Hepatitis C Infection in the Elderly

Saab, Sammy; Rheem, Justin; Sundaram, Vinay

doi:10.1007/s10620-015-3717-6

Cited by 33 publications

(33 citation statements)

References 90 publications

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“…[1] Historically, older patients with CHC have been excluded from clinical trials using IFN-based regimens due to drug toxicities, and an advanced age has been considered as major limitation to IFN-based anti-HCV therapy for reasons of poor tolerability and response. [32–34] Thus, anti-HCV therapy for older patients constitutes a major unmet need. On the other hand, new era of DAA regimen, such as, sofosbuvir- and daclatasvir/asunaprevir-based regimens, have no such contraindications, because the incidences of side effects are considerably lower.…”

Section: Discussionmentioning

confidence: 99%

Assessment of hepatocellular carcinoma risk based on peg-interferon plus ribavirin treatment experience in this new era of highly effective oral antiviral drugs

Lee

Jin²,

Shin³

et al. 2017

Medicine

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In this new era of highly effective oral antiviral drugs for chronic hepatitis C virus (HCV), indications for antiviral treatment may be extendable. This study undertaken to identify suitable candidates for peg-interferon plus ribavirin (PEG-IFN/RBV) treatment by evaluating hepatocellular carcinoma (HCC) risk in patients with chronic HCV treated or not with PEG-IFN/RBV.This large-scale retrospective study was conducted on 1176 patients with chronic HCV without a history of HCC (treatment group [n = 489] and no-treatment group [n = 687]). In the treatment group, patients treated with PEG-IFN/RBV were dichotomized based on the achievement of sustained virologic response (SVR) into SVR (+) and SVR (−) groups.Median follow-up for all study subjects was 31 months (range 6–144 months). Three-year cumulative HCC development rates in the SVR (+) (1.1%) and SVR (−) (8.6%) subgroups were significantly lower than in the no-treatment group (13.5%) (P < 0.01 and P < 0.01, respectively). In all study subjects, presence of cirrhosis (hazard ratio [HR], 9.92, P < 0.01), age (HR 1.03, P < 0.01), SVR (−) (HR 7.02, P < 0.01), and no-treatment (HR 6.76, P < 0.01) were found to be independent risk factors of HCC development. In the treatment group, age, the presence of cirrhosis, and SVR (−) were predictors of HCC development. In the no-treatment group, age, male, and the presence of cirrhosis were independent predictors for HCC development.HCC risk increased in patients with chronic HCV with older age, cirrhosis, SVR (−) after PEG-IFN/RBV treatment, and no PEG-IFN/RBV treatment. Active antiviral therapy based on highly effective oral drugs needs to be considered in these patients.

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Section: Discussionmentioning

confidence: 99%

Assessment of hepatocellular carcinoma risk based on peg-interferon plus ribavirin treatment experience in this new era of highly effective oral antiviral drugs

Lee

Jin²,

Shin³

et al. 2017

Medicine

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“…This is consistent with previous observations demonstrating greater severity of liver disease with advancing age. (27) Additional analysis stratified by the presence or absence of cirrhosis and treatment experience yielded similar findings; treatment with LDV/SOF was highly effective even in the setting of cirrhosis. In addition, subjects 65 years of age had lower mean eGFR, which may increase the risk of anemia with RBV.…”

Section: Discussionmentioning

confidence: 65%

“…(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. (28) Ledipasvir/sofosbuvir (LDV/ SOF) has been found to be effective against a variety of HCV clinical scenarios including special populations such as those with compensated and decompensated cirrhosis, HCV/human immunodeficiency virus coinfection, and immunosuppressed liver transplant recipients who historically have lower sustained virological response than the general population.…”

mentioning

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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“…We did not use age‐standardized rates in the model to avoid masking the known birth‐cohort effect in HCV patients born between 1945 and 1965; this is consistent with the approach used in a recent study of cirrhosis prevalence among US veterans . However, age was included as a stratification variable.…”

Section: Methodsmentioning

confidence: 99%

“…Although rates of new HCV infections have declined since a peak in the 1990s, overall prevalence has increased as patients discover their infection status. Given that individuals born between 1945 and 1965 represent roughly 75% of all US HCV cases, epidemiologists have anticipated a rapid upsurge of HCV‐related liver disease and cirrhosis as this birth‐cohort ages . Moreover, although HCV disproportionately affects men and African Americans, changes in rates of these complications in these demographics have not been well‐studied.…”

Section: Introductionmentioning

confidence: 99%