European activists demand greater access to T-20
AIDS activists demanded on Tuesday that two companies improve access to an investigational antiretroviral drug, T-20, which has shown activity in HIV-infected patients who have failed conventional therapy. T-20 is the first of a new class of antiretroviral drugs called fusion inhibitors, which block HIV cell entry.
The European AIDS Treatment Group said a plan by Swiss-based Roche and its US partner Trimeris to offer T-20 to just 450 people under an expanded access programme was “catastrophically” inadequate. Another 550 to 600 patients will receive the drug in clinical trials.
Roche spokeswoman Maria Vigneau said Roche and Trimeris were unable to make more of the drug available because of the manufacturing constraints. “It’s a very complex drug and requires a novel peptide manufacturing process which has never been performed before at the scale required,” she said.
The drug is currently being made at a pilot plant in Boulder, Colorado, which will only be scaled up to full production in the middle of 2002. Although T-20 has a number of disadvantages, it must be given by injection twice daily and can cause inflammation at the injection site, it is active against resistant HIV strains.
T-20 is now in late-stage, Phase III, trials and the companies hope the US Food and Drug Administration will approve the product for sale by late 2002.
Both T-20 and a second-generation fusion inhibitor in development called T-1249 have already received fast-track status from the FDA. Data released in January showed that T-20 and T-1249 were both potent inhibitors of HIV replication and were well tolerated.
Source: Reuters Health