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Preemptive therapy prevents cytomegalovirus end-organ disease in treatment-naive patients with advanced HIV-1 infection in the HAART era.

ABSTRACT:

Background

The efficacy of preemptive therapy against cytomegalovirus (CMV) infection remains unknown in treatment-naïve patients with advanced HIV-1 infection in the HAART era.

Methods

The subjects of this single-center observation study were 126 treatment-naïve HIV-1 infected patients with positive CMV viremia between January 1, 2000 and December 31, 2006. Inclusion criteria were age more than 17 years, CD4 count less than 100/?l, plasma CMV DNA positive, never having received antiretroviral therapy (ART) and no CMV end-organ disease (EOD) at first visit. The incidence of CMV-EOD was compared in patients with and without preemptive therapy against CMV-EOD. The effects of the CMV preemptive therapy were estimated in uni- and multivariate Cox hazards models.

Results

CMV-EOD was diagnosed in 30 of the 96 patients of the non-preemptive therapy group (31%, 230.3 per 1000 person-years), compared with 3 of the 30 patients of the preemptive therapy group (10%, 60.9 per 1000 person-years). Univariate (HR?=?0.286; 95%CI, 0.087-0.939; p?=?0.039) and multivariate (adjusted HR?=?0.170; 95%CI, 0.049-0.602; p?=?0.005) analyses confirmed that CMV-EOD is significantly prevented by CMV preemptive therapy. Multivariate analysis showed that plasma CMV DNA level correlated significantly with CMV-EOD (per log10/ml, adjusted HR?=?1.941; 95%CI, 1.266-2.975; p?=?0.002). Among the 30 patients on preemptive therapy, 7 (23.3%) developed grade 3-4 leukopenia. The mortality rate was not significantly different between the two groups (p?=?0.193, Log-rank test).

Conclusions

The results indicate that preemptive therapy lowers the incidence of CMV-EOD by almost 25%. Preemptive therapy for treatment-naïve patients with CMV viremia is effective, although monitoring of potential treatment-related side effects is required.

SUBMITTER: Mizushima D

PROVIDER: S-EPMC3665626 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature

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Preemptive therapy prevents cytomegalovirus end-organ disease in treatment-naïve patients with advanced HIV-1 infection in the HAART era.

Mizushima Daisuke D Nishijima Takeshi T Gatanaga Hiroyuki H Tsukada Kunihisa K Teruya Katsuji K Kikuchi Yoshimi Y Oka Shinichi S

PloS one 20130528 5

<h4>Background</h4>The efficacy of preemptive therapy against cytomegalovirus (CMV) infection remains unknown in treatment-naïve patients with advanced HIV-1 infection in the HAART era.<h4>Methods</h4>The subjects of this single-center observation study were 126 treatment-naïve HIV-1 infected patients with positive CMV viremia between January 1, 2000 and December 31, 2006. Inclusion criteria were age more than 17 years, CD4 count less than 100/μl, plasma CMV DNA positive, never having received a ...[more]

PMID: 23724140

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