Daclatasvir plus Sofosbuvir with or without Ribavirin in Patients with HCV Infection and Decompensated Cirrhosis: Interim Analysis of a French Multicentre Compassionate use Programme

Leroy, Vincent; Hézode, Christophe; Métivier, Sophie; Tateo, Mariagrazia; Conti, Fabio; Nguyen‐Khac, Eric; Lacoste, D.; Vergniol, Julien; Truchi, Régine; Guyader, D.; Riachi, Ghassan; Michau, Christophe; Blaison, D; Oberti, Frédéric; Fontaine, H.; Martino, V. Di; Bronowicki, J.-P.; Akremi, Raoudha; Bennai, Y.; Filipovics, A.; Pageaux, Georges Philippe

doi:10.1016/s0168-8278(16)01622-6

Cited by 8 publications

(8 citation statements)

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“…The 94% overall rate of SVR12 in liver transplant patients is consistent with the 91% SVR12 observed in the entire CUP cohort of 485 patients , and with other real‐world analyses of DCV + SOF ± RBV in post‐transplant recurrence and/or advanced liver disease . Our findings are also comparable to the 94% SVR12 rate achieved with DCV + SOF + RBV for 12 weeks in patients with post‐liver transplant HCV recurrence in a phase 3 clinical trial (ALLY‐1) , despite the inclusion of patients with a broader range of liver disease severity and other medical complications such as FCH or renal insufficiency.…”

Section: Discussionsupporting

confidence: 86%

“…The all‐oral combination of DCV + SOF with ribavirin (RBV) was well tolerated and achieved 94% SVR12 after 12 weeks of treatment in patients with post‐liver transplant HCV recurrence in the ALLY‐1 study . Similar findings outside of clinical trials have been reported and provide a body of real‐world evidence to support and validate the clinical development program .…”

Section: Introductionsupporting

confidence: 57%

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Real-world experience with daclatasvir plus sofosbuvir ± ribavirin for post-liver transplant HCV recurrence and severe liver disease

et al. 2017

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SUMMARYOptimizing therapy of post-transplant HCV recurrence remains important, especially in advanced liver disease. We evaluated daclatasvir (DCV) plus sofosbuvir (SOF), with or without ribavirin (RBV), in patients with postliver transplant recurrence in a real-world European cohort at high risk of decompensation or death within 12 months. Recommended treatment was DCV 60 mg plus SOF 400 mg once daily for 24 weeks; RBV use/shorter treatment duration was at physicians' discretion. Patients (N = 87) were 70% male, 93% white, and mostly infected with HCV genotypes 1b (48%), 1a (32%), or 3 (9%); 37 (43%) had cirrhosis (16 decompensated), five had fibrosing cholestatic hepatitis. Sustained virologic response at post-treatment week 12 (SVR12) was 94% (80/85) in a modified intention-to-treat analysis: 95% (58/61) without RBV and 92% (22/24) with RBV, with no virologic failures. SVR12 was 100% (80/80) in an as-observed analysis excluding five nonvirologic failures. Four patients (5%) discontinued therapy for adverse events (AEs); 16 (18%) experienced serious AEs. One patient died on treatment and five during follow-up. Most AEs were associated with advanced liver disease and unrelated to therapy. No clinically significant drug-drug interactions were observed. DCV + SOF AE RBV was well tolerated and achieved high SVR12 (94%) in patients with post-transplant HCV recurrence, including patients with severe liver disease.

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Section: Discussionsupporting

confidence: 86%

Section: Introductionsupporting

confidence: 57%

Real-world experience with daclatasvir plus sofosbuvir ± ribavirin for post-liver transplant HCV recurrence and severe liver disease

et al. 2017

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“…Worldwide, large numbers of HCV-infected patients with decompensated cirrhosis have received antiviral therapy and although sustained virological response (SVR) rates are slightly reduced compared to patients with compensated disease, over 80% of treated patients still achieve viral clearance. Early analysis of patients who responded to therapy showed associated improvements in MELD and Child Pugh scores [1] [2][3][4], although some concerns have been expressed that the rate of malignancy may not change or may, paradoxically, increase [5,6]. Previous studies of interferon-based therapies have demonstrated that HCV clearance improves liver fibrosis, even in cirrhosis [7].…”

Section: Introductionmentioning

confidence: 99%

Outcomes after successful direct-acting antiviral therapy for patients with chronic hepatitis C and decompensated cirrhosis

Cheung

Walker

Hudson

et al. 2016

Journal of Hepatology

378

348

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Cheung, M. C. M. et al. (2016) Outcomes after successful direct-acting antiviral therapy for patients with chronic hepatitis C and decompensated cirrhosis. Journal of Hepatology, 65(4), pp. 741-747. (doi:10.1016Hepatology, 65(4), pp. 741-747. (doi:10. /j.jhep.2016 This is the author's final accepted version.There may be differences between this version and the published version. You are advised to consult the publisher's version if you wish to cite from it.http://eprints.gla.ac.uk/123893/ There was no significant difference in liver cancer incidence (10/406 (2.5%) in months 6-15 and 17/406 (4%) in months 0-6 for treated patients vs 11/261 (4%) in untreated patients).2

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“…The majority had advanced underlying disease, including decompensated cirrhosis, hepatocellular carcinoma, and/or posttransplant HCV recurrence. Real‐world data collected in Europe from patients treated under these initiatives have been published …”

Section: Introductionmentioning

confidence: 99%

“…Real-world data collected in Europe from patients treated under these initiatives have been published. (10)(11)(12) We present the final data from an early access program conducted in the United States in which patients with advanced disease received treatment with DCV1SOF6RBV. Patients with any HCV genotype and decompensated cirrhosis or severe posttransplant HCV recurrence with cirrhosis, advanced fibrosis, or fibrosing cholestatic hepatitis (FCH), were eligible to enroll.…”

Section: Introductionmentioning

confidence: 99%

Daclatasvir and sofosbuvir treatment of decompensated liver disease or post‐liver transplant hepatitis C virus recurrence in patients with advanced liver disease/cirrhosis in a real‐world cohort

Kwo

Fried

Reddy

et al. 2018

Hepatology Communications

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We report the findings of an early access program providing treatment for chronic hepatitis C virus infection (any genotype) with daclatasvir and sofosbuvir with/without ribavirin to patients with Child‐Pugh class C cirrhosis or prior liver transplant recipients with recurrent hepatitis C virus infection and advanced fibrosis/cirrhosis. Patients had <12‐month life expectancies per the local investigator. Patients received daclatasvir 60 mg and sofosbuvir 400 mg once daily, with/without ribavirin, for 24 weeks. Sustained virologic response (SVR) at posttreatment week 12 (SVR12) was measured. Assessments adhered to local standards. One patient (prior Child‐Pugh class C who improved to class B) enrolled by exemption was included in the overall data but not the class C cohort efficacy/safety data. Of the 77 treated patients, including 62 liver transplant recipients (genotype 1, n = 43, 69%; genotype 3, n = 16, 26%) and 14 patients with Child‐Pugh class C cirrhosis (genotype 1, n = 4, 29%; genotype 3, n = 10, 71%), 63 (82%) completed treatment. SVR12 rates by modified intention‐to‐treat analysis (excluding nonvirologic failures lost to follow‐up and withdrawal [consent/no reason]) in the overall, liver transplant, and Child‐Pugh class C cohorts were 84% (n = 64/76), 90% (n = 56/62), and 62% (n = 8/13), respectively. Rates increased to 96% (n = 64/67), 97% (n = 56/58), and 89% (n = 8/9), respectively, in patients with available virologic data (including early discontinuations); 22/23 patients with genotype 3 (96%) achieved SVR12. Single cases of virologic nonresponse and relapse (both in liver transplant recipients with genotype 1) and viral breakthrough (Child‐Pugh class C; genotype 3) occurred. Six patients died, 10 had adverse events leading to discontinuation, and 30 experienced serious adverse events. Conclusion: Daclatasvir plus sofosbuvir, with/without ribavirin, provided high SVR12 rates and was generally well tolerated in patients with life‐threatening disease and high unmet needs. (Hepatology Communications 2018;2:354‐363)

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Daclatasvir plus Sofosbuvir with or without Ribavirin in Patients with HCV Infection and Decompensated Cirrhosis: Interim Analysis of a French Multicentre Compassionate use Programme

Cited by 8 publications

References 0 publications

Real-world experience with daclatasvir plus sofosbuvir ± ribavirin for post-liver transplant HCV recurrence and severe liver disease

Real-world experience with daclatasvir plus sofosbuvir ± ribavirin for post-liver transplant HCV recurrence and severe liver disease

Outcomes after successful direct-acting antiviral therapy for patients with chronic hepatitis C and decompensated cirrhosis

Daclatasvir and sofosbuvir treatment of decompensated liver disease or post‐liver transplant hepatitis C virus recurrence in patients with advanced liver disease/cirrhosis in a real‐world cohort

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