1. Pre-Exposure Prophylaxis: PrEP for Prevention Roy Berkowitz MA, NCC Inova Juniper Program 703-321-2622 roy.berkowitz@inova.org

2. PrEP Overview What is it? Who is it for? What’s the controversy? Who’s prescribing it? What’s happening now? Handouts and Websites

3. PrEP- What is it? PrEP is an FDA approved HIV prevention strategy where HIV negative people who are at risk of getting HIV take one pill of Truvada daily to reduce their chance of getting HIV. Truvada is given to people already infected with HIV : Truvada combines two anti-HIV drugs (tenofovir and emtricitabine [emtriva]) The drugs in the pill help prevent HIV from multiplying, so if you are exposed to HIV it is less likely to multiply in your cells and therefore, it can help to keep the virus from causing a lasting infection.

4. PrEP vs. PEP/nPEP PrEP (Pre-Exposure Prophylaxis) = taking the drugs before person is exposed PEP (Post-Exposure Prophylaxis)= taking meds after person is exposed

5. 5 Pre Exposure Prophylaxis (PrEP) indicated for HIV negative people at on-going high risk of HIV infection January 2011 -MMWR Interim Guidance for MSM: “Truvada, taken orally 1x day as PrEP, is safe and partially effective in reducing HIV acquisition among MSM when provided with regular monitoring of HIV status and ongoing risk-reduction and PrEP medication adherence counseling” August 2012 -Interim Guidance for heterosexually active adults June 2013- Interim Guidance for injecting drug users Findings: PrEP is effective and safe and offers a high level of protection against HIV when adherent to daily medication dose.

6. July 2012 FDA* announced it has approved the drug combination of 300 mg tenofovir and 200 mg emtricitabine (TDF/FTC; brand name Truvada) for daily use by uninfected adults to help prevent the sexual acquisition of HIV. * As of Feb 2014, USA is only country to license drug for this indication

7. PrEP is not meant as a replacement for condom use! “PrEP can tip the balance: when you do all these things together. It needs to be an add- on with all these other [prevention] methods.” ID Doc

8. Counseling Individuals on Comprehensive HIV Prevention TRUVADA for a PrEP indication should only be used as part of a comprehensive HIV prevention strategy. TRUVADA for PrEP does not replace existing HIV prevention strategies..

9. New Clinical Guidelines were released May 14, 2014 These Clinical Practice Guidelines replace the previous interim guidance documents

10. Who is PrEP for? CDC, May 2014 PrEP is for adults * at substantial risk of acquiring HIV and who are HIV-negative ** and : In an on-going sexual relationship with a positive partner Gay or bisexual man who has had anal sex w/o a condom or dx with STD in past 6 months Heterosexual man or woman who does not regularly use condoms with partners of unknown HIV status and at substantial risk of HIV infection (IDUs, bisexual male partners) Have injected drugs in past 6 months and who have shared injection equipment or been in drug tx for injection use in past 6 months Serodiscordant couples who are trying to get pregnant *Data on efficacy and safety for adolescents not sufficient **HIV-Negative status must be documented

11. Who is PrEP not for? PrEP is not meant to be used by: People with HIV People not willing to adhere to treatment protocol People not available or willing to participate in regular diagnostic monitoring People with signs/symptoms of acute infection People who successfully and consistently use other prevention methods Women who are breastfeeding

12. CDC Clinical Guidelines, May 2014 It is recommended as “one prevention option” in preventing HIV transmission... “…patients should be encouraged and enabled to use PrEP in combination with other effective prevention methods.” p.10 “The more prevention options patients choose, the greater their protection.” May 2014, CDC Fast Fact Sheet

13. “A physician can support consistent condom use by providing brief clinical counseling… or by referring patient to…[or] community-based or local health department …services.” p. 27 “Clinicians should provide access, directly or by facilitated referral, to proven effective risk- reduction services.” p. 10 CDC Clinical Guidelines, May 2014

14. How Should People using PrEP be Monitored? CDC guidelines recommend that people taking PrEP be seen at least every 3 months for provider to: – Test for HIV to ensure HIV negative status – Check side effects of truvada – Evaluate and support adherence – Assess risk behaviors, reinforce condom use and other prevention messages – Conduct pregnancy test * – Assess STI symptoms and test and treat as needed - Assess Renal function (baseline and then at least every 6 months) *Not full info on how Truvada affects fetus if you take it for PrEP but appears safe for HIV + women who are already pregnant and take it during pregnancy

15. CDC also suggests that prescription not be more than 90 day supply, renewable only after HIV testing confirms an HIV negative result. REMEMBER… Ideally, PrEP will be time limited: perhaps person has changed sexual activity, or client and his/her partner are both negative and have decided not to have sex outside relationship.

16. Public and Health Care Provider reactions to PrEP have been mixed. Although CDC has developed clinical guidelines for PrEP, And it is FDA approved…

17. Concerns: The Controversy It is a commitment and responsibility (though hopefully not forever) – It is not to be taken intermittently or as needed (e.g. before having sex): it takes one week for enough Truvada to protect you If person becomes infected with HIV while taking PrEP, person could develop resistance to Truvada (so other meds will need to be used) It will not protect person from other STIs Truvada can cause stomach upset in the first weeks of taking it. The drug, though low on side effects as HIV meds go, has been linked to kidney and bone problems in a small percentage of HIV-positive users.

18. A concern of many people: Will taking PrEP increase Sexual Risk-Taking? Will it contribute to a “shift to condomless sex”? Michael Weinstein, pres of AIDS Healthcare Foundation “… MSM who were previously low risk drifting into a higher risk category.” Uptake on PrEP for HIV Slow Among MSM, Lancet, February 1, 2014

19. -Objections raised to “the pill” approved by FDA 54 years ago “We don’t know the side effects of this drug. It hasn’t been studied enough. It will encourage slutty behavior. And why the hell don’t people use condoms?”

20. Benefits From a public health perspective… PREP may be [significant] in the context of a robust, and multi-faceted combination prevention program [which includes condoms]… Being on PrEP may actually make people safer because it raises their consciousness about their health: being on PrEP requires seeing a doctor four times a year for an HIV test and kidney and bone tests. It may actually bolster safer choices. PrEP advocates say it’s safer and cost effective to be on Truvada during periods of high risk than to live with/treat HIV for a lifetime. (Most cost effective when targeted to populations with high HIV incidence) Puts prevention in the hands of the person most at risk

21. It is another tool in the Tool Kit… Along with condoms, which people have not used consistently or correctly AND… A Low/Undetectable Viral Load is the most important thing... PrEP offers added protection

22. Cost and Coverage Most health insurances cover it (patient just pays co-pay for doctor’s visit, and lab tests and drug co-pay*) At Johns Hopkins clinic: $30.00 co-pay/month Remember, there are varying degrees of benefit for all prescription drugs Insurance may require prior authorization Cost- About $13,600 annually (about $1,130 monthly)

23. 1-855-330-5479 Access to meds and co-pays for medical care visits for those Uninsured

24. “Recent cases we are aware of make this plain, where doctors …refuse to give PrEP to those who need it… Also, comments on blogs reacting to people describing their PrEP use have been accusatory and absolutely reprehensible, essentially a new version of slut shaming. David Evans, Project Inform In some literature, people are advised to be cautious about telling others they are on PrEP. Stigma around PrEP: ‘Barebacking Sluts’ ‘Truvada Whore’‘Barebacking Sluts

25. Who prescribes PrEP in VA?

26. Prescriber Barriers Not having information about PrEP Discomfort with asking patients about sexual activity Being unwilling to write a prescription (e.g. for ethical reasons) Increased paperwork Increased visits required Not having skills required or available to address all related issues (e.g. benefits and risks, risk reduction strategies, side effects, etc.)

27. Updates on PrEP: What’s Happening Now?

28. iPrEx OLE is the first PrEP demonstration project to report on its experience All 1603 gay men and tg women who have sex with men were participants in past double blind studies (of 72 weeks) so trial might be biased towards a highly motivated population. (waiting to hear results from other studies where people had not previously participated in a study) http://dx.doi.org/10.1016/ S1473-3099(14)70847-3 Uptake of pre-exposure prophylaxis, sexual practices, and HIV incidence in men and transgender women who have sex with men: a cohort study Lancet Infect Dis 2014 Published Online July 22, 2014 Data from iPrEx Open-Label Extension (OLE) Demonstrate High Interest in PrEP, Longer-term Evidence of Safety and Efficacy, and No Sign of Increased Risk Behavior Among PrEP Users

30. No participant who took PrEP four or more times a week became HIV positive. For those who took the pills two or three times a week, the HIV risk reduction was 84%, showing that adherence doesn't necessarily need to be perfect in order for PrEP to be effective. Despite speculation that being on PrEP would lead to "risk compensation," or an increase in riskier sexual behavior, the opposite was observed. Sexual practices among both groups in the study became safer, based on self-report. Syphilis incidence, a marker of sexual risk behavior, was similar between both groups.

31. Injections Providing Protection Against AIDS in Monkeys, Studies Find Two studies by different laboratory groups each found 100% protection in monkeys that got monthly injections of antiretroviral drugs, and there was evidence that a single shot every three months might work just as well… If the findings can be replicated in humans, they have the potential to overcome a major problem in AIDS prevention: that many people fail to take their antiretroviral pills regularly… adherence has been the ‘Achilles’ Heel’ of PreP. Dr. Ho’s team tested 16 monkeys with rectal washes of HIV. All the injected monkeys were protected…All six who got the placebo were infected quickly. INJECTABLE PrEP: Longer Acting March 4, 2014

32. NEXT-PrEP, [Novel Exploration of Therapeutics (NEXT) for Pre- Exposure Prophylaxis (PrEP)], also known as the HPTN 069/ACTG 5305 study, is an HIV prevention study that is being done to learn more about the safety and acceptability of four different drug combinations when used as PrEP by men who have sex with men and by women who have sex with men. The drugs in this study are called maraviroc (also called Selzentry or MVC), emtricitabine (also called Emtriva or FTC), and tenofovir (also called Viread or TDF). http://www.nextprepstudy.org/

33. Project PrEPare Project PrEPare is for 15 to 17 year old guys & trans girls who are exploring their sexuality and are interested in learning positive approaches to their sexual health. When will Project PrEPare begin, and how long will it last? Project PrEPare began in fall of 2012, and is still open to participation by 15, 16 & 17 year olds. Participants attend 9 visits in 12 months time. Children’s Hospital in DC is a site http://www.projectprepare.net/

34. Washington State: PrEP-DAP In April 2014, the Washington state’s health department started the PrEP Drug Assistance Program, which pays the entire cost of PrEP for uninsured people, and covers co-payments and deductibles for those who do have coverage. On average, PrEP-DAP is covering $400 a month in out-of-pocket costs for its insured participants, according to David Kern, who oversees the program. Mr. Campos has cited PrEP-DAP as one possible model for San Francisco, though the exact approach will be determined based on the December report…he noted that every prevented H.I.V. infection saves $355,000 in treatment costs, a significant offset to the cost of subsidizing PrEP. September 17, 2014

35. Handouts and Websites for the Client and the Clinician PrEP to assist in learning about and prescribing PrEP 2014

36. Resources and Information *http://www.cdc.gov/hiv/basics/prep.html PrEP 101: Basic Facts Sheet for the public *http://www.cdc.gov/hiv/pdf/risk_PrEP_TalkingtoDr_FINALcleared.pdf Brochure on talking with your doctor about PrEP

37. *www.projectinform.org/prep*www.projectinform.org/prep- booklets, info and 4 videos Free copies available in English & Spanish (and PDF version) Resources and Information Is Taking PrEP The Right Choice for You? PrEP: A New Option for Women For Safer Loving How to Get PrEP?

38. www.projectinform.org/prep

40. http://nmac.org/prepareforlife/ Check out our videos and our online resource page here !

41. Resources and Information *www.aids.gov *www.prepfacts.org *www.aidsinfonet.org- Fact Sheet #160 *www.prep4tomorrow.org - Johns Hopkins Clinic (currently looking for participants for trial). For More Information Contact: 443-310-6738 *www.myprepexperience.blogspot.com*www.myprepexperience.blogspot.com- features real stories from people who have chosen to use PrEP as one way to protect themselves from HIV

42. Introducing the CCC PrEPline! September 29, 2014 PrEPline, 855-448-7737 The CCC Pre-Exposure Prophylaxis Service 11 a.m. – 6 p.m. EST We’re excited to announce our brand new service, the CCC Pre-Exposure Prophylaxis consultation telephone service, or PrEPline. This service will provide free, expert advice to clinicians across the country on PrEP, an important new HIV prevention tool. PrEP involves providing antiretroviral drug treatment to HIV uninfected persons to prevent HIV infection “Many of the clinicians prescribing PrEP will have had limited experience prescribing antiretroviral drugs,” said Dr. Goldschmidt (UCSF Professor of Family and Community Medicine and Director of the CCC). “We will guide these clinicians as they work through decisions about who might benefit from PrEP and for whom it’s not advisable to prescribe PrEP, how to provide follow-up to ensure safe medication use, and protocols for averting and identifying new transmissions. Key to PrEP will be continually evaluating patients’ ability to adhere to a daily PrEP regimen, as missed doses can negate the benefits of PrEP.”

43. Welcome to PrEP Watch, a clearinghouse for information on pre-exposure prophylaxis (PrEP) for HIV prevention. PrEP Watch includes information on data, additional research, cost, access and advocacy efforts in the United States and across the globe. Resources and Information For Providers http://www.prepwatch.org/

44. Resources and Information For Providers www.cdc.gov/hiv/pdf/PrEPguidelines2014.pdf The first comprehensive Clinical Practice Guidelines were posted by CDC on May 14, 2014, replacing the interim guidelines. http://www.cdc.gov/hiv/pdf/PrEP_fact_sheet_final.pdf 1 Page CDC Fact Sheet, May 2014 www.hivguidelines.org/clinical-guidelines/ www.hivguidelines.org/clinical-guidelines/ and CLICK Pre-Exposure Prophylaxis -New York State, January 2014 http://www.cdc.gov/hiv/prevention/research/prep/ Information on Clinical Trials

45. Clinical Providers’ Supplement www.cdc.gov/hiv/pdf/guidelines/PrEPProviderSupplement2014.pdf Patient/Provider Checklist HIV Incidence Risk Index for Men Who Have Sex With Men PrEP-related ICD, CPT and LOINC Codes Potential PrEP Practice Quality Measures Methods for Developing the PrEP Clinical Practice Guideline Supplemental Counseling Information (for the Provider) -Medication Adherence Counseling -Sexual Risk Reduction Counseling Patient Information Sheets -PrEP, Truvada -Acute HIV Infection and PrEP -PrEP During Conception, Pregnancy, and Breastfeeding

48. http://aidsetc.org/resources Click RESOURCE LIBRARY and then click GUIDELINES For access to all Updated Guidelines

49. Virginia’s Prep Workgroup Information Training Provider Information Pilot Study