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First fixed dose combination for children approved for PEPFAR use
Keith Alcorn, Wednesday, August 15, 2007
The US Food and Drug administration approved the first fixed dose combination tablet for children under the age of 12 on August 13th, saying that the product represents “a major advance in global AIDS treatment efforts.”

The product contains d4T (stavudine, Zerit), 3TC (lamivudine, Epivir) and nevirapine (Viramune) in two doses depending on the age and weight of the child: stavudine (6mg or 12mg) and lamivudine (30mg or 60mg) and nevirapine (50mg or 100mg). It is now available for purchase by PEPFAR-funded treatment programmes.

Triomune Baby is indicated for infants weighing less than 10kg. Triomune Junior is recommended for infants and children weighing 10 – 30kg. Children weighing more than 30kg should receive treatment with the adult formulation of Triomune.

The new combination constitutes a complete HIV regimen that is taken twice daily, once patients have tolerated 14 days of lead-in treatment with nevirapine taken once daily in combination with separate doses of lamivudine and stavudine. The combination tablet can be dissolved in water for children who cannot swallow tablets.

Previously, small children in developing countries had to be treated either with complicated multiple doses of liquid versions of antiretrovirals, or by splitting adult tablets, a practice that may in the past have resulted in under-dosing of some antiretrovirals.

The formulation is the 51st antiretroviral product to be approved by the US Food and Drug Administration under a scheme known as tentative approval, which allows generic versions of branded products to be licensed by the FDA so that they may be purchased with US taxpayer's money for use in PEPFAR treatment programmes in developing countries.

The paediatric fixed dose combination is still awaiting approval by the WHO prequalification programme, which certifies the quality of medicines for purchase by UNICEF and other UN agencies.