Dataset Information

A new model to predict response to direct-acting antiviral therapy in decompensated cirrhotics due to hepatitis C virus.

ABSTRACT: Aim:of the study: Decompensated hepatitis C virus (HCV) cirrhosis is a difficult to treat cohort, and there is no gold standard predictor of response to direct-acting antiviral (DAA) therapy. We conducted this study to look for factors responsible for improvement in post-therapy status, i.e. attainment of Child-Turcotte-Pugh (CTP) class A from B or C, and devise a new model to predict post-therapy response. Material:and methods: Prospective analysis of data from decompensated HCV cirrhotics was done and association of each parameter with patient outcomes at 36 weeks after treatment was assessed. Results:34 patients (54.8%) attained CTP class A after treatment. Factors that were independently associated with disease outcome included albumin (odds ratio [OR] = 4.84, 95% confidence interval [CI]: 1.43-20.15, p = 0.018), alanine transaminase (ALT) (OR = 1.02, 95% CI: 1-1.04, p = 0.049), bilirubin (OR = 0.41, 95% CI: 0.2-0.75, p = 0.007) and estimated glomerular filtration rate (eGFR) (OR = 1.03, 95% CI: 1.0-1.06, p = 0.045). On multivariate analysis, bilirubin was significantly associated with treatment outcome (OR = 0.28, 95% CI: 0.1-0.64, p = 0.006). A composite model was devised using demographic, biochemical, and clinical features, which has sensitivity, specificity, positive predictive value, negative predictive value and accuracy of 67.86%, 79.41%, 73.08%, 75%, and 73.63% respectively in predicting response to therapy. Only 7.6% of patients with a Model for End-Stage Liver Disease (MELD) score > 15 and none of the patients with CTP class C met the primary end-point of our study. Conclusions:55% of our cohort met the primary end-point at 36 weeks. Patients with CTP class C and a MELD score > 15 should be referred for liver transplantation followed by DAA therapy. Our model was good at predicting improvement in post-therapy liver function.

SUBMITTER: Debnath P

PROVIDER: S-EPMC7592091 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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A new model to predict response to direct-acting antiviral therapy in decompensated cirrhotics due to hepatitis C virus.

Debnath Prasanta P Chandnani Sanjay S Rathi Pravin P Nair Sujit S Junare Parmeshwar P Udgirkar Suhas S Singh Anupam A Contractor Qais Q

Clinical and experimental hepatology 20200930 3

<h4>Aim</h4><b>of the study:</b> Decompensated hepatitis C virus (HCV) cirrhosis is a difficult to treat cohort, and there is no gold standard predictor of response to direct-acting antiviral (DAA) therapy. We conducted this study to look for factors responsible for improvement in post-therapy status, i.e. attainment of Child-Turcotte-Pugh (CTP) class A from B or C, and devise a new model to predict post-therapy response.<h4>Material</h4><b>and methods:</b> Prospective analysis of data from deco ...[more]

PMID: 33145432

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Project description:ImportanceFor patients awaiting heart transplant, hepatitis C-positive donors offer an opportunity to expand the donor pool, shorten wait times, and decrease wait-list mortality. While early reported outcomes among few heart transplant recipients have been promising, knowledge of 1-year outcomes in larger cohorts of patients is critical to shared decision-making with patients about this option.ObjectiveTo better define the association of hepatitis C-positive donors with heart transplant volumes, wait-list duration, the transmission and cure of donor-derived hepatitis C, and morbidity and mortality at 1 year.Design, setting, and participantsThis was a prospective, single-center observational study of 80 adult (age 18 years or older) patients who underwent heart transplant using hearts from hepatitis C-positive donors between September 2016 and April 2019 at a large academic medical center. Among donors, who were considered hepatitis C-positive if results from hepatitis C antibody and/or nucleic acid testing were positive, 70 had viremia and 10 were seropositive but did not have viremia. Follow-up was available through May 15, 2019. Comparisons were drawn with patients who underwent transplant with hearts from hepatitis C-negative donors during the same period.ExposuresIn addition to standard posttransplant management, transplant recipients who developed donor-derived hepatitis C infection were treated with direct-acting antivirals.Main outcomes and measuresThe main outcomes included wait-list duration and 1-year survival in all patients, and for those who developed donor-derived hepatitis C, the response to direct-acting antiviral treatment.ResultsOf 80 patients, 57 (71.3%) were men, 55 (68.7%) were white, and 17 (26.3%) were black; the median age at transplant was 54.5 years (interquartile range, 46-62 years). Following consent to accept hearts from hepatitis C-exposed donors, the median days to heart transplant was 4 (interquartile range, 1-18). No recipients of donors with negative nucleic acid testing results (10 [12.5%]) developed donor-derived hepatitis C. Of 70 patients who were recipients of donors with positive nucleic acid testing results, 67 (95.7%) developed donor-derived hepatitis C over a median follow-up of 301 days (interquartile range, 142-617). Treatment with direct-acting antivirals was well tolerated and yielded sustained virologic responses in all treated patients. Within the cohort with infection, 1-year patient survival was 90.4%, which was not significantly different compared with the cohort without infection or with patients who received transplants from hepatitis C-negative donors during the same period.Conclusions and relevanceIn the era of direct-acting antivirals, hepatitis C-positive donors are a viable option to expand the donor pool, potentially reducing wait-list duration and mortality. In heart transplant recipients with donor-derived hepatitis C, infection is well-tolerated and curable, and 1-year survival is equivalent to that in recipients of hepatitis C-negative donors.

Project description:ImportanceSome payers and clinicians require alcohol abstinence to receive direct-acting antiviral (DAA) therapy for chronic hepatitis C virus (HCV) infection.ObjectiveTo evaluate whether alcohol use at DAA treatment initiation is associated with decreased likelihood of sustained virologic response (SVR).Design, setting, and participantsThis retrospective cohort study used electronic health records from the US Department of Veterans Affairs (VA), the largest integrated national health care system that provides unrestricted access to HCV treatment. Participants included all patients born between 1945 and 1965 who were dispensed DAA therapy between January 1, 2014, and June 30, 2018. Data analysis was completed in November 2020 with updated sensitivity analyses performed in 2023.ExposureAlcohol use categories were generated using responses to the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) questionnaire and International Classification of Diseases, Ninth Revision and International Statistical Classification of Diseases and Related Health Problems, Tenth Revision diagnoses for alcohol use disorder (AUD): abstinent without history of AUD, abstinent with history of AUD, lower-risk consumption, moderate-risk consumption, and high-risk consumption or AUD.Main outcomes and measuresThe primary outcome was SVR, which was defined as undetectable HCV RNA for 12 weeks or longer after completion of DAA therapy. Multivariable logistic regression was used to estimate odds ratios (ORs) and 95% CIs of SVR associated with alcohol category.ResultsAmong 69 229 patients who initiated DAA therapy (mean [SD] age, 62.6 [4.5] years; 67 150 men [97.0%]; 34 655 non-Hispanic White individuals [50.1%]; 28 094 non-Hispanic Black individuals [40.6%]; 58 477 individuals [84.5%] with HCV genotype 1), 65 355 (94.4%) achieved SVR. A total of 32 290 individuals (46.6%) were abstinent without AUD, 9192 (13.3%) were abstinent with AUD, 13 415 (19.4%) had lower-risk consumption, 3117 (4.5%) had moderate-risk consumption, and 11 215 (16.2%) had high-risk consumption or AUD. After adjustment for potential confounding variables, there was no difference in SVR across alcohol use categories, even for patients with high-risk consumption or AUD (OR, 0.95; 95% CI, 0.85-1.07). There was no evidence of interaction by stage of hepatic fibrosis measured by fibrosis-4 score (P for interaction = .30).Conclusions and relevanceIn this cohort study, alcohol use and AUD were not associated with lower odds of SVR. Restricting access to DAA therapy according to alcohol use creates an unnecessary barrier to patients and challenges HCV elimination goals.

Project description:ImportanceDirect-acting antiviral (DAA) therapy for hepatitis C is highly effective but expensive. Evidence is scarce on whether DAA therapy reduces downstream medical costs.ObjectiveTo examine the association of DAA therapy with posttreatment medical costs among Medicare beneficiaries.Design, setting, and participantsThis retrospective cohort study obtained data from various Medicare claims files for 2013 to 2017. The study population comprised patients with a hepatitis C diagnosis in 2014 who were enrolled in fee-for-service Medicare and Part D. Multivariate regression models were used to compare changes in medical costs over a 30-month posttreatment follow-up period between patients who used DAA therapy (treatment group) and a propensity score-matched cohort of patients who did not use DAA (control group). The model was estimated separately for patients with and those without cirrhosis. Data were analyzed between September 1, 2019, and March 31, 2020.ExposuresCompletion of DAA therapy.Main outcomes and measuresTwo outcomes were established: hepatitis C or liver disease-related costs and total medical costs. Costs were measured by Medicare-allowed payments, which included Medicare reimbursements, patient responsibilities, and third-party payments.ResultsA propensity score-matched cohort of 15 198 patients (9038 men [59.5%]; mean [SD] age, 60.2 [10.8] years) was analyzed. During the first 6 months after DAA therapy, hepatitis C or liver disease-related costs decreased by $2498 (95% CI, -$3356 to -$1640) in patients with cirrhosis and by $486 (95% CI, -$603 to -$369) in patients without cirrhosis compared with control or untreated patients. Cumulative reductions in hepatitis C or liver disease-related costs during 30 months after DAA treatment were $15 808 (95% CI, -$22 530 to -$9085) in patients with cirrhosis and $5372 (95% CI, -$6384 to -$4360) in patients without cirrhosis. Among those who used DAA therapy compared with control patients, total medical costs decreased by $2905 (95% CI, -$4832 to -$979) in patients with cirrhosis and by $1287 (95% CI, -$2393 to -$283) in patients without cirrhosis during the first 6 months after DAA therapy. No statistically significant association was found between DAA therapy and total medical cost reductions after 12 months of follow-up. Cumulative reductions in total costs during 30 months after DAA therapy were $7074 (95% CI, -$18 448 to $4298) in patients with cirrhosis and $7497 (95% CI, -$14 287 to -$709) in patients without cirrhosis.Conclusions and relevanceThis study reported that DAA therapy appeared to be associated with a decrease in hepatitis C or liver disease-related costs for 30 months after treatment and with reduction in total medical costs for only 12 months after treatment in patients with or without cirrhosis. Longer-term follow-up studies with diverse outcomes are necessary to assess the value of DAA therapy.

Dataset Information

A new model to predict response to direct-acting antiviral therapy in decompensated cirrhotics due to hepatitis C virus.

Publications

A new model to predict response to direct-acting antiviral therapy in decompensated cirrhotics due to hepatitis C virus.

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