C-HEP Meeting 2012 Controversies in the Management of Viral Hepatitis. 19. October Berlin

Transcription

1 C-HEP Meeting 2012 Controversies in the Management of Viral Hepatitis 19. October Berlin Session 4: Yes: No: HCV-therapy is for specialists only? Marion Peters, USA Michael Biermer, Germany Michael Biermer Leber- und Studienzentrum am Checkpoint Berlin Dres. med. Möller / Heyne / Möller / Biermer / Berg

2 Insulting your audience: You are not special! You are not needed anymore!

3 PSI-7977: The ELECTRON Study GT 2/3 PSI-7977 RBV 12WPEG PSI-7977 RBV 8WPEG PSI-7977 RBV 4WPEG PSI-7977 RBV 0WPEG Behandlungswoche n % <LOD n % <LOD n % <LOD n % <LOD 2 9/ /8 88 8/9 89 8/ / / / / / / / / / / / / SVR4 11/ / / / SVR12 11/ / / / SVR12 11/ / / / Gane EJ. et al. AASLD 2011# 34

4 PSI-7977: The ELECTRON Study GT 2/3 PSI-7977 RBV 12WPEG PSI-7977 RBV 8WPEG PSI-7977 RBV 4WPEG PSI-7977 RBV 0WPEG n % n % n % n % SAE Kopfschmerz Müdigkeit Depression Schlafstörung Angst Reizbarkeit Myalgie Gane EJ. et al. AASLD 2011# 34

5 C-HEP Meeting 2012 Controversies in the Management of Viral Hepatitis 19. October Berlin Session 4: Is the current HCV-therapy for specialists only? Yes: No: Marion Peters, USA Michael Biermer, Germany Michael Biermer Leber- und Studienzentrum am Checkpoint Berlin Dres. med. Möller / Heyne / Möller / Biermer / Berg

6 The specialists: October 2011: Only we can do it! July 2012: It is rather tough, may be we need the not so specialized to get the work done!

7 Physicians registered in Berlin 8 high volume Hepatology Centers including 2 University ambulances 52 patients 71 Gastroenterologists 17 Infectiologists 19 Addiction therapists 4 patients Berlin: 3,5 Mio residents 420 on PI treatm. 0,1 patients 2900 Internists / General practitioners

8 Genotype 1 CHC, prevalence in Berlin 1% - with an indication for treatment 20%??? 8 high volume Hepatology Centers including 2 University ambulances 875 patients 71 Gastroenterologists 17 Infectiologists 19 Addiction therapists 64 patients Berlin: 3,5 Mio residents 7000 patients! 2 patients 2900 Internists / General practitioners

9 A Real-life patient on PI triple therapy male 67 years - retired chronic Hep C -GT1b known since 2004, treatment naive diabetes mellitus II, hypertension ultrasound: fatty liver, no cirrhosis Med. History including a call with the diabetologist medication: Metformin, Saxagliptin, Ramipril, Nifedipin, Amitriptyllin 12.1.

10 A Real-life patient on PI triple therapy Med. History including a call with the diabetologist Patient calls: mild but itchy rash Hematology, Chem., Virology Discussion of side effects New prescription Hematology, Chem., Virology Discussion of side effects Baseline visit Stopping rule? weeks on treatment Telaprevir Peginterfon alpha + Ribavirin

11 A Real-life patient on PI triple therapy Patient calls: mild but itchy rash Hematology, Chem., Virology Discussion of side effects New prescription Med. History including a call with the diabetologist Hematology, Chem., Virology Discussion of side effects Physician s Reimbursement in Germany Baseline visit Stopping rule? 33 per quarter weeks on treatment Telaprevir Peginterfon alpha + Ribavirin

12 A Real-life patient on PI triple therapy Patient calls: mild but itchy rash Hematology, Chem., Virology Discussion of side effects New prescription Med. History including a call with the diabetologist Hematology, Chem., Virology Discussion of side effects Transfusion? Dermatologist? Baseline visit Stopping rule? weeks on treatment Telaprevir Peginterfon alpha + Ribavirin

13 HCV prevalence 1% Genotype 1 with an indication for treatment 20% 8 high volume Hepatology Centers including 2 University ambulances 875 patients 71 Gastroenterologists 17 Infectiologists 19 Addiction therapists 64 patients 3,5 Mio residents HCV patients 2 patients 2900 Internists / General practitioners

14 We can t do it all alone! 8 high volume Hepatology Centers including 2 University ambulances 71 Gastroenterologists 17 Infectiologists 3,5 Mio residents HCV patients 19 Addiction therapists 2900 Internists / General practitioners

15 The family doctor / general practitioner: knows the patient well concomittend medication / herbal extracts expected adherence to the treatment embarrassing issues ideally sees the whole family has more time for the patient?

16 SAE incidence naive treatment exp. French Early Access Programme CUPIC patients with serious adverse events (SAE) in % some with cirrhosis Advance 1 Sprint 2 2 Realize 3 Respond 2 4 ALL cirrhotic Cupic Study 5 1: Jacobsen et al. N Engl J Med Jun 23;364(25): : Poordad et al. N Engl J Med Mar 31;364(13): : Zeuzem et al. N Engl J Med Jun 23;364(25): : Bacon et al. N Engl J Med Mar 31;364(13): : Hezode et al. EASL 2012

17 Triple Therapy - Colour by numbers:

18 Triple Therapy - Colour by numbers:

19 Triple Therapy - Colour by numbers:

20 Triple Therapy - Colour by numbers:

21 Triple Therapy - Colour by numbers:

22 Provocative Question: could it be that the patient is better off when his doctor is...strictly following the rules? as compared to...playing around with treatment durations...switching from boceprevir to telaprevir...ignoring soft contraindications

23 The educative effect: Every doctor who once cured a patient from HCV......knows that this is possible!...will be more vigilant in screening for HCV!

24 55 years old diplomat s wife - GT1 naive h.o. Meningeoma Bradycardia (AV-Block 1 ) BMI: 17 NS3/4A-Inhibitor ((( once daily capsule independent from food NS5A-Inhibitor once daily tablet independent from food Aim: 12 weeks treatment Patient: I don t feel it

25 55 years old diplomat s wife - GT1 naive h.o. Meningeoma Bradycardia (AV-Block 1 ) BMI: 17 NS3/4A-Inhibitor ((( once daily capsule independent from food NS5A-Inhibitor once daily tablet independent from food

26 55 years old diplomat s wife - GT1 naive h.o. Meningeoma Bradycardia (AV-Block 1 ) BMI: 17 NS3/4A-Inhibitor ((( once daily capsule independent from food NS5A-Inhibitor once daily tablet independent from food hcvex

27 C-HEP Meeting 2017 Controversies in the Management of Viral Hepatitis 19. March Kinshasa Session 4: Yes: No: hcvex ready for OTC? Marion Peters, USA Michael Biermer, Germany Michael Biermer Leber- und Studienzentrum am Checkpoint Berlin Dres. med. Möller / Heyne / Möller / Biermer / Berg