Future research and collaboration: the “SINERGIE” project on HCV (South Italian Network for Rational Guidelines and International Epidemiology)

Torti, Carlo; Zazzi, Maurizio; Abenavoli, Ludovico; Trapasso, Francesco; Cesario, Francesco; Corigliano, D; Cosco, Lucio; Costa, Cristina; Curia, RL; Rosa, M De; Giraldi, Cristina; Leone, Rosa; Mc, Liberto; Lucchino, Domenico; Marascio, Nadia; Masciari, Rosanna; Matera, Giovanni; Pisani, Vincenzo; Serrao, N; Surace, L.; Zicca, Emilia; Castelli, Francesco; Ciccozzi, Massimo; Puoti, Massimo; Focà, Alfredo

doi:10.1186/1471-2334-12-s2-s9

Cited by 12 publications

(9 citation statements)

References 19 publications

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“…A retrospective study was conducted in patients treated for chronic HCV infection from January 2014 to December 2018 at Infectious and Tropical Disease Unit of Mater Domini teaching hospital (Southern Italy). This analysis was performed as part of the SINERGIE study protocol [17]. All patients gave their informed consent for participation in this study.…”

Section: Methodsmentioning

confidence: 99%

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Virological and Clinical Outcome of DAA Containing Regimens in a Cohort of Patients in Calabria Region (Southern Italy)

et al. 2020

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Background and objectives: In Italy, Hepatitis C Virus (HCV) infections are most prevalent in people older than 50 years of age, who often experience multi-morbidities, take co-medications, and have a long history of liver disease. These characteristics could potentially affect tolerability of HCV treatments and adherence in this subgroup. After achievement of sustained virological response (SVR), retention into care is very important both to detect the onset of possible complications and prevent further infections. In this study, SVR rates and retention into care of patients treated with directly acting antivirals (DAAs) of a single-center cohort in Southern Italy were evaluated. Materials and Methods: Patients treated with directly acting antivirals from 2014 to 2018 were included. Patients were stratified by age (i.e., <65 vs. ≥65 years) and by cirrhosis presence (i.e., liver stiffness >14.6 KPa or clinical/ultrasound cirrhosis vs. absence of these criteria). Primary outcome was availability of SVR at Weeks 12-24 after the end of treatment. Inter-and intra-group comparisons were performed along the follow-up for significant laboratory parameters. Results: In total, 212 patients were treated; 184 (87%) obtained SVR after the first treatment course and 4 patients after retreatment. Twenty-two (10.4%) patients were lost to follow-up before assessment of SVR, and two patients died before the end of treatment for liver decompensation. Considering only the first treatment episode, per protocol analysis (i.e., excluding patients lost to follow-up) showed the following rates of SVR: 97% (overall), 97% (older age group), 96% (age group <65 years), 94% (cirrhotics), and 100% (non-cirrhotics). By contrast, at the intention to treat analysis (i.e., patients lost were computed as failures), SVR percentages were significantly lower for patients <65 years of age (80%) and for non-cirrhotics (85%). Conclusions: High rates of SVR were obtained. However, younger patients and those without cirrhosis displayed an apparent high risk of being lost to follow-up. This may have important implications: since those who are lost may transmit HCV in case SVR is not achieved, these subpopulations should receive appropriate counselling during treatment.

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Section: Methodsmentioning

confidence: 99%

“…All patients gave their informed consent for participation in this study. The study was conducted in accordance with the Declaration of Helsinki, and the study protocol was approved by the Ethics Committee of Calabria Region (project identification code #2012.58.E; 19 June 2013) [17].…”

Section: Methodsmentioning

confidence: 99%

Virological and Clinical Outcome of DAA Containing Regimens in a Cohort of Patients in Calabria Region (Southern Italy)

et al. 2020

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“…Eight DAA-naïve patients chronically infected with HCV subtype 1b, who were not co-infected with HIV or HBV, were recruited between January and December 2014 at the “Mater Domini” University Hospital of Catanzaro, Italy, as part of the SINERGIE (South Italian Network for Rational Guidelines and International Epidemiology) project [ 48 ]. We provide an overview of the patients’ clinical information in Table 1 .…”

Section: Methodsmentioning

confidence: 99%

Detection of Natural Resistance-Associated Substitutions by Ion Semiconductor Technology in HCV1b Positive, Direct-Acting Antiviral Agents-Naïve Patients

Marascio

Pavia

Strazzulla

et al. 2016

IJMS

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Naturally occurring resistance-associated substitutions (RASs) can negatively impact the response to direct-acting antivirals (DAAs) agents-based therapies for hepatitis C virus (HCV) infection. Herein, we set out to characterize the RASs in the HCV1b genome from serum samples of DAA-naïve patients in the context of the SINERGIE (South Italian Network for Rational Guidelines and International Epidemiology, 2014) project. We deep-sequenced the NS3/4A protease region of the viral population using the Ion Torrent Personal Genome Machine, and patient-specific majority rule consensus sequence summaries were constructed with a combination of freely available next generation sequencing data analysis software. We detected NS3/4A protease major and minor variants associated with resistance to boceprevir (V36L), telaprevir (V36L, I132V), simeprevir (V36L), and grazoprevir (V36L, V170I). Furthermore, we sequenced part of HCV NS5B polymerase using Sanger-sequencing and detected a natural RAS for dasabuvir (C316N). This mutation could be important for treatment strategies in cases of previous therapy failure.

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“…With this objective in mind, we intend to implement our collaboration through the SINERGIE network [25]. In the meantime, spotted observations have been collected.…”

Section: Update On Hcv Genotypes In the Calabria Regionmentioning

confidence: 99%

Update on epidemiology of HCV in Italy: focus on the Calabria Region

et al. 2014

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The epidemiological profile of HCV infection is evolving in Europe, as well as in Italy. We have previously showed genotype distributions and their dynamics in 2,153 HCV RNA positive patients living in Calabria, Southern Italy, over 11 years. In this study, we extend and update this information by evaluating a hospital-based cohort of 945 HCV RNA positive patients attending five hospitals in the Calabria Region from January 2011 to August 2013. We assessed rates of HCV genotypes according to age and gender and the dynamics of HCV genotype distribution over the 3-year period studied. Data showed that genotype 1b is the most prevalent, followed by subtypes 2a/2c and genotype 3. Genotype 4 exhibited an increase between 2011 and 2013. Also, we found a significant decrease in the median age of subjects infected with HCV genotype 3 and 4 during the period studied. Since HCV genotypes are important in epidemiology, pathogenesis and response to antiviral therapy, a continuous epidemiological surveillance is needed.

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Future research and collaboration: the “SINERGIE” project on HCV (South Italian Network for Rational Guidelines and International Epidemiology)

Cited by 12 publications

References 19 publications

Virological and Clinical Outcome of DAA Containing Regimens in a Cohort of Patients in Calabria Region (Southern Italy)

Virological and Clinical Outcome of DAA Containing Regimens in a Cohort of Patients in Calabria Region (Southern Italy)

Detection of Natural Resistance-Associated Substitutions by Ion Semiconductor Technology in HCV1b Positive, Direct-Acting Antiviral Agents-Naïve Patients

Update on epidemiology of HCV in Italy: focus on the Calabria Region

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