HCV In Elderly Patients
Bristol-Myers Squibb Submits First All-Oral, Interferon-Free and Ribavirin-Free Treatment Regimen for Regulatory Review in Japan for Patients with Chronic Hepatitis C Infection
**Study Design and Results For Elderly Patients Provided Only - View all results from the Phase III study with Daclatasvir (DCV) and Aasunaprevir (ASV) , here.
In this open-label, parallel group, Phase III study, interferon- ineligible/intolerant 135 patients and 87 interferon/ribavirin non-responder (NR) patients received daclatasvir 60 mg once daily plus asunaprevir 100 mg twice daily for 24 weeks. The primary endpoint was the percentage of patients with a sustained virologic response at 24 weeks after the end of treatment (SVR24).
Virologic Response - Elderly Only
Patients older then 65 years of age had SVR24 rates similar to those in patients less then 65 years and age did not appear to impact response rates. SVR24 rates for those more 65 years of age were 91.9% (57/62) in the interferon- ineligible/intolerant elderly patient population and 85.2% (23/27) in the non-responder elderly population.
Read the full press release here....
Chronic Hep C in Medicare beneficiaries
As baby boomers age, chronic hepatitis C (CHC) will become increasingly important in Medicare eligible group. Dr Younossi and colleagues from Virginia, USA evaluated trends in Medicare resource utilization for chronic hepatitis C. The team analyzed the Medicare in-patient and out-patient data from 2005 to 2010.
Telaprevir-based triple therapy for elderly patients with genotype 1 chronic hepatitis C
IDSA Oct 2-6 2013, San Francisco, CA
"TVR-based triple therapy can be used successfully and safely to treat elderly patients with genotype 1 chronic hepatitis C. IL28B genotyping and early virological response indicate effectiveness in these difficult-to-treat elderly patients."
Association of Visceral Obesity with High Viral Load and Histological Findings in Elderly Patients with Genotype 1 Chronic Hepatitis C
...visceral obesity was found to be associated with high viral load, steatosis , and age-dependent fibrosis progression in patients with genotype 1 chronic hepatitis C.....
Elderly age is not a negative predictive factor for virological response to therapy with pegylated interferon-α and ribavirin in chronic HCV patients
Age is not a significant predictive factor for achieving SVR, when relevant confounders are taken into account. Since life expectancy in Western Europe at age 60 is more than 20 yr, it is reasonable to treat chronic hepatitis C in selected elderly patients with relevant fibrosis or cirrhosis but without major concomitant diseases, as SVR improves survival and reduces carcinogenesis
Telaprevir safe, effective among older patients with chronic HCV
Furusyo N. J Hepatol. 2013;59:205-212.
Advanced age did not impact the efficacy of triple therapy with pegylated interferon, ribavirin and telaprevir among patients with hepatitis C genotype 1b in a recent study.
In a prospective study, researchers evaluated 120 patients with chronic hepatitis C genotype 1b, including 64 participants aged older than 60 years. All patients received peginterferon alfa-2b, ribavirin and telaprevir for 12 weeks, then 12 weeks of peginterferon and ribavirin.
During prior therapy 53.3% of participants had relapsed, 22.5% were treatment-naive, 20.8% were prior nonresponders and 3.3% had an unknown prior response.
Undetectable HCV RNA (rapid virological response) was observed at 4 weeks in 73.4% of older patients and 73.2% of patients aged younger than 60 years. Sustained virological response at 24 weeks post-treatment occurred similarly between groups: 76.6% of older patients vs. 83.9% of younger patients (P=.314 for difference). Investigators said SVR was more common among all patients with the IL28B TT allele (89.4% of older and 91.9% of younger patients vs. 41.2% and 68.4% among those without; P<.05 for both comparisons).
Multivariate analysis indicated associations between SVR and RVR (OR=7.498; 95% CI, 1.014-65.42) and IL28B TT genotype (OR=14.93; 95% CI, 1.6-142.9), as well as prior nonresponse (OR=8.403; 95% CI, 1.025-66.667), among
older patients. Independent associations with RVR and TT genotype also were noted among younger patients.
Treatment discontinuation for adverse events occurred in 12.5% of all cases. Hemoglobin decreases for levels of 100 g/L or more were observed in 41.1% of younger and 9.4% of older patients; between 85 g/L and 100 g/L in 25% and 40.6%,
and less than 85 g/L was present in 33.9% and 50% of younger and older patients, respectively (P=.0006).
“This study shows there is no impact by age on the virological outcome of TVR-based triple therapy for HCV genotype 1b chronic hepatitis C,” the researchers concluded. “We found that older patients achieve a better virological outcome by TVR-based triple therapy than with the traditional dual therapy. IL28B genotyping and EVR indicate the potential to achieve an
SVR in these difficult-to-treat older patients.”
Abstract: A pilot study of triple therapy with telaprevir, peginterferon and ribavirin for elderly patients with genotype 1 chronic hepatitis C.
Results suggest that 24-week triple therapy with telaprevir 1,500 mg seems
safe and efficacious for elderly Japanese patients infected with HCV genotype 1b.....
Abstract: Various Predictors of Sustained Virologic Response in Different
Age Groups of Patients With Genotype-1 Chronic Hepatitis C.
SVR rate was highest in patients younger than 45 years and lowest in patients older than 65 years even through propensity score matching analysis. As for the SVR predictors ....
May 19 2013
DDW 2013 - Patients with Medicaid less likely to receive HCV treatments
Although diagnosed hepatitis C infection was more common among people with Medicaid insurance, the treatment rates were lower compared with people who had commercial insurance, research presented here at Digestive Disease Week suggests.
Telaprevir can be successfully and safely used to treat older patients with genotype 1b chronic hepatitis C.
This prospective study enrolled 120 genotype 1b patients with chronic hepatitis C who received 12 weeks of triple therapy followed by a 12-week dual therapy that included pegylated interferon-α2b and ribavirin. Patients were categorized according to age: group A, 64 patients aged older then 60 and group B, 56 patients aged less then 60...
Interferon free regimens for the “difficult to treat”: are we there?
Excerpt - Older age is not an absolute contraindication for an interferon-based therapy. A French group showed good efficacy in a small group of patients older than 65 years treated with pegylated interferon and rivabirin (7). Nevertheless, other studies have demonstrated a trend towards lower SVR rates, as well as higher rates of dose reductions and discontinuations of therapy in this population as compared to younger individuals (6, 8). Currently, there are no data on the safety and efficacy of triple therapy in old patients. In the CUPIC French cohort, cirrhotic patients up to 83 years old have been included: though the number of severe adverse events using triple therapy seems clearly higher than those reported with peginterferon and ribavirin alone (9), a specific analysis in older patients has not been performed..continue reading..
Commentary: efficacy and safety of ribavirin plus pegylated interferon-alpha in geriatric patients with chronic hepatitis C
Hadziyannis, S. J. and Sevastianos, V.
The study of Hu et al. from Taiwan adds evidence on the safety and efficacy of treatment with pegylated interferon-alpha plus ribavirin (PR) in elderly patients with chronic hepatitis C virus (HCV) infection.
This topic is of clinical interest, as life expectancy is increasing both in developed and developing countries, anti-HCV positivity in the general population reaches peak prevalence in older age groups, the prevalence of cirrhosis in HCV-infected people above the age of 50 years is climbing and the yearly incidence of HCC reaches somewhere between 2% and 8%.[2, 3]
However, patients >65 years have been excluded from clinical trials of PR, because of a tendency towards lower sustained virological response (SVR) and a higher rate of treatment discontinuation.[4-8] At the same time clinical data encourages the effort of treating chronic HCV in advanced age.
In this context, the results of the present study support the view that treatment should not be denied to patients based on age, or other unfavourable factors, alone. However, because of the small number of cases in the age and HCV-genotype (HCV/G) subgroups, some differences may not have attained statistical significance. Thus, SVR rates were lower in older compared with middle-aged patients but the difference was significant only in HCV/G non-1 infections.
Moreover, the duration of treatment was limited to 24 weeks regardless of HCV/G with SVR rates in HCV/G1 similar, or even higher, in comparison with those in patients from Western countries treated for 48 weeks with PR. Race variations, IL28B genotypes or other factors may account for these differences. Therefore, the findings of this Asiatic study are not transferrable, as such, to Western populations either with G1 or non-1 infections. Possibly the development of new all oral HCV therapies with direct-acting antivirals will become the standard of care in the difficult to treat HCV patients, including the elderly.
Full Text - Efficacy and safety of ribavirin plus pegylated interferon alfa in geriatric patients with chronic hepatitis C
- 1 Hu C-C, Lin C-L, Kuo
Y-L, et al. Efficacy and safety of ribavirin plus pegylated interferon alfa in geriatric patients with chronic
hepatitis C. Aliment Pharmacol Ther 2013; 37: 81–90.
- 2 Fassio
E. Hepatitis C and hepatocellular carcinoma. Ann Hepatol 2010; 9(Suppl.): 119–22.
- 3 Colombo M, de Franchis R, Del
Ninno E, et al. Hepatocellular carcinoma in Italian patients with cirrhosis. New Engl J Med 1991;
- 4 Hiramatsu N, Oze T, Tsuda
N, et al. Should aged patients with chronic hepatitis C be treated with interferon and ribavirin combination
therapy? Hepatol Res 2006; 35: 185–9.
- 5 Iwasaki Y, Ikeda H, Araki
Y, et al. Limitation of combination therapy of interferon and ribavirin for older patients with chronic hepatitis
C. Hepatology (Baltimore, MD) 2006; 43: 54–63.
- 6 Nudo CG, Wong P, Hilzenrat
N, Deschenes M. Elderly patients are at greater risk of cytopenia during antiviral therapy for hepatitis C. Can J
Gastroenterol 2006; 20: 589–92.
- 7 Antonucci G, Longo MA, Angeletti
C, et al. The effect of age on
response to therapy with peginterferon alpha plus ribavirin in a cohort of patients with chronic HCV hepatitis including subjects older than 65 yr.
Am J Gastroenterol 2007; 102: 1383–91.
- 8 Yu JW, Sun LJ, Kang
P, Yan BZ, Zhao
YH. Efficacy and factors influencing treatment with peginterferon alpha-2a and ribavirin in elderly patients with chronic
hepatitis C. Hepatobiliary Pancreat Dis
Int 2012; 11: 185–92.
- 9 Lee SS, Roberts SK, Berak
H, et al. Safety of peginterferon
alfa-2a plus ribavirin in a large multinational cohort of chronic hepatitis C patients. Liver Int 2012;
- 10 Beinhardt S, Rutter K, Stattermayer AF, Ferenci P.
Revisiting the predictors of a sustained virologic response in the era of direct-acting antiviral therapy for hepatitis C
virus. Clin Infect Dis 2013; 56: 118–22.
Article first published online: 22 JAN 2013
Get PDF (78K
Characteristics of elderly hepatitis C virus-associated hepatocellular carcinoma patients.
Standard hep C treatment less effective in elderly
Efficacy and safety of ribavirin plus pegylated interferon alfa in geriatric patients with chronic hepatitis C
Causes, clinical features, outcomes of drug-induced liver
injury different for elderly patients
Common Antibiotics Pose a Risk of Severe Liver Injury in Older
Efficacy of pegylated interferon-alpha-2a plus ribavirin for patients aged at
least 60 years with chronic hepatitis C.
Viral Hepatitis in the Elderly
As life expectancy continues to rise, elderly adults represent a rapidly
growing proportion of the population. The likelihood of complications of
acute and chronic liver disease and overall mortality are higher in elderly populations. Several physiological changes associated with aging, greater prevalence of co-morbid conditions, and cumulative exposure to hepatotropic viruses and environmental hepatotoxins may contribute to worse outcomes of viral hepatitis in the elderly.
Although pharmacotherapy for hepatitis B and C continues to evolve, the efficacy, tolerability, and side effects of these agents have not been studied extensively in elderly adults. Immunization against hepatitis A and B in naïve elderly adults is an important public health intervention that needs to be revised and broadened.
New Antivirals Show Poor Safety in Hepatitis C With Cirrhosis
Two relatively new direct-acting antiviral drugs have poor safety profiles in
patients with hepatitis C virus (HCV) and cirrhosis, including a high rate of
serious adverse events leading to study discontinuation
The effect of pegylated interferon-alpha2b and ribavirin combination therapy for chronic hepatitis C infection in elderly patients
BMC Research Notes 2012, 5:135 doi:10.1186/1756-0500-5-135
Published: 10 March 2012
The complete article is available as a provisional PDF. The fully formatted PDF and HTML versions are in production.
Hiroki Nishikawa, Eriko Iguchi, Yorimitsu Koshikawa, Soichiro Ako, Tadashi Inuzuka, Haruhiko Takeda, Jun Nakajima, Fumihiro Matsuda, Azusa Sakamoto, Sinichiro Henmi, Keiichi Hatamaru, Tetsuro Ishikawa, Sumio Saito, Ryuichi Kita, Toru Kimura and Yukio Osaki
The clearance of hepatitis C virus infection by interferon therapy significantly reduces the incidence of hepatocellular carcinoma and death in elderly chronic hepatitis patients. However, there are few reports concerning the efficacy and safety of pegylated interferon-alpha2b plus ribavirin combination therapy in elderly patients. The aims of the present study were to examine the effect and safety of pegylated interferon-alpha2b plus ribavirin combination therapy in 427 patients with chronic hepatitis C infection. We compared the rates of sustained virological response--defined as the absence of detectable hepatitis C virus in serum 24 weeks after the treatment ended--and the treatment discontinuation rate between 319 younger patients aged <65 years and 108 elderly patients aged [greater than or equal to]65 years. We also examined the factors contributing to a sustained virological response.
There was no significant difference in the sustained virological response rate between younger patients and elderly patients according to their hepatitis C virus genotype (41.5% (100/241) and 40.7% (35/86) for genotype 1; P = 0.899, 89.7% (70/78) and 86.4% (19/22) for genotype 2; P = 0.703, respectively). There was also no significant difference in the treatment discontinuation rate between the two age groups (10.3% (33/319) and 13.9% (15/108), respectively; P = 0.378). There were no serious adverse events requiring hospitalization. The factors contributing significantly to a sustained virological response in elderly patients were gender, hepatitis C virus genotype, platelet count, and the presence of a rapid or early virological response (undetectable hepatitis C virus in serum at weeks 4 or 12 of treatment, respectively). However, upon multivariate analysis, the presence of an early virological response was the only significant factor (odds ratio: 0.115, 95% confidence interval: 0.040-0.330, P < 0.001).
The efficacy and safety of pegylated interferon-alpha2b plus ribavirin combination therapy in elderly patients are not always inferior to those in younger patients. Obtaining an early virological response may be essential to achieve a sustained virological response in elderly patients with chronic hepatitis C infection.
Download Provisional PDF.
February 14, 2012
Resources Needed to Meet Needs of Seniors With Cirrhosis
As people living with cirrhosis age, they are more likely to become disabled, need hospitalization and require more caregiving from family members than seniors not living with liver disease, according to a study published in the January 2012 issue of Hepatology.
The need to provide and coordinate care for elderly people living with liver cirrhosis is expected to increase in the coming
years. In the United States, the number of older people with cirrhosis is growing, driven by an aging population of people living with chronic hepatitis C virus (HCV) infection and non-alcoholic fatty liver disease, a condition linked to obesity, type 2 diabetes, high blood pressure, elevated cholesterol and genetic factors.
Policy makers will need to allocate additional resources, while family members will be called upon to provide more informal
caregiving, according to Mina O. Rakoski MD, and her colleagues from the University of Michigan Medical School in Ann Arbor.
Rakoski and her colleagues used information from Health and Retirement Study (HRS) interviews, Medicare claims and patient records over a minimum of two years to assess measures of well-being among people older than 65. They compared 290 people living with cirrhosis to a matched group of 858 without signs of chronic liver disease.
Demographics were similar, with a few differences: People living with cirrhosis were less educated, more likely to be Hispanic, and had less income than the comparison group.
People living with cirrhosis were twice as likely to describe their health as poor, compared with those in the matched group. Other illnesses, including lung and heart disease, cancer, diabetes and cognitive impairment, were more common among people living with cirrhosis. They were also more likely to experience some degree of disability, and they reported more difficulty performing activities of everyday living (ADLs) such as bathing, toileting, dressing and eating, as well as instrumental activities of everyday living (IADLs), including grocery shopping, managing money, making phone calls and taking medication. In addition, almost 20 percent reported a significant decrease in their ability to perform ADLs and IADLs over a two-year period.
Not surprisingly, overall and out-of-pocket health care costs were much higher for elderly people living with cirrhosis. They had more medical appointments, were more likely to be hospitalized or cared for in a nursing home and received more care from family members than their non-cirrhotic counterparts. In fact, the yearly cost of informal caregiving by a family member ranged from $3,700 to $6,700 for people living with cirrhosis versus $1,600 to $2,900 for those without liver disease.
“It is important to emphasize this study compared subjects with cirrhosis to age-matched individuals, not healthy controls,” noted the authors.
They concluded by underscoring the opportunity to improve quality of care for elderly people living with cirrhosis
while lowering its cost. “Greater focus on a comprehensive delivery of care for patients with cirrhosis, including involvement of caregivers and improved care coordination, is necessary to optimize management of this frail population.”
Hepatitis C-Impact of age > 65 years on svr and relapse
Impact of age more then 65 years on svr and relapse in chronic hepatitis c (chc) patients (pts) treated with peginterferon alfa-2a (40kd) (pegifn?2a[40kd]) plus ribavirin (rbv): final analysis from the large multinational real-world prophesys cohorts
HCV In Elderly Patients
Journal of Viral Hepatitis
Hepatitis C Virus-related Chronic Liver Disease in Elderly Patients: An Italian Cross-sectional Study
A. Gramenzi; F. Conti; F. Felline; C. Cursaro; A. Riili; M. Salerno; S. Gitto; L. Micco; A. Scuteri; P. Andreone; M. Bernardi
Authors and Disclosures
Posted: 07/27/2010; J Viral Hepat. 2010;17(5):360-366.
Abstract and Introduction
Chronic hepatitis C virus (HCV ) infection has been poorly investigated in the elderly.
The Aim Of This Study Was ?
The aim of this study was to identify the age-specific characteristics of chronic hepatitis C by comparing patients more then 65 years with those less then 65 years of age.
Where Did This Study Take Place ?
A cross-sectional study was performed on data collected from consecutive outpatients referred for the first time to two tertiary outpatient clinics for liver diseases located in Bologna (Northern Italy) and Paola, Cosenza (Southern Italy) over a two-year period.
How Many Patients In The Study ?
A total of 560 anti-HCV and HCV -RNA positive patients were enrolled, of whom 174 (31%) were 65 years or older.
The proportion of older patients was significantly higher in the Southern Italy centre, accounting for more than 40%
Comparison Of liver Damage In Young And Older Groups Of Patients
Comparison of younger and older groups showed that 51% patients more then 65 years had advanced liver disease (liver cirrhosis or hepatocellular carcinoma) compared with 26% younger patients (Patients less then 0.0001).
About half of the patients more then 65 years were not aware of their anti-HCV positive status, even if they tended to be more symptomatic than the younger group. By multivariate analysis, patients more then 65 years of age, the alcohol consumption and diabetes were independently associated with advanced liver disease.
Overall, 34 out of 174 patients (20%) in the more then 65 years had received antiviral treatment compared with 122 out of 386 (32%) younger patients (Patients = 0.003).
Our results further emphasize the notion that chronic hepatitis C is becoming a disease of the elderly and that elderly patients with chronic HCV infection often have severe and underestimated disease.
Click Here To See The Full Study , Below Is Only The Summary/Discussion
This study provides a picture of the age-specific differences of patients with HCV-related chronic hepatitis attending tertiary outpatient clinics for liver disease. As a recent Italian population-based survey indicated thatHCV infection seems to follow two different transmission patterns according to a North–South gradient, we conducted our study in two clinical centres located in Northern and Southern Italy.
In our study as a whole, in a two-year period, nearly a third of HCV -RNA positive referred outpatients were 65 years or older. However, when the two recruitment centres were compared, this proportion was significantly higher in the Southern Centre, accounting for more than 40%. Even though a selection bias cannot be excluded, age distribution and mode of infection in the two areas reflect what is known in the general population. These data show that in Northern Italy HCV infection is mainly found in the 31–60 year age group, consistent with intravenous drug use, whereas in Central and Southern Italy the highest HCV seroprevalence rates are detected in patients older than 60 years consistent with health care-related practices in the past. In spite of the different epidemiological pattern, the main virological and clinical features of older patients in the two recruitment areas tended to be homogeneous.
About half of the patients more the 65 years of age in our study were not aware of their anti HCVpositive status, even if they tended to be more symptomatic than their younger counterparts. In addition, the prevalence of laboratory features of chronic liver disease, namely elevated serum ALT, did not differ between the two patient groups. This observation is at variance with previous data showing that most elderly patients with chronic HCV infection have normal ALT, even in the presence of advanced liver disease.[4,16] This difference might simply reflect a referral bias, since a study conducted in outpatient clinics for liver disease tends to enrol sicker patients, transaminase elevation being the main reason for referral.
Even though we do not have hard data on liver fibrosis, such as those deriving from eitherliver biopsy or surrogate markers, we can confirm that patients more the 65 years with chronic HCV infection have more severe liver disease than younger patients.
More than 50% of patients aged 65 years or older had cirrhosis and/or HCC, and the occurrence of liver-related complications as the presenting symptom of HCV -related liver disease was significantly more frequent in patients more then 65 years.
These findings could result from the high selection of the patients we enrolled who were recruited because they had HCV infection. Nevertheless, our results are consistent with those obtained in a large French study in patients referred for chronic HCV infection where the prevalence of cirrhosis, as assessed by biochemical markers of fibrosis, was above 50% in the elderly, and liver-related complications more often heralded the liver disease in patients over 65 years.
Age more then 65 years also emerged as an independent variable associated with advanced liver disease (cirrhosis and/or HCC) on multivariate analysis, together with excessive alcohol consumption and diabetes. However, because of the poor reliability of the information we had on age at infection, we did not include disease duration.
Thus, it cannot be established whether the observed association between age and advanced liver disease was related to an old age at infection or to a longer duration of the disease. Indeed, previous studies have demonstrated that the rate of liver disease progression inHCV chronic infection is more rapid in patients infected at an older age. Nevertheless, in our study the higher prevalence of advanced liver disease among elderly patients could also reflect a selection bias since elderly patients tended not to be screened for HCV unless they had clinically manifest liver disease.
As previously reported, older patients in our study were less frequently treated than their younger counterparts and the proportion of those treated after 65 years was negligible. This is not surprising since elderly patients with HCV infection are considered difficult-to-treat and no standard treatment guidelines are currently available for these particular patients. Indeed, elderly patients with chronic HCV infection are generally excluded from randomized controlled trials and often have comorbidities that contraindicate antiviral treatment.
Nevertheless, a study conducted in Veterans Affairs Medical Centres throughout the United States showed older age to be a strong predictor of not being a treatment candidate, even after adjusting for comorbidities.
Taken together, our results further emphasize the notion that chronic hepatitis C is becoming a disease of the elderly and that elderly patients with chronic HCV infection often have severe and underestimated Liver disease. Therefore, clinicians need to be aware of the importance of ageing when considering either treatment to prevent disease progression or surveillance programs for HCC. However, as it is likely that more and more elderly HCV-positive patients will be identified and brought to care, the current lack of specific guidelines for managing these patients will represent a major challenge for clinicians.
Also See: Cryoglobulinemia in elderly patients with HCV-related chronic hepatitis c
Older Genotype 3 Chronic Hepatitis C Patients Do Not Respond as Well to Interferon-based Therapy
Hepatitis C Virus Infection in the Elderly Population
Older Article/2004 = Seniors and Hepatitis C