Prognostic factors of long-term CD4+count-guided interruption of antiretroviral treatment.
Aim of the study was to determine predictors of the duration of antiretroviral treatment interruption in patients infected with HIV. This pilot prospective, open-label, multicenter trial comprised 62 HIV-seropositive subjects who decided voluntarily to interrupt therapy after two or more years of successful HAART. The primary end-point was the time to patients being free of therapy before reaching a CD4+ cell count < or =350/microl. Fifteen of 62 patients remained in treatment interruption for more than 180 days. Patients restarting therapy had higher HIV-DNA levels (P = 0.05), were treated more frequently with NNRTI-drugs (P = 0.02), had a shorter period of HAART (P = 0.046), and lower CD4+ cell counts after day 14 of interruption of treatment (P = 0.04). Multivariate regression analysis showed that less than 323 baseline proviral HIV-DNA cp/10(6) PBMCs and more than 564 CD4 cells/microl at day 14 after interruption were associated independently with a reduced risk of restarting treatment (P = 0.041 and P = 0.012, respectively). A score based on CD4+ cell counts at nadir, at baseline, at week 2 of treatment interruption, and on baseline HIV-DNA values can identify patients with a prolonged period free safely of treatment.
Sarmati
L
L
Clinic of Infectious Diseases, Tor Vergata University, Rome, Italy.
Andreoni
C
C
Nicastri
E
E
Tommasi
C
C
Buonomini
A
A
D'Ettorre
G
G
Corpolongo
A
A
Dori
L
L
Montano
M
M
Volpi
A
A
Narciso
P
P
Vullo
V
V
Andreoni
M
M
D000328:Adult; D023241:Antiretroviral Therapy, Highly Active / Q000379:methods*; D018791:CD4 Lymphocyte Count; D015496:CD4-Positive T-Lymphocytes / Q000276:immunology*; D004279:DNA, Viral / Q000097:blood; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology; D006801:Humans; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome; D028761:Withholding Treatment
D004279:DNA, Viral