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Executive Summary
Pages 1-18

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From page 1...
... Moreover, because HIV-related deaths occur disproportionately among young, economically productive adults, the epidemic is undermining the economic development and social fabric of entire countries. 1 Human immunodeficiency virus/acquired immunodeficiency syndrome.
From page 2...
... The clinical, financial, and epidemiological effects of implementing such widespread treatment and prevention programs must be considered, and rational methods for informing such efforts developed. One major concern is that of fostering the premature emergence of widespread resistance to ARVs, thereby reducing the long-term viability of ART regimens in developing countries.
From page 3...
... In response to this charge, the committee developed its findings, conclusions, and recommendations using evidence derived from the scientific literature, commissioned papers, and unpublished data drawn from workshop presentations made by individuals currently researching and implementing ART programs in resource-constrained environments. The combined weight of this evidence contributed to the committee's formulation of strategies that require immediate attention and action, as well as recommendations regarding programs, policies, and research that must continue to evolve if efforts aimed at treating millions of individuals in need are to be improved and sustained.
From page 4...
... A considerable challenge for ART scale-up is that unreliable or interrupted drug supplies, combined with poor treatment procedures and program management, could promote treatment failure as well as the emergence of ARV-resistant virus, thereby reducing the long-term durability of more-affordable first-line drug regimens. Therefore, paramount to the longterm success of these programs will be recognition on the part of international and national leaders of the lifelong nature of ART and the need to sustain a constant supply of quality drugs and services in the context of quality supportive care.
From page 5...
... 2 Donors should commit to continuous funding of antiretroviral therapy scale-up for decades to ensure the sustainability necessary to avert the medical hazard of interruptions in the continuity of treatment. Delays in donor funding after treatment programs are initiated will jeopardize the long-term durability of treatment regimens.
From page 6...
... . National and international program planners should coordinate and integrate stronger and more effective HIV/AIDS prevention initiatives concurrently with the scale-up of antiretroviral therapy programs.
From page 7...
... Antiretroviral therapy program managers, international donors, and national planners should take the necessary measures and provide resources to ensure the strict adherence to therapy that is fundamental to program success. Such measures should include timely and adequate provision of drugs and health care, knowledgeable and available pro viders, and appropriate patient education.
From page 8...
... Fixed dose combinations are recommended as most desirable if they are also of high quality, safe, effective, and inexpensive. The committee also strongly endorses a rigorous, standardized international mechanism to support national quality assurance programs for antiretroviral drugs.
From page 9...
... For individual patients about to embark on therapy, general clinical screening for resistance to antiretroviral drugs is not recommended at this time for two reasons: because the prevalence of resistance in HIV infected individuals not previously exposed to antiretroviral therapy is expected to be undetectable or low, and because the proportion of total persons with HIV who are receiving therapy in a given country will also be relatively small in the short term. Coordinated, systematic testing for resistance to antiretroviral drugs should, however, be conducted among a subset of patients failing treatment.
From page 10...
... Ensuring Equitable Care Even in countries such as South Africa, which is not as severely resource-constrained as most of its sub-Saharan neighbors, the vast health and wealth disparities that exist between the "urban poor" and the "rural poorer" create extraordinary logistical and ethical challenges to delivering equitable ART. Resolving such disparities will require immediate investments in rural areas in the basic infrastructure needed for ART programs.
From page 11...
... Donors and organizations with relevant expertise (e.g., academia, in dustry, public health agencies, nongovernmental organizations) should support active partnerships among all institutions possessing such ex pertise and those seeking to acquire the benefits of training; mentoring; and the transfer of antiretroviral therapy­related medical, technical, and managerial knowledge and skills.
From page 12...
... An interruption in the drug supply line -- whether caused by transportation, financial, corruption, or other problems -- will increase the risk of treatment failure regardless of how adherent a patient is or how knowledgeable providers are about HIV/AIDS treatment and care. To provide continuous, secure delivery of quality drugs, diagnostics, and other products, national and international program managers of antiretroviral scale-up efforts should ensure that well-coordinated com modity and logistics systems are in place from the outset of program initiation.
From page 13...
... Program managers should measure the effectiveness of HIV prevention and treatment efforts by means of scientifically valid and systematically conducted surveys of HIV prevalence and incidence, HIV morbidity and mortality, and risk behaviors. ART programs should be designed
From page 14...
... A well-designed operations research program will be critical to gathering as much information as possible during what will of necessity be learning by doing. Lessons learned can be used to establish national guidelines specific to a country's needs, to correct mistakes, and to inform changes and new initiatives.
From page 15...
... Operations research should begin at the initiation of scale-up and continue to inform the future direction and sustainable success of antiretroviral treatment and HIV prevention programs in resource constrained settings. Priorities for operations research should be iden tified by national programs and funded by donors through an explicit allocation that will address the need for rapid development of evidence for policy.
From page 16...
... · Culturally appropriate adherence interventions for both adult and pediatric populations. · Randomized trials quantifying the effects of FDCs on health outcomes and adherence, along with relative benefits compared with blister packages and loose drugs, to better inform decisions about drug selection and delivery.
From page 17...
... Even short-term interruptions in support could be clinically disastrous and ethically unconscionable by allowing successfully suppressed HIV infections to emerge in drug-resistant forms. Thus, ART must not be seen simply as a short-term goal or the end point of a 5-year plan.
From page 18...
... 2003. Operational Plan for Comprehensive HIV and AIDS care, management, and Treatment for South Africa.


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