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PrEP and My Patients: Guidance for
  LGBT Community–Based Primary Care
  Providers on Novel Strategies to Reduce
  Risk of HIV Acquisition




This program is supported by an educational grant from




Originally posted 5/21/2012 at clinicaloptions.com/ss/PrEPGuidance
PrEP and My Patients
clinicaloptions.com/hiv




 About These Slides
  Our thanks to the presenters who gave permission to include their
   original data
  Users are encouraged to use these slides in their own noncommercial
   presentations, but we ask that content and attribution not be changed.
   Users are asked to honor this intent
  This abbreviated slideset was posted to SlideShare to publicize the
   availability of the full slideset. These slides may not be published or
   posted online without permission from CCO (email
   permissions@clinicaloptions.com)
Disclaimer
The materials published on the Clinical Care Options Web site reflect the views of the authors of the
CCO material, not those of Clinical Care Options, LLC, the CME providers, or the companies providing
educational grants. The materials may discuss uses and dosages for therapeutic products that have not
been approved by the United States Food and Drug Administration. A qualified healthcare professional
should be consulted before using any therapeutic product discussed. Readers should verify all information
and data before treating patients or using any therapies described in these materials.
PrEP and My Patients
clinicaloptions.com/hiv




 Faculty Who Contributed to This Program
 Susan Buchbinder, MD             Jared M. Baeten, MD, PhD
 Associate Clinical Professor     Associate Professor
    Departments of Medicine,        Department of Global Health
    Epidemiology, and               and Medicine
    Biostatistics                 University of Washington
 University of California,        Seattle, Washington
    San Francisco
 Director, HIV Research Section
 San Francisco Department of
    Public Health
 San Francisco, California
PrEP and My Patients
clinicaloptions.com/hiv



 Faculty Who Contributed to This Program
 (cont’d)
 Connie Celum, MD, MPH        Albert Liu, MD, MPH
 Professor, Department of     Assistant Clinical Professor
 Global Health and Medicine   Department of Medicine
 University of Washington     University of California,
 Seattle, Washington          San Francisco
                              Director, HIV Prevention
                              Intervention Studies
                              HIV Research Section
                              San Francisco Department of
                              Public Health
                              San Francisco, California
PrEP and My Patients
clinicaloptions.com/hiv




 Disclosures
 Jared M. Baeten, MD, PhD, has no significant financial
 relationships to disclose.
 Susan Buchbinder, MD, has no significant financial
 relationships to disclose.
 Connie L. Celum, MD, MPH , has no significant financial
 relationships to disclose.
 Albert L. Liu, MD, MPH, has no significant financial
 relationships to disclose.
Antiretroviral Therapy for
Preventing HIV Acquisition:
Available Data and Ongoing Trials
PrEP Background
PrEP and My Patients
clinicaloptions.com/hiv



 Using Antiretroviral Medications
 for HIV-1 Prevention
          PrEP                             PEP                       ART


                                  Time of
         Prior to exposure                                   After infection
                               transmission


     Advantages                  Advantages                       Advantages
      Demonstrated efficacy     Shorter course than PrEP        Clinical benefits and
                                                                  reduced infectiousness

     Challenges                  Challenges                       Challenges
      Adherence                 Limited data                    Scale up; resources
      Delivery                  Recognition of risk             Long-term adherence
      Cost-effectiveness        Initiation < 48 hrs             Long term toxicity
      Resistance                 Adherence                      Resistance
                                 Public health impact
PrEP and My Patients
clinicaloptions.com/hiv




 Tenofovir for PrEP
  Completed clinical trials of PrEP have tested tenofovir
        – Oral TDF, oral TDF/FTC, vaginal gel
  Potent: rapid antiretroviral activity
  Safe: Substantial treatment safety experience
  Easy: Once-daily dosing, few drug-drug interactions
  Evidence that concept should work
        – Animal models and postnatal prophylaxis of breastfeeding
          infants showed high levels of protection
Breakthroughs in PrEP
PrEP and My Patients
clinicaloptions.com/hiv




 iPrEx: Eligibility
  Male sex at birth (N = 2499)
  18 yrs of age or older
  HIV-seronegative status
  Evidence of risk for acquisition of HIV infection




Grant RM, et al. N Engl J Med. 2010;363:2587-2599.
PrEP and My Patients
clinicaloptions.com/hiv




 iPrEX Study Sites

                                                   Sites                 11
                                                   Participants         2499


San Francisco
                          9%   Boston
                                                           Chiang Mai
                                                                        5%
                               Iquitos
   12% Guayaquil
                                      Sao Paulo
                    Lima
                                        15%
                      56%
                                  Rio de Janeiro   Cape Town
                                                      4%

Grant R, et al. CROI 2011. Abstract 92.
PrEP and My Patients
clinicaloptions.com/hiv




 iPrEx: Baseline Demographics
 Characteristic, %                                    Overall
                                                     (N = 2499)
 Age
   Younger than 25 yrs                                 50
   25-39 yrs                                           40
   40 yrs or older                                     10
 Race
   White                                               17
    Black                                              9
   Asian                                               5
   Mixed/other                                         69
   Latino                                              72
 Completed some college                                 43
Grant RM, et al. N Engl J Med. 2010;363:2587-2599.
PrEP and My Patients
clinicaloptions.com/hiv




 iPrEx: Efficacy
  Efficacy through study end (mITT): 42% (95% CI: 18% to 60%)
                                       0.12
                                                    Placebo
                                                    FTC/TDF
              Cumulative Probability




                                       0.10
                 of HIV Infection




                                       0.08

                                       0.06
                                                                        P = .002
                                       0.04

                                       0.02

                                         0
                                              0   12 24 36 48 60 72 84 96 108 120 132 144
                                                        Wks Since Randomization
             Pts at Risk, n
                   Placebo 1248 1198 1157 1119 1030 932 786 638 528 433 344 239 106
                  FTC/TDF 1251 1190 1149 1109 1034 939 808 651 523 419 345 253 116
Grant R, et al. CROI 2011. Abstract 92.
Challenges of PrEP
For the rest of this presentation download the full
    PowerPoint slideset for self-study or use in your
    own educational presentations at:
    clinicaloptions.com/ss/PrEPGuidance




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PrEP and My Patients: Guidance for LGBT Community–Based Primary Care Providers on Novel Strategies to Reduce Risk of HIV Acquisition

  • 1. PrEP and My Patients: Guidance for LGBT Community–Based Primary Care Providers on Novel Strategies to Reduce Risk of HIV Acquisition This program is supported by an educational grant from Originally posted 5/21/2012 at clinicaloptions.com/ss/PrEPGuidance
  • 2. PrEP and My Patients clinicaloptions.com/hiv About These Slides  Our thanks to the presenters who gave permission to include their original data  Users are encouraged to use these slides in their own noncommercial presentations, but we ask that content and attribution not be changed. Users are asked to honor this intent  This abbreviated slideset was posted to SlideShare to publicize the availability of the full slideset. These slides may not be published or posted online without permission from CCO (email permissions@clinicaloptions.com) Disclaimer The materials published on the Clinical Care Options Web site reflect the views of the authors of the CCO material, not those of Clinical Care Options, LLC, the CME providers, or the companies providing educational grants. The materials may discuss uses and dosages for therapeutic products that have not been approved by the United States Food and Drug Administration. A qualified healthcare professional should be consulted before using any therapeutic product discussed. Readers should verify all information and data before treating patients or using any therapies described in these materials.
  • 3. PrEP and My Patients clinicaloptions.com/hiv Faculty Who Contributed to This Program Susan Buchbinder, MD Jared M. Baeten, MD, PhD Associate Clinical Professor Associate Professor Departments of Medicine, Department of Global Health Epidemiology, and and Medicine Biostatistics University of Washington University of California, Seattle, Washington San Francisco Director, HIV Research Section San Francisco Department of Public Health San Francisco, California
  • 4. PrEP and My Patients clinicaloptions.com/hiv Faculty Who Contributed to This Program (cont’d) Connie Celum, MD, MPH Albert Liu, MD, MPH Professor, Department of Assistant Clinical Professor Global Health and Medicine Department of Medicine University of Washington University of California, Seattle, Washington San Francisco Director, HIV Prevention Intervention Studies HIV Research Section San Francisco Department of Public Health San Francisco, California
  • 5. PrEP and My Patients clinicaloptions.com/hiv Disclosures Jared M. Baeten, MD, PhD, has no significant financial relationships to disclose. Susan Buchbinder, MD, has no significant financial relationships to disclose. Connie L. Celum, MD, MPH , has no significant financial relationships to disclose. Albert L. Liu, MD, MPH, has no significant financial relationships to disclose.
  • 6. Antiretroviral Therapy for Preventing HIV Acquisition: Available Data and Ongoing Trials
  • 8. PrEP and My Patients clinicaloptions.com/hiv Using Antiretroviral Medications for HIV-1 Prevention PrEP PEP ART Time of Prior to exposure After infection transmission Advantages Advantages Advantages  Demonstrated efficacy Shorter course than PrEP Clinical benefits and reduced infectiousness Challenges Challenges Challenges  Adherence Limited data Scale up; resources  Delivery Recognition of risk Long-term adherence  Cost-effectiveness Initiation < 48 hrs Long term toxicity  Resistance  Adherence Resistance Public health impact
  • 9. PrEP and My Patients clinicaloptions.com/hiv Tenofovir for PrEP  Completed clinical trials of PrEP have tested tenofovir – Oral TDF, oral TDF/FTC, vaginal gel  Potent: rapid antiretroviral activity  Safe: Substantial treatment safety experience  Easy: Once-daily dosing, few drug-drug interactions  Evidence that concept should work – Animal models and postnatal prophylaxis of breastfeeding infants showed high levels of protection
  • 11. PrEP and My Patients clinicaloptions.com/hiv iPrEx: Eligibility  Male sex at birth (N = 2499)  18 yrs of age or older  HIV-seronegative status  Evidence of risk for acquisition of HIV infection Grant RM, et al. N Engl J Med. 2010;363:2587-2599.
  • 12. PrEP and My Patients clinicaloptions.com/hiv iPrEX Study Sites Sites 11 Participants 2499 San Francisco 9% Boston Chiang Mai 5% Iquitos 12% Guayaquil Sao Paulo Lima 15% 56% Rio de Janeiro Cape Town 4% Grant R, et al. CROI 2011. Abstract 92.
  • 13. PrEP and My Patients clinicaloptions.com/hiv iPrEx: Baseline Demographics Characteristic, % Overall (N = 2499) Age  Younger than 25 yrs 50  25-39 yrs 40  40 yrs or older 10 Race  White 17 Black 9  Asian 5  Mixed/other 69  Latino 72 Completed some college 43 Grant RM, et al. N Engl J Med. 2010;363:2587-2599.
  • 14. PrEP and My Patients clinicaloptions.com/hiv iPrEx: Efficacy  Efficacy through study end (mITT): 42% (95% CI: 18% to 60%) 0.12 Placebo FTC/TDF Cumulative Probability 0.10 of HIV Infection 0.08 0.06 P = .002 0.04 0.02 0 0 12 24 36 48 60 72 84 96 108 120 132 144 Wks Since Randomization Pts at Risk, n Placebo 1248 1198 1157 1119 1030 932 786 638 528 433 344 239 106 FTC/TDF 1251 1190 1149 1109 1034 939 808 651 523 419 345 253 116 Grant R, et al. CROI 2011. Abstract 92.
  • 16. For the rest of this presentation download the full PowerPoint slideset for self-study or use in your own educational presentations at: clinicaloptions.com/ss/PrEPGuidance More ways to connect with CCO: