title: Access to antiretroviral treatment, incidence of sustained therapy interruptions, and risk of clinical events according to sex: evidence from the I.Co.N.A. Study.
abstract: Objectives of the study were to assess the differences between sexes in the likelihood of starting antiretroviral therapy (ART), in rates of sustained discontinuation from highly active antiretroviral therapy (HAART), and in clinical progression. In a multicenter cohort study (I.Co.N.A. Study), 2323 men and 1335 women previously naive to antiretrovirals were enrolled. As of September 2002, 807 women and 1480 men started ART. The median time to starting ART was 28 weeks for women and 17 weeks for men (P = 0.0003 by log-rank test). This difference was no longer significant after adjusting for either HIV RNA (P = 0.21) or CD4 count (P = 0.28) at enrollment. Women tend to start HAART less frequently than mono/dual ART after adjusting for potential confounders (odds ratio = 0.78, 95% confidence interval [CI]: 0.60-1.01; P = 0.06). Women who started HAART were 1.4 times more likely than men (95% CI: 1.00-1.99; P = 0.05) to interrupt at least 1 drug because of toxicity. Twenty-one percent of women and 19% of men interrupted HAART altogether for more than 3 months (P = 0.3). Clinical progression was observed in 53 women (22.6%) and 137 men (23.4%; P = 0.56). Risk of developing a clinical event was found to be no different between women and men (relative hazard = 0.84, 95% CI: 0.56-1.26; P = 0.40).
authors.affiliation: Department of Infectious Diseases, Catholic University of Rome, Italy. ritamurri@libero.it
authors.forename: Rita
authors.initials: R
authors.lastname: Murri
authors.forename: Alessandro Cozzi
authors.initials: AC
authors.lastname: Lepri
authors.forename: Andrew N
authors.initials: AN
authors.lastname: Phillips
authors.forename: Enrico
authors.initials: E
authors.lastname: Girardi
authors.forename: Guglielmo
authors.initials: G
authors.lastname: Nasti
authors.forename: Sergio
authors.initials: S
authors.lastname: Ferrara
authors.forename: Maria Stella
authors.initials: MS
authors.lastname: Mura
authors.forename: Cristina
authors.initials: C
authors.lastname: Mussini
authors.forename: Enzo
authors.initials: E
authors.lastname: Petrelli
authors.forename: Massimo
authors.initials: M
authors.lastname: Arlotti
authors.forename: Carlo
authors.initials: C
authors.lastname: De Stefano
authors.forename: Paola
authors.initials: P
authors.lastname: Vigano
authors.forename: Roberto
authors.initials: R
authors.lastname: Novati
authors.forename: Antonietta
authors.initials: A
authors.lastname: Cargnel
authors.forename: Antonella D'Arminio
authors.initials: AD
authors.lastname: Monforte
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy* / Q000276:immunology; D000293:Adolescent; D000328:Adult; D000368:Aged; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects; D018791:CD4 Lymphocyte Count; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D013997:Time Factors