For 1.7 million children living with HIV, a new formulation of a drug for adults is now available – and it could make treatment easier and cheaper.
The pediatric formulation of dolutegravir, a drug recommended as first-line HIV treatment by the World Health Organization, will come as a strawberry-flavored tablet that can be dissolved in water or juice, making it easier to give to children too young to swallow tablets.
The pediatric formulation of dolutegravir was developed through a partnership between ViiV Healthcare (the company that first originated the drug), generic drug manufacturers, Unitaid (an international health-funding organization), and the Clinton Health Access Initiative.
On World AIDS Day Tuesday, Unitaid and Clinton Health Access Initiative released a statement about the drug and announced a pricing agreement to make it available in low- and middle-income countries.
“The 10 mg scored dispersible tablet was developed by Viatris (Mylan) and Macleods based on the technical information provided by ViiV Healthcare,” Clinton Health Access Initiative spokeswoman Regan Lachapelle said in an email.
The drug can be taken by children above four weeks of age and weighing at least 6.6 pounds (3 kilograms), Lachapelle added.
The flavoring will make the drug more palatable to children compared to current options that are bitter to the taste or otherwise hard for kids to consume, according to pediatric HIV experts.
In low- and middle-income countries, the pediatric formulation of dolutegravir will cost about $36 per child per year, based on the pricing agreement brokered by Unitaid and Clinton Health Access Initiative with generic manufacturers Viatris and Macleods.
Since dolutegravir is not a standalone treatment for HIV, and must be taken in conjunction with other drugs as part of a HIV therapy regimen, the overall cost of treatment under the new pricing agreement will go from over $480 to under $120 per child per year, according to Unitaid and Clinton Access Health Initiative.
The drug will become available in Benin, Kenya, Malawi, Nigeria, Uganda and Zimbabwe in the first half of 2021, and in more countries later on, Unitaid and Clinton Health Initiative wrote.
An estimated 100,000 children died of AIDS-related illnesses in 2018, according to the World Health Organization. Without access to testing and treatment, the WHO says that 50% of children affected by HIV will die by the age of 2, and 80% will die before turning 5.
“If infants get treated and their virus stays suppressed or controlled, they can live into their 3rd, 4th or perhaps even 5th decade of life—or longer,” Dr. Deborah Persaud, a professor of pediatrics at Johns Hopkins University and an expert in HIV/AIDS in children, told CNN.
“Treating them early keeps their immune systems healthy,” Persaud added.
In 2019, only 53% of children living with HIV had access to treatment.
“Even if they are on treatment, for many years they have been on suboptimal drugs, because it always takes longer to develop and approve medications for children compared to adults,” Dr. Martina Penazzato, the HIV lead at the World Health Organization, told CNN.
Penazzato said the formulation of pediatric dolutegravir could be “quite transformative” in the fight against pediatric HIV.
The drug was “a missing formulation to allow the provision of the preferred regimen by WHO for children living with HIV,” Penazzato said.
ViiV Healthcare’s pediatric dolutegravir received US Food and Drug Administration approval in June, and the generic product received tentative approval on November 19 under the US President’s Emergency Plan for AIDS Relief (PEPFAR).
“This is the first time a generic product has been positively reviewed within several months of the originator product receiving FDA approval, reducing the gap from three years for the adult version of the same medicine to just five months,” Unitaid and Clinton Health Access Initiative wrote.
“FDA tentative approval via the President’s Emergency Plan for AIDS Relief (PEPFAR) program allows procurement of the product by US agencies such as PEPFAR, USAID,” Lachapelle said in an email.
“Each generic company is also in the process of registering the products within the countries where it will be used.”