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Cipla’s drug gets on to US anti-AIDS initiative

‘First fixed dose drug approved for kids below 12 years’


Junior version

Paediatric Triomune will be given to the PEPFAR initiative at a cost of about $4.5-5 per month.

The medicine is sold in India at $7.5 (Rs 310) per month.


P.T. Jyothi Datta

Mumbai, Aug. 16 Cipla’s paediatric version of triple-combination AIDS drug Triomune can now be purchased by the $15-billion PEPFAR global-initiative to treat the illness. This follows the tentative approval that paediatric Triomune got earlier this week from the US regulatory authority, the Food and Drug Administration (FDA).

Children below 12 years and infected with HIV/AIDS can now receive treatment under the initiative. It is the first fixed dose paediatric AIDS drug to get onto the PEPFAR programme, Mr Amar Lulla, Cipla’s Chief Executive Officer, told Business Line.

In 2003, the US President, Mr George W. Bush had mooted the President’s Emergency Programme for AIDS Relief (PEPFAR) over a five-year period to tackle the illness.

Triomune is a fixed-dose tablet that combines three AIDS medicines — lamivudine, stavudine and nevirapine. Lamivudine is the generic ingredient in GlaxoSmithKline’s AIDS medicine Epivir, stavudine is Bristol-Myers Squibb’s Zerit and nevirapine is Boehringer Ingelheim’s Viramune.

There is a baby and junior version of Triomune. The baby version of Triomune will be given to the PEPFAR initiative at a cost of about $4.5-5 per month. The medicine is sold in India at $7.5 (Rs 310) per month.

In India, the drug is sold in the private market, while the PEPFAR initiative involves structured-sourcing that ensures volumes. It also guarantees API (Active Pharmaceutical Ingredient) prices, Mr Lulla said, explaining the price difference.

AIDS drugs for children have been a concern, as companies had focused their energies only on adult versions of the medicine. These used to be crushed and given to children.

Paediatric Triomune can be swallowed or dissolved in water and can be given to patients weighing as little as 5 kg. It is the first fixed-dose anti-HIV product approved for children under the age of 12 years, said, US FDA’s Dr Debra Birnkrant.

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