Rate scazute de raspuns virusologic rapid la pacienti infectati cronic VHC naivi din punct de vedere terapeutic

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1 Rate scazute de raspuns virusologic rapid la pacienti infectati cronic VHC naivi din punct de vedere terapeutic Camelia Sultana, Gabriela Oprisan, Gratiela Tardei, Simona Ruta si Echipa Proiectului HEPGEN UMF "Carol Davila" Bucuresti, Institutul de Virusologie "St S Nicolau", INCDMI "Cantacuzino", Spitalul de boli infectioase si tropicale "Victor Babes"

2 Background VIRUS Viral load HCV Genotype Mutations HOST Genetic Factors (IL28B, IP-10, scd26) Sex, Age Romania - standard terapeutic = Interferon alfa pegylat si ribavirina (48 de saptamani). Genotipul 1b prevalent (92.6%*, 93.46%**) Rate inalte de raspuns virusologic sustinut (55-60%) in studii clinice din Romania Environamental Factors Alcohol / drugs Co-infections (HIV, HVB) OBIECTIVE Evaluarea impactului replicarii virale si a factorilor genetici ai gazdei asupra ratei de succes terapeutic. ultana, Oprişan, Szmal, Vagu, Temereanca, Dinu, Teleman, Ruta. Molecular Epidemiology of Hepatitis C Virus Strains from Romania. JGLD, 2011, 20(3) Grigorescu M. HCV genotype 1 is almost exclusively present in Romanian patients with chronic hepatitis C. J Gastrointestin Liver Dis 2009; 18(1):

3 Materiale si metode Studiu prospectiv SNP IL28B (rs , Custom TaqMan Single Nucleotide Polymorhism Genotyping Assays, Applied Biosystem) 73 de pacienti VHC cronic genotip 1b netratati anterior Nivelul plasmatic al IP-10 (Interferongamma inducible protein 10) - Quantikine Human CXCL10/IP-10, R&DSystems Replicare virala VHC la momentul 0 sapt 4 (RVR) si sapt 12 (EVR) de la initierea tratamentului Cobas Ampliprep G/CTM HCV quant., vers 2.0,Roche; Fibroza hepatica (FIBROSCAN)

4 Rezultate femei %, varsta medie = 49.2 ± 10.9 ani, viremia VHC baseline ± 2.9 x 10 UI / ml (6.1 log UI/ml); 28.9% - viremie VHC initiala < UI/ml. 6 Viremie VHC / varsta VL HCV age

5 SNP IL 28B VHC inductia interferonului tip III la nivelul hepatocitelor umane corelat cu nivelul hepatic al expresiei genelor ISG (IFNstimulated genes). asocierea dintre SNP IL28, nivelul de ISG si procentul de raspuns virusologic din infectia VHC SNP IL28B (rs ) este asociat cu RVS la regimul terapeutic standard SNP IL28B (rs ) este asociat cu clearance si rate diferite de evolutie spre ciroza hepatica a pacientilor

6 SNP IL28B rs heterozigoti CT % homozigotismul - egal 17.8% CC si 17.8 % TT) Adapted from Macmillan Publishers Ltd: Nature, Thomas, et al, SNP rs variaza ca prevalenta in diferite populatii. Thomas et al, rs SNP pe 2371 subiecti din 51 populatii distincte. prevalenta CC (asociat cu clearance HCV) si TT (asociat cu persistenta infectiei). Asia (Est and Sud) cea mai scazuta prevalenta de alele TT asociate cu persistenta infectiei, Europa - prevalenta intermediara, Africa Sub-Sahariana- prevalenta inalta TT

7 Rezultate RVR-raspuns virusologic rapid (4 s tratament) 12.3% - ating RVR 38,5% CC vs. 8,5% CT vs. 0% TT, p=0.005 Chi-squared test % 80.00% 70.00% EVR-raspuns virusologic timpuriu (12 s de tratament) 52.4% - ating EVR 90% CC vs CT% vs. 34% TT, p=0.02, Chi-squared test RVR la tineri, au incarcare virala baseline mai mica grad de fibroza mai scazut, nu difera din punct de vedere al IP % 50.00% 40.00% 30.00% 20.00% 10.00% 0.00% CC CT TT RVR 38.50% 8.50% 0% EVR 90% 39.10% 34%

8 IP-10 / CXCL10 proteina inductibila de interferonul gama, chemokina cu activitate chemotactica pentru limfocite T, celule NK si monocite, rol imunomodulator complex, corelata cu inflamatia hepatica si caile imunomodulatoare in parenchimul hepatic. Valoare medie IP-10 = ±265 pg/ml ( pg/ml).

9 IP 10 / ARN VHC la 12 S EVR au incarcare virala baseline mai mica grad de fibroza mai scazut, difera din punct de vedere al IP-10. IP 10 coreleaza negativ cu diferenta de viremie VHC dintre T0 si T12 (p=0.0017, r = ).

10 IP 10 / fibroza hepatica (FIBROSCAN) IP 10 / FibroScan normal - 5,5±1,6kPa. F1< 7kPa F2 > 7,1kPa F3 > 9,5kPa F4 (ciroza)>12,5kpa pentru IP-10<400pg/ml - VM FIBROSCAN: 7.8 ± 3.4 (4-15) pentru IP-10>400pg/ml VM FIBROSCAN : 9.5 ± 5.4 ( ) p=0.05, Unpaired t test, Graph Pad InStat

11 Concluzii O proportie importantă de pacienti infectati VHC din România prezinta factori de predictie negativa pentru evolutia infectiei VHC (genotipul 1, replicare inalta VHC, fibroza hepatica avansata, proportie scazuta de SNP IL28B homozigot CC si au obtinut o rata scazuta de RVR (sapt 4); totusi rata EVR este de 4 ori mai mare. RVR si EVR sunt corelate semnificativ statistic cu genotipul homozigot CC al IL28B. Datorita ratei scazute de RVR - considerat a fi un marker predictiv important pentru succesul tratamentului - este necesara urmarirea cineticii replicarii virale pe toata durata tratamentului, pentru definirea pacientilor cu sanse maxime de obtinere a raspunsului virusologic sustinut. Desi necorelat cu RVR, un nivel inalt al IP-10 (>400 pg/ml) poate fi considerat un marker fiabil si ieftin pentru evaluarea severitatii bolii hepatice, dar si a ratei de EVR (sapt 12) la pacientii infectati VHC.

12 PN-II-PT-PCCA , Proiect nr. 88/2012: Investigarea unor markeri virali şi de gazda corelati cu lipsa de raspuns la tratamentul anti-viral in hepatita cronica cu virus C (HepGen) People think focus means saying yes to the thing you ve got to focus on. But that s not what it means; it means saying no to the hundred other good ideas Steve Jobs

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