As a proportion of their number in the US population, African-American men and women and Hispanic men have the greatest concentration of HIV infection.But during 2006-2009, young MSM (13-29), especially those that were African American, were the only subgroups to show increasing HIV infection rates. For AA young MSM, HIV infections increased 48% over those years.
Next considered howPrEP might be provided, what are the steps, from the perspective of a clinician. Walk through from upper left (green box) to lower left (refill visit).At any point, not right for PrEP but with HIV risk, refer for other servicesAt any point, if HIV positive, refer to care
One question for coverage and cost, is how many MSM at high risk are we talking about (walk through slide)
However, a substantial proportion of primary care and other physcians are willing to prescribe PrEP to high risk populations.
There have been many calls for “demonstration projects”. When conducted as evaluation of community PrEP practices, these will teach us a lot about what works well, less well, and with what resources to inform delivery in a sustainable way that contributes to reducing HIV infection in highest risk populations of MSM
CDC believes the developing evidence of safety and efficacy of daily oral PrEP is sufficient to add it to the mix of partially effective prevention methods that should be considered to reduce HIV incidence in the US among MSM. Additional trial results need to be reviewed before determination can be made about any possible role for PrEP in other at-risk populations.
Pep and prep smith
Dawn K. Smith, MD, MS, MPHCenters for Disease Control and Prevention 20 April 2012
Substantial No substantial exposure risk exposure risk < 72 hours since >72 hours since exposure exposure Source patient Source patient of nPEP not known to be HIV+ unknown HIV status recommended Case-by-casenPEP recommended determination
200 MSM given 4-day starter packs (ZDV/3TC) Instructed when to start nPEP Used PrEP after No PrEP after No PrEP and high risk sex high risk sex no high risk sexN (%) 68 (34%) 86 (43%) 46 (23%)HIV infections 1 10 0HIV incidence 1.5% 11.6% 0% Reasons for not starting nPEP ◦ Sex with a steady partner believed to be HIV-negative ◦ Did not consider the exposure high-risk ◦ Concerns about side effects Schechter et al, JAIDS, 2004
Efficacy Study mITT (CI)Behavior Change NS(Explore) 18% (–5, 36)TDF/FTC oral-PrEP in MSM 44% (15, 63)(iPrEx)TDF/FTC oral PrEP in heterosexuals 63% (22, 83)*(TDF2)TDF/FTC oral PrEP in HIV-discordant couples 75% (55, 87)*(Partners PrEP)TDF/FTC oral PrEP in men 84% (54, 94)*(Parters PrEP)TDF/FTC oral PrEP in women 66% (28, 84)*(Parters PrEP)TDF/FTC oral PrEP in women NS 18% (-36,51)*(FEM-PrEP)Early ART in serodiscordant couples 96% (73, 99)(HPTN 052) 0 10 20 30 40 50 60 70 80 90 100 % Efficacy *Provisional
Recruit PrEP Flow Diagram - Provider PerspectiveSelf-referralNetwork referralVenue outreachHealth servicesCBOs Low Risk HIV Risk High Educate Lab Test Neg Screen Yes Screen Eligible Consent? Yes Risk Interest? Pos Mod Not No Eligible No RiskRefer for care Refer for risk-reduction services Refill Pos Prescription Adherence HIV Adherence Client Receives Counseling Neg Test 3 months Counseling PrEP Services* Risk Reduction Risk-Reduction Counseling Counseling Serious Toxicities * Including indicated STI diagnosis and treatment
MSM ◦ NHANES (2001-2006) 1.8 million men aged 18-59 years reported sex with a man in prior year and self-identify as gay 47% reported >2 male sex partners in past year 83% HIV-uninfected ◦ National Survey of Sexual Health and Behavior No condom use among gay men during most recent sexual event was 39% ◦ 275,000 uninfected gay men with >2 male sex partners in past year and no condom use at last anal sex Heterosexual discordant couples ◦ Estimated from multiple population-based data sources ◦ At least 140,000 discordant heterosexual couples in the U.S ◦ Approximately ½ intend future pregnancies Sources: Xu et al. STD 2010; 37(6):399-405. Reece et al. J Sex Med 2010;7(suppl 5):266– 276: Lampe et al. AJOG 2011: 204(6):488e.1-8
Nearly all awareness and acceptability studies in the US have been done with MSM ◦ Low awareness, substantial acceptability DocStyles and HealthStyles 2009 Had heard Support use or prescriptipn of PrEP Support of PrEP public funding of PrEP MSM IDU STD Discordant clients couples Physicians 23% 68% 67% 39% 78% 61% and nurses General 5% 47% 45% 48% 70% 68% population
MSM HRH IDU Discordant CouplesClinical Services LGBT clinics X X STD clinics X X Reproductive health clinics X X Addiction treatment clinics X Primary care clinics X X X X HIV treatment clinics XSupportive Services CBOs X X X Pharmacies X X X X NSEPs X
If safe and ≥75% effective, would provide to… %Injection drug users 69%MSM 66%Patients who change sex partners frequently 57%Uninfected partner wishing to conceive with an HIV+ partner 55%Patients with an STD 34% 2009 web survey of 2156 physicians, ½ primary care
Users ◦ Unaware of level of personal risk ◦ Unaware of intervention ◦ Don’t know how or where to access the intervention ◦ Delay in seeking clinical preventive care ◦ Uninsured/unable to pay for medication ◦ Low adherence to medication Providers ◦ Unaware of intervention ◦ Uncertain how to deliver the intervention ◦ Wary of complexity and time involved ◦ Low index of suspicion for indications ◦ Low access to the highest risk populations ◦ Uncertain how to bill for the intervention
Open-label Studies Implementation Studies (Real World Conditions)Type-specific Acceptability (patients) Acceptability (system)Questions Medication adherence Retention (patients) Longer term safety Sustainability (cost) Practice variation effectsSetting(s) Research clinics Usual clinical care sitesPopulation(s) Clinical trial participants (or Broad population that may similar) benefitConsent Research consent Clinical care consentIncentives $ for time and effort Clinical services onlyProtocol Strict research protocol Very Practice guidelines with similar to trial protocol formal and informal varianceCare Research staff Community care providersProvider(s)Care Funding Research funds Insurance (public, private, or self)
Open-Label Studies Implementation StudiesMSM and iPrEx- OLEM-F TG San Francisco, Boston, Chicago NIAID STD Clinic None San Francisco, Miami California HIV Research Program East Bay, Los Angeles, San DiegoHeterosexual None NoneWomen andMenDiscordant None NoneCouples
Primary care benefits? ◦ hepatitis vaccination, reproductive health care Resistance? ◦ Uncommon if screening for acute infection Adherence? ◦ Poor in some trials, high in others Risk compensation? ◦ Not seen (yet), models suggest unlikely to exceed benefit Cost-effective? ◦ Yes, if targeted to those with high incidence
Factor MeasuresReach Coverage and representativeness of patientsEffectiveness Rate of new HIV infections and adverse outcomesAdoption Availability/representativeness of settings and clinicians who provide PrEPImplementation Extent of delivery consistent with guidelines; resources required and costsMaintenance Patients: Long-term effects and attrition Clinician/setting: sustainability of program
PrEPPrimarily TreatmentBiomedical nPEP as Prevention Uninfected Person MC Condoms Sexual Substance Primarily Behavior Abuse Behavioral Change Change
Dr. Dawn K. Smith email@example.com 404.639.5166"The findings and conclusions in this presentation have not been formally dissemination by CDC and should not be construed to represent any agency determination or policy."