[Ip-health] Fwd: [HEALTHGAP] New Report: Scaling Up Access to Early InfantDiagnostics

[Jean Blaylock]

http://www.globalaidsalliance.org/index.php/925
http://www.globalaidsalliance.org/page/-/PDFs/Scaling_Up_Access_to_Early_In=
fant_Diagnostics_041808.pdf

Scaling Up Access to Early Infant Diagnostics

On April 18, 2008, the Global AIDS Alliance released a policy brief that la=
ys out a series of recommendations for accelerating access to early infant =
diagnostics that will be critical to scaling up pediatric AIDS treatment. I=
n particular, GAA is calling on the President's Emergency Plan for AIDS Rel=
ief (PEPFAR) and other key stakeholders to convene a broad, multi-sector co=
nference to catalyze and coordinate public-private partnerships to scale up=
 infant HIV diagnostics capacity in resource-poor settings.

Click here to download Scaling Up Access to Early Infant Diagnostics: Accel=
erating Progress Through Public-Private Partnerships.
[http://www.globalaidsalliance.org/page/-/PDFs/Scaling_Up_Access_to_Early_I=
nfant_Diagnostics_041808.pdf ]

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 hav=
e decreased significantly over the past two years. Increased funding throug=
h the US President's Emergency Plan for AIDS Relief (PEPFAR) and the Global=
 Fund to Fight AIDS, TB and Malaria, together with innovative funding strat=
egies like those employed by UNITAID, promise to expand the resources avail=
able for care and treatment of pediatric HIV. As a result of the proliferat=
ion of pediatric drugs and the increase in funding for pediatric AIDS, a gr=
eater number of national programs now have plans for addressing their pedia=
tric epidemics. Still, there is much progress to be made to reach the 780,0=
00 children in immediate need of antiretroviral therapy. And there is a cri=
tical need is to ensure universal access to comprehensive prevention of mot=
her-to-child transmission (PMTCT) to prevent the 420,000 new pediatric infe=
ctions 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 provid=
e definitive diagnoses for infants born to HIV-positive mothers. Since infa=
nts 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 requ=
ires 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 te=
sts that can detect HIV antigen proteins. However, NAT assays are significa=
ntly more expensive than antibody tests and require more laboratory equipme=
nt and personnel training. The most practical method of widespread implemen=
tation of NAT in resource-poor environments is through collecting dried blo=
od spots (DBS) deposited on filter paper. DBS samples collected from infant=
s 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 in=
fant diagnostics:

(1) Flexibility and foresight in programming are essential for introducing =
improved technologies and achieving reduced costs in the future. Current pr=
ograms aimed at expanding EID testing networks should not commit to using a=
 single core technology or vendor and should retain the flexibility to adop=
t 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 Organ=
ization, US Food and Drug Administration, and other national regulatory age=
ncies 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.  T=
his should include a pre-made DBS sample collection kit, tests with all nec=
essary 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 co=
untries' EID capability and improve quality control.

(6) High-prevalence countries must design plans for nationwide implementati=
on 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 d=
iagnostics companies, and thereby encourage research and development into n=
ew EID technologies.

(8) The US Office of the Global AIDS Coordinator (OGAC) should take a leadi=
ng 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 incl=
ude negotiations with several different manufacturers of equipment and supp=
lies.




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