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Management of Patients Co-infected with HCV and HIV: A Close Look at the Role for DAAs

Management of Patients Co-infected with HCV and HIV: A Close Look at the Role for DAAs. Susanna Naggie, MD Assistant Professor of Medicine Division of Infectious Diseases. Disclosures. Research: Vertex, Anandys, Synexis, Gilead, Merck, BMS

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Management of Patients Co-infected with HCV and HIV: A Close Look at the Role for DAAs

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  1. Management of Patients Co-infected with HCV and HIV: A Close Look at the Role for DAAs Susanna Naggie, MD Assistant Professor of Medicine Division of Infectious Diseases

  2. Disclosures • Research: Vertex, Anandys, Synexis, Gilead, Merck, BMS • Advisory Board: Vertex, Boehringer Ingelheim, Janssen • Speaker: None

  3. HIV & HCV • 10 million people worldwide • 30% of US patients with HIV have HCV Hepatitis C 180 million HIV 40 million Staples CT. Clin Infect Dis 1999

  4. D:A:D Study: Liver-Related Deaths in Persons with HIV 14.5% DAD Study Group, Arch Intern Med 2006 Thein et al. AIDS 2008; 22:1979 DAD Arch Intern Med;2006;166:1632

  5. Treatment Response in DAA Era

  6. Treatment • Goal of treatment: • Clinical trial definition • Sustained virologic response • What we tell patients… Cure!

  7. Who to Treat? • Prior response? • Risk stratification • Liver Biopsy • Fibroscan/non-invasive testing • Adherence • Other baseline factors • Race/ethnicity • Genotype 1 subtype

  8. HCV Genome: Polyprotein Moradpour Nature Reviews 2007; 5:453-463

  9. Viral Kinetic Parameters AASLD HCV Treatment Guidelines

  10. PK Interactions: Telaprevir & ART Van Heeswijk et al. CROI 2011 Abstract 119 and ICAAC 2011 Abstract A1-1738a

  11. Study 110 Design: Randomized, Double-blind, Placebo-controlled Trial of Telaprevir SVR T/PR TVR + PR PR Follow-up SVR PR48 (control) Pbo + PR PR Follow-up SVR T/PR TVR + PR PR Follow-up 0 12 24 36 48 60 72 Weeks Stopping/Futility Rules Part A: no ART SVR12 1:1 SVR12 Part B: ART (EFV/TDF/FTC or ATV/r + TDF + FTC or 3TC) SVR12 2:1 SVR12 SVR PR48 (control) Pbo + PR PR Follow-up Dieterich et al. CROI 2012 Abstract 46 Barritt and Fried. Gastro 2012; 142:1314

  12. Study 110: SVR-12 Interim Analysis % of Patients with Undetectable HCV RNA n/N= 5/7 11/16 12/15 28/38 2/6 4/8 4/8 10/22 Dieterich et al. CROI 2012 Abstract 46

  13. PK Interactions: Boceprevir & ART Kasserra et al. 18th CROI 2011 Abstract 118; Hulskotte et al. 19th CROI 2012 Abstract 771LB

  14. Stopping/Futility Rules Randomized, double blind, placebo controlled trial of Boceprevir Weeks 12 24 28 48 72 • Two-arm study, double-blinded for BOC, open-label for PEG2b/RBV • 2:1 randomization (experimental: control) • Boceprevir dose 800 mg TID • 4-week lead-in with PEG2b/RBV for all patients • PEG-2b 1.5 µg/kg QW; RBV 600-1400 mg/day divided BID PEG2b +RBV 4 wk Placebo + PEG2b + RBV 44 wk Follow-up SVR-24 wk Arm 1 PEG2b +RBV 4 wk Boceprevir + PEG2b + RBV 44 wk Follow-up SVR-24 wk Arm 2 Futility Rules Sulkowski et al. CROI 2012 Abstract 47 Barritt and Fried. Gastro 2012; 142:1314

  15. SVR-12 Interim Analysis % of Patients with Undetectable HCV RNA n/N= 3/34 3/64 5/34 27/64 8/34 38/64 11/34 47/64 10/34 42/64 9/34 37/61 Treatment Week Sulkowski et al. CROI 2012 Abstract 47

  16. Adverse Events Telaprevir (TVR) Boceprevir (BOC) Jacobson IM, et al. NEJM, 2011. Poordad F, et al. NEJM, 2011

  17. Other Considerations…

  18. Phase II/III Studies *Ouwerkerk-Mahadevain 19th CROI Abstract 49

  19. In a nutshell… • Access to DAA is improving • Daily dosing/fewer AEs • FDA approval 1.5 years • IFN-sparing is coming • Assess severity of liver disease • Consider HCV therapy • Treat those who can’t wait OR • Treat those who will be cured • Clinical Trial

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