terça-feira, fevereiro 28, 2006
Act Up contra licenças na Tailândia
Today February 26 2006, activists from French people-with-HIV/aids group ACT UP-Paris hanged a giant portrait of Thailand Prime Minister Thaksin Shinawatra on the façade of the Thai embassy in Paris with the caption " aids in Thailand : out with Thaksin ". They also showed a banner with the solidarity warning " FTA = death under patent ", in relation with ongoing trade agreement negotiations by Mr Thaksin with the United States, an agreement which endangers access to medication for HIV and other life-threatening diseases. The photographs are available on the Act Up-Paris website.
French PLWHA (People Living with HIV /AIDS) are supporting the fight by Thai PLWHA and Thai communities specially vulnerable to HIV (such as Thai drug users) against the Free Trade Agreement which Mr Thaksin is negotiating with the US. In return for signing the agreement with Thailand, the US demands Mr Thaksin severely limits Thai people’s access to competitive, cheaper medicines, and hand airtight monopolies on medicines to patent-holding US companies.
The Thai HIV movement is a core component of the anti-FTA movement in Thailand, which itself has become a strong force of the anti-Thaksin movement which the recent Shin Corporation tax scandal involving Mr Thaksin has spurred.
French AIDS activists join with Thai movements in demanding the resignation or impeachment of Prime Minister Thaksin, and his replacement by a leader committed to doing everything necessary to end the AIDS crisis, starting with universal access to affordable medicines, to free care and to free clean needles.
Programa de identificação precoce do VIH/sida nos utilizadores de drogas arranca em Gondomar
O Centro de Apoio a Toxicodependentes (CAT) de Gondomar foi a unidade escolhida para a experiência piloto do programa de identificação precoce da infecção VIH/sida e prevenção direccionado a utilizadores de drogas, apresentado hoje pela Coordenação Nacional para a Infecção VIH/sida e pelo Instituto da Droga e Toxicodependência (IDT).
O programa consiste no incentivo ao conhecimento serológico dos utentes daquele centro, através de testes rápidos de identificação da infecção VIH/sida.
O Coordenador Nacional da Infecção VIH/sida, Henrique Barros anunciou que pretende no fim deste ano inserir toda a rede de CATs do país no programa, como também conseguir que 60% dos utentes da rede pública de atendimento a toxicodependentes conheça o seu estado serológico para a infecção VIH/sida. Henrique Barros pretende ainda ter no fim de 2007 dez estruturas de redução de danos em funcionamento e duas unidades móveis do IDT integradas no programa.
De acordo com os responsáveis do projecto, o diagnóstico precoce terá o efeito de alteração dos comportamentos que colocam os outros em risco, permite iniciar o tratamento dos diagnósticos positivos mais precocemente, assim como permite um melhor conhecimento da realidade epidemiológica da infecção em portugal, podendo-se assim mobilizar recursos e respostas adequadas para diminuir a incidência da doença, nomeadamente entre a população toxicodependente.
O presidente do IDT, João Goulão, apontou a importância do programa para o mais fácil encaminhamento dos toxicodependentes seropositivos às unidades de saúde competentes. Por outro lado, salientou ainda que a extracção de novos dados poderá avaliar a tendência crescente da transmissão do VIH por via heterossexual, relacionando-a com o consumo das novas drogas em ambiente de lazer.
Tratamento adequado da grávida pode reduzir risco de transmissão vertical a menos de 2%
A terapêutica combinada à grávida seropositiva conjugado com um tratamento durante o parto de cesariana e aliado depois a um tratamento antirretrovírico ao recém-nascido sem amamentação materna pode reduzir o risco de transmissão vertical do VIH a menos de 2%.
Os dados resultam de vários estudos europeus, entre os quais o estudo de protocolo ACTG 076, apresentado há dias na Faculdade de Medicina do Porto, pela pediatra Laura Marques, do grupo nacional de trabalho sobre a infecção VIH na criança.
Segundo a pediatra, a utilização de zidovudina (AZT) antes do parto, durante o parto e no pós-parto permite a redução de 66% do risco de transmissão vertical.
Daí a importância vincada por Laura Marques para que se proceda rapidamente a medidas que obriguem o rastreio universal das grávidas, no que respeita ao VIH, para que desde logo se encaminhe o tratamento, a prevenção de transmissão e o diagnóstico precoce do recém-nascido.
Por outro lado, Laura Marques realçou igualmente a importância de encorajar a população a realizar sempre consultas pré-concepcionais, onde deve ser inserido o rastreio serológico, assim como a necessidade de melhorar a capacidade de resposta das maternidades ao tratamento de recém-nascidos seropositivos, no que respeita ao acesso à profilaxia antirretrovírica.
Em Portugal, segundo dados do mesmo grupo de trabalho, que estudou os partos de 43 hospitais do país, a taxa de transmissão vertical corresponde ainda a 3,6%, em 2004, sendo que nesse mesmo ano 81,2% das grávidas seropositivas completaram a profilaxia de transmissão vertical. Contudo, note-se que mais de metade das mães seropositivas estudadas apenas foram diagnosticadas com o VIH após o início da gravidez.
Coordenação Nacional promove discussão entre representantes da sociedade civil
O GAT estava presente com vários membros.
Os representantes de várias organizações não-governamentais que trabalham directamente com a infecção VIH/sida discuturam juntos, estes dias, numa reunião no Convento da Arrábida, os items que devem integrar a componente de informação, educação e comunicação do Novo Plano Estratégico da Coordenação Nacional para 2007-2010.
Esta foi uma iniciativa inovadora por parte da Coordenação Nacional, no que respeita à promoção do diálogo entre organizações que trabalham com o VIH/sida, assim como um apelo à participação das mesmas na organização do novo plano.
"Queremos que nos digam o que está mal e o que é preciso melhorar nesta área, porque são as organizações que trabalham no terreno que percebem exactamente quais as políticas que funcionam e não funcionam" disse aos participantes Henrique Barros, Coordenador Nacional para a infecção VIH/sida.
A Coordenação Nacional está assim empenhada em promover uma maior unificação da sociedade civil, através do diálogo e cooperação de projectos, para que em conjunto com as instituições estatais se consiga travar a epidemia em Portugal de forma mais eficaz.
ONGs defendem conteúdos uniformizados nas escolas para promoção da saúde
ONGs defendem conteúdos uniformizados nas escolas para promoção da saúde
A promoção de comportamentos saudáveis e a informação sobre a infecção VIH/sida devem estar inseridos em conteúdos programáticos uniformes em todas as escolas. Esta é a opinião generalizada das Organizações Não-Governamentais (ONGs) que estiveram presentes na reunião da Arrábida, um encontro que promoveu estes dias o debate sobre os conteúdos de informação, educação e comunicação de devem constar no Plano Estratégio da Coordenação Nacional para a infecção VIH/sida entre 2007 e 2010.
Os representantes da sociedade civil consideram a comunicação nas escolas de importância primordial, atendendo a que hoje em dia se toma toda a população por si só como vulnerável à infecção. Contudo, a comunicação deve também passar por uma adequação das mensagens aos diferentes públicos, atendendo aos diferentes contextos em que se inserem.
Por isso, a sociedade civil defende uma metodologia de comunicação à escala local, fortalecendo a comunicação por pares e por líderes de opinião.
Durante a reunião foram ainda focados a importância da educação para o tratamento e a necessidade de adopção de uma linguagem de comunicação simples, incisiva e com mensagens positivas, bem como a criação de uma revista generalista, acompanhada de outras específicas aos diferentes targets como meio de informação e comunicação sobre a infecção VIH/sida.
A reunião da Arrábida consistiu numa primeira aproximação entre a Coordenação Nacional para a Infecção VIH/sida e as ONGs que trabalham no terreno directamente com esta problemática, para que em conjunto haja uma união de esforços nas medidas a tomar para o combate da epidemia em Portugal.
I Encontro da Arrábida
Arrábida, 25 de Fevereiro de 2006
“ Ouvir a Sociedade Civil para incorporar a sua voz na elaboração do futuro
Plano Estratégico Nacional de resposta ao VIH/sida na área de I.E.C.”
Encontro de Trabalho da Coordenação Nacional para a Infecção pelo VIH/sida com representantes das ONGs, PVCVSida, IPSS e peritos profissionais da área.
“O futuro Plano Estratégico Nacional de resposta ao VIH/sida na área de I.E.C.
para as escolas e prisões ”
Os participantes neste I Encontro da Arrábida consideram que face à evolução da situação epidemiológica da infecção pelo VIH em Portugal nos últimos 25 anos, na população geral e no interior das prisões, não é possível planear, implementar, monitorizar e avaliar acções eficazes de I.E.C. para a redução da incidência sem garantir, à partida, o acesso universal à educação sexual no sistema de ensino assim como ao Sistema Nacional de Saúde no sistema prisional. Esta urgente decisão política deverá fazer-se acompanhar de decisões ao nível do executivo capazes de promover e garantir o acesso efectivo da população escolar e prisional aos meios de prevenção concretos das ISTs/VIH/sida (a exemplo dos preservativos em meio escolar ou do material de injecção estéril nas prisões) assim como aos tratamentos continuados.
Sem estarem garantidas as decisões acima referidas, consideram os Participantes deste Encontro de Trabalho que qualquer estratégia de Informação, Educação e Comunicação que pretenda contribuir para a redução da infecção pelo VIH, está condenada a falhar.
1º Workshop sobre a Intervenção do Enfermeiro na Área do VIH/SIDA
HIV Meeting Portugal, 2006
Organizado pela Merck Sharp & Dohme, este encontro internacional pretende reunir a comunidade científica no próximo dia 22 de Abril de 2006, em Cascais, com o objectivo de promover o intercâmbio de experiências, conhecimentos e programas de apoio desenvolvidos no âmbito da problemática da infecção por VIH.
ARV's e Hipersensibilidades Medicamentosas
Dando continuidade ao objectivo de promover diferentes olhares sobre a infecção pelo VIH/SIDA, serão prelectores convidados: o Dr. Vasco Sousa Coutinho, Dermatologista do Hospital de Santa Maria, Lisboa, que irá apresentar a sua visão sobre a temática; e a Dra. Josefina Rodrigues e o Dr. Rui Marques, do Hospital de São João; Porto, que apresentarão a perspectiva do Imunoalerglogista.
As inscrições e os casos práticos deverão ser entregues até ao dia 17 de Março de 2006.
O I Encontro de Sócios da APECS, 2006 terá o apoio da GlaxoSmithKline
Consulte o programa, onde terá ainda acesso ao boletim de inscrição.
Dia Internacional do Ensaio Clínico
20th May 2006
Location: EU Commission, Brussels,
Time: Friday May 19th, 2006 from 10.30 to 13.30
Clinical research requires the active involvement of patients in order to assess the benefits and harms of interventions (drugs, surgery, biotechnology, etc.). The participants in clinical trials may run personal risks for the sake of the common good. The International Clinical Trials’ Day will help to foster awareness of patients and the population in general about the methods and challenges of clinical research. It will also foster discussion and debate among participants in clinical trials, practitioners, researchers, and funders of research (including the drug and device industry).
In recent years, there has been a rapid evolution of legislative and ethical frameworks for clinical research, debates on transparency, and active participation of patients and patients’ associations in the design, organisation, and exploitation of clinical trials. The International Clinical Trials’ Day will become an international focal point for communication events, meetings, and debates on these topics. Because the public health challenges of clinical research are not restricted to a single country, the transnational communication about clinical trials needs initiation and co-ordination by a transnational organisation, having the objective to facilitate better clinical research, relevant to the needs of patients everywhere.
Establishing a Europe-wide and even world-wide communication event under the umbrella of an International Clinical Trials’ Day will allow us all to focus on the central importance of clinical research and clinical trials to the qualities and abilities of our health-care systems. Through various communication channels (meetings and debates with patients, academia, and industry at regional level in various countries, teaching programmes at schools, television and radio programmes, newspapers, and scientific journals), this event will allow to target the patients, patients’ associations, and the general population and will allow in depth discussion with representatives of academic or industry research and with regulators and ethics committees, on the challenges raised by clinical research.
This event was initiated by the Framework Programme 6-funded European Clinical Research Infrastructures Network (ECRIN) in 2005 (http://www.ecrin.org). The May 20th was chosen as the day of celebration with focus on clinical research and clinical trials because it was the day when the Scottish naval surgeon, James Lind, started his famous controlled trial in 1747 (see The James Lind Library at http://www.jameslindlibrary.org/). Other countries have already expressed their interest and commitment to participate in this activity (USA, Canada, Australia). The starting point for this international event will be a workshop followed by a press conference, organised in Brussels under the auspices of the EU Commission in collaboration with the World Health Organisation (WHO) on May 19th to celebrate the International Clinical Trials’ Day on May 20th, 2006. Representatives of European patients’ associations, clinical scientists, scientific agencies, industry sponsors, ethics committees, competent authorities, trials registries, medical journal editors, and the EU Commission will debate with patients’ associations, scientific journals, and news media on the need to improve patients’ and publics’ awareness on the challenges raised by clinical research.
sexta-feira, fevereiro 17, 2006
Bono lança 'Red' para combater SIDA em África
O vocalista dos U2, Bono Vox, apresentou ontem a nova linha de produtos e serviços 'red' (vermelho) com o fim de financiar um fundo de luta contra a Sida no continente africano.
O lançamento desta iniciativa foi feita em Davos, na Suiça, no âmbito do fórum económico mundial, promovido pela Organização Mundial do Comércio (OMS).
O vocalista da banda de rock irlandesa conseguiu assim que pela primeira vez grandes empresas do mundo como a Nike e a subsidiária Converse, a Gap, Georgio Armani e American Express se comprometessem a financiar o Fundo Global, que desde 2002 ajuda pessoas que sofrem com as doenças de SIDA, malária e tuberculose.
A nova marca 'red' vai incorporar um cartão de crédito da American Express, que por enquanto será lançado apenas no Reino Unido, sendo que 1% dos gastos dos utilizadores reverte para o fundo. Além disso, a Nike irá comercializar ténis Converse All Star desenhados por artistas do Mali e a Gap vai lançar t-shirts feitas no Lesoto. A Armani vai apresentar óculos de sol, mas com a perspectiva de alargar a linha 'red' para roupas, acessórios, relógios, perfumes e joalharia. Parte das receitas resultantes da comercialização destes produtos serão assim entregues ao fundo, tendo sido acordado um prazo de cinco anos para a campanha.
Bono, o rosto desta iniciativa, pretende assim aumentar as verbas do Fundo Global, para poder dar um impulso especial ao combate da SIDA em África, onde diariamente a doença mata cerca de 6.500 pessoas 9.000 são infectadas com o vírus.
quinta-feira, fevereiro 16, 2006
BMS avança com licença voluntária para atazanavir
Bristol Myers Squibb announces voluntary licenses for atazanavir in India and South Africa
Bristol Myers Squibb announced today that it will grant voluntary licenses for manufacture of its new protease inhibitor atazanavir, sold in Europe and North America under the brand name Reyataz, to pharmaceutical companies in India and South Africa for sale in India and Africa.
The company will also provide technical know-how to its licensees, Emcure in India and Aspen Pharmacare in South Africa, to teach them how to make the protease inhibitor. Atazanavir is the second protease inhibitor to be offered for technology transfer.
In January Roche announced that it was prepared to transfer the technical know-how to make its protease inhibitor saquinavir to any pharmaceutical manufacturer in Africa that wanted to make the drug, and that it would not enforce its patent rights on saquinavir.
The move potentially broadens the choice of second-line treatments available in resource-limited settings, but atazanavir use may be limited by the lack of access to the boosting agent ritonavir, another protease inhibitor manufactured by Abbott Laboratories.
In Europe atazanavir is only licensed for use in treatment-experienced patients when boosted by ritonavir, but ritonavir is vulnerable to high temperatures and should not be stored outside a refrigerator for more than a few days in a hot climate. Although Abbott Laboratories has developed a heat stable tablet version of its own boosted protease inhibitor Kaletra (lopinavir/ritonavir), it has still to develop a heat stable version of ritonavir.
The heat stable version of Kaletra remains unlicensed outside the United States, and Medecins Sans Frontieres (MSF) last week called on Abbott Laboratories to move quickly to register the new version in all countries eligible to receive the drug at the no-profit access price of approximately $500 a year.
MSF also called on Abbott Laboratories to cut the price of Kaletra through its access programme, arguing that the reduction in pill burden from six to four pills per day justified a reduction in price to approximately $333 a year.
terça-feira, fevereiro 14, 2006
G8 querem financiar vacinas
G-8 Nations Shape Plan to Fight Diseases - Goal Is Getting Drug Makersto Generate Vaccines Against Illnesses in Developing World
By MICHAEL M. PHILLIPS
February 13, 2006; Page A8
Wall Street Journal
MOSCOW -- The U.S. and its wealthy allies are moving to approve a first-of-its-kind plan to encourage pharmaceuticals companies to develop vaccines for diseases that afflict countries too poor to afford them.
Finance ministers from the Group of Eight major industrialized powers, who met here this weekend, expect to approve a pilot project when they next get together, in Washington in April.
Under an advance market commitment plan, the G-8 nations would promise to subsidize the purchase of new vaccines -- for between $800 million and $6 billion -- if pharmaceuticals companies develop ones that meet standards of efficacy and safety. Once the G-8 spends the pledged amount, the drug companies would sell the vaccine at a set discount in the developing world.
The idea is to ensure that companies get a substantial, upfront, government-backed financial incentive to develop the drugs, even if they ultimately have to sell them at a low price. "By restoring appropriate incentives," advance market commitments "can stimulate private research and investment, accelerate the discovery of new vaccines, save lives and contribute to economic development in a cost-effective way," Italian Finance Minister Giulio Tremonti wrote in a report to his G-8 colleagues in December.
Advised by the World Bank and other outside experts, G-8 negotiators are working through details, including which of six Third World killers should be the test case: HIV/AIDS; malaria; tuberculosis; pneumococcus, a source of pneumonia and meningitis; rotavirus, which causes fatal diarrhea in children; or human papillomavirus, a cause of cervical cancer."It is a promising approach," Treasury Secretary John Snow said after two days of meetings by the G-8, which includes the U.S., Britain, Russia, Germany, France, Italy, Japan and Canada.
It is unclear whether the initiative will draw support from big drug companies. "We are aware of the discussions around advanced marketcommitments and are tracking them, but are not involved," a spokesman for the pharmaceuticals company Wyeth, Christopher Garland, said. The company is one of several with new pneumococcus vaccines in the pipeline.
Wyeth already makes a pneumococcus vaccine, Prevnar, that is effective in the U.S. and Europe. But the vaccine doesn't prevent infection by strains of the bacteria that are common in the developing world, according to a Treasury official. What is required, the official said, is accelerated development of a second-generation vaccine made in sufficient quantities to protect children in the developing world.
Mr. Tremonti and Britain's Chancellor of the Exchequer, Gordon Brown, led the effort over the past year to persuade the G-8 to back an advance market pilot. What was just a notion when President Bush and G-8 leaders mentioned it at their summit in Scotland in July looks likely to become a reality in a few months.
The plan aims to address a paradox in the pharmaceutical world: The countries that most need certain drugs are the ones that can least afford them. The result is that drug companies often focus research in areas that are more profitable while poor nations are ravaged by infectious diseases that otherwise might be successfully fought, Mr.Tremonti wrote.
In some cases pharmaceuticals companies are reluctant to invest in Third World diseases because they fear that governments and activists wielding moral suasion will embarrass them into providing new drugs to the poor at unprofitably low prices or free, according to a U.S. official involved in the proposal.
While charities such as the Rockefeller Foundation and the Bill &Melinda Gates Foundation fund vaccine development aimed at poor countries, the amount of money available is too small to generate more than a handful of new drugs, according to research by the Center for Global Development, a Washington think tank that has studied the issue,with Gates Foundation funding. A large promised market would spur more drug-company investment and a wider selection of more-effective vaccines, the center concluded.
The G-8 plan has a few detractors, among them Donald W. Light, professor of comparative health systems at the University of Medicine and Dentistry of New Jersey. Prof. Light doubts the pharmaceuticals companies will respond enthusiastically to the G-8's lure, and so wonders whether the money would be better spent elsewhere. "Why not use this wonderful gift of billions of dollars to purchase effective vaccines that can save millions of lives right now?" he said in an interview last week. He suggested that wider distribution of the hepatitis B vaccine, for example, would have a more certain impact.
The G-8 plan, however, boasts powerful advocates who believe it will increase the overall amount that donors provide for vaccines. With enough political will, donors won't have to decide between providing vaccines now or funding new vaccine development for the future, said Susan McAdams, a World Bank expert who has been advising the G-8 on the vaccine issue.
The Bush administration is enthusiastic about the G-8 idea because it combines philanthropy with market mechanisms. Unlike some other vaccine proposals, in which donors agree to buy a single company's product once developed, the G-8 plan would create a market that would be split among all companies that develop vaccines that are sufficiently safe and effective. Presumably a company whose drug was better than its competitors' products would secure a greater share of the market -- a strong incentive for continued improvements and competition.
The size of the G-8 investment -- and the price of each dose of the vaccine -- would be negotiated in advance. The donors would aim for a price that guarantees a return just generous enough to get the drug companies involved, but not as lucrative as a blockbuster drug. G-8 officials are working to clear obstacles to the project, including how much each nation would contribute to the purchase fund.
The debate over which disease the pilot project should target reflects a philosophical decision the G-8 must face. Some countries might prefer to pick a disease for which a promising vaccine already is well into development, but which, without the advance commitment, might not be manufactured widely enough to help poor countries. Such a choice might lead to faster, more-certain success.
Others may want to aim at the tougher scientific challenges, such as HIV/AIDS or malaria, for which a promising vaccine might be over the horizon, some 10 or 15 years away."I didn't get the impression there were any kinds of division on this issue," a spokesman for U.K. Chancellor Brown said after the G-8 meetings. "It's just a matter of making sure the momentum is kept up," The Treasury Department, which is leading the U.S. negotiations, would prefer to put the G-8's weight behind a vaccine for pneumococcus, a bacteria that killed 1.6 million people in 2002, according to the latest World Health Organization figures.
Such a project would require a G-8 investment of between $1 billion and $1.5 billion and could generate a vaccine in about four years, according to the Italian Ministry of Economy and Finance report. By contrast, the report projects an HIV/AIDS vaccine might need as much as a $6 billion commitment and 15 years to develop. A malaria vaccine might take $5 billion and 11 years; a vaccine for rotavirus just $1 billion and two years.
sexta-feira, fevereiro 03, 2006
Europe to take HIV prevention lead
The political climate in the USA is so hostile to researching new HIV prevention methods for gay men that Europe should take the lead, a top microbicides researcher has said.
Dr Alex Carballo-Diéguez of New York told a meeting of the US Rectal Microbicides campaign that no researcher stood a chance of getting funding if his applications used words like ‘rectal’ or mentioned ‘men who have sex with men’.
A microbicide is a substance which, incorporated into a gel, lube or enema, could prevent or reduce the transmission of HIV and other STDs during sex.
Carballo-Diéguez was one of the researchers behind last year’s trial of a ‘dummy microbicide’ in gay men. He got gay men to squirt different amounts of a lube called Femglide up their butts to see how much might be acceptable during sex. See here for article. “We called the study ‘topical microbicide acceptability in high risk men,” said Diéguez.
“We have to play this infantile game. It gets past people who are hostile to gay men’s work, but it means well-intentioned people trying to find out about rectal microbicide research can’t find the paper.”
The US National Institute of Health has granted $16.5 million (£9.2 m) for rectal microbicide research, but this is only 6% of the $280 million (£156.3m) spent on vaginal microbicides and only 1% on what’s spent on the so-far unsuccessful search for an HIV vaccine.
Diéguez criticised European funders for putting no money into microbicides for anal sex at all. Diéguez’s first trial involved only 18 gay men, but he is planning a second-line trial in 100 men to establish the acceptability of a thicker gel versus a suppository.
He said part of the challenge of introducing gay men (or anyone) to a microbicide was that it introduced a new behaviour during sex – very much like persuading people to use condoms who hadn’t done so before.“You can’t just put on a microbicide like a dab of lube,” he said. “You have to put it right up the rectum with an applicator or it doesn’t get to where it’s needed.” He said the answer might be to put HIV-blocking substances into enemas devised for douching.
Acerca de terapêuticas de resgate e acesso alargado
After getting important feed back from several key activists and assessing the main issues facing patients trying to access multiple active agents for their survival, SalvageTherapies.org has produced the following position statement to guide the pharmaceutical industry in designing ethical and humane research protocols of new agents for the treatment of HIV disease:
1- Patients with resistance to all commercially available HIV medications should not be exposed to monotherapy of any kind, or to “virtual monotherapy”, where one new agent is added to a failing regimen.
2- We recognize that pharmacokinetic (PK) clinical trials including the study of agents administered individually and as a component of a multiple-drug regimen, are extremely important. Whenever possible, PK evaluations should be conducted in HIV-negative study volunteers. When the participation of patients with resistance to all available HIV medications is required, exposure to the experimental agents should be limited to a time period that will not lead to resistance to the study drug. If such period is not known, patients should be clearly informed about the potential risks for resistance in the respective study consent forms.
3- We strongly encourage collaboration among the various pharmaceutical companies with anti-retroviral agents in development to perform early interaction studies so that lack of interaction data does not represent a barrier to performing phase III combination studies, OLSS and expanded access programs (EAP) that allow the use of more than one investigational agent. The U.S. Food and Drug Administration (FDA) has also expressed support for this initiative, as it represents the greater hope for heavily treatment-experienced patients.
4- No unnecessary exclusion criteria should be placed on studies unless there is a strong indication of considerable risks to the well-being of the target population. Examples include exclusions of patients with chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) coinfection, patients with CD4+ cells counts below 50 cells/mm³, and exclusion of Fuzeon (T-20) or other agents in the same phase of development due to lack of interaction data.
5- We recognize that an extensive clinical research program is necessary to determine the clinical utility of an experimental agent, including its various risks and benefits. Here is an overview of the minimum requirements to be satisfied in order to advocate for the approval and use of an experimental agent:
a. PK interaction studies prior to the implementation and enrollment of phase III studies that include all approved and experimental agents in the late stages of development which are most likely to be used in combination with the study drug, opportunistic infection prophylaxis, methadone, and contraceptive hormones. Other interaction data including psychotropic agents, lipid-lowering agents, anti-hypertensive treatments, antacids and agents used for gastric reflux, antiseizure medications, and erectile dysfunction treatments should be obtained prior to FDA approval;
b. Enrollment of people of color, women and other under represented populations should be given high priority, including in pivotal PK studies and phase II/III clinical efficacy studies. Several PK studies have indicated possible sex and gender based differences in drug metabolism that may affect dosing decisions.
c. When considering studies of combination experimental agents, emphasis should be placed on regimens employing two distinct characteristics: regimens that are most likely to be successful, and regimens that are most likely to be used in the “real world.”
6- Community representation in Data Safety Review Boards (DSMB) is strongly recommended for all phase II and phase III studies.
7- Proactive expanded access program (EAP) discussions should begin early with community consultation. The following important considerations should be taken into account:
a. EAPs should be implemented as soon as dosing, safety, efficacy and interaction data from phase II A/B studies are available. Smaller Open Label Safety Studies (OLSS) can be started before EAPs to give patients in dire need of a new agent prompt access in a protocol setting without having to enroll in parallel phase III studies that may present the risk of sequential monotherapy in a placebo + optimized background therapy (OBT) arm.
b. OLSS and EAPs should always facilitate access to more than one active agent and to other experimental agents that have been studied in previous interaction studies that are in or near Phase III development or available through other EAPs.
c. The use of approved agents should not be excluded unless a safety or interaction issue is clearly present.
d. Companies should plan in advance to minimize any drug supply limitations that would prevent early access for people with the greatest clinical need who cannot construct a viable regimen. When drug supply limitations are an unavoidable issue, we recommend a staged process that offers access to those with less than or equal to 100 CD4 cell count and that works up to higher or no CD4 cell count limitation when supply permits. This staged EAP should be preformed with community consultation and regular intervals of status notification to the community, including number of patients screened, enrolled, and on waiting lists.
e. Whenever possible, EAPs should be made available to those patients who have screened out of phase III studies and/or those with geographical limitations that prevent their participation in studies.
f. EAPs should not be site specific and should include community clinics that treat uninsured patients. No geographic limitations should be present for patient access.
g. Companies should optimize the EAP paper work process to enable physicians with busy practices to use the program without road blocks. Practical ways to reimburse for nurses’ time should be sought. It is suggested that a national institutional review board (IRB) should be used to minimize local IRB delays and complications.
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