PEPFAR Implementation Progress and Promise (2007) / Chapter Skim
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5 PEPFAR's Treatment Category
5 PEPFAR's Treatment Category
Pages 141-168
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From page 141... ...
• While the success of PEPFAR-supported roll-out of ART has been gratifying, many obstacles remain and will require continued concerted attention at all levels. These obstacles include shortages of trained medical and paramedical personnel, insufficient quantities of antiretroviral medications, difficulties in delivering ART in many rural districts, weak supply chains for antiretroviral medications and other commodities, and inadequate laboratory capacity.
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From page 142... ...
Global AIDS Coordinator should work to support World Health Organization (WHO) prequalification as the accepted global standard for assuring the quality of generic medications.
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From page 143... ...
, essential laboratory monitoring, equipment and training of personnel for the provision of ART and laboratory monitoring, development of adequate laboratory infrastructure, and support for supply chain management systems for ARVs and related commodities. For purposes of budgeting, complying with budget allocations, and counting progress toward targets, PEPFAR categorizes other services in the care continuum under its other categories.
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From page 144... ...
This target represents a count of the number of people receiving ART that is supported directly or indirectly by PEPFAR, and is a globally accepted and widely used early indicator of program implementation. This count provides limited information and does not indicate how well people receiving ART are doing or how the availability of ART affects a country and its HIV/AIDS epidemic.
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From page 145... ...
. To achieve the treatment target, PEPFAR's approach to implementation is to assist countries in the "development of appropriate treatment protocols and policies to ensure safe and effective treatment services, drug supply, and equitable distribution of health resources," and to work with existing clinical programs and develop additional infrastructure, staff, and technical capacity, as needed, to provide "long-term, widespread, high-quality, safe, and essential services to the maximum number of people in need" (OGAC, 2004, p.
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From page 146... ...
. In addition, PEPFAR has provided funding and technical assistance to strengthen laboratory infrastructure and national procurement and supply chain systems.
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From page 147... ...
• Ensuring a scientific evidence base for ART programs so as to avoid the use of subpar treatment protocols that could compromise the treatment outcomes of individual patients and create the potential for the emergence of widespread drug resistance. The WHO guidelines emphasize consideration of the challenges to ART programs posed by working in resource-limited settings, including human resources, health system infrastructure, and socioeconomic conditions.
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From page 148... ...
In all focus countries visited, the great majority of patients receiving ART have WHO clinical stage 4 disease or clinical stage 3 complicated by major opportunistic infections (usually tuberculosis or severe bacterial disease) or unexplained severe malnutrition.
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From page 149... ...
. Although the ART guidelines in all the focus countries are based on the ARV regimens recommended by WHO, other three-drug regimens may be used at the discretion of the supervising physician in some tertiary treatment sites.
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From page 150... ...
Recognition that people receiving effective ART rapidly gain weight and strength and do not suffer from recurrent opportunistic infections reportedly has greatly enhanced the perceived value of the PEPFAR program in the focus countries. Resistance Monitoring A previous Institute of Medicine report concluded that general screening for resistance to ARVs was not recommended because the prevalence
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From page 151... ...
PEPFAR provides support for resistance monitoring; selected examples of such activities in are presented in Box 5-1. Women as a Proportion of Those Receiving PEPFAR-Supported ART To ensure that women benefit from equitable access to ARVs and other HIV-related treatments, PEPFAR is working to support treatment programs in addressing the many barriers faced disproportionately by women and girls in accessing health care.
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From page 152... ...
The guidance suggests that 15 percent of people receiving PEPFAR-supported ART should be children, but recognizes that while some countries may be able to meet this target for 2007, others may be just initiating their pediatric programs and may feasibly be able to target BOX 5-2 Selected Examples of PEPFAR-Supported Pediatric Treatment Activities PEPFAR is providing technical assistance to support a number of countries in adapting and implementing international pediatric treatment guidelines. In Côte D'Ivoire, PEPFAR supports a National Pediatric ART Reference Center.
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From page 153... ...
Global AIDS Coordinator should ensure that adequate medications are available to place 2 million people on sustained antiretroviral therapy to achieve PEPFAR's stated 5-year treatment target. To achieve this target, the Coordinator should also ensure that adequate linkages are established among prevention, treatment, and care programs and rapidly expand the availability of antiretroviral therapy to both children and adults.
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From page 154... ...
Since CD4 cell count determinations are not available in the majority of treatment sites, PEPFAR can effectively address this issue by supporting countries in ensuring that medical and paramedical personnel at ART sites understand that no CD4 cell count is needed prior to initiation of ART in people with WHO clinical stage 4 and symptomatic clinical stage 3 disease. Preparation for ART A practice observed in a few treatment sites was a rigid requirement for a fixed number of readiness or adherence training sessions.
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From page 155... ...
The effectiveness and sustainability of the PEPFAR program will be dependent on the improved quality of life and return to normal daily activities of a large proportion of patients receiving ART. Data on the effectiveness of ART exist for some cohorts of patients in the focus countries, but are not yet uniformly available.
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From page 156... ...
. Need for Continued Attention to Marginalized Populations There is little data available with which to determine how successful PEPFAR-supported ART programs have been in providing access to treatment by especially vulnerable populations in whom HIV prevalence usually exceeds that of the general population.
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From page 157... ...
Many patients identified as having HIV infection in the focus countries have lost considerable amounts of weight, and are severely malnourished by the time the diagnosis has been established and ART initiated. Several focus country programs are using PEPFAR funds to develop and implement innovative nutritional support programs for patients receiving ARVs, and additional sites have requested that PEPFAR provide funds to increase nutritional support.
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From page 158... ...
This standard differs from that of other donors -- the Global Fund, the World Bank, and the agencies of the United Nations -- as well as that of national HIV/AIDS programs, including those BOX 5-3 Selected Examples of PEPFAR-Supported Nutritional Support Activities In Kenya, PEPFAR is supporting a demonstration/training farm that fills food prescriptions for eligible patients. The initiative is a public–private partnership between U.S.
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From page 159... ...
When PEPFAR started, however, no generic ARVs had FDA approval, and thus the focus countries were unable to use PEPFAR funds to support their purchase -- particularly first-line ARVs and medications that combine two or three ARVs into one pill, known as fixeddose combinations. Consequently, focus countries whose plans called for generic ARVs made arrangements, whenever possible, to use other sources of funding to purchase the desired generics, and used PEPFAR funds for the purchase of ARVs for which no generic version was available -- primarily second-line and pediatric formulations.
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From page 160... ...
To this end, the U.S. Global AIDS Coordinator should work to support World Health Organization (WHO)
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From page 161... ...
PEPFAR's stated goal for laboratory activities and infrastructure is to establish and support national quality-assured networks of tiered laboratory services that provide clear lines of authority and organization for the development of national laboratory policies, quality assurance programs, and standardized training and testing. PEPFAR's approach is to promote the early establishment and regular reinforcement of local referral networks both within and among implementing partners.
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From page 162... ...
. The contract for the Partnership for Supply Chain Management began in October 2005 -- too late for the 2006 planning cycle; thus its activities would, at the earliest, be part of the 2007 Country Operational Plans.
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From page 163... ...
The Partnership for Supply Chain Management is subject to this requirement, which will likely limit its usefulness to many of the focus countries, its efficiency, and its ability to offer medications at the lowest possible cost. The Committee also shares the concern expressed by stakeholders such as the advocacy group Health GAP and the Ecumenical Pharmaceutical Network -- a broadly based international organization that includes many of the faith-based organizations supported by PEPFAR -- that the Partnership for Supply Chain Management could undermine country capacity by creating a parallel system, and thus destabilizing rather than strengthening existing systems; having a brain drain effect by taking personnel from
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From page 164... ...
. The Partnership for Supply Chain Management has articulated plans to address each of these concerns (Partnership for Supply Chain Management, 2006; OGAC, 2007)
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From page 165... ...
Global AIDS Program and the PEPFAR Supply Chain Management System (SCMS)
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From page 166... ...
Washington, DC: OGAC. Partnership for Supply Chain Management.
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From page 167... ...
2006c. Antiretroiral therapy for HIV infection in adults and adolescents: Recommen dations for a public health approach, 00 reision.
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