Treatment of dialysis patients with chronic hepatitis C using pegylated interferon and low-dose ribavirin.
BACKGROUND
No safe and effective therapy exists for chronic hepatitis C in dialysis patients. Available data on the antiviral treatment of hepatitis C in dialysis population is mostly based on standard interferon monotherapy.


OBJECTIVE
We conducted a prospective, cohort trial with combined therapy (pegylated-interferonalpha-2a (135 mcg/week) plus low dose ribavirin (200 mg/day)) for chronic hepatitis C in 15 patients undergoing long-term dialysis. Twelve patients had HCV genotype 1a/1b, three were co-infected with human immunodeficiency virus (HIV), and two had compensated cirrhosis. End-points were sustained viral response and adverse effects.


RESULTS
Sustained virological response was obtained in four patients (including two with HCV genotype 1); the SVR rate was 28.6% (4/14), on an intention-to-treat analysis. One subject with SVR had compensated cirrhosis. All HIV co-infected patients had well controlled HIV and one of them (33%) reached SVR. Seven (50%) of the 14 patients were non-responders, two of which relapsed after discontinuation of therapy. Drop-out rate was 71.4% (10/14). The most frequent side-effect was anemia, which required ribavirin discontinuation in three patients; seven (47%) patients received blood transfusions. Two patients died (week 4 and 14) of causes related to cardiovascular disease, which was frequent in our cohort. Two subjects were hospitalized and discontinued therapy (week 1, and 27).


CONCLUSIONS
Results from this study showed that about one-third of HD patients achieved sustained virological response with pegylated-interferon-alpha-2a plus low-dose ribavirin; however, tolerance to antiviral treatment was unsatisfactory. Well- controlled HIV infection should not be a contraindication to HCV therapy in dialysis patients. Prospective, controlled clinical trials of combined antiviral therapy targeted at HCV in chronic kidney disease population are indicated.
Carriero
D
D
Division of Liver Diseases, Mount Sinai Medical Center and School of Medicine, New York City, USA.
Fabrizi
F
F
Uriel
A J
AJ
Park
J
J
Martin
P
P
Dieterich
D T
DT
D000328:Adult; D000368:Aged; D044966:Anti-Retroviral Agents / Q000627:therapeutic use; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy; D016174:Hepacivirus / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D010352:Patient Dropouts; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins; D012008:Recurrence; D006435:Renal Dialysis; D051437:Renal Insufficiency / Q000150:complications / Q000628:therapy*; D012254:Ribavirin / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load
D044966:Anti-Retroviral Agents; D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C100416:peginterferon alfa-2a