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Harvoni induces high response rates in genotype 4, 5 HCV
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VIENNA — Patients with genotype 4 and 5 hepatitis C virus benefitted from treatment with Harvoni, according to findings presented at the 2015 International Liver Congress.
Armand Abergel, MD, of Médecine digestive, Chu Estaing at Université d'Auvergne, Clermont Ferrand in France, and colleagues treated more than 80 patients with 12 weeks of Harvoni (ledipasvir/sofosbuvir, Gilead Sciences) at five sites in France. “The cohort was a combination of treatment-naive and treatment-experienced patients,” he said. Half of the cohort had compensated cirrhosis.
Twenty percent of the patients had the cirrhosis, although 30% to 40% of treatment-experienced patients had cirrhosis. The analysis included 44 patients with genotype 4 and 41 patients with genotype 5 disease. There were 22 naive and 22 experienced patients in the genotype 4 arm and 21 naive and 20 experienced patients in the genotype 5 arm included in the final analysis.
The regimen was associated with a 93% 12-week sustained virologic response (SVR12) rate in the genotype 4 group and a 95% SVR12 rate in the genotype 5 group.
When the findings were broken down by treatment history, the range of response was between 91% and 100% for both genotypes regardless of previous treatment status.
“There was no significant difference between naive and experienced patients,” Abergel said.
He added that NS5A resistance-associated variants (RAVs at baseline did not impact SVR12 rates. “No patient had an NS5B RAV at baseline,” he said.
An NS5A RAV and an NS5B RAV emerged in one patient with genotype 4 disease at relapse, while an NS5B variant emerged in one patient with genotype 5 disease.
The most frequently occurring adverse events were fatigue (46%) and headaches (26%).
“The tolerance was good,” Abergel said. – by Rob Volansky
For More Information:
Abergel A, et al. Abstract O056. Presented at: International Liver Congress; April 22-26, 2015; Vienna.
Disclosure: Abergel reports receiving grants from Roche; being a consultant with Gilead, Merck, Roche; and giving sponsored lectures for Bristol-Myers Squibb, Gilead, Janssen and Roche.
Editor's note: This article has been updated with clarifications from the presenter.