Pep and prep cahill


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Pep and prep cahill

  1. 1. PrEP: Moving toward implementation HealthHIV SYNChronicity Meeting “PEP-UP & PrEPare: Implementing New Biomedical Strategies” Arlington, VA April 21, 2012 Sean Cahill PhD Director, Health Policy Research The Fenway Institute Boston, MA
  2. 2. Outline I. PrEP has great potential to reduce HIV infections and be cost effective; PrEP could be most effective if combined with TasP II. Overcoming barriers to use A. Patient B. Provider C. Payment D. Regulation2
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  4. 4. PrEP: Moving toward implementation (February 2012, The Fenway Institute) Summarizes PrEP and microbicides research Looks at knowledge of, willingness to use PrEP Addresses concerns about PrEP that could present obstacles to implementation Offers strategies for effective implementation Examines policy issues related to cost and how to make PrEP accessible to most vulnerable Examines regulatory developments and planning underway in U.S. and globally Recommendations for implementation4
  5. 5. RCT evidence for preventing sexual HIV transmission Study Effect size (CI) Treatment for prevention (HPTN 052) 96% (73; 99) PrEP for discordant couples 73% (49; 85) (Partners PrEP with FTC/TDF) PrEP for heterosexuals 63% (21; 48) (Botswana TDF2 with FTC/TDF) Medical male circumcision* 54% (38; 66) (Orange Farm, Rakai, Kisumu) PrEP for MSMs (iPrEX with FTC/TDF) 44% (15; 63) STD treatment* 42% (21; 58) (Mwanza) Microbicide* 39% (6; 60) (CAPRISA 004 tenofovir gel) HIV Vaccine 31% (1; 51) (Thai RV144) 0% 10 20 30 40 50 60 70 80 90 100%Abdool Karim SS & Q. Antiretroviralprophylaxis...Lancet 2011;378:e23-5 Efficacy
  6. 6. Modeling shows PrEP and TasP could dramatically reduce HIV infection . Recent modeling of PrEP implementation coupled with scaled up treatment predicts that PrEP could significantly reduce HIV incidence and prevalence. Studies focused on: MSM in San Francisco (Supervie et al., PNAS, 2010) the general adult population in Botswana (Supervie et al. Scientific Reports, 2011) and serodisc heterosexual couples in S. Africa (Hallet et al., PLoS Medicine, 2011)6
  7. 7. Key policy implication of finding that TasP and PrEP will be most effective Abdool Karim and Abdool Karim (The Lancet, 2011): provide PrEP and TasP “synergistically” They are “two sides of the same coin, and cannot be viewed in isolation from each other.” Coordination between HRSA and CDC is key7
  8. 8. Cost effectiveness of PrEP PrEP cost effective in U.S. models with 90% efficacy (Paltiel et al., Clin Infect Dis, 2009) PrEP could be cost effective in South Africa if targeted at women at highest risk, has 70% efficacy, and costs 50% less than current price (Walensky et al., CROI, Boston, 2011) PrEP and ART with serodiscordant couples in South Africa saves $ on ART costs in general, is cost saving overall with 80% efficacy8 (Hallet et al., PLoS Medicine, 2011)
  9. 9. Concerns often raised about PrEPSome have raised concerns re:  side effects  risk compensation (the idea that people will stop using condoms if PrEP becomes available)  drug resistance However, review of five major clinical trials involving about 6,000 participants by the Forum for Collaborative HIV Research shows no greater risk of side effects, no risk compensation, and no clinically significant development of drug resistance in participants.9
  10. 10. PrEP: Moving toward implementation  PrEP must be accompanied by sustained care and behavioral interventions to ensure adherence, minimize risk compensation, and monitor side effects.  The most effective prevention interventions will be those that combine structural interventions with behavioral interventions and emerging biomedical technologies.  Because the most at-risk do not access regular clinical care, alternative implementation arrangements will be necessary.  National monitoring systems are critical to preventing the spread of drug-resistant HIV.10
  11. 11. Paying for PrEP Cost of PrEP in the U.S. would be substantial, perhaps $8-$9k/year. Private insurers (Kaiser Perm., Wellpoint, Aetna) covering, state Medicaid depts open to coverage (FDA approval, PHS Guidance would help). Low-cost generic medications could enable access in low-income countries. Prioritization of highly vulnerable populations could increase cost-effectiveness. Providing PrEP much less expensive than treating someone for HIV over lifetime.11
  12. 12. Elements of ACA that could enable access to PrEP ACA mandates full coverage (no copays) of a range of preventive services by private insurance ACA mandates coverage of “essential health benefits” by insurance offered in state health exchanges to indivs and small groups EHBs include prescription drugs, prevention and wellness programs Obama Admin. allowing states broad flexibility to determine EHBs; advocacy needed at state level12
  13. 13. RecommendationsIf FDA feels research on PrEP’s efficacy among heterosexuals is inconclusive, it should consider approving PrEP for MSM now.WHO should issue guidance that takes into account the promising results of iPrEx study, Partners PrEP, and the Botswana CDC study.States should provide access to PrEP as a critical prevention service and prescription medication under EHB provision ACA.Global funders should fund PrEP and TasP.13
  14. 14. Recommendations Provision of PrEP to MSM, trans should occur in broader context of clinically competent care CBOs, health depts should preemptively seek to destigmatize PrEP use among target pops Need for public education re: difference between PEP and PrEP; PEP users should be prioritized for PrEP Funders should support community education campaigns about PrEP and other biomed interventions, enhance community14involvement in PrEP roll-out, scale-up
  15. 15. Key messages PrEP has shown efficacy with MSM, heterosexual women and men, including serodiscordant couples Adherence is key to PrEP’s effectiveness Regulatory approval (FDA) would give providers the freedom to prescribe PrEP as part of a comprehensive HIV prevention approach; WHO approval would give countries the ability to allow FTC-TDF to be used for PrEP15
  16. 16. Thank you Sean Cahill PhD Director, Health Policy Research The Fenway Institute Boston, MA 617-927-601616