High Efficacy of ombitasvir/paritaprevir/ritonavir plus dasabuvir in hepatitis C genotypes 4 and 1–infected patients with severe chronic kidney disease. (31st March 2018)

• Record Type: Journal Article
• Authors: 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.
• Is Part Of: Liver international. Volume 38:Number 8(2018)
• Page Start: 1395
• Page End: 1401
• Publication Date: 2018-03-31
• Subjects: chronic kidney disease -- genotype 4 -- hepatitis C virus -- ombitasvir -- paritaprevir; Liver -- Periodicals; Liver -- Diseases -- Periodicals; 616.362
• DOI: 10.1111/liv.13674
• Languages: English
• ISSNs: 1478-3223

Abstract

Abstract: 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 GT1 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 GT1‐ and 4‐infected patients. Methods: In this observational cohort (n = 67), we enrolled stages 4‐5 CKD treatment‐naïve or Peginterferon/RBV‐experienced GT4‐infected patients (n = 32) treated for 12‐24 weeks with OBV/PTV/r ± RBV, and plus DSV in GT1 patients (n = 35, including 3 with GT1/4 co‐infection). RBV was dosed by physician discretion between 200 mg weekly and 200 mg daily. Primary endpoints were SVR12, 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 GT4, and 1 with GT1a; and 19.4% were treated without RBV, including 9 GT1, and 4 GT4. Overall, 65 (97.1%) patients achieved SVR12, including 100% of those with a post‐treatment follow‐up (modified ITT analysis). Of the two patients without SVR12, 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 GT4 and GT1 patients with CKD stages 4‐5. SVR12 rates were high regardless of patient characteristics.