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Minimal Compared With Standard Monitoring During Sofosbuvir-Based Hepatitis C Treatment: A Randomized Controlled Trial.

ABSTRACT: Background:Oral direct-acting antiviral agents (DAAs) for hepatitis C virus (HCV) became government subsidized in Australia in March 2016, bringing the interferon era to a close. The ideal monitoring schedule for patients receiving DAAs is unclear. Methods:This study is a randomized controlled trial comparing standard with minimal monitoring in adults receiving sofosbuvir-based therapy for HCV genotypes 1 or 3. Exclusion criteria were cirrhosis or predicted poor adherence. Standard monitoring included blood tests and face-to-face clinic visits at treatment weeks 4 and 12 and 12 weeks after treatment completion. Minimal monitoring included a phone call at weeks 4 and 12 and one set of blood tests plus a clinic visit 12 weeks after treatment completion. The coprimary outcomes were as follows: (1) proportion of participants with sustained virological response; (2) staff time spent on patient support; and (3) patient satisfaction on a 10-point Likert scale. Results:Thirty-six patients were randomized to standard monitoring and 38 to minimal monitoring. Sustained virological response at 12 weeks after the end of treatment was documented in 32 of 36 (89%) in the standard versus 37 of 38 (97%) in the minimal monitoring group. Staff time was nonsignificantly longer in the standard group (median 69 [interquartile range {IQR}, 54-80] versus 52 [IQR, 40-75] minutes). Patient satisfaction scores were not different (mean 9.8 of 10 standard versus 9.6 of 10 minimal group). There was no difference in adverse events or unplanned hospital visits; mean per-patient blood test costs were higher in the standard monitoring group ($432 versus $123, P?

SUBMITTER: Davis JS

PROVIDER: S-EPMC7025718 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Minimal Compared With Standard Monitoring During Sofosbuvir-Based Hepatitis C Treatment: A Randomized Controlled Trial.

Davis J S JS Young M M Marshall C C Tate-Baker J J Madison M M Sharma S S Silva C C Jones T T Davies J J

Open forum infectious diseases 20200119 2

<h4>Background</h4>Oral direct-acting antiviral agents (DAAs) for hepatitis C virus (HCV) became government subsidized in Australia in March 2016, bringing the interferon era to a close. The ideal monitoring schedule for patients receiving DAAs is unclear.<h4>Methods</h4>This study is a randomized controlled trial comparing standard with minimal monitoring in adults receiving sofosbuvir-based therapy for HCV genotypes 1 or 3. Exclusion criteria were cirrhosis or predicted poor adherence. Standar ...[more]

PMID: 32083146

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Project description:OBJECTIVE:To evaluate whether individualized postdischarge oxycodone prescribing guided by inpatient opioid use reduces the number of unused opioid tablets after cesarean birth. METHODS:We conducted a randomized, controlled trial of women aged 18 years or older undergoing cesarean birth. Participants were randomized at discharge in a 1:1 ratio to a standard (30 tablets of 5 mg oxycodone) or an individualized oxycodone prescription (predicted based on each patient's inpatient opioid use). All women were contacted starting 14 days after cesarean birth to assess number of oxycodone tablets used and adequacy of pain control. The Tennessee Controlled Substance Monitoring Database was accessed to confirm dispensed opioids. The primary outcome was number of unused oxycodone tablets prescribed for pain control after cesarean birth. A total sample size of 160 women was necessary to detect a 30% difference in leftover tablets between groups with 80% power and ? of 0.05. RESULTS:Between June 14, 2017, and August 26, 2017, we screened 323 women and randomized 172. Baseline characteristics and inpatient opioid use were similar between groups. Women in the individualized group were prescribed fewer tablets (14 [interquartile range 12-16] vs 30 [interquartile range 30-30], P<.001) and had 50% fewer unused tablets than women in the standard group (5 [interquartile range 1-8] vs 10 [interquartile range 0-22], P<.001). Overall, 13% (23/172) used no opioids after discharge and 26% (44/172) used all prescribed opioids. There were no differences between the standard and individualized groups in the proportion of women who used no opioids or all opioids and no difference in the proportion of dispensed opioids used (60% [interquartile range 23-100] vs 61% [29-89], P=.93). Women in the individualized group used only half the number of prescribed opioids as women in the standard group (8 [interquartile range 4-14] vs 15 [interquartile range 6-30], P<.001). Patient-reported pain outcomes did not differ significantly by group. CONCLUSION:Individualized opioid prescribing based on inpatient use reduces the number of unused oxycodone tablets compared with standard prescribing. CLINICAL TRIALS REGISTRATION:ClinicalTrials.gov, NCT03168425.

Project description:ImportanceThe efficacy of directly acting antiviral agents in interferon-free regimens for the treatment of chronic hepatitis C infections needs to be evaluated in different populations.ObjectiveTo determine the efficacy and safety of sofosbuvir with weight-based or low-dose ribavirin among a population with unfavorable treatment characteristics.Design, setting, and patientsSingle-center, randomized, 2-part, open-label phase 2 study involving 60 treatment-naive patients with hepatitis C virus (HCV) genotype 1 enrolled at the National Institutes of Health (October 2011-April 2012).InterventionsIn the study's first part, 10 participants with early to moderate liver fibrosis were treated with 400 mg/d of sofosbuvir and weight-based ribavirin for 24 weeks. In the second part, 50 participants with all stages of liver fibrosis were randomized 1:1 to receive 400 mg of sofosbuvir with either weight-based or low-dose 600 mg/d of ribavirin for 24 weeks.Main outcomes and measuresThe primary study end point was the proportion of participants with undetectable HCV viral load 24 weeks after treatment completion (sustained virologic response of 24 weeks [SVR24]).ResultsIn the first part of the study, 9 participants (90%; 95% CI, 55%-100%) achieved SVR24. In the second part, 7 participants (28%) in the weight-based group and 10 (40%) in the low-dose group relapsed after treatment completion leading to SVR24 rates of 68% (95% CI, 46%-85%) in the weight-based group and 48% (95% CI, 28%-69%; P = .20) in the low-dose group. Twenty individuals participated in a pharmacokinetic-viral kinetic substudy, which demonstrated a slower loss rate of infectious virus in relapsers than in participants who achieved SVR (clearance, 3.57/d vs 5.60/d; P = .009). The most frequent adverse events were headache, anemia, fatigue, and nausea. There were 7 grade 3 events including anemia, neutropenia, nausea, hypophosphatemia, and cholelithiasis or pancreatitis. No one discontinued treatment due to adverse events.Conclusion and relevanceIn a population of patients with a high prevalence of unfavorable traditional predictors of treatment response, a 24-week regimen of sofosbuvir and weight-based or low-dose ribavirin resulted in SVR24 rates of 68% and 48%, respectively.Trial registrationclinicaltrials.gov Identifier: NCT01441180.

Dataset Information

Minimal Compared With Standard Monitoring During Sofosbuvir-Based Hepatitis C Treatment: A Randomized Controlled Trial.

Publications

Minimal Compared With Standard Monitoring During Sofosbuvir-Based Hepatitis C Treatment: A Randomized Controlled Trial.

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