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Hormonal contraceptive use and HIV progression: A systematic review

Hormonal contraceptive use and HIV progression: A systematic review. Sharon Phillips, MD MPH Department of Reproductive Health and Research World Health Organization Kate Curtis, PhD Division of Reproductive Health, CDC Chelsea Polis, PhD Office of Population and Reproductive Health

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Hormonal contraceptive use and HIV progression: A systematic review

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  1. Hormonal contraceptive use and HIV progression: A systematic review Sharon Phillips, MD MPH Department of Reproductive Health and Research World Health Organization Kate Curtis, PhD Division of Reproductive Health, CDC Chelsea Polis, PhD Office of Population and Reproductive Health United States Agency for International Development

  2. Need for comprehensive reproductive health services among women living with HIV • Women living with HIV who desire children should have support to safely conceive and deliver • Substantial unmet need for contraception and unintended pregnancy among women living with HIV • All women who wish to prevent pregnancy deserve access to voluntary family planning services

  3. Key Questions Are women living with HIV who use hormonal contraception at increased risk of: • Death or progression to AIDS • Measured by CD4 <200, initiation of ART, or clinical AIDS • Change in CD4 or viral load

  4. Methods

  5. Methods: Study selection • Primary reports of studies examining hormonal contraceptive use among women living with HIV • PUBMED and EMBASE searched for published articles in any language through December 15, 2011 • 634 unique references identified, 16 full-text articles assessed, 12 reports included • Excluded: studies with no comparison group; case control studies • Study information independently abstracted by 2 authors (SP & KC)

  6. Methods: Quality criteria • Methodology used to minimize confounding • Accurate measurement and analysis of exposure • Composition of comparison group • Loss to follow-up • Length of follow-up • Additional considerations for RCTs • Adequate randomization • Allocation concealment • Distribution of potential confounders between groups • Maintenance of comparability of groups

  7. Results

  8. Results • 12 reports (of 11 studies) met inclusion criteria • 1 RCT (2 reports) • 10 observational • Outcomes considered • Mortality or progression to AIDS • Change in CD4 or viral load

  9. Outcome 1: Mortality or progression to AIDS • 9 reports of 8 studies • 1 RCT (2 reports), 7 observational studies

  10. 1. Mortality or progression to AIDS RCT: Stringer et al., 2007/2009 reanalysis Designed to assess safety of IUD in women living with HIV • 599 postpartum women living with HIV, Zambia • Randomized to either copper IUD or hormonal contraception (choice of OCs or DMPA) • 2 year follow-up, 6 month visits • High loss to follow-up rates • 31% of hormonal group, 23% of IUD group • High method discontinuation/switching rates • 49% of IUD users discontinued, 76% of these switched to HC • 13% of hormonal users discontinued, 16% switched to IUD • Within hormonal group, 34% switched between OC and DMPA

  11. 1. Mortality (all cause) or progression to AIDS Stringer 2007/2009 RCT (continued): HR (95% CI)

  12. 1. Mortality or progression to AIDS (Cohort) *Except Allen 2007 (HIV-related mortality only)

  13. Studies assessing injectables and progression to AIDS OR mortality (composite outcome) (adjusted hazard ratio) Stringer RCT (2009)* (DMPA vs IUD) Stringer Multi-Country (2009) (Inj/imp† vs no HC) Morrison (2011) (DMPA vs no HC) Polis (2010) (DMPA vs no HC) Injectables decrease risk of progression Injectables increase risk of progression *Actual use analysis † DMPA, NET-EN, implants

  14. Studies assessing OCs and progression to AIDS OR mortality (composite outcome) (Adj hazard ratio) Stringer RCT (2009)* (OCs vs IUD) Morrison (2011) (OCs vs no HC) Stringer Multi-Country (2009) (OCs vs no HC) Polis (2010) (OCs vs no HC) 1 OCs increase risk of progression OCs decrease risk of progression *Actual use analysis

  15. Results: Outcomes considered • Mortality or progression to AIDS • Change in CD4 or viral load

  16. 2. Change in viral load, CD4 (5 observational studies)

  17. Discussion: Outcome 1Mortality or progression to AIDS • 7 observational studies find no association between HC and HIV disease progression • 1 RCT found increased rates of • time to CD4 count < 200 and • time to CD4 count < 200 and mortality • among HC users compared with IUD users (both OC and DMPA users)

  18. Discussion: Outcome 1Mortality or progression to AIDS • Strengths • Many observational studies with similar findings, 2 with very strong methodology • One very large study (n=7846) • Limitations • Some small sample sizes • Follow-up time • RCT: • loss to follow-up • method switching • comparison with IUD

  19. 20 Discussion: Outcome 2Change in viral load, CD4 • 5 observational studies find no adverse association between HC and change in viral load or CD4 • Limitations • Small sample sizes • Failure to separate HC methods in some studies • Lack of control for potential confounders

  20. 21 Discussion:Study Quality – Observational studies • Quality ranged from poor to good • "Good" studies • Incident HIV cases • Multivariate analysis • Time-varying analysis of use of hormonal contraception • Findings similar to those rated as "fair" and "poor" • "Fair" studies • Prevalent HIV cases • Control for baseline health characteristics in multivariate model • "Poor" studies • No separate analysis of different contraceptive methods • Inclusion of other HC users in comparison group • No multivariate analysis

  21. Discussion:Limitations in body of research • Minimal or no information on newer methods (LNG-IUD, patch, ring, implants) • Limited data for women with clinical AIDS • All studies observational, with the exception of 1 RCT

  22. Conclusion • The preponderance of evidence thus indicates that use of OCs or of DMPA does not affect HIV disease progression among women with HIV

  23. Acknowledgements Members of the WHO Hormonal Contraception & HIV Advisory Group (manuscript review) • Andy Gray, Olav Meirik, & Catherine Hankins Assistance with project development • Mary Lyn Gaffield, Nathalie Kapp, & Roger Chou Assistance with EROS software • Agustin Ciapponi & Demián Glujovsky Assistance with literature search • Nellie Kamau & LaToya Armstrong Contact: phillipss@who.int

  24. Studies assessing injectables and mortality (Adjusted hazard ratio) Stringer RCT (2009)* (DMPA vs IUD) Kilmarx (2000) (DMPA vs non-DMPA†) Polis (2010) (DMPA vs no HC method) Stringer Multi-Country (2009) (Imp/injvs no HC method†) Allen (2007) (unspec inj. vs never used injectables) Injectables decrease risk of mortality Injectables increase risk of mortality *Actual use analysis †Mostly OCs †DMPA, NET-EN, implants

  25. Studies assessing OCs and mortality(Adjusted hazard ratio) Stringer RCT (2009)* (OCs vs IUD) Kilmarx (2000) (OCs vs non-OCs†) MRC (1999) (OCs vs other/no contraception) Polis (2010) (OCs vs no hormonal method) Allen (2007) (OCs vs never used OCs) OCs decrease risk of mortality OCs increase risk of mortality *Actual use analysis †Mostly DMPA

  26. Studies assessing injectables and progression to AIDS (adjusted hazard ratio) Stringer RCT (2009)* (DMPA vs IUD) Stringer Multi-Country (2009) (Inj/imp vs no HC†) Morrison (2011) (DMPA vs no HC) Kilmarx (2000) (DMPA vs non-DMPA†) 1 Injectables decrease risk of progression Injectables increase risk of progression *Actual use analysis †DMPA, NET-EN or implant †Mostly OCs

  27. Studies assessing OCs and progression to AIDS (Adjusted hazard ratio) Stringer RCT (2009)* (OCs vs IUD) Kilmarx (2000) (OCs vs non-OCs†) Morrison (2011) (Low dose OCs vs no HC) Stringer Multi-Country (2009) (OCs vs no HC) MRC (1999) (OCs vs other or no HC) OCs decrease risk of progression OCs increase risk of progression *Actual use analysis †Mostly DMPA

  28. Study Flow

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