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Ombitasvir/paritaprevir/r, dasabuvir and ribavirin for cirrhotic HCV patients with thrombocytopaenia and hypoalbuminaemia
Author(s) -
Forns Xavier,
Poordad Fred,
Pedrosa Marcos,
Berenguer Marina,
Wedemeyer Heiner,
Ferenci Peter,
Shiffman Mitchell L.,
Fried Michael W.,
Lovell Sandra,
Trinh Roger,
LopezTalavera Juan Carlos,
Everson Gregory
Publication year - 2015
Publication title -
liver international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.873
H-Index - 110
eISSN - 1478-3231
pISSN - 1478-3223
DOI - 10.1111/liv.12931
Subject(s) - ombitasvir , paritaprevir , dasabuvir , ritonavir , medicine , ribavirin , gastroenterology , boceprevir , telaprevir , hepatitis c , population , hepatitis c virus , immunology , viral load , virus , environmental health , antiretroviral therapy
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.