Immediate Antiretroviral Therapy for Better Patient Health and HIV Prevention Oliver Bacon, MD, MPH 2 February 2016

Disclaimer Views expressed in this talk do not necessarily reflect those of the San Francisco Department of Public Health or UCSF

Getting to Zero San Francisco: The Power of Collective Impact—and guided by data 90% fewer HIV infections 90% fewer HIV deaths Zero stigma and discrimination By 2020:

Where was San Francisco On Dec ? 2010: Universal ART; HIV test scale-up 2012: PrEP- DEMO 2006: HIV test w/o written consent 2011: LINCS iPrEx

Linkage, retention, and sustained virologic suppression in San Francisco

HIV Infections by Race/Ethnicity: 2014 Race/Ethnicity No. (%) White135 (44.1) African American 33 (10.8) Latino85 (27.8) API/NA40 (13.1) Multiple Races13 (4.2) HIV Infections by Transmission Category: 2014 Transmission Category No. (%) MSM231 (75.5) IDU 20 (6.5) MSM IDU 33 (10.8) Heterosexual 8 (2.6) TFN/Hemophilia 0 (0) Perinatal 0 (0) Other/Unknown 14 (4.6) Demographics of the 306 New HIV Infections in SF in 2014 HIV Semi-Annual Surveillance Report, SFDPH, June 2015

Data Highlight the Gaps If the goal is virologic suppression, 67% is insufficient Need better, faster Linkage Need better Retention Need something to prevent HIV(-)s from getting infected by unknown HIV (+)s Need to decrease stigma, psychosocioeconomic discrimination as a barrier to care, prevention

Strategic Plan: Signature Initiatives PrEP: Expand access to pre-exposure prophylaxis for San Franciscans at-risk for HIV infection RAPID ART: Early diagnosis, with immediate linkage to care and treatment of HIV RETENTION in HIV care STIGMA reduction interventions Committee for each initiative is developing action plan, metrics and milestones, budget

Universal ART…………Faster Delivering ART as early as possible after a new diagnosis of HIV: improves morbidity and mortality in all stages of infection (START Trial 2015) reduces transmission by 96% (HPTN ) in acute HIV infection: limits reservoirs and hyper-infectivity Typical interval of weeks to months between diagnosis, ART, and virologic suppression=lost opportunities Delayed or dropped linkage, retention Immunologic dysfunction Onward Transmission Why can’t ART be started at diagnosis?

RAPID Implementation: Overview Step I Day one New HIV+ Diagnosis Step II Same day, expedited referral Medical/psychosocial evaluation Start ART Partner Services Linkage to HIV 1° care Step III 5-7 days Follow-up with HIV 1° care Review baseline Labs Modify ART as needed The Goal of RAPID is to improve the health of newly diagnosed patients by eliminating delays in ART and access to high-quality HIV care. This means: Starting ART the same day as someone is newly diagnosed with HIV (or within 2-3 days if same-day start is impossible) Their first follow-up visit with HIV 1° care within a week of starting ART Sometimes RAPID patients will be referred to you at Step III, having already completed Steps I and II. Sometimes RAPID patients will undergo all Steps I-III or II-III at your clinic (especially if they were your patients when they were HIV-uninfected)

RAPID Pilot at SFGH: PHAST Team paged with any new confirmed new HIV+ patients on SFGH campus PHAST Team paged by testing sites in SF with any new HIV+ with no/public insurance Expedited intake at Ward 86 (UCSF HIV Clinic at SFGH) Comparison of linkage, virologic outcomes, by era: CD4-guided ART Universal ART RAPID (immediate ART)

561 Referral1 st Clinic Visit 1 st PCP Visit ART Prescribed Viral load suppressed Engagement Timeline, SFGH CD4-guided (2006-9) Universal (2010-3) RAPID Pilcher, IAS 2015

RAPID Time to VL suppression by ART initiation strategy: SFGH RAPID vs. universal ART P<0.001 Universal ART CD4-guided ART Proportion <200 copies Pilcher, IAS 2015

Qualitative Lessons from Interviews with RAPID Pilot Team Members: Keys to Success 1.Single point-of-contact for referrals activates the team (PHAST Pager) 2.Committed team is essential (Counseling, Benefits Navigation, Clinical) 3.Minimize handoffs: Every handoff is a warm handoff 4.Talk about Care first, Insurance later 5.Have a plan for medication access Emergency ADAP Presumptive Medi-Cal Pharma Patient Assistance Cards 6.Check in with patient in the 1-2 days after he/she leaves the appointment

Taking ART Citywide Develop a RAPID Protocol Develop a capacity-building strategy Clinic-wide education Sessions Public Health Detailing of Individual Clinicians, with RAPID Guide for Providers Target High Prevalence Testing Sites Target HIV Clinics where newly HIV+ persons are linked (referral sites) Develop an Evaluation Plan

SFGH (13%) SF City Clinic (14%) AHP/Magnet /Glide/DPH (CHN+ Consortium) (37%) Private/UC SF/StM/CP MC (22%) Kaiser (9%) Other (5%) Citywide RAPID (same day as HIV+ if possible) Disclosure Counseling Partner Services Medical Evaluation Benefits/Insurance Navigation and Rapid Enrollment Linkage to HIV Primary Care within 5 Days Immediate ART (Starter Pack or Prescription) Private/UC SF/StM (32%) SFGH (26%) SFCC/DPH (12%) Kaiser (14%) Other/AHP/VA/ OOJ/Jail (9%) Evaluation Testing sites HIV Primary Care Sites ???(7%)

The Goal: Test, Treat, Retain, and PrEP I. Universal, accessible HIV/STI testing -Frequency determined by risk -Testing for acute infection in high-risk populations/settings II. Immediate ART Eliminate OIs/AIDS ↓ nonAIDS complications ↓ transmission to partners Retention in care to maintain suppression IF(+) IF (-) III. COMBINATION PREVENTION Condoms and Risk Reduction coaching Referrals for Substance use treatment, Mental health care PEP for occasional exposures PrEP for Pts with elevated risk: Inconsistent condom use Multiple partners/non-monogamous steady partnerships Serodiscordant partners including periconception h/o Rectal STIs, PEP

Acknowledgments G2Z Rapid Committee Diane Havlir Diane Jones Stephanie Cohen Chris Pilcher Hiroyu Hatano Susa Coffey Tim Patriarca Janet Grochowski G2Z Steering Committee Shannon Weber PHAST Clarissa Ospina-Norvell Sandra Torres Fabi Calderon Kaiser-SF Brad Hare Marc Solomon Ed Chitty SFDPH Jonathan Fuchs Darpun Sachdev Andy Scheer Susan Scheer