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HIV/AIDS infected children can now benefit from a European and Developing Countries Clinical Trials Partnership funded trial

17.09.2007
In August, the United States (US) Federal Drug Administration (FDA) gave a tentative approval to a fixed-dose anti-HIV drug specifically formulated for paediatric use. The fixed-dose combination scored tablet of lamivudine 30mg, stavudine 6mg and nevirapine 50mg (Triomune Baby) and double this strength (Triomune Junior) is manufactured by CIPLA pharmaceuticals.

It is administered twice daily, according to a simple weight-based table, allowing for easy prescribing. It can also be ‘snapped in half’ and dissolved in water for young children who cannot swallow tablets. As a result of this tentative approval, this FDC antiretroviral drug will be included in the World Health Organisation (WHO) Prequalification Programme and will become available for distribution under the Presidents Emergency Plan for AIDS relief (PEPFAR) and Clinton Foundation programmes.

EDCTP, the funder of the pharmacokinetic study leading to this tentative approval, congratulates Professor Chifumbe Chintu from the School of Medicine and Department of Paediatrics, University Teaching Hospital, Lusaka and his Zambian team, along with research collaborators from the Netherlands and the Medical Research Council (MRC) Clinical Trials Unit, United Kingdom on their work. Triomune Baby and Junior have already been approved in Zambia and are currently being used to treat children there.

Treatment of HIV/AIDS in children is a great challenge in resource-constrained settings. One of the reasons for this is the difficulty and cost of giving paediatric formulations, particularly syrups, of anti-HIV drugs to children. The absence of appropriate paediatric formulations often necessitates administering divided adult tablets to HIV-infected children. This can lead to incorrect dosing, especially under dosing, and increases the risk of the rapid development of resistance to the drugs. The problem is compounded by underlying malnutrition in these children, and the lack of knowledge about how malnutrition affects drug levels in the body.

The pharmacokinetic study undertaken by Professor Chintu and colleagues is part of a larger ongoing randomised trial that is evaluating the necessity of lead-in treatment for one of the anti-HIV drugs (nevirapine) in the triple combination pill. Data generated from the pharmacokinetic (dosing) study were included in the submission for registration and contributed to the US FDA granting tentative approval for the registration of this drug for use in children. This will be the first FDC drug specifically designed for young children to be registered by the FDA.

Triomune Baby and Junior tablets are scored, crushable and water soluble for children who cannot swallow tablets. The fact that all three drugs are combined in one tablet (which is layered to ensure equal distribution of drugs if snapped in half), and that tablets can be stored, distributed, and administered easily to children represents a significant advance in HIV treatment for children in resource-limited settings. The tentative FDA registration paves the way for the drug to receive WHO prequalification status. Additionally, it will allow programmes such as PEPFAR and the Clinton Foundation, which make antiretroviral drugs available in many resource-constrained countries, to purchase the drug for widespread use in HIV-infected children.

Commenting on this achievement Professor Charles Mgone, the Executive Director of EDCTP said, “This is a great achievement which underpins the primary goal of EDCTP of accelerating new or improved interventions against diseases of poverty through north-south collaboration.”

Professor Chifumbe Chintu thanks EDCTP for funding the trial and offering much needed assistance during the still ongoing study. He sends his special gratitude to colleagues: Professor Diane Gibb and her team at MRC Clinical Trials Unit, London; Dr David Burger and his colleagues at Radboud University Medical Centre, Nijmegen, The Netherlands; Dr David Bangsberg and colleagues at the Epidemiology and Prevention Intervention Centre, San Francisco General Hospital and in particular, to the team at the CHAPAS Clinic Lusaka, Zambia. Special thanks go to CIPLA pharmaceuticals for providing the Triomune Baby and Junior tablets for the study.

Tentative approval

An FDA tentative approval is based on the FDA opinion that the product meets all of manufacturing quality and clinical safety and efficacy requirements. Although existing patents and/or marketing exclusivity prevent the approval of the product in the United States, the product can be used for the treatment of AIDS patients abroad.

World Health Organisation Prequalification Programme

This is a program many countries with developing economies use to guide their purchasing of drug products from specific manufacturers so they can be assured they are purchasing quality medicinal products.

Ilona van den Brink | alfa
Further information:
http://www.edctp.org/Press_Releases.292.0.html
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01681.html

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