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BANGKOK IAC Daily Highlights, Thurs July 17: microbicides, Global AIDS, treatment in Thailand
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STORIES BELOW
--Microbicides vs the Female Condom
--US Global AIDS Coordinator Randall Tobias at the Intl AIDS Conference
--UN's Kofi Annan Asks USA's Bush administration For $1 Billion Contribution to Global Fund
--Scaling up globally: access to treatment, treating opportunistic infections
--Saving children's lives: a possible and affordable option
--Thailand is forced to defer ARV drug plan
--Thai's to Launch AIDS Drug for Children in 2005
IAC 2004: Microbicides versus the female condom
HDN Key Correspondents Team
Today's Quote
"The world must really rapidly expand access to the treatment that is so desperately needed."
Dr Richard Feacham, Executive Director of the Global Fund for HIV/AIDS, TB and Malaria
"The female condom and microbicides are important protective options for women. Neither can take the place of the other."
When researchers on the female condom made a breakthrough and unveiled the first workable example in 1992, it was hailed as the "saviour of women's suffering" and a "tool to greater empowerment." But today the female condom is yet to make breakthrough in developing countries, and the focus has shifted to microbicides.
Microbicides are substances that (once researched and developed), will be applied by women before sex and will protect them against sexually transmitted infections such as HIV, and some can also be used as a form of contraceptive.
There are currently more than 50 microbicidal substances under investigation. Once developed, they could be used in the form of film, sponge, gel, cream or diaphragm. They could be applied daily, weekly or monthly depending on preference.
But microbicides will not be available for five or ten years, as even the International Partnership for Microbicides acknowledges. Meanwhile the female condom is already available, but is suffering from the lack of proper marketing and publicity in the developing world.
In his opening address at this Conference, United Nations Secretary-General Kofi Annan mentioned the importance of women's access to microbicides, but did not mention the role that could be played by the female condom in empowering women.
This lack of awareness of the potential of the female condom is a reflection of a general failure to recognise the potential importance of the female condom.
At a satellite session titled "Acting on rights, women and HIV/AIDS" there was a presentation on ethical and gender considerations linked to development of microbicides, but none on what the female condom has done to restore the rights of women.
Zeda Rosenburg from the International Partnership for Microbicides explained that microbicides, once available, may offer partial protection against new infections. She explained how successful microbicides would give women the right to sexual protection and the right to contraception, and could protect women from infection through vaginal tears or abrasion.
She confirmed, however, that it will take five to ten years to develop microbicides
This led some to ask the question: why the focus on microbicides, when they are not yet available, compared to the female condom, which is available? Shouldn't we be promoting universal access to the female condom?
Manju Chatani, from the Africa Microbicides Advocacy Group (AMAG), admits that there is need to popularise the female condom, but adds that microbicides should be researched and developed too.
"The female condom and microbicides are important protective options for women. Neither can take the place of the other," Chatani says. "We have seen the pressure exerted on HIV-positive women. This will not only give them hope, but also power," she added.
In this respect, Dr Rosenburg said that women had actively participated in clinical trials of microbicides in Ghana and South Africa, and had expressed willingness to use them once they are available.
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Office of The Global AIDS Coordinator: Randall Tobias
The Coordinator for U.S. Government Activities to Combat HIV/AIDS Globally is Randall L. Tobias. He has the rank of Ambassador and reports directly to Secretary Powell. The Coordinator's primary role is to advise, direct, shape, and oversee U.S. policy and programs designed to turn the tide against the global HIV/AIDS pandemic.
The Coordinator's mission is to establish primary responsibility for all resources and international activities of the U.S. Government to combat the HIV/AIDS pandemic, including U.S. contributions to the Global Fund to Fight AIDS, Tuberculosis, and Malaria, and to advance the HIV/AIDS prevention, care and treatment goals laid out by the President in his Emergency Plan for AIDS Relief.
The Coordinator chairs interagency meetings to establish and review policy and guidelines for U.S. agencies involved in this issue and to ensure a uniform U.S. Government approach to the fight against HIV/AIDS. The Coordinator is responsible for meeting the Administration's reporting requirements to Congress on all international HIV/AIDS matters, including the 5-year strategic plan and reports on the Global Fund to Fight AIDS, Tuberculosis and Malaria.
As of March 15, 2004, the Office of the U.S. Global AIDS Coordinator relocated to its new office facilities. New meeting location/street address: 2100 Pennsylvania Avenue, Suite #200, Washington, DC, phone: 202-663-2440, fax: 202-663-2979. Our new mailing address: SA-29, 2nd Floor, 2201 C Street, NW, Washington, DC 20522-2920.
Interview With Ambassador Randall Tobias at the International AIDS Conference
July 14, 2004
Kaiser Family Foundation
Bangkok, Thailand
Ambassador Randall Tobias, Head of the U.S. State Department's Office of the Global AIDS Coordinator, on Wednesday at the International AIDS Conference in Bangkok discussed U.S. HIV/AIDS policy in an interview with Kaiser Family Foundation Senior Fellow Jackie Judd for kaisernetwork.org, the official conference webcaster. The following are highlights from the interview. To view the entire interview, visit
http://www.kaisernetwork.org/aids2004/tobias .
"It's disappointing because this year for example the United States will commit almost twice as much to fighting international HIV/AIDS than the rest of the world's donor governments combined. So, in the context of the facts, it really makes no sense. But I think there are a number of people who have broader agendas that this kind of gets caught up in."
"Either intentionally or honestly, there are large numbers of people who simply are confused or misinformed or intentionally want to misunderstand what our strategy is."
"Our strategy is A and B and C; abstinence works, being faithful works, condoms work. They all have a role, but it's not a multiple-choice test where there's one right answer; all of the things have a place and they have a place in the President's emergency plan."
"One of the tragedies of the culture that's developed around this conference is that a relatively small number of people have commanded a very disproportionate share of attention, certainly of the media and probably of the people attending the conference, and as a result of that, attention is not being directed at the other aspects of the conference where people could be exchanging ideas I think a little more efficiently than perhaps takes place."
"You really need to say was the value that was generated by this kind of a conference worth that kind of money or could part of that money be spent more efficiently in some other directions in order to fight HIV/AIDS."
"There is a kind of an industry that's developed of people who spend their time talking to each other, and as others who have said who have been engaged in this a lot longer than I have, we really need to do the kinds of things that this Conference is intended to do, but we also need to focus more and more of our energy and attention on getting at it. And really getting at the implementation of treatment, prevention and care programs, and so I think there really needs to be some evaluation before the next conference."
"I think we need to evaluate, as we tried to do this year, not so much the absolute numbers, but whether or not the right people are coming who really have a need and a reason to be here, and that the value that is generated by the cost of bringing them here, is something that's justified as opposed to putting that money in other parts of our HIV efforts."
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U.S. Draws Line on AIDS Funding
By VIJAY JOSHI
The Associated Press, July 14, 2004
BANGKOK, Thailand (AP) - The United States on Wednesday rejected a call at the International AIDS Conference for a $1 billion contribution next year to the global fund that has become the centerpiece of U.N. efforts against the disease.
``It's not going to happen,'' U.S. AIDS coordinator Randall Tobias said in an interview, noting that Washington already is by far the world's largest donor to the cause.
Tobias' comments were in response to a request Tuesday by U.N. Secretary-General Kofi Annan, who said he hoped the United States would give $1 billion for 2005 alone to the Global Fund, which is far short of its $3.6 billion budget.
The United States is carrying out a $15 billion, five-year Emergency Plan for AIDS Relief, mainly directed toward 14 countries in Africa and the Caribbean, plus Vietnam. Critics say the United States should instead give much of that money to the Global Fund, which reaches 128 countries.
They also say the U.S. money comes with strings attached that can set back efforts to curb the spread of the HIV - which infected 5 million people last year alone - and that the U.N.-sponsored fund best suits the needs of sufferers.
The U.S. money goes to countries that support Bush's abstinence-first policy, and it currently can only buy brand-name drugs, usually American, shutting out cheaper generic versions made by developing countries.
Tobias urged detractors to stop arguing with Washington over condoms and drug patents and join its war on the pandemic, which has claimed 20 million lives and left another 38 million infected worldwide since 1986, most of them in Africa.
There has been furious criticism at the AIDS conference of U.S. policies such as its insistence on abstinence - rather than condoms - as a primary way of battling HIV; its trade policies; and its funding methods. The conference is the biggest gathering ever of AIDS scientists, activists, policy-makers and HIV-infected people.
Critics say a vow of abstinence is difficult to maintain and, when broken, can lead to unprotected sex, raising the risk of HIV infection that could effectively be blocked by a condom.
Tobias was jeered by protesters chanting, ``He's lying! People dying!'' when he was about to defend U.S. policies in a speech Wednesday.
One activist, Mark Milano, 48, of New York, said that when it comes to fighting AIDS, ``every step of the way, the U.S. government is not doing what it should be doing.''
``It's not working with other countries. It's going at it alone, like it did with Iraq,'' he said.
Tobias said that while the United States is not against condoms, an abstinence campaign in Uganda shows that the contraceptives are not the only solution.
``At this point, perhaps the most critical mistake we can make is to allow this pandemic to divide us,'' he said.
He pointed out that the United States will this year spend $2.4 billion, nearly twice as much to fight AIDS as the rest of the world's donor governments combined.
With such massive spending, there's no need to contribute additional money to the U.N.-sponsored Global Fund to Fight AIDS, Tuberculosis and Malaria, he said. The $200 million that President Bush already plans to contribute next year is sufficient, he said told reporters.
Stephen Lewis, the United Nations' special envoy on HIV/AIDS to Africa, said he disagreed ``profoundly'' and that the Tobias stance showed ``an inability to recognize the way the world most effectively works.''
The Global Fund allows generic drugs, costing as little as $150 per person per year, while those approved under the U.S. plan typically cost $700, said Joia Mukherjee, medical director of Partners in Health, which treats the poor in Haiti.
``The last thing I want to worry about is which bottle this stuff is coming out of,'' she said.
Tobias said Washington insists on name-brand drugs because their quality has been tested by the U.S. Food and Drug Administration. However, U.S. AIDS programs have been ready to use generic drugs and copies, provided they are approved by the FDA, Tobias said.
No generic drug maker has come forward to seek FDA approval, and Tobias said the United States would not accept the World Health Organization's certification, describing the WHO's drug approval process as ``not transparent.''
Wednesday's agenda featured sessions on the growing infection rates among youth and women.
Experts say nearly half of all people with HIV are women, and their infection rates in many regions are climbing much faster than men's.
Raoul Fransen of the Netherlands told a plenary session the abstinence-first approach did him no good, and that after learning he was HIV positive at age 15, he thought he would never have sex again, for fear of infecting others.
``It took a while before I was ready to experience intimacy again,'' said Fransen, 26.
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IAC 2004: Scaling up access to treatment
Tuesday morning plenary session
HDN Key Correspondents Team
Today's Quote
"As part of my efforts to help in the fight against AIDSD, I have dedicated my energy to working on developing HIV/AIDS messages through the media in order to reach out to as many people as possible."
Richard Gere
***
"We've failed to do enough in the precious years since Barcelona -- "3 x 5 is our best chance."
A clear and rapid technical update on antiretroviral therapy opened the plenary, as stragglers held up by security checks arrived in the hall. Although the update was too technical for much of the audience, health-care providers were seen nodding their heads and rapidly taking notes on new developments. There are fifteen drugs that are commonly used worldwide, but most of the studies presented by Dr Kiat Ruxrungtham of Thailand featured the five antiretrovirals that will soon be available to millions who live in countries that follow the "3 x 5" recommendations.
The plenary update also included information on new studies that will be presented at this conference. What medications need to be taken by people who have been taking just two drugs? Double therapy is still very common in the developing world. When these two drugs start to fail and people living with HIV want to "upgrade" to three drugs, there is now good news. A simple twice-a-day regimen of efavirenz and ritonavir boosted indinavir is life-saving.
More new information followed. Dr Kiat noted that the 3 x 5-- recommended drug stavudine is just as effective as the more expensive tenofovir when used in common combinations. And switching nevirapine from efavirenz is as simple as changing drugs. When efavirenz is given with the common TB medication rifampicin, no dose adjustments are needed. He also stressed adherence and put the responsibility for adherence on the shoulders of both patients and health-care providers. The relationship between the two is vital.
Dr Papa Salif of Senegal gave a clear summary of how TB programmes can improve care for people living with HIV and, on the other side of the coin, how AIDS programmes can improve care for people with tuberculosis. In HIV testing and counselling settings, up to a third of patients who are asked if they have had a cough have been found to have pulmonary tuberculosis. This simple verbal technology costs little. Dr Salif also recommended that all people who are found to have TB be offered HIV testing and counselling.
He also stressed the use of cotrimoxazole prophylaxis, used increasingly for positive people in Africa since it was first found to halve mortality five years ago. It is especially important for people with pulmonary tuberculosis but is also helpful for people without TB. This life-extending therapy is not often used in Asia, though activists are leading the way in recommending it. Although the impact of ART in reducing the incidence of tuberculosis has been proven in several studies in Africa, it has not yet been studied in Asia.
A short polemic from President Jacques Chirac delivered by a representative of the French government was noisily greeted by a protest by ACT UP Paris. The protesters observed the IAC freedom of expression rule, however, and their much-applauded banner "AIDS -- G8 MUST PAY" was carried away after a few minutes and the programme continued.
Dr Diane Havlir from the US gave an update on opportunistic infections. She presented a synopsis of the wide range of opportunistic infections in both Africa and Asia and noted the differences and similarities. She then went on to say that "three co-infections are having profound effects on the epidemic". Tuberculosis, malaria, and sexually transmitted infections need action. All three can occur whether a person with HIV has a strong or weak immune system. Genital herpes virus infections have long been known to increase HIV transmission in Africa, and this is being increasingly recognised in Asia. Studies are ongoing to determine if the suppression of genital herpes will decrease transmission.
Dr Havlir pointed out the complex relationship between HIV and malaria and difficult treatment challenges for people with HIV. Malaria is more common and more severe among people with HIV. Pregnant women with HIV need antimalarial treatment. Cotrimoxazole prophylaxis will decrease malaria episodes and severity. But will cotrimoxazole lead to drug resistance for the most commonly used drugs used for malaria in Africa? Or will Africa have to begin to use Asia's miracle malaria drug artemisinin?
Prefacing her take-home points with: "Implement antiretroviral therapy -- it is the best prophylaxis" Dr Havlir suggested that care services for tuberculosis, malaria, and sexually transmitted infections are efficient points of entry for ART. She also recommended cotrimoxazole prophylaxis!
Dr Jim Yong Kim of WHO was humble and honest. "We've failed to do enough in the precious years since Barcelona." This was met by embarrassed applause. "3 x 5 is our best chance."
We were reminded that the movement for access to treatment began with activists, many of whom were named personally by WHO's Director of HIV/AIDS. He also named the organisations that had played a part. Most of them were non-governmental. His recognition will encourage more activist working in "kitchens and lean-tos" with very little funding to continue to hold governments, multilaterals, and bilaterals accountable for their commitments.
In a previous satellite session before the official opening, Dr Kim has described what he called an "ethical roll out" as testing and counselling are scaled up. Consent, confidentiality, and counselling are needed for all HIV testing. Meeting the ethical imperative of treating all people who need care will be demanded by communities of people living with the virus and their caregivers.
HDN Key Correspondents Team
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IAC 2004: Saving children's lives: a possible and affordable option
HDN Key Correspondents Team
"The 2001 UN Declaration goals noted that 40% of countries with "generalised epidemics" have no national policies to provide orphaned and vulnerable children with essential support."
It is believed that the total number of children living with HIV/AIDS in 2004 is 2.9 million. AIDS deaths in children aged under 15 years now run at 500,000 a year, and children are being newly infected at the rate of 800,000 per year.
In the 2001 UN Declaration of Commitment on HIV/AIDS, countries around the world committed themselves to massively scaling up prevention programmes. The Declaration's goal was to reduce HIV prevalence among young people by 25% and to reduce perinatal transmission by 20% by 2005 in the most affected countries. It seems certain that these targets will not be met in many parts of the world.
Furthermore, the 2003 report on progress in meeting the 2001 UN Declaration goals noted that 40% of countries with "generalised epidemics" have no national policies to provide orphaned and vulnerable children with essential support. The report also said that only a small minority of these countries are developing policies, while a quarter of them have no plans to do so. Policies are meaningless if there is no commitment to translate them into practical action.
Diagnosis is critical even before children become symptomatic, since mortality is so high. The majority of perinatally infected children become symptomatic by their first birthday, and between 88 and 90% will be so before the age of five. Mortality among these children reaches 75% before the age of five. "There is an urgent need for newer, cheaper and accessible diagnostic tests for use in limited-resource settings", said Dr Philippa Musoke from Uganda in a special session on HIV/AIDS in children.
After the conference, a very well known Argentinian paediatrician, Dr Rosa Bologna, was asked about the "minimal package" for care in paediatric population. The answer looked so simple: "In order to be able to have an early diagnosis it is mandatory to have pregnant women tested". This means that even if it is necessary to look for cheaper and easier virological methods for early diagnosis of newborns from a seropositive mother, more efforts should go for prevention on mother-to-child transmission and its prophylaxis. So, HIV antibody tests for all pregnant women, prophylaxis with cotrimoxazole for Pneumocystis carinii and clinical skills for growth and development monitoring plus ARVs for children, constitute the "minimal kit" in the priority for children care.
What to do when CD4 count and viral load count are not available? Again, simple solutions look sometimes so hard to achieve. Total lymphocyte count (TLC) has a good correlation with CD4%. <2500/mm3 is equivalent to 20% in infants aged 18 months or less, while <1500/mm3 are equivalent to 15%CD4 for infants >18 months.
Even if different criteria for indications of treatment in children need to be set, the biggest challenges for treating them are not technical, but social and financial. For example, children are dependent on adults to identify their treatment needs: to take them to a clinic, to ensure adherence and to supervise them when they are taking the medicines.
Antiretroviral treatment for children presents special challenges. For instance, few HIV medicines are produced in paediatric formulations, and those available as syrups have limitations. Difficulties in measurement for care givers which can lead to incorrect dosage, children rejecting the medication because of taste, short shelf-life, and last but not least, unacceptably high cost. For example, for fixed-dose combinations in the resource-poor setting, cutting a pill in quarters may lead to suboptimal dosage for a child 7 years old.
In fact, according to the Collaborative HIV Paediatric Study (CHIPS) cohort, CD4 count and viral load are poor predictors for progression to AIDS/death in infancy. According to the authors of this study, decisions about starting HAART in paediatric populations are complicated to a lack of studies evaluating early treatments in infancy, adherence difficulties and limited pharmacokinetic data.
On the other hand, an excellent response to ARV therapy was shown in 672 children treated in Botswana. All of them received a three-drug combination comprising Zidovudine or Stavudine, Lamivudine and Nevirapine or Efavirenz. At three months of treatment the mean increase of CD4 count was 25%, while undetectable viral load was achieved by 80% of the children at 12 months. Only two children (0.9%) needed a switch to a second-line therapy, meaning these first-line regimens are not only durable but also appropriate in resource-poor settings.
Disappointing results from dual nucleoside reverse transcriptase inhibitors (NRTI) are therefore not surprising. One hundred children attending paediatric clinics in Bangkok were recruited for a study (presented by Dr Jinlanat Ananworanich) to determine incidence of reverse transcriptase (RT) mutations in Thai children treated with dual NRTI. The evidence shows that almost all children on dual NRTI had RT mutations leading to resistance. As a consequence, salvage therapy with two new NRTI plus one new class drug is likely to fail in most children. There is a lesson to learn from the Botswana experience. Saving children's lives is a possible and affordable option.
Policy makers are moving towards giving adults "first world" treatments, but little is being done regarding reduction of stigma and discrimination. One of the main problems children have to deal with is disclosure in their community, at school, with friends. According to Dr Rosa Bologna from Argentina, disclosure even if difficult itself, sometimes becomes a tool for fixing the puzzle of children's own history, as they then become aware of their parents' cause of death, AIDS.
Distributing HIV treatment services needs to be guided by principles of equity and human rights, such as freedom from stigma and discrimination, education, empowerment of girls and women, ensuring nutrition and reduction of poverty. Continuous pressure is still needed to ensure that national and international health care policies and guidelines on treating children with HIV/AIDS are put into effect. "Children first and always" should be a priority for all of us, since 2.9 million voices are not being heard here in Bangkok.
HDN Key Correspondents Team
For details of how to access discussion archives: http://www.hdnet.org
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Thailand is forced to defer ARV drug plan
Bangkok Post
July 14, 2004
Apiradee Treerutkuarkul
Thailand has been compelled to defer its plan to provide anti-retroviral (ARV) drugs to its immediate neighbours after having failed to secure financial aid commitments from the Global Fund, a government source close to the project said yesterday.
Prime Minister Thaksin Shinawatra had planned to announce his plan at the 15th International Aids Conference with a pledge to give the locally made anti-Aids drug - GPOVIR - to patients in Burma, Cambodia and Laos.
However, the Public Health Ministry's budget is inadequate to put the plan into action.
The Government Pharmaceutical Organisation has the capacity to produce GPOVIR in excess of domestic needs.
But Public Health Minister Sudarat Keyuraphan said yesterday the government was not in a position to implement the project until next year as well-trained staff were also required for the job. It could happen only after a new state-owned factory to produce generic drugs was built, she said.
Petchsri Sirinirund, the Disease Control Department's senior expert in preventive medicine, said as far as she knew the Global Fund had declined to join in the Thai effort. The government would ask the fund to reconsider its decision.
More details needed to be included before the plan was re-proposed to the Global Fund because it offered so many long-term benefits to people in neighbouring countries, she said.
State organs were now working with non-government organisations, such as the Population and Community Development Association and Medicins Sans Frontiers, to provide ARV drugs to infected hilltribe people and HIV-positive patients along the border.
The two-year programme is being run with funding support from the European Union in hospitals in Chiang Saen and Mae Sai district, Chiang Rai. It also draws patients from Burma and Laos.
Don De Gagne, who oversees the project, said at present 13 patients from Burma and Laos were receiving anti-retroviral treatment there.
But it was still necessary to train more medical staff and volunteers and turn hospitals into a "one-stop service" to give people not only care and treatment but also counselling so they could better understand the programme, he said.
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Thai's to Launch AIDS Drug for Children in 2005
BANGKOK (Reuters, July 14, 2004) - Thailand will launch a children's version of its three-in-one generic antiretroviral pill next year to simplify treatment of HIV-infected youngsters, the state drug agency said Wednesday.
"The drug is in clinical trials now and we hope to complete that and make it available on the market by the middle of next year," Government Pharmaceutical Organization (GPO) Managing Director Thongchai Thavichachart told reporters.
Thailand has produced some 40 million tablets of its GPO-VIR generic drug -- which combines copies of stavudine, lamivudine, and nevirapine -- since May 2002. The current dosage, however, is only for suitable for those aged 10 years or over. Those aged below 10 have to either split the tablet or take powder or liquid formulations.
"For those kids living in the far north, doctors have to prescribe gallons of different liquid formulas to them, which make their lives even more difficult," Thongchai said.
"With this first ARV cocktail tablet for kids in Southeast Asia, HIV-infected children will be treated more effectively."
Thongchai said there were about 5,000 children in Thailand in need of antiretrovirals.
Medicins Sans Frontieres, a leading medical and humanitarian organization, has said treating children with HIV/AIDS in poor nations is an uphill battle because drugs and diagnostic tests have not been adapted for youngsters.
GPO planned to spend 500 million baht ($12 million) to boost the production capacity for GPO-VIR to 200 million tablets a year from 50 million now, which would help treat 250,000 HIV/AIDS cases per year from 100,000 cases currently, Thongchai said.
GPO is researching and manufacturing 23 antiretroviral products and plans to add two more -- a saquinavir tablet and a concoction of AZT, 3TC, and nevirapine -- by October. ($1=40.68 Baht)
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