Directly Acting Antiviral-Based Treatment for HCV-Infected Persons Who Inject Drugs: A Multicenter Real-Life Study

Background: We aimed to evaluate the factors associated with a virological response in a cohort of Hepatitis C virus (HCV)-infected people who inject drugs (PWID) treated with direct acting antivirals (DAAs). Methods: We conducted a multicenter retrospective cohort study enrolling HCV-infected PWID treated with DAAs. The primary outcome evaluated was the sustained virological response (SVR12) rate. Results: Five hundred and twenty HCV-infected PWID treated with all-oral DAA-based regimens were enrolled; a total of 168 (32.3%) patients presented genotype 1a, 109 (21.0%) genotype 1b, and 174 (33.5%) genotype 3; a total 152 of the 520 subjects (29.2%) were cirrhotics; a total 118 (22.7%) and 373 (71.7%) were treated with DAA regimens of second and third generation, respectively; a total 169 (33.6%) patients were receiving an opioid agonist at the start of antiviral therapy. Only 11 subjects (2.1%) did not show an SVR12. A significant correlation was found between treatment with opioid substitution therapy (p < 0.001), Human Immunodeficiency Virus (HIV) coinfection (p = 0.002), and treatment with first- or second-generation regimens (p = 0.0015) and HCV failure. Upon multivariate analysis, treatment with a first- or second-generation DAA was the only factor independently associated with failure (OR 10.4, 95% CI: 1.43 to 76.1, p = 0.02). Conclusions: Treatment with DAAs led to a high SVR12 rate (97.9%) in a large cohort of HCV-infected PWID. The only predictor of viral failure found in our analysis was treatment with first- and second-generation DAA.

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Real life rates of sustained virological response (SVR) and predictors of relapse following DAA treatment in genotype 3 (GT3) patients with advanced fibrosis/cirrhosis

PLoS ONE ◽

10.1371/journal.pone.0200568 ◽

2018 ◽

Vol 13 (7) ◽

pp. e0200568 ◽

Cited By ~ 4

Author(s):

Alessandra Mangia ◽

Ruggero Losappio ◽

Giovanni Cenderello ◽

Domenico Potenza ◽

Michele Mazzola ◽

...

Keyword(s):

Sustained Virological Response ◽

Virological Response ◽

Real Life ◽

Advanced Fibrosis ◽

Genotype 3

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Daclatasvir, sofosbuvir with or without ribavirin for 24 weeks in hepatitis C genotype 3 cirrhosis: A real-life study

Annals of Hepatology ◽

10.1016/j.aohep.2018.09.005 ◽

2019 ◽

Vol 18 (3) ◽

pp. 434-438 ◽

Cited By ~ 1

Author(s):

Raffaella Lionetti ◽

Paola Piccolo ◽

Ilaria Lenci ◽

Massimo Siciliano ◽

Ubaldo Visco-Comandini ◽

...

Keyword(s):

Hepatitis C ◽

Real Life ◽

Genotype 3 ◽

Life Study ◽

Real Life Study

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Peginterferon plus ribavirin and sustained virological response rate in HCV-related advanced fibrosis: a real life study

The Brazilian Journal of Infectious Diseases ◽

10.1016/j.bjid.2013.05.007 ◽

2014 ◽

Vol 18 (1) ◽

pp. 48-52 ◽

Cited By ~ 10

Author(s):

Giovanni Faria Silva ◽

Cristiane A. Villela-Nogueira ◽

Carlos Eduardo Brandão Mello ◽

Elza Cotrim Soares ◽

Henrique Sergio M. Coelho ◽

...

Keyword(s):

Sustained Virological Response ◽

Virological Response ◽

Response Rate ◽

Sustained Virological Response Rate ◽

Real Life ◽

Advanced Fibrosis ◽

Virological Response Rate ◽

Life Study ◽

Real Life Study

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Sofosbuvir based treatment of chronic hepatitis C genotype 3 infections—A Scandinavian real-life study

PLoS ONE ◽

10.1371/journal.pone.0179764 ◽

2017 ◽

Vol 12 (7) ◽

pp. e0179764 ◽

Cited By ~ 14

Author(s):

Olav Dalgard ◽

Ola Weiland ◽

Geir Noraberg ◽

Lars Karlsen ◽

Lars Heggelund ◽

...

Keyword(s):

Chronic Hepatitis ◽

Hepatitis C ◽

Chronic Hepatitis C ◽

Real Life ◽

Genotype 3 ◽

Life Study ◽

Real Life Study

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Direct-acting antiviral agents in the treatment of chronic Hepatitis C – “Real-life” experience from an academic centre and two specialized clinical practices

Zeitschrift für Gastroenterologie ◽

10.1055/s-0043-121892 ◽

2017 ◽

Vol 56 (04) ◽

pp. 351-360 ◽

Cited By ~ 3

Author(s):

Manuel Groß ◽

Georg Härter ◽

Johanna Backhus ◽

Eugen Zizer ◽

Thomas Seufferlein ◽

...

Keyword(s):

Chronic Hepatitis ◽

Hepatitis C ◽

Chronic Hepatitis C ◽

Life Experience ◽

Antiviral Agents ◽

Real Life ◽

Clinical Practices ◽

Genotype 3 ◽

Svr12 Rate ◽

Real Life Data

AbstractThe introduction of the new direct antiviral agents has revolutionized the therapy of chronic hepatitis C. Today we are able to cure the vast majority of our patients with an 8- to 12-week therapy course of an antiviral combination therapy with an excellent safety profile. Real-life data are very important to further develop our experience with the new therapeutics and help us to improve the care of our patients in our everyday clinical practice.In our study, we present the retrospective analysis of a representative German cohort of 344 patients with chronic hepatitis C treated with the new direct antiviral agents. The patients were recruited in an academic center of southern Germany (University Clinic of Ulm, Clinic of Internal Medicine I) and in 2 highly specialized clinical practices in the city center and the near region of Ulm. Within this in-detail characterized study cohort, we analyzed the efficacy and safety of antiviral therapy under real-life conditions.In 322 patients, we could document SVR12 data and found an excellent overall SVR12 rate of 97.8 % across all genotypes. In more detail, we could show comparable SVR12 results of 99 % and 99.2 % in patients with the hepatitis C virus subtypes 1a and 1b of and an excellent SVR12 rate of 93.1 % in genotype 3 patients without liver cirrhosis. Nevertheless, SVR12 rates tend to be lower in patients with the presence of liver cirrhosis, especially in genotype 3 patients with the lowest SVR12 rate in the whole study group of only 80 %. In general, there were no major safety issues except of 1 patient treated with a protease-inhibitor-based regimen who developed a generalized skin reaction and needed hospitalization and premature end of antiviral therapy.In summary, our analysis of this well characterized representative cohort of 344 patients adds more information in the field of real-life experience with the new antiviral therapeutics and could therefore contribute to improve the care of our patients. Together with the existing real-life data, we now can proceed in achieving the aim of viral eradication of hepatitis C virus within our population.

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Entecavir monotherapy improves renal function in patients developing renal side effects during long-term tenofovir treatment without compromising virological response: A multicenter real-life study in 103 patients

Digestive and Liver Disease ◽

10.1016/j.dld.2017.01.078 ◽

2017 ◽

Vol 49 (1) ◽

pp. e37

Author(s):

M. Viganò ◽

G. Grossi ◽

A. Loglio ◽

M. Cappelletti ◽

S. Zaltron ◽

...

Keyword(s):

Renal Function ◽

Side Effects ◽

Virological Response ◽

Real Life ◽

Life Study ◽

Real Life Study

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DAA-based treatment for HIV–HCV-coinfected patients: analysis of factors of sustained virological response in a real-life study

Antiviral Therapy ◽

10.3851/imp3353 ◽

2020 ◽

Cited By ~ 1

Author(s):

Loredana Alessio ◽

Lorenzo Onorato ◽

Vincenzo Sangiovanni ◽

Francesco Borrelli ◽

Elio Manzillo ◽

...

Keyword(s):

Sustained Virological Response ◽

Virological Response ◽

Real Life ◽

Life Study ◽

Real Life Study

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Daclatasvir, Sofosbuvir With or Without Ribavirin for 24 Weeks In Hepatitis C Genotype 3 Cirrhosis: A Real-Life Study

Annals of Hepatology ◽

10.5604/01.3001.0012.4901 ◽

2018 ◽

Vol 17 (5) ◽

pp. 0-10

Author(s):

Raffaella Lionetti ◽

Paola Piccolo ◽

Ilaria Lenci ◽

Massimo Siciliano ◽

Ubaldo Visco-Comandini ◽

...

Keyword(s):

Hepatitis C ◽

Antiviral Agents ◽

Real Life ◽

Genotype 3 ◽

Virus Genotype ◽

Serious Adverse Events ◽

Life Study ◽

Drug Agency ◽

Pugh Class ◽

Cirrhotic Patients

Introduction and aim: Cirrhotic patients with hepatitis C virus genotype 3 infection show unsatisfactory outcomes after 12 weeks’ treatment with direct antiviral agents. The National Italian Drug Agency allows 24 weeks of therapy in difficult-to-treat patients, including genotype 3 cirrhotics . Aim of this study was to evaluate efficacy and safety of a 24-week course of sofosbuvir plus daclatasvir±ribavirin in this population. Materials and methods: 106 consecutive cirrhotics (70.8% males, mean age 55.3±7.6 years) in 8 tertiary hepatology centers received sofosbuvir plus daclatasvir for 24 weeks. Ribavirin was administered in 85 (80.2%) based expected tolerability, at a mean dose of 964±202 mg/day. Baseline Child-Pugh class was A 91.5%, B 6.6%, C 1.9%; mean baseline MELD was 8.5±2.7. Results: All patients completed 12-week follow-up post-treatment, and 104 (98.1%) obtained sustained virologcal response (100% in ribavirin -treated patients vs 90.4% without ribavirin; p=0.04). No worsening in renal and liver function was observed, no serious adverse events occurred. Two virological failures showed resistance associated variants (Y93H and S282T). Conclusion: An extended 24-week treatment with sofosbuvir plus daclatasvir+ribavirin obtained 100% efficacy in genotype 3 hepatitis C cirrhosis, with very limited side effects. The role of ribavirin seems crucial in this setting and should be administered if clinically feasible.

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Sofosbuvir-based therapies achieved satisfactory virological response in Chinese with genotypes 3 and 6 infection: a real-world experience from a centre

10.21203/rs.3.rs-85004/v1 ◽

2020 ◽

Author(s):

Qiao Tang ◽

Li Wei ◽

Xiaoqing Liu ◽

Peng Hu

Keyword(s):

Sustained Virological Response ◽

Real World ◽

Virological Response ◽

Genotype 3 ◽

Svr12 Rate ◽

Real World Data ◽

Cirrhotic Patients ◽

The Impact ◽

High Sustained Virological Response

Abstract BackgroundAs previously shown by others, sofosbuvir-based regimens yield high sustained virological response rates in patients with HCV infection except for genotype 3b complicating with cirrhosis. The real-world study aims to explore efficacy and safety of sofosbuvir-based regimens in genotypes 3 and 6 infected patients, especially the impact of ribavirin co-administration on sustained virological response in cirrhotic patients with genotype 3b infection. MethodsA retrospective cohort study included 173 patients initiated on sofosbuvir-based regimens. Main endpoint of treatment was sustained virological response at post-treatment week 12 (SVR12).Results92 patients with sufficient follow-up were included. Overall, SVR12 rate was 96.7% (89/92), including 62 patients treated with addition of ribavirin to sofosbuvir-based regimens, given superior SVR12 rate (98.4%) than ribavirin free regimens (93.3%). SVR12 rates were 96.3% and 96.7% in patients infected with genotype3 (54) and genotype 6 (38) Among patients with genotype 3b infection, SVR12 was achieved in 97.1%, and 100% when complicating with cirrhosis. SVR12 rate was achieved in 96.6% among patients with cirrhosis (28/29), 100% with ribavirin co-administration regimens and 87.5% without ribavirin. Totally, three patients failed to achieve SVR12, including 2 non-cirrhotic patients with genotype 3b and 6a infection treated with sofosbuvir+ribavirin and sofosbuvir/velpatasvir regimen, one cirrhotic patient with genotype 3k infection treated with SOF/VEL regimen. No sever adverse events occurred.ConclusionsReal-world data show that sofosbuvir-based regimens are highly effective and safe for patients with HCV genotypes 3 and 6 infection. Addition of ribavirin to sofosbuvir-based regimens may improve efficacy, especially in patients with genotype 3 infection and cirrhosis.Trial registrationNot applicable.

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