1. The Peterborough AIDS Research Network & The AIDS Committee of Durham Region Central East Opening Doors Oshawa, Ontario Friday October 10 th 9:30-11:00am Myth: “I’ll Never Have Children” Mona Loutfy, MD, FRCPC, MPH Infectious Diseases Specialist & Clinical Researcher Women’s College Research Institute, Women’s College Hospital & Maple Leaf Medical Clinic, Toronto, ON

2. I am HIV positive. HIV and pregnancy –Getting pregnant –Reproductive care –Preventing vertical transmission –Managing HIV while pregnant Can I have a baby?

3. The Women and HIV Research Program I AM HIV-POSITVE, CAN I HAVE CHILDREN? ANSWER: YES –Increased life expectancy and decreased illness –Reduced vertical transmission to < 0.5% with ARVs and no breast feeding; Caesarian section in some cases BIG QUESTION #1

4. The Women and HIV Research Program BIG QUESTION #2 I AM HIV-POSITVE, I WANT TO BECOME PREGNANT, HOW DO I DO IT SAFELY? ANSWER: YES; PREFERABLY WITH A DOCTOR’S GUIDANCE –Three issues: Reducing horizontal transmission – b/w partners Reducing vertical transmission – mother -> child* Keeping mother and baby healthy *Details in DHHS guidelines – http://aidsinfo.nih.gov/guidelines/http://aidsinfo.nih.gov/guidelines/

5. Canadian HIV Fertility Program VISION: To champion a collaborative program that guides and assists people living with HIV in Canada with their fertility desires and pregnancy planning in a holistic, ethical, supportive and medically sound manner

6. The Women and HIV Research Program Canadian HIV Fertility Program Diagram One of Program’s Goal: to have the discussion of pregnancy, reproduction, pre-conception planning as part of routine HIV care –Between all HCP & HIV-positive patients Why: many reasons –Allow for discussion of contraception, sexual health, harm & transmission reduction, criminalization –We want pregnancies of HIV-positive women to be planned in order to improve maternal & infant health, and reduce vertical and horizontal transmission

7. The Women and HIV Research Program Canadian HIV Pregnancy Planning Guidelines

8. The Women and HIV Research Program Issues Related to Pregnancy Planning and HIV Fertility and HIV: Four main issues need to be considered: 1) Prevention of Vertical Transmission Viral transmission from the mother to the child 2) Healthy pre-conception 3) Prevention of Horizontal Transmission Viral transmission between partners or interacting individuals 4) Fertility issues If the individual or couple has infertility Picture from: http://www.tthhivclinic.com/overview_home.htm 1 Perinatal HIV Guidelines Working Group 2007 http://aidsinfo.nih.gov/ContentFiles/PerinatalGL.pdf.http://www.tthhivclinic.com/overview_home.htm

9. The Women and HIV Research Program Women & Infants Transmission Study, 1990-1999 Cooper E et al. JAIDS 2002;29:484-94 More Potent Antiretroviral Regimens are Associated with Lower Perinatal Transmission

10. The Women and HIV Research Program HIV Pregnancy Guidelines Guidelines Updated – 2014: Centers for Disease Control and Prevention. U.S. Public Health Service Task Force recommendations for use of antiretroviral drugs in pregnant HIV-1- infected women for maternal health and interventions to reduce perinatal HIV-1 transmission in the United States. –Including use of ARVs & C/S and not breastfeeding –Up to date guidelines: http://aidsinfo.nih.gov/guidelines/

11. The Women and HIV Research Program General Principles for Pregnancy Planning Taking Folic Acid: 1 mg a day for 1-3 months before and during 1 st trimester of pregnancy Not smoking and drinking Maintaining a balanced diet Terminating the use of recreational drugs 11

12. The Women and HIV Research Program Antiretroviral drugs and fertility Preference is to have HIV+ person on appr. Drugs before pregnancy –Any ARVs except Efavirenz, D4T, ddI, ddC in women –i.e. 3 ARVs – 2 NRTIs (e.g. Combivir, Kivexa, Truvada) + boosted PI or NNRTI or Integrase Inhibitor –For >3-6 months with viral load <40 copies/mL –Future mother and father should not have received HCV treatment for 6 months before conception Exceptions: –Women - long-term or slow progressor who doesn't need ARVs for her own health (i.e. CD4 > 500 cells/uL), can wait until 12-14 weeks gestation

13. The Women and HIV Research Program Prevention of Horizontal Transmission Different clinical scenarios: 1.HIV+ woman with HIV- man (serodiscordant) or who is single or in same sex relationship 2.HIV+ man and HIV- woman (serodiscordant) 3.HIV+ man and woman (seroconcordant) 4.HIV+ man who is single or in same sex relationship or couple seeking egg donation or surrogate mother Different clinical scenarios have different risk of and require different strategies to prevent horizontal transmission 13

14. The Women and HIV Research Program For all scenarios Review all different options for insemination/conception attempt & continuum of risk including: –Unprotected intercourse (on ART, full viral suppression) –Unprotected intercourse with timed ovulation (on ART, full viral suppression) –Home insemination (i.e. turkey baster method) –Intrauterine insemination (IUI) (in fertility clinic) –Sperm washing followed by IUI –Other: IVF, ICSI, gestational carrier, adoption 14

15. The Women and HIV Research Program Fertility Issues Possibly increased in HIV; Age issue Fertility investigations Options for fertility treatment: –Ovulation stimulating drugs –Intrauterine Insemination (IUI) –In Vitro Fertilization (IVF) –Intracytoplasmic Sperm Injection (ICSI)

16. Questions?

17. During Pregnancy Centers for Disease Control and Prevention. U.S. Public Health Service Task Force Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. –July 31, 2012 & March 31, 2014 http://aidsinfo.nih.gov/guidelines/

18. Summary of what is new in DHHS Guidelines – July 2012 Included piece on Pre-concepetion Atazanavir/ritonavir now a preferred drug in pregnancy along with Kaletra –Use in combination with Combivir (preferred), Kivexa (if HLA B-5701 negative) or Truvada (alternative) Treating with ARVs earlier in pregnancy – i.e. no later than week 12 of gestation –Some start ARVs right away when pregnant, even 4 or 6 weeks gestation

19. Summary of what is new in DHHS Guidelines – July 2012 If an HIV+ woman becomes pregnant on ARVs – do not change ARVs if safe –More harm from changing; poss. nausea with new regimen; risk of stopping –Even Sustiva (Atripla) can continue; only said not to use in first 6 weeks gestation If woman presents late in pregnancy (i.e. 3 rd trimester) or with very high viral load, add Raltegravir to regimen –Commonly use Truvada with Kaletra + Raltegravir Changes to use of intravenous (IV) zidovudine during labor if VL < 400c/mL

20. Summary of what is new in DHHS Guidelines – March 2014 Kivexa and Truvada added as preferred NRTI to Combivir Atazanavir/ritonavir and Kaletra still preferred Efavirenz now preferred NNRTI after 8 weeks gestation Raltegravir – alternative

21. The Women and HIV Research Program Scenario #1 27 year old HIV+ woman with HIV- male partner –She is on Atripla with VL < 50 copies/mL & CD4 count 480 cells/uL & they want to get pregnant –How do you counsel them?

22. The Women and HIV Research Program Scenario #1 – HIV+ woman with HIV- male partner Counsel her to switch from Atripla since before pregnancy; start folic acid 1-5 mg per day Insemination options –Unprotected sex with timed ovulation –Home insemination with syringe –Assisted insemination – in fertility clinic (intra-uterine insemination) How to do home insemination –Time ovulation (1 day per month; 14 days before next FDMP) or insert semen on day 11, 13, 15, and 17 of cycle –Use a turkey baster or syringe

23. The Women and HIV Research Program Scenario #2 Couple: HIV+ man and woman in their late twenties –Both on ARVs (he is on Atripla and she is on Truvada + Isentress ) with VL < 50 copies/mL & good CD4 count values –Referred for consideration of and assistance with pregnancy planning and related issues

24. The Women and HIV Research Program Scenario #2 – HIV+ man and woman She can stay on her ARVs & him as well; she is to start folic acid Insemination options –Unprotected sex on ART with timed ovulation – HPTN052 STUDY –Sperm washing in fertility clinic followed by IUI Issues –In this scenario – it is recommended that both individuals be taking ARVs with VL < 50 copies/mL –Risk of SUPERINFECTION because of discordance of virus in genital secretions

25. The Women and HIV Research Program HPTN 052 Study Randomized Control Trial  Compare early versus delayed (CD4 < 250) ART for HIV-1 positive patients having 350-550 CD4 per mm 3 and in stable sexual relationship with uninfected partner –outcome: Transmission to uninfected partner (linked)  893 couples in Early Therapy Arm; 882 couples in Delayed Therapy Arm  28 HIV-transmissions were linked: 27 in Delayed Arm; 1 in Early Arm (occurred at 3 months post-ARVs) (0.1 per 100 person-years) [HR 0.04 (CI 0.01-0.27); p<0.001] = 96% reduction of HIV transmission with ART

26. The Women and HIV Research Program Sharing information: Pamphlets A vailable in French & English at www.catie.ca

27. The Women and HIV Research Program Sharing information: Workshops

28. Canadian HIV Women’s Sexual and Reproductive Health Cohort Study

29. Study Overview: What is CHIWOS? Current Study Provinces Potential Future Study Provinces CHIWOS: the Canadian HIV WOmen’s Sexual and Reproductive Health Cohort Study Cohort of about 1400 women living with HIV in BC, ON, QC 5 year study: April 1 st 2011 to March 31 st 2016 Anchored in Community-based Research principles Guided by Critical Feminist, Anti-Oppression and Social Justice frameworks

30. CHIWOS: Study Goals Among HIV-positive women –To assess barriers to and facilitators of women-specific HIV/AIDS services use –To assess the impact of such patterns of use on sexual, reproductive, mental and women’s health outcomes

31. CHIWOS Study Design Recruitment at clinics, ASOs, PRAs, and aims to enrol 350 women from QC & BC and 700 from ON (esp. hard to reach women) The survey instrument: online; at baseline & then every 18 months Using COMMUNITY-BASED RESEARCH PRINCIPLES Surveys done with PRAs – 21 in ON, 8 in BC & 8 in QC Regional sampling goals in each province Prioritizing harder-to-reach and marginalized populations in order to learn more about their experiences, and to better meet their needs

32. Sampling Targets for Ontario PopulationTargetActualRequired Younger women703832 Older women7077None Trans women35827 LGBQQ2S Women70637 Aboriginal women704129 ACB women70157None ‘Other' women of colour704624 Not accessing care702743 History of IDU706010 History of sex work703436 RegionTargetActualRequiredPercentage Complete Toronto2882028670% Ottawa87 652275% Central West80 413951% South West70 175324% Central East and Eastern701951 27% Northern701654 23% Regional Targets Priority Population Targets Indicates <60% of target met

33. The Women and HIV Research Program This is an Issue of Sexual and Reproductive Rights “All couples and individuals have the right to decide freely and responsibly the number and spacing of their children and to have access to the information, education and means to do so.” World Health Organization, UN Population Fund, Joint United Nations Programme on HIV/AIDS (UNAIDS), and International Planned Parenthood Federation. Sexual and reproductive health and HIV/AIDS: A framework for priority linkages, 2005. Available at http://www.who.int/reproductive-health/stis/docs/framework_priority_linkages.pdf. “…a state of physical, emotional, mental and social well-being in relation to sexuality; it is not merely the absence of disease, dysfunction or infirmity. Sexual health requires a positive and respectful approach to sexuality and sexual relationships, as well as the possibility of having pleasurable and safe sexual experiences, free of coercion, discrimination and violence. For sexual health to be attained and maintained, the sexual rights of all persons must be respected, protected and fulfilled.”

34. The Women and HIV Research Program Acknowledgements I would like to thank the Peterborough AIDS Research Network & the AIDS Committee of Durham Region for inviting me to speak and to be partners in these important knowledge exchange activities

35. 35 Thank You! Our Team Women and HIV Research Program Staff Canadian HIV Fertility Program Investigators, Staff & Students CHPPG Development Team

36. Feedback and questions? Thank you!