Dataset from A Phase IV, Randomised, Multicentre, Double-blind, Study to Evaluate the Clinical Utility of Prospective Genetic Screening (HLA-B*5701) for Susceptibility to Abacavir Hypersensitivity

Study to evaluate the utility of prospective HLA-B*5701 screening on the incidence of
abacavir hypersensitivity (ABC HSR) in 1800 previously ABC-naive adults with HIV-1 from
Europe, Australia and other countries as applicable. The study has two (co-primary)
objectives: i) to determine if screening for HLA-B*5701 prior to ABC-containing HAART results
in a lower incidence of clinically-suspected HSR versus current standard of care (no genetic
screening) and ii) to determine if screening for HLA-B*5701 prior to ABC-containing HAART,
results in a significantly lower incidence of immunologically-confirmed HSR versus current
standard of care (no genetic screening or patch testing). The study consists of up to a
28-day screening period, a randomised observation period (Day 1 through Week 6) and, for
subjects experiencing a suspected ABC HSR and a subset of ABC-tolerant subjects, an
epicutaneous patch test (EPT) assessment period. Eligible subjects will be randomised to one
of two study arms: a Current Standard of Care Arm (no prospective genetic screening: Control)
and a Genetic Screening Arm (prospective genetic screening). Subjects identified as
HLA-B*5701 positive in the prospective Genetic Screening Arm will not receive ABC and will be
excluded from further study. Subjects who experience suspected ABC HSR during the 6-week
observation will be withdrawn from ABC-containing product and undergo EPT patch testing 6
weeks later.