New & experimental HIV treatments

New 75mg darunavir tablet approved by FDA for use by HIV-positive children

Michael Carter
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Drug regulatory authorities in the US have approved a new 75mg darunavir (Prezista) tablet for paediatric use.

On December 18th the US Food and Drug Administration announced that it had approved the new 75mg darunavir tablet for use by children aged between six and 18 years.

Ritonavir-boosted darunavir should be taken twice daily in combination with other anti-HIV drugs by HIV-positive children between these ages, the dose of the drug being determined by the child’s weight. The minimum weight required for treatment with darunavir/ritonavir is 20kg.

Glossary

paediatric

Of or relating to children.

efficacy

How well something works (in a research study). See also ‘effectiveness’.

boosting agent

Booster drugs are used to ‘boost’ the effects of protease inhibitors and some other antiretrovirals. Adding a small dose of a booster drug to an antiretroviral makes the liver break down the primary drug more slowly, which means that it stays in the body for longer times or at higher levels. Without the boosting agent, the prescribed dose of the primary drug would be ineffective.

Food and Drug Administration (FDA)

Regulatory agency that evaluates and approves medicines and medical devices for safety and efficacy in the United States. The FDA regulates over-the-counter and prescription drugs, including generic drugs. The European Medicines Agency performs a similar role in the European Union.

For children weighing 20-30kg the twice-daily dose of darunavir/ritonavir is 375/50mg. Children whose weight is between 30-40kg should receive twice-daily doses of darunavir/ritonavir of 450/60mg. For children weighing over 40kg the dose of darunavir/ritonavir is 600/100mg twice a day.

Darunavir should not be used to treat HIV-positive children aged under three, and the safety and efficacy of the drug in children aged between three and six years has not been established.

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