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Raltegravir (granules for oral suspension, 100 mg/packet)

MSF supports the inclusion of raltegravir granules for oral suspension, 100 mg/packet, as a new formulation in both the WHO Essential Medicines List and the WHO Essential Medicines List for Children, for treatment of HIV among infants and children and living with HIV/AIDS. Raltegravir was the first approved drug in the pharmacological class of integrase inhibitors. In the current WHO Essential Medicines List, raltegravir is included as 400 mg tablet, 25 mg and 100 mg chewable tablet. Raltegravir granules for oral suspension was approved by the US FDA for use in neonates and young infants in December 2013 and by the EMA in June 2018. Raltegravir granules for oral suspension can be used from birth to 4 weeks of age and in young infant beginning antiretroviral treatment. In the 2018 WHO HIV Interim Guidelines “Updated Recommendations on First-Line and Second-Line Antiretroviral Regimens and Post-Exposure Prophylaxis and Recommendations on Early Infant Diagnosis of HIV”, a raltegravir-based regimen may be recommended as an alternative first-line regimen for infants and children for whom approved dolutegravir dosing is not available and a raltegravir-based regimen is recommended as the preferred first-line regimen for neonates. In the 2018 Optimal Formulary and Limited-use List for Paediatric ARVs, raltegravir-based regimens are recommended as preferred first-line treatment (with zidovudine + lamivudine) for neonates, as an alternative first-line treatment for infants (with abacavir + lamivudine), and used “for the shortest time possible, until a solid formulation of lopinavir + ritonavir or dolutegravir can be used.” Raltegravir granules for oral suspension, as preferred first-line treatment for neonates, was also added to Limit-use List for this time-limited purpose.

MSF has been using raltegravir as a third-line treatment option in adults and children but not in neonates in its programs since 2016.

MSF urges the 22 nd Expert Committee on the Selection and Use of Essential Medicines to include raltegravir granules for oral suspension 100 mg/packet in both the WHO Essential Medicines List and the WHO Essential Medicines List for Children. At the end of 2017, in collaboration with Health Authorities, MSF provided antiretroviral treatment for more than 200 000 people living with HIV, including more than 15000 patients on second-line antiretrovirals.

For Médecins Sans Frontières

Myriam Henkens, MD, MPH International Medical Coordinator