A Pragmatic, Randomized Controlled Trial of Oral Antivirals for the Treatment of Chronic Hepatitis C

Sulkowski, Mark S.; Moon, Juhi; Sherman, Kenneth E.; Morelli, Giuseppe; Darling, Jama M.; Muir, Andrew J.; Khalili, Mandana; Fishbein, Dawn; Hinestrosa, Federico; Shiffman, Mitchell L.; Bisceglie, Adrian Di; Reddy, K. Rajender; Pearlman, Brian L.; Lok, Anna S.; Fried, Michael; Stewart, Paul W.; Peter, Joy; Wadsworth, Summer; Kixmiller, Scott; Sloan, Anquenette; Vainorius, Monika; Horne, Patrick; Michael, Larry; Dong, Meichen; Evon, Donna M.; Segal, Jodi B; Nelson, David R.; Team, Prioritize Study

doi:10.1002/hep.32053

Cited by 8 publications

(16 citation statements)

References 30 publications

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“…A detailed description of the PRIORITZE study is reported elsewhere 17 . Briefly, PRIORITIZE was a multi‐site randomized, pragmatic clinical trial.…”

Section: Methodsmentioning

confidence: 99%

“…Despite widespread global use of several different DAA regimens, comparative effectiveness studies that directly compare different DAAs on patient‐centred outcomes have not been conducted until recently. Results from the PRIORITIZE study, the only randomized controlled trial to compare efficacy and tolerability of different DAA regimens, recently demonstrated equivalence between DAA regimens on treatment efficacy, safety, and drug side effect profiles 17 . Beyond sustained virological response (SVR) rates, other characteristics of treatment matter to patients and stakeholders, such as the magnitude and durability of improvements in HCV symptoms and functioning 18 .…”

Section: Introductionmentioning

confidence: 99%

“…The objective of this longitudinal study was to provide a direct comparison of improvements in HCV symptoms and functional well‐being up to two years after SVR, in patients with genotype 1 HCV who were treated with ledipasvir/sofosbuvir (LDV/SOF) or elbasvir/grazoprevir (EBR/GZR) in the PRIORITIZE trial 17 …”

Section: Introductionmentioning

confidence: 99%

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Sustainable and equivalent improvements in symptoms and functional well‐being following viral cure from ledipasvir/sofosbuvir versus elbasvir/grazoprevir for chronic hepatitis C infection: Findings from the randomized PRIORITIZE trial

Evon

Dong

Reeve

et al. 2022

Journal of Viral Hepatitis

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The PRIORITIZE trial (http://clinicaltrials.gov: NCT02786537) was the first comparative effectiveness study to directly compare ledipasvir/sofosbuvir (LDV/SOF) and elbasvir/grazoprevir (EBR/GZR) for the treatment of chronic hepatitis C virus (HCV). A secondary aim of this study was to compare LDV/SOF and EBR/GZR on sustainable changes in several HCV‐associated symptoms and functional well‐being in patients who achieved sustained virological response (SVR). PRIORITIZE, a randomized controlled trial conducted between 2016 and 2020, evaluated change in six PROMIS® symptom scores (fatigue, sleep disturbance, cognitive disturbance, nausea, diarrhoea, abdominal pain) and functional well‐being using the disease‐specific HCV‐PRO instrument. Survey assessments were administered at baseline, early post‐treatment (median = 6 months) and late post‐treatment (median = 21 months). Constrained longitudinal linear mixed‐effects models were used to evaluate within‐treatment change and between‐treatment differences. Data from 793 participants (average 55 years old, 57% male, 44% black, 17% with cirrhosis) were analysed. From baseline to early post‐treatment, 5 out of 6 symptoms and functional well‐being significantly improved (all p's < .05). In the LDV/SOF arm, mean changes ranged from −3.73 for nausea to −6.41 for fatigue and in the EBR/GZR, mean changes ranged from −2.19 for cognitive impairment to −4.67 for fatigue. Change of >3 points was consider clinically meaningful. Improvements in most symptoms slightly favoured LDV/SOF, although the magnitude of differences between the regimens were small. Both regimens demonstrated significant improvements in symptoms and functional well‐being that were sustained during the late post‐treatment phase. EBR/GZR and LDV/SOF regimens had clinically equivalent and durable improvements in HCV symptoms and functional well‐being up to two years after SVR.

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“…A detailed description of the PRIORITZE study is reported elsewhere 17 . Briefly, PRIORITIZE was a multi‐site randomized, pragmatic clinical trial.…”

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Sustainable and equivalent improvements in symptoms and functional well‐being following viral cure from ledipasvir/sofosbuvir versus elbasvir/grazoprevir for chronic hepatitis C infection: Findings from the randomized PRIORITIZE trial

Evon

Dong

Reeve

et al. 2022

Journal of Viral Hepatitis

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show abstract

“…(2) elbasvir/grazoprevir (EBR/GZR), Zepatier™, Merck and Co, Whitehouse Station, NJ; and (3) paritaprevir/ritonavir/ ombitasvir + dasabuvir (PrOD), Viekira Pak/Viekira XR™, AbbVie Pharmaceuticals, Abbott Park, IL [22].…”

Section: Study Design Andmentioning

confidence: 99%

“…The PRIORITIZE trial design, efficacy rates and AEs based on laboratory tests and symptoms reported by clinicians have been previously published [22]. In brief, participants with chronic HCV genotype 1 were enrolled from 34 community and academic liver centers in the US which are part of the HCV-TARGET Network [23].…”

Section: Study Design Andmentioning

confidence: 99%

Concordance between Patients and Clinicians for Reporting Symptoms Associated with Treatment for Chronic Hepatitis C during a Pragmatic Clinical Trial

et al. 2022

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Background. Despite high efficacy rates for direct acting antiviral regimens to cure hepatitis C virus infection, many patients experience treatment-related symptoms. Accurate reporting of adverse events is mandatory to determine drug safety. Previous research in other medical conditions has documented discordance between clinician-reported and patient-reported symptomatic adverse events. Aims. To explore concordance and associated factors, between clinician-recorded and patient-reported fatigue, headache, and nausea/vomiting during a clinical trial of three treatment regimens. Methods. Data were collected between treatment start and 31 days posttreatment. Patients completed Patient-Reported Outcomes Measurement Information System measures of fatigue and nausea/vomiting and the Headache Impact Test. Clinician-recorded data were abstracted from medical records. Concordance was evaluated by weighted kappa. Demographic and clinical factors associated with concordance were identified using logistic regression models. Results. Participants included 1,058 patients treated for chronic hepatitis C (average 54.9 years; 43% Black; 59% male). Weighted kappa estimates and 95% confidence intervals between patients (no/mild vs. moderate/severe symptoms) and clinicians (not present vs. present) were fatigue ( k = 0.09 , 0.02-0.16), headache ( k = 0.08 , 0.02-0.14), and nausea/vomiting ( k = 0.20 , 0.11-0.28). Older age and having private insurance (compared to Medicaid) were associated with better headache concordance. Older age, male, absence of psychiatric condition, and ≤2 comorbidities were associated with better nausea/vomiting concordance. Conclusions. Poor concordance was observed between patient-reported and clinician-recorded symptomatic adverse events. Despite study limitations, previous literature in other conditions support these findings. Integrating patient-reported data to inform adverse event reporting would improve evaluations of treatment safety (http://CT.gov/ Registration: NCT02786537).

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Long-term Follow-up of Hepatitis C Patients Who Achieved Sustained Virologic Response in the Pragmatic PRIORITIZE Study

Lok

Moon

Sherman

et al. 2023

Clinical Gastroenterology and Hepatology

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A Pragmatic, Randomized Controlled Trial of Oral Antivirals for the Treatment of Chronic Hepatitis C

Cited by 8 publications

References 30 publications

Sustainable and equivalent improvements in symptoms and functional well‐being following viral cure from ledipasvir/sofosbuvir versus elbasvir/grazoprevir for chronic hepatitis C infection: Findings from the randomized PRIORITIZE trial

Sustainable and equivalent improvements in symptoms and functional well‐being following viral cure from ledipasvir/sofosbuvir versus elbasvir/grazoprevir for chronic hepatitis C infection: Findings from the randomized PRIORITIZE trial

Concordance between Patients and Clinicians for Reporting Symptoms Associated with Treatment for Chronic Hepatitis C during a Pragmatic Clinical Trial

Long-term Follow-up of Hepatitis C Patients Who Achieved Sustained Virologic Response in the Pragmatic PRIORITIZE Study

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