48-week efficacy and safety results of simplification to single agent lopinavir/ritonavir (LPV/r) regimen in patients suppressed below 80 copies/mL on HAART - the KalMo study
Background: Long term adverse events and expense associated with HAART have led to an interest in simplified therapy. Lopinavir/ritonavir monotherapy is attractive due to its potency and high genetic barrier.
Methods: This is a 48 week interim analysis of a 96 week, open-label, randomized study, to assess the feasibility of using LPV/r monotherapy in patients with undetectable viral load after being on HAART for at least 6 months, and without previous virologic failure. Subjects were randomized (1:1) to either switch from triple HAART to LPV/r monotherapy or to maintain their current triple HAART regimen.
Results: 60 patients were enrolled. Baseline characteristics were similar in both groups. At week 48, by intention-to-treat analysis, 26/30 (86.7%) subjects in the monotherapy arm and 25/30 (83.3%) subjects in the control group had a VL of <80 copies/mL. There was one virologic failure (defined as VL > 1000 cp/ml) in each arm. One subject in the monotherapy arm experienced VF with a VL of 1,200 copies/mL at wk 48. Genotypic resistance results are pending, however, this subject was intensified with TDF + 3TC at the time of VF and subsequently re-suppressed to < 80 copies/mL. One subject in the control arm experienced VF at wk 36. Resistance testing showed no resistance-associated mutations. No statistically significant differences were found with regards to changes in CD4 counts, serum cholesterol, and anthropometric measures. There were no grade 3 or 4 lab abnormalities observed. One subject in the monotherapy group discontinued due to diarrhea. Two subjects in the control group underwent regimen changes due to drug-related toxicities.
Conclusions: Switching from various triple HAART regimens to LPV/r monotherapy, in patients who were virologically suppressed and without a history of previous virologic failure, was effective, safe and well tolerated through 48 weeks.
AIDS 2006 - XVI International AIDS Conference
"E.P.Nunes, et al.
48-week efficacy and safety results of simplification to single agent lopinavir/ritonavir (LPV/r) regimen in patients suppressed below 80 copies/mL on HAART - the KalMo study.
Oral abstract session:
AIDS 2006 - XVI International AIDS Conference: