Treatment activists are demanding that Abbott Laboratories should release its
second generation protease inhibitor ABT-378 to people with no other treatment
options as early as summer 1999. Abbott had previously told activists that an
expanded access programme for ABT-378 was unlikely to begin until the early
months of 2000. However, at a meeting with the company on March 26, members of
the Coalition for Salvage Therapy stressed that people with rising viral load
and CD4 counts below 200 or an active opportunistic infection who have taken one
protease inhibitor already should be offered the drug as soon as possible if
they have no other treatment options left.
But at the moment, there is no information about the effectiveness of ABT-378
in people who have taken other protease inhibitors beforehand. Some activists
have criticised the Coalition for Salvage Therapy for paying too much attention
to an unproven drug (see Mike Barr in Poz magazine for example, at <
>).Abbott is already planning a study in which people who have failed with one
protease inhibitor will be randomised to receive either one new PI of their
choice plus nevirapine and two nucleoside analogues, or ABT-378 plus nevirapine
and two nucleoside analogues.
People who have failed two protease inhibitors will be excluded from this
study, and a proposed study for people with multiple PI experience has been
strongly criticised by the Coalition for Salvage Therapy because it offers no
control group. All participants would receive ABT-378, efavirenz and two
nucleoside anlaogues.
It is unclear at present whether these studies will recruit patients in the
UK or Europe, or whether they will be confined to the US, and when data will be
available from these studies to indicate how ABT-378 might be used in `salvage'
therapy.