1. Michael Hughes, MD Assistant Clinical Professor UCR Eisenhower Medical Associates

2.  HIV Incidence (new infections): The estimated incidence of HIV has remained stable overall in recent years, at about 50,000 new HIV infections per year. Within the overall estimates, however, some groups are affected more than others. MSM continue to bear the greatest burden of HIV infection, and among races/ethnicities, African Americans continue to be disproportionately affected.

3. http://www.cdc.gov/hiv/statistics/basics/ataglance.html

4.  Behavioral strategies  Treatment as prevention  PrEP (Pre-exposure Prophylaxis)  PEP (Post-exposure Prophylaxis)

5.  PrEP is a combination of two antiretroviral medications tenovir disoproxil fumarate (TDF) and emtricitabine (FTC), taken in a single daily pill for HIV prevention  This combination pill (brand name Truvada) was approved by the FDA for use as HIV treatment in 2004, and approved for PrEP in July 2012

6.  No significant differences in serious adverse events, renal function markers or deaths among patients taking study drug compared to those taking placebo  Adverse events more common on TDF or TDF/FTC than placebo in any study included :  Short-duration nausea, vomiting; dizziness  Back pain; decreased weight  Mild elevation in liver enzymes; mild neutropenia  (more with TDF/FTC than TDF)  Small but statistically significant decreases in bone mineral density; no difference in atraumatic fractures Among women who became pregnant, study drug was not associated with increased pregnancy complications

8. STUDYOVERALL Reduction in risk of HIV infection Detectable level of medication in the blood Reduction in risk of HIV infection iPrEx44%>90% TDF262%--- Partners PrEP75%90% BTS49%74% Adapted from summary of research at http://www.cdc.gov/hiv/prevention/research/prep/

9. Men Who Have Sex with Men Heterosexual Women and Men Injection Drug Users Detecting substantial risk of acquiring HIV infection: *Sexual Partner with HIV *Recent bacterial STI *High number of sex partners *History of inconsistent or no condom use *Commercial sex work *Sexual Partner with HIV *Recent bacterial STI *High number of sex partners *History of inconsistent or no condom use *Commercial sex work *Lives in high-prevalence area or network *HIV-positive injecting partner *Sharing injection equipment *Recent drug treatment (but currently injecting) Clinically eligible: *Documented negative HIV test before prescribing PrEP *No signs/symptoms of acute HIV infection *Normal renal function, no contraindicated medicines *Documented Hep B virus infection and vaccination status *Documented negative HIV test before prescribing PrEP *No signs/symptoms of acute HIV infection *Normal renal function, no contraindicated medicines *Documented Hep B virus infection and vaccination status *Documented negative HIV test before prescribing PrEP *No signs/symptoms of acute HIV infection *Normal renal function, no contraindicated medicines *Documented Hep B virus infection and vaccination status Prescription Daily, Continuing, oral doses of TDF/FTC (Truvada), < 90 day supply Other Services: *Follow-up visits every 3 months to provide: HIV test, medication adherence counseling, behavior risk reduction support, side effect assessment *At 3 months and then every 6 months assess renal function *Every 6 months test for bacterial STI *Follow-up visits every 3 months to provide: HIV test, medication adherence counseling, behavior risk reduction support, side effect assessment *At 3 months and then every 6 months assess renal function *Every 6 months test for bacterial STI *Follow-up visits every 3 months to provide: HIV test, medication adherence counseling, behavior risk reduction support, side effect assessment *At 3 months and then every 6 months assess renal function *Every 6 months test for bacterial STI * Do oral/rectal STI Screening*assess pregnancy intent *pregnancy test every three months *access to clean needles/syringes and drug treatment services

10. Substantial risk of acquiring HIV infection  Men who have sex with men (MSM)  HIV-positive sexual partner  Recent bacterial STI  High number of sex partners  History of inconsistent/no condom use  Commercial sex work http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf

11. In the past 6 months:  Have you had sex with men, women, or both?  (if men or both sexes) How many men have you had sex with?  How many times did you have receptive anal sex (you were the bottom) with a man who was not wearing a condom?  How many of your male sex partners were HIV-positive?  (if any positive) With these HIV-positive male partners, how many times did you have insertive anal sex (you were the top) without you wearing the condom?  Have you used methamphetamines (such as crystal or speed)? http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf

12. Substantial risk of acquiring HIV infection  Heterosexual women and men  HIV-positive sexual partner  Recent bacterial STI  High number of sex partners  History of inconsistent/no condom use  Commercial sex work  High-prevalence area or network http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf

13. Substantial risk of acquiring HIV infection  Transgender individuals  Engaging in high-risk sexual behaviors www.hivguidelines.org

14. Substantial risk of acquiring HIV infection  Injection drug users (IDU)  HIV-positive injecting partner  Sharing injection equipment  Recent drug treatment (but currently injecting) http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf

15.  Documented negative HIV test  No signs/symptoms of acute HIV infection  Normal renal function  No contraindicated medications  Documented hepatitis B infection & vaccination status http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf

16.  Are signs/symptoms of acute HIV present now or in prior 4 weeks?  Option 1: retest antibody in one month  Option 2: HIV antibody/antigen assay  Option 3: HIV-1 viral load http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf

17. Symptoms  Fever  Fatigue  Myalgia  Skin rash  Headache  Pharyngitis  Cervical Lymphadenopathy  Arthralgia  Night sweats  Diarrhea Daar ES, Pilcher CD, Hecht FM. Curr Opin HIV AIDS. 2008;3(1):10-15.

18.  Age  Reproductive plan  Osteopenia/osteoporosis www.hivguidelines.org

19. Before starting PrEP:  Clinical eligibility  Educate  Side effects  Limitations  Daily adherence  Symptoms of seroconversion  Monitoring schedule  Safety  Criteria for discontinuation  Partner information  Social history: housing, substance use, mental health, domestic violence Every visit: Assess adherence Risk reduction counseling www.hivguidelines.org

20. After confirmation of clinical eligibility:  Prescribe no more than 90-day supply of PrEP  Truvada 1 tablet PO daily (tenofovir 300mg + emtricitabine 200mg)  Insurance prior approval  Truvada for PrEP Medication Assistance Program Every visit: Assess adherence Risk reduction counseling http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf

21. 3-month visit:  HIV test  Assess for acute infection  Check for side effects  Pregnancy testing  Prescribe 90-day supply of medication Every visit: Assess adherence Risk reduction counseling http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf

22. 6-month  HIV test  STI test  Pregnancy test  Renal function  90 day prescription 9-month  HIV test  Pregnancy test  90 day prescription 12-month  HIV test  STI tests  Pregnancy test  Renal function  90 day prescription  Assess the need to continue PrEP Every visit: Assess adherence Risk reduction counseling http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf

23. Develop trust, avoid judgment  Plan  Monitor  Educate  Identify barriers  Assess for side effects http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf

24.  CDC: http://www.cdc.gov/hiv/pdf/prepguidelines 2014.pdf http://www.cdc.gov/hiv/pdf/prepguidelines 2014.pdf  NYSDOH AI: http://www.hivguidelines.org/http://www.hivguidelines.org/  PrEP Watch/ AVAC: http://www.prepwatch.org/ http://www.prepwatch.org/  REMS clinician materials http://www.truvadapreprems.com/truvada prep-resources http://www.truvadapreprems.com/truvada prep-resources