Generic Form of Pediatric HIV Drug OK’d

February 25,2015

A new licensing agreement with the pharmaceutical company MERCK allows for the manufacture of a generic version of a pediatric AIDS drug. It may be two years before it’s readily available in low- and middle-income countries. However, it’s a step toward having greater access to HIV medicines specifically designed for children.

It’s estimated there are more than three million children living with HIV, but less than a third of them received antiretroviral therapy in 2013.The U.N.-backed Medicines Patent Pool estimates 700 children are newly infected each day, while 500 die of AIDS-related causes.

The MERCK drug – raltegravir – has been approved for children as young as four weeks.

Generic Form of Pediatric HIV Drug OK’d
Kids look on in the Republican Hospital for Infectious Diseases, which specializes in treating HIV-positive children in Ust-Izhora outside St. Petersburg, Russia, May 30, 2006.

Medicines Patent Pool Executive Director Greg Perry said pediatric AIDS drugs are a neglected area of health care. As a result, many kids with HIV are forced to take adult formulations of antiretroviral pills, or ARVs.

“They will taste incorrect. They will have high alcohol content. They will be too big. The children won’t take them. So, there’s a whole series of problems with using adult formulations," he said. "And finally, worst of all, of course, is that when you try and break them down they’re not really perfectly digestible to the children or working properly into the bloodstream.”

Perry explained what the licensing agreement with MERCK will do.

“It does allow really two things. It allows for generic companies to develop and then manufacture low cost versions of raltegravir. It also enables them to make improvements upon the product and, indeed, to use them in combination with other products," he said. "[This] is important because you want to see new fixed dose combinations of pediatric formulations because that’s a clear need in the pediatric field.”

Currently, the drug is considered a third line of defense. But Perry said there are discussions about using it as a first- or second-line drug.

“It’s an important alternative to [the] current, sort of, preferred product, which is called lopinavir/ritonavir. So, from a public health point of view it’s an important product,” he said.

Perry added it’s important to have a wide variety of ARVs in the event HIV builds up resistance to current treatment. He said the Pediatric HIV Treatment Initiative aims to develop new fixed dose drug combinations. The goal is to have up to six new formulations over the next three years.

U.S. Global AIDS Coordinator Dr. Deborah Birx said, “Without antiretroviral therapy 50 percent of infants with HIV die by age two and 80 percent by age five.”