The investigational protease inhibitor, atazanavir, is to be made more widely available by its manufacturer Bristol-Myers Squibb (BMS) in an expanded access programme.
Although the initial phase of the expanded access programme started on 15 May, it is not yet clear which clinics in the UK will be offering the drug, and BMS stress that atazanavir would only be available at a very limited number of sites and the numbers of people receiving the drug would be small.
To receive atazanavir as part of the expanded access programme, a person must be failing on their current HAART regimen (defined as a viral load above 5,000 copies/ml and a CD4 T-cell count below 300 cells/mm3) and are in need of atazanavir in order to construct a viable alternative treatment regimen.
Atazanavir will also be available to people who have experienced severe HAART-associated hyperlipidemia, despite taking lipid-lowering drugs, defined as a triglyceride level above 750mg/dL or a cholesterol level which meets clinical guidelines for treatment with a lipid-lowering agent. Viral load and CD4 restriction criteria do not apply for this group.
Atazanavir is in late stage phase III clinical trials and BMS has said that as more data from the trial is analysed it expects to modify some of the restrictions applying to the expanded access programme, which could allow a greater number of people access to the drug in the future.
However a spokesperson for BMS stressed to aidsmap: “Atazanavir is only going to be available at a very few sites in the UK as part of the expanded access programme, and the list of those sites is currently being drawn up. It’s important that people know that atazanavir is not being made available on a named patient basis.”