The first infant formulation of dolutegravir, an important first-line HIV medication, will be available soon under an agreement between several pharmaceutical companies and global health initiatives.
The new formulation will be strawberry flavored and come in a tablet that dissolves in water or juice so babies can swallow it.
In another announcement also linked to World AIDS Day, which occurs every Dec. 1, the International Partnership for Microbicides, which seeks to protect women from HIV infection, said that, after many years of research, the World Health Organization had approved the dapivirine ring, a vaginal insert that has proved effective in women who use it consistently.
Each year, about 160,000 children are newly infected with HIV, according to the WHO. Most are in Africa and infected at birth or through breastfeeding when their mothers do not realize that they themselves are infected.
About 60% of new HIV infections in Africa each year occur among women, according to the WHO.
Without testing and treatment, half of those babies will die by age 2, and 80% will not reach their 5th birthday. About 80,000 toddlers and young children die each year of AIDS-related illnesses.
Children are hard to treat because many HIV medicines taste bitter, come in pills that infants cannot swallow or are alcohol-based syrups that need refrigeration.
“This is truly an advance,” said Dr. Elaine J. Abrams, chief of pediatrics for ICAP, the global health outreach arm of Columbia University’s Mailman School of Public Health and leader of a WHO treatment guidelines panel. “The products currently available for pediatric treatment are less than optimal. There have been a few new formulations, but they haven’t been as successful as anticipated.”
Jessica Burry, a pharmacist with the Doctors Without Borders access campaign, called it “great news that we finally have dolutegravir for children.”
Both experts noted that the new form could not be used until a child is 1 month old, so a syrup that can be given to newborns is still needed.
Last year, strawberry-flavored “sprinkles” that contained four older HIV drugs, and that could be shaken over cereal or mixed into milk, were introduced for about $365 a year.
The new form of dolutegravir will cost only about $36 a year.
It will be made by Macleods Pharmaceuticals, an Indian company, and Mylan, another generic manufacturer that is now part of a new company called Viatris.
ViiV Healthcare, a partnership created in 2009 by Pfizer and GlaxoSmithKline to develop and market HIV drugs, patented dolutegravir (which it sells as Tivicay) in the United States in 2013. It patented the dissolving pediatric form in June; it is working on a syrup for newborns.
The multicompany deal was brokered by the Clinton Health Access Initiative and Unitaid, a Geneva-based global health agency that oversees a “medicines patent pool” through which Western pharmaceutical companies license patents on their new drugs to generic manufacturers eager to serve the large but low-profit markets in poor countries.
The Food and Drug Administration sped up approval of the pediatric form of dolutegravir so it could be purchased by the President’s Emergency Plan for AIDS Relief, the program begun by the George W. Bush administration to fight AIDS in poor countries.
Doctors treating children in Africa are excited about having a usable form of the drug, Abrams said, because it belongs to a new class of antiretrovirals called integrase inhibitors that work well in adults but have been unavailable to children.
Having a drug from a new class is important, because the rise of resistance to one drug from any class — such as fusion inhibitors or reverse transcriptase inhibitors — often creates cross-resistance to all similar drugs.
The ring approved by the WHO is made of flexible silicone and slowly releases tiny amounts of dapivirine, an antiretroviral drug, for about a month. The drug is meant to prevent the virus from infecting vaginal tissue.
The International Partnership for Microbicides, which announced the WHO approval, has sought approval for the ring in the hope that it will be useful in Africa, where most transmission is through heterosexual sex. It does not need refrigeration, and a woman can use it without her partner knowing about it.
In some couples, experts said, when a woman uses an HIV-prevention device or pill, her partner may accuse her of having HIV or of assuming that he does, which may infuriate him. Parents who discover their teenage daughters are using one may also be angered.
In 2016, two major studies of the dapivirine ring found that it was only about 30% effective at preventing infection, and follow-up studies found it reduced infection risk by only about 35% overall. It failed to do better not because the device didn’t work but because women, especially younger women, did not or could not use it consistently.
In one study, women over age 25 who used it consistently gained better than 60% protection. Finding prevention methods that women can use discreetly has been a major obstacle to beating AIDS in Africa. Tests of pills and vaginal microbicides have failed because women could not use them consistently enough to protect themselves.
The partnership is working on rings that last three months and others that prevent both HIV and pregnancy.
Long-lasting injections and implants, like those that prevent pregnancy, are also being tested.