Fosamprenavir expanded access in UK

A named patient programme (NPP) for fosamprenavir (GW908, Telzir), a pro-drug version of amprenavir, has been announced by GlaxoSmithKline for patients in the UK.

Access criteria are for all patients for whom a regimen containing a protease inhibitor with a low pill count offers the best therapeutic option, in the judgment of the prescribing physician. This may include patients who have previously experienced failure on a PI, are currently taking amprenavir, as well as those for whom adherence is a major problem. There are no CD4 or viral load count criteria.

The usual adult daily dose for fosamprenavir is either 2 x 700mg tablets plus 2 x 100mg capsules of ritonavir taken once daily or split to 1 x 700mg plus 100mg ritonavir twice daily.

The charge for a pack of 70 x 700mg tablets of fosamprenavir is £319.73. Ritonavir is not supplied with this programme.

Further details, information packs containing current clinical trial results and application forms for the NPP can be obtained by contacting Louise Walton, clinical study manager on 020 8990 3363 or Jan Williams, HIV named patient administrator on 020 8990 2317. Completed applications then need to be faxed to 020 8990 2078.

In order to facilitate patient management, therapeutic drug monitoring is available to patients in this programme through the TDM laboratories at Liverpool University. Further details of this service are available by contacting Sara Gibbons on 0151 794 5553, by email at hivgroup@liv.ac.uk or visiting the Liverpool website at
http://hiv-druginterractions.org

Comment

Results from the Phase III studies for fosamprenavir were presented at the Retrovirus conference and are reported earlier in this issue of HTB.

It is very encouraging to note that GSK has included a sponsored therapeutic drug monitoring programme through the Liverpool TDM service. As drug levels remain a concern with protease inhibitors, even in some patients using ritonavir-boosted regimens. Also, fosamprenavir is likely to be included in regimens for which there is limited drug interaction data but where interactions are likely, such as dual and triple-PI containing combinations.