Abbott Labs’ experimental protease inhibitor ABT-378/r is now available in the UK on named patient supply. This type of scheme allows an unlicensed drug to be supplied to an individual named patient whose doctor makes a request for its use on the patient’s behalf. There are no restrictions in terms of patient criteria, but the prescribing physician must agree to take full responsibility for the drug’s use once supplied, and to report safety information back to Abbott on an ongoing basis.
In effect this scheme supplants the previous expanded access study which offered ABT-378 to anyone with viral load above 10,000 copies and CD4 below 200 who had failed or was intolerant to two other PIs. It means that people who fail on one PI can now choose to switch to ABT-378 on the assumption that their chances of success with this new protease inhibitor will be greatest when they have accumulated relatively little resistance to PIs. You can read more about ABT-378 by clicking here. A summary of a study looking at the use of ABT-378 as second-line PI therapy was published in the March 200 issue of AIDS Treatment Update.
Doctors who would like to know more about the scheme should contact the Named Patient Administrator at Abbott on 01628 644370. Note that the administrator cannot discuss the scheme with patients, however.
Further to our report on an interaction between ABT-378/r and the NNRTI efavirenz in March, Abbott have now advised that a dose adjustment should be made whenever the drugs are taken together, regardless of an individual’s prior use of anti-HIV treatment. ABT-378/r should be taken at a dosage of four tablets twice daily when part of a drug combination which includes efavirenz.