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Gastroenterology. 2016 Jun;150(7):1590-1598. doi: 10.1053/j.gastro.2016.02.078. Epub 2016 Mar 11.

Efficacy of Direct-Acting Antiviral Combination for Patients With Hepatitis C Virus Genotype 1 Infection and Severe Renal Impairment or End-Stage Renal Disease.

Author information

1
Division of Gastroenterology/Hepatology, Scripps Clinic and Scripps Translational Science Institute, La Jolla, California.
2
Division of Gastroenterology and Hepatology, University of Pennsylvania, Philadelphia, Pennsylvania.
3
The Liver Institute at Methodist Dallas, Dallas, Texas.
4
Infectious Disease Development, AbbVie Inc, North Chicago, Illinois.
5
Medical Associates Research Group, San Diego, California.
6
Division of Infectious Diseases and Gastroenterology/Hepatology, Johns Hopkins University, Baltimore, Maryland.
7
Division of Gastroenterology, North Shore University Hospital, Manhasset, New York.
8
Global Pharmaceutical Development, AbbVie Inc, North Chicago, Illinois.
9
Statistics and Computer Sciences, AbbVie Inc, North Chicago, Illinois.
10
Clinical Pharmacokinetics, AbbVie Inc, North Chicago, Illinois.
11
Department of Gastroenterology, The Texas Liver Institute, University of Texas Health Science Center, San Antonio, Texas. Electronic address: lawitz@txliver.com.

Abstract

BACKGROUND & AIMS:

Although hepatitis C virus (HCV) infection is common in patients with end-stage renal disease, highly efficacious, well-tolerated, direct-acting antiviral regimens have not been extensively studied in this population. We investigated the safety and efficacy of ombitasvir co-formulated with paritaprevir and ritonavir, administered with dasabuvir (with or without ribavirin) in a prospective study of patients with stage 4 or 5 chronic kidney disease (CKD).

METHODS:

We performed a single-arm, multicenter study of treatment-naïve adults with HCV genotype 1 infection, without cirrhosis and with CKD stage 4 (estimated glomerular filtration rate, 15-30 mL/min/1.73 m(2)) or stage 5 (estimated glomerular filtration rate, <15 mL/min/1.73 m(2) or requiring hemodialysis). Twenty patients were given ombitasvir co-formulated with paritaprevir and ritonavir, administered with dasabuvir for 12 weeks. Patients with HCV genotype 1a infections also received ribavirin (n = 13), whereas those with genotype 1b infection did not (n = 7). The primary end point was sustained virologic response (serum HCV RNA <25 IU/mL) 12 weeks after treatment ended (SVR12). We collected data on on-treatment adverse events (AEs), serious AEs, and laboratory abnormalities.

RESULTS:

All 20 patients completed 12 weeks of treatment. Eighteen of the 20 patients achieved SVR12 (90%; 95% confidence interval: 69.9-97.2). One patient death after the end of the treatment (unrelated to the treatment) and 1 relapse accounted for the 2 non-SVRs. Adverse events were primarily mild or moderate, and no patient discontinued treatment due to an AE. Four patients experienced serious AEs; all were considered unrelated to treatment. Ribavirin therapy was interrupted in 9 patients due to anemia; 4 received erythropoietin. No blood transfusions were performed.

CONCLUSIONS:

In a clinical trial, the combination of ombitasvir, paritaprevir, and ritonavir, administered with dasabuvir, led to an SVR12 in 90% of patients with HCV genotype 1 infection and stage 4 or 5 CKD. The regimen is well tolerated, though RBV use may require a reduction or interruption to manage anemia. ClinicalTrials.gov ID NCT02207088.

KEYWORDS:

NS3/4A Protease Inhibitor; NS5A Inhibitor; RUBY-I; Renal Disease

PMID:
26976799
DOI:
10.1053/j.gastro.2016.02.078
[Indexed for MEDLINE]
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