Efficacy of peginterferon-α-2b plus ribavirin in patients aged 65 years and older with chronic hepatitis C

Honda, Takashi; Katano, Yoshiaki; Shimizu, Junichi; Ishizu, Yoji; Doizaki, Masao; Hayashi, Kazuhiko; Ishigami, Masatoshi; Itoh, Akihiro; Hirooka, Yoshiki; Nakano, Isao; Urano, Fumihiro; Yoshioka, Kentaro; Toyoda, Hidenori; Kumada, Takashi; Goto, Hidemi

doi:10.1111/j.1478-3231.2009.02064.x

Cited by 60 publications

(61 citation statements)

References 29 publications

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“…(16)(17)(18) Historically, age has been a major limitation of antiviral treatment with interferon-based therapy because of its poor tolerability, adverse effects (AEs), and poorer response in older patients. (19)(20)(21)(22)(23)(24)(25) There is a lack of efficacy and safety information on HCV therapy in older patients, primarily due to underreporting and the exclusion of elderly subjects from clinical trials. (26,27) The combination of ledipasvir, an NS5A inhibitor, and sofosbuvir, a nucleotide polymerase inhibitor, has been approved by the US Food and Drug Administration, the European Medicines Agency, and in Japan as a fixed-dose combination tablet for the treatment of HCV genotype 1.…”

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confidence: 99%

Safety and efficacy of ledipasvir/sofosbuvir for the treatment of genotype 1 hepatitis C in subjects aged 65 years or older

et al. 2016

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Elderly subjects have been historically underrepresented in clinical trials involving antiviral hepatitis C therapies. The aim of this analysis was to retrospectively evaluate the safety and efficacy of ledipasvir/sofosbuvir (LDV/SOF) by age groups of <65 years versus 65 years among subjects enrolled in phase 3 trials. Four open-label phase 3 clinical trials evaluated the safety and efficacy of LDV/SOF with or without ribavirin (RBV) for the treatment of genotype 1 chronic hepatitis C virus. Sustained virological response at 12 weeks, treatment-emergent adverse events (AEs), and graded laboratory abnormalities were analyzed according to age group. Of the 2293 subjects enrolled in four phase 3 trials, 264 (12%) were 65 years of age, of whom 24 were aged 75 years. Sustained virological response at 12 weeks was achieved by 97% (1965/ 2029) of subjects aged <65 years and 98% (258/264) of subjects aged 65 years. The most common AEs in both LDV/ SOF groups that occurred in 10% of subjects were headache and fatigue. The rate of study discontinuation due to AEs was similar in the two age cohorts. The use of RBV in 1042 (45%) subjects increased the number of AEs, treatmentrelated AEs, and AEs leading to study drug modification/interruption, particularly among elderly subjects. Conclusions: LDV/SOF with or without RBV was highly effective for treatment of genotype 1 chronic hepatitis C virusin subjects aged 65 and older. Addition of RBV did not increase sustained virological response at 12 weeks rates but led to higher rates of AEs, especially in elderly subjects. (HEPATOLOGY 2016;63:1112-1119 C hronic hepatitis C viral (HCV) infection is an important cause of morbidity and mortality in infected individuals worldwide.(1) The World Health Organization estimates that the worldwide prevalence of HCV infection is 2.2%, representing 123 million people.(2) Globally, HCV accounts for 27% of liver cirrhosis and 25% of hepatocellular carcinoma cases.(3) Although the rate of HCV is decreasing overall due to attrition from mortality, (4,5) the rate of HCV-related cirrhosis is anticipated to increase by Abbreviations: AE, adverse event; CI, confidence interval; eGFR, estimated glomerular filtration rate; HCV, hepatitis C virus; LDV/SOF, ledipasvir/sofosbuvir; RAV, resistance-associated variant; RBV, ribavirin; SVR12, sustained virological response at 12 weeks

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confidence: 99%

Safety and efficacy of ledipasvir/sofosbuvir for the treatment of genotype 1 hepatitis C in subjects aged 65 years or older

et al. 2016

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“…Several factors have been identiied, including age, liver ibrosis, HCV genotype, HCV RNA levels, race, amino acid substitutions in the core and NS5A regions, and interleukin 28B polymorphisms have been reported as predictors of response to IFN therapy [26][27][28][29][30][31]. This study investigated whether HBV coinfection afects response to DAA therapy.…”

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confidence: 99%

Impact of HBV Infection on Outcomes of Direct-Acting Antiviral Therapy of Chronic Hepatitis C

Hayashi¹,

Ishigami²,

Ishizu³

et al. 2017

Update on Hepatitis C

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Background: Most clinical trials of direct-acting antiviral (DAA) therapy for hepatitis C virus (HCV) infection have excluded hepatitis B virus (HBV) coinfection, and litle is known about the efects of DAA on chronic hepatitis C patients with HBV coinfection.Recent studies have reported that DAA therapy for HCV can also cause HBV reactivation in patients with HBV and HCV coinfection. The aim of this study was to assess the efects of DAA on sustained virologic response (SVR) and HBV reactivation in patients with chronic hepatitis C. Methods: Participants comprised 199 chronic hepatitis C patients who received DAA therapy (96 men, 103 women; mean age, 66.7 ± 12.0 years). Results: Twelve patients were coinfected with HCV and HBV. Sixty patients were HBV surface antigen negative but positive for hepatitis B core antibody and/or hepatitis B surface antibody, and one hundred and twenty-seven patients had not been exposed to HBV. Rates of SVR in HBV and HCV coinfected patients, HBV prior infection, and no exposure to HBV were 100, 95, and 97%, respectively. Signiicant diferences were seen between each group. No case showed HBV reactivation. Conclusions: DAA treatments were efective in patients with HBV coinfection or HBV prior infection, as well as HCV monoinfection. As the number of cases was small, we still suggest caution regarding HBV reactivation in HCV and HBV coinfected patients undergoing treatment with DAA.

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“…Ces facteurs prennent en compte des paramètres déterminés par le virus : le génotype, la charge virale. On sait depuis les études sur de grandes cohortes que le génotype 1 (sous type a ou b) et une charge virale élevée (arbitrairement supérieure à 800 0000 UI/ml) diminuent les chances de guérison à moins de 50 % ; les paramètres influençant la réponse et dépendant de l'hôte [1] sont l'âge, le surpoids, la sévérité de l'atteinte histologique et les co-morbidités hépatiques (notamment alcool et consommation de cannabis) : ces facteurs diminuent les chances de guérison [2][3].…”

Section: La Bithérapie Traditionnelleunclassified

Le traitement de l’hépatite C : la révolution des nouvelles molécules pour quels patients ?

Fontanges¹

2011

Hegel

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RésuméL'avènement des antiprotéases est une réelle avancée dans le traitement de l'hépatite C permettant de guérir 3 patients sur 4 de génotype 1, génotype prédominant dans notre pays de sorte que la bithérapie pégylée devient désuète. Nos patients en échec de bithérapie peuvent bénéficier également de ces trithérapies, et ainsi, éviter de renouveler des traitements aux résultats décevants. Ces trithérapies nécessitent une surveillance clinique, biochimique et virologique stricte du fait des interactions médicamenteuses et des évènements indésirables nouveaux. En ce qui concerne les autres génotypes, la bithérapie reste à l'honneur et doit être utilisée en l'optimisant (prise en compte des facteurs de réponse pré-thérapeutiques, intérêt d'un dosage précoce de ribavirine). Mots-clésTrithérapie ; Antiprotéases ; Télaprévir ; Bocéprévir ; Genotype 1 ; Hépatite chronique ; VHC ; Bithérapie pégylée ; génotype non 1 Abstract DAA therapy is a real progress in the management of patients infected by HCV genotype 1; indeed, 75% of new patients can be cured by this new therapy. In case of failure after classical bitherapy, DAA is also the best way to eradicate RNA if compared to the disappointing results obtained with biotherapy retreatment. Nevertheless, due to side effects and drug interactions, DAA requires a careful follow-up of patients. The duration of treatment is strongly correlated with the virological kinetics during the first months and should be rigorous.

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Efficacy of peginterferon-α-2b plus ribavirin in patients aged 65 years and older with chronic hepatitis C

Abstract: The SVR rate was lower in elderly patients than in younger patients. However, in elderly patients combination therapy was most beneficial for genotype 1 patients, male patients with HCV RNA concentrations < 2,000,000 IU/ml and patients with genotype 2.

Cited by 60 publications

References 29 publications

Safety and efficacy of ledipasvir/sofosbuvir for the treatment of genotype 1 hepatitis C in subjects aged 65 years or older

Safety and efficacy of ledipasvir/sofosbuvir for the treatment of genotype 1 hepatitis C in subjects aged 65 years or older

Impact of HBV Infection on Outcomes of Direct-Acting Antiviral Therapy of Chronic Hepatitis C

Le traitement de l’hépatite C : la révolution des nouvelles molécules pour quels patients ?

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