AIDS campaigners dismayed over UK Global Fund pledge

International development organisations in the UK have expressed dismay over the UK’s new pledge to the Global Fund to Fight AIDS, Tuberculosis and Malaria, which they say falls far short of expectations.

The Global Fund is an international funding facility that provides grants to developing country governments and organisations that are tackling AIDS, Malaria and TB. The UK, one of the Fund’s biggest donors, has provided £100 million (approx. $ 200 million) to the fund every year for the past three years. The international development secretary, Douglas Alexander has now promised £1 billion over the next eight years, which equates to around £ 125 million per year.

While the new pledge is an increase on previous donations, it does not tie-in with the promise made by the G8 in July this year to triple donations to the Global Fund by 2010. It has also come as a great disappointment to many who were hoping Gordon Brown, the UK’s new Prime Minister, would continue his previously demonstrated interest in international development issues by increasing international aid.

"It is astonishing how quickly promises become meaningless. In June the G8 promised to treble the size of the Global Fund by 2010, in order to tackle three diseases that kill 6 million people each year. Then in July, at the UN, Gordon Brown claimed moral leadership by warning the world that promises to tackle poverty and disease must be not be broken. Yet today the government has done exactly that, and sadly the effect will be felt by millions of people affected by Aids, TB and malaria across the world," said Steve Cockburn of the UK’s Stop AIDS Campaign.

The UK’s pledge is important both for financing Global Fund programmes and for encouraging others to increase their donations to the Fund. The USA for example has agreed to provide one third of total Global Fund money each year. The less money fellow donors pledge, the less the USA is therefore obliged to donate.

Greater funding for AIDS in particular is desperately needed to achieve the international target of universal access to HIV treatment, care and prevention by 2010. A new report from UNAIDS this week suggested that there is already a US$ 8.1 billion funding gap for 2007 alone. By 2010, around $ 42 billion will be required to ensure that at least 80% of people living with HIV worldwide have access to the services they need. At the current rate of increase, only around $ 17 billion is actually likely to be available.

“The lack of investment 10-20 years ago in the AIDS response, particularly in strengthening health systems and on issues contributing to the drivers of the epidemic such as violence against women and education has resulted in a more serious epidemic and the higher levels of funding needed today,” UNAIDS claims.

The report presents two scenarios for reaching universal access worldwide. The first would see universal access achieved by 2010 and would require a dramatic expansion of services in all low- and middle-income countries affected by AIDS. The second would achieve universal access in 2015 through a phased scale-up based upon individual country targets. This would allow countries to expand services at a more manageable pace and would cost less in the long-term, but more lives would ultimately be lost.

More information about the Global Fund to Fight AIDS, TB and Malaria and the Universal Access by 2010 goals are available on the AVERT website.

New report highlights strengths and weaknesses of major AIDS donors

A new report by HIV/AIDS Monitor and the Center for Global Development has for the first time provided a comparative evaluation of the three major donors of AIDS-related funding: the Global Fund for AIDS, Tuberculosis and Malaria, The World Bank and the US President’s Emergency Fund for AIDS relief.

The report, entitled “Following the funding for HIV/AIDS: a comparative analysis”, focuses specifically on the organisations’ work in Mozambique, Uganda and Zambia. Highlighting the strengths and weakness of each project, it highlights how much developing countries have come to rely on funding provided by the three agencies. In Mozambique for example, government contributions currently make up just 2% of the total sum being spent on AIDS in the country, the rest being derived from PEPFAR, and to a smaller extent, the Global Fund and World Bank.

PEPFAR is by far the largest donor of international funding for AIDS in the three countries, providing 62% of AIDS resources in Zambia, 73% in Uganda and 78% in Mozambique. The programme was praised for its ability to distribute fund quickly and directly. However, much of PEPFAR’s funding is channelled through international (often American) non-governmental organisations, meaning there is little government involvement, and no clear way of handing over responsibility to local stakeholders in the long-term.

The report welcomed the Global Fund’s transparent and flexible funding agreements arranged largely by national governments, but pointed out that a lack of capacity to absorb and process large sums of money meant the distribution and spending of funds was often very slow and involved a great deal of bureaucracy.

Finally, the World Bank, the smallest funder of the three, was praised for its work on strengthening government capacity to cope with AIDS, but as with PEPFAR, doubts were raised about its rigid donor-dictated requirements that mean money is usually allocated according the prerogative of the Bank rather than the country in question.

The paper goes on to recommend greater collaboration between the three agencies, both so funding can be allocated evenly and appropriately, and so each organisation can learn from the others’ successes and failures.

“By learning from each other to fix what is not working and by sharing what is working, PEPFAR, the Global Fund and the World Bank MAP can individually and collectively improve their performance in the fight against AIDS in Africa,” the report states.

Spending on AIDS-related programmes has increased 30-fold since 1996, and last year stood at US$ 8.9 billion. However, this is still far short of the amount that UNAIDS estimates is needed to meet the Millennium Development Goal of reversing the spread of HIV by 2015, and the goal of providing universal access to HIV treatment by 2010.

You can read more about PEPFAR, The Global Fund and other major financing initiatives for AIDS on the AVERT website.

Millions more faulty condoms recalled in South Africa

The South African Department of Health has called for the return of millions of condoms distributed as part of the government's HIV prevention efforts, after some were found to be defective.

This new development comes two months after the government recalled 20 million faulty condoms made by a company called Zalatex. An official from the South African Bureau of Standards (SABS) has been accused of accepting bribes to approve the Zalatex condoms, which failed to meet quality standards.

Now it has emerged that five batches of condoms made by Kohrs Medical Supplies have failed an air burst test. This shows the condoms were not as strong as they should have been, though it does not necessarily mean they would have burst during normal use. There is no evidence that bribes were involved in this case.

One million Kohrs condoms are already in quarantine and the government is appealing for the return of all others bearing the batch number 6809/MED. It is thought that up to four million such condoms may be in circulation. So far barely half of the 20 million Zalatex condoms have been recovered.

Experts fear the recalls could undermine public confidence in condoms and jeopardise South Africa's HIV prevention campaigns.

"It's very frustrating. Condoms are one of the few things we are getting right on prevention," said Dr Francois Venter, president of the Southern African HIV Clinicians' Society. "Heads should roll."

The government has cancelled its contracts with Zalatex and Kohrs. This leaves five companies supplying the 425 million condoms distributed each year.

In a statement to the media, South Africa's Minister of Health, Dr. Manto Tshabalala-Msimang, sought to reassure the public.

"The SABS has indicated that extensive controls and verifications have been implemented throughout the testing and certification process to ensure that all condoms supplied under the SABS mark and under the Choice brand, comply with standards set by the World Health Organisation," said the health minister.

"The two incidents involving Zalatex and Kohrs should not be allowed to impact negatively on the significant progress we have made in promoting condom use in the country."

AVERT.org has more about AIDS in South Africa.

AIDS vaccine may have worsened risk of HIV infection

Hundreds of South Africans who received an experimental AIDS vaccine have been warned that it may have increased their risk of HIV infection.

The study, which began in January, was meant to establish whether a product made by the pharmaceutical company Merck could protect people from HIV. It was stopped last month after researchers found no evidence of effectiveness.

Now it has been revealed that the infection rate was higher among people who received the vaccine than among those given a placebo. Nineteen vaccinated volunteers acquired HIV, compared to eleven in the placebo half of the study.

Every trial participant is now being told whether they received the vaccine or the placebo, and is being warned of the possible consequences.

Merck's vaccine candidate was separately trialled in 3,000 volunteers from the USA, Canada, Australia, Peru and the Caribbean. That study, which began in 2004, was halted at the same time as the South African trial. The ethics board has yet to decide whether to inform the participants - mostly gay men - if they received the vaccine or the placebo.

Experts say the vaccine itself could not have caused HIV infection, but it may have increased the risk of transmission by affecting immune responses.

"Given the complexity of the issue, we feel the best conclusions will be reached when all the data are analyzed in their entirety," said Mark Feinberg, vice president for medical affairs and policy for Merck.

More details are likely to emerge when vaccine researchers meet in Seattle early next month.

Not only is this outcome a major disappointment for researchers, but it may also affect people's willingness to take part in similar trials in the future. A trial of an HIV microbicide was stopped in January after it too found more infections in the treated group compared to those who received a placebo.

AVERT.org has more about AIDS vaccines and microbicides.

Mbeki still unconvinced of HIV/AIDS link, says biographer

A new biography of the South African President, Thabo Mbeki, has uncovered ongoing ‘dissident’ beliefs about HIV and AIDS, an article in The Guardian newspaper has revealed.

Mbeki courted much controversy in 1999 by questioning the safety and efficacy of AZT, one of the first antiretroviral drugs. He then caused a similar storm in 2000 by repeatedly casting doubt on the widely held belief that HIV is the cause of AIDS.

Mbeki officially withdrew from the debate on the cause of AIDS in 2000, though arguments continued within the government. In 2002, Pregs Govender, the chair of a parliamentary committee on the status of women resigned over the issue, and several fellow members of the government strongly criticised Mbeki's views. The President has stayed away from the debate in recent years, though the new biography by the respected author Mark Gevisser reveals that he remains unconvinced of the HIV/AIDS connection to this day, and is aggrieved that he was silenced by colleagues who believed his opinions to be damaging for the country. Though Mbeki has never expressly said that HIV does not cause AIDS, his obvious scepticism has had a deep impact on the government’s reaction to the AIDS crisis. His views are also now shared by the country’s health minister, Manto Tshabalala-Msimang.

In the book, Gevisser describes how Mbeki contacted him personally to tell him of a paper he had secretly authored six years previously and distributed anonymously among senior members of the Africa National Congress. The paper, which Mbeki took care to have personally delivered to Gevisser, compared AIDS scientists to Nazi concentration camp doctors and depicted black people who accepted the standard rhetoric on AIDS as victims of a slave mentality. The paper also describes the "HIV/Aids thesis" as entrenched in "centuries-old white racist beliefs and concepts about Africans".

Much of Mbeki’s career was spent fighting against Apartheid during the many years that South Africa was a nation divided by race. As a consequence, says Gevisser, Mbeki holds a deep suspicion of white ‘colonial’ orthodoxies, and believes AIDS to be a prime example of racist attempts to demean and repress black Africans. He also believes that much of the Western world is in league with pharmaceutical companies in their attempts to make money out of AIDS by selling potentially dangerous treatments.

Over two million people have died of AIDS in South Africa since the first cases were reported, and about nineteen percent of adults are thought to be infected with HIV. The government has in recent years made greater efforts to address the epidemic, and began to distribute antiretroviral drugs in 2003, "but that did not mean, in any way, that [Mbeki] had changed his mind," writes Mr Gevisser. "When I asked him in 2007 how he felt about having to withdraw from the Aids debate, he told me it was 'very unfortunate' that his initiative had been 'drowned'."

Mark Gevisser's biography of Thabo Mbeki goes on sale in South Africa from 7th November.

Generic antiretroviral manufacture has saved Brazil US$ 1 billion.

Brazil’s policy on AIDS drugs has saved the country around US$ 1 billion since 2001, a new study in PLOS medicine has found.

In 1996, Brazil became the first developing country to commit to universal access to antiretroviral AIDS drugs for all HIV positive Brazilians that needed them. To achieve this goal, the country significantly expanded its drug manufacturing capabilities, and today produces eight different antiretroviral drugs (ARVs) in ‘generic’ (i.e. copied) forms. For drugs that are still within their patent period and cannot be copied under intellectual property laws, Brazil has either broken the patent using a compulsory license (in the case of efavirenz) so it can import generic versions from abroad, or it has negotiated significant price reductions for the brand named versions.

The bold programme has proven controversial with major pharmaceutical companies and the US Trade Representative, as they see it as breaching the intellectual property rights of the original manufacturer. However, under World Trade Organisation guidelines, Brazil’s actions are completely legal.

The study, published by researchers at the Harvard School of Public Health in the United States, described Brazil’s efforts and the $ 1 billion saving as “remarkable”, yet they also warned that the relatively high cost of generic ARVs in Brazil, and the increasing HIV positive population may cause problems in the future. The lack of competition for generics manufactured in the country (all are produced on government orders) means that they are more expensive than generics found in other nations (such as in India). The country has an adult HIV prevalence rate of 0.5% and is currently treating around 180,000 people, with numbers growing all the time.

The study’s authors hope that their work will be of use to other developing countries facing an ever-expanding bill for antiretroviral treatment.

“The trends this study highlights provide important information about how AIDS treatment costs are likely to evolve in other developing countries as efforts are made to provide universal access to life-saving ARVs.” the researchers stated. “The specific application of the Brazilian model to other countries will depend, however, on the strength of their health systems, intellectual property regulations, epidemiological profiles, AIDS treatment guidelines, and differing capacities to produce drugs locally.”

AVERT.org has more about AIDS in Brazil and generic antiretroviral treatment.

CDC set to announce big rise in US HIV infections

The US Centers for Disease Control and Prevention (CDC) is set to announce a dramatic increase in the annual number of HIV infections occurring in the USA, an article in the Washington Blade has claimed.

Current CDC literature states that around 40,000 people become infected with HIV every year, a rate that has remained stable since 1992. However, sources at the CDC have told the Washington Blade that the actual figure may now be over 60,000.

It is unclear exactly what has caused the increase, and the CDC is officially remaining tight-lipped on the subject. Greater HIV testing in a wider range of venues, a CDC initiative introduced last year, may be one explanation. Two employees of the agency have also suggested that more accurate reporting techniques recently introduced across the US may have contributed to the rise. If this were the case, it would suggest that annual incidence may have been underreported for some years.

“My view is it’s both better data collection and increased testing as well as a higher rate of [HIV] conversion that is causing the spike in the CDC numbers,” said David Reznik, the head of an HIV dental clinic in Atlanta, Georgia, and former member of the Presidential Advisory Council on HIV/AIDS.

“However, our prevention messages aren’t reaching those at most risk,” Reznik said. “And I believe it’s time to rethink our prevention strategy.”

Government prevention efforts in the USA mainly consist of encouraging greater HIV testing, and there is currently no national scheme to encourage safer sex. If the new statistics are accurate, it is likely that many AIDS organisations will call for a reappraisal of this situation.

The CDC has admitted it is unlikely it will publish the new data, or its annual HIV/AIDS surveillance report, before World AIDS Day this year, stating that it needs more time to subject the data to peer review. Such a move has however drawn accusations of an attempted cover-up.

“The word we’re hearing now is they’re leaning against releasing such bad news on World AIDS Day,” said Jim Driscoll, a Washington adviser to the AIDS Healthcare Foundation. “There’s some talk of them releasing the new figures during the week between Christmas and New Year’s, when the fewest possible people will be paying attention.”

While a quiet launch of the figures may cause less embarrassment for the CDC, it would represent a major missed opportunity to highlight the ongoing seriousness of the AIDS epidemic in the United States.

To find out more about AIDS in the USA, please visit our HIV & AIDS in America section.

UNAIDS releases dramatically revised global HIV estimates

The joint United Nations Programme on AIDS (UNAIDS) has dramatically reduced its estimate of the number of people living with HIV around the world. According to the new statistics, there are now 33.2 million people living with HIV globally, down from the 39.5 million estimate made at the end of 2006.

Much of the reduction can be attributed to better surveillance techniques now being used in many countries, most notably India. Earlier this year, India reduced its HIV estimate by around 3 million people after numbers from a large household survey showed HIV prevalence was much lower than previous antenatal clinic and surveillance site data had suggested. This trend has been echoed in several other countries, and has led UNAIDS to adjust antenatal survey estimates downwards by an average factor of 0.8 for the 2007 report. Antenatal surveys are considered less accurate than more general population sampling, as many of the women that access antenatal clinics will be (by default) more sexually active than other members of the population, and at a higher risk of having HIV.

Not all of the reductions in the new report are attributable solely to technical changes however. Encouragingly, in countries such as Kenya, Zimbabwe and Côte d’Ivoire, HIV prevalence has dropped, a trend which country officials say is due to behaviour change and greater awareness of AIDS. In Sub-Saharan Africa as a whole, there were an estimated 1.7 million new HIV infections in 2007 – considerably fewer than in 2001, when comparatively accurate monitoring of HIV rates first began.

Deaths from AIDS have also fallen, with an estimated 2.1 million people dying in 2007, down from around 2.3 million in 2005.

“For the first time, we are seeing a decline in global AIDS deaths," said Dr. Kevin De Cock, director of the AIDS department at the World Health Organization.

He attributed this decline to better global access to antiretroviral drugs, as well as the fall in HIV prevalence now being seen in many African countries.

"These improved data present us with a clear picture of the AIDS epidemic," added UNAIDS Executive Director, Dr. Peter Piot. "Unquestionably, we are beginning to see a return on investment."

Not everyone believes that the current statistics are any more accurate than previous estimates however. The AIDS Healthcare Foundation in the USA is arguing that the uncertainty highlights fundemental problems in the world's approach to AIDS.

"These figures are rough numbers based upon extrapolations gleaned from unreliable data, since so few people are being tested," said Michael Weinstein, the AHF's president. "Let's stop guessing and make routine testing worldwide a priority."

If the numbers in the new report are accurate, it would imply that the overall numbers of people infected with HIV are still increasing - revised estimates showed there were 2.5 million new infections last year. But HIV incidence - the rate at which new infections occur - is going down, and UNAIDS now believe that it may have peaked in the late 1990s.

UNAIDS has urged for the new statistics not be taken as an excuse to become complacent, or cut funding for AIDS. Dr Dr. Paul De Lay, director of Evidence, Monitoring and Policy at the organisation said that even with the downward revisions, the US$ 40 billion per year recommended for a comprehensive response to AIDS by 2010 would only drop to US$ 38 billion.

Infectiousness Of HIV May Be Reduced By Suppressing Herpes Virus

A recent study of men co-infected with herpes simplex virus type 2 (HSV-2) and HIV revealed that drugs used to suppress HSV decrease the levels of HIV in the blood and rectal secretions, which may make patients less likely to transmit the virus. This study is published in the Journal of Infectious Diseases, now available online.

Most HIV-infected persons are also infected with HSV-2, which is the major cause of genital herpes. Prior studies demonstrated that the risk of passing HIV to a sexual partner is greater when the HIV-infected person has genital ulcers caused by HSV. Previous studies among HIV/HSV-2 co-infected persons and test-tube research have also demonstrated that HIV levels are increased during genital HSV reactivation.

In a pilot study of the effect of HSV-2 suppression on levels of HIV infectiousness, Connie Celum, MD, MPH, Richard Zuckerman, MD, MPH, and a team of researchers at the University of Washington and the research organization Impacta, in Lima, Peru performed a randomized, placebo-controlled cross-over study of daily HSV suppressive treatment in a small group of HIV/HSV-2 co-infected men who have sex with men.

Twenty men aged 22 to 41 enrolled in this trial, which took place in Peru. The men studied had no prior antiretroviral therapy and were not currently receiving antiretroviral therapy for HIV infection. Subjects were randomly assigned to the anti-HSV drug, valacyclovir 500 mg, twice daily or matching placebo for initial treatment. After eight weeks, subjects had a "washout period" in which they received twice daily placebo. Subjects then crossed over to the alternative treatment (placebo or valacyclovir) for eight weeks. Participants visited the clinic three times a week during each treatment arm. At each visit, rectal secretions were collected and weekly blood samples were obtained to determine levels of HIV.

Dr. Celum and her team of researchers found significantly reduced levels of HIV in blood by about 50 percent and rectal secretions by about 30 percent during the 8 weeks when the HIV/HSV-2 co-infected men received valacyclovir to suppress reactivation of HSV. This reduction in HIV levels could have a significant impact on transmission of HIV. Since the only intervention was daily valacyclovir to suppress HSV, this study adds weight to the other evidence that HSV-2 reactivation increases HIV replication. According to the researchers, additional "ongoing randomized trials will answer whether HSV suppression can reduce HIV transmission and address the potential for HSV suppression to delay anti-HIV therapy (antiretroviral) initiation."

First In Class Integrase Inhibitor, 'Isentress'(R) (Raltegravir), Recommended For European Licence For The Treatment Of HIV

'Isentress'(R) (raltegravir), Merck Sharp & Dohme Limited's (MSD) treatment for HIV infection, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Evaluation Agency (EMEA) in Europe. The CHMP opinion for a conditional marketing authorisation recommends that raltegravir is used in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in treatment-experienced adult patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy. A conditional marketing authorisation is granted to a medicinal product that fulfils an unmet medical need when the benefit to public health of immediate availability outweighs the risk inherent in the fact that additional data are still required. The marketing authorisation holder is likely to provide comprehensive clinical data at a later stage. The CHMP, comprised of regulators from all European Union countries, gave the positive opinion following a review of data supporting the efficacy, safety and tolerability profile of raltegravir. Following the conclusion of the CHMP's review, its opinion will be transmitted to the European Commission (EC). If the EC adopts the opinion, raltegravir will be the first integrase inhibitor approved for use in the treatment of HIV-1 infection.

The CHMP decision will apply to the 27 countries that are members of the European Union, including the United Kingdom, Germany, France, Italy and Spain. After undergoing fast-track review by the Food and Drug Administration, raltegravir was approved in the United States on 12 October 2007. We anticipate a decision from the CHMP on the approval of the product in Q1 2008.

Chris Round, Managing Director of MSD, commented, "The advent of raltegravir, used in combination with other antiretroviral medicines, represents a significant milestone in the treatment of HIV infection. Up until now, highly treatment-experienced adult HIV patients, whose infection is not well controlled by their existing antiretroviral drugs, have had very few treatment options. With this, the first integrase inhibitor, a new treatment approach for this patient population is now within our sights."

About raltegravir Raltegravir, to be used in combination with other antiretroviral medicines, offers a new therapeutic option in the management of HIV and AIDS. Up until now, there have been drugs in use that inhibit two other enzymes that play a key role in propagating HIV infection - protease and reverse transcriptase - but there have not, to date, been any approved drugs that inhibit integrase.

Raltegravir, previously referred to as MK-0518, is the first in a new class of antiretroviral agents called integrase inhibitors. Integrase is an enzyme only found in viruses. There is no corresponding enzyme in humans. Integrase is used by HIV to insert its newly made genetic material (DNA) into the host cell's DNA. Inhibiting integrase from performing this function blocks the ability of the virus to replicate and infect new cells.

Tolerability profile of raltegravir

Results from pooled safety analyses from three separate studies in treatment-experienced patients taking 400 mg of raltegravir dosed twice daily plus OBT* or placebo plus OBT showed that after 24 weeks of therapy the rates of discontinuation of therapy due to adverse experiences were 2.0 percent in patients receiving raltegravir plus OBT and 1.4 percent in patients receiving placebo plus OBT.1 In addition, drugrelated clinical adverse events of moderate to severe intensity occurring in 2 percent or more patients were diarrhoea (3.7 percent vs. 3.5 percent), nausea (2.2 percent vs. 3.2 percent) and headache (2.2 percent vs. 1.4 percent) for raltegravir plus OBT and placebo plus OBT, respectively.2

Prevalence of HIV

Prevalence of HIV in the UK has shown a marked increase since the early 1980s.3 In 2005, there were an estimated 63,500 people living with HIV in the UK.3

Risk Of HIV Transmission Increased By Unstable Housing Status

New studies show that there is a demonstrable correlation between a person's housing status and his or her likelihood of transmitting or getting HIV. The groundbreaking research from the Centers for Disease Control (CDC) and others has been reported in a special issue of the journal AIDS and Behavior¹.

According to researchers from the CDC, homelessness and unstable housing "increase the risk of HIV acquisition and transmission and adversely affect the health of people living with HIV." The findings prompted the researchers to issue a call to action that "homelessness be treated as a major public health issue confronting the United States."

The first publication of its kind, this special issue of AIDS and Behavior includes 18 peer-reviewed articles on the relationship of housing status and HIV risk and health outcomes, including a policy perspective from former HUD Secretary Henry Cisneros. Research studies reported in the issue show that:

* Homeless or unstably housed persons were two to six times more likely to "have recently used hard drugs, shared needles or exchanged sex" than similar low-income persons who were stably housed.

* Receipt of housing assistance enabled homeless persons with substance use and mental health problems to achieve stability over time and to cease or reduce both drug related and sexual risk behaviors.

* Over a 12-year period, housing status and receipt of housing assistance consistently predicted entry and retention in HIV medical care, regardless of demographics, drug use, health and mental health status, or receipt of other services.

These and other findings reported in the special issue add to the growing evidence that housing itself independently reduces risk of HIV infection and improves the health of persons living with HIV. This evidence challenges the prevailing "risky person" model for understanding the co-occurrence of homelessness, HIV/AIDS and poor health outcomes.

"The findings reported here suggest that the condition of homelessness, and not simply traits of homeless individuals, influences risk behaviors and health care utilization," says Housing and HIV/AIDS Special Editor Dr. Angela Aidala of the Columbia University Mailman School of Public Health. "This points to housing as a strategic target for intervention -- a potentially exciting new tool to end the AIDS epidemic in America."

$60 Million USAID Grant Goes To Indiana And Moi Universities' AMPATH Program To Combat AIDS In Kenya

AMPATH, a program that grew out of the partnership between Indiana University School of Medicine and the Moi (Kenya) University Teaching and Referral Hospital, has received a 5-year, $60-million grant to prevent and treat HIV/AIDS in Kenya. In addition, the IU School of Medicine will augment this with $6 million over the 5 years of the grant.

The principal investigator of the grant, Robert Einterz, M.D., is associate dean for international affairs at the IU School of Medicine and co-founder of the IU-Moi partnership and AMPATH. He will coordinate all the activities between IU School of Medicine, the Moi Teaching and Referral Hospital, Moi University School of Medicine and other U.S. partners and universities collaborating in the project.

"USAID made the grant to the AMPATH program because of its success in developing and implementing treatment and prevention programs in Kenya for the past decade," said Henrietta H. Fore, the administrator of USAID, director of foreign assistance and undersecretary for management. "Through President Bush's PEPFAR program, we are making resources available in countries with a substantial HIV/AIDS burden. These resources include support for prevention efforts, care and support, and treatment for affected patients," she said.

PEPFAR, the President's Emergency Plan for AIDS Relief, which is a 5-year, $15 billion program initiated in 2003, has treated over a million HIV-positive people in 15 focus countries in sub-Saharan Africa, Asia and the Caribbean. Sen. Richard G. Lugar (R-Ind.) is sponsoring legislation to renew PEPFAR at President Bush's requested increase of $30 billion over the next 5 years.

AMPATH currently provides care for 52,000 HIV-infected patients and has reduced the rate of infection significantly. With this agreement, the goal is to expand the program to provide care to an additional 150,000 Kenyans with HIV by 2012, of which at least 70,000 will be on antiretroviral drugs, and to interrupt the transmission of HIV through home-based counseling and testing in communities served by 19 facilities. In addition, the partnership intends to improve and expand control of tuberculosis, and assist and engage communities and families to meet the basic needs of 20,000 orphans and vulnerable children within the first 2 years of the grant.

"I am proud that our government is making such a dramatic commitment to saving the lives of people suffering from HIV/AIDS," said Dr. Einterz, M.D. "As a Hoosier, I am proud that IU has taken a leadership role in caring for our African neighbors with HIV. This grant supports our core services to treat HIV patients.

"Now, along with our Kenyan partners, we look forward to moving beyond this grant to pursue our groundbreaking mission of home-based counseling and testing, and expand beyond HIV to tackle maternal and infant mortality."

The PEPFAR target in Kenya is to have 250,000 Kenyans on antiretroviral therapy by Sept. 30, 2009. The target for infections averted in the same timeframe through the prevention of mother-to-child transmission programs and other prevention efforts is 425,000. By September 2009, 450 orphans and vulnerable children and 250 people living with AIDS will be receiving palliative care in Kenya.

The grant was announced in Nairobi on Nov. 19 during a signing ceremony in the Ministry of Health Headquarters attended by Administrator Fore; Dr. Einterz, U.S. Ambassador to Kenya Michael E. Ranneberger; AA/AFR Katherine J. Almquist; USAID/Kenya Mission Director Erna Kerst; Joe Mamlin, M.D., IU professor emeritus and co-founder of the IU-Moi Partnership; and, Moi University and USAID administrators and staff members.

Several Vaccine Trials Affected By Halt Of Merck's HIV Vaccine Trial

Several vaccine trials are being postponed or modified following the halt of Merck's experimental HIV vaccine trial, the Philadelphia Inquirer reports (Stark, Philadelphia Inquirer, 11/16). Merck in September announced that it had ended the Phase II trial, which began in late 2004 and involved HIV-negative volunteers, after the experimental vaccine failed to prevent HIV infection in participants or prove effective in delaying the progression of the virus to AIDS.

New data recently suggested that the vaccine was ineffective among some trial participants with a pre-existing immunity to a common cold virus and that the vaccine might have increased their susceptibility to HIV infection. The Merck vaccine was made from a weakened version of a common cold virus that served as a mode for providing three synthetically produced genes from HIV, known as gag, pol and nef.

After several days of discussions at an HIV Vaccine Trials Network conference last week in Seattle of Merck's trial, leaders of the trial on Monday decided to notify all of the trial's 3,000 participants whether they were given the vaccine or a placebo (Kaiser Daily HIV/AIDS Report, 11/14).

According to the Inquirer, other trials have been affected by Merck's trial because the experimental vaccines have a similar structure to Merck's vaccine. Trial participants now must be warned about the potential risks highlighted in the Merck trail if they participate in experiments that use a cold-virus carrier similar to Merck's product, Anthony Fauci, director of the National Institute of Allergy and Infectious Disease, said.

Gary Nabel, director of NIH's Vaccine Research Center, was scheduled to launch the PAVE 100 HIV vaccine trial early next year, but it recently was postponed until at least mid-2008. The PAVE vaccine uses three shots of DNA followed by a cold-virus booster shot, which has different components than the Merck vaccine. Nabel said he plans to modify the study by testing the vaccine only on people with limited exposure to colds and by increasing monitoring of patients.

Hildegund Ertl -- an immunologist at the Wistar Institute who is preparing to test an experimental HIV vaccine that uses a chimpanzee cold virus -- said the Merck trial also likely will affect her study, which is due to start in a year. "The bar will be raised," she said, adding that she hopes the chimp-based cold virus will not cause complications that the human cold virus might be causing (Philadelphia Inquirer, 11/16). Vaccines Using Some Viruses Require Further Testing, Study Says
Ertl and colleagues on Thursday in the Journal of Clinical Investigation reported that experimental HIV vaccines that typically use harmless viruses called adeno-associated viruses might damage the immune system by exhausting important cells, Reuters reports.

According to the group, AAV vaccines when tested in mice directly interfered with immune cells called CD8 T-cells, which are T-cells that a vaccine is supposed to stimulate to fight HIV. "The immune cells become exhausted," Ertl said, adding, "It is simply a defense mechanism of T-cells -- if there is too much antigen for too long a time they simply turn themselves off." The researchers said AAV vaccines should not be tested on people until more studies are conducted. Ertl said it is unclear whether her findings contributed to the developments in Merck's trial, which used an adenovirus.

Fauci said the study should be taken "with a very heavy dose of caution." He added that adenoviruses and adeno-associated viruses are very different microbes, despite the similarity of their names. "We may be dealing with apples and oranges," he said.

Pat Fast of the International AIDS Vaccine Initiative said the group has stopped testing AAV vaccines. "While we find the AAV study by Dr. Ertl and her group ... very interesting and we'll consider whether it can inform our future studies, their study was conducted in mice and there are fundamental differences between mice and humans in their respective immune responses, particularly with regard to the immune response against HIV," Fast said in a statement (Fox, Reuters, 11/15).

The study is available online (.pdf).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation. © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

AMA Recommends Routine HIV Testing While Protecting Patient Autonomy, Privacy

The American Medical Association recently updated its HIV testing policy to include guidelines supporting routine HIV testing, while continuing to advocate for the protection of patient privacy and autonomy, the AP/Google.com reports (AP/Google.com, 5/14).

"Understanding and treatment of HIV has grown substantially over the past few decades," Ardis Hoven, an AMA board member, said, adding, "new policy calls on physicians to routinely test consenting adult patients for HIV and reflects the reality that if HIV is detected early patients can lead full and productive lives" (AMA release, 11/13).

CDC in September 2006 released revised recommendations on HIV testing in the U.S. The recommendations advise that HIV tests become a routine part of medical care for residents ages 13 to 64 and that requirements for written consent and pretest counseling be dropped. According to a study published last month in PLoS One, more than 30 states have laws that hamper doctors from implementing the recommendations (Kaiser Daily HIV/AIDS Report, 10/11).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation. © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Virus Used In HIV Vaccines Weakens Immune System

A new US study has shown that some of the viruses used as carriers in clinical trials for HIV-1 vaccines weaken the immune system and may do more harm than good.

Researchers primed the immune systems of laboratory mice by exposing them to fragments of HIV carried by rAAV (recombinant adeno-associated virus (rAAV) vector), a type that has been used recently in human trials. This resulted in the anticipated creation of special T cells against HIV, but they didn't work properly. They couldn't fight against infection, they didn't release enough cytokines to activate an appropriate immune response, and they didn't reproduce when exposed to HIV in a booster.

The study is the work of Dr Hildegund C.J. Ertl, director of the Wistar Institute Vaccine Center, an independent nonprofit biomedical research institute based in Philadelphia, Pennsylvania, and colleagues, and is published in the November 16th online issue of the Journal of Clinical Investigation.

Leading efforts in human trials to develop an HIV vaccine have depended on the use of viruses to carry scraps of HIV virus as a way to get the patient's immune system to make antibodies against HIV.

However, more recently, evidence has been coming forward that some of these viral "vectors" may weaken the immune system and should not be used.

This study from Ertl and colleagues gives further evidence of this, and suggests that some viral vectors could do more harm than good.

Ertl and colleagues found that while the rAAV based vaccine managed to stimulate the immune system to produce T cells specifically against HIV, as intended, those same T cells also undermined the immune system in various ways.

"Put simply", said Ertl, these results "mean that AAV vaccines against HIV may potentially cause harm and that, without additional pre-clinical studies, they should not be used in humans".

Using laboratory mice, Ertl and colleagues primed the immune system against HIV with an experimental rAAV based vaccine. Then, as would be done in a typical vaccine regimen, they followed this with a booster immunization using a vaccine based on another viral vector, adenovirus (Ad). They also carried out some booster immunizations using other viral vectors.

When they looked at the resulting immune response using follow up assays, they found that in all booster immunization cases, the HIV specific T cells induced by the rAAV vector were ineffective at preventing infection, regardless of time between prime and booster. The T cells protected poorly against HIV, they failed to secrete sufficient levels of cytokines, chemicals that stimulate the immume response, and they did not replicate sufficiently in response to the booster.

The results indicate a condition known as "T cell exhaustion", something that has been observed before with HIV, hepatitis B and hepatitis C, and some cancers like melanomas, said the researchers.

The researchers concluded that:

"Our data suggest that rAAV vectors induce functionally impaired T cells and could dampen the immune response to a natural infection."

Ertl questioned the rationale for injecting people with "a vaccine that's going to have a detrimental effect".

"AAV vaccines against HIV may do more harm than good by robbing people of their natural immune response to HIV," she warned.

Mozambique To Revise National HIV/AIDS Prevention Strategy, Health Minister Says

The Mozambican government has decided to revise its national HIV/AIDS prevention strategy after finding that the current efforts have not been effective in controlling the disease, Health Minister Ivo Garrido, recently said, AIM/AllAfrica.com reports. Garrido, who also serves as the spokesperson for the Steering Council of the country's National AIDS Council, said a meeting of the council held on Monday highlighted 10 areas that should guide the revision.

He said that the AIDS council will seek to increase coordination between HIV/AIDS advocacy groups in the country; develop a mechanism for gauging the effectiveness of HIV prevention strategies; and improve HIV counseling and testing programs. The review also will address the definition of "high-risk groups," Garrido said. He said that he believes "almost everybody" is at risk but added that a task group was established to investigate this issue.

Garrido said the Steering Council hopes to have "proposals on coordination" by early next year. The country in 2004 had an estimated HIV prevalence of 16.2% among adults ages 15 to 49 (AIM/AllAfrica.com, 11/14).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation. © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Opinion Piece Examines HIV/AIDS Policy Views Of Giuliani Adviser

A recent opinion piece by Sally Pipes -- president and CEO of the Pacific Research Institute, a think tank that receives some funding from drug companies -- about intellectual property rights and compulsory licenses for patented antiretroviral drugs is "frightening," Andrew Green, a publishing fellow, writes in the American Prospect. If Pipes were "just running a think tank with pharmaceutical funding, it could be read as a shill piece and dismissed. But there's more to Pipes' biography: She is also a health care adviser to Rudy Giuliani," the former New York City mayor who is running for the Republican presidential nomination, Green adds (Green, American Prospect, 11/15).

In her opinion piece, Pipes says it was a "staggering display of cluelessness" for Rep. Tom Allen (D-Maine) and Sen. Sherrod Brown (D-Ohio) to sponsor a resolution that praises the Thai government for its decision to issue compulsory licenses to make generic versions of patented antiretroviral drugs. She adds that Thailand's actions "threaten to upset the economic incentives that allow Western firms to produce novel cures," saying, "Without patent protections, the drug industry as we know it would collapse, and development of new drugs would be significantly curtailed" (Kaiser Daily HIV/AIDS Report, 10/18).

Pipes opinion piece "can be read both as a signal that her role is expanding and as a preview of the HIV/AIDS policy she is encouraging Giuliani to adopt, specifically one without regard for the immediate need for as many cheap generic antiretrovirals as possible," Green writes. According to Green, while this is "cause for concern," the "real crisis" is that "Giuliani might actually be receptive to her arguments."

Giuliani has "expressed an interest in continuing and possibly expanding the President's Emergency Plan for AIDS Relief," but it is "apparent" he has "thought little about what that actually means," Green says. In addition, Giuliani has not described his HIV prevention strategy or whether he would expand treatment options, according to Green. "His lack of investment or concern about the issue leaves him vulnerable to insiders like Pipes, whose business-first agendas are prepackaged," Green writes. He adds that it is "not outlandish to think that [Giuliani] might make AIDS relief contingent on buying brand-name antiretrovirals" or "levy trade restrictions and financial penalties on countries, like Thailand, that determine the best way to immediately reach the most HIV/AIDS patients is to produce their own antiretrovirals."

Green suggests that all presidential candidates "study the AIDS policy Democrat John Edwards has introduced," adding that the "first move Giuliani should make, though, is to send Pipes back to the sideline and hire some advisers whose values aren't predicated on profit margins" (American Prospect, 11/15).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation. © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

New Guide on 'Unseen' Disabilities for Small Businesses

To help small businesses avoid unintentionally discriminating against people living with long-term conditions, such as HIV and cancer, the National AIDS Trust has produced 'You can't always tell- a guide to 'unseen' disabilities for small businesses'. The free guide provides clear, practical advice to help small business owners ensure that they are providing a fair and equal working environment for employees who may be living with one of these conditions and that they are not breaking the law.

more...

No Increase in HIV Prevention Spend Despite Massive Increase in Need

The results of a survey by the National AIDS Trust suggest that investment in HIV prevention in England has stagnated, and probably decreased, over the last ten years, despite the fact that the potential for HIV transmission in the UK is greater than it has ever previously been.


more...

New Issue of Impact Examines HIV and the Law

The National AIDS Trust has launched the latest issue of Impact, its policy bulletin which stimulates debate on key HIV policy topics. This issue focuses on HIV and the law and aims to give an overview of both the current legal developments that can affect the lives of people living with HIV and the work that the National AIDS Trust and other organisations are doing to ensure that the law protects, rather than infringes, the rights of people living with HIV.

more...