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JAC Advance Access originally published online on August 21, 2007
Journal of Antimicrobial Chemotherapy 2007 60(4):724-732; doi:10.1093/jac/dkm302
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© The Author 2007. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org

Systematic review

Sex issues in HIV-1-infected persons during highly active antiretroviral therapy: a systematic review

Emanuele Nicastri1,*, Sebastiano Leone1, Claudio Angeletti1, Lucia Palmisano2, Loredana Sarmati3, Antonio Chiesi2, Andrea Geraci2, Stefano Vella2, Pasquale Narciso1, Angela Corpolongo1 and Massimo Andreoni3

1 National Institute for Infectious Diseases, IRCCS ‘Lazzaro Spallanzani’, Rome, Italy 2 Department of Drug Research and Evaluation, Istituto Superiore di Sanità, Rome, Italy 3 Department of Public Health, University of Rome Tor Vergata, Rome, Italy

Received 19 December 2006; returned 11 July 2007; accepted 15 July 2007


* Corresponding author. Tel: +39-0655170420; Fax: +39-0655170400/7; E-mail: nicastri{at}inmi.it

Background: Since the introduction of highly active antiretroviral therapy (HAART), morbidity and mortality rates have sharply decreased among HIV-infected patients. Studies of possible differences between men and women in the course of HIV infection give conflicting results. The objective of this study was to assess sex differences during HAART.

Methods: A literature search by using the MEDLINE database between March 2002 and February 2007 was performed to identify all published studies on the sex-specific differences on the impact of HAART. All articles with measures of effect (preferably adjusted odds ratio, relative risk or hazard ratio with 95% CI) of sex on viroimmunological and clinical parameters during HAART were included. Five different topics of interest in our research were selected: time of initiation of HAART, adherence, viroimmunological response, clinical response and adverse reactions during HAART.

Results: US data report an initiation of HAART at an earlier disease stage in men compared with women. After initiation of HAART, most authors do not report any viroimmunological difference, although a few clinical studies showed a significantly better virological response in women compared with men. Nevertheless, women were more likely to be less adherent to antiretrovirals and to have non-structured treatment interruptions than men. This is likely to be related to the higher number of adverse reactions they experience during HAART. Finally, discordant opinions with regard to clinical benefits during HAART exist, but recent clinical and observational trials suggest a better clinical outcome for women.

Conclusions: We found little evidence of sex differences during antiretroviral treatment. Nevertheless, most of these studies were underpowered to detect sex differences and had limited follow-up at 6 or 12 months. Design of new gender-sensitive clinical trials with both prolonged follow-up and sample size representative of the current HIV prevalence among women are strongly needed to detect the likely sex differences of antiretroviral agents during HIV infection.

Keywords: gender , HAART , long-term clinical progression


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