ministry of Public Health.

Source: cbc.ca

Popularity: 2% [?]

A closer look at the HIV vaccine study results announced recently suggests the vaccine may be less impressive than originally suggested, the WSJ reports.

Researchers said last month that the vaccine lowered the risk of infection by about 31% — a “modest benefit,” they said, but one that was statistically significant, suggesting the finding was not a fluke. Another slice of the data that was not released at the time — one that looked only at patients who received all of their shots as scheduled and had the full sequence of shots before becoming infected — suggested the vaccine was 26% effective, the WSJ reported this weekend. But that benefit was not statistically significant: There was a 16% chance that benefit may have been a fluke, and the cutoff for statistical significance is 5%.

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So should the researchers have released this finding as well when they announced their results a few weeks back, or waited to inform the public until the full results were published in a peer-reviewed journal or presented at a scientific conference?

The U.S. Military research program that was one of the study’s sponsors published an online update this weekend explaining the timing and release of data. (The study was conducted in Thailand.):

The Thai Ministry of Public Health and other trial collaborators wished to inform the volunteers and Thai citizens of the results as soon as possible, instead of waiting for a scientific conference or publication. … The multiple statistical analyses are all consistent with the same conclusion: that the vaccine was modestly effective at preventing HIV. However, explaining the differences between them is complex and the appropriate venue for this technical discussion of statistics is at an open scientific conference and in the scientific publication now under review at a major journal.

The study and its release points to some thorny issues regarding medical research and the press. If scientists release data suggesting a major medical advance, the press is going to report on the findings, even if the data haven’t been vetted in the peer-review process. And, if a deeper analysis points to a more nuanced picture — as appears to be the case in this instance — whatever follow-up stories that do appear are unlikely to get as much attention as the initial stories that were based only on the data scientists chose to make available.

A blog run by the journal Science posted on the unreported findings last week, and quoted a report that included a useful reminder: “No matter what the headlines say, a single number is not the full result.”

Source: The Wall Street Journal

Popularity: 1% [?]

FDA’s advisory panel voted 10 to 4 in favor of Pfizer’s Selzentry for use in treatment-naïve adult patients with CCR5-tropic HIV-1 virus as part of combination therapy. It remains to be seen whether the drug will pass muster at the FDA as data showed that Selzentry (maraviroc) along with Combivir® was as effective as Sustiva® plus Combivir at reducing viral load.

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Selzentry was granted accelerated approval in August 2007 and full approval in November 2008 by the FDA for use in treatment-experienced adult patients with only CCR5-tropic HIV-1 virus in combination with other antiretroviral therapies. The drug works by inhibiting viral entry into uninfected cells by blocking its predominant entry route, the CCR5 co-receptor.

Monogram Biosciences provides a companion diagnostic for Selzentry, called Trofile®. This assay identifies patients with CCR5-tropic HIV-1 virus.

FDA’s Antiviral Drugs Advisory Committee made its decision based on 48- and 96-week efficacy and safety data from an ongoing Phase III MERIT (maraviroc versus efavirenz regimens as initial therapy) trial and MERIT ES (analysis of the MERIT study with the enhanced sensitivity Trofile™ assay).

Results of MERIT at 48 weeks showed that Selzentry plus Combivir was as effective as Sustiva (efavirenz) plus Combivir at reducing viral load for the co-primary endpoint of less that 400 copies/mL. The combination, however, did not show noninferiority for the co-primary endpoint of less than 50 copies/mL at 48 weeks. Safety results at 96 weeks showed that among those patients who remained on therapy, less than half the number of malignancies were observed in patients taking Selzentry compared to those taking Sustiva.

MERIT ES is a retrospective analysis, which utilized Trofile in screening samples from the MERIT trial. Results of MERIT ES at 48 weeks showed that treatment-naïve patients with CCR5-tropic HIV-1 in the Selzentry combo arm experienced comparable virologic suppression to undetectable levels (< 50 copies/mL) as those in the Sustiva combo arm.

Source: GEN News

Popularity: 5% [?]

A U.S. Food and Drug Administration advisory panel on Thursday recommended Pfizer Inc’s <PFE.N> HIV drug Selzentry be approved for wider use in certain patients with the disease, despite concern from several panel members that they were underwhelmed by the data.

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Pfizer is seeking U.S. approval to market Selzentry for HIV patients who have a specific type of HIV-1 — one of two strains of the human immunodeficiency virus that causes AIDS — who have not tried any medications yet. It would be taken with other antiretroviral drugs.

In a 10-4 vote, panel members backed the wider use, saying it did offer doctors and patients another choice even if more data is needed.

“We’re not looking for the absolute best, we’re looking for an option,” said panelist Dr. Victoria Cargill, who heads minority research at the National Institutes of Health’s Office of AIDS Research, and voted for the drug.

FDA officials will weigh the panel’s vote before making its final approval decision. Pfizer said it expects a decision by Nov. 20.

Selzentry, also known as maraviroc, is already approved for use along with other drugs for HIV patients who have tried other antiretrovirals but have developed a resistance to them.

If approved, Selzentry would be expanded to adults with chemokine (c-c motif) receptor 5, or CCR5, tropic HIV-1 who have not yet begun treatment. Patients would need to first be tested for that particular strain before taking the medication, the company said.

But a number of panelists, even those who opted for the drug, said they were conflicted about backing the wider use given the company’s somewhat limited data.

Panelist Dr. Russell Van Dyke, professor at Tulane University School of Medicine, said he voted for the expanded use despite feeling some anxiety about it.

“I worry that it’s not quite as potent as we’d like it to be,” he said.

Pfizer officials said their trial, which compared Selzentry to efavirenz, showed its drug helped reduce viral load. Efavirenz is marketed as Sustiva by Bristol-Myers Squibb Co <BMY.N>.

But some panelists said that a number of other options have hit the U.S. market in recent years. Several panelists said the company’s data was underwhelming, especially given other available drugs.

They noted concerns about the number of patients in the study who stopped using the drug because of side effects like dizziness or rash as well as those who developed a resistance.

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“We have several first-line options available to us in 2009. I’m not convinced that this drug is my first choice” for patients who are new to HIV medications, said Dr. Barbara McGovern, a professor of medicine at Tufts University School of Medicine who voted against the drug.

Overall, panelists said they wanted Pfizer to gather more data on the effect of the drug in pregnant women as well as patients with hepatitis or tuberculosis. They also urged FDA officials to make the drug’s limitations clear on its label.

While the FDA does not factor costs into its approval decisions, some consumer advocates after the panel’s vote called on Pfizer to lower the price of Selzentry, which it says has risen 10 percent since its initial approval in 2007 to $13,767 per patient for a year’s worth of treatment.

“While any new HIV/AIDS drug is welcome, we urge Pfizer to use restraint and to lower the price of Selzentry immediately,” said AIDS Healthcare Foundation President Michael Weinstein, whose nonprofit groups provides health care to HIV and AIDS patients around the world.

Some panelists also mentioned the drug’s cost. Pfizer reported $46 million in Selzentry sales in 2008.

In a statement, Pfizer said it was pleased with the panel’s vote and would work with the FDA on the drug’s label.

Source: Reuters

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