Bristol-Myers Squibb wrote to all US health care professionals on August 1 to notify them that the prescribing information for its anti-HIV drug didanosine (Videx) tablets had been changed and the preferred dosing frequency was now twice daily. In the letter, the company said that although once daily dosing was available, "it should only be considered for adult patients whose management requires once-daily administration of the drug."
The change has arisen because the results of a trial (BMS study AI454-148) that used a once daily dosing frequency have become available and have shown that the 48-week virological response in the didanosine study arm is significantly lower than that in the comparator arm (a non-didanosine combination). Thus, there is now more evidence for use of the drug twice daily, BMS says.
Miss Sian Lloyd (virology product manager, Bristol-Myers Squibb, UK) told The Journal on August 15 that the letter referred to Videx 200mg tablets. The recommendation had arisen because, from a US regulatory point of view, there was more trial data, at this stage, on the use of twice daily dosing than there was on once daily use. The kinetics of didanosine suggested that once daily administration was appropriate and the company had no plans to change the UK summary of product characteristics. Both once and twice daily dosing was licensed in the UK and the frequency chosen depended on which was most easy for individual patients to use, she said. Miss Lloyd added that a letter from the company clarifying the issue would be sent, in the near future, to doctors and pharmacists working in the HIV area in the UK.