Lopinavir/Ritonavir
as Single-drug Maintenance Therapy in Patients with HIV Suppression This
study compared continuation of triple therapy (T) vs. LPV/r monotherapy (MT) followed
by re-induction with two nucleosides if virological rebound occurred [without
major protease inhibitor (PI) mutations] in patients with suppressed HIV replication
on lopinavir/ritonavir (LPV/r)
and two nucleosides, Patients
were eligible for this non-inferiority trial if they had no history of virological
failure while receiving a PI and were receiving 2 nucleosides + LPV/r with serum
HIV RNA <50 c/mL for >6 months. The
primary endpoint was percent of patients without therapeutic failure, defined
as confirmed HIV RNA >500 c/mL with exclusion of MT patients who re-suppressed
to <50 c/mL after resuming baseline nucleosides, or loss to follow-up, or change
of randomized therapy other than re-induction. Results
198 patients were randomized to the MT (n=100) or T (n=98) arms.
Baseline characteristics were similar in both arms.
After 48 weeks, percentage of patients without therapeutic failure: 94% (MT) vs
90% (T) (T-MT= - 4%; upper limit 95%CI: 3.4%).
Percentage of patients with HIV RNA <50/500 c/mL at 48 weeks (ITT, M = F, Re-induction
= F): 85/89% (MT) vs 90/90% (T) (p=0.4/0.99).
Therapeutic failures: 6/100 in MT (3 lost to follow-up, 2 confirmed rebound with
PI resistance, 1 treatment change) and 10/98 in T [4 lost to follow up, 3 confirmed
rebound (2 without and 1 with PI resistance), 3 adverse events].
4 patients with confirmed rebound after MT were re-induced and remain with HIV
RNA <50 c/mL.
"In
this trial, 48 weeks of LPV/r MT was non-inferior to continuation of T in patients
with prior stable suppression," write the authors in their conclusion. Further,
they add "The majority of MT patients maintained HIV RNA < 50 c/ml without
re-induction." Hospital
La Paz, HIV Unit, Madrid, Spain, Hospital Doce de Octubre, HIV Unit, Madrid, Spain,
Hospital Doce de Octubre, Laboratory of Molecular Microbiology, Madrid, Spain,
Abbott, Virology. Medical Dpt., Madrid, Spain, Hospital Ramón y Cajal,
HIV Unit, Madrid, Spain, Hospital Príncipe de Asturias, HIV Unit, Alcalá
de Henares, Spain, Hospital General de Alicante, HIV Unit, Alicante, Spain, Hospital
Virgen de las Nieves, HIV Unit, Granada, Spain, Hospital de Donostia, HIV Unit,
San Sebastián, Spain, Hospital Xeral Cies, HIV Unit, Vigo, Spain, Hospital
Gregorio Marañón, HIV Unit, Madrid, Spain, Hospital del Mar, HIV
Unit, Barcelona, Spain, Hospital La Paz, Investigation Unit, Madrid, Spain, Abbott,
Antivirals. GPRD, Abbot Park. IL, United States. 08/18/06
Reference
J Arribas, F Pulido, R Delgado, and others (OK04 Study Group).
Lopinavir/ritonavir as single-drug maintenance therapy in patients with HIV-1
viral suppression: Forty eight week results of a randomized, controlled, open
label, clinical trial (OK04 Study). 16th International AIDS Conference. August
13-18, 2006. Toronto, Canada. Abstract THLB0203.
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