Effectiveness and Safety of Direct-Acting Antiviral Combination Therapies for Treatment of Hepatitis C Virus in Elderly Patients: Results from the German Hepatitis C Registry

Dultz, G.; Müller, Tobias; Petersen, Jörg; Mauss, Stefan; Zimmermann, Tim; Muche, Marion; Simon, Karl-Georg; Berg, Thomas; Zeuzem, Stefan; Hüppe, D; Böker, K. H. W.; Wedemeyer, Heiner; Welzel, Tania M.; Deutschland, Leberstiftungs-GmbH

doi:10.1007/s40266-018-0572-0

Cited by 18 publications

(10 citation statements)

References 46 publications

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“…Treating older adults with HCV in the interferon era was fraught with complications 2,3,10,11 . The elderly discontinued interferon (IFN)‐based treatment more frequently due to side effects and achieved lower sustained virologic response (SVR) rates than younger patients 2,5,7–9,12,13 .…”

Section: Introductionmentioning

confidence: 99%

“…The advent of direct‐acting antivirals (DAAs) has opened up treatment to previously difficult‐to‐treat groups, including the elderly 7 . Adults aged 65 years and older were underrepresented in the original phase III licensing studies for most DAA regimens, but data are emerging that DAAs are safe and produce equivalent SVR rates in older adults as younger patients 2,10,11,13,15–17 …”

Section: Introductionmentioning

confidence: 99%

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Hepatitis C direct‐acting antiviral outcomes in patients 75 years and older

et al. 2020

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Background and AimElderly patients with hepatitis C virus (HCV) infection have worse interferon‐based treatment outcomes than young patients. Direct‐acting antiviral (DAA) regimens have enabled the treatment of previously difficult‐to‐cure populations. There are few studies that specifically assess DAA treatment outcomes in patients over 75 years of age.MethodsDesign: This was a cohort study. Setting: The setting was three Canadian HCV specialty sites. Participants: Patients aged 75 years and older and treated with DAA without interferon were enrolled. Measurements: Patient demographics, liver fibrosis by transient elastography, treatment regimen, and treatment outcome data were collected.ResultsThe mean age of 78 patients in our analysis was 78.6 years (SD 3.5; range: 75–88 years). The most common genotype was 1b (35%). The most frequently utilized regimens included sofosbuvir‐velpatasvir (33%) and ledipasvir‐sofosbuvir (32%). Ribavirin was included for 17% of recipients. Sustained virological response (SVR) was achieved in 94% of patients (69% of those receiving ribavirin and 98% of patients on ribavirin‐free regimens). Ribavirin toxicity contributed to the lower SVR rates in ribavirin‐exposed patients. Ribavirin dosage was decreased in three patients and ultimately discontinued in two of these patients. All treatment was discontinued in another two patients.ConclusionRibavirin‐free DAA therapy is safe and achieves SVR rates in older adults comparable to those described in the general population. RBV inclusion frequently results in complications, often leads to treatment modification or interruption, and does not improve SVR rates in those with advanced age.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Hepatitis C direct‐acting antiviral outcomes in patients 75 years and older

et al. 2020

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“…Treatment recommendations for hepatitis C now make no distinction between HIV/HCVcoinfected and HCV-monoinfected patients, as there are no differences in response rates regardless of liver cirrhosis, shortened treatment duration or age [4,5]. Although HIV/HCVcoinfected patients require careful evaluation of potential interactions between HCV drugs and HIV antiretroviral therapy, medication for substance abuse, substances consumed and other comedications, the largest challenge globally remains the lack of effective models to eliminate HCV in HIV-infected patients receiving care in hospital outpatient clinics [6].…”

Section: Introductionmentioning

confidence: 99%

Hepatitis C virus-microelimination program and patient trajectories after hepatitis C virus cure in an outpatient HIV clinical unit

Lions

Laroche

Zaegel-Faucher

et al. 2019

European Journal of Gastroenterology &Amp; Hepatology

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Treatment recommendations for hepatitis C now make no distinction between HIV/HCVcoinfected and HCV-monoinfected patients. The largest challenge remained lack of effective models to eliminate HCV in people living with HIV.We report the results of a microelimination program evaluating the possibility of eradicating HCV infection in an HIV-outpatient clinical unit within 12 months. MethodsThis HCV-microelimination program began in February 2016 in an unit following approximately 1000 HIV-infected patients and combined screening and therapeutic components according to the French guideline. A nested cohort study evaluating the impact of HCV cure on different health outcomes was conducted through self-administered questionnaires and using generalized mixed models. ResultsAmong 601 patients eligible for HCV serological testing, 445 were evaluated, and two HCV acute infection were diagnosed. Among the 151 patients eligible for HCV RNA quantification, 119 were evaluated, and one reinfection with HCV was diagnosed. Among the 110 patients eligible for DAA treatment, 51 (46.4%) patients initiated treatment within the 12 months program, and 35 (31.8%) after. Sustained virologic response (SVR) rate was 96.1%, and two treatment failed. At least one self-reported symptom was declared by 72.5% (n=29) of patients. Positive impact of HCV cure was observed on various markers of physical and mental health as well as on health habits. ConslusionOur program should be considered as a proof of concept, which confirmed the feasibility of a HCV-microelimination program at the scale of an HIV clinical unit. However, 12 months were not sufficient to achieve our objective despite the specific organization.

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“…Data on 14 603 patients with an established genotype who had completed treatment were retrospectively analysed making this one of the largest hepatitis C treatment cohorts evaluated globally 12,13 . Unlike other real‐world reports which describe experience with a single treatment regimen 12,14 or selected subpopulation (eg elderly patients 15 ), this cohort includes all patients and treatment options that have been available in England since 2014. Mandatory data collection through the national registry ensures that clinician‐generated patient selection bias is avoided.…”

Section: Discussionmentioning

confidence: 99%

English hepatitis C registry data show high response rates to directly acting anti‐virals, even if treatment is not completed

Drysdale

Ntuli

Bestwick

et al. 2020

Aliment Pharmacol Ther

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Summary Background In England, choice of hepatitis C therapy is determined by national contracts that change with time, facilitating comparisons between different regimens. England has a diverse population with hepatitis C including large proportions of uncommon viral genotypes. Aim To evaluate efficacy of directly acting anti‐viral treatments for hepatitis C in England using real‐world data from the national treatment registry. Methods Sustained virological response (SVR) rates 12 weeks after treatment completion for patients treated between 2014 and August 2018 who attended for SVR tests were analysed in univariate subgroups using Chi‐squared tests. Multivariate models were constructed with clinically relevant variables to determine predictors of SVR and evaluate the impact of treatment regimens. Results SVR data were available on 14,603 treated patients. The overall SVR rate was 95.59% [95% CI 95.25%‐95.91%]. Multivariable regression modelling in patients with genotype 1 infection showed that the odds of SVR with elbasvir/grazoprevir were higher than for those treated with sofosbuvir/ledipasvir (OR 1.891, 95% CI 1.072‐3.336, P = 0.028). For genotype 3, we found no significant difference between any of the treatment regimens. Patients who completed at least one third of the planned treatment duration achieved SVR rates in excess of 80%. Conclusions All of the currently licensed hepatitis C direct‐acting anti‐viral regimens had similar efficacy (>95%) in an unselected population. Noncompletion of planned treatment duration still resulted in over 80% SVR rates provided that more than one third of treatment was completed.

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Effectiveness and Safety of Direct-Acting Antiviral Combination Therapies for Treatment of Hepatitis C Virus in Elderly Patients: Results from the German Hepatitis C Registry

Cited by 18 publications

References 46 publications

Hepatitis C direct‐acting antiviral outcomes in patients 75 years and older

Hepatitis C direct‐acting antiviral outcomes in patients 75 years and older

Hepatitis C virus-microelimination program and patient trajectories after hepatitis C virus cure in an outpatient HIV clinical unit

English hepatitis C registry data show high response rates to directly acting anti‐virals, even if treatment is not completed

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