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Objectives: Optimized diagnostic algorithms to detect active infections are crucial to achieving HCV elimination. We evaluated the cost effectiveness and sustainability of different algorithms for HCV active infection diagnosis, in a context of a high endemic country for HCV infection. Methods: A Markov disease progression model, simulating six diagnostic algorithms in the birth cohort 1969‐1989 over a 10‐year horizon from a healthcare perspective was used. Conventionally diagnosis of active HCV infection is through detection of antibodies (HCV‐Ab) detection followed by HCV‐RNA or HCV core antigen (HCV‐Ag) confirmatory testing either on a second sample or by same sample reflex testing. The undiagnosed and unconfirmed rates were evaluated by assays false negative estimates and each algorithm patients' drop‐off. Age, liver disease stages distribution, liver disease stage costs, treatment effectiveness and costs were used to evaluate the quality‐adjusted life‐years (QALYs) and the incremental cost‐effectiveness ratios (ICER). Results: The reference option was Rapid HCV‐Ab followed by second sample HCV‐Ag testing which produced the lowest QALYs (866,835 QALYs). The highest gains in health (QALYs=974,458) was obtained by HCV‐RNA reflex testing which produced a high cost‐effective ICER (€891/QALY). Reflex testing (same sample‐single visit) vs two patients' visits algorithms, yielded the highest QALYs and high cost‐effective ICERs (€566 and €635/QALY for HCV‐Ag and HCV‐RNA, respectively), confirmed in 99.9% of the 5,000 probabilistic simulations. Conclusions: Our data confirm, by a cost effectiveness point of view, the EASL and WHO clinical practice guidelines recommending HCV reflex testing as most cost effective diagnostic option vs other diagnostic pathways. [ABSTRACT FROM AUTHOR]

Inmates have higher HCV prevalence than general population, representing a fundamental step towards HCV eradication. Our aim was to compare 8‐week glecaprevir/pibrentasvir treatment in a case‐control study between incarcerated and free patients. Eleven Italian prisons and six outpatient clinics were involved. Patients were matched for sex, risk factors, METAVIR grade, HIV and HBV co‐infections. About 131 incarcerated (Group A) and 131 free patients (Group B) were included. Mean age was 43.0 ± 9.6 years and 42.8 ± 9.9 in Group A and B, respectively (P =.74). SVR rates were 96.2% and 99.2% in Group A and Group B respectively (P =.21). Five drop‐outs occurred in Group A, one in Group B. Incarceration, being PWIDs and OST were not associated with SVR reductions (CI 95%). In conclusion, imprisonment does not influence unplanned interruptions or SVR rates when receiving short‐term therapies. Short schedules with pangenotypic regimens could be a good approach to hard‐to‐reach populations, such as incarcerated patients. [ABSTRACT FROM AUTHOR]

Background/Aims: Patients with genotype 3 hepatitis C virus (G3-HCV) cirrhosis are very difficult to treat compared to patients with other HCV genotypes. The optimal treatment duration and drug regimen associated with ribavirin (RBV) remain unclear. To evaluate the efficacy and safety of daclatasvir (DCV)/sofosbuvir (SOF) plus a flat dose of 800 mg RBV (flat dose) compared to DCV/SOF without RBV or DCV/ SOF plus an RBV dose based on body weight (weight-based) in G3-HCV patients with compensated or decompensated cirrhosis. Methods: We analyzed data for 233 G3 cirrhotic patients. Of these, 70 (30%), 87(37%) and 76 (33%) received SOF/DCV, SOF/DCV/RBV flat dose, and SOF/DCV/ RBV weight-based dose, respectively. Treatment duration was 24 weeks. Sustained virological response (SVR) was evaluated at week 12 posttreatment (SVR12). Results: Overall, SVR12 was achieved in 220 out of 233 patients (94.4%). The SVR12 rate was lower in the DCV/SOF group than in the DCV/SOF/RBV flat-dose group and the DCV/ SOF/RBV weight-based group (87.1% vs 97.7% and 97.4%, respectively, p=0.007). A higher incidence of anemia occurred in the DCV/SOF/RBV weight-based group compared to those in the other two groups (p<0.007). Conclusions: We found that the DCV/SOF/RBV flat-dose regimen is an effective treatment in terms of efficacy and safety in patients with G3-HCV compensated or decompensated cirrhosis. Therefore, antiviral regimens without RBV should be restricted only to naïve patients with G3-HCV compensated cirrhosis who have a clear contraindication for RBV. [ABSTRACT FROM AUTHOR]

Aim To evaluate the effect of a multi-disciplinary standardized management model on the efficacy of pegylated (Peg)-interferon α-2b plus ribavirin treatment of chronic hepatitis C in drug addicts undergoing substitutive or antagonist therapy. Design Observational prospective multi-centre study. Setting Six clinical infectious disease centres in collaboration with 11 drug dependency units (DDU) in five Italian regions. Participants Intravenous drug users affected by chronic hepatitis C engaged in detoxification programmes. Methods Application of a multi-disciplinary standardized management model for HCV treatment involving DDU operators, psychologists or psychiatrists and infectious disease specialists. Measurements Very early, early, end-of-treatment and sustained virological response to Peg-interferon α-2b plus ribavirin. Findings Fifty-three subjects were studied [43.4% with hepatitis C virus (HCV) genotypes 1 or 4]. Intent-to-treat analysis showed an end-of-treatment virological response in 58.5% of patients (39.1% genotypes 1 or 4; 73.4% genotype 3) and a sustained virological response in 54.7% (34.8% genotypes 1 or 4; 70.0% genotype 3). There were 19 (35.8%) dropouts and three (5.7%) non-responders: one genotype 1 and two genotype 4. Two (3.8%) patients relapsed: genotypes 1 and 3. On-treatment analysis showed negative HCV-RNA in 40 (93.1%) of 43 subjects who completed the first 12 treatment weeks and in 35 who completed the first 24 treatment weeks. All subjects with an end-of-treatment response, except one with genotype 3 infection, had a sustained response. Conclusions Our data show that antiviral treatment in the context of a multi-disciplinary standardized management model helps many HCV-positive drug addicts achieve a good virological response. [ABSTRACT FROM AUTHOR]

Compares the safety profile and efficacy of the antiviral agent ribavirin combined with leucocyte interferon (IFN)-alpha or with recombinant IFNalpha-2b in treatment-naive patients with chronic hepatitis C. Lower number of adverse events in patients receiving leucocyte IFNalpha; Effectiveness of both regimens in inducing a sustained response in naive patients.