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Reaching women and children
As part of its commitment to ensure treatment availability for children and women, PEPFAR bilateral programs have led international partners in supporting host nations in tracking clients by age and gender. Table 13 shows that of those for whom PEPFAR provided downstream support for treatment in the focus countries, approximately 63 percent were women, which is higher than the estimated percentage of women living with HIV in sub-Saharan Africa.
PEPFAR has also expanded access to treatment for children, with the number of children receiving ART through downstream PEPFAR support increasing 51 percent from FY2007 levels. PEPFAR dedicated approximately $140 million to pediatric treatment in FY2008, reaching approximately 130,100 children with downstream support in FY2008, compared with only 4,800 in FY2004.
Pediatric treatment has made steady progress, increasing the share of those receiving PEPFAR-supported treatment who are children from 3 percent in FY2004 to 8 percent in FY2008. This percentage is above UNAIDS’ estimate of the global share of HIV-positive people who are children (7.5 percent). For FY2008, PEPFAR directed all focus countries to increase their level of support for pediatric treatment, moving toward having children represent 10 percent to 15 percent of all individuals on treatment.
Improving infant diagnosis
Increasing the availability of pediatric treatment is pressing because 50 percent of HIV-positive children will die by age 2 if they are not treated. However, effectively addressing the issue of pediatric treatment requires more than increased resources. Standard HIV tests, which test for HIV antibodies, cannot reliably identify children as being HIV-infected until after 18 months of age due to the presence of maternal antibodies. Thus, it is difficult to determine which infants and children are infected and need treatment. To accurately diagnose HIV infection in infants and children so they can access treatment, PEPFAR supports nations in expanding polymerase chain reaction (PCR) testing to identify the presence of HIV. To expand access to accurate diagnosis, PEPFARsupported programs are testing infants and children using dried blood spots on filter paper, which require less blood per test than older methods and can be easily transported to central laboratories for testing.
PEPFAR has supported country-level policy change to allow PCR-based dried blood spot testing in order to reduce the cost and burden of infant diagnosis. Most PEPFAR countries have now adopted such policies, making accurate diagnosis and management of pediatric treatment a growing reality.
Addressing ongoing barriers to pediatric treatment
Other barriers currently limiting the scale-up of pediatric treatment and care services include a lack of providers equipped with the necessary skills to address the special needs of HIV-positive children, the relatively high cost of pediatric ARV formulations, regulatory barriers to registering pediatric ARV formulations, weak linkages between PMTCT and treatment services, and limited information about pediatric doses of medicines at different ages and weights. To address these barriers, PEPFAR supports training programs to teach health care workers how to treat pediatric patients, and has supported the development of dosing guides for children of various ages and sizes. PEPFAR also continues to work with pharmaceutical companies, implementing organizations, and multinational organizations such as UNICEF and WHO through a PPP (announced by Laura Bush in 2006) to address these barriers.
Increasing the availability of safe, effective, low-cost generic medications
PEPFAR’s impact on treatment access extends beyond PEPFAR-supported programs to increased availability of safe, effective, low-cost, generic ARVs in the developing world. To meet the need for such ARVs, the Food and Drug Administration within the U.S. Department of Health and Human Services (HHS/FDA) introduced an expedited “tentative approval” process to allow ARVs from anywhere in the world, produced by any manufacturer, to be rapidly reviewed to assess quality standards and subsequently cleared for purchase under PEPFAR. As of December 20, 2008, 78 generic ARV formulations had been approved or tentatively approved by HHS/FDA under the expedited review, including 16 fixed-dose combination products that contain two drugs in the same
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