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High Efficacy of ombitasvir/paritaprevir/ritonavir plus dasabuvir in hepatitis C genotypes 4 and 1–infected patients with severe chronic kidney disease
Author(s) -
Sanai Faisal M.,
Alghamdi Abdullah S.,
Afghani Ahmad A.,
Alswat Khalid,
AlZanbagi Adnan,
Alghamdi Mosfer N.,
AlMousa Abdallah,
Aseeri Mohammed,
Assiri Abdullah M.,
Babatin Mohamed A.
Publication year - 2018
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.13674
Subject(s) - ombitasvir , paritaprevir , dasabuvir , ritonavir , medicine , gastroenterology , kidney disease , ribavirin , hepatitis c virus , immunology , viral load , virus , antiretroviral therapy
Background & Aims Limited data have shown high efficacy of co‐formulated ombitasvir/paritaprevir/ritonavir ( OBV / PTV /r) in the treatment of hepatitis C virus ( HCV ) genotype ( GT )‐4, and combined with dasabuvir ( DSV ) in GT 1 patients, with chronic kidney disease ( CKD ) stages 4‐5 (<30 mL/min/1.73 m 2 ). We assessed real‐world safety and efficacy of OBV / PTV /r ± DSV in GT 1‐ and 4‐infected patients. Methods In this observational cohort (n = 67), we enrolled stages 4‐5 CKD treatment‐naïve or Peginterferon/ RBV ‐experienced GT 4‐infected patients (n = 32) treated for 12‐24 weeks with OBV / PTV /r ± RBV , and plus DSV in GT 1 patients (n = 35, including 3 with GT 1/4 co‐infection). RBV was dosed by physician discretion between 200 mg weekly and 200 mg daily. Primary endpoints were SVR 12, calculated on intention‐to‐treat ( ITT ) basis, and occurrence of serious adverse events. Results The mean age of the cohort was 45.7 ± 12.7 years, 50.7% were females, 20.9% had cirrhosis, 35.8% were treatment‐experienced and 97% were on haemodialysis. Three patients (F4) received 24‐week treatment, 2 with GT 4, and 1 with GT 1a; and 19.4% were treated without RBV , including 9 GT 1, and 4 GT 4. Overall, 65 (97.1%) patients achieved SVR 12, including 100% of those with a post‐treatment follow‐up (modified ITT analysis). Of the two patients without SVR 12, one died from sepsis‐related complications and the other from a myocardial infarction 2 weeks after completing therapy. Grades 3‐4 anaemia occurred in 8.9%. Conclusion A 12‐week regimen of OBV / PTV /r ± DSV with or without RBV is highly effective with a favourable safety profile amongst GT 4 and GT 1 patients with CKD stages 4‐5. SVR 12 rates were high regardless of patient characteristics.