Condomless Sex: Was the Swiss statement correct in 2008? Renslow Sherer University of Chicago

Condomless Sex: Was the Swiss statement correct in 2008? Renslow Sherer University of Chicago

Disclosures and Objectives Disclosures Advisory Board Yes Gilead Sciences A PLWHIV on ART w/ VL < 50, as per the Swiss Statement, is NOT a public health threat.but that does not finish the discussion on how a primary clinician should talk to HIV+ and HIV at-risk persons about condom-less sex. 2 key issues: Objectives At the end of the session, the participant will be able to: 1. cite current evidence on the efficacy and effectiveness of ART as prevention; 2. review current evidence on the efficacy and effectiveness of preexposure prophylaxis (PrEP); 3. Describe the clinician's role in counseling HIV+ and HIV at-risk patients for sexual health, condoms, and condom-less sex

Efficacy vs Effectiveness the extent to which an intervention causes its intended effect under ideal circumstances, such as in a randomized clinical trial, the extent to which an intervention achieves its intended effect in the usual clinical setting Efficacy Clinical trial Controlled setting Limited variation Narrow intervention Designed to define degree of biologic effect of intervention Effectiveness Observational study Real world setting Broad variation Uncontrolled variables Designed to assess success of intervention in real world settings

Who is transmitting HIV in the US? Purpose: Estimate rate and number of HIV transmissions in US in 2009 Method: Mathematical modeling using data from National HIV Surveillance System, National HIV Behavioral Surveillance System, and Medical Monitoring Project Results: HIV+ but undiagnosed (18.1% of total HIV+ pop.) caused 30.2% HIV+ but not retained in care (45.2% of HIV+) caused 61.3% of estimated 45,000 HIV transmissions in 2009. TOTAL 91.5% Conclusion: Improvements in HIV diagnosis and retention in care, as well as reductions in sexual and drug use behavior, primarily for persons undiagnosed and not receiving ART, would substantially affect HIV transmission in the US JAMA Intern Med. 2015;175(4):588-596. doi:10.1001/jamainternmed.2014.8180. Published online February 23, 2015.

Outline Efficacy vs effectiveness Limits of TasP and PrEP Care cascades & disparities The Magnificent Condom: Facts & Myths Condom-less sex in 2017 What is an HIV Clinician to advise? March For Science, Chicago April 22, 2017

HPTN 052: HIV Transmission Reduced by 96% in 1,763 Serodiscordant Couples Single transmission in patient in immediate ART arm believed to have occurred close to time therapy began and prior to suppression of VL Total HIV-1 Transmission Events: 39 (4 in immediate arm and 35 in delayed arm; P <.0001) Linked Transmissions: 28 Unlinked or TBD Transmissions: 11 Delayed Arm: 27 Immediate Arm: 1 28% (11/39) of transmissions from outside the couple P<.001 TBD = to be determined. Cohen MS et al. N Engl J Med. 2011;365(6):493-505.

Limits of ART as Prevention Partner study: 0 Tx in 282 MSM, 495 het. couples Selected, long term pts on ART x 5 years Less likely to include poor adherence, drop outs Confidence intervals wide, 0-4% in MSM, 0-2% het

CDC: Continuum of HIV Care in 1,178,350 United States, 2009 941,950 Percentage 80% 725,302 77% 480,395 66% 426,590 89% 328,475 77% HIV- Infected HIV- Diagnosed Linked to Care Retained to HIV Care Engagement in HIV Care On ART Suppressed Viral Load ( 200 copies/ml) MMWR (60), 2011 Skarbinski J, et al. 19th CROI; Seattle, WA; March 5-8, 2012. Abst. 138.

100% Percentage 60 50 40 30 20 Percent of HIV Infected Individuals with 49 Lower suppression rates in: women people of color IDUs youth Durable Virus Suppression in U.S., 2014 44 40 48 56 53 38 48 44 41 48 33 40 45 50 43 41 48 10 0 Male Female Black Hispanic White MSM Male IDU MSM/IDU MSM Hetero Female IDU Female Hetero 13-24 Years 25-34 Years 35-44 Years 45-54 Years > 55 Years in 2013 Prior to 2013 Data from 33 states or jurisdictions, n = 630,965 Two or more VLs: 339,515 (54%), one VL: 92,309 (14%), No VL: 199,141 (32%) 50+% NOT VL < 50 Sex Race/Ethnicity Transmission Category Age Diagnosis Year Crepaz N, et al. 24th CROI; Seattle, WA; February 13-16, 2017. Abst. 31.

Key PrEP Studies: Relative Reduction in HIV Incidence with 90% Adherence MSMs and Transgender Women Heterosexual Men and Women IDUs Reduction (%) 100 80 60 40 P=0.005 44% 56% 92% 8% 100 90% 10% 25% 80 75% Reduction (%) 60 40 Reduction (%) 100 80 60 40 51% 49% 70% 30% 20 0 Oral FTC/ TDF Overall Oral FTC/ TDF Detectable TDF 20 0 Oral FTC/ TDF Overall Oral FTC/ TDF Detectable TDF 20 0 Oral TDF Overall Oral TDF Detectable TDF iprex (n=2499) Partners PrEP (n=4758) Bangkok Tenofovir (n=2413) Grant RM, et al. N Engl J Med. 2010;363:2587-2599; Baeten J, et al. N Engl J Med. 2012;367:399-410; Thigpen MC, et al. N Engl J Med. 2012;367:423-434; Choopanya K, et al. Lancet. 2013;381:2083-2090.

PrEP Efficacy Trials: HIV Infxs on PrEP Study Name Partners PrEP TDF2 Study Heterose xual couples Men & women N Placebo incidence 4,758 2/100 p-y Results TDF: 67% efficacy FTC/TDF: 75% efficacy # HIV infections in PrEP pts TDF 17 TDF/FTC 13 30 1,219 3/100 p-y FTC/TDF: 62% efficacy TDF/FTC: 9 iprex MSM 2,499 4/100 p-y FTC/TDF: 44% efficacy TDF/FTC: 36 Population FEM- PrEP Women 1,951 5/100 p-y FTC/TDF: futility TDF/FTC: 33 VOICE Women 5,029 6/100 p-y TDF: futility Vaginal TFV gel: futility FTC/TDF: futility TDF: 52 TDF/FTC: 61 IDU Bangkok IDU men & women 2,413 0.68/100 p-y TDF: 49% efficacy TDF: 17 Total: 238 HIV infections in 9,736 pts on PrEP in 6 clinical trials Kahle E, et al. 19th IAC; Washington, DC; July 22-27, 2012; Abst. TUAC0102.

50 yo MSM on PrEP in Amsterdam was neg at enrollment, had adequate TDF-DP levels by pill ct, report &DBS levels of 2234 fmol/punch ( 6 months) and 2258 fmol/punch (8 months) 8 months on PrEP he had a indeterminate 4th gen HIV AG/AB test, VL non detectable 3 weeks after seroconversion VL 40,000c/m; he responded to CART No resistance No STIs, GUDx Failure of PrEP with good adherence Hoornegorg, E. et al, 953 2 PrEP failures in 2016 w/ multi-resist HIV Knox D. CROI 2016. 169aLB; Grossman H. Poz 10.2016

US PrEP Demonstration Project: Adherence to PrEP by TDF Levels in Dried Blood Spots Open Label PrEP among MSM and transgender women in San Francisco (n=300), Miami (n=157), and Washington DC (n=100) Engagement (Percentage) 100% 80% 60% 40% 20% 0% 4 12 24 36 48 Visit Week 30% 40% No Visit BLQ <2 doses 2-3 doses 4-7 doses Hosek S, et al; 8th IAS, Vancouver, Canada, July 19-22, 2015; Abst. TUAC0204LB.

Disparities in PrEP uptake Kelley C, et al. CID, 2015 12% Mayer, K. et al., CROI 2017, ABS 971 28%

The Humble, Magnificent, and Much Reviled (M&F) Condom! low cost widely available WIDELY USED highly effective side-effect free (almost! latex allergy) flexible, portable multi-purpose high tech and low tech Sexy, fun, forgiving, personal PREVENTS HIV GC, chlamydia, LGV hepatitis B &C Trichomonas bacterial vaginosis Pregnancy

HIV Prevention with Condoms Works New HIV infections in Thailand by year New HIV infections (number of people, in thousands) 160 140 120 100 80 60 40 20 0 100% condom policy 1985 1986 1987 1988 1989 19901991 1992 1993 1994 1995 19961997 1998 1999 2000 2001 2002 Year Royal family support Government $$$, admin. Community engagement Public Health leadership Health system promotion Lesson: Condom results reflect effort, funding, leadership given to their promotion Spouse: heterosexual transmission of HIV in cohabiting partnerships; SW: HIV transmission through sex work IDU: HIV transmission through injecting drug use; MTCT: mother to child transmission of HIV Source: Thai Working Group on HIV/AIDS Projections, 2001 2004 Report on the Global AIDS Epidemic (Fig 4)

Condom effectiveness 94%?.a undeservedly weak evidence base Condoms work most of the time, >90%, with proper use Studies Holmes KK, Levine R, Weaver M. Effectiveness of condom in preventing sexually transmitted infections. Bull WHO 2004; 84:454-461. Pinkerton SD, Abramson PR. Effectiveness of condoms in preventing HIV transmission. Soc Sci Med 1997;44:1303-1312. Rietmeijer CA, Krebs JW, Feorina PM, et al. Condoms as physical and chemical barriers against human immunodeficiency virus. JAMA 1988;259:1851-1853. Saifuddin A, Lutaloa T, Wawerb M, et al. HIV Incidence and Sexually Transmitted Disease Prevalence Associated with Condom Use: A Population Study in Rakai, Uganda. AIDS 2001;15:2171-2179. Van de Perre P, Jacobs D, Sprecher-Goldberger S. The latex condom, an efficient barrier against sexual transmission of AIDS-related viruses. AIDS 1987; 1:49-52.

Condom Myths #1&2 Condoms don t work CDC: 90+% efficacy Record of high effectiveness No one uses condoms MSMs King Cty: 82% sometimes/usually US youth condom use in last 3 mos: 57% in 2015 Golden M. CROI 2017. #56 CDC. Youth Behavior Surveillance Report. 2015.

Implication #4: Condoms Condom Use Among MSM STD Clinic Patients, King County, WA 2016 HIV- MSM (n=3018) HIV+ MSM (n=469) Never Sometimes/ Usually Always 0.7% 82% 18% 4% 89% 8% MSM use a lot of condoms! Need to integrate condoms into a comprehensive prevention message Choice is not 100% condom use or no condom use Golden M. CROI 2017. #56

For King Holmes 1996 2010: Epidemiology of HIV and STI post-haart, Resurgence of STIs in US, Europe, particularly in MSMs GC in MSMs King County Figure 5: Incidence of Reported Gonorrhea among Women, Heterosexual Men, and MSM* 15 years and older, King County, WA, 1992-2010 2000 Syphilis, GC in MSM LGV proctitis return in MSM Hepatitis C in MSM; no longer confined to IDUs Women 1800 Heterosexual men MSM 1600 Cases per 100,000 persons Dramatic resurgence of STI in US and Europe, esp. in MSM 1400 1200 1000 800 600 400 200 GC fluoroquinolone resistance from Asia to US, concentrated in MSM 1976 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 Year * In 2004, a field for gender of sex partners was added to the STD case report form. Before 2004, ascertainment of MSM status was likely less complete than in 2004 and after 4500 Incidence per 100,000 MSM GC decreasing cephalosporin susceptibility, concentrated in MSM Azithromycin-resistant T. pallidum in US, Dublin; in MSM 0 4000 3500 3000 HIV+ HIV3016 2500 2000 1500 1000 500 0 Holmes K. Plenary Presentation, ACTHIV 2012, Denver, May 15, 2012. Syphilis in HIV+ in King County 4163 195

Multi-Drug Resistant Gonorrhea: A Reality in 2017 STI Sequelae Epidemic neurosyphilis in MSM Most women w/ chlamydia, GC have no Sx 15% of women w/ chlamydia & no Rx get PID PID and silent STIs à infertility 2.86 million cases of chlamydia/yr in US 820,000 cases of gonorrhea/yr in US Unemo M, Shafer W. Clin Micro Review 2014;27:587

Condom Myths #1 & 2 & 3 1. Condoms don t work CDC: 90+% efficacy Record of high effectiveness 2. No one uses condoms A LOT of people at HIV Open risk carefully, use condoms, no sharps often FACT: most don t use condoms all the time When used, they work so Care w/ still animal useful skins 3. Advising pts to use condoms doesn t work LIMITS TO CONDOM EFFICACY Requires agreement of wearer Re-use, over-sized Use w/ fat-soluble lube Use old, opened, dry Care w/ non-us brands Latex allergy alternatives Not effective vs HPV Brief counseling works to reduces unsafe sex

Daskalakis. CROI 2017. #108 The New York Plan

Why PrEP Alone is Not Enough PrEP alone does not reduce risk of STIs, pregnancy, harmful consequences of IDU For HIV Prevention, combining methods improves protection When HIV drug doses are missed or unavailable When medication alone does not completely block HIV transmission The US will become a place where new HIV infections are rare. US Nat l HIV/AIDS Strategy Dawn K Smith, CDC 2014

HIV Primary Caregivers: Recommendations re: Condom-less Sex 1. Promote, encourage sex, intimacy, safe touch - Screen for, recognize, address unsafe, coerced sex 2. Promote & encourage condom use; give condoms - Counter negative image, pessimism - Many people use condoms, often

HIV Primary Caregivers: Recommendations re: Condom-less Sex 3. Expand testing; engage & retain; ART for all Most HIV transmitted by recent Infx (1/3) or known HIV+ out of care (2/3) 4. Advise Both And : TasP/PrEP/PEP and condoms - Recommend careful candidates for long term condom-less sex and short term condom free moments - Review TasP & PrEP & condom evidence w/ pts - Follow CDC & USPHS PrEP eligibility guidelines - BROAD & generous interpretation! Streamline PrEP Access!

Thank You

3 Questions for Shannon When would you estimate that the US will achieve 90-90-90 targets (like NY, SF)? 2 years? 5 years? More? At that time, would you recommend condom-less sex with anyone known to be HIV+? Did PEPFAR waste US taxpayer $$$ by providing 770 million condoms worldwide in 2012? How should we describe the risk of PrEP failure to our pts? USAID. https://www.usaid.gov/what-we-do/global-health/ hiv-and-aids/technical-areas/addressing-condom-supply-and-demand-pepfar