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Adverse
Events are the Main Cause of Treatment Failure in a Multicentre
Trial in Naïve Patients, comparing Zidovudine/Lamivudine vs Stavudine/Didanosine,
plus Efavirenz, Nevirapine or Indinavir/Ritonavir
This prospective, randomized, open-label Spanish study evaluated
drug regimen efficacy, tolerability and resistance among treatment-naïve patients.
Results
·
69 patients
were included, median age 37 years, 77% male, 33% with previous
AIDS.
·
Median
baseline plasma viral load (pVL) and CD4+ cells count were 4.92
log10 copies/ml and 180 cells/mL.
·
At baseline,
one major mutation in the RT gene was found in two patients (M41L
and V118I) and no major mutations in the PRO gene.
·
After a
median follow-up of 12 months, 85% (on-treatment (OT) analysis)
and 48% (intention-to-treat (ITT) analysis) had a pVL below 50 copies/mL,
with a better ITT response for zidovudine/lamivudine
(AZT/3TC)
compared to stavudine/didanosine (d4T/ddI), and no significant differences
when comparing nevirapine/
NVP vs efavirenz/EFV, or NNRTIs vs indinavir/ritonavir
(IDV/RTV).
·
Failure
was due to adverse events in 18 patients, mainly with IDV/RTV (8
patients) and d4T/ddI (4 patients).
·
Virological
failure was present only in 2 patients, with a new major mutation (M184V)
in one.
·
Median
increase in CD4+ count was 195 cells/mL, significantly greater with
d4T/ddI compared to ZDV/3TC (206 vs 116 cells/mL, p: 0.025), without
differences between NVP, EFV and IDV/RTV.
Tolerability
was the main factor influencing efficacy, with a better response
with AZT/3TC when compared to d4T/ddI, mainly due to a higher rate
of adverse events with d4T/ddI. Immunological recovery was significantly
better on patients receiving d4T/ddI. Virological failure was infrequent
and most failures were due to adverse events, which were significantly
more frequent in patients receiving IDV/RTV.
AMADEUS
Study Group, Madrid, Spain,AEC GESIDA, Madrid, Spain.
08/08/05
Reference
A
Antela and others. Adverse events are the main cause of failure
in a prospective, randomized, open-label, multicentre trial in naïve,
HIV-1-infected patients, comparing ZDV/3TC vs d4T/ddI, plus efavirenz,
nevirapine or indinavir/ritonavir (AMADEUS 01 Study). Abstract
WePe6.3C04 (poster). Program
and Abstracts of the 3rd IAS Conference on HIV Pathogenesis
and Treatment. July 24-27, 2005. Rio de Janeiro, Brazil.
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