Jaunākais C hepatīta ārstēšanā Latvijā. Agita Jēruma SIA RAKUS stacionārs Latvijas Infektoloģijas centrs Rīgas Stradiņa universitāte
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1 Jaunākais C hepatīta ārstēšanā Latvijā Agita Jēruma SIA RAKUS stacionārs Latvijas Infektoloģijas centrs Rīgas Stradiņa universitāte
2 Aktualitāte Specifisku sūdzību nav! gadu laikā ~20% pacientu aknu ciroze >30 gadi 50% aknu ciroze Aknu cirozes dekompensācija Asiņošana no barības vada vēnām Ascīts HCC risks 1 5% gadā
3 Hepatīta C vīruss Aprakstīts gadā (Hougton M., Choo Q-L., Kuo G., Weiner A. J.) Dzimta Flaviviridae Vienpavediena lineāra RNS ~ 9500 nukleotīdu 6 genotipi
4 HCV izplatība HCV inficēto skaits Pasaulē ~ miljoni Eiropā ~9 miljoni Latvijā ~ 40 tūkstoši 2,4% antihcv pozit. 1,7% HCV RNS pozit. I.Tolmane, B.Rozentale, J.Keiss, F.Arsa, G.Brigis, A.Zvaigzne Prevalence of Viral Hepatitis C in Latvia: Population Based Study Medicina (Kaunas) 2011;47(10): Katru gadu tiek reģistrēti 3-4 miljoni jaunu HCV infekcijas gadījumu
5 HCV izplatība
6 C hepatīta dabiskā norise Akūta inficēšanās ar C hepatīta vīrusu Subklīniska forma 85% Klīniska forma 15% Atveseļošanās 20% Hronisks C vīrushepatīts 80%
7 C hepatīta dabiskā norise Normālas aknas Hronisks iekaisums Fibroze Ciroze HCC
8 Hroniska VHC terapijas mērķi HCV iznīcināšana Novērst hroniska hepatīta progresēšanu Novērst aknu cirozes attīstību vai dekompensāciju Mazināt hepatocelulāras karcinomas attīstības risku Saglabāt un uzlabot pacienta dzīves kvalitāti
9 Indikācijas ārstēšanai Ārstēšana vēlama visiem neārstētiem vai iepriekš neveiksmīgi ārstētiem HVHC pacientiem Ārstēšana prioritāra pacientiem ar izteiktu aknu fibrozi (F3 un F4) Ārstēšana ir pamatota pacientiem ar mērenu aknu fibrozi (F2) Pacientiem bez fibrozes vai ar minimālu fibrozi (F0 un F1) lēmums par ārstēšanas uzsākšanu pieņemams individuāli
10 Hroniska VHC terapija 1986.gads 1998.gads Interferons alfa-2a (IFN) Interferons alfa-2b (IFN) Ribavirīns (RBV) 2000.gads Peginterferons (PEG IFN) 2011.gads HCV NS3 serīna proteāzes inhibitori: Boceprevir (BOC) Telaprevir (TVR) 2014.gads Jaunie tiešās darbības antivirālie medikamenti (DAA) Sofosbuvir (SOF) Simeprevir (SIM) Daclatasvir (DAC) 2015.gads...
11 Hroniska VHC terapija Latvijā Standarta interferona lietošana uzsākta gadā, nelieto kopš gada Kopš gada peginterferons un ribavirīns ir iekļauti valsts kompensējamo medikamentu sarakstā Tiek nozīmēta atbilstoši C vīrushepatīta pacientu etiotropās ārstēšanas vadlīnijām Lēmumu par terapijas lietderību pieņem infektologu konsīlijs gadā uzsāktas 2 pacientu līdzjūtības programmas izmantojot triple terapiju ar 1. paaudzes proteāzes inhibitoriem
12 Hroniska VHC terapijas standarts līdz gadam PEG IFN + Ribavirīns HCV 1./4. genotips: 48 nedēļas HCV 2./3. genotips: 24 nedēļas
13 Terapijas efektivitāte HCV 1. genotips Noturīga virusoloģiska atbildes reakcija 40,5 65% HCV 2. un 3. genotips Noturīga virusoloģiska atbildes reakcija 76 82,3% Pēcterapijas recidīvu biežums HCV 1. genotips 16,8% HCV 2. un 3. genotips 10,1%
14 Terapijas efektivitāte pielietojot proteāzes inhibitorus 1b genotipa pacientiem rezultāti labāki kā 1a genotipa pacientiem Noturīga virusoloģiska atbildes reakcija iepriekš neārstētiem pacientiem 70-75% Noturīga virusoloģiska atbildes reakcija iepriekš ārstētiem pacientiem: pacienti ar pēcterapijas recidīvu 69-88% daļēji atbildētāji 40-61% nulles atbildētāji 31-33%
15 Terapijas efektivitāte - proteāžu inhibitori kombinācijā ar PEG IFN/RBV 100% 90% 88% 80% 75% 70% 60% 50% 52% 59% Boceprevir 40% 33% Telaprevir 30% 20% 10% 0% Recidīvs Daļēji atbildētāji Nulles atbildētāji Bacon BR, et al. N Engl J Med. 2011;364: Zeuzem S, et al. N Engl J Med. 2011;364:
16 Tiešās darbības antivirālie medikamenti Sofosbuvir nukleotīdu analogs HCV RNS polimerāzes inhibitors 400 mg/dn Simeprevir NS3/4A proteāzes inhibitors 150 mg/dn Daclatasvir NS5A komleksa replikācijas inhibitors 60 mg/dn
17 SVR12 (%) SVR12 (%) NEUTRINO: SVR12 With Sofosbuvir + PEG IFN/RBV According to Genotype and Fibrosis Level SVR12 According to Genotype SVR12 According to Fibrosis Level n/n = 261/292 27/28 7/7 GT 1 GT 4 GT 5, /273 43/54 No Cirrhosis Cirrhosis Lawitz E, et al. EASL Abstract Reproduced with permission.
18 SVR12 (%) FISSION: SVR12 According to Genotype and Fibrosis Level Sofosbuvir + RBV PegIFN + RBV n/n = 0 58/59 44/54 10/11 8/13 89/145 99/139 13/38 11/37 No Cirrhosis Cirrhosis No Cirrhosis Cirrhosis Genotype 2 Genotype 3 Gane E, et al. EASL Abstract 5. Reproduced with permission.
19 AbbVie 3D terapijas shēma ABT-450/r, ombutasvir, dasabuvir 2./ 3.fāzes pētījumi Placebo/ citas shēmas kontrolēti Bez interferona 12/ 24 nedēļas Ar/ bez RBV HCV GT1 Feld J, et al. N Engl J Med 2014;370:
20 Īpašās pacientu grupas +/- RBV 3DAA + RBV AbbVie 3D terapijas shēma: galvenie pētījumi (GT1) M SAPPHIRE I (GT1 neārstēti, placebo kontrolēti) N=631 M SAPPHIRE II (GT1 ārstēti, placebo kontrolēti) N= % 96.3% Placebo-kontrolēti pētījumi SVR iespēja terapijā ar RBV: GT1 neārstēti GT1 ārstēti Drošība vs. placebo M PEARL II (GT1b ārstēti, +/- RBV) N=186 M PEARL III (GT1b neārstēti, +/- RBV) N=419 M PEARL IV (GT1a neārstēti, +/- RBV) N= % 99.0% 97.0% Dažādas terapijas shēmas SVR iespēja ar vai bez RBV: GT1b neārstēti GT1b ārstēti GT1a neārstēti M TURQUOISE-II (GT1 neārstēti/ ārstēti, cirozes pac.) N=380 M Methadone/buprenorphine (Phase 2) M Aknu transplantāta pacienti (Phase 2) 95.9% 97.4% 96.2% SVR iespēja kombinācijā ar RBV: GT1 ārstēti/ neārstēti cirozes pac. GT1 opiātu substitūcijas programmas pacienti. Aknu transplantāta pacienti ar GT1 infekcijas recidīvu Feld J, et al. N Engl J Med 2014;370: ; Zeuzem S, et al. N Engl J Med 2014;370: ; Andreone P, et al. Gastroenterology 2014;146:S-159:929e; Ferenci P, et al. J Hepatol 2014;60, Suppl 1:S-527:P1299; Bernstein D, et al. Gastroenterology 2014;146:S-977-8:Su1061; Poordad F, et al. N Engl J Med 2014; online DOI: /NEJMoa ; Lalezari J, et al. CROI 2014 program and abstracts:428:662lb; Kwo P, et al. J Hepatol 2014;60:Suppl 1:S-47:O114
21 Pacientu līdzjūtības programma AbbVie ABT-450/r, ombutasvir, dasabuvir 16 pacienti ar hronisku VHC aknu cirozes stadijā 1 pacients pēc aknu transplantācijas
22 Terapijas efektivitāte 2016 MSD Janssen Gilead BMS Boehringer Ingelheim
23 VHC terapijas efektivitāte % 97% 90% 89% 80% 70% 67% 60% 55% 50% 40% 42% 30% 20% 16% 10% 0% IFN 12mēn. IFN+RBV 12 mēn. PEG IFN+RBV 6-12 mēn. P/R + BOC/TVR 12 mēn. P/R+SOF 3mēn. P/O 3 mēn.
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Jaunākais vīrushepatīta C ārstēšanā Latvijā Agita Jēruma SIA RAKUS stacionārs Latvijas Infektoloģijas centrs Rīgas Stradiņa universitāte
Jaunākais vīrushepatīta C ārstēšanā Latvijā Agita Jēruma SIA RAKUS stacionārs Latvijas Infektoloģijas centrs Rīgas Stradiņa universitāte Hroniska VHC terapijas mērķi HCV eradikācija Novērst hroniska hepatīta
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