The short‐term incidence of hepatocellular carcinoma is not increased after hepatitis C treatment with direct‐acting antivirals: An ERCHIVES study

Li, Darrick K.; Ren, Yanjie; Fierer, Daniel S.; Rutledge, Stephanie; Shaikh, Obaid S.; Re, Vincent Lo; Simon, Tracey G.; Abou‐Samra, Abdul‐Badi; Chung, Raymond T.; Butt, Adeel A.

doi:10.1002/hep.29707

Cited by 150 publications

(168 citation statements)

References 27 publications

(61 reference statements)

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“…Interestingly, unlike our results, a recent report indicated that DAA treatment was associated with an unexpected high rate of HCC . Investigators suggest that the high rate of HCC may actually be the results of the “warehousing effect”—a state where curative treatment was offered to those who were the sickest and were unable to be cured with the prior IFN treatment . A recent study of U.S. veterans found that DAA treatment was not associated with a higher risk of HCC in patients with HCV with cirrhosis .…”

Section: Discussioncontrasting

confidence: 99%

Impact of All‐Oral Direct‐Acting Antivirals on Clinical and Economic Outcomes in Patients With Chronic Hepatitis C in the United States

et al. 2019

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Approved treatment for hepatitis C virus (HCV) with all-oral direct acting antivirals (DAA) therapy is now entering into its fourth year; however, little has been reported on the real world clinical [decompensated cirrhosis (DCC) and hepatocellular carcinoma (HCC)] and economic outcomes. A retrospective cohort analysis of the Truven Health MarketScan Database (2012 - 2016) was conducted. In a cohort of 26,105 newly diagnosed HCV patients, 30% received all-oral DAA therapy (DAA group) and 70% were not treated (untreated group). Multivariate Cox proportional hazards models were used to compare the risk of developing HCC and DCC, stratified by cirrhosis status. Among cirrhotic patients (n=2,157), DAA therapy was associated with a 72% and a 62% lower incidence of HCC (hazard ratio (HR): 0.28; 95% confidence interval (CI):0.15-0.52) and DCC (HR: 0.38; 95% CI: 0.26-0.56). Similarly, DAA therapy was associated with a 57% and a 58% lower incidence of HCC (HR: 0.43; 95% CI:0.26-0.71) and DCC (HR: 0.42; 95% CI: 0.30-0.58) in non-cirrhotic HCV patients (n=23,948). A propensity-score matched cohort of 8,064 HCV-infected patients who had at least a 12-month follow-up after HCV treatment was included for economic analysis. For cirrhotic patients in the DAA group, the mean adjusted liver-related costs ($1,749 vs $4,575; P<0.001) and all-cause medical costs ($19,300 vs $33,039; P<0.001) were significantly lower compared to those in the untreated group. The mean adjusted costs were not statistically different between the two groups among non-cirrhotic patients. Conclusions: In the short term, all-oral DAA treatment for HCV infection was associated with a decreased risk of developing HCC and DCC resulting in decreased healthcare costs, especially in cirrhotic patients. A longitudinal study is necessary to confirm our findings.

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Section: Discussioncontrasting

confidence: 99%

Impact of All‐Oral Direct‐Acting Antivirals on Clinical and Economic Outcomes in Patients With Chronic Hepatitis C in the United States

et al. 2019

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“…In a propensity score‐matched study, the incidence and recurrence of HCC was not different between patients treated with interferon and interferon‐free therapies . In a larger retrospective study using the electronically retrieved cohort of HCV infected veterans (ERCHIVES) database, the HCC incidence was similar among patients with cirrhosis who had achieved SVR after either interferon or DAA therapy . In our study, 70 of the 79 patients with advanced fibrosis did not have a diagnosis of HCC prior to therapy; of these 70 patients, 3 patients (4.3%) developed new HCC over a median follow‐up of 22 months.…”

Section: Discussionmentioning

confidence: 54%

“…(38) In a larger retrospective study using the electronically retrieved cohort of HCV infected veterans (ERCHIVES) database, the HCC incidence was similar among patients with cirrhosis who had achieved SVR after either interferon or DAA therapy. (39) In our study, 70 of the 79 patients with advanced fibrosis did not have a diagnosis of HCC prior to therapy; of these 70 patients, 3 patients (4.3%) developed new HCC over a median follow-up of 22 months. This rate is similar to the 3.16% reported after 24 weeks post-SVR among patients with cirrhosis in Italy, (40) 4.1% after a median follow-up of 15 months post-SVR among patients with cirrhosis in Austria, (41) and 4.5% after a median follow-up of 23 months post-HCV treatment in patients with all levels of fibrosis in Japan.…”

Section: Discussionmentioning

confidence: 55%

Liver Disease Monitoring Practices After Hepatitis C Cure in the Underserved Population

Kim

Magee

Cummings

et al. 2018

Hepatology Communications

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Recent hepatitis C virus (HCV) guidelines recommend disease monitoring and hepatocellular carcinoma (HCC) screening in patients with advanced fibrosis after a sustained virologic response (SVR) with direct‐acting antiviral (DAA) therapy. However, data on practice patterns in this setting is lacking. We aimed to characterize disease monitoring and HCC screening practices post‐SVR in an underserved HCV‐infected cohort. Records of 192 patients who received DAA therapy at the San Francisco safety‐net health care system between January 2014 and January 2016 with ≥12 months of follow‐up post‐SVR were reviewed. Patient characteristics were median age 58 years, 61.5% men, 39.1% White (23.4% Black, 16.7% Latino, 16.2% Asian), 78.1% English proficient, 48.9% intravenous drug use, 53.2% alcohol use, and 41% advanced (F3 and F4) fibrosis (26.6% with decompensation, 11.4% with HCC). Median post‐SVR follow‐up time was 22 months. A higher proportion of patients with advanced fibrosis attended liver clinic visits (mean, 1.94 ± 2.03 versus 1.12 ± 1.09 visits; P = 0.014) and had liver imaging (41.4% versus 9.73%; P < 0.001) post‐SVR, but there was no difference in alanine aminotransferase (ALT) testing (72.2% versus 66.4%; P = 0.40) compared to those without advanced fibrosis. However, 20% with advanced fibrosis had no HCC screening while 35% with no advanced fibrosis had liver imaging. Three patients with cirrhosis developed new HCC. Conclusion: Although the majority of patients with advanced fibrosis in this underserved cohort received post‐SVR monitoring, gaps in HCC screening were identified and new cases of HCC occurred during a short follow‐up. This highlights the importance of incorporating recently enhanced guidelines to optimize post‐SVR monitoring, especially in difficult to engage populations.

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“…The panel A of Figure reproduces HCC incidence rates by treatment group according to SVR status in patients with cirrhosis, extracted from the Electronically Retrieved Cohort of HCV Infected Veterans (ERCHIVES) database . Strikingly, the HCC incidence rates observed in the SVR and non‐SVR subgroups were both consistently higher in the interferon‐free than in the interferon‐based treatment groups (although the differences reported in the paper were not significant due to a lack of power, our issue here concerns the order between incidence rates by treatment groups in the different SVR subgroups).…”

mentioning

confidence: 94%

Comparing interferon‐free with interferon‐based regimens in HCV patients: Rogers phenomenon and Simpson’s paradox

Carrat

Nahon

Fontaine

et al. 2019

Journal of Viral Hepatitis

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Comparisons of time‐to‐event clinical outcomes between patients with or without a sustained virological response (SVR) after treatment of chronic hepatitis C infection have been repeatedly reported in emphasizing the potential clinical impact of treatment. Combining recently published data from different therapeutic eras with simple examples, we show that comparisons of incidence rates by SVR status between patients treated with interferon‐based and interferon‐free regimens are flawed through confounding by prognosis. The relevant analysis for evaluating and comparing the clinical impact of these regimens should be a comparison between randomized treatment groups, irrespective of the SVR status.

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The short‐term incidence of hepatocellular carcinoma is not increased after hepatitis C treatment with direct‐acting antivirals: An ERCHIVES study

Cited by 150 publications

References 27 publications

Impact of All‐Oral Direct‐Acting Antivirals on Clinical and Economic Outcomes in Patients With Chronic Hepatitis C in the United States

Impact of All‐Oral Direct‐Acting Antivirals on Clinical and Economic Outcomes in Patients With Chronic Hepatitis C in the United States

Liver Disease Monitoring Practices After Hepatitis C Cure in the Underserved Population

Comparing interferon‐free with interferon‐based regimens in HCV patients: Rogers phenomenon and Simpson’s paradox

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