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

Autores de IIS La Fe

• María Del Valle Pedrosa Del Moral

  Autor

• 

  Marina Berenguer Haym

  Autor

Participantes ajenos a IIS La Fe

• Forns X
• Poordad F
• Wedemeyer H
• Ferenci P
• Shiffman ML
• Fried MW
• Lovell S
• Trinh R
• Lopez-Talavera JC
• Everson G

Grupos

• Hepatología, Cirugia Hepatobiliopancreática y Trasplantes

Abstract

Background & AimsThrombocytopaenia 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. MethodsWe 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. ResultsOf 380 genotype 1-infected patients in TURQUOISE-II, 104 had either a platelet count <100x10(9)/L or albumin <3.5g/dl. Sustained virologic response rates were 89 and 97% in patients with thrombocytopaenia, and 84 and 89% in patients with hypoalbuminaemia after 12 and 24weeks 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 24weeks). HCV genotype 1a-infected patients with thrombocytopaenia or hypoalbuminaemia had higher response rates when treated for 24weeks, 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. ConclusionsThe 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.

Keywords

• direct-acting antiviral agents; hepatitis C virus; portal hypertension; TURQUOISE-II