The Beckoning Future:   How Hepatitis C Drugs in Development   May Affect Practice Today and TomorrowThis program is suppo...
How Hepatitis C Drugs in Development May Affect Practice Today and Tomorrowclinicaloptions.com/hepatitis About These Slide...
How Hepatitis C Drugs in Development May Affect Practice Today and Tomorrowclinicaloptions.com/hepatitis Program Faculty P...
How Hepatitis C Drugs in Development May Affect Practice Today and Tomorrowclinicaloptions.com/hepatitis Faculty Disclosur...
How Hepatitis C Drugs in Development May Affect Practice Today and Tomorrowclinicaloptions.com/hepatitis Faculty Disclosur...
Today’s Direct-Acting Antivirals:Benefits and LimitationsNezam H. Afdhal, MD, FRCPIAssociate Professor of MedicineHarvard ...
How Hepatitis C Drugs in Development May Affect Practice Today and Tomorrowclinicaloptions.com/hepatitis To Treat or Not t...
How Have Boceprevir andTelaprevir Improved HCV Care?
How Hepatitis C Drugs in Development May Affect Practice Today and Tomorrowclinicaloptions.com/hepatitis Boceprevir or Tel...
How Hepatitis C Drugs in Development May Affect Practice Today and Tomorrowclinicaloptions.com/hepatitis Telaprevir in Gen...
How Hepatitis C Drugs in Development May Affect Practice Today and Tomorrowclinicaloptions.com/hepatitis Boceprevir in Gen...
How Hepatitis C Drugs in Development May Affect Practice Today and Tomorrowclinicaloptions.com/hepatitis SVR Rates With BO...
How Hepatitis C Drugs in Development May Affect Practice Today and Tomorrowclinicaloptions.com/hepatitis High SVR Rates Ac...
How Hepatitis C Drugs in Development May Affect Practice Today and Tomorrow clinicaloptions.com/hepatitis    SVR Rates Wit...
What New Challenges HaveBoceprevir and Telaprevir       Presented?
…download the full PowerPoint slideset for   self-study or use in your own educational   presentations at:   clinicaloptio...
Upcoming SlideShare
Loading in...5
×

The Beckoning Future: How Hepatitis C Drugs in Development May Affect Practice Today and Tomorrow

716

Published on

Review the current benefits and limitations with protease inhibitor-based HCV therapies, and the emerging data on potential future regimens, and the advances they represent

Published in: Health & Medicine, Business
0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total Views
716
On Slideshare
0
From Embeds
0
Number of Embeds
0
Actions
Shares
0
Downloads
0
Comments
0
Likes
0
Embeds 0
No embeds

No notes for slide

The Beckoning Future: How Hepatitis C Drugs in Development May Affect Practice Today and Tomorrow

  1. 1. The Beckoning Future: How Hepatitis C Drugs in Development May Affect Practice Today and TomorrowThis program is supported by educational grants fromOriginally posted 11/15/2011 at clinicaloptions.com/ss/HCVFuture
  2. 2. How Hepatitis C Drugs in Development May Affect Practice Today and Tomorrowclinicaloptions.com/hepatitis About These Slides  Users are encouraged to use these slides in their own noncommercial presentations, but we ask that content and attribution not be changed. Users are asked to honor this intent  This abbreviated slideset was posted to SlideShare to publicize the availability of the full slideset. These slides may not be published or posted online without permission from CCO (email permissions@clinicaloptions.com) Disclaimer The materials published on the Clinical Care Options Web site reflect the views of the authors of the CCO material, not those of Clinical Care Options, LLC, the CME providers, or the companies providing educational grants. The materials may discuss uses and dosages for therapeutic products that have not been approved by the United States Food and Drug Administration. A qualified healthcare professional should be consulted before using any therapeutic product discussed. Readers should verify all information and data before treating patients or using any therapies described in these materials.
  3. 3. How Hepatitis C Drugs in Development May Affect Practice Today and Tomorrowclinicaloptions.com/hepatitis Program Faculty Program Director: Eric Lawitz, MD, CPI Medical Director Stefan Zeuzem, MD Alamo Medical Research Professor of Medicine Hepatologist Chief, Department of Medicine I Camden Medical Center JW Goethe University Hospital San Antonio, Texas Frankfurt, Germany Faculty: Andrew J. Muir, MD, MHS Nezam H. Afdhal, MD, FRCPI Associate Professor of Medicine Division of Gastroenterology Associate Professor of Medicine Director, Gastroenterology/Hepatology Harvard Medical School Research Chief of Hepatology Duke Clinical Research Institute Beth Israel Deaconess Medical Center Duke University School of Medicine Boston, Massachusetts Durham, North Carolina
  4. 4. How Hepatitis C Drugs in Development May Affect Practice Today and Tomorrowclinicaloptions.com/hepatitis Faculty Disclosures Nezam H. Afdhal, MD, FRCPI, has disclosed that he has received consulting fees from Biogen, Biolex, Boehringer Ingelheim, Echosens, Fibrogen, Gilead Sciences, GlaxoSmithKline, Human Genome Sciences, Idera Pharmaceuticals, Ligand, Merck/Schering-Plough, Novartis, Spring Bank, and Vertex; and has contracted research with Echosens, Gilead Sciences, GlaxoSmithKline, Merck/Schering-Plough, Novartis, Quest, and Vertex. Eric Lawitz, MD, CPI, has disclosed that he has received research or grant support from Abbott, Achillion, Anadys, Biolex, Boehringer Ingelheim, Bristol- Myers Squibb, Gilead Sciences, GlaxoSmithKline, GlobeImmune, Idenix Pharmaceuticals, Idera Pharmaceuticals, Inhibitex Pharmaceuticals, Medarex, Medtronic, Merck, Novartis, Pharmasset, Pfizer, Roche, Schering-Plough, Santaris Pharmaceuticals, Scynexis Pharmaceuticals, Tibotec/Janssen Therapeutics, Vertex, ViroChem Pharma, and ZymoGenetics; is on the speaker’s bureaus for Gilead Sciences, Merck, and Vertex; and is on the advisory board for Abbott, Achillion, Anadys, Biolex, GlobeImmune, Inhibitex, Merck, Pharmasset, and Tibotec/Janssen Therapeutics.
  5. 5. How Hepatitis C Drugs in Development May Affect Practice Today and Tomorrowclinicaloptions.com/hepatitis Faculty Disclosures Andrew J. Muir, MD, MHS, has disclosed that he has received grant or research support from Abbott, Anadys, Gilead Sciences, GlaxoSmithKline, Idera Pharmaceutical, Inc, Medtronic, Merck, Pfizer, Pharmasset, Roche, Scynexis, Santaris, Three Rivers Pharma, Vertex, and Zymogenetics; and has received consulting fees from Bristol-Myers Squibb, Merck, Pharmasset, Salix, Santaris, Vertex, and Zymogenetics. Stefan Zeuzem, MD, has disclosed that he has received consulting fees from Abbott, Anadys, Achillion, Boehringer-Ingelheim, Bristol-Myers Squibb, Gilead Sciences, iTherX, Janssen Therapeutics, Merck, Novartis, Pfizer, Pharmasset, Roche, Santaris, and Vertex; and has received fees for non-CME services from Bristol-Myers Squibb, Gilead Sciences, Novartis, Merck, and Roche.
  6. 6. Today’s Direct-Acting Antivirals:Benefits and LimitationsNezam H. Afdhal, MD, FRCPIAssociate Professor of MedicineHarvard Medical SchoolChief of HepatologyBeth Israel Deaconess Medical CenterBoston, Massachusetts
  7. 7. How Hepatitis C Drugs in Development May Affect Practice Today and Tomorrowclinicaloptions.com/hepatitis To Treat or Not to Treat: A Constellation of Considerations Genotype: Histologic stage Duration of virus, 20%+ lifetime risk infection patient (IL28B) of cirrhosis Personal plans Family and (marriage, Age other support pregnancy) Patient mindset ALT Occupation Extrahepatic Contraindications features HIV coinfection & comorbidities; (fatigue, EMC, PCT) insulin resistance
  8. 8. How Have Boceprevir andTelaprevir Improved HCV Care?
  9. 9. How Hepatitis C Drugs in Development May Affect Practice Today and Tomorrowclinicaloptions.com/hepatitis Boceprevir or Telaprevir + PegIFN/RBV: The New Standard of Care for Genotype 1  Potent inhibitors of HCV NS3/4A protease  Both approved by FDA and EMA in mid 2011 – Indicated in combination with pegIFN/RBV for treatment of genotype 1 HCV–infected patients – Previously untreated or previous treatment failuresTelaprevir [package insert]. May 2011. Boceprevir [package insert]. May 2011.EMA. Telaprevir [package insert] 2011. EMA. Boceprevir [package insert] 2011.
  10. 10. How Hepatitis C Drugs in Development May Affect Practice Today and Tomorrowclinicaloptions.com/hepatitis Telaprevir in Genotype 1 Patients  750 mg (two 375-mg tablets) q8hr with food (not low fat; standard fat meal is 21 g, eg, 1/2-cup nuts or 2-oz cheddar cheese) Treatment Naive and Previous Relapsers eRVR; stop at Wk 24 TVR + PR PR No eRVR; PR Previous Partial or Null Responders TVR + PR PR 0 4 12 24 48  Treatment-naive patients with compensated cirrhosis and eRVR may benefit from additional 36 wks of pegIFN + RBV (ie, to Wk 48) Time Point Criterion Stopping Rule Wk 4 or 12 HCV RNA > 1000 IU/mL Discontinue all therapy Wk 24 Detectable HCV RNA Discontinue PR Any Discontinuation of PR for any reason Discontinue TVRTelaprevir [package insert]. May 2011. EMA. Telaprevir [package insert] 2011.
  11. 11. How Hepatitis C Drugs in Development May Affect Practice Today and Tomorrowclinicaloptions.com/hepatitis Boceprevir in Genotype 1 Patients  800 mg (four 200-mg capsules) q8hr with meal or light snack Treatment Naive BOC + PR Early response; stop at Wk 28 PR BOC + PR PR Previous Relapsers or Partial Responders Early response; BOC + PR stop at Wk 36 PR BOC + PR PR 0 4 8 12 24 28 36 48 Wks  All cirrhotic patients should receive lead-in followed by PR + BOC for 44 wks  If considered for treatment, null responders should receive lead-in then PR + BOC for 44 wks  EMA label recommends fixed-duration therapy for all trt-expd patients: LI + 32 wks triple + 12 wks PR Time Point Criterion Stopping Rule Wk 12 HCV RNA ≥ 100 IU/mL Discontinue all therapy Wk 24 Detectable HCV RNA Discontinue all therapy Any Discontinuation of PR for any reason Discontinue BOCBoceprevir [package insert]. May 2011. EMA. Boceprevir [package insert] 2011.
  12. 12. How Hepatitis C Drugs in Development May Affect Practice Today and Tomorrowclinicaloptions.com/hepatitis SVR Rates With BOC or TVR in Genotype 1 Treatment-Naive Patients 100 80 63-75 60 SVR (%) 38-44 40 20 0 PegIFN/RBV BOC or TVR + PegIFN/RBVPoordad F, et al. N Engl J Med. 2011;364:1195-1206.Jacobson IM, et al. N Engl J Med. 2011;364:2405-2416.
  13. 13. How Hepatitis C Drugs in Development May Affect Practice Today and Tomorrowclinicaloptions.com/hepatitis High SVR Rates Across Baseline Patient and Virus Factors ADVANCE: TVR + PegIFN/RBV in Treatment-Naive Genotype 1 Data from T12PR arm only 100 79 78 78 74 75 71 62 SVR (%) 50 25 n/ 118/ 152/ 64/ 207/ 226/ 45/ N = 149 213 82 281 290 73 0 1b 1a < 800K ≥ 800K F0-2 F3-F4 Genotype HCV RNA (IU/mL) FibrosisJacobson IM, et al. N Engl J Med. 2011;364:2405-2416.
  14. 14. How Hepatitis C Drugs in Development May Affect Practice Today and Tomorrow clinicaloptions.com/hepatitis SVR Rates With BOC or TVR in GT1 Treatment-Experienced Patients 100 PegIFN + RBV 69-83 80 BOC or TVR + PegIFN + RBV 60 40-59SVR (%) 40 29-38 24-29 20 7-15 5 0 Relapsers Partial Responders Null RespondersBacon BR, et al. N Engl J Med. 2011;364:1207-1217. Zeuzem S, et al. N Engl J Med.2011;364:2417-2428.Vierling JM, et al. AASLD 2011. Abstract 931.
  15. 15. What New Challenges HaveBoceprevir and Telaprevir Presented?
  16. 16. …download the full PowerPoint slideset for self-study or use in your own educational presentations at: clinicaloptions.com/ss/HCVFutureGo online for more from CCO Hepatitis, including:Conference Coverage of major liver diseasemeetings; Capsule Summaries and ExpertCommentaries on key papers in the literature; andCME-certified Treatment Updates onkey elements of HCV managementMore ways to connect with CCO:

×