Active hepatocellular carcinoma is an independent risk factor of direct-acting antiviral treatment failure: A retrospective study with prospectively collected data

Yen, Yi‐Hao; Chen, Chien‐Hung; Hung, Chao‐Hung; Wang, Jing‐Houng; Lu, Sheng–Nan; Kee, Kwong‐Ming; Hu, Tsung–Hui

doi:10.1371/journal.pone.0222605

Cited by 11 publications

(7 citation statements)

References 31 publications

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“…Our findings were similar to Yen et al that inactive HCC did not significantly reduce the SVR12. 17,19 With the expanding armamentarium of systemic therapy for HCC, our finding supports the motion of treating HCV patients with stable HCC using DAA in order to improve liver synthetic function in these patients.…”

Section: Discussionsupporting

confidence: 67%

Efficacy and safety of sofosbuvir/velpatasvir in a real‐world chronic hepatitis C genotype 3 cohort

Wong

Thurairajah

Kumar

et al. 2020

J of Gastro and Hepatol

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Background and Aim Real‐world data on sofosbuvir/velpatasvir with and without ribavirin (SOF/VEL ± RBV), particularly among patients with genotype 3 (GT3) decompensated cirrhosis, prior treatment, coinfection, and hepatocellular carcinoma (HCC), are scarce. We aimed to assess the efficacy and safety of SOF/VEL ± RBV in a real‐world setting that included both community and incarcerated GT3 hepatitis C virus (HCV) patients. Methods We included all GT3 HCV patients treated with SOF/VEL ± RBV in our institution. The primary outcome measure was the overall sustained virological response 12 weeks after treatment (SVR12), reported in both intention‐to‐treat (ITT) and per‐protocol analyses. The secondary outcome measures were SVR12 stratified by the presence of decompensated cirrhosis, prior treatment, HCC, and HIV/hepatitis C virus coinfection and the occurrence rate of serious adverse events requiring treatment cessation or hospitalization. Results A total of 779 HCV patients were treated with 12 weeks of SOF/VEL ± RBV, of which 85% were treated during incarceration. Among the 530 GT3 HCV patients, 31% had liver cirrhosis, and 6% were treatment‐experienced. The overall SVR12 for GT3 was 98.7% (95% confidence interval: 97.3%, 99.5%) and 99.2% (95% confidence interval: 98.1%, 99.8%) in ITT and per‐protocol analyses, respectively. High SVR12 was also seen in ITT analysis among GT3 HCV patients with decompensated cirrhosis (88%), prior treatment (100%), HCC (100%), and HIV/hepatitis B virus coinfection (100%). Apart from one patient who developed myositis, no other serious adverse events were observed. Conclusion The SOF/VEL ± RBV is a safe and efficacious treatment option for GT3 HCV patients in a real‐world setting. SOF/VEL with RBV may be considered for decompensated GT3 HCV patients.

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Section: Discussionsupporting

confidence: 67%

Efficacy and safety of sofosbuvir/velpatasvir in a real‐world chronic hepatitis C genotype 3 cohort

Wong

Thurairajah

Kumar

et al. 2020

J of Gastro and Hepatol

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“…Most of the DAA failures in patients with previous HCC diagnosis occurred among patients with active cancers, where DAA failed in almost half of the cases [9] , possibly because HCC may serve as a sanctuary for HCV. In agreement with these findings, in a preliminary report from our group, we did observe unusually low SVR rates among de novo and recurrent HCC cases, leading us to suggest that treatment failure should be considered a clue of a yet undetected HCC [58,59] .…”

Section: Multivariate Analysis Of Factors Associated With De Novo Hccsupporting

confidence: 89%

Response rates to direct antiviral agents among hepatitis C virus infected patients who develop hepatocellular carcinoma following direct antiviral agents treatment

Burlone¹,

Fangazio²,

Croce³

et al. 2020

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Aim: Patients with chronic hepatitis C virus (HCV) infection who develop hepatocellular carcinoma (HCC) soon after treatment with direct antiviral agents (DAA) may have been harboring hitherto hidden tumors. If this were true, they should have a lower sustained viral response (SVR) rate, since active HCC hampers DAA efficacy. We aimed to verify this hypothesis. Methods: We included all patients who attended an HCV clinic, provided that they: (1) had no previous history of HCC; (2) had received at least one DAA dose; and (3) had been followed-up clinically and ultrasonographically for at least six months after concluding DAA. Results: The study population included n = 789 patients (55% males, median age 62 years). A median of 9.3 months (8.8-11.9) after concluding DAA, n = 19 (2.4%) patients were discovered to harbor HCC. In comparison to all others, patients with HCC were more commonly male (84% vs. 54%, P = 0.009), obese (47% vs. 17%, P = 0.002), and cirrhotic (95% vs. 35%, P < 0.001) and had less commonly achieved an SVR (68% vs. 98%, P < 0.001). Moreover, they had a trend for being less commonly treatment naïve (58% vs. 67%, P = 0.051). Based on multivariate analysis, the independent predictors of HCC were male sex (P = 0.031), cirrhosis (P = 0.004), obesity (P = 0.006), and failure to achieve an SVR (P < 0.001). Conclusion: Lack of achieving SVR is a strong independent predictor of development of HCC early after treatment of hepatitis C with DAA. Treatment failure should further alert clinicians to the possibility of this dreadful complication.

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“…27 In the multivariate analysis, active HCC (vs inactive HCC and non-HCC) was associated with DAAs failure (OR, 24.5 [95% CI, 4.4-136.9], P < .001). 27 Two recently published meta-analysis confirmed a reduced SVR rate in patients with active HCC when compared with patients with inactive HCC or without HCC. 28,29 Our results are similar to those previously reported by other cohorts describing advanced liver disease as one of the main predictors of DAAs failure.…”

Section: Discussionmentioning

confidence: 95%

Decompensated cirrhosis and liver transplantation negatively impact in DAA treatment response: Real‐world experience from HCV‐LALREAN cohort

Ridruejo

Piñero

Mendizábal

et al. 2020

Journal of Medical Virology

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Introduction Although the effectiveness of direct‐acting antivirals (DAAs) for the treatment of chronic hepatitis C virus (HCV) has been reported in real‐world settings, predictive factors of treatment failure are lacking. Therefore, we sought to explore the baseline predictors of treatment response to DAAs. Methods This was a prospective multicenter cohort study from the Latin American Liver Research Educational and Awareness Network (LALREAN) including patients who received DAA treatment from May 2016 to April 2019. A multivariate logistic regression model was conducted to identify variables associated with unachieved sustained virological response (SVR), defined as treatment failure (odds ratios [OR] and 95% confidence intervals [CIs]). Results From 2167 patients (55.2% with cirrhosis) who initiated DAA therapy, 89.4% completed a full‐course treatment (n = 1938). Median treatment duration was 12 weeks, and 50% received ribavirin. Definitive suspension due to intolerance or other causes was observed in only 1.0% cases (n = 20). Overall non‐SVR12 was 4.5% (95% CI, 3.5‐5.7). There were no significant differences in treatment failure according to HCV genotypes and the degree of fibrosis. Independently associated variables with DAA failure were liver function impairment according to the Child‐Pugh score B OR, 2.09 (P = .06), Child‐Pugh C OR, 11.7 (P < .0001); and liver transplant (LT) recipient OR, 3.75 (P = .01). Conclusion In this real‐life setting, higher DAA treatment failure rates were observed in patients with decompensated cirrhosis and in LT recipients. These predictive baseline factors should be addressed to individualize the appropriate time‐point of DAA treatment (NCT03775798; http://www.clinicaltrials.gov).

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Active hepatocellular carcinoma is an independent risk factor of direct-acting antiviral treatment failure: A retrospective study with prospectively collected data

Cited by 11 publications

References 31 publications

Efficacy and safety of sofosbuvir/velpatasvir in a real‐world chronic hepatitis C genotype 3 cohort

Efficacy and safety of sofosbuvir/velpatasvir in a real‐world chronic hepatitis C genotype 3 cohort

Response rates to direct antiviral agents among hepatitis C virus infected patients who develop hepatocellular carcinoma following direct antiviral agents treatment

Decompensated cirrhosis and liver transplantation negatively impact in DAA treatment response: Real‐world experience from HCV‐LALREAN cohort

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