Safety and efficacy of ledipasvir-sofosbuvir in black patients with hepatitis C virus infection: A retrospective analysis of phase 3 data.
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.
Type
Journal articleSubject
AdolescentAdult
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
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https://hdl.handle.net/10161/12751Published Version (Please cite this version)
10.1002/hep.28334Publication Info
Afdhal, N; Gitlin, N; Howell, C; Jeffers, LJ; Kowdley, K; McHutchison, JG; ... Zhu,
Y (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.This is constructed from limited available data and may be imprecise. To cite this
article, please review & use the official citation provided by the journal.
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Show full item recordScholars@Duke
Andrew Joseph Muir
Professor of Medicine
Hepatitis C
Primary sclerosing cholangitis
Cirrhosis
Liver Transplantation
Clinical Trials
Healthcare disparities in liver disease
Outcomes Research
Julius Middleton Wilder
Assistant Professor of Medicine
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