16th International AIDS Conference


Toronto, Canada - August 13 - 18, 2006

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

Int Conf AIDS. 2006 Aug 13-18;16 Abstract No. TuAb0103

E.P. Nunes1, M.S. Oliveira2, M.M.T.B. Almeida1, J.H. Pilotto2, J.E. Ribeiro2, J.C. Faulhaber1, M. Norton3, M. Schechter1, R. Zajdenverg1
1 Federal University of Rio de Janeiro (UFRJ), Projeto Praça Onze, Rio de Janeiro, Brazil, 2 Hospital Geral de Nova Iguaçu, Infectious Diseases, Rio de Janeiro, Brazil, 3 Abbott Laboratories, Chicago, United States

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.

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2006-08-13
TuAb0103

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