Ombitasvir/paritaprevir/r, dasabuvir and ribavirin for cirrhotic HCV patients with thrombocytopaenia and hypoalbuminaemia

Xavier Forns, Fred Poordad, Marcos Pedrosa, Marina Berenguer, Heiner Wedemeyer, Peter Ferenci, Mitchell L. Shiffman, Michael W. Fried, Sandra Lovell, Roger Trinh, Juan Carlos Lopez-Talavera, Gregory Everson

Research output: Contribution to journalArticlepeer-review

13 Scopus citations

Abstract

Background and Aims: Thrombocytopaenia and hypoalbuminaemia are surrogate markers for portal hypertension and hepatic synthetic dysfunction respectively. Patients infected with hepatitis C virus (HCV) with these surrogates have reduced likelihood of sustained virologic response and increased risk for hepatic decompensation or death when treated with peginterferon/ribavirin plus either telaprevir or boceprevir. Methods: We conducted a post-hoc analysis of the TURQUOISE-II clinical trial in patients with cirrhosis to examine the impact of these surrogates on efficacy and safety of ombitasvir/paritaprevir/ritonavir and dasabuvir with ribavirin. Results: Of 380 genotype 1-infected patients in TURQUOISE-II, 104 had either a platelet count <100 × 109/L or albumin <3.5 g/dl. Sustained virologic response rates were 89 and 97% in patients with thrombocytopaenia, and 84 and 89% in patients with hypoalbuminaemia after 12 and 24 weeks of ombitasvir/paritaprevir/ritonavir and dasabuvir with ribavirin respectively. These rates were similar to those observed in the overall study population (92 and 97% for 12 and 24 weeks). HCV genotype 1a-infected patients with thrombocytopaenia or hypoalbuminaemia had higher response rates when treated for 24 weeks, whereas only 1 of 35 genotype 1b patients did not achieve a sustained virologic response. Adverse event rates and discontinuations because of adverse events were low. Conclusions: The findings of these analyses support the use of ombitasvir/paritaprevir/ritonavir and dasabuvir with ribavirin in these subpopulations with cirrhosis. Genotype 1a-infected patients with indicators of portal hypertension may benefit from a 24-week treatment duration.

Original languageEnglish (US)
Pages (from-to)2358-2362
Number of pages5
JournalLiver International
Volume35
Issue number11
DOIs
StatePublished - Nov 2015

Keywords

  • Direct-acting antiviral agents
  • Hepatitis C virus
  • Portal hypertension
  • TURQUOISE-II

ASJC Scopus subject areas

  • Hepatology

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