The US Food and Drug Administration has approved twice daily dosing of nelfinavir following the review of a phase III study which showed no significant difference between twice and three times daily dosing of the protease inhibitor in terms of viral load responses or side effects.
The recommended dose is 1250mg twice daily (five tablets twice daily) for adults. Although some clinics have been recommending this dosing schedule since mid-1998, when 48 week follow-up data was first presented at international conferences, this week's official confirmation is likely to be welcomed by patients and doctors looking for regimens that are easier to manage.
Nelfinavir package inserts will continue to specify three-times daily dosing in Europe until a similar license application is reviewed by the European Medicines Evaluation Agency's scientific committee