Clinical Trials Have Gone Global: Is This a Good Thing?

via plosmedicine.org, by Trudie Lang and Sisira Siribaddana

Why Do We Need Trials and What Makes a Trial a Trial?

Clinical trials are needed globally to reduce disease burdens by helping developing safe and effective new therapies and vaccines. These solutions may be for non-communicable diseases like cancer and diabetes, or, as is especially needed in the poorest regions of the world, infectious disease. Developing countries are under-represented in research due to lack of commercial viability and trained researchers, yet it is in these poorest regions where research-led solutions could bring the greatest impact to high rates of early mortality.

As a research tool clinical trials are fundamental in the effort to develop new products by gaining the data required by regulators, whether for product license extensions for existing therapies for common ailments or to bring cutting edge new therapies and vaccines into approved use. However, there is also a need for clinical trials to bring evidence to determine how to improve the management of health issues; these studies often do not involve a medicinal product but instead compare different options, such as different types of management of an illness in hospital with community-based care. Or, for example, a clinical trial might be used to assess different mechanisms to improve patient adherence to therapy. These pragmatic disease management trials can bring about significant improvements in public health and often require large yet simple trial designs.

The World Health Organization and journal editors define clinical trials as “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes” [1]. Patients may be randomised to an intervention involving either an investigational new product or the standard-of-care treatment, or the patient might be randomised to be cared for by nurses who have been trained in one of two or more comparative ways.

Read the rest.


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ARV gel almost ready to roll out

via the Daily News, by Liz Clarke

In the time it takes parents to see their children grow from birth to adulthood, the vaginal gel containing the antiretroviral tenofovir has been under close and intense scrutiny.

Now nobody is more keen to see the fast-track roll-out of the life-saving microbicide than Professor Quarraisha Abdool Karim.

Research initiated 20 years ago at the Medical Research Council and in the past ten years at Caprisa finally culminated in a definitive proof that a microbicide, namely tenofovir gel, reduces the risk of women contracting HIV.

“Twenty years might sound a long time,” she said this week, “but this sort of science requires painstaking input from every member of the research team. We have had to ensure that every avenue – from concept to proof – has been covered. Now that we can prove that tenofovir gel works, we are looking forward to implementing the next step.”

That next step, awaiting approval from the Medicines Control Council, will test the feasibility of integrating tenofovir gel provision into family planning services.

As a principal researcher in the Caprisa 004 scientific research programme, Abdool Karim demonstrated that the gel prevented both HIV and Herpes Simplex Virus (HSV) Type 2 infection.

It’s a finding that has been lauded as one of the most significant scientific breakthroughs in the fight against Aids by WHO, UNaids and several leading organisations

“But there is no time to rest on these laurels,” she says. “There is much work still to do.”

Read the rest.


[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

The Latest Treatment Action Campaign (TAC) Briefing - Antiretrovirals and Prevention

via the Treatment Action Campaign (TAC), by Catherine Tomlinson and Nathan Geffen

Exciting new evidence has demonstrated the potential of antiretroviral medicines (ARVs) to prevent HIV from being sexually transmitted. This TAC briefing explains the evidence and then discusses policy implications.

Our recommendations

1.The WHO must release its guidelines on serodiscordant couples.
2.People living with HIV should be offered highly active antiretroviral treatment (ART) when their CD4 counts fall below 350 cell/mm3, or if they have an AIDS illness or TB.
3.HIV-positive people in serodiscordant couples should be offered ART irrespective of their CD4 count.
4.For serodiscordant couples trying to conceive, both partners should be offered ARVs until conception is confirmed, after which the HIV-positive partner should continue on ART.
5.Pre-exposure prophylaxis (PrEP) should be made available to sex workers.
6.In other cases, pre-exposure prophylaxis should be made available to HIV-negative people who request it or who will --in the opinion of their nurse or doctor-- likely benefit from it.
7.The rollout of ARVs for prevention must not divert funding away from treatment programmes. Achieving universal access for people with HIV must remain the priority for governments, policy makers and funders.
8.Effective prevention interventions such as voluntary medical male circumcision and ensuring availability of male and female condoms continue to be critically important.

Read the rest.

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Treatment as Prevention – The Tough Road Ahead

Via PlusNews.

The sixth International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention started optimistically as the hype surrounding the use of antiretroviral treatment to prevent HIV infection gained momentum. But the focus of much discussion in Rome from 17-20 July will undoubtedly be on how to transform the recent promising research findings into workable policy.

The most significant of these is the HPTN052 randomized control trial, which found that earlier antiretroviral treatment can reduce the risk of heterosexual HIV transmission by as much as 96 percent; other studies have proven the efficacy of ARVs for prevention in HIV-negative people.

"We need to ensure that the advances we are making in research – such as the now proven concept of antiretroviral treatment as a means of HIV prevention – are translated into action for people in developing countries," said IAS local co-chair Stefano Vella, research director at Italy’s Istituto Superiore di Sanità, at the official opening of the conference.

But translating the research into action will require money, and if recent trends are any indication, that will be difficult, and there is much scepticism about the ability to significantly increase the numbers on treatment with such limited funds.

Donor pressure
"We need to keep up the pressure on donors... Donors are used to seeing costs rising year after year, but now we can show them a light at the end of the tunnel... We can show them that investing today will lead to lower costs tomorrow," Brenda Waning, coordinator of market dynamics with the health financing mechanism, UNITAID, said. "We also need to learn how to do more with limited resources."

Treatment as prevention will mean putting significantly more people on treatment earlier; at present, 15 million people are estimated to need ARVs – only 6.6 million have access to them.

"Treatment as prevention is possible, it is feasible, but we must not fool ourselves into thinking it's going to be easy," said Paul de Lay, deputy executive director of UNAIDS. "We put an additional 1.4 million new people on treatment in 2010 – if we maintain that momentum we will not achieve the goal of 15 million on treatment by 2015.

"We need to get to US$22 to $24 billion a year from the $15 billion a year we are currently spending; we need African governments to abide by the Abuja Declaration commitment to spend 15 percent of national budgets on health and we need donors to meet their commitments," he added.

"If we can convince donors that we can stop the epidemic within a finite amount of time, the money will be found," said Brian Williams, an epidemiologist with the UN World Health Organization (WHO).

Scaling-up HIV testing
Key to putting more people on treatment earlier will be finding those who need it; according to De Lay, most countries with hyper-endemic epidemics are testing just 4 percent of their populations.

Read the rest here.

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

AIDS conference opens in Rome

This the beginning of IRMA's coverage of the IAS conference in Rome which opened yesterday, and which is being attended by several IRMA advocates.

Via Associated Press, by Alessandra Rizzo.

The head of the United Nations AIDS program called Sunday for an increase in access to drugs that help treat or prevent the spread of the disease, saying it is "morally wrong" to keep millions of people off lifesaving medication.

Michael Sidibe, executive director of UNAIDS, said the gap in access to HIV treatment should be closed both within and between countries.

Sidibe called for better delivery on the ground, a reduction in the number of years it now takes to turn scientific discoveries into actual progress for the poor, and increased cooperation among states, pharmaceutical companies and international organizations.

"We must use innovation to overcome social division and inequity," he said at the opening of an international AIDS conference in Rome.

In Africa, the hardest hit continent, 6.6 million people are now on AIDS medication, but 9 million people eligible for treatment are on waiting lists, according to the World Health Organization. In the United States, many state assistance programs that help people access AIDS medications also have waiting lists.

"Most of those people don't know what'll happen to them. Do we tell them that they should die?" Sidibe said. "Having 9 million people wait day and night with their families is morally wrong. It is socially unacceptable."

The conference opened a few days after the announcement of a significant scientific breakthrough in stopping the spread of the virus: Two studies conducted in Africa showed that an antiretroviral drug made by United States firm Gilead Sciences already known to help prevent the spread of the virus in gay men also works for heterosexual men and women, researchers said. One of the studies showed the drug lowered the risk of infection for those believed to be regularly taking the pills by roughly 78 percent, the researcher reported.

In both studies, participants were also offered counseling and free condoms, which may help explain the relatively low overall infection rate.

According to figures provided at the conference, more than 25 million people have died of AIDS-related illnesses since the beginning of the pandemic 30 years ago, and an estimated 33.3 million people are currently living with HIV. Every day, 7,000 people across the world are infected, and more than 4,900 die from AIDS-related illness.

Even as conference speakers hailed the encouraging scientific advances, questions remained unanswered: How to make sure people remain on treatment, how to achieve universal coverage and how to reduce the risk of people abandoning condoms? Sidibe said these questions needed urgent answers.

And, he added, any discovery must be translated more quickly into policies accessible to those who need treatments, particularly in poor nations. Sidibe also said any trade agreement that would limit access to medication, especially generic ones, should be opposed.

That concern was shared by Elly Katabira, the president of the International AIDS Society and conference chair, who said: "I hope our voice will be heard in asking that access to all drugs, including generic drugs, will not be diminished by new laws or regulations anywhere in the world."

Gilead Sciences Inc., based in California, is a major producer of AIDS drugs. Two of its pills — Truvada and Viread — were used in the recent studies conducted in Botswana, Kenya and Uganda. The company has recently agreed to allow a range of its AIDS drugs to be made by generic manufacturers, potentially increasing their availability in poor countries.

The conference organized by IAS gathers some 5,000 researchers, scientists, clinicians and public health experts. It runs through Wednesday.

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

UNAIDS rejects prejudice and misconceptions about men who have sex with men and transgender people

Via UNAIDS.

UNAIDS lauds efforts by India’s National AIDS programme to provide HIV services for men who have sex with men and transgender people. Currently around 67% of men who have sex with men in India are accessing prevention services. According to estimates of the National AIDS Control Organization, there are more than 400 000 men who have sex with men inIndia; HIV prevalence in this population is about 7.3% compared to a national adult HIV prevalence of 0.31%.

“India’s rich tradition of inclusivity and social justice must include men who have sex with men and transgender people,” said Michel Sidibé, UNAIDS Executive Director, on the side lines of the National Convention of Parliamentarians and elected representatives. “India’s successful AIDS response has been possible due to the strong participation of communities of men who have sex men, sex workers, people who inject drugs and transgender people backed by a strong and progressive National AIDS policy.”

UNAIDS welcomes the call by the Prime Minister of India, Dr Manmohan Singh, to have an “HIV sensitive” policy and programmes so that the marginalized populations affected by HIV are not denied the benefits of health and development programmes. “We should work to assure for them a life of dignity and wellbeing. We have to ensure that there is no stigma and discrimination towards HIV infected and affected persons,” said Dr Singh. During the inauguration of the National Convention, Dr Singh reiterated his government’s strategy to provide HIV services to groups at higher risk of HIV infection.

“There is no place for stigma and discrimination on the basis of sexual orientation,” said Mr Sidibé. “I welcome the bipartisan call by Mrs Sonia Gandhi and Mrs Sushma Swaraj to end all forms of stigma and discrimination against people at increased risk of HIV infection.”

In 2009 the Delhi High Court overturned a law that criminalized consensual adult sexual behaviour. This stand was also supported by the Government of India in its affidavit filed with the Supreme Court.

“Consistent with WHO’s disease classification, UNAIDS does not regard homosexuality as a disease,” said Mr Sidibé. According to the recently released UNAIDS and WHO guidelines on prevention and treatment of HIV and other sexually transmitted infections among men who have sex with men and transgender people, legislators and other government authorities should establish anti-discrimination and protective laws in order to eliminate discrimination and violence faced by men who have sex with men and transgender people.

UNAIDS is committed to providing support to India’s successful AIDS response, which has seen new HIV infections drop by more than 50% in the last decade. India currently produces more than 85% of high-quality generic antiretroviral drugs for the majority of low- and middle income countries.India’s courts have progressively protected the human rights of people living with HIV and men who have sex with men by striking down discriminatory laws.

UNAIDS will work with the Government of India, civil society and community groups in realizing the vision of zero new HIV infections, zero discrimination and zero AIDS-related deaths in India.


Find the statement here.

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

New Guidelines on HIV Programming for MSM

Via IRIN.

HIV and gay rights activists say new guidelines released by the UN World Health Organization (WHO) on HIV programming for men who have sex with men (MSM) will not only improve health service provision for MSM, but will also act as an advocacy tool in the fight for the rights of this marginalized population.

"The document provides well-researched and evidence-based recommendations for HIV prevention and treatment of MSM, which will be useful for clinicians," said Kevin Rebe, a doctor with Health4Men, a South African health service provider which caters specifically for MSM. "The language of the paper is couched in human rights, and makes a strong call for decriminalization of same sex sexual activity, so it will also be useful for activists seeking to end discrimination."

The guidelines are designed for use by national public health officials and managers of HIV/AIDS and STI (sexually transmitted infections) programmes, NGOs and health workers. They contain MSM-specific programme activities such as the use of water- and silicone-based lubricant for the correct functioning of condoms during anal sex.

The guidelines do not advise medical male circumcision - a measure WHO recommends for HIV prevention among heterosexual men - for HIV prevention among MSM due to the lack of sufficient research on its effect of its use in MSM sexual activity.

They further recommend that health services adhere to the principles of medical ethics and the right to health, and ensure that MSM feel comfortable enough to seek medical care, with MSM-specific health needs catered for within national health systems.

"Like many other African countries, all men in South Africa are assumed to be straight, so health workers are not aware of the need to identify people of different sexualities during consultations; outside of centres like ours, there is little competency in providing health care to MSM," said Rebe. "By availing this knowledge, the guidelines will empower health workers to provide better care to MSM."


Wake-up call

In countries like Uganda, where homophobia is deeply entrenched both within society and the law, gay rights groups hope the new guidelines will serve as a wake-up call to the government about the need to include MSM in HIV programming.

"I hope the new guidelines will be an eye-opener to the government, who have so far ignored MSM within HIV prevention, treatment and support; it should show them that MSM exist in Uganda and are at high risk," said Frank Mugisha, executive director of the NGO Sexual Minorities Uganda. "They therefore cannot be ignored and urgently require HIV interventions."
 
Read the rest here.

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

WHO Urges India to Address Medical Needs of Gay Men, Transgenders

Via The Hindu.

India must make an “extra effort” in addressing the medical needs of men who have sex with men (MSM) and transgender people affected by HIV and sexually-transmitted infections, a top WHO official said on Tuesday.

“Though India has addressed the HIV problem among MSM and transgender people, it has to make an extra effort in scaling up treatment and prevention services for HIV and sexually transmitted infections,” Dr. Gottfried Hirnschall, Director of HIV Department in World Health Organisation, told PTI.

In India, around 1.5 million transgender people and around 30.5 million MSM are vulnerable to the HIV and sexually-transmitted infections.

“In Asia, the odds of MSM being infected with HIV are 18.7 times higher than in the general population and the HIV prevalence ranges from 0 per cent to 40 per cent,” he said.

The WHO on Tuesday issued, for the first time, new public health recommendations to sensitise governments and health pressure groups in the developing world about the need to provide adequate medical treatment and prevention services to MSM and transgender people affected by HIV and sexually transmitted infections.

The guidelines call on governments to develop anti-discrimination laws and measures and provide more inclusive services for MSM and transgender people.

Health pressure groups must provide HIV testing and counselling followed by treatment for patients with CD4 count 350 or below.

Dr. Hirnschall said “criminalisation, and legal policy barriers play a key role in the vulnerability of MSM and transgender people to HIV.”

Read the rest here.

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

WHO Announces New HIV Strategy for 2011-2015

by Aldona Martinka

According to a news release from the United Nations’ website, the five year strategy that the World Health Organization announced yesterday could prevent as many as 4.2 million new HIV infections and save as many as 2 million lives.

The strategy for the coming years focuses on four strategic directions: “To optimize HIV prevention, diagnosis, treatment and care outcomes”, “to leverage broader health outcomes through HIV responses”, “to build strong and sustainable health systems “, and “to address inequalities and advance human rights.” Within these directions there are many exciting goals, such as reducing stigmatization of those with HIV/AIDS, promoting human rights where abuses are barriers to getting tested and/or treated, and driving the development of new preventative interventions.

The strategy specifically mentions PrEP, ARV therapy as prevention, and microbicides as potentially effective new interventions, and plans to guide countries in implementing these programs when the results of evaluations become widely available.

This strategy, unanimously adopted by the Sixty-Fourth World Health Assembly, will serve as a guide for the actions of the WHO and for governments worldwide in facing the AIDS crisis in the first half of the second decade of the new millennium.

Read the full strategy here, or get more information here.


[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

HIV/AIDS: Straight Talk with Stephen Lewis

Via PlusNews

A former politician, diplomat and aid worker, few people have witnessed the fight against HIV from as many international vantage points as former UN Special Envoy for AIDS in Africa, Stephen Lewis.

Now co-director of the international advocacy organization, AIDS-Free World, Lewis spoke to IRIN/PlusNews about the direction of the international response to HIV.

Excerpt:

The fight against HIV is at a very difficult moment, there's no question and for two reasons. First, the decline in funding could be truly catastrophic by or before the end of this year. Western governments, which are reducing their contributions to the Global Fund to Fight AIDS, Tuberculosis and Malaria, and the United States, which is flat-lining the US President's Emergency Plan for AIDS Relief, do it all on the ostensible rationale of the financial crisis but that's just utter nonsense. There's never a financial crisis when you have to bail out the banks or provide a stimulus package... there's only a financial crisis when you’re dealing with global public health and putting people at risk.

We have 10 million people who require HIV treatment urgently and there is no guarantee we'll be able to roll out the drugs fast enough to keep people alive. There are already many projects in Africa that cannot enrol new patients. This is preposterous. It's happening in Malawi, it's happening in Uganda, it's happening in Zambia, and there are drug stock-outs. It's becoming increasingly clear that the hazard of cutbacks financially is putting more and more lives at risk.

The other factor: there is a determination to expand the portfolio of health interventions in a way that is prejudicial to the work on HIV and AIDS. HIV is possibly the worst pandemic in human history - 30 million people dead, 33 million people infected... 15 million orphans – how in God's name is [this] not exceptional?

That doesn't mean that other things should be prejudiced by AIDS... no one who works on HIV and AIDS would deny funding for maternal and child health or for non-communicable diseases... You have a moral obligation to enlarge the pie to encompass all the requirements of health and what [funders] are doing in a kind of Pavlovian, unthinking way is to fail to analyze the overall needs. 

Read the rest

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

WHO Priority Interventions - 2010

Priority Interventions
HIV/AIDS prevention, treatment, and care in the health sector

The document aims to:

• describe the priority health sector interventions that are needed to achieve universal access to HIV prevention, treatment and care;
• summarize key policy and technical recommendations developed by WHO and its partners and related to each of the priority health sector interventions;
• guide the selection and prioritization of interventions for HIV prevention, treatment and care;
• direct leaders to the key WHO resources and references containing the best available information on the overall health sector response to HIV/AIDS and on the priority health sector interventions with the aim of promoting and suporting rational decision-making in designing and delivering HIV-related services.

UNAIDS, WHO Meeting: Follow-Up Studies Of ARV-Containing Microbicide Gel Must Start Soon

via Kaiser Family Foundation

Experts gathered at a joint meeting of UNAIDS and the WHO last week called for two additional clinical trials to test the effectiveness and safety of a microbicide vaginal gel containing the antiretroviral tenofovir, which previous studies have shown reduces the risk of HIV transmission in women who used it before and after sex by 39 percent, PANA/Afrique en ligne reports (9/5).

"The results of the first trial of the tenofovir-based gel, [conducted by the Centre for the AIDS Programme of Research in South Africa (CAPRISA)] … announced in July at the XVIII International AIDS Conference in Vienna, must be confirmed before the product can be made available for general use," U.N. News Centre reports.

The follow-up trials will build off of "[t]he CAPRISA study [which] was conducted in South Africa with women aged 18 to 40 years who used the gel once during the 12 hours before sex and once during the 12 hours after sex," the news service continues. One of the two trials, which will also be held in South Africa, will test the effectiveness of the microbicide in "sexually active 16- and 17-year-olds in settings where HIV incidence is high," according to the U.N. News Centre.

"The other study will be conducted in other African countries and examine if a different dosing schedule is safe and effective. It will test if a single application of the gel before sex, or failing that immediately after, is equally effective and safe as the original two-dose regimen," the news service adds (9/3).

According to VOA News, "The first trials are likely to get under way early next year. The next phase of the research is estimated to cost $100 million." The article includes comments by UNAIDS Chief Scientific Adviser Catherine Hankins (Schlein. 9/3).

Pharma Times, also reporting on the meeting, writes, "An ongoing trial being conducted by the Microbicides Trial Network, which is evaluating the same gel used daily, will generate additional data on safety and product use. Research in the communities where the CAPRISA 004 trial was carried out will look at how to best promote, distribute and monitor gel use through existing family planning facilities." The news service continues, "While participants at the meeting in Johannesburg agreed on research priorities for the tenofovir gel, concerns were expressed over the limited funding committed so far to carry forward the next phase of research" (Mansell, 9/7).

The New York Times reports that "about $58 million of the $100 million needed for follow-up research has been pledged, according to UNAIDS." The newspaper explores the perception that donor nations are rethinking their commitments because of "shifting global health priorities and tight finances," and how "[e]xperts say investing in AIDS prevention is fiscally far preferable to the costs for lifelong treatment." The article includes quotes from Stefano Bertozzi of the Bill & Melinda Gates Foundation, Nomfundo Eland of Treatment Action Campaign, Hankins of UNAIDS, and Mead Over of Center for Global Development (Dugger, 9/3).

Source.

Nurses 'critical link' in implementing new WHO HIV guidelines

via Aidsmap, by Carole Leach-Lemens
 
Active support of nurses is critical for effective implementation of the revised World Health Organization (WHO) HIV treatment guidelines, MaryAnn Vitiello and Suzanne Willard state in a letter published in the August 2010 online edition of AIDS.

The authors are nurses who work in countries which receive US PEPFAR support, and they are affiliated with the International Training and Education Center on Health (I-TECH) and the Elizabeth Glaser Pediatric AIDS Foundation respectively.

While a well-informed and highly skilled nursing workforce is considered essential for all national health care systems, in reality it just doesn’t happen, note the authors.

Nurses are on the front lines of care, represent the largest group of health care workers and have the most interaction with women and children, highlight the authors.

Recognising and understanding the training and support needs of those who interact with women and children affected by HIV – nurses (as well as clinical officers, midwives, physicians and the community)- is vital to ensuring the successful implementation of the guidelines, and an integral part of a comprehensive approach to the prevention of mother-to-child transmission, Vitiello and Willard note.

Nurses are proven leaders in HIV treatment and care, often under the most trying of circumstances, and nurses in both resource-rich and resource-poor settings continue to adapt standards and practices to meet the needs of their patients, say the authors.

For more click here.

New Study: Neither Wealth Nor Poverty are Reliable Predictors of HIV Infection in Africa

Via PlusNews

A new study has challenged widely held assumptions about income level in relation to HIV, finding that neither wealth nor poverty are reliable predictors of HIV infection in Africa.

Previously, the argument that poverty drove HIV epidemics was supported by the World Bank and UNAIDS, as well as less reliable authorities like former South African President Thabo Mbeki, who told the International AIDS Conference in Durban in 2000 that the disease was a partner with "poverty, suffering, social disadvantage and inequity".

More recent research suggests that the reality is far more complex. For example, Botswana and South Africa, described as two of the wealthiest countries on the continent, also have among the highest rates of HIV infection.

For the full study (published in the July issue of the Bulletin of the World Health Organization) click here.

U.S. and WHO guidelines call for earlier HIV treatment

via Bay Area Reporter, by Liz Highleyman

To coincide with World AIDS Day, the U.S. Department of Health and Human Services and World Health Organization both released revised guidelines calling for earlier initiation of antiretroviral therapy (ART) for HIV.

The updated DHHS "Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents," issued December 1, raise the CD4 T-cell threshold for starting treatment from 350 to 500 cells/mm3.

The revision also adds the first integrase inhibitor, raltegravir (Isentress), as a "preferred" drug for first-line therapy. Efavirenz (Sustiva), ritonavir-boosted atazanavir (Reyataz), and boosted darunavir (Prezista) are the other three preferred options – all used with tenofovir plus emtricitabine (the drugs in the Truvada combination pill) – while lopinavir/ritonavir (Kaletra) has been demoted to an "alternative."

Read the rest.

Testing Formula to Better Predict Treatment Failure/Drug Resistance

via Deborah Baron
IRMA Steering Committee Member

The Journal of the International AIDS Society published an article on a recent study testing a formula to better predict ARV treatment failure and possible drug resistance in the absence of viral load testing. According to a New York Times article on the study, "Scientists from Makerere University’s hospital in Kampala, Uganda, along with American and Belgian scientists, have developed a formula, based on close questioning of patients, for predicting which ones are most likely to have treatment failure."

The researches then compared their formula with the existing WHO guidelines, which relies on clinical and immunological criteria to identify treatment failure. They concluded that although "the WHO guidelines are used as a standard across many RLS [resource-limited setting, i]t is our view that this standard of care needs to be improved to reduce the late detection of viral failure and to minimize unnecessary switching of patients to second-line ART."

This formula could help provide useful insight to the ARV-based prevention research field, as it prepares for possible scenarios and challenges (if and when a product proves effective) around scaling up ARV-based prevention.

Check it out "Development and evaluation of a clinical algorithm to monitor patients on antiretrovirals in resource-limited settings using adherence, clinical and CD4 cell count criteria."

You can also link to the New York Times article on this study, "AIDS: Questions Help Find AIDS Patients Who Are Vulnerable to Drug Resistance"

Lack of services for Asia gays is fuelling epidemic

via The Earth Times

Manila - The World Health Organization (WHO) warnedTuesday that unprotected male-to-male sex was fuelling the spread of HIV and AIDS in Asia, where the epidemic could worsen amid a lack of services to gays. "Men who have sex with men have been identified as one of the most at-risk populations for HIV/AIDS," the Manila-based WHO Regional Office for the Western Pacific said in a statement ahead of a meeting in Hong Kong.

"Asia is believed to have the world's largest number of men having sex with men, estimated at 10 million," the office added.

WHO noted that a review in December 2007 of the HIV/AIDS situation in Asia showed that in Cambodia and Vietnam, men who have sex with men were more likely to contract the deadly virus compared with the general population.

The risk of infection was also 45 times higher for men who have sex with men in China.

Read the rest.

WHO and UNAIDS resource kit for writing Global Fund HIV proposals for round 9

As applicants prepare their proposals for the next round of HIV funding, Round 9, UNAIDS and WHO have jointly developed an online resource kit to provide guidance in planning and writing strong Global Fund proposals.

The Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund) is a financial mechanism that provides grants in support of evidence-informed, technically sound and cost-effective programmes for the prevention and treatment, care and support of persons infected and directly affected by HIV, tuberculosis and malaria. By 1 December 2008, it had signed grant agreements worth US$ 10.2 billion for 579 grants in 137 countries around the world.

The aim of the fund is to direct money to areas of greatest need so that a real difference can be made in peoples' lives. As a part of this process hundreds of pages of technical documentation on how to design programmes or write a grant proposal have been developed by a range of technical experts. The challenge for the country partners writing their proposals is sifting through these myriad long and complex guidelines.

To simplify this, the resource kit has been designed to focus on the essential points which are presented in a user friendly way. The information is structured in a way that echoes the development of a proposal. It is aimed to be a practical tool that country partners can use with ease.
People are already finding it useful. "In the jungle of technical guidance for writing proposals that's out there, communicating the unique relevance of this tool is the biggest challenge. However, country teams across this region have already begun to benefit from this important resource." said Geoff Manthey, UNAIDS Global Fund regional focal point, Asia Pacific Regional Support Team.

Compilation of guidance

The content of the resource kit is a compilation of existing guidance developed by different technical agencies including UNAIDS, UNFPA, UNICEF and the World Health Organization. In preparation of the kit, the team reviewed Global Fund feedback on previous proposals and identified recurring weakness areas so that the content of this kit could address these.

"This toolkit is the result of close collaboration between WHO, UNAIDS, and other UN and civil society partners," said Mazuwa Banda, Medical Officer, World Health Organization.

"We hope that it is widely distributed and, most importantly, used; and we will continue to work together to improve it in response to feedback from its users."

It includes a number of technical guidance notes on cross-cutting issues relevant in the design of any HIV programme. These include gender, human rights and law, sexual minorities and social change communication. A number of notes on health systems strengthening are also included as well as guidance on specific intervention areas including HIV prevention, treatment, care and support.

There are also a number of practical tools included on managing the proposal development process including a planning matrix and costing tool.

Know your epidemic

Country data is vital to knowing a country's epidemic in order to design an effective response. Statistics on HIV interventions, links to latest epidemiological fact sheets and other useful country information are also included in the resource kit.

Finding support

In addition to sharing guidance, the online kit includes a "Finding support" section which gives direction to assistance offered through WHO and UNAIDS as well as useful contacts and a list of focal points. While the response to and coordination of technical support to countries should be first addressed at country level within the UN theme group, WHO and UNAIDS can offer support by facilitating the proposal development process and providing general or specific technical guidance, to ensure that the proposal is technically sound and meets the other requirements. UNAIDS has established "Technical Support Facilities" across the world that help match countries technical assistance needs with most well suited technical assistance in the form of individuals and/or companies.

UNAIDS and the Global Fund

Given the complementary strengths and shared commitment to the global AIDS response, Global Fund and UNAIDS collaborate to accelerate progress towards universal access to HIV treatment, prevention, care and support services.

By offering a range of support to country partners to help applicants prepare strong proposals for Global Fund resources UNAIDS, as the United Nations coordinating programme on HIV, also helps to make the resources of the Global Fund work. UNAIDS also supports the Global Fund in monitoring and evaluating the performance of its grantees through strengthening the capacity of principal recipients and sub-recipients to report on grant implementation.

This collaboration is leading to real results on the ground as Nancy Fee who works in Indonesia as UNAIDS Country Coordinator notes: "As Indonesia has seen, a successful application to the Global Fund results in a grant that can make a huge difference to a country's AIDS response."

"Given all the guidance that exists on the application process, a user-friendly web-based tool such as this one, structured to compliment proposal development, can enable a country to navigate the complexities of the process and develop a strong proposal," she added.

Click here to check it out.

Can treatment-as-prevention end the pandemic?

AIDS activists around the world cautiously praised the findings of an important new study published today in the medical journal The Lancet. The study, by a group of scientists from the HIV/AIDS and STOP TB departments at the World Health Organization (WHO), uses mathematical models to test the effectiveness of a strategy that includes universal annual HIV testing and immediate treatment for those who are found to be HIV positive. The authors hypothesize that this strategy, if fully implemented, could reduce HIV rates in Southern Africa to 1 in 1000 by 2016 and to 1% prevalence in fifty years.

IRMA is pleased to see the recognition of treatment as an important element in a full spectrum of prevention options. We would like to point one one element from the study summary which is an annoyingly recurring phrase in global HIV policy and studies. The summary states: "We used data from South Africa as the test case for a generalised epidemic, and assumed that all HIV transmission was heterosexual."

To quote from our very own excellent report (if we do say so ourselves), Less Silence, More Science: Advocacy to Make Rectal Microbicides a Reality:

"By focusing almost exclusively on gay men, MSM, and the West when developing policy related to anal intercourse (AI) in the context of HIV prevention programming, we neglect to identify the prevalence of AI between women and men as well as the HIV prevalence among, and indeed, the mere existence of, gay men and other MSM in Asia, Africa and other parts of the developing world. This neglect costs lives. In its ground-breaking report Off the Map, the International Gay and Lesbian Human Rights Commission decried the wall of silence that surrounds AIDS and same-sex practices in Africa. The situation in developing countries outside of Africa is often much the same regarding the collective blind eye turned toward MSM and anal sex practices between women and men.

Precious little research has examined the role of AI in HIV transmission in developing countries. However, studies in Senegal, Ghana, Kenya and Sudan indicate that rates of HIV prevalence among MSM are significantly higher than in the general population. This has also been demonstrated in most countries of Latin America, and in several countries and cities in Asia.

The illegality of AI in many countries and jurisdictions, the strong taboo and homophobia associated with anal sex, and the imprecise language we use to describe populations and behaviours conspire to render these realities invisible. We tend to conflate sex acts with identity through the use of imprecise, misleading language. Phrases like “heterosexual transmission” mask the fact that women and men who identify as heterosexual engage in AI. This lack of clarity, honesty and specificity negates that a significant portion of the pandemic is likely driven by unprotected anal intercourse in regions broadly characterized as being “driven by heterosexual HIV infection.” In this construct, heterosexual HIV transmission automatically translates to vaginal intercourse. While identity, sexual orientation and sexual practices may be related, they are not always so clearly delineated. “HIV infection via unprotected vaginal intercourse” would be a more accurate phrase than “heterosexually acquired HIV infection”.

These are more than innocuous semantics; language matters. Inaccurate language impacts quite concretely on program design and delivery; on research design, particularly for microbicides; on stigma faced by communities, including gay men and other MSM; and, on the deceptive absence of other populations that engage in AI, including heterosexual men and women, lesbians, and bisexuals across the globe." (p.13-14)

The Lancet, Early Online Publication, 26 November 2008
doi:10.1016/S0140-6736(08)61697-9Cite or Link Using DOI

Universal voluntary HIV testing with immediate antiretroviral therapy as a strategy for elimination of HIV transmission: a mathematical model
Reuben M Granich MD a , Prof Charles F Gilks DPhil a, Prof Christopher Dye DPhil b, Prof Kevin M De Cock MD a, Brian G Williams PhD b

Background
Roughly 3 million people worldwide were receiving antiretroviral therapy (ART) at the end of 2007, but an estimated 6·7 million were still in need of treatment and a further 2·7 million became infected with HIV in 2007. Prevention efforts might reduce HIV incidence but are unlikely to eliminate this disease. We investigated a theoretical strategy of universal voluntary HIV testing and immediate treatment with ART, and examined the conditions under which the HIV epidemic could be driven towards elimination.
Methods
We used mathematical models to explore the effect on the case reproduction number (stochastic model) and long-term dynamics of the HIV epidemic (deterministic transmission model) of testing all people in our test-case community (aged 15 years and older) for HIV every year and starting people on ART immediately after they are diagnosed HIV positive. We used data from South Africa as the test case for a generalised epidemic, and assumed that all HIV transmission was heterosexual.
Findings
The studied strategy could greatly accelerate the transition from the present endemic phase, in which most adults living with HIV are not receiving ART, to an elimination phase, in which most are on ART, within 5 years. It could reduce HIV incidence and mortality to less than one case per 1000 people per year by 2016, or within 10 years of full implementation of the strategy, and reduce the prevalence of HIV to less than 1% within 50 years. We estimate that in 2032, the yearly cost of the present strategy and the theoretical strategy would both be US$1·7 billion; however, after this time, the cost of the present strategy would continue to increase whereas that of the theoretical strategy would decrease.
Interpretation
Universal voluntary HIV testing and immediate ART, combined with present prevention approaches, could have a major effect on severe generalised HIV/AIDS epidemics. This approach merits further mathematical modelling, research, and broad consultation.

For the full article: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(08)61697-9/fulltext.

Please share your views with IRMA!

Kenya Launches Male Circumcision Program

(from http://www.kaisernetwork.org/)

The Kenyan Ministry of Health on Monday launched a voluntary male circumcision program as part of the country's national HIV prevention strategy, the Kenya Broadcasting Corporation reports.The ministry has allocated one billion Kenyan shillings, or about $13.2 million, for the program over the next two years (Achienga, Kenya Broadcasting Corporation, 11/24).

In addition, Family Health International has received an $18.5 million, five-year grant from the Bill & Melinda Gates Foundation to establish the Male Circumcision Consortium in partnership with the Kenyan government, the University of Illinois at Chicago and EngenderHealth. The President's Emergency Plan for AIDS Relief also is supporting the program. The consortium will conduct research and training on the safest and most effective ways to provide male circumcision as part of an HIV prevention strategy.

The consortium's members have consulted officials from the World Health Organization to ensure the consortium's objectives are in line with WHO and UNAIDS recommendations on male circumcision. The consortium will support the Kenyan government and local partners to develop and implement the national male circumcision strategy. It also will expand a research and training center in Kisumu, Kenya, to train providers, increase capacity of health facilities and monitor outcomes. In addition, the consortium aims to address misunderstandings about male circumcision (FHI release, 11/24).

The program will be launched in six districts in Kenya's Nyanza province before being expanded to the rest of the country (Kenya Broadcasting Corporation, 11/24). The initiative aims to reduce HIV prevalence in Kenya by 60%, Public Health and Sanitation Minister James Gesami said Monday at the program launch. Gesami also emphasized the importance of ensuring that all circumcisions are performed in sanitary conditions. "Traditional circumcisers should use septic techniques by not using one knife on several individuals," he said.

WHO Country Representative David Okello said that circumcision should not be seen as an excuse to practice risky behaviors. "Circumcision should be promoted along with other HIV prevention strategies including safer sex, reduction in the number of sexual partners, plus the correct and consistent use of condoms," Okello said (Ndong'a, Capital News, 11/24).

Gesami added that the health ministry will provide no-cost counseling to couples on the benefits of male circumcision to prevent HIV transmission as part of the program. According to the Daily Nation, two-thirds of HIV-positive adults in Kenya are married or in a relationship, and one spouse is HIV-positive in 10% of marriages. Peter Cherutich, head of the national task force on circumcision, said that counseling is critical for couples and that women "have to be involved for the full benefits [of the procedure] to be felt" (Ngirachup, Daily Nation, 11/24).