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The Body Covers: The 4th Conference on Retroviruses and Opportunistic Infections
Final Results of CAESAR Study Demonstrate a Survival Benefit With 3TC
Coverage provided by Ramon Torres, M.D.
January 1997
Dr.David Cooper from St. Vincent's Hospital in Sydney, Australia
presented the final
results of the multicenter study called CAESAR (conducted in Canada,
Australia, Europe
and South Africa) at the 4th National Conference on Retroviruses and
Opportunistic
Infections in Washington D.C. The objective of the study which enrolled
1892 HIV positive
patients with CD4 counts between 25 and 250, was to assess whether the
addition of
3TC with or without loviride, a new nonnucleoside reverse transcriptase
inhibitor,
to AZT containing regimens (AZT, AZT + ddI or AZT+ ddC) delayed HIV disease
progression
and improved survival. Patients enrolled were either antiretroviral naive
(14-16%)
or experienced (85%) and were randomly assigned in a 1:2:1 fashion to
placebo, 3TC
or the combination of 3TC and loviride. After one year open label
administration of both
drugs was offered. The average CD4 count ranged form 121-123 among the
three arms.
Sixty one percent of the patients were on AZT monotherapy at entry. More
than half
of the patients completed the trial (52%) without reaching a study endpoint
(disease progression
or death). After a median follow-up of 27-29 months the rates of new AIDS
defining
events were 55% lower for those on the 3TC arms than those on placebo and
those on 3TC had a 58% reduction in mortality, even after adjusting for
baseline characteristics.
The reduction in disease progression was greater for the antiretroviral
naive patients.
There was no difference between the 3TC and 3TC and loviride arms, yet a
subset analysis showed a strong trend favoring the 3TC + loviride arm for
those who had
baseline CD4 counts between 175-250 (rates = 3% and 6% for 3TC + loviride
and 3TC,
respectively). There were no differences in the rates of Grade 3 or 4
toxicities
among the three arms; most of the toxicities were hematological (anemia).
The authors concluded
that adding 3TC to AZT or AZT + ddI or AZT + ddC significantly improved
survival
and delayed disease progression, although the additional benefit of
loviride was
not proven.
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