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HIV-HCV Coinfection in the era of effective antiviral therapy

HIV-HCV Coinfection in the era of effective antiviral therapy. Mark Sulkowski, MD Professor of Medicine Medical Director, Viral Hepatitis Center Johns Hopkins University Baltimore Maryland USA.

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HIV-HCV Coinfection in the era of effective antiviral therapy

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  1. HIV-HCV Coinfection in the era of effective antiviral therapy Mark Sulkowski, MD Professor of Medicine Medical Director, Viral Hepatitis Center Johns Hopkins University Baltimore Maryland USA

  2. Liver disease is the second leading specific causes of death amongst HIV-positive individuals in the D:A:D study AIDS. 2010 Jun 19;24(10):1537-48.

  3. SVR or virologic relapse following HCV treatment was associated improved survival Sulkowski MS, et al. CROI 2010. Abstract 166.

  4. Ribavirin800 mg/day (n=135) Ribavirin 1000/1200 mg/day (n=275) SVR rates among HIV/HCV coinfected patients treated with PegIFN alfa-2a/RBV 50 40 30 26 24 SVR (%) 22 86 176 20 20 19 275 62 13 135 77 9 10 5 33 40 0 All patients Caucasian Hispanic Black Rodriguez-Torres et al. AASLD 2009

  5. Telaprevir and Boceprevir in HCV/HIV coinfected patients • All contraindications to PegIFN/RBV apply • Coadministration with other drugs • Highly dependent on CYP3A for clearance • Strongly induce CYP3A • Safety and efficacy not established in persons coinfected with HIV Telaprevir and Boceprevir; Prescribing information, May 2011

  6. Phase 2 studies of HCV PI + PR

  7. Efficacy

  8. Undetectable HCV RNA over 24 weeks:Telaprevir (12 wks) + PR Vs. PR

  9. % Patients With Undetectable HCV RNA 8/32 35/62 3/34 5/34 24/64 11/32 43/61 3/64

  10. Safety and Tolerability

  11. Telaprevir + PR No severe rash report with TVR TVR/PR - bilirubin AEs 27% (4/15) versus none of control (0/8)

  12. Telaprevir + PR

  13. Virologic Breakthrough • No HIV RNA breakthrough • HCV RNA breakthrough, 7 patients • Efavirenz, 4 of 16 • Atazanavir/r, 3 of 15

  14. Boceprevir + PR: Most Common Adverse Events With a Difference of ≥10% Between Groups *A difference of ≥10% for patients receiving PEG2b/RBV+BOC when compared with PEG2b/RBV.

  15. Safety Boceprevir + PR

  16. Boceprevir + PR: Hematologic AEs *To maintain blinding in this continuing study the table only shows data where events occurred in at least 1 patient in each treatment group.

  17. Virologic Breakthrough • HIV RNA breakthrough, 4 patients • 2 on placebo • 2 on BOC + ATV/r with increase HIV RNA • No HCV RNA breakthrough reported

  18. Drug Interactions

  19. Telaprevir – ARV Interactions Thomas DL et al. ClinInfec Diseases 2011 in press

  20. Boceprevir Drug Interactions with ART (limited data) Interaction studies of BOC and Atazanavir/r, Daruanvir/r, and Lopinavir/r have been completed. Boceprevir capsules [package insert]. Whitehouse Station, NJ: Merck & Co., Inc.; 2011.

  21. Provisional use of HCV PIs in HIV/HCV coinfected patients • Referral to clinical trials is strongly recommended • PegIFN + Ribavirin remains an appropriate regimen for many co-infected patient • However, if available, data support the cautious use of telaprevir or boceprevir + PR in carefully selected patients: • No antiretroviral therapy  TVR or BOC • RAL  TVR or BOC • ATV/r  TVR • EFV  TVR (requires increase TVR dose) • Other ARVs  Insufficient data; NOT recommended • Major limitations to therapy • Efficacy and tolerability of PegIFN • Cost

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