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Title: Sofosbuvir and daclatasvir therapy in patients with hepatitis C-related advanced decompensated liver disease (MELD ≥ 15).
Austin Authors: McCaughan, G W;Thwaites, Phoebe A ;Roberts, S K;Strasser, S I;Mitchell, J;Morales, B;Mason, S;Gow, Paul J ;Wigg, A;Tallis, C;Jeffrey, G;George, J;Thompson, A J;Parker, F C;Angus, Peter W 
Affiliation: Department of Gastroenterology, The Alfred Hospital, Melbourne, Victoria, Australia
Australian National Liver Transplant Unit, Royal Prince Alfred Hospital, Camperdown, NSW, Australia
Victorian Liver Transplant Unit
South Australian Liver Transplant Unit, Flinders Medical Centre, Bedford Park, SA, Australia
Queensland Liver Transplant Unit, Princess Alexandra Hospital, Woolloongabba, Qld, Australia
Western Australian Liver Transplant Unit, Sir Charles Gairdner Hospital, Nedlands, WA, Australia
Department of Gastroenterology and Hepatology, Westmead Hospital, Westmead, NSW, Australia
St Vincent's Hospital, University of Melbourne, Melbourne, Victoria, Australia
Issue Date: Feb-2018
Date: 2017-12-05
Publication information: Alimentary Pharmacology & Therapeutics 2018; 47(3): 401-411
Abstract: Antiviral therapy for hepatitis C has the potential to improve liver function in patients with decompensated cirrhosis. To examine the virological response and effect of viral clearance in patients with decompensated hepatitis C cirrhosis all with MELD scores ≥15 following sofosbuvir/daclatasvir ± ribavirin. We prospectively collected data on patients who commenced sofosbuvir/daclatasvir for 24-weeks under the Australian patient supply program (TOSCAR) and analysed outcomes including sustained viral response at 12 weeks (SVR12), death and transplant. 108 patients (M/F, 79/29; median age 56years; Child-Pugh 10; MELD 16; genotype 1/3, 55/47) received sofosbuvir/daclatasvir and two also received ribavirin. On intention-to-treat, the SVR12 rate was 70% (76/108). Seventy-eight patients completed 24-weeks therapy. SVR12 was achieved in 56 of these patients on per-protocol-analysis (76%). SVR12 was 80% in genotype 1 compared to 69% in genotype 3. Thirty patients failed to complete therapy. In patients achieving SVR12, median MELD and Child-Pugh fell from 16(IQR15-17) to 14(12-17) and 10(9-11) to 8(7-9), respectively (P<.001). In those who died, MELD increased from 16 to 23 at death (P=.036). Patients who required transplantation had a significantly higher baseline MELD (20) compared to those patients completing treatment (16) (P=.0010). The odds ratio for transplant in patients with baseline MELD ≥20 was 13.8(95%CI 2.78-69.04). SVR12 rates with sofosbuvir/daclatasvir in advanced liver disease are lower than in compensated disease. Although treatment improves MELD and Child-Pugh in most patients, a significant proportion will die or require transplantation. In those with MELD ≥20, it may be better to delay treatment until post-transplant.
DOI: 10.1111/apt.14404
ORCID: 0000-0001-5250-2086
Journal: Alimentary Pharmacology & Therapeutics
PubMed URL: 29205432
Type: Journal Article
Appears in Collections:Journal articles

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