Providing Safe and Effective Preventative Antiretroviral Prophylaxis to HIV-Exposed Newborns Via a Novel Drug Delivery System in Tanzania.

Dahinten, Alexander P. BEng; Dow, Dorothy E. MD; Cunningham, Coleen K. MD; Msuya, Levina J. MD; Mmbaga, Blandina T. MD; Malkin, Robert A. PhD
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Background: In developing countries, antiretroviral therapy provides life-saving treatment to HIV-positive women and their children before, during and after birth. However, supply chain challenges such as long distances, medication shortages and non-facility deliveries often compromise consistent access to prophylactic treatment for at-risk infants. A proposed intervention to address these challenges, often referred to as the "Pratt Pouch", allows for liquid formulation medications, such as nevirapine (NVP), to be repackaged into single-dose pouches. These pouches are distributed antenatally.

Methods: HIV-positive women at Kilimanjaro Christian Medical Centre (KCMC) in Moshi, Tanzania received fourteen pouches each containing a single dose of NVP for prevention of mother-to-child transmission. Women were trained on how to open the pouch and dispense the medication to their infant after delivery. All participating women were asked to return to KCMC 7-14 days after delivery, where infant blood spots were collected to assess NVP levels.

Results: All enrolled women (21/21) administered NVP to their infants within 24 hours of birth. All enrolled infants (22/22) had NVP blood concentrations over 100ng/ml and exhibited no health concerns attributable to over or under dosing.

Conclusions: The Pratt Pouch intervention provides a clinically appropriate solution for addressing liquid formulation antiretroviral access challenges in developing countries.