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Transcript of HCV Cascade of HCV Asembia slides v3.pdf¢  HCV Cascade of Care In order to eliminate HCV,...

  • HCV Cascade of Care

    In order to eliminate HCV, we will need to:  Find people with HCV infection

     Screen with antibody testing  HCV RNA for antibody positive to diagnose chronic infection

     Link them to HCV care  Inform them of their diagnosis  Evaluate readiness/appropriateness of treatment  Refer them to appropriate provider

     Treat them with antivirals  Achieve sustained virologic response (SVR)

    Diagnosed with HCV

    Linked to Care

    Access to Treatment

    Prescribed HCV

    Treatment Achieved

    SVR

    HCV = hepatitis C virus.

  • HCV Continuum of Care: Identifying Priorities to Improve Outcomes

    Yehia BR et al. CROI 2014. Boston, MA; #669; Holmberg SD. N Engl J Med. 2013;368:1859-1861; Pawlotsky JM. J Hepatol. 2015;62:s87-s99.

    Chronic HCV-Infected

    Diagnosed and

    Aware

    Prescribed HCV

    Treatment

    HCV RNA Confirmed

    Underwent Liver Biopsy

    Access to Outpatient

    Care

    Achieved SVR

    Treatment Cascade for People with Chronic HCV Infection, Prevalence Estimates with 95% CI

    100% 50% 43% 27% 17% 16% 9% 0%

    10%

    20%

    30%

    40%

    50%

    60%

    70%

    80%

    90%

    100% 3,500,000

    Half of whom are estimated to be PWID, homeless, immigrants, or incarcerated

    Unaware of diagnosis

    CI = confidence interval; PWID = persons who inject drugs.

  •  Conduct free testing at Avella pharmacies and/or in institutions implementing the Collaborative Hepatitis C Care Program

     Tactics  Press release  Informational handouts  CarePoints flyer  Copromotions

    Hepatitis Testing Day

  • Bob Has a Question

    What is Hepatitis

    C ?

  • The Role of Pharmacists in Viral Hepatitis

     “The Action Plan for the Prevention, Care & Treatment of Viral Hepatitis 2014–2016,” prepared by US Department of Health and Human Services, identified pharmacists as key stakeholders in the continuum of care of those living with viral hepatitis.

     CDC: Pharmacists can reduce fragmentation of care, lower healthcare costs, and improve patient health outcomes.  There are many opportunities for pharmacists beyond the

    traditional role of dispensing and managing medications.

    CDC = Centers for Disease Control and Prevention.

  • Kabiri M et al. Ann Intern Med. 2014;161:170-180. For educational purposes only.

    “Our study underscores the need for more- aggressive screening strategies to reduce the burden of HCV infection.”

    HCV Projected to Be a Rare Disease by 2036

    Estimated HCV prevalence in the US from 2001–2050

    Screening strategies that work today may not work tomorrow. DAA = direct-acting antiviral agent.

  • HCV/HIV Coinfection Outbreak in Indiana

    84% Coinfected with HCV

    HIV = human immunodeficiency virus.

  • Goals of Therapy for Hepatitis C

     Sustained virologic response  Undetectable HCV RNA 3–6 months after

    completing treatment  Delay progression of advanced liver

    disease  Liver fibrosis regression

     Treatment is prevention  Intravenous drug users  Women of childbearing age

  • Hepatitis C: Beyond the Liver

    Cacoub et al. J Hepatol. 2016;65:s82-s94. For educational purposes only.

  • Source: American Association for the Study of Liver Diseases (AASLD) HCV Guidance: Recommendations for Testing, Managing and Treating Hepatitis C.

    Recommendations for When and in Whom to Initiate Treatment • Treatment is recommended for all patients with chronic HCV infection, except those

    with short life expectancies that cannot be remediated by treating HCV, by transplantation, or by other directed therapy. Patients with short life expectancies owing to liver disease should be managed in consultation with an expert. Rating: Class I, Level A

    Benefits of Treatment at Earlier Fibrosis Stages (Metavir Stage Below F2) Initiating therapy in patients with lower-stage fibrosis augments the benefits of SVR. In a long-term follow-up study, 820 patients with Metavir stage F0 or F1 fibrosis confirmed by biopsy were followed up for up to 20 years (Jezeuel, 2015). The 15-year survival rate was statistically significantly better for those who experienced an SVR than for those whose treatment had failed or for those who remained untreated (93%, 82%, and 88% respectively; P = .003). The study results argue for consideration of earlier initiation of treatment. SEveral modeling studies also suggest a greater mortality benefit if treatment is initiated at fibrosis stages prior to F3 (Ovrehus, 2015); (Zahnd, 2015); (McCombs, 2015).

  • Treatment Selection: Raising the Bar

    0 10 20 30 40 50 60 70 80 90

    100

    SV R

    %

    GT 1 GT 2

    95%– 100%

    93% 93%– 99%

    94%– 99%

    95%– 100%

    99%– 100%

    Data from McHutchison J. N Engl J Med.1998;339;1485; Fried MW. N Engl J Med. 2002;347:975; Poordad F. N Engl J Med. 2011;364:119; Jacobson IM. N Engl J Med. 2011;364:2405; Jacobson IM. Lancet. 2014;384:403; Lawitz E. N Engl J Med. 2013;368:1878; Afdhal N. N Engl J Med. 2014;370:1889; Feld JJ. N Engl J Med. 2014;370:1594; Sulkowski MS. N Engl J Med. 2014;370:211; Feld JJ N Engl J Med. 2015;373:2599-2607.

    DCV = daclatasvir; EBR = elbasvir; GT = genotype; GZR = grazoprevir; LDV = ledipasvir; OPrD = ombitasvir, paritaprevir, ritonavir, and dasabuvir; RBV = ribavirin; SMV = simeprevir; SOF = sofosbuvir; VEL = velpatasvir.

  • Clinical Trials Versus Clinical Practice

    Randomized Controlled Trial  Homogenous population  Optimal compliance  Excludes complex patients  Excludes comorbidities

    Real World  Heterogeneous population  Real-world compliance  Includes complex patients  (PWID, psychiatric, etc)  Multiple comorbidities

    Efficacy vs Effectiveness

  • Real-world Results Mirror Those of Clinical Trials

    Cohort Regimen N* SVR Naïve (%)

    SVR Experienced (%)

    SVR Cirrhosis (%)

    TARGET LDV/SOF 8 weeks 154/-/- 97 -- --LDV/SOF 12 weeks 627/-/239 97 -- 96

    TRIO LDV/SOF 8 weeks 263/-/- 95 -- -- LDV/SOF 12 weeks 632/-/121 95 -- 84 LDV/SOF 24 weeks -/-/329 NA -- 92

    VA LDV/SOF 8 weeks 2027/-/- 94 -- -- LDV/SOF 12 weeks 2899/933/925 95 96 92 LDV/SOF 24 weeks 141/479/473 92 95 93

    Hepather

    SOF/DCV±RBV 12 weeks 66/82/118 89 91 90

    SOF/DCV±RBV 24 weeks 59/349/442 88 97 96

    Israel PrOD±RBV -/-/253 -- -- 99

    German PrOD±RBV 208/322 /252 96 97 95

    *N for naïve/experienced/cirrhotic. NA = not applicable.

  • Real World: GT 1, Treatment-Naïve, Noncirrhotic Patients Can Be

    Treated for 8 Weeks

    Tsai N. HEP DART 2015. December 6-10, 2015; Wailea, HI. For educational purposes only.

  • Evaluation of Newer Drug Therapies for Hepatitis C at a Specialty Pharmacy

     Retrospective chart review

    Determine if clinical trial data differs from “real-world” data

    based on SVR12 rates at a specialty pharmacy

    (N = 578)

    SVR12 from SP GT 1a = 91% GT 1b = 90% GT 2 = 89% GT 3 = 95%

    SVR12 from Clinical Trials GT 1a = 97% GT 1b = 97% GT 2 = 93% GT 3 = 59%

     Overall, SVR12 at SP confirms clinical trial data (91% for both groups when aggregating GT)

     Cirrhotic patients had a higher SVR12 (91%) vs clinical trials (84%)  Headache was the most commonly reported AE, but 2-fold lower than

    PI  Medicare had the highest coverage rate at 85% with Medicaid at the

    lowest, 30% AE = adverse event; SP = specialty pharmacy.

  • Conclusions: Real-World Evidence

     Several real-world studies confirm efficacy and safety of DAA treatment

     All ethnicities and patient populations can be treated with high cure rates

     New treatments will continue to reduce treatment duration and provide alternatives for any patients who fail first-line DAAs

  • Patient Y

     50-year-old African American male, diagnosed with chronic hepatitis C. Referred for treatment evaluation

     Medical history: Hypertension, diabetes  Social history: unmarried, lives alone; smokes

    cannabis and cigarettes daily; drinks alcohol on weekends – binge pattern; remote IVDU and opiate use

    IVDU = intravenous drug use.

  • Prescription Process

    PA = prior authorization.

  • Prescription Process

    Tx = treatment.

  • Further Workup for HCV Treatment

     Assess for barriers to adherence  Health literacy  Substance use disorders  Untreated mental health conditions

     Assess for drug-drug interactions

  • Patient Data Compliance Safety

     Laboratory test values  Patient-specific data  Skills of daily living and

    physical information  Compliance rate  Discontinuation and

    reasons why  Drug-specific outcomes at

    targeted levels

     How often is patient missing doses? Why?

     Has patient discontinued therapy? Why?

     Has patient been referred to HCP or manufacturer patient support?

     What disposition?

     Which patients have experienced (1) ED visit/hospitalization