HIV Prevention, Hepatitis Programming, and Drug User Health An Integrated Service Model at SFDPH Protecting and Promoting Health and Equity CHE&P 3/12/15 Presented by: Katie Burk, MPH 1 San Francisco Department of Public Health Population Health Division
2 Overview Hepatitis overview Understanding HCV prevention as HIV prevention HCV screening Challenges and opportunities in doing HCV work Current SFDPH efforts around HCV Opportunities along the HCV prevention and care continuum
3 Hepatitis A, B, C Hepatitis A B C Route of transmission Oral-fecal Body fluids Blood-to-blood Chronic infection No Yes (mostly) Prevention Vaccine Vaccine, risk reduction Cure Body clears No YES!!! Yes (in 75-80% of cases) Blood donor screening, Risk reduction HAV, HBV, and HCV are not different stages of one infection and one does not turn into the other. It is possible for a person to have more than one type of Viral Hepatitis at the same time.
ACUTE VS. CHRONIC INFECTIONS Acute Hepatitis Lasts less than 6 months Can be caused by HAV, HBV, or HCV Often asymptomatic and infection sometimes clears on its own People with a weak immune system (i.e. HIV+ patients) may have a harder time fighting off infection Chronic Hepatitis Lasts more than 6 months Can be caused by HBV or HCV Infection does not clear on its own and liver damage may occur May require treatment to reduce the risk of liver disease II. Viral Hepatitis & The Impact of Co-Morbidities
HCV Disease Progression 100 people infected 15-20 people clear within 6 months of being infected 80-85 people remain chronically infected 20% never suffer significant liver damage or symptoms 80% get long-term symptoms or liver damage over 10-40 years 20% develop cirrhosis after 20-30 years 75% stable for 5-10 years (10-12% of all) 25% liver failure or cancer over 5-10 years (3-4% of all)
Hepatitis C Virus (HCV) Basics Passed through contact with infected blood or blood products. Usually a chronic disease. If you have had it and cleared it, you can get it again. There is no vaccine!
Statistics about HCV 170 million cases in world - 3% of the world has hep C 4 million cases in U.S. - 19,000-30,000 new infections annually - 5x as many cases of hep C as HIV in US
8 SF Data Lab reporting was not mandated until 2007 not reported consistently until 2009 due to complex state requirements around reporting anti-hcv results Chronic HCV reports have to be confirmed by doctor or patient SFDPH conducted enhanced surveillance on 14.4% of cases via CDC grant in 2010 (20% is the current goal) Surveillance data do not measure incidence or prevalence of HCV Some not tested Some tested before reporting requirements were established Some may have cleared HCV
9 SF Co-infection Data Takeaways Linkage of HIV and hepatitis registries for the year 2010 1,278 HIV/HCV co-infected San Franciscans o 1,108 men o 170 women African-Americans disproportionately represented in coinfection data 6.6% of general population 23.5% of HIV/HCV co-infected population Injection drug use most common risk factor identified in HIV acquisition of the HIV/HCV co-infected population 35.6% were MSM but not IDUs Raises the question of the role of sexual transmission Sanchez MA, et. al. Epidemiology of the Viral Hepatitis-HIV Syndemic in SF: A Collaborative Surveillance Approach. Public Health Reports September 2014: Volume 129.
HIV, HBV, and HCV-related deaths in the U.S. 1999-2007 HBV 1,815 HIV 12,734 HCV 15,106
11 Hepatitis Funding Disparities Edlin BR. Nature, 2011. 474, s18-s19
12 Hep C Prevalence by group Edlin BR. Nature, 2011. 474, s18-s19
Exploring the Intersections: HIV, HCV, and OD HIV/HCV Co-infection 25-30% of HIV+ people are co-infected with HCV In SF, 12.6% of HCV co-infected with HIV* 35.6% co-infected males were MSM but not IDU HCV is the leading cause of non-hiv related death for people with HIV HCV infection can impact HIV treatment HIV and Overdose Overdose is a significant cause of mortality among HIV+ persons HIV infection puts people who inject drugs at greater risk of fatal overdose. Overdose prevention services can connect people who use drugs to HIV prevention, care, and drug treatment services. Sexual transmission of HCV more likely for HIV+ persons 40-90% of IDUs have HCV *Sanchez MA, et. al. Epidemiology of the Viral Hepatitis-HIV Syndemic in SF: A Collaborative Surveillance Approach. Public Health Reports September 2014: Volume 129.
Hep C & Injection Drug Use (IDU) About 3 out of 5 new cases of Hep C are transmitted via IDU. Approximately 50 80% of IDUs become infected with Hep C within 5 years of beginning IDU. Methadone and buprenorphine safe for the liver. (unless the liver is severely damaged) IV. Reducing the Harm of Substance Use & Mental Illness IDU HIV Prevention. Viral Hepatitis and Injection Drug Users. CDC. 2002.
15 HCV Screening Recommendations CDC recommends screening for: Anyone born between 1945 through 1965 Anyone who has ever injected drugs Prior recipients of transfusions or organ transplants (particularly before 1992) CDC identifies screening of uncertain need for: Intranasal drug users History of tattoos or piercings Persons with a history of multiple sex partners or STDs Other important groups/considerations HIV+ MSM HIV- MSM (PrEPers?) Crack smokers Transgender women
16 HCV Screening Rapid test available Tests for antibodies but does not indicate a chronic infection For HCV antibody-positive people, they have to undergo RNA testing to determine whether or not they are chronically infected Challenges around participant confusion May think they ve been vaccinated May have never followed up after a positive antibody screen (think they have HCV when they ve cleared it) Been told not to worry about HCV by a doctor years ago
17 HCV Community-Based Screening It is recommended that clients receive a hepatitis C test along with their HIV test, if the client has risk for hepatitis C. 1 1 SFDPH Policies and Operations Manual for HIV/HCV Testing Services in Community-Based Settings - Policy 9.04
18 Hepatitis C Challenges and Opportunities Opportunities Challenges Highly effective, interferon-free regimen now available (interferon obsolete) Early drafts of state and federal budgets include hepatitis funding increases New treatments as an incentive to engage drug users in care Cost and access Extreme funding deficit for viral hepatitis programming Too few treating doctors
19 SFDPH Viral Hepatitis Programming HCV community-based screening pilot Making plans for expansion HAV/HBV vaccine program PCSI screening protocols published HBV/HCV surveillance grant Partnership with Hep B Free Partnership with HCV Task Force SFDPH doctors screening and treating patients
20 Viral Hepatitis Needs Assessment Meeting with internal and external stakeholders Participation in national viral hepatitis work group HCV education/support group attendance (TWC, BAART, county jail) Focus groups Community HCV screeners Medical providers Facilitated internal SFDPH planning meeting 3.16.15 Where are we now? Where do we want to be? How can we better align our efforts in different SFDPH branches to have a more coordinated response to viral hepatitis?
21 SF HCV Task Force Priorities 2015 1. Public Policy Demand budgetary support for Hepatitis C activities by the San Francisco Dept. of Public Health 2. Prevention, Education, Awareness and Testing Increase number of providers and settings for HCV testing and education, including urging physicians to routinely offer HCV tests to all Baby-Boomers, PWHIV, as well as those with behaviors putting them at risk 3. Care and Treatment Expand capacity and access to care and treatment for all people with hepatitis C
HCV Visioning: Opportunities for Intervention at SFDPH 22 Prevention Clear, harm reduction-based messaging about risk and prevention Continue to support and expand syringe access Screening Increased community screening initiatives Providers cross-trained to do HCV screening, counsel participants around risk reduction HAV/HBV vaccines available to IDUs Linkage Motivate participants to engage in care Culturally competent eligibility workers Patient navigators Treatment Increase number of providers who prescribe HCV meds Administrative support for prescribers to navigate insurance and patient assistance program process
23 HCV Visioning What do you see as HPPC s contribution to HCV efforts moving forward? Key issues: Funding Integration
Thank you Katie Burk HIV Set-Aside and Viral Hepatitis Coordinator katie.burk@sfdph.org 24 San Francisco Department of Public Health Population Health Division
Hepatitis C Treatment Access in California The Hope of Cure as Prevention HIV Prevention Planning Council March 12, 2015
Keep Our Eyes on the Prize
We Can Eliminate Hep C in the U.S. We have effective screening and diagnostic tools Antibody and viral load (PCR) tests We have effective treatments with few side effects that cure over 90% of people Treatment duration 8-24 weeks We have effective preventive tools to stem incidence Syringe access & disposal programs Evidence-based opiate treatment (e.g., buprenorphine, methadone) Cure as prevention
The Promise of Elimination Cannot be realized until: Everyone living with hepatitis C, regardless of stage of disease, has access to curative treatments People who use drugs have access to curative treatments The majority of new hepatitis C infections are transmitted through shared drug injection equipment
Potential Impact of Treatment as Prevention based on Prevalence Prevalence in many US cities falls close to 50%- 65% Treating just 8% of active injectors per year would reduce prevalence by 50% to 90% in 15 years MartinHepatology 2013.
Rapid Progress in Interferon-sparing All- Oral Hepatitis C Treatments Genotype 1 (most common in U.S. at 75%) Sovaldi + Olysio Sovaldi + ribavirin Harvoni Viekira Pak +/- ribavirin Genotype 2 and 3 Sovaldi + ribavirin The new regimens work just as well for monoinfected people as people living with HIV/HCV co-infection. Genotypes 4-6 not addressed here (rare in the U.S.) Some regimens require interferon still More drugs in the pipeline! Hope for pan-genotypic drug that does not require ribavirin
Price of Hep C Cure Coming Down Gilead announced at last share holder meeting that it will provide 46% discounts on its two drugs Presence of AbbVie drug on the market is creating fierce competition California Technology Assessment Forum stated that at an average of $40,000 per cure, the new medications are high value
Californians with Hepatitis C 750,000 Californians estimated to be living w/ hepatitis C 200,000 in Medi-Cal (our state Medicaid program) 4000 in the state AIDS Drug Assistance Program (ADAP)
State Public Payers Rationing Care Medi-Cal and ADAP have treatment utilization policies that limit access to new medications Medi-Cal & ADAP authorize treatment ONLY for people with advanced liver disease (i.e., F3-F4) or certain extrahepatic conditions Medi-Cal prohibiting treatment for people who use drugs or alcohol unless they they have six months of abstinence or are actively engaged in drug treatment These requirements are purely rationing and costcontainment measures Not based on the FDA-approved labels, clinical evidence, or guidance developed by the American Association for the Study of Liver Diseases/Infectious Diseases Society of America
Medi-Cal Managed Care Issues One-third of Californians are on Medi-Cal 75% are in managed care plans, rather then feefor-service Managed care plans instituting additional restrictions beyond the treatment utilization policy e.g., limiting to one specialist in an entire county, requiring abstinence only, denying every initial request, refusing to allow infectious disease docs to prescribe
Utilization of Hep C Drugs in Medi-Cal is Low Only 0.8% of the estimated 200,000 Medi-Cal patients living with hepatitis C treated from January 1, 2014 September 30, 2014 Medi-Cal Managed Care = 1375 members Medi-Cal Fee-for-Service = 320 members
Letter to State Office of AIDS re: ADAP
Utilization of Hep C Drugs in ADAP is Low The State Office of AIDS (OA) estimates that 12% of ADAP clients are co-infected with hepatitis C virus OA estimates 32.4% of the co-infected clients have stage F3 or F4 liver disease, and 10% of ADAP s co-infected subpopulation with stage F3 or F4 disease will be treated for hepatitis C each fiscal year (FY). OA estimates 69 clients will be treated for HCV in FY 14-15 OA estimates 135 clients will be treated for HCV in FY 15-16 These estimates mean utilization will only be 5% total over two FYs for all co-infected patients in ADAP. Of special concern because hepatitis C progresses more rapidly in people with HIV.
Covered California & Commercial Payers Tiering of drug formularies (tier 1 is low-cost generics, tier 4 is specialty or high-cost drugs) All new hepatitis C drugs are on highest tier in every Covered California plan Cost-sharing up to 30% on these medications Many Covered California and private payers are engaged in similar rationing as the public programs
Building a Movement to Cure All* *Thanks to Daniel Raymond at Harm Reduction Coalition for coming up with this phrase
Discussion and Questions
Contact Information Emalie Huriaux Director of Federal & State Affairs, Project Inform Co-Chair, California Hepatitis Alliance (415) 580-7301 ehuriaux@projectinform.org