1 Answer: The number of persons living Good News: People are living - PDF document

Top 10 stories in HIV Medicine Disclosures n Receive funding for research from NIH n Gilead sciences provides antiretroviral therapy for NIH funded SEARCH research study n Ate breakfast at Roche Laboratory advisory meeting n Serve on advisory board for Gilead/Vatican collaboration for Tanzania study Diane Havlir, MD Professor of Medicine University of California, San Francisco AR1: The number of persons Story 1: Global HIV trends and living with HIV globally is trendiness n Decreasing n Staying about the same n Increasing 1

Answer: The number of persons living Good News: People are living longer with HIV is increasing: 36.7 million because of the ART expansion Year Total living with New HIV n 17 million persons are HIV ( millions) infections/year in millions accessing ART 2001 29.4 3.2 n WHO calls for 2011 34.0 2.5 treatment of all ART 2015 36.7 2.1 persons - 36.7 million Deaths - not restricted by CD4 n Even though new HIV • Many countries are infections are decreasing adopting these guidelines n Persons are living longer such as South Africa, with HIV Kenya • Some countries are still n Result-- Net gain in persons lagging behind such as living with HIV and more Nigeria needs for care! Less Good News: Eastern Europe & And also in the Middle East & North Central Asia Africa– challenges • 1.5 Million persons with HIV • 230,000 persons with HIV • Only 17% of PLWHA on ART • >90% of new HIV infections • 57% increase in new HIV infections since 2010 among key populations and their sex partners Source: T. Zafar • Only 1 in 5 people living with HIV on ART • Increasing proportion of UNAIDS, migrants with delayed 2016 diagnosis Source: Pascal Dumont UNAIDS, 2016; El Bassel et al 2016; Hernando et al, 2015 Adapted from: Steffanie Strathdee: Opening Plenary Address AIDS 2016, & UNAIDS Report 2016 Adapted from: Steffanie Strathdee: Opening Plenary Address AIDS 2016, & UNAIDS Report 2016 2

What about elimination of HIV And we have a new “Youth Bulge” infection among children globally? in Sub-saharan Africa n Increase in proportion of youth in SSA • At risk for HIV (population demographics) • Children with HIV moving into adolescence Still falling short: 150,000 children infected with HIV in 2015 100+ 100+ 90-94 90-94 80-84 80-84 70-74 70-74 60-64 60-64 50-54 50-54 40-44 40-44 30-34 30-34 20-24 20-24 10-14 10-14 0-4 0-4 -2.0 -1.0 0.0 1.0 2.0 -4.0 -2.0 0.0 2.0 4.0 Females Males Females Males 1950 2050 AR2: What is the latest trend in Why is this important? HIV care in Africa? n Drone delivery of HIV medications n Adolescents do worse on ART n 2 drug therapy AGE GROUP 2014 VIRAL SUPPRESSION n Injectable HIV therapy n Uninfected youth n Treatment “Clubs” bulge (esp. women) 5 – 9 year-olds 71% (95 CI; 71 – 72%) may be particularly 10 – 15 year-olds 65% (95 CI; 65 – 66%) challenging for PREP 15 – 19 year-olds 61% (95 CI; 60 – 61%) • Young women have Maskew, TUAB0102, AIDS 2016 lower PrEP adherence, poorer effectiveness Adapted from Strathdee, TUPL0101, AIDS 2016 3

Answer: Treatment Clubs What are treatment clubs? Health care worker-managed group n “Treatment Clubs” are part of a larger movement n Who? Patients stable on ART of “Differentiated Care” for 6-12 months with viral n What is Differentiated Care? suppression • A client-centered approach that simplifies and adapts HIV n What? Meet every 3 months, services across the cascade to reflect the preferences and expectations of various groups of people living with HIV pick up medications, while reducing unnecessary burdens on the health system physician visit annually, Client-managed group nurse visits for viral load to group n Why? Patients like it better, decongestion in health clinic with universal treatment Outcomes: Adherence Clubs in Cape Town Where? Health care worker managed Wilkinson et al, TMIH, 2016 Clubs 97%, 96%, 94% virally supressed 35,000 30% Location and club “type” Also known as: Data as of June 2016: 30,000 25% ART Adherence N=53,523– 36% of the cohort clubs, family clubs, 25,000 20% youth clubs, 20,000 patient adherence 15% groups • Cumulative retention: 15,000 http://www.differentiatedcare.org/Models/ 10% • 12 months: 95.2% HealthCareWorkerManagedGroup 10,000 • 24 months: 89.3% 5% 5,000 • 36 months: 82.1% 0 0% Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Jan Feb Mar 2011 2012 2013 2014 2015 # RIC in Adherence Clubs % of total ART cohort in an Adherence Club 16 4

Story 2: ART options – the new AR3: Which of these is not a first “+2”: TAF/FTC line preferred regimen? EFV + TAF/FTC 1. DTG + TAF/FTC 2. Duranaivr/R/TAF/FTC 3. Evitegravir/Cobi/TAF/FTC 4. Raltegravir/+ TAF/FTC 5. Answer: EFV + TAF/FTC is alternate Phase 3 Trials Find TAF Non-inferior to TDF first line Studies 104 and 111: Week 48 Combined Analysis Virologic Outcome Treatment Difference (95% CI) Recommended First Line Regimens HIV-1 RNA <50 c/mL, % Favors E/C/F/TDF Favors E/C/F/TAF INSTI based DTG/ABC/3TC* DTG + TDF/FTC or + TAF/FTC EVG/COBI/TDF/FTC or EVG/COBI/ TAF/FTC RAL + TDF/FTC or + TAF/FTC 2.0% ‒0.7% 4.7% PI based DRV/r + TDF/FTC or + TAF/FTC From 2016 updated DHSS Guidelines: * HLAB5701 negative Cr Clearance >70 0 ‒12% +12% E/C/F/TAF was non-inferior to E/C/F/TDF at Week 48 in each study n • 93% E/C/F/TAF vs. 92% E/C/F/TDF (Study 104) STARTMRK, GS 102 and 103, SINGLE, FLAMINGO, and • 92% E/C/F/TAF vs. 89% E/C/F/TDF (Study 111) • No differences in outcome when stratified by CD4 and VL ACTG 5257 suggest that integrase inhibitor–based regimens are the preferred starting regimens in the majority of pts Wohl D, et al. 22nd CROI; Seattle, WA; February 23-26, 2015. Abst. 113LB. 5

Story 2A: What about 2 drugs only Story 3: Missing persons for initial therapy? n Increasing data with 2 drug regimens 777777777 • Dolutegravir + 3TC 777777777] • Dolutegravir + ripilvirine 7777777777\ n Not ready for prime time– 7777777777\\ phase III studies on going Tent encampment in San Francisco Project Hope Study 6 Month Intervention PN + Contingency Patient Navigation (PN) n To assess the effect of a 6 month structured patient up to 11 sessions Management navigation intervention with and without conditional financial n Strengths-based approach n Escalating scale of incentives to improve rates of HIV viral suppression at 1 year incorporates reinforcement: among substance users recruited with elevated viral loads • 11 PN meetings(up to $220) • Stages of change theory • *Completion of paperwork (up to • Motivational $80) interviewing (MI) • 4 HIV care visits (up to $180) 801 HIV-infected • Substance use treatment (up to • Motivates linkage to HIV adults admitted to 11 $90) primary care, initiation hospitals • Drug-free specimens (up to and maintenance of ART $220) • 2 blood draws (up to $50) • Emphasizes importance • HIV medications (up to $170) of substance use • *2-log10 drop in viral load ($50) treatment 24 Metsch, JAMA, 2016 • *HIV viral suppression ($100) *Reimbursement for these target behaviors was non-escalating. 6

AR4: What do you think Answer: Modest effect at 6 months and no effect at happened? 12 months 100% n Patients used funds to buy drugs and no effect 90% 6-Months Primary n Modest effect at 6 and 12 months 80% χ 2 (2)=6.54, Outcome n Large effect at 6 months, no effect 12 months p=.04 χ 2 (2)=0.78, 70% n Modest effect at 6 months and no effect at 12 p=.68 60% months 46.2% 50% 39.1% 38.6% 35.7% 33.6% 34.1% 40% 30% 20% 11.0% 11.3% 10.3% 10% 0% Baseline 6-months 12-months TAU PN PN+CM 26 Story 4: Long acting agents: What next? Update n Continue to study and innovate to find the best ways to reach this patient population n Work with community partners and leaders on housing, mental health services and substance use support n Provide dignity, empathy and support for our patients as best we can while we figure this out 7