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Background & Aims: Ledipasvir/Sofosbuvir (LDV/SOF) with or without Ribavirin (RBV) has shown good results in terms of efficacy and safety in clinical trials in advanced liver cirrhosis, but real-life data are still needed in order to confirm this profile. We investigated the efficacy and safety of LDV/SOF in a large Romanian population with liver cirrhosis and genotype 1b hepatitis C virus (HCV). Methods: We analyzed a multicentric retrospective cohort enrolling 349 patients with decompensated liver cirrhosis due to HCV who received LDV/SOF±RBV 12/24 weeks (301/48). Patients were included between 2017-2018, all with genotype 1b. Main inclusion criteria were liver cirrhosis and detectable HCV RNA. The cases were followed-up monthly during therapy and 12 weeks after the end of therapy. Results: The cohort included 60% females with a median age of 61, 16% interferon (IFN) pre-treated, 53% with comorbidities, 40/53/7% with Child Pugh A/B/C, 4% with virus B co-infection and 8% with previously treated hepatocellular carcinoma. Mean initial MELD score was 11.92 (6.82÷ 24.5). Six patients were lost during follow-up. Sustained virologic response (SVR) in intention-to-treat was reported in 85.1%. Predictive factors of SVR in decompensated cirrhosis were female gender (p=0.01), advanced age (p<0.001), lower bilirubin levels (p=0.002) and lower CTP score (p=0.02). In patients with CTP score B or C low bilirubin levels (p=0.003), low INR (p<0.001), increased platelet count (p=0.04), low CTP score (p<0.001), lack of encephalopathy (p=0.02), serum albumin >3.5g/dl (p=0.002) predicted improvement of liver function. Serious adverse events were reported in 16/349 (4.6%), most of them due to severe liver decompensation (9/16). Conclusions: LDV/SOF±RBV proved to be highly efficient in our difficult to treat population with 85.1% SVR. [ABSTRACT FROM AUTHOR]

Background & Aims: Real-world assessments of efficacy and safety of advanced therapies used for inflammatory bowel disease (IBD) patients are limited. We aimed to report safety, efficacy and treatment persistence of new molecules (infliximab, adalimumab, vedolizumab, tofacitinib, ustekinumab) in a retrospective multicentric national Romanian analysis. Methods: We conducted a nationwide, retrospective observational multicentric study. Data were collected retrospectively from electronic and paper files. Patients who started on one of the five investigated molecules during December 2019-December 2021 were included. The main outcome measures were clinical remission, endoscopic healing, persistence on treatment and safety data. Results: A total of 678 adult patients from 24 Romanian IBD centers with a diagnosis of ulcerative colitis or Crohn's disease were included. Participants had previously failure to one (268, 39.5%), two (108, 15%) or more treatment lines and only 38% (259) were biologic naïve. In the 24 months study period, most patients were started on vedolizumab (192, 28%), followed by adalimumab, infliximab, ustekinumab and tofacitinib. In biologic-naïve patients, most physicians (72%) preferred anti-TNF treatment as first line biologic (93 patients started on infliximab, 92 on adalimumab), followed by vedolizumab, ustekinumab and tofacitinib. During follow-up, 71% (470, p=0.05) of patients achieved clinical remission and 36% (134, p=0.03) achieved mucosal healing. The 6 months milestone for persistence was reached in 78% (530) of cases. Almost half of patients (47%, 316 patients) persisted on their current treatment for over 12 months. Overall, an adverse reaction was reported for 67 (10.4%) patients, with no lethal events. Conclusions: Population of biologic-experienced IBD patients in Romania is increasing and is becoming more difficult to achieve long-term disease control. Discontinuation rates for advanced therapies are high. [ABSTRACT FROM AUTHOR]

Aim: The study was designed to evaluate the efficacy and safety of peginterferon α-2a in HBeAg-positive chronic hepatitis B patients, nonresponders or relapsers after previous lamivudine or standard interferon therapy. Methods: This prospective, national, multicentric, open label, not randomized trial enrolled 43 HBeAg-positive chronic hepatitis B patients with detectable HBsAg for at least 6 months prior to screening, positive HBeAg and negative anti-HBe, serum HBV DNA levels of at least 500,000 copies/mL by PCR assay, elevated ALT up to 10 × ULN, no response or relapse after previous lamivudine or standard interferon therapy. All eligible patients received pegIFN α-2a 180 μg weekly for 48 weeks with 24 weeks treatment free follow-up. There were two main efficacy assessments: HBeAg seroconversion and viral supression below 100,000 copies/mL. Results: HBeAg seroconversion rate at the end-of-treatment was 4.65% (n=2; p<0.05) increasing to 11.62% 24 weeks after end of therapy (n=5; p<0.05). The rate of viral supression at levels below 100,000 copies/mL was 23.25% (n=10; p< 0.05) at end-of-treatment, and 16.3% (n=7; p<0.05) at end of follow-up. ALT normalization was obtained in 20.9% (p<0.05) of patients at end-of-treatment, the percentage being significantly higher - 37.2% (p<0.05) at the end of follow-up. Conclusions: Even in a difficult-to-treat patient population with HBeAg-positive chronic hepatitis B, peginterferon alfa 2a proved to be efficient in a defined proportion of patients. The increase in HBeAg seroconversion rate from end-of-treatment (4.65%) to the end of follow-up period (11.62%) also proves the benefits of prolonged immunological effect of pegIFN α-2a. [ABSTRACT FROM AUTHOR]

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]

Background: Several environmental factors have been associated with onset of inflammatory bowel diseases (IBD): smoking, hygiene, microorganisms, oral contraceptive pills (OCPs), non-steroid anti-inflammatory drugs, antibiotics, appendectomy, diet, breastfeeding, vitamin D, stress and ambient air pollution. The aim of this study was to investigate the prevalence of these factors in a Romanian and Belgian population with IBD. Material and methods: A total of 129 patients with an IBD diagnosis (76 from Romania and 53 from Belgium) participated in an interview and were asked to fill in a questionnaire regarding environmental factors before and after the onset of IBD; 35 Romanian and 21 Belgian healthy individuals constituted the control group. Results: A total of 40 patients with ulcerative colitis (UC) and 89 with Crohn's disease (CD) were included. Gender distribution was 43% males and 57% females. They had a median age of 42 years (range between 19-74 years), a median disease duration of eight years and 79% were in clinical remission. Both Romanian and Belgian IBD patients reported an increased antibiotic consumption before IBD onset compared to controls: 58% vs 10% (p<0.001) and 51% vs 5% (p<0.001), respectively. Belgian IBD patients declared significantly more frequent OCP use (53% vs 9%, p <0.001), they were breastfed in a lower proportion (49% vs 76%, p <0.001) and had experienced a higher level of psychosocial stress (p<0.001). Conclusions: Antibiotic consumption before IBD onset may play a pivotal role in IBD development in both Romanian and Belgian populations. In Belgian patients, OCP consumption, a higher level of psychosocial stress and lack of breastfeeding may also be involved. [ABSTRACT FROM AUTHOR]

The article focuses on occurrence and recurrence of hepatocellular carcinoma in patients with hepatitis C virus (HCV) genotype 1b related cirrhosis treated with Ledipasvir + Sofosbuvir ± Ribavirin. Topics include the direct antiviral agents therapy for HCV has been revolutionary with a sustained virologic response rate with favorable effects on improving liver function complications, and the impact of treatment on de novo or recurrent hepatocellular carcinoma development is still debated.