Gilead – “I’m exhausted, I’m exhausted.” “When will this be over?” Dr. Eva Natukunda, a pediatric HIV specialist at the Joint Clinical Research Center in Kampala, Uganda, says she frequently hears this refrain from HIV-positive teenagers and young adults.
Eva has been following many of these patients since birth and has discovered that by adolescence, children who have grown up living with HIV are tired of having to take 4 to 6 tablets every day, because single-tablet regimens are not available everywhere for children. Some people who stop taking their medicines have a recurrence of the virus and risk having HIV-positive children – “and then the epidemic continues with another generation of babies,” she warns.
Eva, on the other hand, wishes to end the pattern. She is one of several clinicians working with Gilead scientists throughout the world to develop more advanced and accessible medicines for the estimated 1.7 million children living with HIV worldwide, with 9 out of 10 residing in Sub-Saharan Africa.
“Medications for children have historically lagged behind those for adults,” explains Kathryn Kersey, Executive Director of Gilead’s Virology Clinical Development. “I believe it is fair to say that children living with HIV have been left behind, and there is a need to bridge the treatment gap between adults and children.”
In fact, according to World Health Organization projections for 2020, only 54% of children with HIV are receiving antiretroviral medication, compared to 74% of adults.
Gilead has been at the vanguard of transforming HIV treatment and prevention for decades, and it is also committed to accelerating the development and availability of new drugs for children. It established a global Pediatric Center of Excellence in Dublin last year to coordinate and optimize the execution of pediatric clinical studies.
“The goal is to develop innovative therapies and have them approved as soon as possible so that they can reach children all over the world,” Kathryn explains.
More than 100 employees work at the center to develop and test new HIV, hepatitis, and COVID-19 medicines. Scientists have already started looking at new kid cancer treatments and will soon start looking into remedies for childhood inflammatory diseases.
“It’s an old adage, but children aren’t mini-adults,” Kathryn explains. “There are many different considerations in terms of how their bodies respond to medication – issues of metabolism and the impact on developing organs.”
There are practical considerations in how to conduct clinical studies with children, such as informed permission and seemingly basic procedures such as drawing a blood sample from a child. Furthermore, youngsters may have difficulty swallowing large, bitter-tasting medications. To assist overcome this last barrier, Gilead is working with the Clinton Health Access Initiative and the Penta ID network to develop dispersible drugs that can be dissolved in water, making medications more appealing to children.