Author information
1
Australian National Liver Transplant Unit, Royal Prince Alfred Hospital, Camperdown, NSW, Australia.
2
Victorian Liver Transplant Unit, Austin Health, Heidelberg, Vic., Australia.
3
Department of Gastroenterology, The Alfred Hospital, Melbourne, Vic., Australia.
4
South Australian Liver Transplant Unit, Flinders Medical Centre, Bedford Park, SA, Australia.
5
Queensland Liver Transplant Unit, Princess Alexandra Hospital, Woolloongabba, Qld, Australia.
6
Western Australian Liver Transplant Unit, Sir Charles Gairdner Hospital, Nedlands, WA, Australia.
7
Department of Gastroenterology and Hepatology, Westmead Hospital, Westmead, NSW, Australia.
8
St Vincent's Hospital, University of Melbourne, Melbourne, Vic., Australia.
Abstract
BACKGROUND:
Antiviral therapy for hepatitis C has the potential to improve liver function in patients with decompensated cirrhosis.
AIMS:
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.
METHODS:
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.
RESULTS:
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).
CONCLUSIONS:
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.