Implementation of Pre-Exposure Prophylaxis (PrEP) and Other HIV Prevention Initiatives in Rhode Island

Transcription

1 Implementation of Pre-Exposure Prophylaxis (PrEP) and Other HIV Prevention Initiatives in Rhode Island Philip A. Chan, MD Assistant Professor of Medicine Division of Infectious Diseases The Miriam Hospital Brown University Thursday, March 27 st, 2014 Yale AIDS Colloquium Series (YACS) Center for Interdisciplinary Research on AIDS (CIRA) Yale University 12:00pm-1:00pm

2 Objectives 1. Review recent research related to preexposure prophylaxis (PrEP); 2. Describe challenges of PrEP implementation; 3. Discuss implementation of a PrEP program and other HIV prevention initiatives in Rhode Island.

3 Disclosures Funding sources include National Institutes of Health (NIH), Gilead Sciences, and the Rhode Island Department of Health.

4 What is the most common STD in the United States?

5 STD MADDNESS!!!

6 STD MADDNESS!!!

7 STD MADDNESS!!!

8 STD MADDNESS!!!

9 STD MADDNESS!!!

10 STD MADDNESS!!!

11 STD MADDNESS!!!

12 STD MADDNESS!!! An estimated percent of sexually active adults will acquire a genital tract HPV infection before the age of 50 (MMWR, 2006)

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14 Pre-exposure prophylaxis (PrEP)

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16 PrEP to Prevent HIV A single pill taken once a day by HIV negative individuals to prevent HIV infection

17 STUDY LOCATION POPULATION DESIGN OVERALL iprex (Grant) DETECTABLE LEVELS Partners PrEP (Baeten) TDF2 (Van Damme) FEM-PrEP (Thigpen) VOICE (Marrazzo) Bangkok Tenofovir (Choopanya) NSS=Not statistically significant; NP=Not performed; TDF=Tenofovir; FTC=Emtricitabine

18 STUDY LOCATION POPULATION DESIGN OVERALL iprex (Grant) Partners PrEP (Baeten) US, Thailand, South Africa, Brazil, Ecuador, Peru Kenya, Uganda DETECTABLE LEVELS TDF2 (Van Damme) FEM-PrEP (Thigpen) VOICE (Marrazzo) Bangkok Tenofovir (Choopanya) Botswana Kenya, South Africa, Tanzania South Africa, Uganda, Zimbabwe Thailand NSS=Not statistically significant; NP=Not performed; TDF=Tenofovir; FTC=Emtricitabine

19 STUDY LOCATION POPULATION DESIGN OVERALL iprex (Grant) Partners PrEP (Baeten) TDF2 (Van Damme) US, Thailand, South Africa, Brazil, Ecuador, Peru Kenya, Uganda Botswana 2,499 MSM/ transgender women 4,747 serodiscordant MSF/FSM 1,219 MSF/ FSM DETECTABLE LEVELS FEM-PrEP (Thigpen) VOICE (Marrazzo) Bangkok Tenofovir (Choopanya) Kenya, South Africa, Tanzania South Africa, Uganda, Zimbabwe Thailand 2,120 women 3,019 women 2,411 IDUs NSS=Not statistically significant; NP=Not performed; TDF=Tenofovir; FTC=Emtricitabine

20 STUDY LOCATION POPULATION DESIGN OVERALL iprex (Grant) Partners PrEP (Baeten) TDF2 (Van Damme) US, Thailand, South Africa, Brazil, Ecuador, Peru Kenya, Uganda Botswana 2,499 MSM/ transgender women 4,747 serodiscordant MSF/FSM 1,219 MSF/ FSM FTC/TDF vs. placebo TDF, FTC/TDF, or placebo FTC/TDF vs. placebo DETECTABLE LEVELS FEM-PrEP (Thigpen) VOICE (Marrazzo) Bangkok Tenofovir (Choopanya) Kenya, South Africa, Tanzania South Africa, Uganda, Zimbabwe 2,120 women FTC/TDF vs. placebo 3,019 women TDF, FTC/TDF, or placebo Thailand 2,411 IDUs TDF vs. placebo NSS=Not statistically significant; NP=Not performed; TDF=Tenofovir; FTC=Emtricitabine

21 STUDY LOCATION POPULATION DESIGN OVERALL iprex (Grant) Partners PrEP (Baeten) TDF2 (Van Damme) US, Thailand, South Africa, Brazil, Ecuador, Peru Kenya, Uganda Botswana 2,499 MSM/ transgender women 4,747 serodiscordant MSF/FSM 1,219 MSF/ FSM FTC/TDF vs. placebo TDF, FTC/TDF, or placebo FTC/TDF vs. placebo 44% 67% TDF; 75% FTC/TDF 63% DETECTABLE LEVELS FEM-PrEP (Thigpen) VOICE (Marrazzo) Bangkok Tenofovir (Choopanya) Kenya, South Africa, Tanzania South Africa, Uganda, Zimbabwe 2,120 women FTC/TDF vs. placebo 3,019 women TDF, FTC/TDF, or placebo Thailand 2,411 IDUs TDF vs. placebo NSS NSS 49% NSS=Not statistically significant; NP=Not performed; TDF=Tenofovir; FTC=Emtricitabine

22 STUDY LOCATION POPULATION DESIGN OVERALL iprex (Grant) Partners PrEP (Baeten) TDF2 (Van Damme) US, Thailand, South Africa, Brazil, Ecuador, Peru Kenya, Uganda Botswana 2,499 MSM/ transgender women 4,747 serodiscordant MSF/FSM 1,219 MSF/ FSM FTC/TDF vs. placebo TDF, FTC/TDF, or placebo FTC/TDF vs. placebo 44% 92% 67% TDF; 75% FTC/TDF 63% NP DETECTABLE LEVELS 86% TDF; 90% FTC/TDF FEM-PrEP (Thigpen) VOICE (Marrazzo) Bangkok Tenofovir (Choopanya) Kenya, South Africa, Tanzania South Africa, Uganda, Zimbabwe 2,120 women FTC/TDF vs. placebo 3,019 women TDF, FTC/TDF, or placebo Thailand 2,411 IDUs TDF vs. placebo NSS NSS 49% 74% NP (26% with levels) NP (<30% with levels) NSS=Not statistically significant; NP=Not performed; TDF=Tenofovir; FTC=Emtricitabine

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24 Overall NNT: 62 MSM RAI without a condom: 36

25 Rembold, BMJ 1998

26 Consistent use of condoms results in 80% reduction in HIV incidence.

27 PrEP Implementation: Does efficacy translate into real-world impact?

28 PrEP IMPLEMENTATION Clinical Trials Demonstration Projects Clinical Programs Efficacy Feasibility 1. Delivery 2. Uptake 3. Adherence 4. Risks 5. Impact Real world Prospective, observational cohorts, defined time periods, free medications

29 DELIVERY Defining and targeting a priority population Role with other HIV prevention strategies Primary care, HIV specialists, community clinics, other

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31 UPTAKE Do people want to take it? Attitudes and stigma about PrEP Use during highest risk periods

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33 ADHERENCE Do people actually take it? Patterns of use (daily versus intermittent) Is adherence high enough to protect?

34 The estimated PrEP efficacy was 76% for 2 doses/week, 96% for 4 doses/week, and 99% for 7 doses/week. Anderson et al., Science Trans Med, 2011

35 RISKS Sexual behavior while on PrEP Risk compensation, behavioral disinhibition Side-effects, drug resistance, long-term safety, pregnancy

36 Grant et al., iprex, NEJM 2010

37 iprex Partners PrEP Grant et al., iprex, NEJM 2010; Mugwanya et al., Partners PrEP, Lancet ID 2013

38 IMPACT Costeffectiveness HIV incidence Coverage of the population needed

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40 STUDY SPONSOR LOCATION POPULATION STATUS The Demo Project NIAID Miami, San Francisco, Washington DC MSM, transgender women Complete, 2014 ATN 110/113 NIH 14 US Cities Young MSM HPTN 073 NIH North Carolina, Washington DC, LA Black MSM CRUSH California HIV/AIDS Research Program East Bay, California Young MSM of color 2012-X PATH California HIV/AIDS Research Program LA County MSM, transgender women 2012-X ALERT California HIV/AIDS Research Program San Diego, other California clinics All 2012-X SHIPP CDC Chicago, Newark, Philadelphia, Houston iprex OLE NIH Boston, other countries All MSM, transgender women Pending

41 PrEP in Rhode Island?

42 PrEP Implementation Project Awarded 18 month grant (Gilead) Amy Nunn, ScD, and Leandro Mena, MD Two sites: Providence, RI and Jackson, MS Collaboration with Fenway Community Health Implement PrEP into STD clinics Evaluation of the process including barriers

43 The Miriam Hospital HIV/STD Clinic Started testing on 1/13/12 Wed/Thurs/Fridays Walk-in Anonymous Free if uninsured Syphilis, Gonorrhea, Chlamydia (Lifespan) Free penicillin from the DOH (for syphilis) HIV and hepatitis C tests (DOH)

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45 HIV/AIDS in Rhode Island Total State Population: 1,052,567 (2010) Total HIV population: 3,730-4,061 (2011)

46 Rhode Island HIV Risk Factors

47 Reducing Barriers to HIV/STD Testing 1) Community-based 2) Friendly, culturally competent 3) Normalized sexuality and STD/HIV testing 4) Nonjudgmental 5) Counseling and informational materials available 6) Anonymous 7) Walk-in hours 8) Short wait times 9) Call in for results

48 Number of Individuals Presenting for HIV/STD Testing (per 30 day increments) Average: 40/week

49 The Miriam Hospital HIV/STD Clinic N=1,327 MALE FEMALE 75% 25%

50 The Miriam Hospital HIV/STD Clinic N=1,327 MSF 42% MSM 27% MALE 75% MSM/MSF 5% FEMALE 25%

51 The Miriam Hospital HIV/STD Clinic N=1,327 MSF MSM 42% 27% MALE 75% MSM/MSF 5% FEMALE 25% FSM 21% FSF 1% FSF/FSM 2%

52 AGE (years) % % % % >55 6%

53 AGE (years) % % % % >55 6% Race Asian 3% AA/Black 18% Cape Verdean 2% White 70% Other 5% NA 2%

54 AGE (years) % % % % >55 6% Race Asian 3% AA/Black 18% Cape Verdean 2% White 70% Other 5% NA 2% Ethnicity Hispanic 22% Non-Hispanic 76% NA 2%

55 Sex Partners in the Past Year (Average): 4.3 (Range: 0-201) Drugs and Alcohol During Sex: 30% Anonymous Sex: 30% Prior STD: 30% History of IDU: 4% Incarcerated: 9% Forced to have Sex: 5% Exchanges sex for Money: 2%

56 Heard of PEP: 29% Taken PEP: 3% Heard of PrEP: 23% Taken PrEP: 1%

57 HIV: 1.4% HCV: 1.3% Chlamydia: 9.2% Syphilis: 4.3% Gonorrhea: 2.8%

58 HIV: 1.4% HCV: 1.3% Chlamydia: 9.2% Syphilis: 4.3% Gonorrhea: 2.8% Any STD: 10.9%

59 HIV: 1.4% HCV: 1.3% Chlamydia: 9.2% Syphilis: 4.3% Gonorrhea: 2.8% Any STD: 10.9% MSM HIV: 4.2% Syphilis: 11.5%

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61 The Miriam Hospital HIV/STD Clinic PrEP Implementation Screen for risk behaviors Rapid HIV Test Discuss PrEP Follow-up Appointment Prescribe PrEP Q3 Month Follow-ups

62 PrEP Implementation Project The Miriam Hospital HIV/STD Clinic Interest in PrEP Attitudes Financial Barriers Adherence Side-effects Behavioral Changes Specimen Banking Drug Levels

63 Initial PrEP Clinical Visit HIV Antibody Test Evaluate for Acute HIV Pregnancy Test Hepatitis B Serologies Renal Function Other STDs Q3 Month Clinical Visit HIV Antibody Test Adherence Measures Behavior Assessment Evaluate Side-effects Renal Function Other STDs Based on CDC Interim Guidance for HIV Pre-Exposure Prophylaxis

64 Pre-exposure Prophylaxis Implementation Program The Miriam Hospital HIV/STD Clinic 502 Total Number Testing for HIV/STDs 161 (32% of Total) MSM Testing for HIV/STDs 100 (62% of MSM) Total MSM Counseled about PrEP 15 additional patients initiated PrEP from other referral sources. 20 total patients on PrEP as of 3/20/ (31%) Total MSM Interested in PrEP 17 (10.5%) PrEP Appointments Scheduled 5 (3.1%) On PrEP Concerned about side effects/drug interaction At no/low perceived risk Need to think about it more Did not respond to follow-up Trying to get insurance Missed their appointments Made their appointments but were rescheduled to follow-up with insurance Reporting period: 10/30/ /28/2014

65 The Miriam Hospital HIV/STD Clinic FUTURE DIRECTIONS

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67 Explore other clinical partners!! (i.e. Connecticut)

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70 The Miriam Hospital HIV/STD Clinic Robert Ducharme Gail Yates Justine Maher Kaitlyn Tracy Pre-Exposure Implementation Program Co-I: Amy Nunn Co-I: Leandro Mena Consultant: Ken Mayer Project Director: Danielle Poole Social Media: Joanna Zhang Qualitative: Sharon Parker, Nathan Sison

71 Philip A. Chan, MD Director, HIV/STD Prevention Clinic The Miriam Hospital Immunology Center 1125 North Main Street Providence, RI (401)