Wednesday, September 23, 2015

Tentative FDA approval of lopinavir/ritonavir oral pellet formulation closes treatment gap for children with HIV

The Paediatric HIV Treatment Initiative welcomes this important step towards closing the treatment gap for children with HIV

Infants and young children living with HIV will finally have access to an improved formulation of an antiretroviral (ARV) treatment, following the U.S. Food and Drug Administration's (FDA) tentative approval last week of lopinavir/ritonavir (LPV/r) oral pellets developed by the Indian generic company Cipla.

Lopinavir.svg(lopinavir)  Ritonavir.svg(ritonavir)

"The announcement of tentative FDA approval of the lopinavir/ritonavir oral pellet formulation is an important step forward in increasing access to World Health Organization-recommended antiretroviral treatment for children under three years of age," said Ambassador Deborah L. Birx, M.D., U.S. Global AIDS Coordinator and U.S. Special Representative for Global Health Diplomacy. "This supports the goals of key PEPFAR initiatives to improve paediatric HIV/AIDS services, including the Accelerating Children's HIV/AIDS Treatment Initiative and the Global Pediatric ARV Commitment to Action".

Until now, the only available version of this combination treatment was a harsh-tasting syrup that required refrigeration and contained 40% alcohol. Only a quarter of children with HIV are currently on treatment and the lack of child-adapted formulations contributes to this unacceptable situation.
"UNITAID and its partners in the Paediatric HIV Treatment Initiative (PHTI)* also welcome the approval of these oral pellets, which brings us a step nearer to closing the shameful treatment gap for the 3.2 million children living with HIV around the world," said Lelio Marmora, Executive Director of UNITAID which is funding the development of paediatric formulations for HIV.

Importantly, intellectual property issues around access to future LPV/r combinations will be reduced, thanks to a licensing agreement the Medicine Patent Pool (MPP) signed in in December 2014 with AbbVie, the patent holder for LPV/r. "This is a crucial licence for paediatric programmes as it benefits low- and middle-income countries where 99% of children with HIV in the developing world live," said Greg Perry, Executive Director of the MPP.

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