Scaling Up Access to Early Infant Diagnostics
On April 18, 2008, the Global AIDS Alliance released a policy brief that lays out a series of recommendations for accelerating access to early infant diagnostics that will be critical to scaling up pediatric AIDS treatment. In particular, GAA is calling on the President's Emergency Plan for AIDS Relief (PEPFAR) and other key stakeholders to convene a broad, multi-sector conference to catalyze and coordinate public-private partnerships to scale up infant HIV diagnostics capacity in resource-poor settings.
Treatment for the 2.5 million children living with HIV is on the cusp of a great expansion. An increasing number of antiretroviral medications are now available in pediatric formulations, and prices for these formulations have decreased significantly over the past two years. Increased funding through the US President's Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund to Fight AIDS, TB and Malaria, together with innovative funding strategies like those employed by UNITAID, promise to expand the resources available for care and treatment of pediatric HIV. As a result of the proliferation of pediatric drugs and the increase in funding for pediatric AIDS, a greater number of national programs now have plans for addressing their pediatric epidemics. Still, there is much progress to be made to reach the 780,000 children in immediate need of antiretroviral therapy. And there is a critical need is to ensure universal access to comprehensive prevention of mother-to-child transmission (PMTCT) to prevent the 420,000 new pediatric infections that occur annually.
The largest barrier to widespread treatment of HIV-positive children is the current lack of access to early infant diagnosis (EID), which would provide definitive diagnoses for infants born to HIV-positive mothers. Since infants are born with maternal antibodies circulating in their blood, standard adult antibody tests are not effective in diagnosing most children younger than 18 months of age. Definitive diagnosis in infants under 18 months requires direct detection of the HIV virus, either through nucleic acid tests (NAT) that measure the quantity of viral DNA or RNA in the blood or other tests that can detect HIV antigen proteins. However, NAT assays are significantly more expensive than antibody tests and require more laboratory equipment and personnel training. The most practical method of widespread implementation of NAT in resource-poor environments is through collecting dried blood spots (DBS) deposited on filter paper. DBS samples collected from infants can be easily stored and sent to central testing locations, allowing for country-wide testing networks that require fewer capital and human resource investments.
Following are GAA's key recommendations for accelerating access to early infant diagnostics:
(1) Flexibility and foresight in programming are essential for introducing improved technologies and achieving reduced costs in the future. Current programs aimed at expanding EID testing networks should not commit to using a single core technology or vendor and should retain the flexibility to adopt improved technologies in the future.
(2) Increased funds should be dedicated to developing point-of-care infant diagnostics, especially at major public research institutions, such as the US National Institutes of Health, and in the research and development arms of the private sector, such as the Bill & Melinda Gates Foundation.
(3) Diagnostic companies must work more closely with the World Health Organization, US Food and Drug Administration, and other national regulatory agencies to accelerate regulatory approval of existing technologies.
(4) Diagnostic companies and companies that manufacture equipment and other supplies should discuss selling more inclusive versions of their tests. This should include a pre-made DBS sample collection kit, tests with all necessary reagents, and complete analyzing kits.
(5) Diagnostics companies must introduce and expand market availability for new testing modalities. Increased automation of the tests will enhance countries' EID capability and improve quality control.
(6) High-prevalence countries must design plans for nationwide implementation of NAT and DBS testing networks.
(7) WHO and UNAIDS should conduct global needs forecasting for EID testing. Quantifying the global market for EID will map potential incentives for diagnostics companies, and thereby encourage research and development into new EID technologies.
(8) The US Office of the Global AIDS Coordinator (OGAC) should take a leading role in coordinating a public-private partnership for infant diagnostics, and should dedicate a specific working group to address the challenges of procurement and implementation of EID technologies. This will likely include negotiations with several different manufacturers of equipment and supplies.