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Background & Aims: The sofosbuvir (SOF) / velpatasvir (VEL) / voxilaprevir (VOX) combination has been evaluated in more than 800 patients enrolled in phase II and phase III studies, where it demonstrated excellent safety and efficacy, achieving overall sustained viral response (SVR) rates of more than 95%. We aimed to assess the efficacy and safety of SOF/VEL/VOX in a real-world study, including patients previously treated for genotype 1b hepatitis C virus (HCV) infection that did not obtain a sustained viral response with previous direct-acting antivirals (DAAs) therapy. Methods: In Romania, through a nationwide government-funded program in 2019-2020, 213 patients with chronic hepatitis C non-responders to previous DAAs therapy, received treatment with SOF/VEL/VOX 400/100/100 mg/day for 12 weeks. We performed a retrospective longitudinal study that included 143 individuals who were treated in Bucharest, Iași, Craiova and Constanța clinics, all with genotype 1b HCV infection. Efficacy was assessed by the percentage of patients achieving SVR 12 weeks post-treatment (SVR12). Serious adverse events (SAE) were registered. Results: Our cohort comprised 53% males with a median age of 60 years (27÷77); 47% were pre-treated with ombitasvir/paritaprevir/ritonavir+dasabuvir ± ribavirin, 40% with ledipasvir/SOF, 13% with elbasvir/grazoprevir. 42% of patients associated co-morbidities, 45% had compensated liver cirrhosis, 2% had treated hepatocellular carcinoma (HCC) and 1% had hepatitis B virus co-infection. SVR by intention to treat was reported in 139/143 (97.2%) and per protocol in 141/143 (98.6%). No predictive factors for SVR were identified. Rate of liver decompensation in patients with cirrhosis was 6% and was statistically associated in multivariate analysis with Child-Pugh score (p<0.01) and with severe steatosis (p=0.004). Occurrence of new HCC was reported in 3.6% of all patients with cirrhosis and was associated with poor liver function [higher Child-Pugh score (p=0.001) and low albumin levels (p=0.02)]. Serious adverse events related to therapy were reported in 1/143(0.7%). Conclusions: SOF/VEL/VOX was highly efficient in our population of patients with a 97.2% SVR. Liver decompensation occurred in 6% of cirrhotic patients at SVR, related to hepatic dysfunction. [ABSTRACT FROM AUTHOR]

Background. Bevacizumab (Bev) is approved in Europe and USA in combination with chemotherapy (CTH) based on fluoropirimidine (FP) in the treatment of adult patients with metastatic colorectal cancer (mCRC) in the first line of therapy, as maintenance treatment, postprogression, and in the second line of therapy. It was performed a retrospective analysis on mCRC patients treated with CTH + Bev in succesive lines in the Medical Oncology Department of the Fundeni Clinical Institute, Bucharest. Method. We collected demografic and clinical data: the disease stage at diagnosis, histopathology data, duration and CTH line, grade 3/4 adverse events, response rate (RR), progression-free survival (PFS), and overall survival (OS). Between August 2007 and December 2018 there had been treated with Bev 516 patients. At 3-6 months from the diagnosis, 384 patients (67.4%) presented synchronous metastases and 168 patients (32.6%) presented metachronous metastases. Results. A total of 358 patients (69.2%) received Bev in the first line of the treatment, of which 260 patients (72.6%) received FP + oxaliplatin (OX): FOLFOX/CAPOX, and 86 patients (24%) received FP + irinotecan(IRI): FOLFIRI/ CAPIRI. Four patients received FOLFOXIRI in the first line, and eight patients received only FP. As maintenance therapy, it was administered Bev/Bev+FP in 88 patients (79.3%) in the OX group and in 20 patients (18%) in the IRI group. A total of 128 patients (35.8%) received Bev beyond progression, of which 99 patients (79.8%) in the OX group and 22 patients (17.7%) in the IRI group; 137 patients (38.3%) received subsequent therapy lines after Bev failure. The medium chemotherapy duration for patients who received OX was 9.9 months (95% CI; 8.67-11.18), and 9.2 months (95% CI; 6.72-11.62) for those who received IRI. A total of 219 patients presented a therapy response, with a RR of 75.34% on OX, and a RR of 24.65% on IRI. The median PFS was 8.12 months (95% CI; 6.89-9.35) for OX and 8.35 months (95% CI; 6.6-10.1) for IRI, with p=0.034. The median OS was 17.03 months (95% CI; 14.66-19.40) for OX and 18.87 months (95% CI; 15.28-22.46) for IRI, with p=0.900. Conclusions. In our experience, Bev-OX had a similar efficacy as Bev-IRI regarding both PFS and OS, but with a higher response rate for those treated with OX. [ABSTRACT FROM AUTHOR]

Background & Aims: Inflammatory bowel diseases (IBD) patients management has been challenging during the ongoing coronavirus disease 2019 (COVID-19) pandemic, due to lockdowns, limitation of access to medical facilities and new recommendations regarding patient management. The implications of the COVID-19 pandemic on IBD patients' management were assessed in our Tertiary Gastroenterology Center in Bucharest, Romania. Methods: Medical records of IBD patients admitted between 15th of March and 15th of August 2020 were retrospectively reviewed and compared to a control cohort of consecutive IBD patients admitted to our unit during the corresponding period of 2019. Results: There was a highly significant shift towards one-day hospitalization during the referral period in 2020 for IBD cases (91% in 2020 vs 82.2% in 2019, p=0.0001). There was no statistically significant difference between the distribution of patient's gender, IBD phenotype or newly diagnosed IBD cases. A significantly lower proportion of admitted patients received 5-aminosalicylic acid (29% vs 41.2%, p=0.0001), whereas a substantially higher number of patients were prescribed biological therapy in 2020 in comparison to the corresponding 2019-time frame (79.5% vs 57.9%, p<0.0001). The distribution of the biological agent used was significantly different in 2019 in comparison to the 2020 period mainly due to the increase in vedolizumab prescription in 2020 (p<0.0001). During the study period in 2020, seven IBD patients (1.7%) were diagnosed with severe acute respiratory syndrome coronavirus 2 (SARS-Cov2) infection, all of them with mild symptoms without impact on the IBD course. Conclusions: The COVID-19 pandemic led to reorganizing medical care, limiting the hospital admissions in favor of severe IBD cases, favoring telemedicine for mild disease and optimization of treatment for moderate to severe IBD with an increased use of biologicals aimed to maximize the risk/benefit ratio. Incidence of SARS-Cov2 infection during the first wave of COVID-19 infection in our study group was 1.7% and did not adversely impact the IBD disease course. [ABSTRACT FROM AUTHOR]