Clinical and Ethical Issues in Managing HCV Co-Infection Curtis - - PowerPoint PPT Presentation

clinical and ethical issues in managing hcv co infection
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Clinical and Ethical Issues in Managing HCV Co-Infection Curtis - - PowerPoint PPT Presentation

Clinical and Ethical Issues in Managing HCV Co-Infection Curtis Cooper, MD, FRCPC Associate Professor of Medicine University of Ottawa Division of Infectious Diseases Disclosures Industry Investigator: Merck, GS, Abbvie


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Clinical and Ethical Issues in Managing HCV Co-Infection

Curtis Cooper, MD, FRCPC

Associate Professor of Medicine University of Ottawa Division of Infectious Diseases

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Disclosures

  • Industry

– Investigator: Merck, GS, Abbvie – Consultant /Advisor: Merck, GS, Abbvie – Speaker: Merck, GS, Abbvie

  • Government

– MOH – OHTN – CIHR – CDR – Health Canada – MAC-FI HIV, HCV

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HIV-HCV Co-Infection

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Case

 45 yo HIV-HCV male  Risk Factor- IDU- still active  Used ETOH in the past now the occasional

bender

 HIV- Atripla x 6 years  Episodes of treatment interruption but when on

ARVs, rarely misses

 CD4- 450  HIV RNA- <40

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Case

 Likely HCV-infected in early 20’s  Genotype 1  HCV RNA 7.8 x 105IU/mL  Received Peg-IFN / RBV in 2007 but interrupted

after 6 weeks for poor tolerance and a ‘bender’ (RNA declined by about 2 logs at week 4)

 Bx in 2006 suggested stage 2 fibrosis but poor

quality and during a period of excess alcohol use

 No Fibroscan performed but APRI 1.8

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Case

 Patient is a daily MJ users and frequently takes

‘liver cleansing’ remedies

 Has a longstanding PPI prescription which he

uses PRN for GERD

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Case

 Patient wants therapy now….  Key questions:

 What are the DAA treatment options?  What are the DDI concerns?  What is the best fibrosis assessment modality?  What about re-infection risk?  Are HCV treatment outcomes really as good in HIV-

HCV co-infection as they are in HCV mono-infection?

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Canadian HIV/Hepatitis C Management and Treatment Guidelines CIHR CANADIAN HIV TRIALS NETWORK (CTN)

  • Similar mx in HIV-HCV as HCV mono-infection
  • Anticipated SVR rates in HIV-HCV co-infection

are similar to HCV mono-infection with interferon- free, DAA regimens

  • Carefully evaluate for DDIs before and during

treatment

  • Select ARVs in anticipation of subsequent HCV

DAA treatment

  • Discuss harm reduction strategies in those at risk

for HCV exposure

  • Active injection drug use
  • MSM
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Key Co‐Infection Regimens

  • Sofosbuvir + daclatasvir

(ALLY‐2) (N=203)1

  • Grazoprevir + elbasvir

(C‐EDGE) (n=218)2

Adapted from

  • 1. Levin J, et al. Presented at EASL 2015; Poster #P1353.
  • 2. Rockstroh JK, et al. Presented at EASL 2015; Poster #P0887.

Treatment-naive Treatment- experienced

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Naïve vs Experienced Overall Cirrhosis Status Overall HCV Rx Experienced HCV Rx Naïve No Cirrhosis Cirrhosis 321/335 142/150 179/185 63/67 258/268

SVR12 (%)

10

ION‐4

Overall

Error bars represent 95% confidence intervals.

Naggie S, et al. ION-4 Study. NEJM 2015

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Results: SVR12 by Cirrhosis or Prior Treatment

†Patients LTFU were incarcerated, one patient on Day 1 and one patient on Week 4

Error bars represent 95% confidence intervals. Brau, IAS, 2016; Data on File, Gilead Sciences.

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ASTRAL-5 HIV/HCV Coinfection Study 95 94 100 93 97 94 97 20 40 60 80 100 SVR12 (%)

82 87 19 19 71 75 30 31

Non‐ cirrhotics Cirrhotics Treatment Naïve Treatment Experienced Total

101 106

High SVR12 achieved in HIV‐coinfected patients regardless of cirrhosis status and treatment experience

45 48 56 58

Black Non‐black

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Drug-Drug Interactions between HCV DAAs and HIV Antiretrovirals

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Impact of DAA Regimens on Co-Infection Guidelines

 Priority shifts from early HIV treatment to early HCV treatment  Fewer contraindications for HCV treatment  Target populations for HCV antiviral tx is expanded  Issues related to DDI reduced  Benefits for Patient-Health Care Team relationship  Increased network of HCV treaters

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Barriers

 Concentration of Barriers to Engagement and

Treatment Success

 Socioeconomic  Mental Health  Substance Abuse  Stigma  Diverse populations within the HIV community

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Research Needs

 Non-Genotype 1 Treatment  Treatment of HIV-HCV co-infection in more

advanced disease

 RGT  HCV treatment post OLT

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HIV-HCV Management Conclusions

 Gap in SVR has been bridged  Safety and tolerability issues eliminated  Tx issues not unique to HIV-HCV  Same general approach to work-up, treatment

and long-term follow-up

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Discussion