Real World Evidence of the Effectiveness and Clinical Practice Use of Glecaprevir/Pibrentasvir in DAA Treatment-Experienced Patients With Chronic Hepatitis C Genotype 1 in Russian Federation (CHOICE)

Hepatitis C virus (HCV) infection is among the most common of all chronic liver diseases. HCV predominantly affects liver cells and causes the liver to become inflamed and damaged. This can lead to cirrhosis (scarring of the liver), liver cancer or the need for liver transplant. This study will evaluate how effective glecaprevir/pibrentasvir (GLE/PIB) is in participants with chronic HCV infection. Effectiveness will be assessed as the achievement of sustained virologic response.
GLE/PIB is an approved drug for the treatment of HCV. Participants 12 years or older with chronic HCV infection will be enrolled. This is a prospective (conducted in future) study in therapy of direct-acting antiviral (DAA) treatment-experienced participants with chronic hepatitis C genotype 1. Around 67 participants will be enrolled at multiple sites in Russian Federation.
Participants will receive oral GLE/PIB tablets as prescribed by the physician in accordance with local clinical practice, international guidelines and/or label. Prescription is independent from this study and is decided before providing opportunity to the participate in the study.
There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice and participants will be followed for 12 weeks.

Start Date07 Oct 2020

Sponsor / Collaborator

AbbVie, Inc.

ChiCTR2000032526 / SuspendedPhase 4IIT

A Multicenter, Observational Study Inverstigating the Distribution of Concomitant Medications and Predicted Drug-Durg Interactions with Direct-Acting Antiviral Agents in Chinese Patients with Chronic Hepatitis C Virus Genptype 1 Infections

Start Date01 Jun 2020

Sponsor / Collaborator-

ChiCTR1900026159 / SuspendedPhase 4

A Multicenter, Observational Study for Investigating the Distribution of Concomitant Medications and Predicted Drug-Drug Interactions With Direct-Acting Antiviral Agents in Chinese Patients With Chronic Hepatitis C Virus Genotype 1 Infections

Start Date28 Oct 2019

Sponsor / Collaborator

Shanghai MSD Pharmaceutical Trading Co. Ltd.

100 Clinical Results associated with Chronic hepatitis C genotype 1

100 Translational Medicine associated with Chronic hepatitis C genotype 1

0 Patents (Medical) associated with Chronic hepatitis C genotype 1

1,734

Literatures (Medical) associated with Chronic hepatitis C genotype 1

01 Nov 2024·Journal of Infection

IFNL4 genotype and other personal characteristics to predict response to 8-week sofosbuvir-based treatment for chronic hepatitis C

Article

Author: Pfeiffer, Ruth M ; Prokunina-Olsson, Ludmila ; Lai, Jennifer B. ; O'Brien, Thomas R. ; Witt, David J ; Baker, Francine S ; Witt, David J. ; O'Brien, Thomas R ; Morrissey, Kerry Grace ; Saxena, Varun ; Lai, Jennifer B ; Baker, Francine S. ; Chen, Sabrina ; Pfeiffer, Ruth M.

BACKGROUNDShorter duration therapy for hepatitis C virus (HCV) infection might reduce treatment costs and increase the number of patients treated and cured. We determined factors associated with treatment response after an 8-week sofosbuvir-based therapy and developed a simple model to predict an individual's likelihood of treatment success.METHODSAmong 2907 patients who received ledipasvir/sofosbuvir for 8 weeks, we determined failure rates by demographic and clinical characteristics, and IFNL4-∆G/TT genotype. We estimated the average IFNL4 genotype-related treatment failure rate in major ancestry groups by applying our IFNL4 genotype results to genotype distributions from reference populations. We created a treatment response model based on three personal characteristics.RESULTSOverall, 4.4% of the patients failed treatment. We observed significantly lower failure rates for persons <50 years (1.6%), females (2.6%), those carrying the IFNL4-TT/TT genotype (1.8%), those with HCV RNA <5.8 log₁₀ copies/mL (2.0%) or HCV genotype-1B infection (2.6%). In a model based on ancestry, age and sex, the predicted probability of treatment failure ranged from 0.5% among females of East Asian ancestry <50 years of age to 8.5% among males of African ancestry age ≥65 years.CONCLUSIONApplying this algorithm at the point-of-care might facilitate HCV elimination, especially in low- and middle-income countries.

01 Nov 2024·Journal of Hepatology

Epigenetic scars in regulatory T cells are retained after successful treatment of chronic hepatitis C with direct-acting antivirals

Article

Author: Choi, In Ah ; Koh, June-Young ; Lee, Eun Young ; Park, Su-Hyung ; Lee, Ha Seok ; Ko, Yun Yeong ; Jung, Min Kyung ; Shin, Eui-Cheol ; Kim, Won ; Lee, Jeong Seok ; Kim, Hyung-Don ; Park, Jun Yong ; Lee, Dong Hyeon ; Jeong, Hye Won ; Kim, So-Young ; Choi, Seong Jin

BACKGROUND & AIMSChronic HCV infection results in abnormal immunological alterations, which are not fully normalized after viral elimination by direct-acting antiviral (DAA) treatment. Herein, we longitudinally examined phenotypic, transcriptomic, and epigenetic alterations in peripheral blood regulatory T (Treg) cells from patients with chronic HCV infection before, during, and after DAA treatment.METHODSPatients with chronic genotype 1b HCV infection who achieved sustained virologic response by DAA treatment and age-matched healthy donors were recruited. Phenotypic characteristics of Treg cells were investigated through flow cytometry analysis. Moreover, the transcriptomic and epigenetic landscapes of Treg cells were analyzed using RNA sequencing and ATAC-seq (assay for transposase-accessible chromatin with sequencing) analysis.RESULTSThe Treg cell population - especially the activated Treg cell subpopulation - was expanded in peripheral blood during chronic HCV infection, and this expansion was sustained even after viral clearance. RNA sequencing analysis revealed that viral clearance did not abrogate the inflammatory features of these Treg cells, such as Treg activation and TNF signaling. Moreover, ATAC-seq analysis showed inflammatory imprinting in the epigenetic landscape of Treg cells from patients, which remained after treatment. These findings were further confirmed by intracellular cytokine staining, demonstrating that Treg cells exhibited inflammatory features and TNF production in chronic HCV infection that were maintained after viral clearance.CONCLUSIONSOverall, our results showed that during chronic HCV infection, the expanded Treg cell population acquired inflammatory features at phenotypic, transcriptomic, and epigenetic levels, which were maintained even after successful viral elimination by DAA treatment. Further studies are warranted to examine the clinical significance of sustained inflammatory features in the Treg cell population after recovery from chronic HCV infection.IMPACT AND IMPLICATIONSDuring chronic HCV infection, several immune components are altered both quantitatively and qualitatively. The recent introduction of direct-acting antivirals has led to high cure rates. Nevertheless, we have demonstrated that inflammatory features of Treg cells are maintained at phenotypic, transcriptomic, and epigenetic levels even after successful DAA treatment. Further in-depth studies are required to investigate the long-term clinical outcomes of patients who have recovered from chronic HCV infection.

30 Aug 2024·Cureus

Effectiveness of Ledipasvir-Sofosbuvir 12 Weeks After Hepatitis C Virus Genotype 1 Infection and the Factors Associated With Sustained Virologic Response: A Retrospective Study

Article

Author: Al-Namer, Mamoon ; Mahdi, Wadhah ; Alshoaibi, Ismaeel A ; Alzanen, Khaled H ; Alhakamy, Mohammed ; Abdullah, Mohammed ; Mohammed, Marwa ; Abdo, Basheer ; Ahmed, Faisal ; Alzanen, Khaled H ; Al-Gamli, Abdullah ; Tamesh, Munther ; Abdo, Zeyad

BACKGROUNDThe combination of ledipasvir and sofosbuvir (LDV/SOF) has been licensed to treat genotype 1 hepatitis C virus infection (HCV) with a 12-week regimen. However, there is scant data from Yemen regarding this combination regimen. Here, we investigate sustained virologic responses (SVR) 12 weeks after HCV treatment with LDV/SOF regimens and the factors that contribute to SVR failure.MATERIAL AND METHODA retrospective cross-sectional study was conducted at Althora General Hospital in Ibb, Yemen, from June 1, 2019, to October 31, 2022, on 53 cases with HCV genotype 1 infection who received combined therapy of LDV/SOF and completed treatment for 12 weeks. The clinical characteristics and treatment follow-up were obtained from patient medical records. Factors associated with SVR failure were investigated in univariate analysis with odds ratio (OR) and 95% confidence interval (CI).RESULTThe mean age was 50 ± 15.3 years, and most cases were female (n=36, 67.9%). Comorbidities were diabetes, hypertension, and fatty liver, which were represented in 12 (22.6%), nine (17.0%), and eight (15.1%) cases, respectively. A total of 13 (24.5%) patients had compensated liver cirrhosis, while the remaining 40 patients (75.5%) were non-cirrhotic healthy individuals. The baseline viral load (HCV RNA) was more than 800000 IU/mL in 21 patients (39.6%). Early virological response (ERV) was achieved in 51 patients (96.2%). After treatment, 46 of the patients (86.8%) achieved SVR at Week 12, while failure occurred in two patients (3.8%) and relapse occurred in five patients (9.4%). Blood liver enzymes, including alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase, returned to normal, with statistically significant improvements in non-cirrhotic healthy persons than compensated liver cirrhosis individuals (p= 0.006, 0.006, and 0.010; respectively). Factors associated with SVR failure were older age (OR:1.13; 95% CI: 1.03-1.30, p=0.009), presence of liver cirrhosis (OR: 5.48; 95% CI: 1.04-28.98, p=0.031), having diabetes (OR: 6.33; 95% CI: 1.19-37.93, p= 0.019), baseline higher viral load (OR: 2.27; 95% CI: 0.45-12.73, p<0.001), and not achieving EVR (OR:7.63; 95% CI: 3.77- 17.78, p= 0.009).CONCLUSIONIn this study, we found that LDV/SOF regimens are effective against HCV genotype one infection, allowing for the expansion of 12-week treatment for suitable patients in clinical settings. Additionally, older age, liver cirrhosis, diabetes, higher pretreatment viral load, and non-completion of EVR were associated with SVR failure. However, due to the small number of HCV genotype 1 infected individuals in this study, more corporate data is required to get a clear conclusion.

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