HTB

Early access programme for MK-0518 integrase inhibitor

7 October 2006. Related: Antiretrovirals.

A named patient programme (NPP) for MK-0518, an integrase inhibitor currently in Phase 3 development by Merck, was due to be launched in the UK, with expected availability in the UK from late October. The programme is also called EARMRK and started in the US on 11 September 2006.

Entry criteria for the programme include patients on a currently failing regimen with resistance to at least one drug in each of the three classes of oral antiretrovirals (RTI, NNRTI and PI) and who are at risk of clinical or immunologic progression. It is the responsibility of the clinician ‘to determine that they need such an investigational medication to construct a potentially viable regimen’.

Currently, the medical affairs department at Merck UK are directing doctors to Parexel, the contract research organisation responsible for conducting the programme, and to register patients in the US through these websites:

EARMRK, the expanded access research program from Merck
http://www.earmrk.com

BENCHMARK HIV Investigational Studies
http://www.benchmrk.com

Merck in the UK can be contacted on 01992-467272 (main switchboard, ask for external affairs or medical information departments).

Comment

Data presented at the IAC conference and reported in the September issue of HTB, together with further data form ICAAC reported in this issue, show MK-0518 to be potentially one of the most important new options for patients with drug resistance. [1]

Data in treatment naIve patients was presented at the 13th Conference on Retroviruses and OIs (CROI) earlier this year. [2]

MK-0518 needs to be used in combination with other drugs that are active. Currently, the only potential drug interaction with other ARVs is the investigational NNRTI etravirine (TMC-125).

Source: MSD press release

References:

  1. Markowitz M, Nguyen B-Y, Gotuzzo E et al. Potent antiretroviral effect of MK-0518, a novel HIV-1 integrase inhibitor, as part of combination ART in treatment-naIve HIV-1 infected patients. Late breaker abstract THLB0214. See HTB September 2006
    http://www.i-base.info/htb/2805
  2. Grinsztejn B et al. Potent antiretroviral effect of MK-0518, a novel HIV-1 integrase inhibitor, in patients with triple-class resistant virus. 13 CROI Abstract 159LB. See HTB March 2006.
    http://www.i-base.info/htb/2796

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