THU-197-Comparative effectiveness of 8 versus 12 weeks of ombitasvir/paritaprevir/ritonavir and dasabuvir in treatment-naive patients infected with HCV genotype 1b with non-advanced hepatic fibrosis

Aim. Evaluate efficacy and safety of a combination of direct - acting antivirals narlaprevir/ritonavir with daclatasvir in patients with viral hepatitis C. Materials and methods. The study enrolled adult patients with HCV genotype 1b infection without demonstrated NS5A resistance - associated substitutions Y93C/H/N/S and/or L31F/M/V/I. Patients were treated with narlaprevir 200 mg QD, ritonavir 100 mg QD and daclatasvir 60 mg QD. Treatment duration was 12 weeks. Proportion of patients achieving sustained virological response 12 weeks after treatment (SVR12) was the primary efficacy endpoint. Results and discussion. In total, 105 (75.0%) patients were treatment with the study combination. Patients’ age varied from 21 to 69 years, the mean age being 43.2±10.9 years. There were slightly more women (55.2%), and 69 patients (65.7%) had comorbidities. SVR 12 was 89.5% (95% CI 82.0-94.7%). In 10 of 11 patients with treatment failures NS5A resistance - associated substitutions in residues 31 and/or 93 were found, as well as less clinically relevant substitutions L28M, P58S, R30Q, Q62K. Adverse events (AEs) were found in less than one half of patients (45 patients, or 42.9% in the safety population). Almost all recorded AEs were mild to moderate. Conclusion. Efficacy of treatment with a combination of narlaprevir/ritonavir and daclatasvir in treatment - naïve patients with HCV genotype 1b was close to 90%. This combination was found to be safe and well - tolerated.

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Association of the Sialylation of Antibodies Specific to the HCV E2 Envelope Glycoprotein with Hepatic Fibrosis Progression and Antiviral Therapy Efficacy

Disease Markers ◽

10.1155/2020/8881279 ◽

2020 ◽

Vol 2020 ◽

pp. 1-9

Author(s):

Oleg Kurtenkov ◽

Jelena Jakovleva ◽

Boris Sergejev ◽

Julia Geller

Keyword(s):

Antiviral Therapy ◽

Sustained Virological Response ◽

Hepatic Fibrosis ◽

Virological Response ◽

Envelope Glycoprotein ◽

Neutralizing Antibodies ◽

Predictive Biomarkers ◽

Hcv Infection ◽

Hcv Genotype ◽

Treatment Naïve

The E2 envelope glycoprotein of the hepatitis C virus (HCV) is a major target of broadly neutralizing antibodies that are closely related to a spontaneous cure of HCV infection. There is still no data about the diversity of E2-specific antibodies (Abs) glycosylation. The aim of this study was to analyze the level and sialylation of E2 IgG Abs, the relation of the respective changes to hepatic fibrosis (F) progression and their possible association with the efficacy of interferon-α-2a plus ribavirin (IFN-RBV) antiviral therapy. One hundred three HCV infected treatment-naive patients were examined using ELISA with E2 recombinant protein as antigen and sialic acid-specific Sambucus nigra agglutinin. The efficacy of the IFN-RBV treatment of patients with HCV dominant 1b and 3a genotypes (GT) was evaluated. A significant decrease of E2 Abs sialylation in the late stages of fibrosis was found irrespective of HCV genotype. On this basis, the F4 stage of fibrosis can be discriminated from its F0 or F1-3 stage by an about 75-79% accuracy. HCV infection of 1b genotype is associated with the production of lower sialylated E2 Abs, a higher frequency of F4 stage fibrosis, and a worse response to antiviral therapy. The increased SNA reactivity of E2 Abs was observed in patients with a sustained virological response (SVR). The proportion of SVR responders was significantly higher among patients with 3a genotype. However, for both dominant HCV genotypes (3a and 1b), an increased sialylation of E2 IgG was associated with a higher rate of patients with sustained virological response to antiviral therapy. Thus, the association of alterations of anti-E2 IgG Abs sialylation with hepatic fibrosis stage, HCV genotype, and the efficacy of antiviral therapy enables using these changes as novel noninvasive predictive biomarkers. The clinical potential of these findings is discussed.

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P1299 PEARL-III: 12 WEEKS OF ABT-450/R/267 + ABT-333 ACHIEVED SVR IN >99% OF 419 TREATMENT-NAIVE HCV GENOTYPE 1B-INFECTED ADULTS WITH OR WITHOUT RIBAVIRIN

Journal of Hepatology ◽

10.1016/s0168-8278(14)61466-5 ◽

2014 ◽

Vol 60 (1) ◽

pp. S527 ◽

Cited By ~ 4

Author(s):

P. Ferenci ◽

A. Nyberg ◽

P. Enayati ◽

D. Bernstein ◽

Y. Baruch ◽

...

Keyword(s):

Hcv Genotype ◽

Genotype 1B ◽

Treatment Naïve

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Naturally Occurring Mutations in the Nonstructural Region 5B of Hepatitis C Virus (HCV) from Treatment-Naïve Korean Patients Chronically Infected with HCV Genotype 1b

PLoS ONE ◽

10.1371/journal.pone.0087773 ◽

2014 ◽

Vol 9 (1) ◽

pp. e87773 ◽

Cited By ~ 10

Author(s):

Dong-Won Kim ◽

Seoung-Ae Lee ◽

Hong Kim ◽

You-Sub Won ◽

Bum-Joon Kim

Keyword(s):

Hepatitis C Virus ◽

Hepatitis C ◽

Hcv Genotype ◽

Korean Patients ◽

Naturally Occurring ◽

Genotype 1B ◽

Treatment Naïve

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Efficacy and Tolerability of Simeprevir and Daclatasvir for 12 or 24 Weeks in HCV Genotype 1b-Infected Treatment-Naïve Patients with Advanced Fibrosis or Compensated Cirrhosis

Journal of Hepatology ◽

10.1016/s0168-8278(16)01470-7 ◽

2016 ◽

Vol 64 (2) ◽

pp. S754 ◽

Cited By ~ 1

Author(s):

C. Hezode ◽

P. Almasio ◽

S. Bourgeois ◽

P. Buggisch ◽

A. Brown ◽

...

Keyword(s):

Advanced Fibrosis ◽

Hcv Genotype ◽

Compensated Cirrhosis ◽

Genotype 1B ◽

Treatment Naïve

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Interferon-Free Regimen: Equally Effective in Treatment Naive and Experienced HCV Patients

Annals of Hepatology ◽

10.5604/01.3001.0012.2236 ◽

2018 ◽

Vol 17 (5) ◽

pp. 0-10

Author(s):

Crina Fofiu ◽

Alina Boeriu ◽

Felicia Coman ◽

Alexandru Fofiu ◽

Nikola Panic ◽

...

Keyword(s):

Sustained Virologic Response ◽

Virologic Response ◽

High Rate ◽

County Hospital ◽

Treatment Experience ◽

Hcv Genotype ◽

Compensated Cirrhosis ◽

Genotype 1B ◽

Treatment Naïve ◽

Chronic Hcv

Introduction and aim: Interferon-free regimen has been reported to be highly efficient in treatment of HCV infection, including patients with compensated cirrhosis. We compared the efficacy of Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir and Ribavirin (OBT/PTV/r, with DSV and RBV) therapy in patients with chronic HCV genotype 1b infection and compensated cirrhosis with and without prior treatment experience with pegylated interferon and ribavirin (IFN/RBV). Methods: A prospective two-center study was conducted in Mures County Hospital and Brasov County Hospital, Romania in period November 2015–July 2016. Both treatment naïve and PegIFN/RBV experienced patients with chronic HCV genotype 1b infection received 12 weeks of OBT/PTV/r, with DSV and RBV. Sustained virologic response 12 weeks after the treatment and eventual discontinuation of therapy due to adverse events were assessed in order to estimate safety and efficiency of therapeutic regimen. Results: Fifty nine patients were included in study, 35 (59.3%) of them were previously treated with IFN/RBV. Forty four (74.5%) patients were previously diagnosed with cirrhosis Child Pugh score 5, while 15 (25.4%) with Child Pugh score 6. All 59 patients achieved a SVR12 of 100% and one patient from treatment naïve cohort discontinued the therapy due to hyperbilirubinemia and encephalopathy. However viral load assessed at 12 weeks after discontinuation of therapy in this patient was undetectable. Conclusion: An all-oral regimen of co-formulated OBT/PTV/r with DSV and RBV results in high rate of sustained virologic response at post-treatment week 12 among HCV GT1b infected patients associated with compensated cirrhosis, regardless of previous treatment experience with PegIFN/RBV.

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