Volume 4 Number 9 November 2003

This is the third consecutive issue of HTB to lead with an FDA or EMEA drug warning letter.

The issue this month is that the triple-nucleoside combination of ddI/3TC/tenofovir failed to produce a viral load reduction >2logs by week 12 in a group of treatment naïve patients. It did however provide nearly all of them with their first set of drug-resistant mutations. It should be noted that the European version of this issue letter from Gilead also cautions against using ddI/3TC/tenofovir in treatment experienced patients.

Fortunately, this combination is unlikely to be currently widely used in the UK, and the caution against triple-nucleoside combinations in the 2003 BHIVA guidelines should limit any further prescribing of any triple-nucleoside combination in first-line therapy.

A further report of yet another poorly performing triple-nucleoside combination – this time with abacavir/ddI/d4T – is included.

The November HTB issue also includes a report on strategic treatment interruptions studies in resource-limited settings from the 13th International Conference on AIDS and STIs in Africa (ICASA).

STIs have now been well studied in countries which have widespread access to ARV therapy, and results from recent studies are reported on.

These finding have not been particularly encouraging and the risk from resistance when stopping and restarting NNRTI-based regimes will apply wherever these studies are being run.