Sustained virologic response of 100% in HCV genotype 1b patients with cirrhosis receiving ombitasvir/paritaprevir/r and dasabuvir for 12 weeks

Jordan J. Feld, Christophe Moreno, Roger Trinh, Edward Tam, Stefan Bourgeois, Yves Horsmans, Magdy Elkhashab, David E. Bernstein, Ziad Younes, Robert W. Reindollar, Lois Larsen, Bo Fu, Kevin Howieson, Akshanth R. Polepally, Andreas Pangerl, Nancy S. Shulman, Fred Poordad

Research output: Contribution to journalArticlepeer-review

134 Scopus citations

Abstract

Background & Aims Patients with chronic hepatitis C virus (HCV) infection and cirrhosis have a higher risk for liver-related complications and have historically been more difficult to cure than patients without cirrhosis. We evaluated the safety and efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir, without ribavirin, for 12 weeks in patients with HCV genotype 1b infection and compensated cirrhosis. Methods Treatment-naïve and peginterferon/ribavirin treatment-experienced patients received 12 weeks of ombitasvir/paritaprevir/ritonavir (25/150/100 mg once daily) and dasabuvir (250 mg twice daily). Key inclusion criteria were hemoglobin ≥10 g/dl, albumin ≥2.8 g/dl, platelet count ≥25 × 109/L, creatinine clearance ≥30 ml/min, and Child-Pugh score ≤6. Efficacy was assessed by the percentage of patients achieving SVR (HCV RNA <25 IU/ml) 12 weeks post-treatment (SVR12). Efficacy and safety were assessed in all patients receiving study drug. Results Sixty patients with HCV genotype 1b infection and cirrhosis received treatment. The study population comprised 62% male, 55% treatment-experienced, 83% with IL28B non-CC genotype, 22% with platelet count <90 × 109/L, and 17% with albumin <3.5 g/dl. All 60 patients completed treatment, and SVR12 was achieved in 100% (95% CI, 94.0-100%) of patients. The most common adverse events were fatigue (22%), diarrhea (20%), and headache (18%). Only one patient (1.7%) experienced a serious adverse event. Laboratory abnormalities were infrequently observed and not clinically significant. Conclusions The HCV regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir without ribavirin for 12 weeks achieved 100% SVR12 and was well tolerated in HCV genotype 1b-infected patients with cirrhosis, suggesting that this 12-week ribavirin-free regimen is sufficient in this population.

Original languageEnglish (US)
Pages (from-to)301-307
Number of pages7
JournalJournal of Hepatology
Volume64
Issue number2
DOIs
StatePublished - Feb 1 2016

Keywords

  • 3D
  • Cirrhosis
  • Direct-acting antivirals
  • TURQUOISE-III

ASJC Scopus subject areas

  • Hepatology

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