Jaunākais vīrushepatīta C ārstēšanā Latvijā Agita Jēruma SIA RAKUS stacionārs Latvijas Infektoloģijas centrs Rīgas Stradiņa universitāte
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1 Jaunākais vīrushepatīta C ārstēšanā Latvijā Agita Jēruma SIA RAKUS stacionārs Latvijas Infektoloģijas centrs Rīgas Stradiņa universitāte
2 Hroniska VHC terapijas mērķi HCV eradikācija Novērst hroniska hepatīta progresēšanu Novērst aknu cirozes attīstību vai dekompensāciju Mazināt hepatocelulāras karcinomas attīstības risku Saglabāt un uzlabot pacienta dzīves kvalitāti
3 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
4 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...
5 Hroniska VHC terapija Latvijā Standarta interferona lietošana uzsākta gadā, netiek lietots 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
6 Hroniska VHC terapijas standarts līdz gadam PEG IFN + Ribavirīns HCV 1./4. genotips: 48 nedēļas HCV 2./3. genotips: 24 nedēļas
7 HCV 1. genotips Terapijas efektivitāte 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%
8 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 75-88% daļēji atbildētāji 52-59% nulles atbildētāji 31-33%
9 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:
10 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
11 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.
12 SVR12 (%) FISSION: SVR12 According to Genotype and Fibrosis Level Sofosbuvir + RBV PegIFN + RBV n/n = 58/59 44/54 10/11 8/13 89/145 99/139 13/38 11/37 0 No Cirrhosis Cirrhosis No Cirrhosis Cirrhosis Genotype 2 Genotype 3 Gane E, et al. EASL Abstract 5. Reproduced with permission.
13 NEUTRINO: Topline Results in Treatment Naïve GT1,4,5,6 Patients Primary Efficacy Endpoint: SVR 12* Overall Genotype 1 Genotypes 4, 5, 6 91% (295/327) 89% 97% Gilead Sciences Press Release. February 4, Lawitz E, et al. APASL 2013 LB-02
14 GT 2 and GT 3 Treatment-Naïve: SOF+RBV vs PEG- IFN+RBV FISSION Summary Efficacy Endpoints: SVR 12 FISSION Treatment Naive Overall Genotype 2 Genotype 3 SOF + RBV x12 weeks 67% 97% 56% PEG-IFN + RBV x24 weeks 67% 78% 63% Gane E, et al. EASL Amsterdam, The Netherlands. Oral #5. Lawitz E, et al. N Engl J Med. 2013;368:
15 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:
16 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
17 Pacientu līdzjūtības programma AbbVie ABT-450/r, ombutasvir, dasabuvir 16 pacienti ar hronisku VHC aknu cirozes stadijā 1 pacients pēc aknu transplantācijas
18 HCV 1.genotips Npk. Ārstēšanas variants Ilgums, nedēļas Komentāri Pierādījumu līmenis Efektivitāte, SVR iespēja 1. PEGIFN+RBV+SOF 12 A1 89% 2. PEGIFN+RBV+SIM 12 1b gt. iepriekš recidīvs, iesk. ciroze A1, B1 80% PEGINF+RBV +12 Kopā 24 Th pārtraukt, ja HCV-RNS >25IU/ml 4., 12. vai 24.nedēļā PEGIFN+RBV+SIM 12 1b gt. iepriekš nulles vai daļēja atbilde, iesk. PEGINF+RBV +36 Kopā 48 ciroze Th pārtraukt, ja HCV-RNS >25IU/ml 4., 12. vai 24.nedēļā 3. PEGIFN+RBV+DAC 12 1b gt. B1 87% +12 Kopā 24 Ja HCV-RNS >25 IU/ml 4.nedēļā un pozitīvs 10.nedēļā PEGIFN+RBV +12 Kopā 24 Ja HCV-RNS <25 IU/ml 4.nedēļā un negatīvs 10.nedēļā 4. RBV+SOF 24 Ja KI vai nepanes IFN B2 84% 5. SOF+SIM 12 B1 96% +/- RBV Ja ciroze vai iepriekš neefektīva terapija SOF+DAC 12 Neārstētiem B1 100% 24 Neefektīva terapija 95% +/- RBV Ja ciroze vai iepriekš neefektīva terapija 7. PEGIFN+RBV+TVR PEGIFN+RBV+BOC 48 Ja nav pieejami ārstēšanas variants A % 63-66% 8. PEGIFN+RBV 48 Ja nav pieejami ārstēšanas variants Th pārtraukt, ja 12.nedēļā nav 100-kārtīgs HCV-RNS pazeminājums, salīdzinot ar izejas līmeni A1 40%
19 VHC terapijas efektivitāte % 90% 80% 89% 97% 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.
20 Paldies par uzmanību!
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