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

Abstract

BACKGROUND & 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 × 10(9)/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.

• Authors: 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
• Journal: Liver international : official journal of the International Association for the Study of the Liver (Liver Int) Vol. 35 Issue 11 Pg. 2358-62 (Nov 2015) ISSN: 1478-3231 [Electronic] United States
• PMID: 26248955 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2015 The Authors. Liver International Published by John Wiley & Sons Ltd.

Chemical References

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

Topics

• 2-Naphthylamine
• Adolescent
• Adult
• Aged
• Anilides (therapeutic use)
• Antiviral Agents (therapeutic use)
• Carbamates (therapeutic use)
• Cyclopropanes
• Drug Resistance, Viral
• Drug Therapy, Combination
• Female
• Genotype
• Hepacivirus (genetics)
• Hepatitis C, Chronic (complications, drug therapy)
• Humans
• Hypertension, Portal (physiopathology)
• Hypoalbuminemia (drug therapy)
• Lactams, Macrocyclic
• Liver Cirrhosis (virology)
• Macrocyclic Compounds (therapeutic use)
• Male
• Middle Aged
• Proline (analogs & derivatives)
• Ribavirin (therapeutic use)
• Sulfonamides (therapeutic use)
• Thrombocytopenia (drug therapy)
• Treatment Outcome
• Uracil (analogs & derivatives, therapeutic use)
• Valine
• Young Adult