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Background and aims. For the 8-week OPrD regimen, real world data are insufficient. This study aims to compare the efficacy of the two types of regimens (12-week versus 8-week) in a real world cohort of patients with genotype 1b. Material and methods. We analysed a multicentric retrospective cohort enrolling 1436 patients who started HCV therapy in 2018-2019. Liver fibrosis was staged in all subjects by Fibromax. Efficacy was assessed by the percentage of patients achieving SVR 12 weeks post-treatment (SVR12). Results. Out of the 1436 analysed patients, 112 received 8 weeks therapy and 1324 received 12 weeks. In this cohort the proportion of male patients was 25.2%, the median age 61 years, 28.2% were interferon pre-treated, and the rate of co-morbidities was 47%. 42% of the subjects had F2 fibrosis, 29% F1 fibrosis, 16% F3 and 12% F4. The SVR rate was comparable in both groups of patients (97% in those treated with OPrD 12 weeks vs 96.4% in those that received OPrD 8 weeks) (by intention-to-treat). In the 12 weeks arm, the drop-out rate was 0.8% and the rate of severe adverse events was 1%, while in the arm of 8 weeks therapy there were no severe adverse events reported and no drop-out (p = 0.25). The only predictive factor for non-response in both treatment arms was the male sex. Conclusions. OPrD 8 weeks proved to be highly efficient in our patients with a 96.4% SVR. No serious adverse events and no drop out were reported. [ABSTRACT FROM AUTHOR]

Odată cu introducerea terapiei cu antivirale directe în opţiunile terapeutice ale hepatitei C, s-au stabilit şi criterii de eligibilitate pentru tratament. În România, în anul 2016, s-a aprobat, în cadrul unui program naţional, tratamentul cu ombitasvir / paritaprevir / ritonavir şi dasabuvir pentru pacienţii cu fibroză stadiu F4 dovedită prin Fibromax sau biopsie hepatică. Scopul acestui studiu a fost evaluarea eligibilităţii pacienţilor pentru terapie şi a concordanţei între testele serologice, elastometrice şi imagistice pentru evaluarea fibrozei într-o cohortă de pacienţi cu hepatită C. Au fost evaluaţi atât pacienţi nou diagnosticaţi, cât şi pacienţi cunoscuţi cu hepatită cronică C cu fibroză avansată, pe durata a 7 luni, între 1 noiembrie 2015 şi 31 mai 2016. S-au colectat date clinice, biologice, ultrasonografice, elastografice şi endoscopice. Au fost evaluaţi 146 de pacienţi pentru eligibilitatea la terapia antivirală fără interferon. Dintre aceştia, 89 (61%) au fost femei şi 57 (39%) bărbaţi, cu o medie de vârstă de 60 ± 8 ani. În ceea ce priveşte terapiile antivirale anterioare, 58 (52,5%) au fost naivi, 30 (27,4%) nonresponderi, 19 (17,81%) relapseri si 3 (2,74%) netoleranţi la biterapie. 80 (54,8%) au prezentat valori crescute ale alfa-fetoproteinei, fiind evaluaţi imagistic pentru excluderea unui hepatocarcinom - dintre aceştia, 8 pacienţi au fost diagnosticaţi cu hepatocarcinom. Ecografic, apoape jumătate dintre pacienţi aveau dilataţie de ax spleno-port, iar la endoscopia digestivă superioară 42% aveau varice esofagiene. Elastografia Fibroscan a fost efectuată la 88 / 146 de pacienţi: 82,95% aveau fibroză F4, 1,14% F3-F4, 9,09% F3 şi 7,2%

With the introduction of direct acting antivirals in the therapeutic armamentarium of hepatitis C (HCV), policy makers have set criteria for treatment eligibility. In Romania, the combination of ombitasvir/paritaprevir/ritonavir and dasabuvir is reimbursed for F4 fibrosis on liver biopsy/Fibromax, or F3 with contraindication to interferon (IFN). Our aim was to assess treatment eligibility and discordance between serological, elastometric and imaging evaluation of fibrosis in a cohort of patients with HCV. We evaluated both newly diagnosed and previously known HCV patients with advanced fibrosis, from our database, during a period of 7 months, between November 1st, 2015 and May 31st, 2016. Clinical, biological, ultrasound, elastography and endoscopy data were collected. Altogether 146 patients were assessed for treatment eligibility. Among them, 61% were females, with a mean age of 60 ± 8 years. Regarding treatment status, 52.5 % were naive, 27.4% nonresponders, 17.81% relapsers and 2.74% intolerant to bitherapy. 54.8% had elevated alpha-fetoprotein and were checked by advanced imaging for exclusion of hepatocellular carcinoma (HCC) - of them, 8 were diagnosed with HCC. On ultrasound, almost 1/2 patients had dilated splenoportal axis and at endoscopy 42% had esophageal varices. Transient elastography (Fibroscan) was done in 88/146 patients: 82.95% were F4, 1.14% F3-F4, 9.09% F3 and 6.82%