Sustained Virological Response After Early Discontinuation of Hepatitis C Treatment.

To date, the effectiveness of direct-acting antivirals (DAAs) discontinued before 4 weeks has not been analysed in routine clinical practice. The study aimed to determine whether such a short therapy will enable achieving a sustained virological response under real-world experience. The study population of 97 patients who discontinued DAA therapy and had data enabling analysis of patient and disease characteristics, and assessment of treatment effectiveness was selected from 16,815 patients registered in the EpiTer-2 database. The most common reason for discontinuation was hepatic decompensation (20.6%) or the patient's personal decision (18.6%). Patients who discontinued treatment were significantly older, more frequently therapy-experienced, more likely to have cirrhosis, a history of decompensation and a Child-Pugh B or C classification than those who completed treatment. SVR was achieved by 93.5% of patients who discontinued treatment after 4 weeks, 60.9% if discontinued at 3 or 4 week and 33.3% at Week 1 or 2. Patients receiving pangenotypic but not genotype-specific treatment who discontinued after 4 weeks were as likely to achieve SVR as those who completed therapy. Patients who responded to treatment that lasted no longer than 2 weeks had a low baseline viral load (<400,000 IU/mL). Despite discontinuation of therapy after Week 4, the chances of SVR are high. Very early discontinuation does not preclude therapeutic success, especially in patients with low baseline viral load.

Direct-acting antivirals in women of reproductive age infected with hepatitis C virus.

Eliminating hepatitis C virus (HCV) infection in the population of women of reproductive age is important not only for the health of women themselves but also for the health of newborns. This study aimed to evaluate the implementation of this goal by analysing the effectiveness of contemporary therapy in a large cohort from everyday clinical practice along with identifying factors reducing therapeutic success. The analysed population consisted of 7861 patients, including 3388 women aged 15-49, treated in 2015-2022 in 26 hepatology centres. Data were collected retrospectively using a nationwide EpiTer-2 database. Females were significantly less often infected with HCV genotype 3 compared to males (11.2% vs. 15.7%) and less frequently showed comorbidities (40.5% vs. 44.2%) and comedications (37.2% vs. 45.2%). Hepatocellular carcinoma, liver transplantation, HIV and HBV coinfections were reported significantly less frequently in women. Regardless of the treatment type, females significantly more often reached sustained virologic response (98.8%) compared to males (96.8%). Regardless of gender, genotype 3 and cirrhosis were independent factors increasing the risk of treatment failure. Women more commonly reported adverse events, but death occurred significantly more frequently in men (0.3% vs. 0.1%), usually related to underlying advanced liver disease. We have demonstrated excellent effectiveness and safety profiles for treating HCV infection in women. This gives hope for the micro-elimination of HCV infections in women, translating into a reduced risk of severe disease in both women and their children.

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.

Clinical practice guidelines for Clostridioides (Clostridium) difficile infection and fecal microbiota transplant protocol - recommendations of the Polish Society od Epidemiology and Infectious Diseases.

Symptomatic Clostridium difficile infection (CDI) is an acute inflammatory disease of the gastrointestinal tract, manifesting in at least 3 unformed stools within 24 hours. Predicting factors for CDI include contact with medical care (mainly hospitalization), antibiotic therapy in the last 12 weeks, use of proton pump inhibitors (PPI), H2 blockers, cancer chemotherapy, especially in the neutropenia stage, gastrointestinal surgery, advanced age and concomitant chronic diseases (renal failure, liver failure, chronic inflammatory bowel disease - especially ulcerative bowel disease, cancer, HIV infection, cachexia and hypoalbuminaemia) and vitamin D deficiency. Clinical classification distinguishes three types of CDI - mild / moderate, severe, and fulminant. The principles of treatment of the first and subsequent CDI incidents depending on the clinical course are based on oral vancomycin. CDI is recurrent. The basis for treating CDI relapses is vancomycin administered orally at a dose of 4x125 mg for 10 days followed by concomitant vancomycin dose reduction therapy. The use of fecal microbiota transfer (FMT) in the treatment of CDI relapses is considered to be the most effective therapy for recurrent CDI. An indication for FMT is antibiotic-resistant C. difficile infection, regardless of the number of incidents CDI. The panel of tests recommended for a bacterial flora donor is presented in the recommendations.

Differences in subjective and objective evaluation of hyperhidrosis. Study among medical students.

INTRODUCTION: Hyperhidrosis is a condition that significantly impairs patients' quality of life. Qualification for treatment in most cases is based only on subjective evaluation of symptoms without objective confirmation. AIM: To evaluate the differences between subjective and objective evaluation of sweating among medical students. MATERIAL AND METHODS: There were 179 participants involved in the study. Subjective evaluation of sweating was conducted using the Hyperhidrosis Disease Severity Scale and Numeric Rating Scale in 4 body areas: the face, palms, armpits and abdomino-lumbar area. Objective evaluation of sweating was performed using gravimetry. RESULTS: The prevalence of hyperhidrosis in gravimetric measures was 1.12%. In subjective evaluation hyperhidrosis (HDSS 3 or 4) was present in 11.17% of cases. There was no significant difference in subjective evaluation of hyperhidrosis between men and women (15% vs. 9.24%; p = 0.32). In gravimetry men showed a higher perspiration rate on the face (5.85 vs. 3.38; p < 0.05) and in the armpits (17.27 vs. 9.12; p < 0.05). Individuals with body mass index ≥ 25 kg/m2 reported hyperhidrosis more often (28% vs. 8.44%; p < 0.05); however, in gravimetric evaluation, beside the facial area, no significant differences in above-mentioned groups were observed. CONCLUSIONS: There is a discrepancy between subjective and objective methods of evaluating sweating.

The high incidence of late presenters for HIV/AIDS infection in the Lodz province, Poland in the years 2009-2016: we are still far from the UNAIDS 90% target.

The present study retrospectively analyses the prevalence of late diagnosis in patients with newly-diagnosed HIV infection in Lodz, Poland from January 2009 to December 2016, and assesses the predictive factors associated with late presenters. Late presentation is defined as a diagnosis of HIV with a CD4 count<350 cells/µL, or the occurrence of an AIDS- defining event, regardless of the CD4 cell count. Two hundred and fifty-nine (62.86%) patients were late presenters, 178 of whom (68.72%) were advanced late presenters (CD4 cell count below 200 cells/µL). Multivariate factors associated with late HIV presentation included referral from physician for HIV testing (OR: 3.95, 95% CI 2.42-6.46), older age (OR: 1.81, 95% CI: 1.38-2.38) and route of HIV transmission. Heterosexual patients (OR 1.98, 95% CI: 1.01-3.90), active drug users (OR: 3.49, 95% CI: 1.63-7.48) and patients who did not report the route of transmission (OR: 4.29, 95%: CI 1.45-12.62) were more likely to present late than MSM subjects. In conclusion, the majority of HIV-infected patients are still diagnosed late. There is a need for expanded testing not only in MSM group, in which HIV prevalence is the highest, but also in intravenous drug users, or among subjects who are heterosexual or from a higher age group.

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.

Prevalence of anti-HCV antibodies in the population of young women and general medicine patients

BACKGROUND: Comparison of the estimated prevalence of HCV infection and number of detected chronic hepatitis C (CHC) cases shows that most infections in Polish population remain undetected. Until now we have probably diagnosed and treated only approximately 20% of the whole HCV-infected population in Poland. METHODS: We performed anti-HCV antibodies testing in the groups of patients with arterial hypertension or diabetes mellitus and compared proportions of positive results with rates obtained in the group of young, healthy women aged < 35 years. All patients had positive history of at least one hospitalisation. RESULTS: The analysis of patient subgroups according to study inclusion criteria revealed the highest ratio of positive anti-HCV results in the group of young women aged < 35 years with positive history of at least one hospitalisation (5/91, 5.5%). Among patients with arterial hypertension and diabetes 6/505 (1.2%) and 1/94 (1.06%) positive anti-HCV results were detected, respectively. The difference in the proportion of positive anti-HCV results between the group of young women and subgroups of patients with arterial hypertension and diabetes was statistically significant (p=0.00327). CONCLUSION: In view of obtained results it seems reasonable to look for new risk groups of HCV infection in order to increase efficacy of screening tests.

Interferon-free regimens containing setrobuvir for patients with genotype 1 chronic hepatitis C: a randomized, multicenter study.

BACKGROUND & AIMS: Setrobuvir is a direct-acting antiviral (DAA) non-nucleoside inhibitor of hepatitis C virus (HCV) polymerase. This study examined interferon-free combinations containing setrobuvir, a ritonavir-boosted protease inhibitor (danoprevir/r) and ribavirin, with/without the nucleoside inhibitor mericitabine in HCV genotype (G)1 patients. METHODS: Non-cirrhotic treatment-naïve patients (N = 110) were randomized to five groups. Three groups received a 14-day mericitabine/ribavirin lead-in followed by treatment with 3 DAAs (setrobuvir, danoprevir/r, mericitabine) plus ribavirin for 12 weeks (Group A: G1a; D: G1b) or 24 weeks (B: G1a), and two groups received 2 DAAs (setrobuvir, danoprevir/r) plus ribavirin for 12 weeks (E: G1b) or 24 weeks (C: G1a). Efficacy was defined as sustained virological response (HCV RNA <25 IU/ml after 12 weeks' follow-up, SVR12). RESULTS: Two groups met predefined futility criteria for breakthrough (C) or relapse (A) and were discontinued. SVR12 rates were 42.9% (3/7) and 74.1% (20/27) in G1a patients in Groups A and B, respectively, and 95.7% (22/23) and 68.2% (15/22) in G1b patients in Groups D and E respectively. All G1a patients assigned to 24 weeks of treatment who experienced a decrease in HCV RNA of ≥2.3 log10 IU by the end of the lead-in period (n = 28) achieved SVR12. Overall, treatment was well tolerated and most adverse events were mild to moderate. No major safety signals were identified. CONCLUSIONS: An interferon-free setrobuvir-based regimen (3 DAAs plus ribavirin) is safe and effective in treatment-naïve G1 patients.

Adherence to antiviral therapy in HIV or HBV-infected patients.

BACKGROUND: Antiviral therapies in HIV and chronic HBV infection are lifelong and require strict adherence to medication to ensure therapeutic success. AIMS: The aim of this study was to analyze adherence levels in HIV patients on antiretroviral regimen and in B-infected patients treated with nucleos(t)ide reverse transcriptase inhibitors. MATERIAL AND METHODS: The study group consisted of 134 HIV-infected patients and 42 with chronic hepatitis B. The self-reported Morisky 8-Item Medication Adherence Scale (MMAS-8) was used to assess the adherence to medication. We analyzed potential predictors of optimal adherence to the antiretroviral therapy. RESULTS: Mean adherence levels according to MMAS-8 in HIV-infected patients on antiretroviral therapy was 6.64 (SD+/- 1.47) and was significant lower than in patients with chronic hepatitis B 7.48 (SD+/- 1.40) (p < 0.0001). However, adherence levels in HIV-infected patients treated with One-pill-Once a-day antiretroviral regimen were similar to patients with chronic hepatitis B (p>0.05). In univariante logistic regression alcohol abstinence, sexual route of HIV transmission, once daily dosing and reduced number of pills were significantly associated with high adherence. According to multivariante logistic regression analysis, only once-daily drug regimen was independent factor of high adherence (OR=2.89, p=0.038). Higher adherence had positive impact on the effectiveness of antiretroviral therapy (p=0.04). CONCLUSIONS: The implementation of once-daily antiretroviral regimen has improved adherence that had beneficial effect on the effectiveness of antiretroviral therapy.

Epidemiology of hepatitis C virus infections in Lódzkie voivodeship / Epidemiologia zakazen HCV w województwie lódzkim

INTRODUCTION: Epidemiology of HCV subtypes plays an increasing role in treatment decision making in the era of direct acting antivirals. Data on incidence of HCV subtypes in Poland are sparse and equivocal. AIM OF THE STUDY: The aim of this study was to assess the distribution of HCV subtypes basing on data collected in Lodzkie province in 2015. MATERIALS AND METHODS: Patients with chronic hepatitis C were evaluated for antiviral treatment in one of the three infectious diseases departments in Lodzkie province in 2015 and had HCV genotype/subtype determined. The exclusion criteria were as follows: HBV and/or HIV coinfection and age under 18 years old. RESULTS: The study included 555 patients aged from 18 to 87 years. The rate of women was 52.8%, mean age was 47.4 years and treatment-experienced patients comprised 22.7% of study group. Genotypes 1, 3 and 4 were detected in 512 (92.25%), 34 (6.13%) and 7 (1.26%) patients, respectively. Subtype determination was performed in 464 patients infected with HCV genotype 1. The frequency of subtype 1a and 1b was 18.8% and 81%, respectively. Mean age in patients with HCV 1a infection was 28.6 years and was significantly lower than in patients infected with HCV 1b (52.5 years, p<0.05). A significant correlation between age and HCV subtype was observed. CONCLUSIONS: Prevalence of subtype 1a in patients with chronic hepatitis C in Lodzkie province is high, moreover, this subtype dominates in population of young adults (18-29 years).

Expression of selected genes in liver biopsy specimens in relation to early virological response in patients with chronic hepatitis C with HCV mono- and HIV/HCV co-infection.

The aim of our study was to evaluate the significance of IL-28B single-nucleotide polymorphism and hepatic expression of IFI27, SOCS3 and miR-122 in order to predict early virological response (EVR) in patients infected with HCV genotype 1 or 4. The study group consisted of 65 patients: 46 with HCV mono- and 19 with HIV/HCV co-infection. Analyses of IL-28B single-nucleotide polymorphism C/T (rs12979860) in the blood and expression of SOCS3, IFI27 and miR-122 in liver biopsy samples obtained before PegIFN and ribavirin treatment were performed by the RT-PCR method. EVR was defined as a >2log decline in HCV viremia at week 12. EVR was associated with a lower expression of IFI27 and a more frequent presence of the IL28BCC genotype. IFI27 expression was lower in patients with the CC genotype, irrespective of EVR. In multivariate logistic regression, only IL28B CC genotype and age above 40 years influenced EVR (OR =5.09 and 0.29 respectively). In contrast to IFI27, expression of miR-122 and SOCS3 in patients with different IL28B genotypes was not statistically significantly different. A correlation between miR-122 and SOCS3 was found (Rho =0.495094 p< 0.0001). Analysis of IFI27, SOCS3 and miR-122 hepatic expression does not provide substantial benefits for the prognosis of EVR. The only independent prognostic factors for EVR are age and IL28B genotype. The prognostic significance of IFI27 expression for EVR is dependent on the genetic polymorphism of IL28B.

The influence of selenium addition during germination of Brassica seeds on health-promoting potential of sprouts.

The correlation among selenium uptake, the content of bioactive compounds in sprouts, and biological activities triggered in cultured human cells by sprout extracts was investigated. Seeds of Brassica crops and rye were treated with SeO2 water solution. The selenium levels in sprouts increased from 1.0-4.1 to 53.3-382 µg/g dw with no influence on plant physiology according to the indices used. Neither the composition of glucosinolates (GL) in Brassica sprouts nor the myrosinase activity nor the composition of GL breakdown lipophilic products were significantly affected. In all Brassica sprouts, conversion to health-promoting isothiocyanates (ITC) and indoles corresponded to only 1% of total GLs. Low ITC concentration may explain observed lack of induction of glutathione S-transferases (GST) and quinone oxidoreductase (NQO) detoxifying enzymes in HT29 cells exposed to sprout extracts. The insignificant impact on cell growth and genome function suggests that Brassica sprouts may be safe vehicle of selenium to combat its dietary deficiency.

Ribavirin priming has no beneficial effects for chronic hepatitis C patients.

AIM: The aim of this study is to assess the efficacy of an initial dose of ribavirin administered before a 48-week course of treatment with peg-IFN + ribavirin in treatment-naïve patients and in patients after previous failure of CHC treatment. MATERIAL AND METHODS: A total of 103 patients with chronic hepatitis C infected with genotype 1 HCV were qualified to the study. Study patients were randomised to receive one of two treatments: A- RBV for 4 weeks followed by combined therapy with peg-IFN alpha-2a +RBV for 48 weeks (n = 73), or B- combined therapy with peg-IFN alpha-2a +RBV for 48 weeks (n = 30). RESULTS: SVR 24 was observed in 44% patients in group A and in group 40% patients in group B (40%), p > 0.05. Comparing subgroups of the naive patients, it was found that the SVR24 value was higher in group A than group B (57% vs. 47%, p > 0.05). In the re-therapy subgroups, higher treatment response rates in patients not responding earlier was found in group A than group B (39% vs. 16%, p > 0.05). CONCLUSION: No significant advantage was found in the use of a priming method over a standard regimen. However, it could be recommended in patients with a total lack of response to peg-IFN and ribavirin when no other therapeutic options are available.

Has COVID-19 Changed the Incidence and Profile of Late Presenters for HIV Infection in Lodz, Polish Reference Centre, Poland?

Objectives: The aim of this study was to compare the prevalence and characteristics of HIV late presenters (LPs) and advanced LPs (aLPs) registered in the Lodz HIV centre during the COVID-19 pandemic (2020-2021) with those of the pre-pandemic period (2017-2019). Methods: A retrospective analysis was performed of the predictive factors associated with HIV LPs and aLPs based on multivariable logistic regression. The patient entry into specialist HIV care after diagnosis during the pandemic was analysed. Results: Of 121 newly diagnosed HIV infections during the pandemic, 49.6% had late presentation and 36.4% had advanced HIV disease (AHD). In the pre-pandemic period, out of 154 newly diagnosed patients, 58.4% were LPs and 38.3% were aLPs. Independent risk factors for HIV late presentation were older age (OR: 1.04, 95% CI: 1.01-1.076; p = 0.008), diagnosis in hospital (OR: 5.63, 95% CI: 2.87-11.05; p < 0.001) and negative VDRL as compared to positive VDRL (OR: 2.48, 95% CI: 1.19-5.15; p = 0.015). The same predictive factors were associated with aLPs: older age (OR: 1.07, 95% Cl 1.04-1.11; p < 0.001), HIV diagnosis in hospital (OR: 4.25, 95% CI 2.17-8.29; p < 0.001) and negative VDRL as compared to positive VDRL (OR: 4.95, 95% CI 1.87-13.10; p = 0.001). HIV diagnosis during the pandemic was not a risk factor for late presentation nor for advanced late presentation. However, the time between HIV diagnosis and the first visit to an HIV centre was statistically lower in the pre-pandemic period (p = 0.0048); the median lengths of time between the date of HIV testing, the first visit to the centre and the initiation of ART did not differ between these two periods in LPs and aLPs (p > 0.05). Conclusions: The COVID-19 pandemic did not change the prevalence or characteristics of late presentation and aLPs among newly diagnosed patients, nor did it extend the time to enrolment in HIV care or ART introduction in these groups.

Real-world experience with direct-acting antiviral therapy in HCV-infected patients with cirrhosis and esophageal varices.

BACKGROUND: Hepatitis C virus (HCV) infection affects 50 million people worldwide with around 242,000 deaths annually, mainly due to complications such as cirrhosis and hepatocellular carcinoma (HCC). Portal hypertension (PH) caused by cirrhosis leads to severe consequences, including esophageal varices (EV). This study aimed to evaluate the effectiveness and safety of direct-acting antiviral (DAA) treatment in patients with and without EV. METHODS: This retrospective analysis involved consecutive HCV-infected adults undergoing DAA therapy at 22 Polish hepatology centers from July 1, 2015, to December 31, 2022. Patients with cirrhosis were categorized based on the presence of EV diagnosed by gastroscopy. Treatment effectiveness was measured by sustained virologic response (SVR), with safety outcomes monitored for 12 weeks post-treatment. RESULTS: A population of 3393 HCV-infected patients with cirrhosis was divided into groups with (A, n = 976) and without (B, n = 2417) EV. Group A showed a significantly higher prevalence of comorbidities and concomitant medications. Genotype (GT)1b infections predominated in both groups, and GT3 infections were more common in the EV group. Group A exhibited more severe liver disease, and higher rates of decompensation, HCC, and HBV co-infection. SVR was significantly higher in group B (91.5% vs. 96.3%, p < 0.0001). Male gender, GT3, EV presence, and Child-Pugh grade B were identified as independent negative SVR predictors. Group A had a worse safety profile, with notably higher adverse event incidence and mortality. CONCLUSIONS: DAA therapies are highly effective and well tolerated in patients with cirrhosis, but EV presence predicts poorer virologic responses.