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US Food and Drug Administration approves once-daily use of abacavir and lamivudine for children with HIV

27 Apr 2015

In April 2015, the US Food and Drug Administration (FDA) agreed that it is safe and effective for children with HIV to take the drugs abacavir and/or lamivudine once a day as part of their anti-HIV treatment. They previously had to be taken twice a day.

Now that children have the option to take abacavir and/or lamivudine once a day, it could make their anti-HIV treatment simpler for some families.  This could make it easier for children to take their drugs regularly, or for carers to give children their drugs regularly, without missing doses or affecting their activities. 

The FDA made their decision based on the findings of the ARROW, PENTA 13 and PENTA 15 clinical trials.  The ARROW trial took place in Zimbabwe and Uganda and included over 1,200 children.  The PENTA trials took place in the UK and in hospitals across Europe. 

All of these trials compared the effects of giving children with HIV abacavir and/or lamivudine once a day, compared to the standard treatment of giving the drugs twice a day.  The trials found that the once-daily treatment plan was just as effective at treating the HIV infection as the twice-daily treatment plan.  They also found that the once-daily treatment plan was just as safe for the children as the twice-daily plan. 

The PENTA trials also found that changing to a once daily dose of abacavir and/or lamivudine could make it easier for some carers to make sure their child receives their anti-HIV medication regularly. 

The FDA is the organisation that approves drugs for use in the United States.  Their decision applies to the treatment of children with HIV in all countries within the United States.

The European Medicines Agency (EMA), which approves drugs for use in the European Union, is also currently looking at licensing once-daily abacavir and/or lamivudine.

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