module3.1-section2-7



CASCADE study: Slower disease progression following HIV seroconversion in women (n=3,414 women & 3,509 men)

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Jarrin I, et aI. Am J Epidemiol 2008;168:532–40


COHERE: Time with CD4 ≥500 cells/mm3 allows men, but not women, to reach similar mortality rates to general population

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Adapted from Lewden C et al. 17th CROI, 2010. Poster 527. Abstract L-166



Treatment guidelines for the third agent do not differentiate between men and women (except those planning pregnancy/who are pregnant)

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Table adapted from:

1. http://www.europeanaidsclinicalsociety.org/guidelinespdf/EACS-EuroGuidelines_FullVersion.pdf. Accessed March 2011.
2. http://aidsinfo.nih.gov/contentfiles/AdultandAdolescentGL.pdf. Accessed March 2011.
3. Thompson MA et al. JAMA 2010; 304:321–333.



FDA meta-analysis: Similar efficacy of ART in women vs men

  • Results
    • 22,411 HIV+ subjects in 43 RCTs for 16 ARVs; 20% women
    • No significant gender differences in treatment response at week 48, discontinuations for AEs, lost to follow-up or death
    • Higher rate of discontinuations for virological failure in males (8.15%) than females (4.25%)

    Soon G, et al. 50th ICAAC 2010. Abstract H-1812

module3.1-section2-11


Representation of women in randomised controlled trials in naïve patients

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Summary of women’s efficacy outcomes in selected randomised controlled trials

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1. Riddler SA, et al. N Engl J Med 2008;358:2095
2. Squires K, et al. J Antimicrob Chemother 2011;66:363–70
3. Smith K, et al. CROI 2011:Abstract 536
4. Fourie J, et al. IAS 2009, poster CDB072
5. Currier J, et al. Ann Intern Med 2010;153:349–57



GRACE study design

Open-label, single-group, phase 3b study performed at 65 sites in US, Puerto Rico and Canada

module3.1-section2-14

Currier J, et al. Ann Intern Med 2010;153:349–57



GRACE: Virological response not significantly different in women vs men at 48 weeks

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1. Currier J, et al. Ann Intern Med 2010;153:349–57
2. Squires K, et al. IAS 2009. Poster MOPEB042



GRACE: Similar rates of adverse events between women and men

module3.1-section2-16

Adapted from Currier J, et al. Ann Intern Med 2010;153:349–57



CASTLE: Study design

module3.1-section2-17

Molina JM, et al. J Acquir Immune Defic Syndr 2010;53:323–32 Squires KE, et al. J Antimicrob Chemother 2011;66:363–70



CASTLE: Overall efficacy of ATV/r compared to LPV/r regimen at 96 weeks (ITT)

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Squires K, et al. J Antimicrob Chemother 2011;66:363-370



CASTLE: Incidence of diarrhoea and nausea at Week 96 more common in both women and men administered LPV/r vs ATV/r

module3.1-section2-19

Squires KE, et al. J Antimicrob Chemother 2011; 66: 363–370



ACTG 5202: Time to virological failure over 4 years similar between treatment groups (Primary efficacy endpoint)

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Daar ES, et al. Ann Intern Med 2011 Feb 14. [Epub ahead of print]



ACTG 5202: Association of race/ethnicity and sex with outcomes

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Smith K, et al. CROI 2011. Poster 536