Etravirine (TMC-125) available on named patient programme in the UK
A named patient programme (NPP) will be available in the UK from 16 October 2006, for access to etravirine (TMC-125), a second-generation NNRTI currently in Phase 3 development by Tibotec.
The program will provide access for HIV-1-positive patients who need the compound to construct a viable treatment regimen. TMC125 is a next-generation NNRTI active against NNRTI-resistant strains of HIV. The phase 3 clinical trials (DUET 1 and 2) in treatment-experienced HIV-1-positive patients are ongoing and have recently completed enrollment. The safety and efficacy of TMC125 in combination with other antiretroviral agents have not been established.
The TMC125 EAP is available to HIV-1-positive adults, at least 18 years old, who have limited treatment options either due to virological failure or intolerance to multiple ARV regimens. Patients must be three-class experienced, having received licensed treatment from each of the 3 major oral classes of anti-HIV drugs (NRTIs, NNRTIs, and PIs), and must have received at least two PI-based regimens.
Although TMC-125 is active against some strains on NNRTI-resistant virus, as with other new drugs, it has to be used in combination with other drugs to which the patient is sensitive. TMC125 is dosed at 200mg twice daily, (2 tablets twice daily) with food.
Named patient programmes are developed for patients who are in need of investigational treatments that show promise in early studies, prior to receiving a regulatory decision.
Doctors who are interested in access for their patients should make anunsolicited request to the Medical Information at Tibotec on:
01494 567444. Although the UK access is outside of a formal trial, entry criteria and related information are similar to the international access programme, details of which are listed at:
Results from a Phase 2 study of etravirine in 199 treatment experienced patients were presented in Toronto and reported in the last issue of HTB, showing approximate reductions in viral load of -1 log at week 48 when added to optimum background regimen (OBR) compared to an OBR control arm.
There are several new agents that are likely to support combination for multidrug resistant patients. This choice now includes the protease inhibitor darunavir (TMC-114, already available on NPP), MK-0518, the integrase inhibitor available on NPP from late October, and T-20 for patients who still havent used this entry inhibitor.
MK-0518 should not be used with TMC-125 until results of an interaction study have been completed. Both drugs are metabolised through a glucuronidation pathway that may make them cotrindicated.
Source: Press release: Tibotec announces Expanded Access Program for its investigational agent TMC125 (25 September 2006).