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Background

Benefits of PrEP as an adjunctive method of HIV prevention during attempted conception between HIV-uninfected women and HIV-infected male partners: A modeling approach. R. Hoffman 1 , R. Vardavas 2 , A. Jaycocks 2 , G. Wagner 2 , J. Lake 1 , D. Mindry 3 , J. Currier 1 , R. Landovitz 1.

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Background

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  1. Benefits of PrEP as an adjunctive method of HIV prevention during attempted conception between HIV-uninfected women and HIV-infected male partners: A modeling approach R. Hoffman1, R. Vardavas2, A. Jaycocks2, G. Wagner2, J. Lake1, D. Mindry3, J. Currier1, R. Landovitz1 1David Geffen School of Medicine at University of California, Los Angeles, 2RAND Corporation, Santa Monica, 3 University of California, Los Angeles, Center for Culture and Health, Department of Psychiatry and Behavioral Sciences

  2. Background • Globally, HIV-infection is estimated to affect over 34 million individuals, with 2/3 of infections heterosexually acquired1 • 20-75% desire to conceive2-6 • Serodiscordant couples engage in transmission-risk behavior in order to conceive7 1UNAIDS Global Summary of HIV Infection, 2011 2 Stanwood NL et al., Contraception 2007 3 Finocchario-Kessler S et al., AIDS Behavior 2010 4 Cooper D et al., AIDS Behavior 2009 5 Schwartz SR et al., AIDS Behavio, 2012 6 Landovitz RJ et al., 20th CROI 2013, Abstract #1069 7 Brubaker SG et al., HIV Medicine 2010

  3. Background • Protection against HIV transmission during conception among serodiscordant couples remains challenging • Options include self insemination or assisted reproduction • Optimal procedures are often prohibitive due to cost and lack of widespread availability (sperm washing+adjunctive) • Less costly menu of options: Timing of intercourse, STI treatment, PrEP, ART for positive partner. And of course, the good-old-fashioned approach

  4. Aims • To evaluate the additive benefit of PrEP for successful conception, without HIV transmission in the setting of an HIV+ male and HIV- female • To explore the relative benefits of ART and PrEP, singly and in combination across multiple clinical scenarios • To evaluate the impact of maternal age on annual successful conception/HIV non-transmission probabilities • Primary outcome of interest is a previously HIV- woman remaining HIV-uninfected and successfully conceiving and delivering a child

  5. Methods – 1: Model Inputs 1 Quinn TC et al., NEJM 2000 2 Hughes JP et al., J Inf Dis 2012 3 Gray RH et al., J Inf Dis 2012 4Hollingsworth TD et al., J Inf Dis 2008 5Wawer MJ et al., J Inf Dis 2005 6 Cohen MS et al., NE Engl J Med 2011 7Grosskurth H et al., Lancet 1995 8Baeten JM et al. N Engl J Med 2012

  6. Methods – 1: Model Inputs 1 Quinn TC et al., NEJM 2000 2 Hughes JP et al., J Inf Dis 2012 3 Gray RH et al., J Inf Dis 2012 4Hollingsworth TD et al., J Inf Dis 2008 5Wawer MJ et al., J Inf Dis 2005 6 Cohen MS et al., NE Engl J Med 2011 7Grosskurth H et al., Lancet 1995 8Baeten JM et al. N Engl J Med 2012

  7. Methods – 1: Model Inputs 1 Quinn TC et al., NEJM 2000 2 Hughes JP et al., J Inf Dis 2012 3 Gray RH et al., J Inf Dis 2012 4Hollingsworth TD et al., J Inf Dis 2008 5Wawer MJ et al., J Inf Dis 2005 6 Cohen MS et al., NE Engl J Med 2011 7Grosskurth H et al., Lancet 1995 8Baeten JM et al. N Engl J Med 2012

  8. Methods – 1: Model Inputs 1 Quinn TC et al., NEJM 2000 2 Hughes JP et al., J Inf Dis 2012 3 Gray RH et al., J Inf Dis 2012 4Hollingsworth TD et al., J Inf Dis 2008 5Wawer MJ et al., J Inf Dis 2005 6 Cohen MS et al., NE Engl J Med 2011 7Grosskurth H et al., Lancet 1995 8Baeten JM et al. N Engl J Med 2012

  9. Methods – 1: Model Inputs 1 Quinn TC et al., NEJM 2000 2 Hughes JP et al., J Inf Dis 2012 3 Gray RH et al., J Inf Dis 2012 4Hollingsworth TD et al., J Inf Dis 2008 5Wawer MJ et al., J Inf Dis 2005 6 Cohen MS et al., NE Engl J Med 2011 7Grosskurth H et al., Lancet 1995 8Baeten JM et al. N Engl J Med 2012

  10. Methods – 1: Model Inputs 1 Quinn TC et al., NEJM 2000 2 Hughes JP et al., J Inf Dis 2012 3 Gray RH et al., J Inf Dis 2012 4Hollingsworth TD et al., J Inf Dis 2008 5Wawer MJ et al., J Inf Dis 2005 6 Cohen MS et al., NE Engl J Med 2011 7Grosskurth H et al., Lancet 1995 8Baeten JM et al. N Engl J Med 2012

  11. Methods-2 • Additional Model Inputs: • Probability of conception by age • Probability of successful delivery by age • Number of unprotected sex acts to achieve successful conception • Classification and Regression Tree (CART) analysis was used to establish hierarchy of importance of parameters to outcome of interest

  12. Potential Outcomes

  13. Potential Outcomes

  14. Optimal Scenario Sub-optimal Scenario 0-12 Sex Acts localized to Ovulation Period (Sampled around 3) 0-60 Sex Acts distributed over Entire Menstrual Cycle (Sampled around 15)

  15. Optimal Scenario Sub-optimal Scenario 0-12 Sex Acts localized to Ovulation Period (Sampled around 3) 0-60 Sex Acts distributed over Entire Menstrual Cycle (Sampled around 15)

  16. Results - 1: Optimal Scenario* p = NS⌘ 27.6% 30.6% 30.7% 29.5% *Assumes STIs diagnosed and treated in both partners ⌘All other pair-wise comparisons p < 0.0001

  17. Results - 2: Suboptimal Scenario*⌘ 30.3% 17.0% 29.3% 24.1% *Assumes STIs diagnosed and treated in both partners ⌘All pair-wise comparisons p < 0.0001

  18. Results - 3: Both Scenarios* p < 0.0001 p < 0.0001 p < 0.0001 p < 0.0001 30.3% 17.0% 29.3% 24.1% 27.6% 30.6% 30.7% 29.5% 30.3% 17.0% 29.3% 24.1% *Assumes STIs diagnosed and treated in both partners

  19. Results - 2 • CART analysis of the outcome of an HIV-uninfected woman delivering a child • In the optimal clinical scenario, age is the most influential factor • In the sub-optimal clinical scenario, for women <40, ART treatment is next-most important parameter

  20. Clinical Application Prototype

  21. Conclusions • Based upon our inputs to our model, PrEP provides little added benefit when all are true: • The HIV-infected male partner is on ART • Unprotected intercourse is limited to the period of ovulation • STIs are diagnosed and treated in both partners • In the timing-optimized scenario, there is little absolute difference between any of the 4 strategies • In the non-timing optimized scenario, ART treatment of the HIV+ male partner drives the differences between strategies • The model highlights that younger age is associated with the desired outcome

  22. Public Health Implications and Caveats • Model results are limited by inputs, and do not substitute for clinical decision making on individual basis • These data are reassuring that patients can have desired results without the addition of PrEP if they are motivated to optimize other modifiable risk factors (provided ART is available)

  23. Acknowledgements • UCLA AIDS Institute and the UCLA Center For AIDS Research, AI28697 • NIH/NIDA K23DA026308 (PI: Landovitz) • NIH/NIAID K24AI56933(PI: Currier) • NIH/NICDH R01HD072633 (PI: Wagner)

  24. Thank You!

  25. Outcome: HIV+, no child 3.5% 2.9% 1.3% 0.6% 0.2% 7.4% 31.1% 15.1%

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