Bob Holtkamp, Director of Prevention & Outreach 1636 S. Glenstone Springfield, MO 65804 417-881-1900 Bob Holtkamp, Director of Prevention & Outreach Bob.Holtkamp@APO-Ozarks.org

PrEP (Pre-Exposure Prophylaxis) PrEP is a method for people who are HIV-negative and at substantial risk for HIV infection Pill contains two anti-retroviral medicines which taken daily reduces risk of HIV infection by 95% . Effective after 7 days use for men and 21 days for women. Side effects such as an upset stomach or headache, but are mild and usually disappear within the first month.

iPrEx study 2,499 gay, bisexual, and other men who have sex with men in US, Peru, Thailand, Ecuador, and South Africa Average of 18 sexual partners in the last 3 months 60% reported condomless sex in the last 3 months 77.5% reported condomless sex with a partner of unknown HIV status in the last 6 months 2.5% reported condomless sex with a HIV-positive partner in the last 6 months

Reported Side Effects 2% Elevated Creatinine (Measure of kidney function) 2% Weight Loss 2% Nausea 4% Headache Monitor Kidney Function and bone mineral density www.healthline.com/health/truvada-prep-preventing-hiv-with-daily-pill-Infographic

IPrEx and Safety N Engl J Med 363;27 December 30, 2010 Adverse Event Drug (N = 1251) Placebo (N = 1248)   no. of patients (%) no. of events P Value* Any adverse event 867 (69) 2630 877 (70) 2611 0.50 Any serious adverse event 60 (5) 76 67 (5) 87 0.57 Any grade 3 or 4 event 151 (12) 248 164 (13) 285 0.51 Any grade 3 event 110 (9) 197 117 (9) 225 0.65 Any grade 4 event 41 (3) 51 47 (4) 60 Elevated creatinine level 25 (2) 28 14 (1) 15 0.08 Headache 56 (4) 66 55 0.10 Depression 43 (3) 46 62 (5) 63 0.07 Nausea 20 (2) 22 9 (<1) 10 0.04 Unintentional weight loss (≥5%) 27 (2) 34 19 Diarrhea 46 (4) 49 61 0.36 Bone facture 15 (1) 16 11 (<1) 12 0.41 Death 1 (<1)** 1 4 (<1) 4 0.18 Discontinuation of study drug Permanently 26 33 0.82 Permanently or Temporarily 79 (6) 99 72 (6) 92 0.49 * P values calculated by log rank test ** Death due to motorcycle accident N Engl J Med 363;27 December 30, 2010

iPrEx Results 44% reduction in HIV transmission among all participants 77% reduction among participants who reported that they were taking the drug 92% reduction among participants with detectable levels of drug in the blood 99% reduction among participants with levels of drug in the blood consistent with daily adherence

PrEP Dosing Doses/week Risk reduction (95%CI) 2 / week 76% 4 / week 96% 7 / week 99% Sci Transl Med. 2012 September 12; 4(15)

IPrEX and Behaviors Reported High risk behavior decreased substantially after enrollment and remained lower Counseling, testing, and dispensing condoms may have contributed to Safer behaviors Taking a pill a day may have served as a daily reminder of imminent risk and promoted planning for sex which has been associated with lower risk N Engl J Med 363;27 December 30, 2010

Uses of PrEP Serodiscordant couples (1 person with HIV and the other is not) Men who Sex with Men (MSM) Transgender persons Sex Workers/Transactional sex People who Inject Drugs (PWID) High-risk individuals-multiple partners/unknown status Individuals with multiple STIs in the previous year Mother-to-child prevention

CDC Recommendations Must be HIV-Negative Must be retested for HIV and STIs every 3 months Not intended to be used without condoms Creatine levels monitored

What PrEP not do? Does not protect a person against diseases like chlamydia, syphilis, herpes, or gonorrhea Does not prevent pregnancy Not a cure for HIV Doesn’t work as treatment for someone already living with HIV Doesn’t work if not taken consistently and correctly myprepexperience.blogspot.com

TRUVADA as PrEP Only Prescription medication approved (July 16, 2012) by the FDA for pre-exposure prophylaxis (PrEP) Fixed-dose anti-retroviral (combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg) was originally approved in 2002 for treatment of HIV. Well known side effect profile. www.truvadapreprems.com/

Insurance Coverage for PrEP? ”We have not heard of any insurance company or any medicaid program outright denying coverage of truvada as PrEP. Some companies and programs are requiring prior-authorization, however, which requires paperwork to be filled out. And the type of insurance coverage you have, including prescription drug benefits, will determine the cost to you…” myprepexperience.blogspot.com

How to Pay: Insurance, Medicaid, Medicare Copay assistance from Gilead at 877-505-6986 and/or Patient Access Network at 866-316-PANF If Uninsured, free antiretroviral medicines through the Gilead at 855-330-5479 Resources: CDC.gov/hiv/pdf/prevention_PrEP_factsheet.pdf ProjectInform.org/prep PrEPFacts.org WhatisPrEP.org MyPrEPexperience.blogspot.com PrEPWatch.org Prep-faq.com

COPAY ASSISTANCE FOR TRUVADA if you have insurance Gilead HIV co-pay assistance coupon card You may be able to save on the co-pay for your TRUVADA prescription, with a GILEAD HIV co-pay coupon card. Visit www.Gileadcopay.com or call 1-877-505-6986 for more information and to see if you are eligible.* *Enrollees will have to answer a few questions to confirm eligibility, restrictions apply. The program is subject to change at any time.

www.prep-faq.com

WHY PrEP? Personal control to limit risk of HIV infection Once-a-day dose for all-day risk reduction Daily reminder to stay HIV negative

QUESTIONS?