Real-world effectiveness and safety of direct-acting antivirals in patients with cirrhosis and history of hepatic decompensation: Epi-Ter2 Study.

BACKGROUND AND AIMS: The aim of this study was to assess the real-life effectiveness and safety of direct acting antivirals (DAAs) in patients with cirrhosis and history of hepatic decompensation compared to those with compensated cirrhosis. METHOD: Data of patients treated with DAAs and included in the EpiTer-2 database (N = 10 152) were collected retrospectively. The primary endpoint was sustained viral response (SVR) at 12 weeks posttreatment. Patients were also evaluated in terms of liver-related adverse events and treatment modification/discontinuation. RESULTS: The overall SVR rate was 91.4% in the intent to treat (ITT) analysis and 95.2% in the per-protocol (PP) analysis (P < .001). Patients with decompensated cirrhosis had lower SVR rates compared to those with compensated cirrhosis in ITT analysis (86.4% vs 92.0%, P < .001), while not in PP analysis (92.9% vs 95.5%, P > .05). Adverse events (AE) occurred 45.6% and 29.3% of patients with decompensated and compensated cirrhosis (P < .001). Patients with decompensated cirrhosis were at higher risk of death (5.4% vs 0.9%; P < .0001) or liver decompensation (21.5% vs 1.3%; P < .0001). Treatment with protease inhibitors was not associated with hepatic decompensation (P = .3). Only 82.6% of patients with decompensated cirrhosis completed DAA treatment (vs 92.8% in compensated cirrhotics; P < .0001). CONCLUSION: Despite higher frequency of AE and treatment modifications, once completed, DAAs yield comparable results for patients with decompensated and compensated cirrhosis. High rate of serious adverse events in patients with advanced liver disease treated with PI may not be related to the detrimental effect of the medications, but rather to the disease itself.

Is an 8-week regimen of glecaprevir/pibrentasvir sufficient for all hepatitis C virus infected patients in the real-world experience?

BACKGROUND AND AIMS: The revolution of the antiviral treatment of hepatitis C virus (HCV) infection resulting in higher effectiveness came with the introduction of direct-acting antivirals with pangenotypic regimens as a final touch. Among them, the combination of glecaprevir (GLE) and pibrentasvir (PIB) provides the opportunity for shortening therapy to 8 weeks in the majority of patients. Because of still insufficient evaluation of this regimen in the real-world experience, our study aimed to assess the efficacy and safety of 8-week GLE/PIB in chronic hepatitis C patients depending on liver fibrosis and genotype (GT). METHODS: The analysis included patients who received GLE/PIB for 8 weeks selected from the EpiTer-2 database, large retrospective national real-world study evaluating antiviral treatment in 12 584 individuals in 22 Polish hepatology centers. RESULTS: A total of 1034 patients with female predominance (52%) were enrolled in the analysis. The majority of them were treatment naïve (94%), presented liver fibrosis (F) of F0-F3 (92%), with the most common GT1b, followed by GT3. The overall sustained virologic response after exclusion of nonvirologic failures was achieved in 95.8% and 98%, respectively (P = 0.19). In multivariate logistic regression HCV GT-3 (beta = 0.07, P = 0.02) and HIV infection (beta = -0.14, P < 0.001) were independent predictors of nonresponse. CONCLUSIONS: We demonstrated high effectiveness of 8-week GLE/PIB treatment in a non-GT3 population irrespective of liver fibrosis stage. Comparable efficacy was achieved in non-cirrhotic patients regardless of the genotype, including GT3 HCV.

Real-world experience with Grazoprevir/Elbasvir in the treatment of previously "difficult to treat" patients infected with hepatitis C virus genotype 1 and 4.

BACKGROUND AND AIM: Grazoprevir/elbasvir (GZR/EBR) was approved for the treatment of chronic hepatitis C virus (HCV) genotype 1 and 4 infected patients with or without compensated liver cirrhosis. The aim of this study was to assess GZR/EBR regimen in the real-world experience, particularly in previously "difficult-to-treat" patients with chronic kidney diseases, human immunodeficiency virus-coinfected, cirrhotics, and treatment-experienced. METHODS: The analysis included patients treated with GZR/EBR selected from 10 152 individuals from the EpiTer-2 database, large national real-world study evaluating antiviral treatment in 22 Polish hepatology centers between 2015 and 2018. Data were completed retrospectively and submitted online. RESULTS: A total of 1615 patients who started GZR/EBR therapy in 2017 and 2018 with a female predominance (54%) and median age of 54 years were analyzed. The majority were infected with GT1b (89%) and treatment naïve (81%). Liver cirrhosis was diagnosed in 19%, and 70% of patients had comorbidities, of which chronic renal disease was present in 7% and HIV-coinfection in 4%. Overall, a sustained virologic response (SVR) was achieved by 95% according to intent-to-treat (ITT) and 98% after exclusion of lost to follow up (modified ITT). No differences were found in cure rate between all included patients and subpopulations previously considered as difficult-to-treat. Majority of patients completed the treatment course as scheduled, adverse events were mostly mild and did not lead to therapy discontinuation. CONCLUSIONS: GZR/EBR treatment carried-out in patients infected with HCV genotype 1 and 4 demonstrated good tolerability and an excellent SVR rate with no effectiveness reduction in so called difficult-to-treat populations.

Monoexponential and Biexponential Fitting of Diffusional Magnetic Resonance Imaging Signal Analysis for Prediction of Liver Fibrosis Severity.

OBJECTIVE: The objective of this study is to compare the value of monoexponential and biexponential approach to the diffusion-weighted magnetic resonance imaging signal in the prediction of the liver fibrosis. METHODS: Forty patients with hepatitis C were included. Quantification of the apparent diffusion coefficient (ADC) and pure molecular diffusion (D), pseudodiffusion (D*), and perfusion fraction (f) was performed using 9 b values (b = 0, 20, 50, 100, 200, 400, 600, 800, 1000 s/mm). RESULTS: Significant fibrosis was found in 14 subjects. Monoexponentally derived ADC parameters were significantly correlated. Apparent diffusion coefficient calculated from all b values and ADC based on high b values were significantly related to the fibrosis grade (P < 0.02), and none of intravoxel incoherent motion parameters presented such an association. Apparent diffusion coefficient based on high b values was the best predictor of significant fibrosis with area under the curve of 0.81, sensitivity of 0.57, and specificity of 0.92. CONCLUSION: Intravoxel incoherent motion parameters did not allow for prediction of the liver fibrosis. Apparent diffusion coefficient calculated based on high b values presents considerable specificity in predicting significant fibrosis.

The efficacy of paritaprevir/ritonavir/ombitasvir+dasabuvir and ledipasvir/sofosbuvir is comparable in patients who failed interferon-based treatment with first generation protease inhibitors - a multicenter cohort study.

BACKGROUND: According to the EASL and AASLD guidelines, the recommended treatment for patients who failed to achieve a sustained virologic response (SVR) on prior interferon-based triple therapy with protease inhibitors (PI), is a combination of sofosbuvir and NS5A inhibitors. Polish national recommendations also allow the use of paritaprevir/ritonavir/ombitasvir+dasasbuvir±ribavirin (PrODR) in this group of patients. The aim of the study was to evaluate the efficacy and safety of PrODR vs. ledipasvir/sofosbuvir±RBV (LSR) in PI-experienced patients in real-life setting. METHODS: Our analysis included patients registered in the nationwide, investigators initiated, multicentre EpiTer-2 database. Among 4530 patients registered, 335 with genotype 1 (93% 1b) were previously treated with IFN-based regimens with PIs: 127 with boceprevir (BOC), 208 with telaprevir (TVR). Patients with advanced fibrosis (F3/F4) were significantly predominant (BOC 28.4%/61.4%, TVR 18.8%/64.4%, respectively). Subjects were assigned to IFN-free retreatment as follows: BOC - 64 (50.4%) PrODR and 63 (49.6%) LSR; TVR- 103 (49.5%) PrODR and 105 (50.5%) LSR. RESULTS: SVR rates were comparable for particular groups: BOC → PrODR- 100%; BOC → LSR - 98%; TVR → PrODR - 97%; TVR → LSR - 96% (intent-to treat analysis-ITT) and BOC → PrODR→100%; BOC → LSR - 99%; TVR → PrODR - 99%; TVR → LSR - 98% (modified intent-to treat analysis-mITT). Both treatment regimens had a favourable safety profile. Adverse events (AEs) were generally mild or moderate in severity. Three deaths were reported. The treatment was stopped due to AEs in five patients (three treated with PrODR and two with LSR). CONCLUSION: Efficacy and safety of treatment with PrODR and LSR is comparable in BOC or TVR-experienced patients.

Steatosis influences hepatocytes proliferative potential in chronic hepatitis C patients.

The study evaluates the influence of steatosis on hepatocytes proliferative potential, reflected by proliferating cell nuclear antigen (PCNA) expression in chronic hepatitis C (CHC) patients both in steatotic and non-steatotic areas of lobules. The liver histology was evaluated according to Kleiner's score. Nonalcoholic steatohepatitis (NASH) was also defined as the presence of lobular inflammation, hepatocyte ballooning and steatosis. Expression of PCNA was significantly in patients with definite NASH compared to those with simple steatosis, but not to those with borderline NASH. Advanced steatosis negatively influenced PCNA expression. NASH not only affects PCNA expression in staetotic, but also in non-steatotic lobule areas. Expression of PCNA could be an independent indicator of changes in hepatocyte metabolism in CHC patients. High NAS values and low PCNA expression may be a negative prognostic factor in predicting the further course of the disease.

Long-term outcomes of thyroid dysfunction in patients with chronic hepatitis C treated with pegylated interferon alpha and ribavirin

INTRODUCTION: Thyroid dysfunctions (TDs) are associated with pegylated interferon and ribavirin (PegIFN-α/RBV) therapy in patients with chronic hepatitis C (CHC) and are considered as possible extrahepatic manifestation of HCV infection OBJECTIVES: This study aimed to assess the long-term outcomes of TDs in patients with CHC treated with PegIFN-α/RBV METHODS: A total of 1,047 treatment-naïve patients with CHC were treated with PegIFN-α/RBV. TSH and FT4 were assessed at baseline, every 3 months during therapy and 6, 12 and 24 months after the end of therapy. Analysis was performed for two groups of patients depending on the absence (group A, n=77) or presence (group B, n=39) of TDs at baseline RESULTS: At baseline, TDs' prevalence was 3.7%; 53.8% hypothyroidism, 38.5% goiters, and 7.7% hyperthyroidism. 77 (7.4%) out of 1,008 euthyroid patients developed TDs; 45.5% hypothyroidism, 33.8% hyperthyroidism, 19.5% destructive thyroiditis, and 1.3% goiters. TDs' remission (TDR) was achieved in 59/116 (50.9%) of treated patients; 64.9% in group A and 23.1% in group B (p<0.001). Hyperthyroidism as compared to hypothyroidism increases the odds of TDR (OR=4.87 (1.65-14.35), p=0.004), whereas preexisting TDs and higher baseline viral load tend to decrease the probability of TDR (OR=0.21 (0.07-0.58), p=0.003 and OR=0.4 (0.22-0.73), p=0.003, respectively) CONCLUSIONS: The prevalence of TDs was low but over one-third of patients in whom TDs developed under PegIFN-α/RBV therapy did not recover. In one-fourth of patients with preexisting TDs remissions were observed. Treatment with PegIFN-α in the past must be taken into account as a potential cause of TDs

Efficacy and safety of elbasvir/grazoprevir and sofosbuvir/pegylated interferon/ribavirin: A phase III randomized controlled trial.

BACKGROUND & AIMS: Direct-acting antiviral agents have improved treatment outcomes for patients with hepatitis C virus (HCV) infection; however, head-to-head comparisons are limited. The C-EDGE Head-2-Head Study compared the safety and efficacy of elbasvir/grazoprevir (EBR/GZR) with sofosbuvir plus pegylated interferon/ribavirin (SOF/PR) in patients with HCV infection. METHODS: This was a randomized, open-label, phase III trial. Two hundred fifty-seven patients with HCV genotype (GT)1 or 4 infection and baseline viral load >10,000IU/ml were randomized to receive 12weeks of EBR/GZR 50mg/100mg once daily (n=129) or sofosbuvir (400mg once daily) plus PR (n=128). Primary efficacy objective was sustained virologic response 12weeks after the end of therapy (SVR12, HCV RNA <15IU/ml). The primary safety objective was the proportion of patients experiencing a tier 1 safety event. RESULTS: The majority of patients were non-cirrhotic (83.1%), treatment-naïve (74.9%) and had HCV GT1b infection (82.0%). SVR12 rates were 99.2% (128/129) and 90.5% (114/126) in the EBR/GZR and SOF/PR groups, respectively. The estimated adjusted difference in SVR12 was 8.8% (95% confidence interval [CI], 3.6-15.3%). Because the lower bound of the 1-sided 1-sample exact test was greater than -10% and greater than zero, both non-inferiority and superiority of EBR/GZR vs. SOF/PR were established. The frequency of tier 1 safety events was lower among patients receiving EBR/GZR than SOF/PR (0.8% vs. 27.8%, between group difference, 27.0% [95% CI, -35.5% to -19.6%; p<0.001]). CONCLUSIONS: EBR/GZR has a superior efficacy and safety profile in patients with HCV GT1 or 4 infection compared with SOF/PR. LAY SUMMARY: The combination of elbasvir/grazoprevir for 12weeks was highly effective in treating patients with chronic hepatitis C, genotypes 1 or 4 infection. This regimen was more effective than sofosbuvir/pegylated interferon/ribavirin for 12weeks, and was notably superior in patients regarded as difficult to treat, including those with previous treatment failure, cirrhosis, or a high baseline viral load. The combination of elbasvir/grazoprevir also demonstrated a superior safety and tolerability profile based on fewer serious adverse events, no serious drug-related adverse events, and no treatment discontinuations. CLINICAL TRIAL REGISTRATION: Clinical trials.gov Identifier: NCT02358044.

Ulceroglandular tularemia complicated by pneumonia--a case report.

UNLABELLED: Tularemia is an antropozoonosis caused by Gram-negative coccobacillus Francisella tularensis. The majority of tularemia cases are reported in summer due to exposure to insect and tick bites. This paper discusses a case of 11-year-old boy diagnosed with ulceroglandular tularemia complicated by pneumonia. CONCLUSIONS: tularemia should be considered in differential diagnosis of febrile condition and lymphadenopathy in children who contracted disease in summer or autumn, especially if there is a history of insect or tick bite.

[Thyrotoxicosis induced by interferonotherapy of chronic hepatitis C in a woman with Hashimoto's thyroiditis]. / Tyreotoksykoza indukowana interferonoterapia przewleklego zapalenia watroby typu C u kobiety z choroba Hashimoto.

Interferon alpha in combination with ribavirin has been for years a standard therapy of chronic hepatitis C (CHC). This treatment is burdened with numerous side effects, including thyroid dysfunctions. Their incidence in patients receiving dual therapy is estimated at 4.6-33.3%. The paper presents a case of a patient with Hashimoto's thyroiditis, in whom at the time of CHC therapy with pegylated interferon alfa and ribavirin hyperthyroidism episode evolved with an increased level of TSH receptor antibodies after introducing an antiviral treatment and its decrease after the use of antithyroid drugs. After a short break, this therapy was continued, without achieving the therapeutic success. The authors take up the discussion on the possibility of taking CHC therapy in this patient in the future. Participants are an endocrinologist and a hepatologist.

Efficacy of pegylated interferon α-2b and ribavirin in chronic hepatitis C virus (genotypes 1 and 4) infection.

BACKGROUND AND OBJECTIVE: The course of chronic hepatitis C in children is often mild or asymptomatic, but may lead to liver cirrhosis and neoplasm. The aim of our study was retrospective evaluation of treatment efficacy using pegylated interferon (IFN)-α2b with ribavirin in children and adolescents with chronic hepatitis C, both treatment naïve and re-treated. METHODS: The study comprised 79 patients with chronic hepatitis C ages 8 to 18 years (43 patients re-treated; 54 infected with genotype 1 hepatitis C virus and 25 with genotype 4), treated with pegylated IFN-α2b (1.5 µg · kg⁻¹ · week⁻¹) plus ribavirin (15 mg · kg⁻¹ · day⁻¹) for 48 weeks. The primary endpoint was sustained virologic response (SVR). RESULTS: Early viral response (EVR) was observed in 43.1% and end-of-treatment response in 47.9% of patients. In 44.3% of patients, SVR was achieved, which was maintained for at least the next 6 months. Patients not treated before significantly more frequently attained EVR, end-of-treatment response, and SVR (64%, 65.6%, and 63.9%, respectively) as compared with re-treated patients (30%, 33.3%, and 27.9%, respectively). Among 28 patients who attained EVR, 23 achieved SVR. In 2 patients, despite lack of EVR, SVR was observed. There were numerous adverse effects. They were not so severe as to discontinue therapy. CONCLUSIONS: Combined therapy with pegylated IFN-α2b and ribavirin in patients with chronic hepatitis C, infected with hepatitis C virus genotypes 1 and 4, was more effective in treatment-naïve patients (63.9%) as compared with re-therapy cases (27.9%). SVR was maintained for at least the next 6 months in all of the patients. The applied treatment has limited efficacy and evokes numerous adverse effects; thus, search for new methods of treatment is mandatory.

Preparation of HCV infected patients to the triple therapy with first generation protease inhibitors.

In 2011 the European Medicines Agency approved two new drugs (boceprevir and telaprevir) to treat patients with chronic hepatitis C or compensated liver cirrhosis infected with genotype 1 HCV. Their usage together with a standard therapy, ie. pegylated interferon alfa and ribavirin significantly increased the chance of sustained virologic response among both previously unsuccessfully treated and naïve patients. However, this involves a greater number of side effects that poorly monitored can be life threatening. To the known side effects of standard therapy joined new, such as dysguasia, anorectal symptoms. Both drugs can compromise cardiac complications, especially in predisposed patients. Furthermore there is also a greater risk of rash and serious skin reactions. New problem is the interaction between drugs and first generation protease inhibitors resulting from the inhibition of cytochrome p450, common to many drugs pathway.

Distribution of HCV genotypes in Poland.

UNLABELLED: Available data on prevalence of HCV genotypes in Poland are insufficient. The aim of the study was the analysis of distribution of HCV genotypes in Poland over the period of recent 10 years regarding the age of patients and the regions of the country. MATERIAL AND METHODS: Analysis of HCV genotypes in Poland was carried out between 2003 and 2012, and included 14 651 patients from 22 centers where patients with chronic viral hepatitis C are diagnosed and treated. Genotypes were analyzed in age groups (< 20 years of age, 20-40 years of age, > 40 years of age) as well as in populations of HBV and HIV co-infections. RESULTS: Genotype (G) 1 infection was demonstrated in 79.4%, G2 -0.1%, G3- 13.8%, G4- 4.9%, G6-0.09% and mixed infections in 1.6%. There was no infection with genotype 5. The highest prevalence of G1 was observed in the Lódzkie voivodship (89.2%) and the Slaskie voivodship (86.7%) while the lowest one in the Warminsko-mazurskie (62.0%) and the Podlaskie voivodships (68.2%). Genotype 3 most commonly occurs in the Warminsko-mazurskie (28.1%), and the Podlaskie voivodships (23.0%) and is least common in the Malopolskie (7.9%) and the Lódzkie voivodships (9.0%). Genotype 4 is more common in the Kujawsko-pomorskie (11.7%) and the Podlaskie voivodships (8.6%) and relatively less common in the Lubelskie (1.1%) and the Lódzkie voivodships (1.8%). Prevalence of G1 infection in 2003-2004 was 72% and increased up to 85.6% in 2011-2012, that was accompanied by decrease of G3 prevalence from 17% to 8% in this period. In HBV co-infected (n = 83), G1 infection was demonstrated in 85.5%, G3 - in 7.2%, G4 -4.8%, and mixed genotypes in 6%. Among HIV co-infected (n = 391), a much lower prevalence of G1 (33.0%) and a high of G3 (40.4%) as well as G4 (24.0%) were observed. CONCLUSIONS: There is a geographic variability of HCV genotypes prevalence in Poland. Increase of HCV G1 infections and decrease of G3 and G4 were observed in the last 10 years. Genotypes G3 and G4 occur more often in HCV/HIV co-infected than in HCV mono-infected patients.

[Leptospirosis--disease with many faces]. / Leptospiroza--choroba o róznych obliczach.

Leptospirosis is a zoonotic disease of global reach caused by pathogenic spirochetes of the genus Leptospira. The disease has two periodic phases (septic and immune phase) and its clinical manifestations are diverse. Central nervous system involvement in leptospirosis most commonly occurs as aseptic meningitis, often asymptomatic, only with abnormal cerebrospinal fluid findings. Weil's syndrome is defined as liver damage with acute renal failure and bleeding diathesis, has a high mortality rate. A pulmonary form may occur as an acute respiratory distress syndrome. The reference standard assay is the microscopic agglutination test. A titer of at least 1:400 in the presence of symptoms confirms the diagnosis. The prognosis depends on a rapid identification and treatment with antibiotics. The paper presents selected cases of leptospirosis with its different clinical manifestations. The common feature was a severe illness and sometimes the need for cooperation of doctors of various specialities.

Vertical genotype 1 HCV infection treated successfully in the second year of life: a case report.

BACKGROUND: Perinatal HCV transmission appears to be an important cause of HCV in children. Treatment of chronic hepatitis C in young children is controversial because of spontaneous HCV clearance and possible adverse events. CASE REPORT: Vertical HCV genotype 1 infection was diagnosed in a 3-month-old infant. In the subsequent clinical examination we still observed hepatomegaly, fluctuations of ALT, AST and GGT activity, with the highest values 2206 U/L, 1319 U/L, and 297 U/L, respectively. In qPCR, HCV RNA was >700.000 IU/ml. In the 42nd week of observation, liver biopsy was performed with Grade 1 grading and Grade 1 staging. At age 12 months, interferon-alpha2b (1.5 MU 3 times a week) and ribavirin (2×80 mg daily) were administered for 48 weeks. At the beginning of the treatment we observed fever after IFN injection. In the 12th week of therapy, HCV RNA disappeared followed by SVR, and it was sustained for 6 years. To our knowledge, this is the first report of a pediatric (1-year-old) patient treated with combined IFN alpha-2b and ribavirin therapy. CONCLUSIONS: This case report confirms the possibility of successful anti-HCV treatment in a young child, with 6-year sustained virological response without significant adverse events.

Treatment of chronic hepatitis C in children with pegylated interferon α2a and ribavirin--a multi-center study.

Pegylated interferon α and ribavirin in treatment of chronic hepatitis C in children is used rarely. The aim of the study was to find prognostic factors for sustained virological response and to analyze the safety of pegylated interferon α2a and ribavirin in children with chronic hepatitis C. The study covered a group of 44 children, mean age 14 years, with diagnosed chronic hepatitis C. Clinical, biochemical and virological parameters, as well as side effects were evaluated. Combined treatment allowed to obtain sustained virological response in a total of 77.5% of the treated children. Lower viral load and lower fibrosis grade contributed to sustained virological response. The response was not gender-related. The best response is obtained in children whose treatment was started after they attained the age of 10 years. Therapy with pegylated interferon α2a and ribavirin is well tolerated by pediatric patients.

[Forecasting of efficacy of chronic hepatitis B therapy]. / Prognozowanie skutecznosci terapii przewleklego zapalenia watroby typu B.

Predictors of effective chronic hepatitis B therapy were described in that article. The predictors are: ALT, HBV genotype, HBV DNA, qantification of HBsAg. New predictors as cccDNA and level of HBeAg were described too.

[Efficacy of triple therapy in patients with chronic hepatitis C not treated and patients previously treated ineffectively]. / Skutecznosc terapii trójlekowej u chorych przewlekle zakazonych HCV, nieleczonych i z nieskuteczna wczesniejsza terapia.

Since ten years pegylated interferon alpha and ribavirin (PR) are a standard treatment for the patients with chronic HCV infection. Recently, new drugs emerge called direct-acting antivirals. The first of them, telaprevir (TVR) and boceprevir (BOC), which peptidomimetic NS3/4A HCV serine protease inhibitors, have been recorded this year in Europe. Adding them to the PR significantly increases efficacy of standard treatment and creates the possibility of its reduction. This paper presents, based on the results of the third phase studies, the efficacy of triple therapy in selected groups of patients. Also includes current recommendations for treatment with BOC or TVR in combination with PR.

Efficacy of 8- versus 12-week treatment with ledipasvir/sofosbuvir in chronic hepatitis C patients eligible for 8-week regimen in a real-world setting.

Introduction: Non-cirrhotic treatment-naive hepatitis C patients infected with genotype 1 can be treated with ledipasvir/sofosbuvir (LDV/SOF) for 8 weeks, but in practice this regimen is frequently extended up to 12 weeks at least in part due to insufficient real-world data supporting shortening of treatment. The aim of our study was to compare 8- and 12-week regimens' efficacy in patients eligible for 8-week therapy in a real-world setting. Material and methods: Data of HCV genotype 1 infected patients treated with LDV/SOF between 2015 and 2018 included in the EpiTer-2 database were analyzed with respect to patients' characteristics and length of treatment. Results: Among a total of 1718 patients treated with LDV/SOF, 679 were included in the analysis, 238 (35%) received 8-week regimen, whereas 441 were treated for 12 weeks although they fulfilled the criteria for a shorter course. The majority of patients were infected with genotype 1b (89%) and demonstrated minimal fibrosis (55%). The 12-week regimen was assigned significantly more frequently to patients with comorbidities, concomitant medications and advanced liver fibrosis. The sustained virologic response rate was similar after 8 (98%) and 12 (97%) weeks of therapy according to intent-to-treat analysis and reached 99% in both groups after exclusion of patients lost to follow-up. Conclusions: We confirmed high effectiveness regardless of treatment duration with LDV/SOF in non-cirrhotics infected with HCV genotype 1 eligible for the 8-week regimen according to the current label. This real-world study also demonstrated no need for addition of ribavirin (RBV) in this population and showed that shortening of treatment significantly improves the safety profile of LDV/SOF medication.

HCV Genotype Has No Influence on the Incidence of Diabetes-EpiTer Multicentre Study.

HCV infection is one of the main reasons for liver cirrhosis and hepatocellular carcinoma. In recent years, one finds more and more extrahepatic manifestations of HCV infection, including its possible influence on the development of diabetes. In the presented work, one finds the frequency analysis of the incidence of diabetes among 2898 HCV infected patients treated in Poland, and the assessment of their relevance to the HCV genotype and the progression of fibrosis. The results indicate that the hepatitis C infection seems to be a risk factor for diabetes in persons with more advanced liver fibrosis, for older people, and for the male gender. Thus, one found no differences regarding the frequency of its incidence depending on HCV genotype, including genotype 3.