Health Evidence™ hosted a 90 minute webinar examining the effect of antiretroviral therapy for pregnant women living with HIV or hepatitis B. Click here for access to the audio recording for this webinar: https://youtu.be/91moFmIoI3w Dr. Reed A.C. Siemieniuk, MD, PhD(c), Department of Medicine, University of Toronto, Department of Health Research Methods, Evidence, and Impact, McMaster University led the session and presented findings from their recent systematic review: Siemieniuk R, Foroutan F, Mirza R, Mah Ming J, Alexander PE, Agarwal A, et al. (2017). Antiretroviral therapy for pregnant women living with HIV or hepatitis B: A systematic review and meta-analysis. BMJ Open, 7(9), e019022. This review assesses the impact of various antiretroviral/antiviral regimens in pregnant women living with HIV or hepatitis B virus (HBV). Forty-three studies were included in the review. The most common comparison was tenofovir and emtricitabine versus zidovudine and lamivudine. There was no apparent difference between tenofovir-based regimens and alternatives in maternal outcomes, including serious laboratory adverse events and serious clinical adverse events. There was no difference between NRTIs in vertical transmission of HIV or vertical transmission of HBV. We found moderate certainty evidence that tenofovir/emtricitabine increases the risk of stillbirths and early neonatal mortality and the risk of early premature delivery at less than 34 weeks. Tenofovir/emtricitabine is likely to increase stillbirth/early neonatal death and early premature delivery compared with zidovudine/lamivudine, but certainty is low when they are not coprescribed with lopinavir/ritonavir. Other outcomes are likely similar between antiretrovirals. Lyuba Lytvyn, MSc, PhD(c), Department of Health Research Methods, Evidence, and Impact, McMaster University also briefly presented the findings from their linked systematic review on values and preferences of pregnant women with HIV: Lytvyn L, Siemieniuk R, Dilmitis S, Ion A, Chang Y, Bala M, et al. (2017). Values and preferences of women living with HIV who are pregnant, postpartum or considering pregnancy on choice of antiretroviral therapy during pregnancy. BMJ Open, 7(9), e019023.

1. Welcome!
Antiretroviral therapy for
pregnant women living
with HIV or hepatitis B:
What's the evidence?
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and overviews
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3. After Today
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recording will be made available
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3

4. What’s the evidence?
Siemieniuk R, Foroutan F, Mirza R, Mah Ming J,
Alexander PE, Agarwal A, et al. (2017).
Antiretroviral therapy for pregnant women
living with HIV or hepatitis B: A systematic
review and meta-analysis. BMJ Open, 7(9),
e019022.
https://healthevidence.org/view-
article.aspx?a=antiretroviral-therapy-
pregnant-women-living-hiv-hepatitis-
systematic-review-33013

5. What’s the evidence?
Lytvyn L, Siemieniuk R, Dilmitis S, Ion A, Chang
Y, Bala M, et al. (2017). Values and preferences
of women living with HIV who are pregnant,
postpartum or considering pregnancy on choice
of antiretroviral therapy during pregnancy. BMJ
Open, 7(9), e019023.
https://www.ncbi.nlm.nih.gov/pubmed/28893
759

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8. Poll Question #1
How many people are watching
today’s session with you?
A. Just me
B. 2-3
C. 4-5
D. 6-10
E. >10

9. Students:
Sarah Neil-Sztramko (Postdoctoral fellow)
Emily Belita (PhD candidate)
Patricia Burnett (PhD candidate)
Grace Thomas
Research Assistant
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Research Coordinator
Heather Husson
Administrative Director
The Health Evidence™ Team
Maureen Dobbins
Scientific Director
Olivia Marquez
Research Coordinator
Maureen Dobbins
Scientific Director
Claire Howarth
Research Coordinator
Liz Kamler
Research Assistant
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10. What is www.healthevidence.org?
Evidence
Decision
Making
inform

11. Why use www.healthevidence.org?
1. Saves you time
2. Relevant & current evidence
3. Transparent process
4. Supports for EIDM available
5. Easy to use

12. A Model for Evidence-
Informed Decision Making
National Collaborating Centre for Methods and Tools. (revised 2012). A
Model for Evidence-Informed Decision-Making in Public Health (Fact
Sheet). [http://www.nccmt.ca/pubs/FactSheet_EIDM_EN_WEB.pdf]

13. Stages in the process of
Evidence-Informed Public Health
National Collaborating Centre for Methods and Tools. Evidence-Informed
Public Health. [http://www.nccmt.ca/eiph/index-eng.html]

14. Poll Question #2
Have you heard of PICO(S) before?
A. Yes
B. No

15. Searchable Questions Think “PICOS”
1.Population (situation)
2.Intervention (exposure)
3.Comparison (other group)
4.Outcomes
5.Setting

16. How often do you use systematic reviews
to inform a program/services?
A. Always
B. Often
C. Sometimes
D. Never
E. I don’t know what a systematic review is
Poll Question #3

17. Dr. Reed A.C.
Siemieniuk
MD, PhD(c), Department of Medicine,
University of Toronto, Department of Health
Research Methods, Evidence, and Impact,
McMaster University

18. Lyuba Lytvyn
MSc, PhD(c), Department of Health Research
Methods, Evidence, and Impact, McMaster
University

19. HIV and women
http://www.unaids.org/en/resources/infographics/girls-and-women-living-with-HIV*Most are childbearing age

20. Pregnancy
• >1.4 million women living with HIV
become pregnant every year1
• Without any intervention, vertical
transmission occurs in approximately 1/3
1. World Health Organization. Number of women living with HIV. Geneva, Switzerland: World Health Organization, 2017.

21. Vertical transmission
• ART is the
most
effective
way to
reduce
vertical
transmission
300/1000  5/1000

22. The Global Plan towards the elimination of new HIV infections among
children by 2015 and keeping their mothers alive
“The road to zero new transmissions”

23. Secondary benefits
Focus on reducing vertical transmission:
• Fewer HIV complications in women
• Building up healthcare systems
• Engaging women in care for non-HIV
issues
• Healthier children
• Few undesirable consequences

24. ART in pregnancy:
woman-centered options

25. ART in pregnancy
• Many options
– AZT alone (the preferred option until
recently)
– Combination ART

26. Recommendations:

27. PROMISE

28. PROMISE

29. PROMISE

30. Should the WHO continue to recommend
tenofovir as first line for pregnant
women?
A. Continue to recommend tenofovir
B. Recommend an alternative (eg AZT)
C. No recommendation
Poll Question #4

31. BMJ Rapid Recommendations
• https://youtu.be/KnF0AOqZD3E

32. Recommendations
• Patient
• Family
• Healthcare provider
• Society
• Payer

33. Recommendations
• Patient
• Family
• Healthcare provider
• Society
• Payer

34. Values and preferences –
Collaborating with women
living with HIV
• Three women living with HIV were co-authors:
Rhonda Marama Mullen (New Zealand), Teresia
Otenio (United States/Kenya), and Florence
Anam (Kenya)
• Women-centred perspective
– Two had children, one was considering having
children in the future
– Involved in not-for-profit advocacy work
related to women living with HIV

35. Values and preferences –
Collaborating with women
living with HIV
1. Informed outcomes most important to
women
– Main concern was child’s health, not pill
burden
2. Led discussion of values and preferences
during teleconference
3. Helped interpret and provide context for
evidence

36. Values and preferences –
Systematic review of
published literature

37. • 15 qualitative studies
• 6 themes: reduction of vertical transmission,
child’s health, side effects to child, own health,
side effects to oneself, pill burden
• No study weighed the relative importance of
outcomes directly, but pill burden appeared to
be lower priority
Overall: Panel considerations aligned with
empirical evidence on what mattered for most
women
Values and preferences –
Systematic review of
published literature

38. Systematic review

39. Woman
1. RCTs pregnant
women
2. RCTs non-pregnant
adults
3. Observational
studies pregnant
women
Child
1. RCTs pregnant
women
1. Living w/ HIV
2. Pre-exposure
prophylaxis, HBV
2. RCTs non-pregnant
adults
3. Observational
studies pregnant
women

40. Included studies

41. Woman: Acceptability

42. Woman: Mortality

43. Woman: Adverse effects

44. Child: stillbirth or early neonatal mortality

45. Premature delivery <34 weeks

49. Poll Question #5
As a pregnant woman living with HIV,
do you choose:
A. Tenofovir/emtricitabine
B. AZT/lamivudine
C. Neither

50. Additional public health
considerations
• “Ensuring optimal drug availability and lower costs facilitates
harmonization of regimens across countries and populations. The
recommendation by Siemieniuk et al would fragment the ART market
across populations in low and middle income countries, thereby likely
increasing risk of stock outs, raising prices and complicating supply
chains. These operational realities are critical to consider when making
ART recommendations that affect low- and middle-income countries, but,
unfortunately, appear to not be adequately considered by the authors.”
– Jennifer Cohn, Anja Giphart, Nick Hellman, Elizabeth Glaser Pediatric AIDS Foundation

51. Public Health Consideration:
Different recommendations for
pregnant women will
complicate provision of care

52. Poll Question #6
As a public health official, do you
recommend:
A. Tenofovir/emtricitabine
B. AZT/lamivudine
C. Neither

53. Summary
• TDF/FTC might increase the risk of
stillbirth and neonatal mortality
– Certainty is LOW
• Most women place a high value on giving
their child the best chance of surviving
• Public health officials might sometimes
place a higher value on improving access
to ART

54. Poll Question #7
The information presented today was
helpful
A. Strongly agree
B. Agree
C. Neutral
D. Disagree
E. Strongly disagree

55. What can I do now?
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56. Poll Question #8
What are your next steps? [Check all
that apply]
A. Access the full text systematic review
B. Access the quality assessment for the
review on www.healthevidence.org
C. Consider using the evidence
D. Tell a colleague about the evidence

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58. Thank you!
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