MSF: Pharmaceutical corporations failing children with HIV

Pharma industry delays development and availability of pediatric formulations of HIV medicines

Chiradzulu: HIV care for adolescents

MALAWI 2017 © Luca Sola/MSF

NEW YORK, NOVEMBER 29, 2018—Developing countries are struggling to provide HIV-positive children with World Health Organization (WHO)-recommended treatments because pediatric versions of HIV medicines don’t exist, are priced out of reach, or haven’t been registered in all countries that need them, said the international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) ahead of a Vatican City meeting of HIV stakeholders on scaling up diagnosis and treatment for children. Worldwide, only about half of HIV-positive children receive treatment, and half of those continue to receive suboptimal regimens, putting them at risk of increased side effects, resistance, and treatment failure. Pharmaceutical companies must stop dragging their feet and address their delays and failure to develop appropriate formulations of HIV medicines for children.

“Pharmaceutical corporations simply don’t consider children with HIV a priority, forcing us to use older, suboptimal treatments for the youngest people in our care that make it harder for them to stick to their treatment,” said Dr. David Maman, medical coordinator for MSF in Malawi. “Worse, increasing resistance to existing HIV medicines in sub-Saharan African countries means that the older treatments may not work in infants and children who are in urgent need of better treatment options. How long will children with HIV have to continue to suffer or die because of pure indifference?”

Despite the fact treatment coverage among children living with HIV is unacceptably low—with only 52 percent of HIV-positive children receiving treatment in 2017—pediatric HIV remains a neglected disease, and the small market for pediatric HIV medicines means they have never been a priority for either multi-national pharmaceutical corporations or generic manufacturers. Delays have plagued both the development and introduction of newer pediatric drug formulations and scale-up of existing formulations.

For example, the HIV drug dolutegravir—which is recommended by WHO as the preferred first-line treatment for infants and children, and was first approved for use in adults in 2013 and is still not available as dispersible tablet formulation, which is easier for children to take. Another example is a pediatric granule formulation of the key drug raltegravir, which Merck has been slow to register in developing countries.

The alternative to dolutegravir recommended by WHO is the combination of lopinavir/ritonavir, but its pediatric formulation has also been plagued with problems. Generics manufacturers Mylan and Cipla have been very slow in scaling up the supply of the pediatric formulations (in pellet and granule forms), and have also set their prices three times higher than the harsh-tasting lopinavir/ritonavir syrup that their products are supposed to replace.

At a meeting in Vatican City one year ago, representatives from global health organizations and executives from pharmaceutical corporations committed to increasing access to treatment for children and adolescents living with HIV, but very little progress has been made. The meeting is being re-convened this year on December 6-7.

“Children need access to the best and most robust medicines possible given that they need to stay on HIV treatment for life,” said Jessica Burry, HIV pharmacist for MSF’s Access Campaign. “Pharmaceutical corporations need to stop dragging their feet and start taking concerted action so that more young lives can be saved.” WHO recommends all children diagnosed with HIV immediately start antiretroviral therapy. However, without optimal pediatric HIV drug formulations, countries will continue to struggle to implement this recommendation.

In sub-Saharan Africa, home to 90 percent of all children living with HIV, there are high rates of resistance to existing HIV drugs, including nevirapine and efavirenz. The death rate among HIV-positive children remains high, especially during their first four years of life. In 2017, AIDS-related illnesses killed 110,000 children worldwide.