kronik hcv güncel tedavisi & evliya Çelebi e.a.h ...¼ncel-tedavisi...non-sirotik veya...
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Kronik HCV güncel tedavisi & Evliya Çelebi E.A.H. Gastroenteroloji
verileri
Dr.Süleyman Coşgun
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İngilterede yapılan bir araştırmaya göre
karaciğer kaynaklı mortalide artışı
1971–2007
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Tüm dünyada HCV – 250 million
World Health Organization. Hepatitis C. Fact sheet Number 164, revised October 2000.
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Bulaş yolları
• Kan ve kan ürünü transfüzyonu
• Enfekte iğne(kaynatma)
• Dövme/ piercing
• Uyuşturucu bağımlısı
• Perinatal geçiş
• Girişimler
– Diş
– Hemodiyaliz
• Cinsel temas?
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Alternatif bulaş yolları
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HCV yaşam döngüsü
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Genotip
adapted from Los Alamos National Laboratory HCV sequence database, http://hcv.lanl.gov
GT 1
GT 2
GT3
GT 5
GT 4 GT 6
GT 7
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〜15% 6 ay içinde
〜85%
Decompensated
Virüs temizlenmesi
Akut HCV
%20–30 kişi asemptomatik
kronic HCV
HCC
Yılda %7
Siroz
% 10−20 (20 yıl)
Dekompanse siroz
HCV seyir ve prognoz
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Kronik viral hepatit– Hastalık seyri
Kronik
hepatit
Siroz HCC(ve siroz)
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İleri karaciğer yetmezliği komplikasyonları
Ascites
Varis
Sarılık
Kaput medusa
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HCV ve ekstrahepatik bulgular
Hematolojik • Mix cryglobulinemi • Aplastik anemi
• Trombositopeni
• Non-Hodgkin b-cell lenfoma
Endokrin • Hipotiroidi
• DM
Dermatolojik • Porfiria kutanea tarda
• Liken planus
• Kutanöz nekrotizan vaskülit
Renal • Glomerülonefrit • Nefrotik sendrom
Oküler • Korneal Ülser • Üveit
Vasküler • Nekrotizan vaskülit • PAN
Nöromusküler • Güçsüzlük, miyalji • Periferal nöropati • Artrit, artralji
Otoimmün fenomen
• CREST ssendromu
Nöropsikiyatrik
• Depresyon
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HIV ve HBV enfeksiyonunun aksine Kronik HCV enfeksiyonunda kür elde edilebilir(siroz ise komplikasyonlar açısından takibe
devam)
Akut
enfeksiyon
Kronik
enfeksiyon
Başarılı tedavi
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SVR GT1
0
20
40
60
80
100
IFN 6 mo
IFN 12 mo
IFN/RBV 6 mo
IFN/RBV 12 mo
PEG-IFN 12 mo
PEG-IFN/RBV 12 mo
PI/PEG-IFN/RBV 6-12 mo
68-75
54-56
39 42 34
16
6
1986 1998 2002 2001 2011
SV
R R
ate
(%
)
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Genotip 1/4 PEG-IFN/RBV: 〜50%
Genotip 2 PEG-IFN/RBV: 〜80%
Genotip 3 PEG-IFN/RBV: 〜70%
HCV genotipi-tedavi başarısı
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IL28B gen haplotiplemesi ve İNF bazlı
rejimde SVR prediksiyonu
Haplotipleme
CC CT TT CC CT TT CC CT TT
IL28B
% S
VR
Ge et al. Nature. 2009
80
42
70
40
22
42
35
2024
0
10
20
30
40
50
60
70
80
90
European Americans African Americans Hispanics
CC CT TT CC CT TT CC CT TT
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Proteaz inhibitörleri
• 1. jenerasyon
– HCV replikasyonunu inhibe eden onaylanmış ilk ilaçlar
– anti-HCV ilaçlardan «direct acting antivirals (DAAs)»
Denenlerin ilkleri
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Proteaz ilavesi ile SVR
0
20
40
60
80
100
IFN 6 mo
IFN 12 mo
IFN/RBV 6 mo
IFN/RBV 12 mo
PEG-IFN 12 mo
PEG-IFN/RBV 12 mo
PI/PEG-IFN/RBV 6-12 mo
68-75
54-56
39 42 34
16
6
1986 1998 2002 2001 2011
SV
R R
ate
(%
)
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HCV yaşam döngüsünde «Direct-Acting Antivirals (DAAs)» ilaçların hedefi
Translation and polyprotein processing
NS3/4
protease
inhibitors
Receptor binding
and endocytosis Transport
and release
Virion
assembly
RNA replication
Fusion and uncoating
(+) RNA
Membranous web
NS5B polymerase
inhibitors
Nucleos(t)ide
Non-nucleoside
NS5A inhibitors
Replication and assembly
• HCV replikasyon mekanizmalarının ortaya çıkarılması ilave DAA sınıflarının geliştirilmesine yol açmıştır.
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DAA Sınıf özellikleri
Source: J Viral Hepat, 2012 Blackwell publishing
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İdeal tedavi • Etkinlik
– Hastalığın evresinden ve virüse ve bireye özgü farklardan bağımsız yüksek etkin olmalı(ileri evre siroz, ırk, cins, hastanın genetiği, BMI, HCV genotipi)
• Güvenlik – Tolere edilebilir ilaç – Minimal yan etki – İleri evrede bile güvenli, komorbid durumlarda(KBY)
kullanışlı
• Basit – Oral tedavi – Kısa süre – Günlük tablet sayısı – Minimal ilaç-ilaç etkileşimi – Her genotipe etkili tek bir rejim
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İnterferonlu ve interferonsuz rejimlerde SVR
0
20
40
60
80
100
IFN 6 mo
IFN 12 mo
IFN/RBV 6 mo
IFN/RBV 12 mo
PEG-IFN 12 mo
PEG-IFN/RBV 12 mo
PI/PEG-IFN/RBV 6-12 mo
68-75
54-56
39 42
34
16
6
1986 1998 2002 2001 2011
SV
R R
ate
(%
)
>90
DAA +/-RBV 8-24weeks
2014
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NS3/4A proteaz inhibitörleri sonu –previr
NS5A inhibitörleri sonu -asvir
NS5B polimeraz inhibitörleri sonu -buvir
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Yeni onaylı ilaçlar
1 tablet/gün yemekle Vosevi
3 tablet/gün yemekle Mavyret
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ilaçlar
• Sofosbuvir (aç veya tok)
400mg/gün
%80 atılım böbrek, %15 feçes
GFR<30? Diyaliz hastası?
Amiodaron!!!
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• Sofosbuvir+ledipasvir 400mg+90mg (aç veya tok)
Ledipasvir safra ile atılım
GFR ve Diyaliz!!!
En yaygın yan etki halsizlik ve baş ağrısı
www.hep-druginteractions.com
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• Sofosbuvir+velpatasvir 400mg+100mg(aç veya tok)
Velpatasvir major ekskresyonu biliyer
Baş ağrısı, halsizlik, bulantı en yaygın yan etkisi
GFR ve Diyaliz!!!
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• Sofosbuvir+velpatasvir+voxilaprevir (400mg+100mg+100mg) 1x1 yemekle birlikte
Voxilaprevir büyük oranda biliyer ekskrese
Child A da verilebilir, B de önerilmez, C de kontraindike
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• Ritonavir+paritaprevir+Ombitasvir(50mg+75mg+12,5mg) 1x2 yemekle birlikte
• +dasabuvir250mg2x1 • Genotip 1 • Paritaprevir fekal • Ombitasvir fekal • Dasabuvir hepatobiliyer • En yaygın yan etkiler yorgunluk ve bulantı • Child B ve C de önerilmiyor • KBY ve diyaliz hastalarında kullanılabiliyor • İlaç etkileşimi dikkat!!!
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• Grazoprevir+elbasvir (100mg+50mg) 1x1 aç veya tok
• biliyer ve fekal ekskresyon
• Child B ve C de önerilmez
• Hafif-orta-ağır renal yetmezlikte doz ayarlama önerilmez
• Yorgunluk ve başağrısı
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• Glecaprevir+pibrentasvir(100mg+40mg)
• 1x3 yemekle birlikte
• Major eliminasyon biliyer
• Child B ve C de kontrendike
• En sık yan etki baş ağrısı ve yorgunluk
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Non-sirotik veya kompanse sirotik
• * Triple combination therapy efficacious but not useful due to the efficacy of double combination regimens. a Treatment-naïve patients without cirrhosis or with compensated (Child-Pugh A) cirrhosis. b Treatment-naïve and treatment-experienced patients without cirrhosis or with compensated (Child-Pugh A) cirrhosis with an HCV RNA level ≤800,000IU/ ml (5.9 Log10 IU/ml). c Treatment-naïve and treatment-experienced patients without cirrhosis. d Treatment-naïve and treatment-experienced patients with compensated (Child-Pugh A) cirrhosis. e Treatment-naïve patients without cirrhosis or with compensated (Child-Pugh A) cirrhosis with an HCV RNA level ≤800,000 IU/ml (5.9 Log10 IU/ml).
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Tedavi naif veya deneyimli non sirotik
%98 %98 %98 %97
%99 %100 %100 %99 %99
%99 %98
%98 %95
%100 %99 %95 %100
%97 %100 %95
%97 %100 %96
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Tedavi naif veya deneymili kompanse sirotik
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Nakil gerektiren veya gerektirmeyen ileri karaciğer hastası
• Tedavi edilmemiş hastada nakil sonrası nüks
• Nakil öncesi tedavi nüksü önler ve nakile kadar karaciğeri stabilize edebilir
• Canlıda nakil zamanı öngörülür
• Kadavra bekleyen hastada ise ne zaman organ bulunacağı bilinemez, belki daha tam eradikasyon sağlanamadan organ bulunup nakile çağrılabilir
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• Nakil listesinden çıkarılıp tedavi başlanırsa bu süreçte hastalık ilerleyebilir, HCC gelişip hasta kaybedilebilir, nakil bu süreçte ertelenmeyip önce nakil sonra HCV tedavisi daha uygun olur.
• Proteaz inhibitörleri dekompanse sirozda önerilmez, daha önce dekompansasyon atağı yaşayan hastada da önerilmez
Nakil gerektiren veya gerektirmeyen ileri karaciğer hastası
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Evliya Çelebi
• 28E
• 57K
• -------------
• 30TD
• 55Naif
• ---------
• Genotip3 2hasta
• Genotip4 1 hasta
• 49 non sirotik
• 21 kompanse
• 15 dekompanse
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• 42bx+ • 43bx- • --------------- • 6 6/6 • 3 5/6 • 9 4/6 • 11 3/6 • 9 2/6 • 4 1/6
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• 24 SOF/LDV
• 5 SOF/LDV/RBV
• 2 SOF/RBV
• 37 OBV/PTV/r+DSV
• 16 OBV/PTV/r+DSV/RBV
• 1 DSV/RBV
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• 24 SOF/LDV
• 5 SOF/LDV/RBV
• 2 SOF/RBV
• 37 OBV/PTV/r+DSV
• 16 OBV/PTV/r+DSV/RBV
• 1 DSV/RBV
~ %100
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