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

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 12weeks in patients with HCV genotype 1b infection and compensated cirrhosis.

METHODS:

Treatment-naïve and peginterferon/ribavirin treatment-experienced patients received 12weeks of ombitasvir/paritaprevir/ritonavir (25/150/100mg once daily) and dasabuvir (250mgtwicedaily). Key inclusion criteria were hemoglobin ⩾10g/dl, albumin ⩾2.8g/dl, platelet count ⩾25×10(9)/L, creatinine clearance ⩾30ml/min, and Child-Pugh score ⩽6. Efficacy was assessed by the percentage of patients achieving SVR (HCV RNA <25IU/ml) 12weeks 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 <90×10(9)/L, and 17% with albumin <3.5g/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 12weeks 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.

• Authors: 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
• Journal: Journal of hepatology (J Hepatol) Vol. 64 Issue 2 Pg. 301-307 (Feb 2016) ISSN: 1600-0641 [Electronic] Netherlands
• PMID: 26476290 (Publication Type: Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2015 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

Chemical References

• Anilides
• Antiviral Agents
• Carbamates
• Cyclopropanes
• Drug Combinations
• Lactams, Macrocyclic
• Macrocyclic Compounds
• Sulfonamides
• ombitasvir
• Ribavirin
• Uracil
• Proline
• 2-Naphthylamine
• dasabuvir
• Valine
• Ritonavir
• paritaprevir

Topics

• 2-Naphthylamine
• Adult
• Aged
• Anilides (administration & dosage, adverse effects)
• Antiviral Agents (administration & dosage, adverse effects)
• Carbamates (administration & dosage, adverse effects)
• Cyclopropanes
• Drug Administration Schedule
• Drug Combinations
• Drug Resistance, Viral
• Drug Therapy, Combination (methods)
• Female
• Genotype
• Hepacivirus (genetics)
• Hepatitis C, Chronic (complications, drug therapy, virology)
• Humans
• Lactams, Macrocyclic
• Liver Cirrhosis (complications, drug therapy, virology)
• Macrocyclic Compounds (administration & dosage, adverse effects)
• Male
• Middle Aged
• Proline (analogs & derivatives)
• Ribavirin (administration & dosage, adverse effects)
• Ritonavir (administration & dosage, adverse effects)
• Sulfonamides (administration & dosage, adverse effects)
• Sustained Virologic Response
• Treatment Outcome
• Uracil (administration & dosage, adverse effects, analogs & derivatives)
• Valine