Developing and Delivering Appropriate HIV Medicines for Children

Today (Feb. 24) the Medicines Patent Pool (MPP) announced a new licensing agreement with pharmaceutical company Merck & Co. that will allow generic manufacturers to produce low-cost pediatric versions of Merck's HIV medication, raltegravir. Generic manufactures will be able to sell the medication at a  low cost in 92 low- and middle-income countries hit hardest by the HIV epidemic. This announcement comes two months after MPP signed a similar agreement with pharmaceutical company AbbVie Inc. allowing generic use of inexpensive versions of its HIV medicines, lopinavir and ritonavir, for children.

At EGPAF, we know that these latest agreements are part of a larger effort to make HIV treatment more accessible for the 3.2 million children worldwide who are currently living with the virus. Read below for a blog by MPP’s Executive Director Greg Perry about the recently launched Pediatric HIV Treatment Initiative (PHTI), which seeks to develop innovative pediatric HIV treatment approaches and improve access to HIV medications for children in resource-limited settings. 

This blog was orginally published on June 18, 2014. 

On Tuesday, June 17, 2014, leading HIV organizations, including the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF), the Medicines Patent Pool (MPP), the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), Drugs for Neglected Diseases initiative (DNDi) and others — gathered in Washington, D.C. to discuss key challenges to ensuring that millions of children living with HIV have access to lifesaving medications.

The importance of this effort seems obvious. Most organizations that participated in Tuesday’s panel discussions have treating and caring for kids living with HIV as a primary focus.

In practice, however, we are not doing an adequate job of meeting children’s needs. While the international community has made significant strides in improving treatment programs for adults, only 647,000 children are currently on antiretroviral therapy (ART)—that is just one quarter of those who are living with HIV.

Moreover, antiretroviral treatment is woefully inadequate for small stomachs and hands. Consider the case of a preteen named Clinton living in Kenya; he is on a tiresome and complicated regimen of taking nine tablets, twice a day. More seriously, he is developing a resistance to several of his key medicines, and a lack of new drugs at affordable prices means that his options for future treatments are limited. And for six-year-old Peace, unpalatable medicines, formulated for adults and with high alcohol content, lead to constant vomiting and tears.

To meet the World Health Organization’s (WHO) HIV care and treatment guidelines, UNITAID, DNDi, and MPP have launched a new initiative to develop better-adapted pediatric HIV medicines.  The Pediatric HIV Treatment Initiative (PHTI) seeks to develop innovative treatment approaches, such as fixed dose combinations — several antiretroviral drugs blended into one pill, sprinkle, or powder that are easily digestible for children across all age groups and can be distributed in resource-limited settings.

The development of these new formulations requires collaboration among many different companies to pool the intellectual property, data, and know-how needed to support the manufacture of generic and thus low-cost versions of new drugs quickly.  MPP will be leading this effort working with both originator and generic companies. Bristol-Myers Squibb, Gilead Sciences and ViiV Healthcare have already licensed pediatric formulations to the MPP. Other partners, such AbbVie and Merck/MSD, are currently in active negotiations. The initiative will also help sustain the pediatric HIV market over the long-term and prepare countries for the implementation of new drugs into current national treatment programs.

On Tuesday, we were pleased to note commitment from many U.S.-based organizations, including EGPAF, our partner in hosting the event, along with representatives from PEPFAR and other U.S. companies. Since 2003, when President George W. Bush launched PEPFAR, the U.S. has been a game-changer in jump-starting rapid scale-up of ART and supporting a range of programs for people living with HIV.

Continued funding for purchasing organizations such as PEPFAR and the Global Fund to Fight AIDS, Tuberculosis and Malaria are crucial to the success of PHTI.  We look forward to the engagement of the Obama Administration, the U.S. Congress, and the private sector in concert with MPP to improve HIV pediatric care. Clearly we have our work cut out for us. Without lifesaving medications, half of all children living with HIV will die before the age of two and 80 percent won’t see their fifth birthday.  Treating more children with available, appropriate, quality, and child-friendly HIV medicines must now be a public health priority.

Greg Perry is the executive director of Medicines Patent Pool (MPP) where he marries more than 20 years of experience in pharmaceuticals, intellectual property and health care policy with MPP’s mission to increase access to quality, appropriate, affordable medicines for people living with HIV in developing countries.