Monotherapy with lopinavir/ritonavir versus standard of care in HIV-infected patients virologically suppressed while on treatment with protease inhibitor-based regimens: results from the MoLo study.
This study compared the cost-efficacy ratios of lopinavir/ritonavir monotherapy (LPV/r-MT) and of standard of care in virologically suppressed HIV-infected patients. The results of the efficacy and safety analyses are presented. We conducted a multicentre, randomised, open-label trial of HIV-infected adults on stable treatment, with HIV- RNA <50 copies/mL, randomised to continue the ongoing regimen (cART-arm) or to switch to LPV/r (400/100 mg BID) MT (MT-arm). Time to virological rebound (VR = confirmed HIV-RNA ?50 copies/mL) was estimated by Ka- plan-Meier method and changes in laboratory values during follow-up were evaluated by univariate mixed-linear models. Ninety-four patients were randomised and analysed (43 in the MT-arm and 51 in the cART-arm). Five (four in the MT and 1 in the cART-arm; p=0.175) had VR, but time to VR did not statistically differ between the two arms (p=0.143). Major PI mutations were not detected at VR. Patients on MT had significant increases in total choles- terol [difference in mean change between MT and cART arm: 0.77 (±0.30) mg/dL per month; p=0.012] and eGFR [difference in mean change between MT and cART arm: 0.24 (±0.11) mL/min/1.73 m2 per month; p=0.029]. LPV/r-MT seems safe in most patients and should be considered in patients who have developed kidney toxicity from tenofovir.
Infectious Diseases Department, San Raffaele Scientific Institute, Milan, Italy.
Nicola
N
Gianotti
Andrea
A
Poli
Massimo
M
Galli
Angelo
A
Pan
Giuliano
G
Rizzardini
Alessandro
A
Soria
Pierluigi
P
Viale
Antonio
A
Di Biagio
Tiziana
T
Quirino
Paolo
P
Viganò
Paolo
P
Bonfanti
Antonella
A
d'Arminio Monforte
Ida
I
Fortino
Adriano
A
Lazzarin
D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D017320:HIV Protease Inhibitors / Q000627:therapeutic use*; D015497:HIV-1 / Q000187:drug effects / Q000235:genetics / Q000502:physiology; D006801:Humans; D061466:Lopinavir / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D019438:Ritonavir / Q000627:therapeutic use; D019562:Viral Load / Q000187:drug effects
D019380:Anti-HIV Agents; D017320:HIV Protease Inhibitors; D061466:Lopinavir; D019438:Ritonavir