The effect of antiviral therapy on hepatitis C virus-related thrombocytopenia: a case report

Background & Aims: Smoking has multiple effects on factors influencing hepatitis C and antiviral therapy, including lipid metabolism, fibrosis, platelet count and adherence aspects. The aim of this analysis was to determine the impact of smoking on hepatitis C virus antiviral therapy. Methods: Data of two cohorts of an observational multicenter study including therapy-naïve patients infected with genotype 1 hepatitis C virus (HCV) treated with dual antiviral therapy (n=7,796) with pegylated interferon alpha 2a in combination with ribavirin, or triple antiviral therapy (n=1,122) containing telaprevir or boceprevir, were analysed. Results: In the univariate matched pair analysis of dual antiviral therapy patients (n=584), smoking was significantly associated with lower sustained viral response rates (p=0.026, OR 0.69 CI: 0.50 – 0.96). The effect of smoking on sustained viral response remained significant (p=0.028, OR 0.67 CI: 0.47 – 0.96) in the multivariate analysis when adjusting for all other baseline parameters with a significant association in the univariate analysis, i.e. diabetes, fibrosis, body mass index, transaminases and baseline viral load. Under protease inhibitors the influence of smoking on virological response did not arise. Conclusions: Smoking has a negative impact on antiviral therapy in naïve patients infected with HCV genotype 1 independently of age, gender, history of drug use or alcoholic liver disease. The effects of smoking might be overcome by the new antiviral agents.Abbreviations: APRI: AST to platelet ratio index; DAA: direct antiviral agent; DT: dual antiviral therapy; EoTR: end of treatment response; RVR: rapid virological response; EVR: early virological response; HCV: hepatitis C virus; IFN: interferon alpha; MPA: Matched Pair Analysis; NS: non-smokers; PEG-IFN: pegylated interferon alpha 2a; PI: protease inhibitor; RBV: ribavirin; SAE: serious adverse event; SOC: standard of care; S: smokers; SVR: sustained viral response.

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Faculty Opinions recommendation of Triphasic decline of hepatitis C virus RNA during antiviral therapy.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.1105127.561309 ◽

2008 ◽

Author(s):

Varun Garg

Keyword(s):

Hepatitis C Virus ◽

Hepatitis C ◽

Antiviral Therapy ◽

Hepatitis C Virus Rna ◽

Virus Rna

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Faculty Opinions recommendation of EGFR and EphA2 are host factors for hepatitis C virus entry and possible targets for antiviral therapy.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.12498956.13719054 ◽

2011 ◽

Author(s):

Ray Chung ◽

Nikolaus Jilg

Keyword(s):

Hepatitis C Virus ◽

Hepatitis C ◽

Antiviral Therapy ◽

Virus Entry ◽

Host Factors

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Treatment of chronic hepatitis C virus infection with crushed ledipasvir/sofosbuvir administered through a percutaneous endoscopic gastrostomy tube in a patient with HIV coinfection

American Journal of Health-System Pharmacy ◽

10.1093/ajhp/zxaa328 ◽

2020 ◽

Vol 78 (1) ◽

pp. 36-40

Author(s):

Vanessa Huffman ◽

Diana C Andrade ◽

Elizabeth Sherman ◽

Jianli Niu ◽

Paula A Eckardt

Keyword(s):

Case Report ◽

Hepatitis C Virus ◽

Hepatitis C ◽

Percutaneous Endoscopic Gastrostomy ◽

Fixed Dose ◽

Pharmacokinetic Data ◽

Percutaneous Endoscopic Gastrostomy Tube ◽

Endoscopic Gastrostomy ◽

Hiv Coinfection ◽

Peg Tube

Abstract Purpose Ledipasvir/sofosbuvir is an oral combination therapy containing fixed doses of direct-acting antiviral agents indicated for the treatment of hepatitis C virus (HCV) infection. Currently there are limited data on the clinical efficacy of crushed ledipasvir/sofosbuvir administered via feeding tube. Summary This case report discusses the successful treatment of chronic HCV genotype 1b infection with crushed ledipasvir/sofosbuvir administered through a percutaneous endoscopic gastrostomy (PEG) tube in a patient with human immunodeficiency virus (HIV) coinfection and high-grade sarcoma who had severe swallowing difficulties. The patient received crushed ledipasvir/sofosbuvir daily for a total of 12 weeks. At 12 weeks the patient had achieved a sustained virologic response. Conclusion Currently, ledipasvir/sofosbuvir is available only as a tablet, with limited pharmacokinetic data available to guide clinicians on use of the fixed-dose combination medication in crushed form. This case report highlights our experience treating a patient with HCV/HIV coinfection through administration of crushed ledipasvir/sofosbuvir via PEG tube, which we found to be a safe and effective therapeutic option.

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Management of HIV/hepatitis C virus-coinfected patient non-responders to hepatitis C virus antiviral therapy and relapsers

Current Opinion in HIV and AIDS ◽

10.1097/coh.0b013e3282f0dce1 ◽

2007 ◽

Vol 2 (6) ◽

pp. 496-502

Author(s):

Cristina Tural ◽

Ramon Planas ◽

Guillermo Sirera ◽

Bonaventura Clotet

Keyword(s):

Hepatitis C Virus ◽

Hepatitis C ◽

Antiviral Therapy ◽

Coinfected Patient

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Hepatocellular carcinoma associated with direct-acting antiviral therapy for hepatitis C virus: A report of two cases

Revista de Gastroenterología de México (English Edition) ◽

10.1016/j.rgmxen.2020.04.007 ◽

2021 ◽

Author(s):

R. Tapia-Sosa ◽

F. Hernández-Cabral ◽

A. Gabutti ◽

V.M. Páez-Zayas ◽

I. García-Juárez

Keyword(s):

Hepatocellular Carcinoma ◽

Hepatitis C Virus ◽

Hepatitis C ◽

Antiviral Therapy ◽

Direct Acting Antiviral ◽

Direct Acting

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Idenix v. Gilead: The enablement and written description limits of a genus claim

Journal of Generic Medicines The Business Journal for the Generic Medicines Sector ◽

10.1177/17411343211013572 ◽

2021 ◽

Vol 17 (2) ◽

pp. 77-83

Author(s):

Keith A Zullow ◽

Cindy Chang ◽

Sean Anderson

Keyword(s):

Case Report ◽

Hepatitis C Virus ◽

Hepatitis C ◽

Supreme Court ◽

The Supreme Court ◽

Federal Circuit ◽

Written Description ◽

Insufficient Number

In Idenix Pharms. LLC v. Gilead Sci. Inc., 941 F.3d 1149 (Fed. Cir. 2019), the Federal Circuit affirmed a judgment of invalidity of a patent claiming methods for treating Hepatitis C virus for, inter alia, lack of enablement. The Supreme Court denied Idenix’s petition for a writ of certiorari, meaning that the Federal Circuit decision stands, and genus claims covering thousands of compounds that were supported by an insufficient number of examples have failed the enablement test not once, but twice. See Wyeth & Cordis Corp. v. Abbott Labs., 720 F.3d 1380 (Fed. Cir. 2013). This case report presents the context surrounding the Federal Circuit’s Idenix decision and the Supreme Court’s decision not to hear the case.

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