96 Week follow-up of HIV-infected patients in rescue with raltegravir plus optimized backbone regimens: a multicentre Italian experience.
BACKGROUND
Long term efficacy of raltegravir (RAL)-including regimens in highly pre-treated HIV-1-infected patients has been demonstrated in registration trials. However, few studies have assessed durability in routine clinical settings.


METHODS
Antiretroviral treatment-experienced patients initiating a RAL-containing salvage regimen were enrolled. Routine clinical and laboratory follow-up was performed at baseline, week 4, 12, and every 12 weeks thereafter. Data were censored at week 96.


RESULTS
Out of 320 patients enrolled, 292 (91.25%) subjects maintained their initial regimen for 96 weeks; 28 discontinued prematurely for various reasons: death (11), viral failure (8), adverse events (5), loss to follow-up (3), consent withdrawal (1). Eight among these 28 subjects maintained RAL but changed the accompanying drugs. The mean CD4+ T-cell increase at week 96 was 227/mm(3); 273 out of 300 patients (91%), who were still receiving RAL at week 96, achieved viral suppression (HIV-1 RNA <50 copies/mL). When analyzing the immuno-virologic outcome according to the number of drugs used in the regimen, 2 (n = 45), 3 (n = 111), 4 (n = 124), or >4 (n = 40), CD4+ T-cell gain was similar across strata: +270, +214, +216, and +240 cells/mm(3), respectively, as was the proportion of subjects with undetectable viral load. Laboratory abnormalities (elevation of liver enzymes, total cholesterol and triglycerides) were rare, ranging from 0.9 to 3.1%. The mean 96-week total cholesterol increase was 23.6 mg/dL.


CONCLUSIONS
In a routine clinical setting, a RAL-based regimen allowed most patients in salvage therapy to achieve optimal viral suppression for at least 96 weeks, with relevant immunologic gain and very few adverse events.
1st Division of Infectious Diseases, Luigi Sacco Hospital, Milano, Italy. capetti.amedeo@hsacco.it
Amedeo
A
Capetti
Simona
S
Landonio
Paola
P
Meraviglia
Antonio
A
Di Biagio
Sergio
S
Lo Caputo
Gaetana
G
Sterrantino
Adriana
A
Ammassari
Barbara
B
Menzaghi
Marco
M
Franzetti
Giuseppe Vittorio
GV
De Socio
Giovanni
G
Pellicanò
Elena
E
Mazzotta
Alessandro
A
Soria
Marianna
M
Meschiari
Michele
M
Trezzi
Lolita
L
Sasset
Benedetto Maurizio
BM
Celesia
Patrizia
P
Zucchi
Sara
S
Melzi
Elena
E
Ricci
Giuliano
G
Rizzardini
D000328:Adult; D023241:Antiretroviral Therapy, Highly Active; D018791:CD4 Lymphocyte Count; D015496:CD4-Positive T-Lymphocytes / Q000187:drug effects / Q000821:virology; D024882:Drug Resistance, Viral / Q000187:drug effects; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D019428:HIV Integrase Inhibitors / Q000627:therapeutic use*; D015497:HIV-1 / Q000187:drug effects* / Q000502:physiology; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D011760:Pyrrolidinones / Q000627:therapeutic use*; D000068898:Raltegravir Potassium; D016879:Salvage Therapy; D019562:Viral Load / Q000187:drug effects
D019428:HIV Integrase Inhibitors; D011760:Pyrrolidinones; D000068898:Raltegravir Potassium