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Hepatology. 2015 Jul;62(1):25-30. doi: 10.1002/hep.27890. Epub 2015 Jun 1.

Safety and tolerability of ledipasvir/sofosbuvir with and without ribavirin in patients with chronic hepatitis C virus genotype 1 infection: Analysis of phase III ION trials.

Author information

1
Department of Medicine, Johns Hopkins Hospital, Baltimore, MD.
2
Hepatology, Beth Israel Deaconess Medical Center, Boston, MA.
3
Department of Medicine, Johann Wolfgang Goethe University, Frankfurt, Germany.
4
Gastroenterology, Henry Ford Health System, Detroit, MI.
5
Department of Hepatology, Casa Sollievo della Sofferenza Hospital, San Giovanni Rotondo, Italy.
6
Gastroenterology-Hepatology, Indiana University School of Medicine, Indianapolis, IN.
7
Liver Center, University of North Carolina Health Care, Chapel Hill, NC.
8
Liver Diseases, Gilead Sciences, Inc, Foster City, CA.
9
Indianapolis Gastroenterology Research Foundation, Indianapolis, IN.
10
Division of Gastroenterology, Hospital of the University of Pennsylvania, Philadelphia, PA.
11
Department of Hepatology, Centre Hospitalier Universitaire Beaujon, Clichy-sous-Bois, France.
12
Liver Care Network and Organ Care Research, Swedish Medical Center, Seattle, WA.

Abstract

In phase III studies, treatment with the once-daily fixed-dose combination tablet of ledipasvir/sofosbuvir (LDV/SOF) with and without ribavirin (RBV) resulted in high rates of sustained virological response (SVR) in patients chronically infected with genotype 1 hepatitis C virus, including those with compensated cirrhosis. We conducted an analysis of data from these trials to compare the safety and tolerability profile of LDV-SOF with and without RBV. We analyzed treatment-emergent adverse events (AEs) and laboratory abnormalities in patients who were randomized to 8, 12, and 24 weeks of LDV/SOF with or without RBV. In total, data from 1,952 patients (of whom 872 received LDV/SOF with RBV and 1,080 received LDV/SOF alone) were analyzed. Overall, 308 patients (16%) were African American, 224 (11%) had compensated cirrhosis, 501 (26%) had a body mass index ≥30 kg/m(2) , and 440 (23%) were treatment experienced. Treatment-related AEs occurred in 71% and 45% of patients treated with and without RBV, respectively, including fatigue, insomnia, irritability, and rash/pruritus. Patients receiving RBV with LDV/SOF were more likely to require dose modification, interruptions of treatment resulting from AEs, or require the use of concomitant medications than those receiving LDV/SOF alone. Rates of treatment-related serious AEs and discontinuations resulting from AEs were similarly low (<1%) in both groups. The rate of SVR in those receiving RBV and those not receiving RBV was the same (97%).

CONCLUSION:

LDV/SOF plus RBV was associated with a greater incidence of AEs as well as concomitant medication use than LDV/SOF alone. Use of RBV did not impact the efficacy of LDV/SOF regimens in the ION phase III studies.

PMID:
25963890
DOI:
10.1002/hep.27890
[Indexed for MEDLINE]

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