High Efficacy of Ledipasvir/Sofosbuvir with Ribavirin in HCV Genotype-1 Infected Patients with Decompensated Liver Disease: Analysis by MELD Score from the SOLAR-1 and SOLAR-2 Trials.
1Intermountain Medical Center, Salt Lake City
2Vancouver General Hospital, Vancouver, Canada
3Hopital Saint Joseph, Marseilles, France
4Northwestern University, Chicago
5Duke University, Durham
6University of North Carolina, Chapel Hill
7UCSF, SF
8Gilead Sciences Inc, Foster City
9Hannover Medical School, Hannover, Germany
10BIDMC, Boston.
Meeting: 2016 American Transplant Congress
Abstract number: 265
Keywords: Hepatitis C, Liver cirrhosis, Liver failure, Liver transplantation
Session Information
Date: Monday, June 13, 2016
Session Name: Concurrent Session: Viral Hepatitis
Session Time: 2:30pm-4:00pm
Presentation Time: 3:06pm-3:18pm
Location: Ballroom A
Introduction: HCV infected patients with decompensated liver disease have significant morbidity & mortality. The efficacy & safety of LDV/SOF + RBV was evaluated in a pooled analysis of HCV GT-1 infected patients with decompensated liver disease enrolled in the SOLAR-1 & SOLAR-2 clinical trials.
Methods: Patients with HCV GT-1 infection & decompensated liver disease (CPT-B or CPT-C) who were either pretransplant or post liver transplant were included in the safety analysis. Patients were randomized 1:1 to receive 12 or 24 weeks of LDV/SOF+RBV treatment. These analyses were performed according to MELD categories of MELD ≤10, 11-14, 15-18 and >/= 19).
Results: 309 patients were included for safety analysis (202 pretransplant & 107 posttransplant). The majority of patients were treatment experienced (74 %), white (93%), males (73%), with IL28B non-CC (79%). The combined 12 & 24 week SVR12 rates by baseline MELD categories were ≤10 (100% & 97%), 11-14 (87% & 92%), 15-18 (83% & 68%) and ≥19 (70% & 83%) for pretransplant & posttransplant patients respectively. There were few relapses, 13 (7.3%) & 4 (4%) in the pretransplant & posttransplant groups respectively. The incidence of SAEs by MELD categories that were ≤10 were (18% & 24%), 11-14 (23% & 27%), 15-18 (37% & 42%) and ≥19 (58% & 67%) for pretransplant and posttransplant patients respectively. There were 14 (4.5%) treatment-emergent deaths with a higher incidence in patients with MELD scores ≥ 15 (7.3% vs 3.3%). Deaths were primarily associated with clinical progression of end stage liver disease; all were considered unrelated to study drug.
Conclusions: In HCV GT-1 infected patients with decompensated liver disease, LDV/SOF+RBV for 12 or 24 weeks resulted in high SVR rates. Patients with higher MELD scores ≥ 15 had higher rates of SAEs and death due to the severity of their underlying liver disease.
CITATION INFORMATION: Charlton M, Yoshida E, Bouliere M, Flamm S, Muir A, Fried M, Terrault N, Arterburn S, Yun C, Pang P, Osinusi A, Spellman J, Natha M, Brainard D, McHutchison J, Manns M, Afdhal N. High Efficacy of Ledipasvir/Sofosbuvir with Ribavirin in HCV Genotype-1 Infected Patients with Decompensated Liver Disease: Analysis by MELD Score from the SOLAR-1 and SOLAR-2 Trials. Am J Transplant. 2016;16 (suppl 3).
To cite this abstract in AMA style:
Charlton M, Yoshida E, Bouliere M, Flamm S, Muir A, Fried M, Terrault N, Arterburn S, Yun C, Pang P, Osinusi A, Spellman J, Natha M, Brainard D, McHutchison J, Manns M, Afdhal N. High Efficacy of Ledipasvir/Sofosbuvir with Ribavirin in HCV Genotype-1 Infected Patients with Decompensated Liver Disease: Analysis by MELD Score from the SOLAR-1 and SOLAR-2 Trials. [abstract]. Am J Transplant. 2016; 16 (suppl 3). https://atcmeetingabstracts.com/abstract/high-efficacy-of-ledipasvirsofosbuvir-with-ribavirin-in-hcv-genotype-1-infected-patients-with-decompensated-liver-disease-analysis-by-meld-score-from-the-solar-1-and-solar-2-trials/. Accessed April 20, 2021.« Back to 2016 American Transplant Congress