ABSTRACT
Background: The present study aimed at evaluation of changes in estimated glomerular filtration rate (eGFR) among chronic Hepatitis C virus (HCV) patients with chronic kidney disease (CKD) Stages 3–5 who were treated with 12 weeks of ritonavir-boosted paritaprevir, ombitasvir plus ribavirin.
Methods: Changes in renal functions were compared across follow up time points (baseline, SVR4, and SVR8). Data on on-treatment adverse events (AEs), serious AEs, laboratory abnormalities, treatment discontinuation were collected.
Results: 171 patients were included (females 35%, mean age 53 years). 29 patients had liver cirrhosis. The most common etiologies of CKD were diabetes and/or hypertension (n = 67). All included patient reached the end of treatment (EOT) with no treatment discontinuations. The overall EOT response was 100%. 122/122 (100%) patients who reached 4 weeks post-treatment have achieved SVR4, and 80/80 (100%) have achieved SVR12. No reported SAEs. Ribavirin therapy was interrupted in 25% (43/171) of patients due to anemia; 16 patients required blood transfusions. The median eGFR improved from 33.5 (15) mL/min/1.73 m2 at baseline to 35 (36) mL/min/1.73 m2 at SVR8 (p = 0.0003).
Conclusions: The use of ombitasvir, paritaprevir, and ritonavir for treatment of HCV-infected patients with advanced renal disease was safe and effective, moreover, it was associated with significantly improved eGFR.
Author contributions
M. Said, Y. Saad, K. El Saeed, M. El Serafy and Y. El Shazly planned the study. H. Dabes and S. Hamed attended patients follow up visits and collected patient data. Z. Soliman did the statistical analysis. H. Omar and M. Said drafted the manuscript, the revisions, and the response to reviewers. All authors contributed equally in manuscript revision and editing. M. Said is responsible for the overall content as guarantor. All authors revised and approved the final version of this work.
Declaration of interest
The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
Reviewer disclosures
A reviewer on this manuscript has disclosed that they have served as a consultant for Abbvie; MSD; Gilead and Janssen.