The program has opened in the US and will open shortly in Canada and Europe, subject to the necessary approvals. The program will provide access for HIV-1 infected patients who need the compound to construct a viable treatment regimen. Currently, over 15 US sites have initiated the expanded access program.
TMC125 fights against NNRTI-resistant strains of HIV. The phase III clinical trials in treatment-experienced HIV-1 infected patients are ongoing and have recently completed enrollment. The safety and efficacy of TMC125 in combination with other antiretroviral agents have not been established.
“We know that many people living with HIV/AIDS have limited treatment options because of the increasingly significant issue of viral resistance, and we are working to provide eligible individuals with access to TMC125 as soon as possible through this program,” said Roger Pomerantz, president of Tibotec R&D.
The TMC125 EAP is available to HIV-1 infected adults who have limited treatment options either due to virological failure or intolerance to multiple ARV regimens. Patients must have received licensed treatment from each of the 3 major oral classes of anti-HIV drugs and must have received at least two PI-based regimens to be eligible for the treatment.
Tibotec has received fast track designation for TMC125 from the FDA.