what’s new in hepatitis c? · • casl & cag – canadian digestive disease week - (february...
TRANSCRIPT
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What’s new in Hepatitis C?Community Report-back from Victoria 2013
Presented by Scott Anderson and Jeff RiceCATIEApril 16th, 2013
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Introduction – Organizations & acronyms
• Canadian Association for the Study of the Liver (CASL)
• Canadian Association of Gastroenterology (CAG)• Canadian Association of Hepatology Nurses (CAHN) • National CIHR Research Training Program in Hepatitis
C (NCRTP-HepC)• Action Hepatitis Canada • CATIE
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Introduction – Organizations & events
• CASL & CAG – Canadian Digestive Disease Week -(February 26 – March 4)
• CAHN – Education Day(s) (February 28 – March 2)• CASL – Annual Winter Meeting (March 1-4)• Action Hepatitis Canada – Strategic Planning Meeting
(March 2 – 3)• CATIE – Community Info Sharing Session (March 3)• CATIE – Learning Institute/Rapporteur Project (March
3-5)• NCRTP-HepC – 2nd Canadian Symposium on Hepatitis
C Virus (March 4)
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Overview
• New Hep C treatments• Treat or wait?• Managing side effects• Specific populations
• Liver transplant• Pregnant people• People who use drugs
• Screening / testing and cost-effectiveness• What about the ‘Baby Boomers’?• Action Hepatitis Canada
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Hepatitis C treatments
in the pipeline
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Terms
• Sustained virological response (SVR)• Treatment naïve• Prior relapsers• Null responders
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Current treatment
DirectActing Anti-viral (DAA)
Standard Treatment
Genotype SVR (cure rate)
peg-interferonribavirin (PegIFN/RBV)
All G1 45%G2 + G3 80%
telaprevir (Incivek)
peg-interferonribavirin(PegIFN/RBV)
1 74% (Tx naïve)
boceprevir(Victrelis)
peg-interferonribavirin(PegIFN/RBV)
1 65% (Tx naïve)
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Why are new treatments important?
• Current treatment options are difficult • Interferon injections• High pill burden• Side effects• Length of treatment
• Increase SVR –currently 45-74% (treatment naïve G1)
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What’s going on in the treatment pipeline?
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Which treatments will be first?
DirectActing Anti-viral (DAA)
Standard Treatment
Genotype SVR (cure rate)
peg-interferonribavirin (PegIFN/RBV)
All G1 45%G2 + G3 80%
telaprevir (Incivek)
peg-interferonribavirin(PegIFN/RBV)
1 74% (Tx naïve)
boceprevir(Victrelis)
peg-interferonribavirin(PegIFN/RBV)
1 65% (Tx naïve)
new drug(s) peg-interferonribavirin (PegIFN/RBV)
1a, 1b, 4,5,6 71-97%
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New triple therapies
• simeprevir- protease inhibitor• faldaprevir-protease inhibitor• daclatasvir-NS5A inhibitor• sofosbuvir-nucleotide polymerase inhibitor
• Each drug is taken with peg-interferon and ribavirin (PegIFN/RBV)
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New triple therapies
• Once daily dosing• No food requirement with pills• None or few side effects • Shorter treatment length, in some cases 12
weeks• Work for several genotypes• SVR: 71-97%
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Quad Therapy
• 2 DAA’s + PegIFN/RBV• daclatasvir + asunaprevir + PegIFN/RBV
for 24 weeks• SVR 12 or 24: 90-95%
• danoprevir +mericitabine + PegIFN/RBV for 24 weeks• SVR 12: 84%
• May be a good option for null responders
J. Feld NCRTP-HCV 2013 14
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Interferon-free treatments
Some promising combinations…
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Interferon-free treatment: Genotype 2 + 3
sofosbuvir + ribavirin
• 12 or 16 weeks of treatment • sofosbuvir: 1 dose/day• ribavirin: weight based dose 2x/day• Genotype 2: 86-94% SVR• Genotype 3: 30-61% SVR
S. Shafran CAHN 2013
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Interferon-free treatments – Genotype 1
• faldaprevir + BI 207127 + ribavirin• sofosbuvir + ledipasvir + ribavirin• ABT-450/ritonavir, ABT-267, ABT-333 +
ribavirin
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Interferon-free treatment summary
• Multiple options for interferon-free treatment• 12 weeks or less• 1-2 doses/day + ribavirin• Cure rates of 90% and up (G1,2,4,5,6)• High cure rates even for people who did not
previously respond to treatment• Few serious side effects
J. Feld NCRTP-HCV 2013
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When will these treatments emerge from the pipeline?
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• Predictions by Dr. S. Shafran:• 2014
• simeprevir triple therapy • sofosbuvir triple therapy • sofosbuvir + ribavirin for G 2 + 3• Maybe faldaprevir triple therapy
• 2015 or 2016• Interferon-free treatment will be approved
S. Shafran, CAHN 2013
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Is this the end of Hep C? Not quite yet. Here’s why…
Some questions about the new treatments
• Will the treatment options work for people with severe liver damage?
• Will the treatment options work for people who have other illnesses (HIV, chronic kidney disease)?
• What will be the cost of the new drugs?• Will treatment options be developed for people with
genotype 3?
J. Feld NCRTP-HCV 2013
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So now what?: Treat or Wait?
• Considerations:• Amount of liver damage• Previous response to treatment?• Age• Situation of person with Hep C: motivation,
drug coverage, family planning, support, able to manage treatment
J. Feld CASL 2013S. Shafran, CAHN 2013
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Managing side effects of current treatments
• Mental Health Issues• Depression, anxiety, fatigue, cognitive
problems are common• 10% suicidal thoughts
• citalopram (anti-depressant) first line of treatment for depression
• Mood assessment and sleep assessment considered best practise
• Hepatitis C infection, antiviral treatment and mental health: a European expert consensus statement.
C. Taylor, CAHN 2013 22
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Beyond medications: What do we need to do to end Hep C?
• Increase testing for Hep C• Need to have needle exchange programs and
opiate substitution programs AND Hep C treatment
• Address barriers to health care for people who use injection drugs
• Need infrastructure to deliver care to marginalized groups
J. Feld NCRTP-HCV 2013G. Dore NCRTP-HCV 2013
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Specific populations
• Post-liver transplant• Pregnant people• People who use drugs
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Hep C treatment post-liver transplant
Case study of a young woman with Hep C who had a liver transplant
First successful treatment of post-liver transplant hepatitis C fibrosing cholestatic hepatitis with boceprevir, peginterferon and ribavirin in a pre-transplant null responder. Annals of Hepatology 12(1):156-60 (2013)
J. Ford CAHN 2013
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Hep C and Pregnancy
• Person who is pregnant to child transmission of hep C accounts for 10% of Hep C cases
• Higher number of Hep C variants transmitted when the person who is pregnant is also co-infected with HIV-1 (4-fold risk of transmission to child)
• Those who are pregnant must be screened for Hep C
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Hep C and people who use drugs
• People who use drugs are just as treatment adherent as those who don’t use drugs
• Information, education and support is needed• Patient ‘citizenship’ (agency) is needed and can be
developed with assistance from peers and front-line workers
• Multi-disciplinary approach to care, treatment and support is essential
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Hep C and people who use drugs
• East Toronto Hepatitis C Program is one model of a multi-disciplinary approach
• Client / Patient, caregiver alliance• People who have been marginalized often crave a
sense of ‘community’• One-stop shop provides: screening/testing, peer
workers, treating physicians, nurses/nurse practitioners, social workers, counsellors, psychiatrist, support group, engaging activities (meals, discussions), all working together with the client/patient as the focus.
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Hep C and people who use drugs
• There is ‘memory’ in terms of successful immune response following Hep C infection and this is protective
• Encouraging news for anyone who becomes re-infected, including people who use drugs, as some people, including drug users, have resolved two successive infections
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Screening / Testing and cost-effectiveness
• Several ways to screen for the Hep C virus
• Risk-based approach (Example - testing all people who inject drugs)
• Population-based approach (Example - testing all people of a certain age or people from a country where Hep C is endemic)
• Using clinical results such as ALT levels (Alanine transaminase)
Dr. Bryce Smith (CDCP) – Population-based Strategies for HCV Testing
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Screening / Testing and cost-effectiveness
• Cost-effectiveness of population-based screening
• Directly related to higher prevalence and burden of disease
• In the U.S., persons in 1945-1965 birth cohort are 5X more likely to test positive for antibodies to Hep C (anti-Hep C) than other cohorts -prevalence 3.25%
Dr. Murray Krahn (UHN) – Hepatitis C Treatment Cost Effectiveness: A Synthesis of Available DataMaxim Trubnikov (PHAC) – Increased Reported Rates of HCV in Canadian “Baby Boomers”: Results of a 20 Year Cohort Analysis of Nationally Reported Data
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Screening / Testing and cost-effectiveness
• In the U.S., the Centre for Disease Control (CDC) suggested that one-time only testing of this birth cohort would diagnose many new cases, substantially reducing burden of disease
• In the U.S., immigrant populations could also benefit from one-time testing
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Screening / Testing and cost-effectiveness
• Some cost-effectiveness studies of Hep C testing and treatment have over-estimated the benefits
• Boceprevir and telaprevir both cost-effective, however boceprevir more-so that telaprevir
• Most pronounced health outcomes are found in those who are midway through Hep C disease progression, much lesser benefits later
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Fibroscan testing
• Greater access to fibroscan testing• Better clinical guidelines for fibroscanning• Better reimbursement policies through
government formularies, across the country
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The Debate: Baby boomer testing
• Testing and Screening for Hepatitis C Virus Infection: Should we screen everyone born between 1945-1965?
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The Debate: Baby boomer testing (Pro)
Dr. Bryce Smith
• Catch more Hep C positive results in a cohort vsrisk-based testing
• Cost-effective when compared to other diseases• Other benefits include Hep A and B vaccinations,
behaviour change in alcohol consumption
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The Debate: Baby boomer testing (Con)
Dr. Greg Dore (Con)
• Current surveillance data in U.S. is flawed • Access to treatment for boomers will be
problematic
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Action Hepatitis Canada
• New name!
Action Hepatitis Canada / Action hépatites Canada
• New tagline:
Ensuring an equitable response to hepatitis B & C /Assurer une réponse equitable à l’hépatite B et C.
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Action Hepatitis CanadaBack (L-R): Annika Ollner (PASAN), Billie Potkonjak (CLF), Deb Schmitz (Pacific Hep C Network), Colin Green (Hep NS), Patricia Bacon (Blood Ties), Paul Sutton (CTAC). Front (L-R): Jeff Rice (CATIE), Alexandre Laporte (Hépatites Ressources), Cheryl Reitz (Hep C BC), Douglas Laird. Missing: Danny Sung (SFU), Michel Long (CHS), Karyne Giguère (CAPAHC) 39
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Community RapporteursL-R: Billie Potkonjak (CLF), Jeff Rice (CATIE), Paul Sutton (CTAC) Deb Schmitz (Pacific Hep C Network), Colin Green (Hep NS), Patricia Bacon (Blood Ties), Hywel Tuscano (CATIE), Scott Anderson (CATIE), Annika Ollner (PASAN), Cheryl Reitz (Hep C BC), Lara Barker (CATIE). Missing: Alexandre Laporte (Hépatites Ressources), Danny Sung (SFU). 40
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Thank you
• Dr. Jordan Feld• Dr. Stephen Shafran• Colina Yim
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Future CATIE webinar
New Developments in HCV Research and their implications for front-line practice
Dr. Curtis Cooper, Ottawa Hospital Research InstituteMonday, June 17 English webinarDate of French webinar TBA
Topics include: new HCV treatments in pipeline, HCV-HCV coinfection, sexual transmission of HCV, new multidisciplinary service delivery model, and others
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Organization Links
• Canadian Association for the Study of the Liver (CASL) - http://www.hepatology.ca/
• Canadian Association of Gastroenterology (CAG) -http://www.cag-acg.org/
• Canadian Association of Hepatology Nurses (CAHN) -http://www.livernurses.org/
• National CIHR Research Training Program in Hepatitis C (NCRTP-HepC)- http://www.ncrtp-hepc.ca/
• Action Hepatitis Canada -http://www.canadianhepatitiscoalition.ca/
• CATIE – http://www.catie.ca/ ; www.hepcinfo.ca
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Resources
• Management of chronic hepatitis B: Canadian Association for the Study of the Liver consensus guidelines
• Management of chronic hepatitis C: Canadian Association for the Study of the Liver consensus guidelines
• Available at www.hepatology.ca• Hepatitis C infection, antiviral treatment and
mental health: a European expert consensus statement. www.elpa-info.org
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Contact information
• Jeff Rice – Hepatitis C [email protected]
• Scott Anderson – Hepatitis C Researcher/Writer
Catie.caHepcinfo.ca
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Keep in-touch with us, find out what’s new from CATIE, and stay in the loop on the newest HIV and HCV treatment and prevention information.
Join in the conversation! Join us on Twitter and Facebook!
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