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

Publication ,  Journal Article
Wilder, JM; Jeffers, LJ; Ravendhran, N; Shiffman, ML; Poulos, J; Sulkowski, MS; Gitlin, N; Workowski, K; Zhu, Y; Yang, JC; Pang, PS; Muir, AJ ...
Published in: Hepatology
February 2016

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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Published In

Hepatology

DOI

EISSN

1527-3350

Publication Date

February 2016

Volume

63

Issue

2

Start / End Page

437 / 444

Location

United States

Related Subject Headings

  • Young Adult
  • Uridine Monophosphate
  • Treatment Outcome
  • Sofosbuvir
  • Retrospective Studies
  • Middle Aged
  • Male
  • Humans
  • Hepatitis C, Chronic
  • Gastroenterology & Hepatology
 

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Wilder, J. M., Jeffers, L. J., Ravendhran, N., Shiffman, M. L., Poulos, J., Sulkowski, M. S., … Reddy, K. R. (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), 437–444. https://doi.org/10.1002/hep.28334
Wilder, Julius M., Lennox J. Jeffers, Natarajan Ravendhran, Mitchell L. Shiffman, John Poulos, Mark S. Sulkowski, Norman Gitlin, et al. “Safety and efficacy of ledipasvir-sofosbuvir in black patients with hepatitis C virus infection: A retrospective analysis of phase 3 data.Hepatology 63, no. 2 (February 2016): 437–44. https://doi.org/10.1002/hep.28334.
Wilder JM, Jeffers LJ, Ravendhran N, Shiffman ML, Poulos J, Sulkowski MS, et al. Safety and efficacy of ledipasvir-sofosbuvir in black patients with hepatitis C virus infection: A retrospective analysis of phase 3 data. Hepatology. 2016 Feb;63(2):437–44.
Wilder, Julius M., et al. “Safety and efficacy of ledipasvir-sofosbuvir in black patients with hepatitis C virus infection: A retrospective analysis of phase 3 data.Hepatology, vol. 63, no. 2, Feb. 2016, pp. 437–44. Pubmed, doi:10.1002/hep.28334.
Wilder JM, Jeffers LJ, Ravendhran N, Shiffman ML, Poulos J, Sulkowski MS, Gitlin N, Workowski K, Zhu Y, Yang JC, Pang PS, McHutchison JG, Muir AJ, Howell C, Kowdley K, Afdhal N, Reddy KR. Safety and efficacy of ledipasvir-sofosbuvir in black patients with hepatitis C virus infection: A retrospective analysis of phase 3 data. Hepatology. 2016 Feb;63(2):437–444.
Journal cover image

Published In

Hepatology

DOI

EISSN

1527-3350

Publication Date

February 2016

Volume

63

Issue

2

Start / End Page

437 / 444

Location

United States

Related Subject Headings

  • Young Adult
  • Uridine Monophosphate
  • Treatment Outcome
  • Sofosbuvir
  • Retrospective Studies
  • Middle Aged
  • Male
  • Humans
  • Hepatitis C, Chronic
  • Gastroenterology & Hepatology