The New HIV Epidemic Challenges: Policy, Politics, and Poor Patients

Transcription

1 The New HIV Epidemic Challenges: Policy, Politics, and Poor Patients John T. Carlo, MD, MS Chief Executive Officer AIDS ARMS, INC.

2 Conflict of Interest None 2

3 Learning Objectives Review three important policy updates related to current and future funding for HIV treatment Understand the geopolitical tension that is currently brewing regarding future HIV healthcare access Appreciate how poverty impacts efforts to slow the epidemic 3

4 Recent Advances Treatment as Prevention (TasP) Pre-exposure Prophylaxis (PrEP) Treatment recommendations and options Functional cure and long-acting treatments 4

5 Treatment Prevents HIV Transmission No reports in literature of sexually transmitted infection in heterosexual couples with viral load below 400 copies/ml HPTN 052 Trial: Treatment reduced infection risk by 96% Swiss Consensus statement (2008): an HIVinfected person effectively treated is not sexually infectious Unknown whether same risk reduction is possible for men who have sex with men Attia S, et al. AIDS. 2009; 23(11): Cohen, MS, et al. NEJM. 2011; 365(5): Muessig KE, et al. AIDS. 2012; 26(18):

6 Estimated number of new HIV transmissions along the care continuum 61% from those diagnosed but not retained in care 30% from undiagnosed Skarbinski,J. et al., JAMA, 2/23/15

7 PrEP A daily pill can prevent HIV Risk reduced by 92% Indicated for someone with potential exposure to HIV through sex or injection drug use dex.html 7

8 PrEP Works Biologically iprex 44% reduction in the incidence of HIV. Partners PrEP 90% reduction in relative risk with detectable drug levels of TDF- FTC. TDF2 62% reduction in heterosexual men and women Grant RM, Lama JR, Anderson PL, et al. N Engl J Med. 2010; 363: Baeten JM, Donnell D, Ndase P, et al. N Engl J Med; 2012; 367: Thigpen MC, et al. N Engl J Med. 2012; 367: AIDS Arms, Inc.

9 Additional PrEP Studies ANRS Ipergay Trial (PrEP on demand) 88% study retention rate No change in sexual behavior during study (70% no condom use) Mean follow-up 13 months 86% RR in HIV-1 incidence 18 treat = 1 infection PROUD 86% efficacy if entry seroconversions excluded 13 treat = 1 infection Molina JM, et al Conference on Retroviruses and Opportunistic Infections (CROI), Seattle, abstract 23LB, McCormack S, et al Conference on Retroviruses and Opportunistic Infections (CROI), Seattle, abstract 22LB, AIDS Arms, Inc.

10 START: Strategic Timing of Anti-Retroviral Treatment Trial Treatment is Indicated at Any CD4 Primary Events, % 5% 4% 3% 2% 1% Hazard of Developing Serious AIDS Event, Serious Non-AIDS Event, or Death 4.1% N=96 (1.38/100PY) 57% Reduction in Events with Early Treatment p< % N=42 (0.60/100PY) 0% Delayed Treatment Early Treatment Lundgren D, et al. IAS Vancouver, CAN. Oral # MOSY03 Lundgren D, et al. NEJM 2015 Published Epub ahead of print July 20, 2015 DOI: /NEJMoa

11 Emerging Research in HIV Cures AIDS Arms, Inc.

12 Long-Acting HIV Medications 8 week dosing schedule Rate of viral suppression was >90% Margolis DA, et al. The Lance Infectious Diseases. 2015;15(10):

13 Newest HIV Medications Dolutegravir (DTG) Once a day dosing Very low resistance potential Grade 3 and 4 events less than 2% Few medication interactions Tenfovir Alafenamide (TAF) New formula of tenfovir Limits side effects to kidneys and bone Mesplède T et al. Viruses Aug 27; 6(9): & 13

14 ACA Updates Drug coverage decisions discourage people with HIV from selecting their plans 1 12 of 48 plans have evidence of adverse tiering Adverse tiering plans more than triple out-ofpocket costs Provider networks failing to comply with ACA guidelines 2 1. Jacobs D and Sommers B. NEJM. 2015; 372L Oaks J

15 Ryan White Program Changes Crowley J & Kates J. The Kaiser Family Foundation

16 340B Program and HIV Treatment Ryan White HIV/AIDS Program grantees are eligible covered entities Enables [us] to stretch scarce Federal resources as far as possible, reaching more eligible patients and providing more comprehensive services Average savings of 25-50% Estimated $7 billion in drug purchases last year Represents 2% of total drug market share Over 80% of spending is through hospitals House Report, No , Part II, Pg. 12, 102 nd Congress, 2 nd Session Scholz L. 340B Drug Discount Program SNHPA

17 HIV Prevalence Rate, by Country Denning P & DiNenno E. NHBS-HET and UNAIDS Estimates 2007

18 Age-Adjusted* Rate of Death among persons with HIV Infection, by State, United States, 2010 *Standard: age distribution of 2000 US population Per 1,000 persons living with a diagnosed HIV infection.

19 Distribution of Poverty in the U.S.

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21 Status of Medicaid Expansion Decisions in the South as of April 2014 DE MD WV VA KY DC NC TN OK AR SC MS AL GA TX LA FL Implementing the Medicaid Expansion in 2014 (6 States, including DC) Not Moving Forward at this Time (11 States) SOURCES: State decisions on the Medicaid expansion as of April Based on data from the Centers for Medicare and Medicaid Services, available at: Levels/medicaid-chip-eligibility-levels.html with state updates.

22 U.S. Senators by Party

23 New HIV Diagnoses, Deaths, and People Living with HIV in Texas, New HIV Diagnoses People Living with HIV Deaths in People Living with HIV *There is a two-year lag in availability of complete death data Texas Dept. of State Health Services 23

24 Poverty and HIV Strongly Intersect 44% of HIV patients in care in the U.S. are at or below the Federal Poverty Level 1 Black MSM vs. White MSM, twice the poverty rate and homelessness; no differences individual risk factors 2 Poverty clearly increases vulnerability to HIV for women 3 1. CDC HIV Surveillance Special Report Sullivan P, et al. PLoS One. 2014; DOI: Rodrigo C & Rajapakse S. International Health. 2010;

25 Race/Ethnicity and HIV HIV is the leading cause of death for black women aged years High levels of incarceration rates among black Americans Limited sexual networks will continue current trends The CDC. 2008: Shrange L. The New York Times. December 11,

26 Estimated Incidence of HIV Infection for MSM by Race/Ethnicity and Age, 2010 Source: CDC. Estimated HIV incidence among adults and adolescents in the United States,

27 HIV Care Funding By Region Funding Program Ryan White (2010) Medicaid Spending (2009) Medicaid % PLWH Covered (2009) South Northeast Midwest West $2,488.8 $2,659.5 $2,463.6 $2,603.1 $20,808.1 $35,964.8 $21,710.8 $26, Reif S & Whetten K. CHPIR, Duke University. 2012

28 Estimated HIV Treatment Costs* Item Source Annual Estimate HIV Medications Average AWP of current first-line regimens -16.7% $27,000-30,000 Provider visits visits per year $ Vaccines Laboratory Influenza, Hep A & B, HPV, Pneumonia, Tdap Viral Load (HIV RNA), CD4, CBC, Chem Panel, Lipid Panel, others $1350 $ Total $27,885 59,468 Gencarelli D. NHPF Issue Brief. June 7, No 775. George Washington University. * Estimates are for one patient s annual expenses for an uncomplicated HIV infection. Average Wholesale Price: 28

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30 Final Thoughts Policy, politics, poverty all impact the HIV care continuum Future accomplishments in therapies and ultimately ending AIDS undoubtedly will be buffered against these forces

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