Partnerships for Treatment

It was just a few years ago that many doubted that large-scale ART programs could work in the world’s poorest nations. Millions of people are living proof that they can.

Over 2.1 million people, including more than 2 million in the 15 focus countries, received treatment with support from rapidly scaled-up bilateral PEPFAR partnerships with host nations. In FY2008, PEPFAR provided nearly $1.6 billion in support of treatment programs, including treatment for pediatric patients, or 48.4 percent of program funding in the focus countries. The striking growth of PEPFAR support for treatment in the focus countries is shown in Figure 18, Table 11, and Table 12.

By September 2008 in the focus countries, approximately 54,100 individuals were being added to the number of people benefiting from PEPFAR support for life-extending treatment every month. The number of sites providing treatment increased 80 percent from FY2007 to FY2008, and each month approximately 197 new treatment sites came on line.

Progress in national scale-up

The maps in Figure 19 depict the increase in PEPFAR support for treatment coverage as programs scaled up toward the 5-year target of treatment support for 2 million people.

Beyond the focus countries, other bilateral PEPFAR treatment programs supported an additional 115,000 people (including only those reached with downstream PEPFAR support), for a total of over 2.1 million receiving treatment with PEPFAR support worldwide.

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

The safety, reliability, and efficacy of drugs procured with PEPFAR funding is of the utmost importance. Any known or suspected failure of a PEPFAR-procured ARVs to meet its required specifications in quality-assurance testing, or to perform as expected when used properly, results in immediate action to inform USG staff and partners in the field. Where necessary, the product is recalled and necessary substitutions in patient regimens are made along with efforts to locate a manufacturer with a more reliable product.

Table 14 is drawn from the work of SCMS in 2007 and shows that SCMS has been able to achieve the lowest price on nearly 70 percent of antiretroviral regimens for which internationally published prices were available (17 of 20 first-line regimens and three of nine second-line regimens).

While this level of savings is a considerable achievement, the use of generics within and between countries varies, and significant challenges remain including:

• Prices for pediatric ARV formulations and second-line ARVs remain higher than first-line regimens.
   
• In countries where approval and registration of generic ARVs is slow, partners may still have to use innovator drugs.
   
• Some buyers continue to purchase branded ARVs, due to unfounded concerns that even HHS/FDA-approved generics are not as effective.

In addition, the increasing cost of raw materials for ARVs could slow or stop the decline of ARV prices, and fluctuations in the value of the U.S. dollar against other currencies can also have an impact.

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