Long-term (4 years) efficacy of lopinavir/ritonavir monotherapy for maintenance of HIV suppression.
OBJECTIVE
Data are scarce on the long-term efficacy of lopinavir/ritonavir monotherapy for the maintenance of HIV suppression. Four years of results of patients randomized to monotherapy in the Only Kaletra (OK) pilot clinical trial are presented.


METHODS
Twenty-one HIV-infected patients with suppressed HIV replication (<50 copies/mL) for at least 6 months and without previous failure while receiving a protease inhibitor-based regimen started lopinavir/ritonavir monotherapy. Follow-up was performed within the OK pilot clinical trial during the first 2 years and according to routine clinical practice during the 3rd and 4th years.


RESULTS
Fourteen patients (67%) remain on monotherapy and with RNA <50 copies/mL (intention-to-treat analysis, with missing patients scored as failures). Five patients (24%) had virological rebound and all of them were successfully re-suppressed by adding two nucleosides. No major protease inhibitor mutations were found.


CONCLUSIONS
Our data support the long-term efficacy and safety of lopinavir/ritonavir monotherapy for the maintenance of HIV suppression, a finding that must be confirmed in larger studies.
Pulido
Federico
F
Unidad HIV, Hospital 12 de Octubre, Universidad Complutense de Madrid, Madrid, Spain. pulidof@gmail.com
Delgado
Rafael
R
Pérez-Valero
Ignacio
I
González-García
Juan
J
Miralles
Pilar
P
Arranz
Alberto
A
Hernando
Asunción
A
Arribas
José R
JR
D000328:Adult; D024882:Drug Resistance, Viral / Q000235:genetics; D005260:Female; D006678:HIV / Q000235:genetics / Q000302:isolation & purification; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology*; D017320:HIV Protease Inhibitors / Q000627:therapeutic use*; D006801:Humans; D008137:Longitudinal Studies; D061466:Lopinavir; D008297:Male; D009154:Mutation; D011744:Pyrimidinones / Q000627:therapeutic use*; D012367:RNA, Viral / Q000097:blood; D019438:Ritonavir / Q000627:therapeutic use*; D016896:Treatment Outcome; D019562:Viral Load
D017320:HIV Protease Inhibitors; D011744:Pyrimidinones; D012367:RNA, Viral; D061466:Lopinavir; D019438:Ritonavir