Access to Pediatric Formulations of Raltegravir

Partnership objective

Provide access to raltegravir to HIV-infected children in developing countries where the burden of HIV infection is highest.

A partnership designed to improve access and develop new formulations of raltegravir for pediatric populations in low- and middle-income countries with significantly high rates of pediatric HIV A partnership designed to improve access and develop new formulations of raltegravir for pediatric populations in low- and middle-income countries with significantly high rates of pediatric HIV Copyright Medicines Patent Pool

What are the health needs and challenges?

Resource-limited countries are among the hardest hit by diseases such as HIV/AIDS; the vast majority of people living with HIV are in low- and middle-income countries, particularly in sub-Saharan Africa. There are 3.2 million children worldwide living with HIV, most infected by HIV+ mothers during pregnancy, childbirth or breastfeeding. Without antiretroviral treatment, 50 percent of infants living with HIV/AIDS will die by the age of two, and 80 percent by the age of five.

It is estimated that less than a quarter of all children infected with HIV worldwide are receiving antiretrovirals. Therefore, it is critical to develop innovative formulations to meet this unmet medical need while ensuring access to existing therapies.

Description of partnership activities and how they address needs and challenges

MSD has entered into an agreement with the Medicines Patent Pool (MPP) to license its pediatric formulations of raltegravir—chewable tablets and granules for oral suspension— for use in treating HIV-1 infection in infants and children from four weeks to under 12 years of age. This is the MPP’s first agreement to provide access to an HIV integrase inhibitor for use in combination HIV therapy for infants and children in this age range. The agreement also allows for development of novel pediatric formulations of raltegravir and novel combinations.

Raltegravir is the only integrase inhibitor approved for use in infants and children as young as four weeks in the United States and European Union. As such, the World Health Organization (WHO) guidelines have listed raltegravir as an important product needed for certain pediatric populations.

The agreement is designed to improve access to raltegravir for pediatric populations in low- and middle-income countries with significantly high rates of pediatric HIV, totalling 92 countries. In addition to providing expanded access, the agreement allows for development of new pediatric formulations of raltegravir, in support of the “Global Pediatric Antiretroviral Commitment-to-Action” announced by the United States President’s Emergency Plan for AIDS Relief (PEPFAR), the Pediatric HIV Treatment Initiative (PHTI), and the Global Fund to Fight AIDS, Tuberculosis and Malaria, to accelerate the development of new, high-priority pediatric antiretroviral co-formulations.

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Medicines Patent Pool - Partnering for the Future of HIV Treatment

Partnership information

Company(ies) MSD

Partner(s) Medicines Patent Pool

Type of Partner(s) NGOs

Therapeutic Focus Infectious Diseases, Women and Children's Health

Disease(s) Children's Health, HIV/AIDS, Women's Health

Program Type(s) Availability of Treatment - Technology Transfer - Manufacturing and Entrepreneurial Know-How

Targeted Population(s) Children, Mothers

Region(s) East Asia & Pacific, Europe & Central Asia, Latin America & Caribbean, Middle East & North Africa, South Asia, Sub-Saharan Africa

Number of Countries 92

Country(ies) Afghanistan, Angola, Armenia, Bangladesh, Benin, Bhutan, Bolivia, Botswana, Burkina Faso, Burundi, Cambodia, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Congo, Côte d'Ivoire, Democratic Republic of the Congo, Djibouti, Egypt, El Salvador, Equatorial Guinea, Eritrea, Ethiopia, Gabon, Georgia, Ghana, Guatemala, Guinea, Guinea-Bissau, Guyana, Haiti, Honduras, India, Indonesia, Kenya, Kiribati, Kyrgyzstan, Lao PDR, Lesotho, Liberia, Madagascar, Malawi, Maldives, Mali, Mauritania, Mauritius, Micronesia, Moldova, Mongolia, Morocco, Mozambique, Myanmar, Namibia, Nepal, Nicaragua, Niger, Nigeria, North Korea, Pakistan, Papua New Guinea, Paraguay, Philippines, Rwanda, Samoa, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, Solomon Islands, Somalia, South Africa, South Sudan, Sri Lanka, Swaziland, Syria, Tajikistan, Tanzania, The Gambia, Timor-Leste, Togo, Tuvalu, Uganda, Ukraine, Uzbekistan, Vanuatu, Vietnam, West Bank and Gaza, Yemen, Zambia, Zimbabwe

Start Date 2015

More information MSD's Press Release

Anticipated completion date Ongoing

« Raltegravir adds to our arsenal of paediatric licences in supporting better options for children in low- and middle-income countries and can benefit the most neglected sub-segment: infants and toddlers less than three years of age. »

Greg Perry, Executive Director, MPP