8 weeks of sofosbuvir/ledipasvir is effective in DAA-naive non-cirrhotic HCV genotype 4 infected patients (HEPNED-001 study)

Boerekamps, Anne; Vanwolleghem, Thomas; Valk, Marc van der; Berk, Guido E van den; Kasteren, Marjo van; Posthouwer, D.; Dofferhoff, A.S.M.; Hoek, Bart van; Ramsoekh, Dewkoemar; Koopsen, Jelle; Schinkel, Janke; Florence, Éric; Arends, Joop E.; Rijnders, Bart J. A.

doi:10.1016/j.jhep.2018.10.032

Cited by 5 publications

(7 citation statements)

References 11 publications

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“…The current study demonstrated the overall high efficacy of the DAA treatment in HCV/HIV coinfected patients, not different from the effectiveness obtained in the group of those with HCV GT4 monoinfection. Our data on the comparable SVR rate regardless of the HIV status support results from numerous clinical trials with the usage of different DAA regimens in HIV positive GT4 infected patients [14][15][16][17][18]24]. In groups of 5 to 30 HCV GT4/HIV-coinfected participants of C-EDGE CO-INFECTION (GZR/EBR), ASTRAL-5 (SOF/VEL), TURQOISE-I (OPr ± DSV ± RBV), EXPEDITION-2 (GLE/PIB), ION-4 (SOF/LDV), and HEPNED-001 studies, effectiveness of 93-100% following therapy with different DAA regimens was reported [14][15][16][17][18]24].…”

Section: Discussionsupporting

confidence: 84%

Pangenotypic and Genotype-Specific Antivirals in the Treatment of HCV Genotype 4 Infected Patients with HCV Monoinfection and HIV/HCV Coinfection

Zarębska-Michaluk

Jaroszewicz

Parfieniuk‐Kowerda

et al. 2022

JCM

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The introduction of the direct-acting antivirals (DAA) has substantially improved the effectiveness of the therapy in patients with chronic hepatitis C. We aimed to compare the efficacy of pangenotypic and genotype-specific DAA in the cohort of genotype (GT) four patients with HCV monoinfection and HIV coinfection. A total of 662 GT4-infected patients treated in 2015–2020—of whom 168 (25.3%) were coinfected with HIV, selected from the retrospective EpiTer-2 database—were enrolled in the analysis. Among HIV-coinfected patients, 54% (90) were treated with genotype-specific regimens and 46% (78) with pangenotypic options, while among HCV-monoinfected patients, the rates were 72% and 28%, respectively. Significantly higher rate of males (67.9% vs. 57.7%, p = 0.01), a lower rate of liver cirrhosis (10.2% vs. 18.1%, p = 0.02), and higher of treatment-naïve patients (87.5% vs. 76.7%, p = 0.003) were documented in the HIV coinfected population. The overall sustained virologic response after exclusion of non-virologic failures was achieved in 98% with no significant difference between HIV-positive and HIV-negative patients, 96.2% vs. 98.5%, respectively. While the genotype-specific regimens resulted in a similar cure rate regardless of the HIV status, the pangenotypic options were more efficacious in patients with HCV monoinfection (99.3% vs. 94.4%, p = 0.05). Hereby, we demonstrated the high effectiveness and good safety profile of the DAA therapy in the population of HCV GT4 infected patients with HIV coinfection supporting the current recommendations to treat HCV/HIV coinfected patients with the same options as those with HCV monoinfection.

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Section: Discussionsupporting

confidence: 84%

Pangenotypic and Genotype-Specific Antivirals in the Treatment of HCV Genotype 4 Infected Patients with HCV Monoinfection and HIV/HCV Coinfection

Zarębska-Michaluk

Jaroszewicz

Parfieniuk‐Kowerda

et al. 2022

JCM

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“…Hepatitis C virus (HCV) infection, affecting, by the most recent estimations of the World Health Organization (WHO), approximately 71 million people globally, is one of the major public health issues [1,2]. Effective antiviral treatment is a first step to prevent the most serious complications of chronic hepatitis C (CHC), such as liver cirrhosis and hepatocellular carcinoma, resulting in nearly 400,000 deaths annually [1,3].…”

Section: Introductionmentioning

confidence: 99%

Are There Still Difficult-to-Treat Patients with Chronic Hepatitis C in the Era of Direct-Acting Antivirals?

Pabjan

Brzdęk

Chrapek

et al. 2022

Viruses

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Difficult-to-treat populations with chronic hepatitis C (CHC), in the era of interferon treatment, included patients with liver cirrhosis, kidney impairment, treatment-experienced individuals, and those coinfected with the human immunodeficiency virus. The current study aimed to determine whether, in the era of direct-acting antivirals (DAA), there are still patients that are difficult-to-treat. The study included all consecutive patients chronically infected with hepatitis C virus (HCV) who started interferon-free therapy between July 2015 and December 2020 in the Department of Infectious Diseases in Kielce. The analyzed real-world population consisted of 963 patients, and most of them were infected with genotype 1 (87.6%) with the predominance of subtype 1b and were treatment-naïve (78.8%). Liver cirrhosis was determined in 207 individuals (21.5%), of whom 82.6% were compensated. The overall sustained virologic response, after exclusion of non-virologic failures, was achieved in 98.4%. The univariable analysis demonstrated the significantly lower response rates in males, patients with liver cirrhosis, decompensation of hepatic function at baseline, documented esophageal varices, concomitant diabetes, body mass index ≥25, and previous ineffective antiviral treatment. Despite an overall very high effectiveness, some unfavorable factors, including male gender, genotype 3 infection, liver cirrhosis, and treatment experience, significantly reduce the chances for a virologic response were identified.

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“…Among a total of 39 included patients, 6 (of whom 2 were patients at the Antwerp University Hospital) did not meet the primary study endpoint, being HCV RNA negative at 12 weeks after therapy. Retrospective phylogenetic analyses on biobanked samples revealed that 4/6 of these patients had been reinfected (12).…”

Section: Discussionmentioning

confidence: 99%

“…Asians have a higher seroprevalence of HBV infection, and presumably of HCV infection as well (10–12). This population is known to be difficult to reach, and epidemiological data in the Belgian-Asian/Chinese migrant population is lacking.…”

Section: Methodsmentioning

confidence: 99%

Biobanking for Viral Hepatitis Research

Hees

Goethals

et al. 2019

Front. Med.

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Introduction: Viral hepatitis is a worldwide, important health issue. The optimal management of viral hepatitis infections faces numerous challenges. In this paper, we describe how biobanking of biological samples derived from viral hepatitis patients collected both in-hospital and during community outreach screenings provides a unique collection of samples. Materials and Methods: All samples and materials were provided with a study code within the SLIMS system Study protocols and an informed consent form were approved by the Antwerp University Hospital/University of Antwerp Ethical Committee. Systematic biobanking was initiated in October 2014. Collected sample types include: (1) serum and plasma of all newly diagnosed HBV, HCV, HDV, and HEV positive patients; (2) left-over serum and plasma samples from all PCR analyses for HBV and HCV performed in the context of routine clinical care; (3) left-over liver tissue not needed for routine histological diagnosis after liver biopsy; and (4) additional virus-specific, appropriate sample types using a scientific rationale-based approach. A community outreach screening program was performed in three major Belgian cities. Serum, EDTA, Tempus Blood RNA and BD Vacutainer CPT were collected. CPT tubes were centrifuged on-site and mononuclear cells collected within 24 h. Results: Concerning community screening: 298 individuals supplied all 4 sample types. Samples were stored at −150°C and were logged in the biobank SLIMS database. Samples were used for HBV-related immunological and biomarker studies. DNA isolated from plasma samples derived from chronic HBV patients was used to investigate Single Nucleotide Polymorphism rs 1790008. Serum samples collected from chronic hepatitis C patients were used to assess the efficacy of HCV treatment. Peripheral Blood Mononuclear Cells (PBMC) isolated from chronic HBV patients and healthy controls were used for different immunological study purposes. Virus isolated from biobanked stool of a chronic hepatitis E patient was used to establish a mouse model for Hepatitis E infections, allowing further HEV virology studies. Conclusion: The establishment of a biobank with samples collected both in-hospital and during community-outreach screening resulted in a unique, continuously expanding collection of biological samples which provides an excellent platform for prompt answers to clinically and translational relevant research questions.

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8 weeks of sofosbuvir/ledipasvir is effective in DAA-naive non-cirrhotic HCV genotype 4 infected patients (HEPNED-001 study)

Cited by 5 publications

References 11 publications

Pangenotypic and Genotype-Specific Antivirals in the Treatment of HCV Genotype 4 Infected Patients with HCV Monoinfection and HIV/HCV Coinfection

Pangenotypic and Genotype-Specific Antivirals in the Treatment of HCV Genotype 4 Infected Patients with HCV Monoinfection and HIV/HCV Coinfection

Are There Still Difficult-to-Treat Patients with Chronic Hepatitis C in the Era of Direct-Acting Antivirals?

Biobanking for Viral Hepatitis Research

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