The investigational fusion inhibitor T-20 (Fuzeon) is being made available on a named patient basis in the UK from mid-November as part of a worldwide early access programme.
Roche, the manufacturer of the drug, is stressing that supplies of T-20 will be limited and that it will only be available to people in most need of it. The UK has been allocated enough T-20 to treat forty people. However, Roche is releasing the drug in monthly waves as production capacity for the drug is currently restricted. Approximately seven people per month in the UK will be provided with the drug between now and March 2003. Roche has told aidsmap that the November and December allocations have already been taken up.
Although the drug will be made available on a “first-come-first-served” basis, Roche is urging clinicians to prioritise people who can use T-20 as part of a viable HAART regimen and to avoid using the drug as “functional monotherapy” (adding a single new drug to failing treatment). Additional criteria are a CD4 count below 100 cells mm3 and a viral load above 10,000 copies m/L. Roche is encouraging doctors to use both phenotypic and genotypic resistance testing when trying to construct viable therapy for people with limited treatment options and has said it will help to put clinicians in touch with experts to interpret these results.
Approximately 1,200 people world-wide will be given T-20 as part of the expanded access scheme, 600 in the USA, with allocations to other countries based on WHO HIV prevalence figures. Should some countries fail to take up their full allocation, it is possible that additional supplies of T-20 may become available for UK patients.
T-20 is administered by twice daily subcutaneous injection, and Roche acknowledge that people provided with the drug will need “high levels of support.” A patient information video on taking T-20 will be given to all patients and home nursing support will also be available. Details of how to avoid injection site reactions will also be provided.
It is also necessary for people to reconstitute their T-20 on a daily basis, although it is possible to prepare both the morning and evening dose at the same time and refrigerate the dose to be taken later in the day. Due to the complexities involved in taking T-20 anybody provided with the drug will be given training at their HIV clinic by T-20 specialist nurses on preparing, storing, and injecting the drug and managing injection site reactions. Despite the difficulties involved with T-20, only 3% of participants in clinical trials withdrew and adherence of 85% to 90% was reported.
It is anticipated that Roche will be receive a US and European license for T-20 in February/March 2003 with the licensed product expected to be launched in April 2003. A pegylated form of T-20, which could be taken once weekly, is being investigated.
T-20 is considerably more expensive than all the currently available HIV antiretrovirals and as part of the named patient scheme Roche will be providing the drug free of charge between now and March 2003, however, normal pricing policies will aply once the drug is licensed.
People who think that they might benefit from T-20 should contact their HIV treatment centre to see if it is participating in the named patient scheme. Roche will be making the drug available to clinics in London and across the UK.
For more information about T-20 click here.