Researchers have found a better way to deliver antiretroviral medication to babies—via a disposable pouch like a ketchup packet.According to
The waiting room in Ecuador’s Enrique Sotomayor hospital has the feel of a Department of Motor Vehicles: chimes going off every minute to summon the next patient in line, benches crammed with pregnant women and their families, and peeling paint under fluorescent lights.
The noisy hallways in the largest maternity hospital in South America lead past a courtyard where a Virgin Mary statue presides, past a nursery with wall-to-wall bassinets, past a room the size of a gymnasium outfitted with beds for new mothers, and to a dingy pharmacy that offers a simple yet innovative treatment: a single-serving dose of antiretroviral medication for newborns.UNAIDS, 240,000 children were born with HIV in 2013. Without intervention, the risk of transmission from mother-to-child—which can occur during pregnancy, labor and delivery, or breastfeeding—is as high as 45 percent. With the proper antiretroviral therapy, that risk falls to less than 2 percent.
More than 25,000 babies, representing 15 to 20 percent of Ecuador’s births, are delivered every year at this hospital in Guayaquil, the country’s most populous city and main port built on the western banks of the muddy Guayas River. Among the pregnant women tested, the average incidence of HIV is .5 percent, or one in every 200, according to Fundación VIHDA, a nonprofit organization founded in 2006 by Humberto Mata.
“There’s a huge stigma,” says Mata, a businessman and former politician who was moved to act after witnessing the devastation of the AIDS epidemic and losing a boyfriend to the disease. “People think it’s a punishment from God and that you have to accept your fate.”
Two of Mata’s nephews, who both interned at VIHDA and attended Duke University, told him about a pouch developed by Robert Malkin, director of Duke’s Developing World Healthcare Technology Laboratory.
In partnership with the Ministry of Health and the maternity hospital, VIHDA offers testing during pregnancy, an elective Cesarean delivery (which can prevent HIV transmission), a 30-day course of antiretroviral medication to newborns, and infant formula for up to 18 months.
Mothers with HIV in developing nations have long struggled to medicate their infants at home. They can crush an antiretroviral tablet and mix it with water, but for infants, the oral liquid version of the medication is preferable, for ease of swallowing, sterile preparation, and to ensure correct dosing.
However, the liquid antiretroviral can precipitate into solids, Malkin said. That is, when the medication is transferred to a spoon, cup, syringe, or different-sized bottle, the liquid—usually a milky suspension—turns clear where it has separated.
His lab tested whether that was due to spoilage or evaporation: neither, as it turned out, but because of improper packaging. The pharmaceutical company ships liquid medication in a large bottle. When divided into the prescribed amounts for an individual patient, and no longer in the manufacturer’s bottle, it is prone to losing its effectiveness.
Malkin likens it to paint, which remains a liquid in the can because of the volume-to-surface ratio, but becomes a solid when spread on the wall.
Mata’s lab soon developed its own single-serving medication solution in a pouch. In Ecuador, such pouches are common, offering detergent, shampoo, and condiments in economical, portable sizes. In this case, the pouch also helps mothers administer the proper dose—no need to measure, no fear of spilling—and preserves medication for a year or more.
Nora, a 30-year-old homemaker in Guayaquil, says she was comfortable using the pouch on her infant daughter—it’s easier than the antiretroviral pill she chokes down every day.
Researchers have tested the pouches, made of polyethylene with metal foil and outer plastic, in Tanzania and Namibia, and conducted human clinical trials in Ecuador and Zambia last year.
A cross-sectional study published earlier this year, presenting data from Ecuador’s clinical trial, concluded that the pouch is a highly accurate and easy-to-use device for delivering liquid antiretroviral to infants.
At the maternity hospital, pharmacists fill and label the pouch with the pediatric dosage under sanitary conditions and stack them in a blue plastic box. Mothers bring back the discarded pouches for medical staff to tally and inspect for their proper use.
The combination and dose of medications for the newborn can vary, depending on the mother’s health and her viral load, as well as the weight of the child. A newborn might take a single pouch a day, or several with different medications. The pouch offers flexibility if new research suggests changes in the dosing regimen.
Taking antiretrovirals during pregnancy can suppress the virus, but at least a quarter of the women in Ecuador give birth without seeing a doctor until labor and delivery. Someday, VIHDA’s Mata hopes, midwives could teach mothers-to-be how to use the antiretroviral pouches.
For infants, the pouch is now available in Ecuador, Tanzania, and Namibia, and next year, will likely be in Uganda and Nigeria. Malkin, the Duke professor, is also researching how it might be used to administer medication for tuberculosis and pneumonia.
In Ecuador, VIHDA is trying to secure funding from NGOs and private donors to expand the pilot program, making it standard at the maternity hospital in Guayaquil and elsewhere in the country at public and private hospitals.
At VIHDA’s offices, Nora cuddles her five-year-old son, who peeks into our interview and proudly shows off his new pack of crayons, each rainbow point still sharp in the box.
After Nora contracted HIV from the father of her third child, he disparaged her to the neighbors, and she became estranged from her mother.
“This has been a very tough situation,” she says. “At first I saw [HIV] as a punishment from God, but now I feel it’s a privilege because I have more compassion for other people. And in time, people saw a new Nora, who is struggling but who is going up.”
Vanessa Hua reported from Ecuador on an International Reporting Project fellowship.