Four HIV patients to begin receiving experimental drugs TMC 114 and TMC 125

published on January 11, 2006

(Vancouver) – Four HIV-positive patients will begin treatment comprising experimental drugs TMC 114 and TMC 125 as early as tomorrow, the B.C. Centre for Excellence in HIV/AIDS announced today.

On Dec. 20, Health Canada approved a compassionate use protocol, or clinical trial, to use the two drugs in combination

The Centre has now obtained all necessary institutional approvals for the clinical trial to proceed. The Centre is grateful for the ongoing co-operation and support of Providence Health Care Research Institute and the University of B.C. in this matter.

The Centre has also now secured a supply of TMC 114 and TMC 125 from the drug company, Tibotec. The Centre would also like to acknowledge Tibotec for expediting the necessary process of making these drugs available to the Centre’s patients in need through a clinical trial.

The clinical trial has been facilitated by the Canadian HIV Trials Network.

Earlier last year, the Centre had six HIV-positive patients who became resistant to all conventional drug treatments. Their situations are life-threatening and the experimental drugs TMC 114 and TMC 125 are considered their only hope. In April, the Centre applied to Health Canada’s Special Access Program (SAP).

SAP is specifically designed for patients with serious or life-threatening conditions who require “emergency” and/or “compassionate” access to drugs that are not authorized for use in Canada.

The Centre’s application and subsequent appeal were denied. One of the six original patients died during this time period (a second patient has not been located in ongoing followup attempts by the Centre). SAP cited a “lack of sufficient data to support the use of these two products in combination.” The Centre contends data pertaining to experimental drugs that are in early stages of development, or that have not been formally tested, cannot meet the appropriate scientific standards required to constitute evidence for “use, safety and efficacy.”

While the Centre is relieved some patients have now been granted access to the experimental drugs TMC 114 and TMC 125, it is concerned by Health Canada’s unique provision of a “compassionate use protocol,” rather than allowing the drugs through the more expeditious SAP.

Drug resistance among HIV-patients is a growing concern. The current TMC clinical trial will not allow for additional patients in need.

BC Centre for Excellence in HIV/AIDS

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Four HIV patients to begin receiving experimental drugs TMC 114 and TMC 125

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