Safety and efficacy of ledipasvir-sofosbuvir in black patients with hepatitis C virus infection: A retrospective analysis of phase 3 data.

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Date

2016-02

Authors

Wilder, Julius M
Jeffers, Lennox J
Ravendhran, Natarajan
Shiffman, Mitchell L
Poulos, John
Sulkowski, Mark S
Gitlin, Norman
Workowski, Kimberly
Zhu, Yanni
Yang, Jenny C

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Abstract

UNLABELLED: Black patients chronically infected with genotype 1 hepatitis C virus (HCV) have historically had lower rates of response to interferon-based treatment than patients of other races. In the phase 3 ION program, the single-tablet regimen of the NS5A inhibitor ledipasvir and NS5B nucleotide polymerase inhibitor sofosbuvir was shown to be safe and highly effective in the general population. The aim of this study was to evaluate the safety and efficacy of ledipasvir/sofosbuvir in black patients using data from the three open-label ION clinical trials, which evaluated the safety and efficacy of 8, 12, and 24 weeks of ledipasvir/sofosbuvir with or without ribavirin for the treatment of treatment-naïve and treatment-experienced patients with genotype 1 HCV, including those with compensated cirrhosis. The primary endpoint was sustained virologic response at 12 weeks after the end of therapy (SVR12). For our analysis, rates of SVR12, treatment-emergent adverse events, and graded laboratory abnormalities were analyzed in black versus non-black patients. Of the 1949 patients evaluated, 308 (16%) were black. On average, black patients were older, had higher body mass index, were more likely to be IL28B non-CC, and had a lower serum alanine aminotransferase at baseline than non-black patients. Overall, 95% of black and 97% of non-black patients achieved SVR12. The rate of relapse was 3% in black patients as compared with 2% in non-black patients. The most common adverse events included fatigue, headache, nausea, and insomnia. The majority of adverse events occurred more frequently in the ribavirin-containing arms of the studies. No differences were observed in overall safety by race. CONCLUSION: A once-daily dosage of ledipasvir/sofosbuvir was similarly effective in black and non-black patients with genotype 1 HCV infection. The addition of ribavirin did not appear to increase SVR12 but was associated with higher rates of adverse events.

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Adolescent, Adult, African Americans, Aged, Aged, 80 and over, Antiviral Agents, Benzimidazoles, Female, Fluorenes, Hepatitis C, Chronic, Humans, Male, Middle Aged, Retrospective Studies, Treatment Outcome, Uridine Monophosphate, Young Adult

Citation

Published Version (Please cite this version)

10.1002/hep.28334

Publication Info

Wilder, Julius M, Lennox J Jeffers, Natarajan Ravendhran, Mitchell L Shiffman, John Poulos, Mark S Sulkowski, Norman Gitlin, Kimberly Workowski, et al. (2016). Safety and efficacy of ledipasvir-sofosbuvir in black patients with hepatitis C virus infection: A retrospective analysis of phase 3 data. Hepatology, 63(2). pp. 437–444. 10.1002/hep.28334 Retrieved from https://hdl.handle.net/10161/12751.

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Scholars@Duke

Wilder

Julius Middleton Wilder

Associate Professor of Medicine
Muir

Andrew Joseph Muir

Professor of Medicine
  • Hepatitis C 
  • Primary sclerosing cholangitis
  • Cirrhosis
  • Liver Transplantation
  • Clinical Trials
  • Healthcare disparities in liver disease 
  • Outcomes Research

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