Real-World Effectiveness and Safety of Oral Combination Antiviral Therapy for Hepatitis C Virus Genotype 4 Infection

Crespo, Javier; Calleja, José Luís; Fernández, Inmaculada; Sacristan, B.; Ruíz-Antorán, Belén; Ampuero, Javier; Hernández‐Conde, Marta; García-Samaniego, Javier; Gea, Francisco; Buti, Marı́a; Cabezas, Joaquín; Lens, Sabela; Morillas, Rosa María; Salcines, J.R.; Pascasio, J.M.; Turnés, Juan; Sáez-Royuela, F; Arenas, Juan; Rincón, Diego; Prieto, M.; Jorquera, Francisco; Ruano, Juan; Navascués, C.A.; Molina, Esther; Moya, Adolfo Gallego; Planas, J.M. Moreno; Montoliu, Silvia; Serra, Miguel; Andrade, Raúl J.; Fernández, Conrado; Bermejo, Miguel Fernández; Simón, Miguel Ángel; Bonet, Lucía; Vega, Juan de la; Diago, M.; Fernández, José R.; Sánchez-Antolín, Gloria

doi:10.1016/j.cgh.2017.02.020

Cited by 25 publications

(23 citation statements)

References 8 publications

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“…The majority were male (57.9%), with a mean age of 60 (range, years. Genotype (GT) distribution was GT 1,86.8% (1a, 14.3%; 1b, 72.5%); GT 4,13.2% and 176 patients (21.9%) were cirrhotic. Overall, among 588 patients with available data, 570 (96.9%) achieved sustained virologic response at 12 weeks post-treatment (SVR12).…”

Section: Discussionmentioning

confidence: 99%

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Effectiveness and safety of elbasvir/grazoprevir therapy in patients with chronic HCV infection: Results from the Spanish HEPA‐C real‐world cohort

Hernández‐Conde

Fernández

Perelló

et al. 2018

Journal of Viral Hepatitis

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Summary In randomized controlled trials of patients with chronic HCV infection, elbasvir/grazoprevir (EBR/GZR) demonstrated high cure rates and a good safety profile. This study assessed the effectiveness and safety of EBR/GZR, with and without ribavirin, in a real‐world HCV patient cohort. HEPA‐C is a collaborative, monitored national registry of HCV patients directed by the Spanish Association for the Study of the Liver and the Networked Biomedical Research Centre for Hepatic and Digestive Diseases. Patients entered into HEPA‐C between December 2016 and May 2017, and treated with EBR/GZR with at least end‐of‐treatment response data, were included. Demographic, clinical and virologic data were analysed, and adverse events (AEs) recorded. A total of 804 patients were included in the study. The majority were male (57.9%), with a mean age of 60 (range, 19‐92) years. Genotype (GT) distribution was GT 1, 86.8% (1a, 14.3%; 1b, 72.5%); GT 4, 13.2% and 176 patients (21.9%) were cirrhotic. Overall, among 588 patients with available data, 570 (96.9%) achieved sustained virologic response at 12 weeks post‐treatment (SVR12). SVR12 rates by genotype were GT 1a, 97.7%; GT 1b, 98.6%; and GT 4, 98.1%. No significant differences in SVR12 according to fibrosis stage were observed. Eighty patients experienced an AE, resulting in treatment discontinuation in three. In this large cohort of patients with chronic HCV managed in a real‐world setting in Spain, EBR/GZR achieved high rates of SVR12, comparable to those observed in randomized controlled trials, with a similarly good safety profile.

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Section: Discussionmentioning

confidence: 99%

“…Analyses were as described in previous studies from the HEPA‐C registry on the effectiveness and safety of other oral DAA combination regimens in patients with HCV GT1 or GT 4 in routine clinical practice. Briefly, results were analysed using the intent‐to‐treat (ITT) approach.…”

Section: Methodsmentioning

confidence: 99%

Effectiveness and safety of elbasvir/grazoprevir therapy in patients with chronic HCV infection: Results from the Spanish HEPA‐C real‐world cohort

Hernández‐Conde

Fernández

Perelló

et al. 2018

Journal of Viral Hepatitis

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“…High SVR12 rates of 96.2% or 95.4% were reported in HCV GT4‐infected patients treated with either OBV/PTV/r (n = 122) or SOF/LDV (n = 130), respectively, with or without RBV in a real‐world setting, but an analysis of the prevalence of NS5A baseline polymorphisms was not included in the study results . Another study reported SVR12 rates of 93% (41/44) in GT4‐infected patients treated with SOF/LDV, which included 25 patients with baseline polymorphisms L28M and/or L30R/S in NS5A; all 3 virologic failures had L28M/V with or without L30R in NS5A at baseline, which corresponds with a 37‐ to 67‐fold change in LDV activity against L28M/V and L30R in GT4 .…”

Section: Discussionmentioning

confidence: 99%

Characterization of demographics and NS5A genetic diversity for hepatitis C virus genotype 4‐infected patients with or without cirrhosis treated with ombitasvir/paritaprevir/ritonavir

Schnell

Tripathi

Beyer

et al. 2018

Journal of Viral Hepatitis

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Hepatitis C virus (HCV) genotype 4 (GT4) is genetically diverse with 17 confirmed and 4 provisional subtypes. In this report, HCV GT4-infected patient samples from Phase 2/3 clinical studies were analysed to characterize global demographics and genetic diversity of GT4 infection among patients treated with ombitasvir (OBV, NS5A inhibitor) plus paritaprevir/r (NS3/4A inhibitor codosed with ritonavir). Among 17 subtypes isolated from GT4-infected patients in the PEARL-I and AGATE-I studies, subtype prevalence by country of enrolment and country of origin suggested that subtypes 4a and 4d were likely circulating in Europe, while heterogeneous GT4 subtypes and a portion of GT4a detected in European and North American countries were likely due to immigration of HCV-infected patients from Africa. The distributions of birth cohort and race were also significantly different across GT4 subtypes 4a, 4d, and non-4a/4d. In addition, phylogenetic analyses of NS5A sequences revealed clustering within subtype 4a which segregated by the patient-reported country of origin and the presence of the L30R/S polymorphism. HCV NS5A sequences derived from GT4a-infected patients who originated from Europe and the United States clustered separately from sequences derived from patients who originated from Egypt, suggesting that genetically distinct strains of subtype 4a may be circulating globally. Finally, NS5A baseline polymorphisms were frequently detected at amino acid positions of interest for the inhibitor-class and OBV retained activity against 37 of 39 NS5A GT4 clinical isolates, with no impact on treatment outcome in the PEARL-I and AGATE-I studies.

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“…Particularly in cirrhotic, SVR12 was 91.2% with OMV/PTV/r ± RBV and 93.2% with LDV/SOF ± RBV. No significant difference was found in SVR12, according to the fibrosis stage(17).…”

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confidence: 76%

Real World Experience with All-Oral Interferon Free Regimen for the Treatment of Lebanese Patients with Hepatitis C Virus (HCV) Infection

et al. 2018

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Objectives:The treatment of hepatitis C has dramatically improved since the introduction of new direct-acting antivirals (DAAs). The aim of this study was to assess the efficacy and safety of all oral DAAs, with or without ribavirin, in the treatment of naive and treatment experienced hepatitis C virus (HCV) Lebanese patients. Methods:This study reviewed all cases approved for hepatitis C treatment with DAAs, according to Lebanese guidelines for treatment of HCV at the Ministry of Public Health from October 2015 to December 2016. Available data on age, gender, genotype (GT) and subtype, fibrosis stage, previous treatment (if present), new DAAs treatment, and sustained virological response at week 12 (SVR12) were collected.Results: During a period of 15 months, a total of 186 patients were treated with DAAs. In total, 57% were male. The mean age of the patients was 54.3 years. Genotype 1 was the most prevalent (45%), followed by genotype four (34%) and genotype three (12%). More than 72% of patients had advanced fibrosis (F3 -F4) before starting DAAs and 42% of patients were treatment experienced. Regarding the different DAAs protocols used, SVR12 was achieved in 93% of cases, while 4% did not achieve SVR. Furthermore, 3% of cases were either lost to follow up or had major adverse events. Sustained virological response at week 12 was 93%, 96%, and 94% in GT1, GT3, and GT4, respectively. In cirrhotic patients, SVR12 was 90%. There was no difference in SVR12 between treatment naive and treatmentexperienced patients. Hepatocellular carcinoma developed in five patients during the period of the study.Conclusions: This is the first real world Lebanese data concerning hepatitis C treatment with DAAs. It showed a satisfactory response rate irrespective of previous treatments or the stage of fibrosis.

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Real-World Effectiveness and Safety of Oral Combination Antiviral Therapy for Hepatitis C Virus Genotype 4 Infection

Cited by 25 publications

References 8 publications

Effectiveness and safety of elbasvir/grazoprevir therapy in patients with chronic HCV infection: Results from the Spanish HEPA‐C real‐world cohort

Effectiveness and safety of elbasvir/grazoprevir therapy in patients with chronic HCV infection: Results from the Spanish HEPA‐C real‐world cohort

Characterization of demographics and NS5A genetic diversity for hepatitis C virus genotype 4‐infected patients with or without cirrhosis treated with ombitasvir/paritaprevir/ritonavir

Real World Experience with All-Oral Interferon Free Regimen for the Treatment of Lebanese Patients with Hepatitis C Virus (HCV) Infection

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