Anemia in liver transplant recipients undergoing antiviral treatment for recurrent hepatitis C

Saab, Sammy; Oh, Mina K.; Ibrahim, Ayman; Durazo, Francisco; Han, Steven; Yersiz, Hasan; Farmer, Douglas G.; Ghobrial, Rafik M.; Goldstein, Leonard I.; Tong, Myron J.; Busuttil, Ronald W.

doi:10.1002/lt.21184

Cited by 36 publications

(34 citation statements)

References 65 publications

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“…However, interferon therapy poses many challenges in elderly patients and those with advanced liver disease because of limited efficacy, safety, and tolerability [11]. Adverse effects, such as hemolytic anemia, are exacerbated in older patients [17][18][19][20][21]. Elderly patients are more likely to have concomitant comorbidities particularly metabolic (P \ 0.001) [11] and cardiovascular (P \ 0.001) [11] disease, along with renal, pulmonary, and hematologic conditions that prevent the use of PegIFN and RBV [22].…”

Section: Introductionmentioning

confidence: 99%

Hepatitis C Infection in the Elderly

2015

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Hepatitis C virus (HCV) infection in the elderly population is a global medical burden and healthcare utilization concern. The majority of patients with hepatitis C in the USA are "baby boomers," who were born between 1945 and 1965. Consistently worldwide, HCV infection in elderly population is overrepresented and poses public health concerns. These individuals have been infected now for over two decades and are presenting with advanced liver disease. Traditionally, the use of pegylated interferon-based therapy has been limited in the elderly because of its adverse effects. The sustained virologic responses have also tended to be lower in the elderly than in younger adults. The emergence of non-interferon-based therapy with direct acting antiviral agents has expanded the pool of patients eligible for treatment. These agents have been found to be effective, tolerable, and safe in the elderly population.

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Section: Introductionmentioning

confidence: 99%

Hepatitis C Infection in the Elderly

2015

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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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“…The HCV load became undetectable at week 2 (n = 1), 4 (n = 3), and 8 (n = 1; Table 1 The introduction of pegylated interferon and ribavirin improved the virological efficacy for recurrent HCV in post-transplant patients. Although the SVR rate for liver transplantation patients with a history of HCV genotype 1 infection was improved to 30-50% (5,15,16), more than 50% of the recipients suffered from recurrent HCV infection. The use of protease inhibitors in LDLT recipients is limited due to strong drug-todrug interactions.…”

Section: Resultsmentioning

confidence: 99%