Pediatric Formulations for antiretrovirals (ARVs)
Active Since: 2007
Contributing to SDGs…
Making antiretroviral viral medicines available to children with HIV/AIDS in developing countries in sub-Saharan Africa and Asia.
Academia or research institute
Amfars TreatAsia Program
Clinton Health Access Initiative
Elizabeth Glaser Pediatric AIDS Foundation
- Make antiretroviral viral medicines available to children with HIV/AIDS in developing countries in sub-Saharan Africa and Asia.
What are the health needs and challenges?
Of the 2.5 million HIV-positive children in the world in 2007, nearly 90% were in sub-Saharan Africa, according to UNAIDS. Antiretrovirals (ARVs) are developed for adults, most clinical trials are in adults, with doses and dosage forms designed for adults. But children cannot be dosed like small adults, as their metabolic capacity to absorb ARVs is not simply proportional to their weight. Safety, efficacy and dosage need to be determined via specific pediatric trials. Most ARVs were developed in tablet form, yet these are impractical for children under five, who require special liquid formulations. While older children can take tablets, those intended for adults often contain too large a dose.
Partnership activities and how they address needs and challenges
This partnership researches and develops new medicines and/or new formulations of existing medicines to treat children with HIV/AIDS, especially in developing countries in sub-Saharan Africa and Asia. In some cases, partners have signed licensing, patent and/or technology transfer agreements with generic drug manufacturers in South Africa, India and Brazil to make existing HIV/AIDS medicines available in developing countries at lower costs.
AbbVie, first as Abbott, has a long-standing commitment to the treatment of children with HIV. In 2007, AbbVie (as Abbott) launched the first lower-strength tablet formulation of lopinavir/ritonavir in the developing world (Uganda) before making the product available in developed countries. The lopinavir/ritonavir tablet is the only co-formulated protease inhibitor tablet that can be used in children (generic versions of this tablet formulation have been made available subsequent to 2007). The tablets do not require refrigeration and can be taken with or without a meal, an important advance in delivering HIV medicine in developing countries. The tablet is easier for children to take than its liquid formulation, which has been used in Africa since 2001. The lower-strength tablet is sold at half the price of the original formulation in 69 countries, including all of Africa. AbbVie is developing a sprinkle formulation of norvir, suitable for use in children living with HIV. The new powder has no alcohol or propylene glycol, has significantly improved shelf life from the liquid formulation currently in use, and will not require refrigeration.
Bristol-Myers Squibb produces pediatric formulations for SUSTIVA® (efavirenz) as capsule sprinkles and REYATAZ® (atazanavir) as an oral powder. Both SUSTIVA® and REYATAZ® are approved in the United States (US) and European Union (EU) for treatment of HIV-1 infection in combination with other antiretroviral agents (ARVs). SUSTIVA® is approved for use in patients 3 months and older who weigh at least 3.5 kg. REYATAZ® is approved for patients 3 months and older who weigh at least 5 kg. For more information about Bristol-Myers Squibb’s initiatives to expand access to medicines for people with HIV/AIDS and people in developing countries click here.
SDGs THE PARTNERSHIP CONTRIBUTES TO
SDG 3: Good Health and Wellbeing
- 3.1: Reduce Maternal Mortality
- 3.2: Reduce Under-5 Mortality
- 3.3: Communicable Diseases & NTDs
- 3.4: NCDs (including mental health)
- 3.7: Access to sexual and reproductive health-care services
SDG 9: Industry Innovation and Infrastructure
SDG 10: Reduced Inequalities
SDG 17: Partnerships for the Goals
- Burkina Faso
- Cabo Verde
- Central African Republic
- Côte d'Ivoire
- Democratic Republic of the Congo
- Equatorial Guinea
- Sao Tome and Principe
- Sierra Leone
- South Africa
- South Sudan
- United Republic of Tanzania
- Mental & Neurological Disorders
- Cardiovascular Diseases
- Respiratory Diseases
- General Noncommunicable Disease Care (Health System)
- Other NCD
Women’s and Child Health
- Children's Health
Infectious and Parasitic Disease