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Kaletra Monotherapy Induction-Maintenance in Naives Compared to Efavirenz, 96 Weeks
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"A two-year randomised controlled clinical trial in antiretroviral-naïve subjects using lopinavir/ritonavir monotherapy after initial induction treatment compared to an efavirenz 3-drug regimen.
96 week results, Study M03-613"
Late Breaker Thursday 2:15pm oral session
Oral Presentation #THLB0201
Reported by Jules Levin
XVI Intl AIDS Conference, Toronto, Aug 17, 2006
Authors: DW Cameron1, BA da Silva2, JR Arribas3, R Myers4, NC Bellos5,
N Gilmore6, KR Niemi2, KJ Wikstrom2, MS King2, GJ Hanna2, SC Brun2
1University of Ottawa at The Ottawa Hospital, Ottawa, Ontario, Canada
2Abbott Laboratories, Abbott Park, IL, USA
3Hospital La Paz, Madrid, Spain
4Body Positive, Inc., Phoenix, AZ, USA
5Southwest Infectious Disease Associates, Dallas, TX, USA
6Montréal Chest Institute, Montréal, Québec, Canada
Study design and methods
Treatment-naïve patients with no evidence of resistance, any CD4 & HIV-RNA>1000, randomized to receive Kaletra soft-gel capsules 400/100 bid + AZT/3TC (n=104) or EFV 600 mg qd +AZT/3TC (n=51). The study is a 96-week trial.
VL monitored monthly for 18 months, then every 2 months through month 24.
In the LPV/r group, subjects with VL < 50 / mL for 3 consecutive months from
month 3 to 11 discontinued ZDV/3TC at the next visit (earliest month 6), and
remained on LPV/r monotherapy. Subjects not meeting these criteria remained on LPV/r + ZDV/3TC.
Primary outcome: HIV-1 viral load < 50 c/mL at week 96 (24 months)
Primary analysis: intention-to-treat, prior failure (> 50 c/mL x 2) = failure
DEMOGRAPHICS
Mean CD4 count at baseline was 227-250. Mean VL was 5.0 log in LPV/r and 4.8 log in EFV. 42% in LPV/r had >100,000 and 31% had >100,000 in EFV. About 80% were men. 28% Black in LPV/r and 33% in EFV, 6% Hispanic in LPV/r and 16% Hispanic in EFV.65% Caucasian in LPV/r and 63% in EFV.
AUTHOR SUMMARY & CONCLUSIONS
With successful LPV/r + ZDV / 3TC treatment, subsequent
LPV/r monotherapy continuously maintained VL suppression in a large proportion of patients.
Patients receiving LPV/r monotherapy experienced more VL breakthrough of 50 - 500 c/mL versus EFV + ZDV / 3TC:
-- LPV/r monotherapy VL breakthrough was usually 50 - 500 c/mL
-- VL breakthrough generally re-suppressed to < 50 c/mL
-- Detection of drug resistance mutations did not differ in proportion for LPV/r versus EFV
LPV/r monotherapy may provide an alternative treatment option for selected patients.
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