High efficacy of direct‐acting anti‐viral agents in hepatitis C virus‐infected cirrhotic patients with successfully treated hepatocellular carcinoma

Persico, Marcello; Aglitti, Andrea; Aghemo, Alessio; Rendina, Maria; Lleo, Ana; Ciancio, Alessia; Marco, V. Di; Lampertico, Pietro; Brunetto, M.R.; Zuin, Massimo; Andreone, Pietro; Villa, Erica; Troshina, Giulia; Calvaruso, V.; Degasperi, Elisabetta; Coco, B.; Giorgini, Alessia; Conti, Fabio; Leo, Alfredo Di; Marzi, Luca; Boccaccio, V.; Bollani, S.; Maisonneuve, Patrick; Bruno, Savino

doi:10.1111/apt.14685

Cited by 28 publications

(36 citation statements)

References 30 publications

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“…Study characteristics were summarised in Tables and . Fifty‐six studies were included, with a total of 5522 patients with HCC, while 27 studies enrolled non‐HCC patients as control groups. Fifty‐three (95%) studies were observational cohorts (45 retrospective and eight prospective) and three studies were clinical trials.…”

Section: Resultsmentioning

confidence: 99%

“…Study characteristics were summarised in Tables 1 and 2. Fifty-six studies 11,13,28,30,31, were included, with a total of 5522 patients with HCC, while 27 studies enrolled non-HCC patients as control groups.…”

Section: Study Characteristicsmentioning

confidence: 99%

“…[23][24][25] For example, some recommended DAA treatment deferral (ie at least 4-6 months) following potentially curative HCC management. [26][27][28][29] Third, the DAA response among patients with HCC is relevant, particularly in relation to optimum timing of initiation. In two cohort studies conducted in the United States, the virological response to DAA therapy was impaired in HCV-related HCC patients, compared to the non-HCC population.…”

Section: Introductionmentioning

confidence: 99%

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Systematic review with meta‐analysis: effectiveness of direct‐acting antiviral treatment for hepatitis C in patients with hepatocellular carcinoma

Lockart

Alavi

et al. 2019

Aliment Pharmacol Ther

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Summary Background Direct‐acting antiviral (DAA) therapy for hepatitis C virus (HCV) infection is highly curative and tolerable. Among patients with hepatocellular carcinoma (HCC), optimal timing of DAA therapy remains unclear. Data on efficacy of DAA therapy in patients with HCC would inform this decision‐making. Aim To evaluate response to DAA therapy among patients diagnosed with HCV infection and HCC. Methods Bibliographic databases and conference abstracts were searched. Meta‐analysis was conducted to pool sustained virologic response (SVR) estimates. Results Fifty‐six studies with 5522 patients with HCV and HCC were included. Overall SVR was 88.3% (95% CI 86.1‐90.4). Twenty‐seven studies included patients with prior or present HCC (n = 3126) and patients without HCC (n = 49 138), in which SVR was 88.2% (95% CI 85.0‐91.4) and 92.4% (95% CI 91.1‐93.7) among patients with and without HCC, respectively (odds ratio: 0.54, 95% CI 0.43‐0.68, P < .001). In the subgroup analyses, higher SVR was seen in patients who received curative HCC management (SVR 90.4%, 95% CI 88.3‐92.4), or treated with sofosbuvir + NS5A inhibitor DAAs (SVR 96.9%, 95% CI 94.3‐99.4), or in patients with HCV genotype 1 infection (SVR 92.0%, 95% CI 88.1‐95.6). Conclusion Response to DAA therapy was lower in patients with HCC compared to those without HCC, regardless of cirrhosis status. Among HCC patients, there was an impact of proportion with curative HCC management on DAA therapy response.

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Section: Resultsmentioning

confidence: 99%

Section: Study Characteristicsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Systematic review with meta‐analysis: effectiveness of direct‐acting antiviral treatment for hepatitis C in patients with hepatocellular carcinoma

Lockart

Alavi

et al. 2019

Aliment Pharmacol Ther

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“…In the present study, HCC patients showed a high SVR rate with DCV/ASV combination therapy, because they had mostly compensated liver disease with high adherence to antiviral therapy. Similarly, recent studies have shown that antiviral efficacy in HCC patients after curative treatment with DAAs is comparable to those without HCC . Thus, antiviral treatment should be offered to HCC patients who were curatively treated with enough life expectancy.…”

Section: Discussionmentioning

confidence: 97%

“…Because ASV is not labeled for decompensated cirrhosis, previous data are limited, but a recent study reported 100% of SVR in 10 decompensated cirrhosis, 24 DAAs is comparable to those without HCC. 25,26 Thus, antiviral treatment should be offered to HCC patients who were curatively treated with enough life expectancy.…”

Section: Treatment Withdrawal and Adverse Events During DCV Plus Asmentioning

confidence: 99%

Real‐life effectiveness and safety of the daclatasvir/asunaprevir combination therapy for genotype 1b chronic hepatitis C patients: An emphasis on the pretreatment NS5A resistance‐associated substitution test

Jang

Kim

et al. 2019

Journal of Medical Virology

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This study aimed to investigate the real‐life effectiveness and safety of daclatasvir (DCV) and asunaprevir (ASV) combination therapy in Korean patients. We consecutively enrolled patients with genotype 1b hepatitis C virus (HCV) infection treated with at least one dose of DCV/ASV combination therapy in seven tertiary hospitals of South Korea. The sustained virologic response (SVR) rates and safety according to intention‐to‐treat (ITT) and per‐protocol (PP) analyses were evaluated. Among the 526 enrolled patients, 91% showed negative (87%) or “undetermined” (4%) resistance‐associated substitution (RAS); 9% did not undergo RAS testing. The SVR rates for ITT and PP were 89.3% and 95.0% in treatment‐naive patients and 93.2% and 95.6% in treatment‐experienced patients, respectively. In PP analysis, negative RAS was associated with higher SVR (96.3%) than with “undetermined RAS” (85.7%) or “not tested for RAS” (84.4%). Adverse events were reported in 185 (35.4%) patients, and events leading to discontinuation were observed in 4.3% of the study population. Forty‐two (8.0%) patients developed transaminase elevation (≥2 × upper normal limit), resulting in treatment discontinuation in six (1.1%) patients. DCV/ASV combination therapy showed acceptable efficacy in genotype 1b compensated HCV‐infected patients with negative pretreatment RAS. Although most adverse events were tolerable to continue antiviral treatment, adequate monitoring for transaminase elevation is warranted.

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Cure With Interferon‐Free Direct‐Acting Antiviral Is Associated With Increased Survival in Patients With Hepatitis C Virus‐Related Hepatocellular Carcinoma From Both East and West

Dang

Yeo

Yasuda³

et al. 2020

Hepatology

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BaCKgRoUND aND aIMS:Survival data among patients with hepatitis C virus (HCV)-related hepatocellular carcinoma (HCC) after achieving sustained virologic response (SVR) with interferon-free direct-acting antivirals (DAAs) in both Asian and western countries are limited. Survival rates were compared between patients with HCV-related HCC who were untreated for HCV and those who achieved SVR. appRoaCH aND ReSUltS: Using data from two U.S. and six Asian centers from 2005 to 2017, we categorized 1,676 patients who were mono-infected with HCV-related HCC into patients untreated for HCV (untreated group) and DAA-treated patients with SVR (SVR group) and matched by propensity score matching (PSM); multivariable Cox regression with HCV treatment status as a time-varying covariate was used to determine mortality risk and landmark analysis to avoid immortal time bias. There were 1,239 untreated patients and 437 patients with SVR. After PSM, background risks of the 321 pairs of matched patients were balanced (all P > 0.05). After time-varying adjustment for HCV treatment initiation compared with untreated patients, patients with SVR had significantly higher 5-year overall survival (87.78% vs. 66.05%, P < 0.001). Multivariable Cox regression showed that SVR was independently associated with a 63% lower risk of 5-year all-cause mortality (hazard ratio [HR], 0.37; 95% confidence interval [CI], 0.16-0.83; P = 0.016) and 66% lower risk of 5-year liver-related mortality (HR, 0.34; 95% CI, 0.13-0.88; P = 0.026) with similar trends after removing patients with liver transplants. Landmark analysis at 90, 180, and 360 days showed consistent results (HRs ranged 0.22 to 0.44, all P < 0.05). CoNClUSIoN:In this multinational consortium, patients with HCV-related HCC who obtained SVR achieved a 60%-70% improvement in 5-year survival (both all-cause and liver related) compared with patients untreated for HCV. Patients eligible for HCC therapy should also be considered for DAA therapy.

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High efficacy of direct‐acting anti‐viral agents in hepatitis C virus‐infected cirrhotic patients with successfully treated hepatocellular carcinoma

Abstract: This large real-life study proves that the efficacy of DAA in cirrhotic patients is not impaired by successfully treated HCC.

Cited by 28 publications

References 30 publications

Systematic review with meta‐analysis: effectiveness of direct‐acting antiviral treatment for hepatitis C in patients with hepatocellular carcinoma

Systematic review with meta‐analysis: effectiveness of direct‐acting antiviral treatment for hepatitis C in patients with hepatocellular carcinoma

Real‐life effectiveness and safety of the daclatasvir/asunaprevir combination therapy for genotype 1b chronic hepatitis C patients: An emphasis on the pretreatment NS5A resistance‐associated substitution test

Cure With Interferon‐Free Direct‐Acting Antiviral Is Associated With Increased Survival in Patients With Hepatitis C Virus‐Related Hepatocellular Carcinoma From Both East and West

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